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August 10, 2022

Cend Therapeutics and Prospective Merger Partner Caladrius Biosciences Announce Collaboration Agreement with Roche to Evaluate CEND-1 in Combination with Immunotherapy to Treat Pancreatic Cancer

SAN DIEGO, CA and BASKING RIDGE, NJ, Aug. 10, 2022 — Cend Therapeutics, Inc. (“Cend”) and Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius”), today announced Cend’s execution of a collaboration agreement with F. Hoffmann-La Roche Ltd. (“Roche”) to evaluate Cend’s lead investigational drug, CEND-1, in combination with atezolizumab (Tecentriq®), Roche’s PD-L1 checkpoint inhibitor, along with standard-of-care chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma (“mPDAC”). Under the terms of the agreement, Roche will be responsible for operational management of the trial while Cend and Roche share equally in the costs of the CEND-1 treatment arms in the study.

“We are extremely pleased to work with Roche, a global leader in oncology, to explore the potential of CEND-1 in combination with chemotherapy and immunotherapy for the treatment of pancreatic cancer,” stated David Slack, Chief Executive Officer of Cend. “We are committed to exploring applications of CEND-1 to improve clinical outcomes for patients with this deadly disease. This collaboration represents a desire to explore a novel combination that may enable immunotherapy to benefit pancreatic cancer patients, who, to date, have not benefited broadly from this important emerging class of anti-cancer treatments.”

“We are truly delighted to report progress regarding the development of CEND-1 supported by our collaboration agreement with Cend. Caladrius’ commitment of resources, including its investment in Cend, provide support for this collaboration. We are excited to work with Roche as Caladrius and Cend combine to form Lisata Therapeutics,” stated David Mazzo, Ph.D., Chief Executive Officer of Caladrius. “We hope that this collaboration is the harbinger of many similar collaborations with other partners as we work to expand the application of CEND-1 across different tumor types and in combination with different anti-cancer agents.”

Phase 1b clinical results with Cend’s investigational drug, CEND-1, in combination with standard-of-care chemotherapy regimen of gemcitabine and nab-paclitaxel, have been previously reported and recently published in Lancet Gastroenterology and Hepatology (https://www.thelancet.com/journals/langas/article/PIIS2468-1253(22)00197-2/fulltext). Additionally, a controlled Phase 2b clinical trial of the CEND-1/gemcitabine/nab-paclitaxel regimen in first-line mPDAC recently has been initiated and plans for treatment combinations in Phase 1b/2 clinical trials in additional solid tumor indications are being actively planned.

About Morpheus Phase 1b/2 study of CEND-1 in combination with Atezolizumab in mPDAC

The co-funded evaluation of CEND-1 in combination with atezolizumab will be conducted as part of Roche’s Morpheus Platform. The Morpheus Platform is a collection of Phase 1b/2 clinical trials in multiple high unmet need cancer indications including pancreatic cancer, designed to assess safety and early efficacy to enable more rapid and efficient development of novel cancer immunotherapy combinations.

The trial including CEND-1 will be a Phase 1b/2, open-label, randomized, multi-national study in patients with first-line mPDAC. It will add Roche’s anti-PD-L1 (programmed death ligand-1) checkpoint inhibitor drug, atezolizumab, to the CEND-1/gemcitabine/nab-paclitaxel regimen. The study includes three arms to compare the atezolizumab/CEND-1/gemcitabine/nab-paclitaxel versus CEND-1/gemcitabine/nab-paclitaxel regimen or gemcitabine/nab-paclitaxel alone and will be conducted at sites across the United States as well as in Germany, Spain and South Korea.

About Pancreatic Cancer

Pancreatic cancer is the third leading cause of cancer-related death with very poor five-year survival. Globally, pancreatic cancer accounts for over 430,000 deaths each year, including over 48,000 in the United States. Pancreatic ductal adenocarcinoma (PDAC) is characterized by marked desmoplasia that creates a dense capsule or stroma around the tumor that contributes to drug resistance due, in part, to poor anti-cancer drug delivery to tumor tissue.

About CEND-1

CEND-1 is an investigational drug that modifies the tumor microenvironment. It is targeted to tumor vasculature by its affinity for alpha-v integrins that are selectively expressed in tumor but not healthy tissue vasculature. CEND-1 is a cyclic peptide that, once bound to these integrins, is cleaved by proteases expressed in the tumor microenvironment to release a peptide fragment, called a CendR fragment, which binds to a second receptor, neuropilin-1, to activate a novel uptake pathway (the CendR pathway) that allows anti-cancer drugs to penetrate solid tumors. The ability of CEND-1 to modify the tumor microenvironment to enhance delivery and efficacy of co-administered drugs has been demonstrated in models of a range of solid tumors. CEND-1 has also been shown in animal models of pancreatic and other cancers to alter the tumor microenvironment to decrease immunosuppression selectively within the tumor, which may enable a patient’s immune system and immunotherapies to fight cancer with greater effectiveness.

About Cend Therapeutics

Cend is a privately held, clinical-stage drug discovery and development company focused on a novel approach to enable more effective treatments for solid tumor cancers. The CendR Platform™ provides a tumor-targeted tissue penetration capability to specifically enhance drug delivery to tumors. Cend is also applying its technology to alter immunosuppression selectively within the tumor microenvironment to enable a patient’s immune system and immunotherapies to fight cancer with greater effectiveness. For more information on Cend, please visit www.cendrx.com.

About Caladrius Biosciences

Caladrius Biosciences, Inc. is a clinical-stage biopharmaceutical company dedicated to the development of innovative therapies designed to treat or reverse disease. Caladrius’s current product candidates include: XOWNA® (CLBS16), the subject of both a recently completed positive Phase 2a study and an ongoing Phase 2b study (www.freedom-trial.com) in the U.S. for the treatment of coronary microvascular dysfunction (“CMD”); CLBS12 (HONEDRA® in Japan), recipient of a SAKIGAKE designation in Japan and eligible for early conditional approval for the treatment of critical limb ischemia (“CLI”) and Buerger’s disease based on the results of an ongoing clinical trial; and CLBS201, designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for diabetic kidney disease (“DKD”). For more information on Caladrius, please visit www.caladrius.com.

Caladrius recently announced that it has signed a definitive merger agreement with Cend Therapeutics, Inc. (www.cendrx.com) to form Lisata Therapeutics. Upon closing, Lisata will be a publicly-traded company with an advanced clinical development pipeline and strong balance sheet, which is expected to fund development compounds to their next development milestone. The merger is expected to close in the third quarter of 2022.

Contact:

Investors and Media:

Cend Therapeutics, Inc.
David Slack, MBA
President and Chief Executive Officer
info@cendrx.com

Caladrius Biosciences, Inc.
John Menditto
Vice President, Investor Relations and Corporate Communications
Phone: 908-842-0084
Email: jmenditto@caladrius.com

 

July 6, 2022

Cend Therapeutics Announces Publication of Pancreatic Cancer Trial Data in the Lancet Gastroenterology and Hepatology

SAN DIEGO, CA (July 6, 2022) – Cend Therapeutics, Inc. (“Cend”), a privately-held, clinical-stage drug discovery and development company developing a novel approach to enable more effective treatments for solid tumor cancers, today announced that The Lancet Gastroenterology and Hepatology published data from the Phase 1b study of CEND-1, Cend’s lead investigational drug, in combination with gemcitabine and nab-paclitaxel for the treatment of first-line, metastatic pancreatic ductal adenocarcinoma (“mPDAC”). The study was published online on July 5, 2022, and can be accessed by visiting https://www.thelancet.com/journals/langas/article/PIIS2468-1253(22)00167-4/fulltext.

The publication details the results of an open-label, multi-center, Phase 1 trial conducted in 31 patients in the safety population and 29 patients in the efficacy population. The objectives of the study were to determine the safety, tolerability, pharmacokinetics, and preliminary efficacy of CEND-1 in combination with gemcitabine and nab-paclitaxel in patients with mPDAC.

“Pancreatic cancer has always been one of the most difficult tumors to treat. The protective meshwork, or tumor stroma, that surrounds the cancer cells has proved a difficult barrier for chemotherapy drugs to penetrate.  In this first-in-human study using the new treatment modality, it appears that CEND-1 may overcome this barrier, and although the sample size was small, we were extremely excited to see such a significant response rate and prolonged progression-free survival with a number of long-term survivors,” said Andrew Dean, M.D., lead investigator at the St. John of God Hospital, Subiaco, Australia. “I believe CEND-1 has the potential to provide a substantial benefit as part of a combination treatment and look forward to the results of the ongoing expansion studies.”

“We are proud to have the very encouraging results of our Phase 1b study of CEND-1 in pancreatic cancer published in a prestigious peer-reviewed journal,” stated Harri Järveläinen, Chief Operating Officer of Cend. “These results reinforce our belief that CEND-1 could become a transformative new medicine for the treatment of pancreatic cancer and other difficult-to-treat solid tumor cancers.”

The data in the publication expand on the preliminary findings presented at the 2020 European Society for Medical Oncology (ESMO) Congress. Importantly, the new results suggest a potential for marked and durable improvement in treatment effectiveness in combination with standard-of-care (“SoC”) drugs for mPDAC. Principal results include:

  • CEND-1 was well-tolerated; no dose-limiting toxicities were identified; safety of the combination was consistent with SoC alone
  • Pharmacokinetic profile in the target range that is associated with optimal efficacy
  • Median Progression-Free Survival 9.7 months
  • Median Overall Survival 13.2 months (after extended follow-up of patients continuing treatment)
  • Overall Response Rate (Partial Response (PR) + Complete Response (CR)) 59%
  • Disease Control Rate at 16 weeks 90%
  • CA19-9 circulating tumor biomarker reductions of 50% or greater in 91% of patients

About CEND-1

CEND-1 is an investigational drug that modifies the tumor microenvironment. It is targeted to tumor vasculature by its affinity for alpha-v integrins that are selectively expressed in tumor, but not healthy tissue vasculature. CEND-1 is a cyclic peptide that, once bound to these integrins, is cleaved by proteases expressed in tumors to release a peptide fragment, called a CendR fragment, which binds to a second receptor, called neuropilin-1, to activate a novel uptake pathway that allows anticancer drugs to more selectively penetrate solid tumors. The ability of CEND-1 to modify the tumor microenvironment to enhance delivery and efficacy of co-administered drugs has been demonstrated in models of a range of solid tumors.

About Cend Therapeutics

Cend is a privately held, clinical-stage drug discovery and development company focused on a novel approach to enable more effective treatments for solid tumor cancers. The CendR Platform™ provides a tumor-targeted tissue penetration capability to specifically enhance drug delivery to tumors. Cend is also applying its technology to alter immunosuppression selectively within the tumor microenvironment to enable a patient’s immune system and immunotherapies to fight cancer with greater effectiveness.  For more information on Cend, please visit www.cendrx.com.

Cend recently announced that it has signed a definitive merger agreement with Caladrius Biosciences, Inc. (www.caladrius.com) to form Lisata Therapeutics.  Upon closing, Lisata will be a publicly-traded company with an advanced clinical development pipeline and a cash balance expected to fund development compounds to their next development milestone.  The merger is expected to close in the third quarter of 2022.

About Caladrius Biosciences

Caladrius Biosciences, Inc. is a clinical-stage biopharmaceutical company dedicated to the development of innovative therapies designed to treat or reverse disease. We currently are developing first-in-class autologous cell therapy products based on the finely tuned mechanisms for self-repair that exist in the human body. Our technology leverages and enables these mechanisms in the form of specific cells, using formulations and modes of delivery unique to each medical indication.

 

June 9, 2022

Cend Therapeutics Announces First Patient Treated in Phase 2b Trial of CEND-1 led by Australasian Gastro-Intestinal Trials Group

SAN DIEGO, CA (June 9, 2022) – Cend Therapeutics, Inc. (“Cend”) today announced that the first patient has been treated in the Phase 2b study of CEND-1, Cend’s lead investigational drug, in patients with first-line metastatic pancreatic ductal adenocarcinoma.

The ASCEND trial is a 125-patient, double-blind, randomized, placebo-controlled clinical trial is being conducted at up to 40 sites in Australia and New Zealand  designed and led by the Australasian Gastro-Intestinal Trials Group (“AGITG”) in collaboration with the NHMRC Clinical Trial Centre at the University of Sydney. Cend will provide funding, study drug and regulatory support.

“Building on the encouraging safety and antitumor activity in pancreatic cancer patients in Phase 1b, this trial represents an important next step in advancing this potentially meaningful new treatment approach to benefit pancreatic cancer patients,” said Andrew Dean, MD, Principal Investigator for the study.

“Dosing the first patient in our Phase 2b trial represents a significant accomplishment for our team as we have worked diligently to achieve this milestone,” stated Harri Järveläinen, Chief Operating Officer of Cend. “Pancreatic cancer has one of the highest mortality rates of all cancers and affects tens of thousands of patients each year. While progress has been made in understanding and treating pancreatic cancer, more effective treatments are needed. We are thrilled at the progress being made to help move CEND-1 forward in the clinical trial process for the potential benefit of patients with pancreatic cancer. We are thankful to AGITG, for conducting this study.”

About CEND-1

CEND-1 is an investigational drug that modifies the tumor microenvironment. It is targeted to tumor vasculature by its affinity for alpha-v integrins that are selectively expressed in tumor, but not healthy tissue vasculature. CEND-1 is a cyclic peptide that, once bound to these integrins, is cleaved by proteases expressed in tumors to release a peptide fragment, called a CendR fragment, which binds to a second receptor, called neuropilin-1, to activate a novel uptake pathway that allows anticancer drugs to more selectively penetrate solid tumors. The ability of CEND-1 to modify the tumor microenvironment to enhance delivery and efficacy of co-administered drugs has been demonstrated in models of a range of solid tumors.

About Cend Therapeutics

Cend is a privately held, clinical-stage drug discovery and development company focused on a novel approach to enable more effective treatments for solid tumor cancers. The CendR Platform™ provides a tumor-targeted tissue penetration capability to specifically enhance drug delivery to tumors. Cend is also applying its technology to alter immunosuppression selectively within the tumor microenvironment to enable a patient’s immune system and immunotherapies to fight cancer with greater effectiveness.  For more information on Cend, please visit www.cendrx.com.

The Company recently announced that it has signed a definitive merger agreement with Caladrius Biosciences, Inc. (NASDAQ: CLBS and www.caladrius.com).  The merger is expected to close in the third quarter of 2022.

About Caladrius Biosciences

Caladrius Biosciences, Inc. is a clinical-stage biopharmaceutical company dedicated to the development of innovative therapies designed to treat or reverse disease. We currently are developing first-in-class autologous cell therapy products based on the finely tuned mechanisms for self-repair that exist in the human body. Our technology leverages and enables these mechanisms in the form of specific cells, using formulations and modes of delivery unique to each medical indication.

May 26, 2022

Caladrius Biosciences and Cend Therapeutics Announce Poster Presentation at the 2022 American Society of Clinical Oncology Annual Meeting

Poster Presentation to highlight ongoing clinical study of CEND-1 with FOLFIRINOX-based therapies in pancreatic, colorectal and appendiceal cancers.

BASKING RIDGE, N.J. and SAN DIEGO, CA (May 26, 2022) – Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”), a clinical-stage biopharmaceutical company dedicated to the development of innovative therapies designed to treat or reverse disease, and Cend Therapeutics, Inc. (“Cend”), a privately-held, clinical-stage biopharmaceutical company focused on a novel approach to enable more effective treatments for solid tumor cancers, under their joint development agreement as part of their recently announced pending merger, today announced that data highlighting the ongoing clinical Phase 1b/2b study of CEND-1 in combination with neoadjuvant FOLFIRINOX-based therapies in pancreatic, colorectal, and appendiceal cancers will be presented at the American Society of Clinical Oncology (“ASCO”) Annual Meeting, being held from June 3–7, 2022 in Chicago, Illinois.

Details of the presentation are as follows:

  • Abstract Title: Phase Ib/IIa trial of CEND‐1 in combination with neoadjuvant FOLFIRINOX-based therapies in pancreatic, colorectal, and appendiceal cancers (CENDIFOX)
  • Abstract Number: 384156
  • Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
  • Session Type: Poster Session
  • Presenter: Anup Kumar Kasi, MD, MPH, University of Kansas Medical Center
  • Presentation Date & Time: Saturday, June 4th at 8:00am – 11:00am (CDT)

The full abstract will be released on May 26, 2022 at 5:00 PM (EDT). For more information about the 2022 ASCO Annual Meeting, please visit conferences.asco.org.

May 23, 2022

Cend Therapeutics, together with prospective merger partner Caladrius Biosciences, to present at the HC Wainwright Global Investment Conference

Cend CEO, David Slack, and prospective merger partners from Caladrius Biosciences (Press Release here) will be at the HC Wainwright Global Investment conference in Miami May 23-26.

April 27, 2022

Caladrius Biosciences and Cend Therapeutics Announce Definitive Merger Agreement 

Combined company to be renamed Lisata Therapeutics upon transaction closing

Combination will create a financially sound Nasdaq-listed company with a diverse product development pipeline, strong existing partnerships and potential for future attractive partnerships

Lisata to combine development pipelines from both companies with an emphasis on advancing Cend’s CendR Platform™ technology products in a range of solid tumor oncology indications

The merged company projects a number of potential value-creating data and business development milestones over the next 24 months

Caladrius to make an immediate investment of $10 million in Cend in connection with a development collaboration agreement to maintain development momentum of the Cend pipeline

Caladrius Management will host a conference call today at 8:30 a.m. Eastern Time

BASKING RIDGE, N.J. and SAN DIEGO, CA (April 27, 2022) – Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”), a clinical-stage biopharmaceutical company dedicated to the development of innovative therapies designed to treat or reverse disease, and Cend Therapeutics, Inc. (“Cend”), a privately-held, clinical-stage biotechnology company focused on a novel approach to enable more effective treatments for solid tumor cancers, today announced that the companies have entered into a definitive merger agreement under which Cend will merge with a wholly owned subsidiary of Caladrius in an all-stock approximate “merger of equals” transaction unanimously approved by the Boards of Directors of each company. Following closing, the combined company will be renamed Lisata Therapeutics, Inc. (“Lisata”) and will trade on the Nasdaq under the ticker symbol “LSTA”. The merger is currently expected to close in the third quarter of 2022 subject to the approval of Caladrius and Cend stockholders as well as the satisfaction of certain other customary closing conditions and applicable approvals.

“As we communicated to our shareholders frequently over the last year, Caladrius has been seeking to identify and evaluate strategic development opportunities with the aim of consummating transactions that will deliver additional value to our shareholders beyond our current development pipeline. After a comprehensive review of available opportunities and with the aid of specialized consultants, we concluded that a merger with Cend provides Caladrius shareholders with an attractive opportunity for potential value creation by immediately expanding and diversifying our development portfolio,” stated David J. Mazzo, PhD, President and CEO of Caladrius. “We believe that Cend’s technology has the potential to deliver novel and improved treatments in patients with solid tumor cancers with a lead program in pancreatic cancer that already has shown great promise based on early clinical data. Furthermore, we expect that the complementarity of expertise, experience, and resources between the two companies will accelerate the development and availability to patients of this innovative and potentially important new cancer treatment.”

“Our team has spent the past several years developing and advancing a novel and differentiated approach to treat solid tumor cancers. The CendR Platform™ provides a targeted tissue penetration capability which is designed to specifically enhance drug delivery to solid tumors. Cend’s lead investigational drug, CEND-1, has been combined with other anticancer products to potentially enable more effective treatment of difficult to treat solid tumor cancers,” said David Slack, CEO of Cend. “For us, an attractive aspect of this business combination is the addition of Caladrius’ development team, which has experience and expertise in a diverse array of therapeutic areas, including oncology. We are excited to be working together to improve outcomes for cancer patients.”

Following the closing of the merger, Lisata is expected to advance CEND-1 as its lead product candidate in a variety of difficult to treat solid tumor applications, including pancreatic ductal adenocarcinoma (PDAC), where the product is being evaluated in ongoing Phase 1 and Phase 2 clinical studies with Cend and its partner in China, Qilu Pharmaceutical. CEND-1 is a proprietary cyclic peptide which undergoes protease mediated cleavage in the tumor microenvironment producing a C-end Rule or “CendR” peptide that potentiates transport across the tumor stroma and improves delivery of anticancer drugs to the tumor. Additional Phase 1b/2 PDAC clinical data is expected as early as 2023. Lisata also plans to initiate an additional trial in PDAC in combination with immunotherapy as well as a trial or trials exploring applications of CEND-1 in other difficult to treat solid tumors, such as hepatocellular, gastric and breast cancers along with additional therapeutic combinations. We see CEND-1’s advancement as supported by compelling Phase 1b data previously presented at the 2020 European Society for Molecular Oncology (ESMO), which not only demonstrated favorable safety and tolerability, but importantly, the potential for marked improvement in treatment effectiveness in combination with standard of care drugs for PDAC. With its unique tumor-targeted, tissue penetrating technology, we believe that the CendR Platform™ holds the potential to enable more effective solid tumor treatment for a range of emerging treatment modalities, including RNA-based drugs. We believe that this could provide Lisata with additional partnering and product opportunities to benefit cancer patients and Lisata shareholders.

About the Proposed Transaction

Under the terms of the definitive merger agreement, David J. Mazzo, Ph.D., current President and CEO of Caladrius will be the Chief Executive Officer of Lisata, David Slack, current President and CEO of Cend, will be Lisata’s President and Chief Business Officer, and Kristen K. Buck, MD, current Executive Vice President of R&D and Chief Medical Officer, will continue in those roles with Lisata. Upon closing, shareholders of Cend will receive approximately 60.5 million shares of Caladrius common stock, subject to certain closing conditions, resulting in the shareholders of each company owning approximately 50% of the combined company. The transaction values each company at $90 million, which for Caladrius represents a 136% premium to its market cap as of the market close on April 26, 2022. At the effective time of the merger, the Board of Directors of Lisata is expected to comprise four directors designated by Caladrius and four directors designated by Cend, with the possibility of one additional independent director, whose appointment will be mutually agreed upon by both Caladrius and Cend.

Conference Call Details:

Date: Wednesday, April 27, 2022
Time: 8:30 a.m. Eastern time
Toll-free Dial-in Number: (866) 595-8403
International Dial-in Number: (706) 758-9979
Conference ID: 4166037

A live webcast along with the accompanying slides, which will be used during the webcast, are immediately available on the Events & Presentations page (https://ir.caladrius.com/news-events/events-presentations) under the Investors & News section of the Caladrius website.
A telephone replay will also be available through May 4, 2022. To access replay, please dial (855) 859-2056 (Domestic) or (404) 537-3406 (International). At the system prompt, please enter the code 4166037 followed by the sign #.

About Caladrius Biosciences

Caladrius Biosciences, Inc. is a clinical-stage biopharmaceutical company dedicated to the development of innovative therapies designed to treat or reverse disease. We are and have been developing first-in-class autologous cell therapy products based on the finely tuned mechanisms for self-repair that exist in the human body. Our technology leverages and enables these mechanisms in the form of specific cells, using formulations and modes of delivery unique to each medical indication.

The Company’s current product candidates include: XOWNA® (CLBS16), the subject of both a recently completed positive Phase 2a study and an ongoing Phase 2b study (www.freedom-trial.com) in the U.S. for the treatment of coronary microvascular dysfunction (“CMD”); CLBS12 (HONEDRA® in Japan), recipient of a SAKIGAKE designation in Japan and eligible for early conditional approval for the treatment of critical limb ischemia (“CLI”) and Buerger’s disease based on the results of an ongoing clinical trial; and CLBS201, designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for diabetic kidney disease (“DKD”). No assurance can be given with respect to the future of these programs. For more information on the Company, please visit www.caladrius.com.

About Cend Therapeutics

Cend is a clinical-stage biotech company focused on a novel approach to enable more effective treatments for solid tumor cancers. The CendR Platform™ provides a tumor-targeted tissue penetration capability to specifically enhance drug delivery to tumors. Cend is also applying its technology to alter immunosuppression selectively within the tumor microenvironment to enable a patient’s immune system and immunotherapies to fight cancer with greater effectiveness. For more information on Cend, please visit www.cendrx.com

Forward-Looking Statements

This communication contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements.  In addition, when or if used in this communication, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict”, “see” and similar expressions and their variants, as they relate to Caladrius, Cend or the management of either company, before or after the aforementioned merger, may identify forward-looking statements. Examples of forward-looking statements include, but are not limited to, statements relating to the timing and completion of the proposed merger; Caladrius’s continued listing on the Nasdaq Capital Market until closing of the proposed merger; the combined company’s listing on the Nasdaq Capital Market after closing of the proposed merger; expectations regarding the capitalization, resources and ownership structure of the combined company; the approach Cend is taking to discover and develop novel therapeutics; the adequacy of the combined company’s capital to support its future operations and its ability to successfully initiate and complete clinical trials; the difficulty in predicting the time and cost of development of Cend’s product candidates; the nature, strategy and focus of the combined company; the executive and board structure of the combined company; and expectations regarding voting by Caladrius’s and Cend’s stockholders. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the risk that the conditions to the closing of the transaction are not satisfied, including the failure to timely or at all obtain stockholder approval for the transaction; uncertainties as to the timing of the consummation of the transaction and the ability of each of Caladrius and Cend to consummate the transaction; risks related to Caladrius’s ability to correctly estimate its operating expenses and its expenses associated with the transaction; the ability of Caladrius or Cend to protect their respective intellectual property rights; unexpected costs, charges or expenses resulting from the transaction; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the transaction; and legislative, regulatory, political and economic developments. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in Caladrius’s Annual Report on Form 10-K filed with the SEC on March 22, 2022. Caladrius can give no assurance that the conditions to the transaction will be satisfied. Except as required by applicable law, Caladrius undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

No Offer or Solicitation

This communication is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities or the solicitation of any vote in any jurisdiction pursuant to the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law.  No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the United States Securities Act of 1933, as amended. Subject to certain exceptions to be approved by the relevant regulators or certain facts to be ascertained, the public offer will not be made directly or indirectly, in or into any jurisdiction where to do so would constitute a violation of the laws of such jurisdiction, or by use of the mails or by any means or instrumentality (including without limitation, facsimile transmission, telephone and the internet) of interstate or foreign commerce, or any facility of a national securities exchange, of any such jurisdiction.

Important Additional Information Will be Filed with the SEC

In connection with the proposed transaction between Caladrius and Cend, Caladrius intends to file relevant materials with the SEC, including a registration statement that will contain a proxy statement and prospectus. CALADRIUS URGES INVESTORS AND STOCKHOLDERS TO READ THESE MATERIALS CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT CALADRIUS, THE PROPOSED TRANSACTION AND RELATED MATTERS.  Investors and shareholders will be able to obtain free copies of the proxy statement, prospectus and other documents filed by Caladrius with the SEC (when they become available) through the website maintained by the SEC at www.sec.gov.  In addition, investors and stockholders will be able to obtain free copies of the proxy statement, prospectus and other documents filed by Caladrius with the SEC by contacting Investor Relations by mail at Attn: Investor Relations, Caladrius Biosciences, Inc., 800 Westchester Avenue, Suite N341, Rye Brook, NY 10573.  Investors and stockholders are urged to read the proxy statement, prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed transaction.

Participants in the Solicitation

Caladrius and Cend, and each of their respective directors and executive officers and certain of their other members of management and employees, may be deemed to be participants in the solicitation of proxies in connection with the proposed transaction. Information about Caladrius’s directors and executive officers is included in Caladrius’s Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 22, 2022 and amended on April 21, 2022.  Additional information regarding these persons and their interests in the transaction will be included in the proxy statement relating to the transaction when it is filed with the SEC. These documents can be obtained free of charge from the sources indicated below.

Contact:

Investors:
Caladrius Biosciences, Inc.
John Menditto
Vice President, Investor Relations and Corporate Communications
Phone: 908-842-0084
Email: jmenditto@caladrius.com

November 16, 2021

Cend Therapeutics Announces First Patient Dosing in Clinical Trial of CEND-1 for the Treatment of Selected Gastrointestinal Cancers

Patient dosing has begun in a Phase 1b/2a clinical trial to evaluate the safety, tolerability and pharmacologic activity of CEND-1 in pancreatic, appendiceal and colon cancers in collaboration with the University of Kansas Cancer Center (KUCC).

This investigator-initiated clinical trial will combine CEND-1 with FORFIRINOX, a standard chemotherapy regimen for all 3 cancer types. In colon cancer patients without a K-RAS mutation, the epidermal growth factor receptor (EGFR) therapeutic antibody, panitumumab, will also be given.

“Encouraging safety and antitumor activity in pancreatic cancer patients were presented at the European Society for Medical Oncology (ESMO) meeting last year with CEND-1 in combination with gemcitabine and nab-paclitaxel as first-line therapy. We are keen to explore how CEND-1 may improve patient outcomes with additional therapeutic combinations in pancreatic and other difficult to treat solid tumors,” said Anup Kasi, MD, MPH, principal investigator for the trial at KUCC.

“This trial is a significant step forward in our goal to establish the safety and efficacy of CEND-1 in a broad range of solid tumors, in combination with a broad range of anti-cancer agents” said Harri Järveläinen, Chief Operating Officer of Cend. “Importantly, the study will enable translational assessments to identify potential indicators and biomarkers of efficacy as well as the ability of CEND-1 to modify the tumor immune microenvironment.”

Cend will continue to to advance CEND-1/gemcitabine/nab-paclitaxel development for first-line, metastatic pancreatic cancer and explore applications of CEND-1 in combination with additional agents, including immunotherapies for additional solid tumor cancer indications.

About CEND-1

CEND-1 is an investigational drug that modifies the tumor microenvironment. It is targeted to tumor vasculature by its affinity for alpha-v integrins that are selectively expressed in tumor, but not healthy tissue vasculature. CEND-1 is a cyclic peptide that, once bound to these integrins, is cleaved by proteases expressed in tumors to release a peptide fragment, called a CendR fragment, which binds to a second receptor, called neuropilin, to activate a novel uptake pathway that allows anticancer drugs to more selectively penetrate solid tumors. The ability of CEND-1 to modify the tumor microenvironment to enhance delivery and efficacy of co-administered drugs has been demonstrated in models of a range of solid tumors.

About Cend Therapeutics

Cend is a clinical-stage biotech company focused on a novel approach to enable more effective treatments for solid tumor cancers. Poor penetration of drugs into tumors is a major issue in cancer therapy as it limits access and therefore efficacy of current therapies. The CendR PlatformÔ provides a targeted tissue penetration capability to specifically enhance drug delivery to tumors. Cend is also applying its technology to alter immunosuppression selectively within the tumor microenvironment to enable a patient’s immune system and immunotherapies to more effectively fight cancer.

June 29, 2021

Cend Therapeutics’ CEND-1 Granted Fast Track Designation for Pancreatic Cancer

San Diego, June 29, 2021 (San Diego, CA) – The US Food and Drug Administration (FDA) has granted Fast Track Development (FTD) status for Cend’s investigational drug, CEND-1, for the first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) in combination with gemcitabine/nab-paclitaxel.

In addition, following encouraging Phase 1b/2 clinical trail results, Cend and collaborators are initiating a controlled Phase 2b clinical trial in mPDAC. CEND-1 was granted Orphan Drug Designation by the FDA for the treatment of pancreatic cancer in January 2019.

“By awarding Fast Track Designation, the FDA has recognized CEND-1’s potential to meaningfully improve outcomes for pancreatic cancer patients,” said Andrew Dorr, MD, Chief Medical Officer of Cend. “FTD is designed to facilitate the development and expedite the review of investigational treatments that demonstrate the potential to address unmet medical needs in serious or life-threatening conditions.”

Cend will also explore applications of CEND-1 in combination with additional agents, including immunotherapies for mPDAC, and plans to expand development into additional solid tumor cancer indications.

About Fast Track Designation

FTD is an FDA process designed to facilitate the development, and expedite the review of, medicines to treat serious conditions and fill unmet medical need. The FDA created this process to help deliver important new drugs to patients earlier, and it covers a broad range of serious illnesses. Fast Track designation can lead to an Accelerated Approval and Priority Review if certain criteria are met.

About Pancreatic Cancer

Pancreatic cancer is the third leading cause of cancer-related death with very poor five-year survival. Globally, pancreatic cancer accounts for over 430,000 deaths each year, including over 48,000 in the US. Pancreatic ductal adenocarcinoma (PDAC) is characterized by marked desmoplasia that creates a dense capsule or stroma surrounding the tumor that contributes to drug resistance due, in part, to poor drug delivery to tumor tissue.

About CEND-1

CEND-1 is an investigational drug that modifies the tumor microenvironment. It is targeted to tumor vasculature by its affinity for alpha-v integrins that are selectively expressed in tumor vasculature but not normally expressed in vasculature of healthy tissues. CEND-1 is a cyclic peptide that, once bound to these integrins, is cleaved by proteases expressed in tumors to release a peptide fragment, called a CendR fragment, which binds to a second receptor, called neuropilin, to activate a novel uptake pathway that causes anticancer drugs to more selectively penetrate solid tumors.

About Cend Therapeutics

Cend is a clinical-stage biotech company focused on a novel approach to enable more effective treatments for solid tumor cancers. Poor penetration of drugs into tumors is a major issue in cancer therapy as it limits access and therefore efficacy of current therapies. The CendR Platform provides a targeted tissue penetration capability to specifically enhance drug delivery to tumors. Cend is also applying its technology to alter immunosuppression selectively within the tumor microenvironment to enable a patient’s immune system and immunotherapies to more effectively fight cancer.

For additional information, please visit www.cendrx.com or contact us via info@cendrx.com.

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February 16, 2021

Cend Therapeutics and Qilu Pharmaceutical Announce Partnership

SAN DIEGO and JINAN, China, Feb. 16, 2021 — Cend Therapeutics, Inc., a clinical-stage biotech company, and Qilu Pharmaceutical, a major Chinese pharmaceutical company, announced today that the companies have entered a Collaboration and License Agreement to develop and commercialize Cend’s investigational drug, CEND-1, in Greater China.

Cend presented favorable clinical results at the European Society for Molecular Oncology (ESMO) meeting September 2020 and is advancing into Phase 2 clinical trials in pancreatic cancer with CEND-1 in combination with gemcitabine and nab-paclitaxel. The Company is planning registration clinical trials in pancreatic cancer and will explore combinations with additional therapies, including immunotherapies, as well as expansion of its programs into additional solid tumor cancers.

“This partnership with Qilu will help us bring our treatment to patients with pancreatic and other solid tumor cancers in China. This collaboration will also speed global development to bring the treatment to market expeditiously. Qilu’s excellent development team and market position will position CEND-1 for success in China,” commented David Slack, CEO of Cend.

“CEND-1 has generated encouraging clinical results in combination with standard of care chemotherapy for the treatment of pancreatic cancer, which remains a significant health issue in China. We are pleased to work with Cend to advance this program and explore broader potential applications for CEND-1,” commented Oliver Kong, MD, Chief Medical Officer and Corporate Vice President of Qilu.

About the Qilu-Cend Partnership

In the Collaboration and License Agreement, Qilu will gain exclusive rights to CEND-1 in Greater China, including Taiwan, Hong Kong and Macau. Qilu will take on development as well as commercialization responsibilities within Greater China. Cend will continue to retain all rights outside of Greater China. Qilu will pay Cend an up-front license fee of US$10 million. Cend will be eligible to receive up to $225 million in milestones as well as tiered double digit royalties on product sales in the region.

About CEND-1

CEND-1 is an investigational drug that modifies the tumor microenvironment. It is targeted to tumors by its affinity for alpha-v integrins, which are selectively expressed in tumors but not normally expressed in healthy tissues. CEND-1 is a cyclic peptide that, once bound to these integrins, is cleaved by protease expressed in tumors to release a peptide fragment, called a CendR fragment, which binds to a second receptor, called neuropilin, to activate a novel uptake pathway that causes anticancer drugs to more selectively penetrate solid tumors. CEND-1 has also been shown to further modify the tumor microenvironment by selectively depleting tumor-infiltrating immunosuppressive cells, including T regulatory cells, and to increase the number of cancer-fighting immune cells within the tumor, potentially enabling patients’ immune systems or immunotherapies to more effectively fight cancer.

About Qilu Pharmaceutical

Qilu Pharmaceutical is one of the leading vertically integrated pharmaceutical companies in China focusing on the development, manufacturing and marketing of innovative medicines, active pharmaceutical ingredients (APIs) & finished formulations. Qilu currently has 12 subsidiaries, 10 manufacturing sites and over 23,000 employees worldwide. Qilu ranks among the top Chinese pharmaceutical companies by sales revenue in 2019. Dedicated to offering more affordable medicines to the world and improving people’s well-being, Qilu has exported its products to over 80 countries. Qilu has always maintained an innovative development strategy based on unmet medical needs and is achieving its organic growth strategy utilizing a strong pool of 2000+ scientists spread across 5 R&D platforms based in the US (Seattle WA, Boston MA, San Francisco CA) and China (Shanghai, and Jinan). To date, Qilu has launched 200+ products with 30+ products “First to launch” in China and 3 products “D181 launch” in US. The company also has a robust pipeline, including 200+ generic products, 20+ biosimilar products and 50+ innovative products. Qilu’s finished formulations and APIs have been approved by US FDA, European Medicines Agency(EMA), Therapeutic Goods Administration (TGA) of Australia, Medicines and Healthcare products Regulatory Agency (MHRA) of UK, PMDA of Japan and other national regulatory authorities.

About Cend Therapeutics

Cend is a clinical-stage biotech company focused on a novel approach to enable more effective treatments for solid tumor cancers. Poor penetration of drugs into tumors is a major issue in cancer therapy as it limits access and therefore efficacy of current therapies. The CendR Platform provides a targeted tissue penetration capability to specifically enhance drug delivery to tumors. The presence of immunosuppressive cell types, such as T regulatory cells, in the tumor microenvironment can limit the ability of patients’ immune systems to fight their cancer and render some tumors refractory to immunotherapies. Cend is applying its technology to deplete such immunosuppressive cells from the tumor microenvironment to enable patients’ immune system and immunotherapies to more effectively fight cancer.

November 20, 2020

World Pancreatic Cancer Day 2020

To honor the Pancreatic Cancer Awareness Day (today) and Pancreatic Cancer Awareness Month (November) we are raising awareness about the symptoms and risks of this devastating disease and the urgent need for earlier detection.

The results of our first clinical trial testing CEND-1 in pancreatic cancer patients were published at the annual European cancer meeting ESMO 2020 and Annals of Oncology. We are now preparing to test CEND-1 in multi-center randomized clinical trials in pancreatic cancer patients and expand into additional indications in our effort to help patients with hard-to-treat solid tumors.

September 25, 2020

Cend Therapeutics Announces Acquisition of Impilo Therapeutics

San Diego, September 21, 2020 – Cend Therapeutics, Inc., a clinical-stage biotech company, announced today that it has acquired Impilo Therapeutics, Inc. The combination expands Cend’s drug delivery capabilities to create a unique platform for targeted tissue penetrating delivery of nucleic acid-based medicines to solid tumor cancers.

While antisense and siRNA medicines have reached market for a range of metabolic, neurological and neuro-muscular conditions, none have reached market for anticancer applications. “By combining Impilo with Cend our objective is to address delivery issues that have limited the ability of nucleic acid-based medicines to benefit cancer patients,” commented David Slack, CEO of Cend.

“Cend’s lead asset, CEND-1, has generated encouraging clinical data showing the ability to enhance delivery of standard-of-care chemotherapy for pancreatic cancer patients, and the Company has generated similarly encouraging preclinical results for a variety of therapeutic modalities,” commented Sangeeta Bhatia, MD, PhD, scientific co-founder of Impilo and Director of MIT’s Center for Cancer Nanomedicine.

“With the combination of Cend and Impilo technologies, we have demonstrated unique abilities to deliver antisense, siRNA, microRNA, and immunostimulatory oligonucleotides selectively to solid tumor cancers and certain immune cells,” commented Frank Slack, PhD, scientific cofounder of Impilo and Director of Harvard’s Initiative for RNA Medicine.

“The scientific founders of Cend and Impilo have collaborated for many years and generated significant publications” commented Cend Executive Chairman, Erkki Ruoslahti. “Cend will continue to work closely with Impilo’s founders as part of our extended team.”

Via acquisition of Impilo’s assets, the CendR PlatformÔ combines Cend’s clinical-stage targeted tumor penetrating peptide, CEND-1, with additional targeting capabilities. It also brings nanoparticle technologies, including fusogenic nanoparticles that can deliver high payloads of nucleic acid-based drugs directly into the cytosol compartment of cells.

Financial details of the transaction have not been disclosed. Accompanying the acquisition, Sangeeta Bhatia and Frank Slack will join Erkki Ruoslahti, MD, PhD; Tambet Teesalu, PhD; and Kazuki Sugahara, MD on Cend’s Scientific Advisory Board. Impilo scientific co-founder and Distinguished Professor at UC San Diego, Michael Sailor, PhD will join Cend’s Board of Directors. About Cend Therapeutics

September 15, 2020

Cend Therapeutics Announces Presentation and Abstract Publication at 2020 European Society for Medical Oncology (ESMO) Meeting

San Diego, September 15, 2020 – Cend Therapeutics, Inc., a clinical-stage biotech company, announced the publication of its abstract on the website of the annual meeting of the European Society for Medical Oncology. The poster that includes the detailed results will be presented at the virtual meeting on September 17, 2020.

The poster presenter and the Principal Investigator, Andrew Dean, MD of the St. John of God Hospital , Subiaco, Australia. Dr. Dean commented: “This first-in-human clinical study with CEND-1 provides encouraging results and highlights potential to enhance delivery of standard-of-care therapy for patients with metastatic pancreatic ductal adenocarcinoma (PDAC).”

“Inability to target delivery of drugs to primary tumor and metastases represents a significant factor limiting successful treatment of pancreatic cancer patients, who represent a high-need patient population. Our aim with CEND-1 is to provide a new tumor-targeted penetration capability to improve outcomes for pancreatic cancer patients,” commented Harri Jarvelainen, Chief Operating Officer at Cend Therapeutics.

The details of the poster are as follows:
Title: Phase I trial of the first-in-class agent CEND-1 in combination with gemcitabine and nab-paclitaxel in patients with metastatic pancreatic cancer
Presentation Number: 1528P
Speaker: Andrew Dean (Subiaco, WA, Australia)
Date: 17.09.2020

About Cend Therapeutics
Cend is a clinical-stage biotech company focused on a novel approach to enhance and more selectively deliver treatments for solid tumor cancers. Poor penetration of drugs into tumors is a major issue in cancer therapy as it limits access and therefore efficacy of current therapies. The CendR Platform™ provides a targeted tissue penetration capability to specifically enhance drug delivery to tumors.

July 8, 2020

CEND Therapeutics Announces Board Member David Slack Will Succeed Erkki Ruoslahti as President & CEO

LA JOLLA, Calif., July 08, 2020 — Cend Therapeutics, Inc. (formerly DrugCendR, Inc.), a clinical-stage biotech company, announced today changes in the senior management of the company. David Slack, MBA will take over as President and CEO. Erkki Ruoslahti, MD, PhD, co-founding CEO will remain Chairman and serve as a senior advisor for the Company.

Mr. Slack has over 25 years of experience in the biotech and pharmaceutical industry having served in senior positions in several companies with focus on advancing innovative treatments for cancer patients. He has served as a member of the Cend Therapeutics board of directors since 2019. Most recently, Mr. Slack served as Chief Business Officer of Viracta Therapeutics. Prior to Viracta, he has served as co-founding CEO at Kinagen, Inc.; Vice President for Business Development at Ionis Pharmaceuticals; and in senior roles at Aventis Pharma, Rhone-Poulenc Rorer Pharmaceuticals and RPR Gencell.

Dr. Ruoslahti said: “I am very pleased to announce David’s appointment as CEO. He brings extensive senior management, financing and business development expertise to the Company. Cend has come a long way in the past 5 years; we have nearly completed a Phase 1 clinical trial with our lead investigational drug, CEND-1, in combination with standard-of-care chemotherapy for the treatment of metastatic pancreatic cancer, and we have an extensive preclinical-stage opportunities to apply our CendR drug delivery platform. David is the right leader to take the company through the next stage in its development.”

Mr. Slack said: “I am honored to take on this role with Cend. In addition to the encouraging results in the clinic, Erkki and the Cend team have laid the groundwork for broad applications of the Company’s technology, which opens up additional funding, product and partnering opportunities.”

May 5, 2020

Cend Therapeutics to Participate in BIO Digital Conference June 8-12, 2020

LA JOLLA, CA, May 5, 2020 — Cend Therapeutics Inc. a clinical stage oncology biotech, today announced that the company will attend the BIO Digital Conference on June 8-12, 2020.

Harri Jarvelainen, Chief Operating Officer will host virtual one-on-one meetings throughout the conference. Please contact us to arrange a meeting.

March 18, 2020

Cend Therapeutics Selected as a Buzz of BIO 2020 Finalist

Cend Therapeutics Inc, a clinical-stage oncology company developing innovative therapies to overcome drug delivery barriers in solid tumors, today announced that it was selected as one of the finalists of Buzz of BIO International Convention.

The Buzz of BIO contest provides great visibility and an excellent opportunity for companies looking to make the connections needed to take their product to the next phase. The contest helps to identify companies based in the U.S. with groundbreaking technologies that have the overall potential to improve lives in difficult-to-treat conditions.

To vote, visit https://www.bio.org/events/bio-international-convention/buzz-bio-voting and select Cend Therapeutics in the “Pipelines of Promise” category (companies are listed alphabetically). Harri Jarvelainen, COO of Cend Therapeutics, is available for meetings during the conference.

August 28, 2019

DrugCendR reinforces its IP portfolio with a broad patent covering CendR peptides

La Jolla, CA (August 28, 2019) – DrugCendR Inc., a clinical-stage biopharmaceutical company dedicated to developing novel treatment approached designed to overcome the barriers of drug delivery in solid tumors, announced today that the United States Patent and Trademark Office (USPTO) has issued a new patent related to CendR peptides, further strengthening the company’s intellectual property portfolio beyond the already granted composition of matter patents. U.S. Patent No. 10370245B2 (‘Methods and compositions related to peptides and proteins with c-terminal elements’) has 183 claims and an adjusted expiry in November 2030. The patent is already active in Europe, Japan and China.

“This new patent that provides broad coverage on peptides with CendR element ensures a robust intellectual property position around the CEND-1 platform technology and the claims granted in this particular patent exemplify the novel mechanistic approach of our science” said Harri Jarvelainen, Chief Operating Officer of DrugCendR Inc. “This development becomes more and more important as we progress with our clinical trial in patients with metastatic pancreatic cancer and prepare to publish the results at a major upcoming scientific meeting next year”.

August 20, 2019

DrugCendR Inc. Announces the Appointment of Dr. Daniel Von Hoff as Clinical Advisor

LA JOLLA, Calif., Aug. 20, 2019 — DrugCendR, Inc., a clinical-stage biotech company developing next generation therapies for the treatment of solid tumors, today announced that Dr. Daniel Von Hoff will be a clinical advisor to the company. In this role, Dr. Von Hoff will guide the company with its clinical development programs.

Dr. Daniel Von Hoff is Physician in Chief, Distinguished Professor at the Translational Genomics Research Institute (TGen) in Phoenix, Arizona. Dr. Von Hoff has conducted more than 200 clinical trials to date and his clinical trial work has led to the approval of 3 of the 4 drugs approved by the FDA for treatment of patients with advanced pancreatic cancer, including the gemcitabine and Abraxane® combination therapy.  The new treatment approaches he has helped to pioneer have helped tens of thousands of patients with breast, ovarian, prostate, colon, leukemia, skin (advanced basal cell carcinoma) and pancreatic cancer today.

“I am very pleased to be supporting DrugCendR at an especially exciting time in the development program for CEND-1,” said Dr. Von Hoff, adding “Any new therapy that could offer significant benefit to hard-to-treat solid tumors in patients is a welcome lead.”

For more information please contact:
Harri Jarvelainen, COO

January 31, 2019

DrugCendR welcomes Heidi Henson to its Board of Directors

DrugCendR welcomes Heidi Henson to its Board of Directors

– USA, CA – DrugCendR Inc., a clinical-stage biopharmaceutical company dedicated to developing next generation cancer therapies designed to overcome the barriers of drug delivery in solid tumors, reported today positive progress with its ongoing pancreatic cancer clinical trial. In addition, the lead program received orphan-drug designation from the US Food and Drug administration in pancreatic cancer. The company also announced a new member of board of directors.

The ongoing clinical trial in metastatic pancreatic cancer patients (CEND1-001, Clinical trial reference NCT03517176) has been accruing patients rapidly – the first Phase 2a -type expansion cohort for early efficacy is now open. The study is expected to be fully enrolled with at least 30 patients in the second quarter of 2019. The early results are reportedly encouraging, with high response rates as well as favorable safety profile, with no dose-limiting toxicities. “The progress with the pancreatic cancer trial has exceeded our expectations,” said Harri Jarvelainen, Chief Operating Officer of DrugCendR Inc. “Our near term goal is to validate the CEND-1 platform technology in multiple indications so clinicians can treat patients with cancers with high unmet medical need more effectively.”

Receiving the FDA orphan drug designation was also announced today. It is a significant development milestone as it can facilitate the future development through several benefits such as tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval. The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S.

Lastly, the company announced that it has appointed Heidi Henson, an industry veteran, to its Board of Directors. “I am pleased to welcome Heidi Henson to our board, where her extensive expertise in financial management and strategy will be a major asset to DrugCendR as we continue to advance the company programs,” said Erkki Ruoslahti, M.D., Ph.D., Founder, President, Chief Executive Officer and Chairman of DrugCendR. Mrs Henson, an independent board member, is the Chief Financial Officer of Respivant Biosciences. Her previous experience includes serving as the Chief Financial Officer of Kura Oncology and Wellspring Bioscience.

About CEND-1

DrugCendR’s proprietary technology platform is a based on a bifunctional molecular mimicry agent CEND-1. The agent is able to manipulate the tumor microenviroment, effectively making it into a temporary drug conduit. This allows an enhanced delivery and efficacy of various types of co-administered anti-cancer compounds. The action is tumor-specific, thanks to the tumor-homing RGD motif of the molecule. To date the compound has been investigated, by the company founders and by numerous independent groups, in more than 150 publications and it has shown efficacy in more than 40 different cancer models.

About DrugCendR

DrugCendR Inc. is a privately held biopharmaceutical company founded in 2015. The initial focus of company’s technology is pancreatic cancer because, in addition to its poor prognosis, it is characterized by a dense extracellular matrix stroma, which acts as a physical barrier to drug entry. Since the active transport process initiated by CEND-1 overcomes this obstacle, and the target receptors for are highly expressed in advanced pancreatic cancer, CEND-1 appears particularly well suited to target PDAC. The company is planning for additional clinical trials in other cancer indications for its lead program and has already started a follow-up CEND-2 program, which works through a well-validated immune-oncology pathway.

For more information : https://www.drugcendr.com

January 31, 2019

DrugCendR Announces Pancreatic Cancer Clinical Trial Data, New Member of Board of Directors and FDA Orphan Drug Designation

LA JOLLA, Calif., Jan. 31, 2019 — DrugCendR Inc., a clinical-stage biopharmaceutical company dedicated to developing next generation cancer therapies designed to overcome the barriers of drug delivery in solid tumors, reported today positive progress with its ongoing pancreatic cancer clinical trial. In addition, the lead program received orphan-drug designation from the US Food and Drug administration (FDA) in pancreatic cancer. The company also announced a new member of board of directors.

The ongoing clinical trial in metastatic pancreatic cancer patients (CEND1-001, Clinical trial reference NCT03517176) has been accruing patients rapidly – the first Phase 2a -type expansion cohort for early efficacy is now open. The study is expected to be fully enrolled with at least 30 patients in the second quarter of 2019. The early results are reportedly encouraging, with high response rates as well as favorable safety profile, with no dose-limiting toxicities. “The progress with the pancreatic cancer trial has exceeded our expectations,” said Harri Jarvelainen, Chief Operating Officer of DrugCendR Inc. “Our near term goal is to validate the CEND-1 platform technology in multiple indications so clinicians can treat patients with cancers with high unmet medical need more effectively.”

Receiving the FDA orphan drug designation was also announced today. It is a significant development milestone as it can facilitate the future development through several benefits such as tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval. The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S.

Lastly, the company announced that it has appointed Heidi Henson, an industry veteran, to its Board of Directors. “I am pleased to welcome Heidi Henson to our board, where her extensive expertise in financial management and strategy will be a major asset to DrugCendR as we continue to advance the company programs,” said Erkki Ruoslahti, M.D., Ph.D., Founder, President, Chief Executive Officer and Chairman of DrugCendR. Mrs Henson, an independent board member, is the Chief Financial Officer of Respivant Biosciences. Her previous experience includes serving as the Chief Financial Officer of Kura Oncology and Wellspring Bioscience.

About CEND-1

DrugCendR’s proprietary technology platform is a based on a bifunctional molecular mimicry agent CEND-1. The agent is able to manipulate the tumor microenviroment, effectively making it into a temporary drug conduit. This allows an enhanced delivery and efficacy of various types of co-administered anti-cancer compounds. The action is tumor-specific, thanks to the tumor-homing RGD motif of the molecule. To date the compound has been investigated, by the company founders and by numerous independent groups, in more than 150 publications and it has shown efficacy in more than 40 different cancer models.

About DrugCendR

DrugCendR Inc. is a privately held biopharmaceutical company founded in 2015. The initial focus of company’s technology is pancreatic cancer because, in addition to its poor prognosis, it is characterized by a dense extracellular matrix stroma, which acts as a physical barrier to drug entry. Since the active transport process initiated by CEND-1 overcomes this obstacle, and the target receptors for are highly expressed in advanced pancreatic cancer, CEND-1 appears particularly well suited to target PDAC. The company is planning for additional clinical trials in other cancer indications for its lead program and has already started a follow-up CEND-2 program, which works through a well-validated immune-oncology pathway.

August 13, 2018

DrugCendR Announces Initiation of CEND1-001 Phase 1

La Jolla, CA (August 13, 2018) – DrugCendR Inc., a biopharmaceutical company dedicated to developing next generation cancer therapies designed to overcome the barriers of drug delivery in solid tumors, announced today the treatment of the first patient in a Phase 1 clinical trial evaluating its lead compound CEND-1 (scientifically known as iRGD), in patients with metastatic pancreatic adenocarcinoma (CEND1-001, Clinical trial reference NCT03517176).

“Treating the first patient is an exciting milestone for our technology platform and for the company.” said Erkki Ruoslahti, President and CEO of DrugCendR Inc. “We chose to conduct the first study in pancreatic cancer, a cancer that is in desperate need of more effective therapies and shown to respond to CEND-1. Studies in preclinical models conducted all over the world also show that CEND-1 has wider potential; it enhances the therapy of many types of cancers by many types of drugs. We hope to make that potential a reality in the treatment of human cancer.”

Chief Operating Officer, Harri Jarvelainen continues,” We initiated our IND-enabling program a year ago so it is a great achievement to start dosing in this multi-site trial already now. Data from more than 100 publications have consistently demonstrated that CEND-1 is effective in the treatment of various types of solid tumors – but importantly, it is also a safe and well tolerated compound, thanks to its tumor specific mechanism of action. As the extent of preclinical validation is almost unprecedented, we have a high confidence in the clinical translation of our therapy and hope that it will be soon available to patients with this and other cancers with high unmet medical need.”

About the CEND1-001 Phase 1 Clinical Trial

CEND1-001 is an open label, multicenter (4 hospitals in Australia), safety, pharmacokinetic and pharmacodynamic study in patients diagnosed with metastatic pancreatic adenocarcinoma. The study will assess the safety of the combination with gemcitabine and Abraxane, and determine an appropriate dose level for future studies. The principle for co-administrating CEND-1 with anti-cancer agents is that through enhancing their tumor penetration, the efficacy of the therapies is increased, while their toxicities are decreased.

January 1, 2018

DrugCendr Inc. to present at Biotech Showcase Conferences in San Francisco on January 7 and 10, 2018

Next week is the most important week in healthcare as representatives from hundreds of biopharma companies arrive for meetings in and around San Francisco’s Union Square.

During the week, the COO of DrugCendR Inc., Harri Jarvelainen, will present on 2 occasions – first at the China Showcase on Sunday, January 7, as then at the Biotech Showcase, on Wednesday, January 10.

The meeting details are as follows:

China Showcase:

Date: Sunday, January 7
Time: 3:15 PM
Room: Parc 55, Level 4, Cyril Magnin I
Biotech Showcase:
Date: Wednesday, January 10
Time: 10:15 AM
Room: Hilton San Francisco Union Square Hotel / Franciscan B

As DrugCendR is now preparing to transition from a preclinical to a clinical-stage company, the company will present details on their Phase I –ready lead compound CEND-1 – a highly innovative molecular mimicry agent that is able to activate a drug transport mechanism specifically in solid tumors. To date, there are more than 100 studies using DrugCendR’s proprietary technology, providing an unprecedented amount of preclinical validation / proof-of-concept. As the therapy progresses to human studies, the hope is that in addition to increasing the efficacies of anti-cancer therapies, this highly tumor-specific approach could be able to decrease the toxicities caused by the anti-cancer agents.

Biotech ShowcaseTM and China ShowcaseTM are investor and networking conferences produced by Demy-Colton and EBD Group.

Additional links and information: https://www.drugcendr.com/

July 20, 2017

DrugCendR Inc. Announces Appointment of Harri Jarvelainen, DVM, PhD, as Interim Chief Operating Officer

Dr. Harri Jarvelainen has joined DrugCendR Inc. as the Interim Chief Operating Officer (COO). He has more than 20 years of scientific, managerial and executive experience in the drug industry –  bringing small molecule drugs and biologicals from discovery to early development in multiple therapeutic areas. He has contributed to more than 30 first-in-man projects and has collaborated with and consulted for more than 50 biotechnology companies over the years.

Erkki Ruoslahti, CEO of DrugCendR, stated: “We are pleased to have Dr. Jarvelainen in our team. He has provided a valuable service to our company in his previous role as a consultant role and will now be instrumental in the developing DrugCendR from a start-up into a biotech ready for the clinic.” 

 

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Publications

More than 200 scientific papers from laboratories all over the world provide non-clinical validation for Cend’s technology and show enhanced antitumor activity of a variety of therapeutics in a range of solid tumor types, documenting the broad applicability of Cend’s technology.

March 10, 2021

Nature Communications: Tumor-penetrating therapy for β5 integrin-rich pancreas cancer

August 10, 2018

Cancer Research: Nanoparticles That Reshape the Tumor Milieu Create a Therapeutic Window for Effective T-cell Therapy in Solid Malignancies

August 10, 2018

Molecular Cancer Therapeutics: iRGD-guided Tumor-penetrating Nanocomplexes for Therapeutic siRNA Delivery to Pancreatic Cancer:

August 24, 2017

Nature Communications: In vivo cation exchange in quantum dots for tumor-specific imaging

April 17, 2017

The Journal of Clinical Investigation: Tumor-penetrating peptide enhances transcytosis of silicasome-based chemotherapy for pancreatic cancer

April 1, 2016

Advanced Drug Delivery Reviews: Tumor penetrating peptides for improved drug delivery

August 1, 2015

Cancer Research: Improving Drug Penetrability with iRGD Leverages the Therapeutic Response to Sorafenib and Doxorubicin in Hepatocellular Carcinoma

March 18, 2014

British Journal of Cancer: Anticancer effects of gemcitabine are enhanced by co-administered iRGD peptide in murine pancreatic cancer models that overexpressed neuropilin-1

May 21, 2010

Science: Coadministration of a Tumor-Penetrating Peptide Enhances the Efficacy of Cancer Drugs

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