Lisata Therapeutics, Inc.

Lisata Therapeutics, Inc. Targeted Therapy Delivered In addition, Lisata also has clinical development programs based on its autologous CD34+ cell therapy technology platform.

Lisata Therapeutics is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapies for the treatment of advanced solid tumors and other major diseases. Lisata’s lead investigational product candidate, LSTA1 (formerly known as CEND-1), is designed to modify the tumor microenvironment by activating a novel uptake pathway that allows anti-cancer drugs to penetrate solid tumors more effectively. LSTA1 actuates an active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor, while normal tissues are not affected. LSTA1 has demonstrated favorable safety, tolerability, and activity in clinical trials to enhance delivery of standard-of-care chemotherapy for pancreatic cancer. Lisata and its collaborators have also amassed significant non-clinical data demonstrating enhanced delivery of a range of emerging anti-cancer therapies, including immunotherapies and RNA-based therapeutics. Lisata is exploring the potential of LSTA1 to enable a variety of treatment modalities to treat a range of solid tumors more effectively.

Lisata Therapeutics’ preliminary CENDIFOX trial data was recently featured in Cancer Network, highlighting the encouragi...
10/21/2025

Lisata Therapeutics’ preliminary CENDIFOX trial data was recently featured in Cancer Network, highlighting the encouraging results from the pancreatic ductal adenocarcinoma cohort presented at the American Association for Cancer Research (AACR).

The article, written by Assistant Editor, Roman Fabbriacatore, discusses how certepetide in combination for FOLFIRINOX demonstrated safety and feasibility in patients with resectable or borderline resectable PDAC, with promising efficacy signals including a 50% R0 resection rate and 70% pathologic partial response rate among evaluable patients.

Read the full article here: https://www.cancernetwork.com/view/certepetide-folfirinox-displays-encouraging-preliminary-feasibility-in-pdac

The addition of certepetide to a FOLFIRINOX-based regimen was safe in patients with resectable or borderline resectable pancreatic ductal adenocarcinoma.

Advanced solid tumors present unique treatment challenges due to the dense tumor microenvironment that prevents anti-can...
10/20/2025

Advanced solid tumors present unique treatment challenges due to the dense tumor microenvironment that prevents anti-cancer drugs from effectively reaching tumor cells. The CendR Platform® is designed to overcome this critical barrier through targeted pe*******on technology that enhances drug delivery directly to solid tumors.

Our lead investigational drug, certepetide, selectively targets tumor cells and activates a novel uptake pathway that enhances drug delivery while modifying the tumor microenvironment to make cancers more susceptible to treatment. This innovative approach has the potential to revolutionize treatment for advanced solid tumors, ultimately leading to better patient outcomes.

Learn more: https://www.lisata.com/research-technology/cendr-platform/

We're honored to announce that Lisata's CendR Platform® has been named a finalist in the Drug Delivery Technology catego...
10/15/2025

We're honored to announce that Lisata's CendR Platform® has been named a finalist in the Drug Delivery Technology category of the Fierce Innovation Awards: Life Sciences Edition 2025!

This recognition from Fierce Life Sciences Events reflects our commitment to addressing a critical challenge in oncology: enabling therapies to selectively target and pe*****te solid tumors more effectively.

Our lead investigational drug, certepetide, is designed to convert the tumor stroma from a barrier into a conduit for drug delivery while modifying the tumor microenvironment. This mechanism is supported by recent preliminary Phase 2b (ASCEND) trial data: patients receiving two doses of certepetide plus standard-of-care achieved 60.8% six-month progression-free survival compared to 25% in the placebo-treated group. These encouraging results further underscore the value of continuing the expedited investigation of certepetide for metastatic pancreatic cancer and other advanced solid tumors.

Winners will be announced on November 19th.

Lisata is proud to collaborate with Catalent to evaluate certepetide and its analogs for use as SMARTag® payloads across...
10/08/2025

Lisata is proud to collaborate with Catalent to evaluate certepetide and its analogs for use as SMARTag® payloads across multiple ADCs designed to address difficult-to-treat-diseases.

“This collaboration is based on positive preclinical results generated by Catalent’s use of an iRGD peptide as part of its SMARTag® ADC platform. It underscores our mutual belief in certepetide’s broad potential and is another significant step forward in Lisata’s mission to bring transformative therapies to patients. Catalent’s technology and innovative approach are a perfect complement to certepetide’s biology.” - Kristen K. Buck MD, Executive Vice President of Research and Development and Chief Medical Officer of Lisata

Read the press release for details: https://ir.lisata.com/news-releases/news-release-details/lisata-therapeutics-and-catalent-announce-global-antibody-drug

Today, Catalent announced with Lisata Therapeutics, Inc., Inc. a new, global license agreement for developing antibody-drug conjugates (ADCs) with the goal of creating a new class of bioconjugate therapies and ultimately improving cancer treatment outcomes.

This collaboration enables Catalent to leverage our proprietary SMARTag® technology platform to incorporate Lisata’s certepetide and its analogs into next-generation ADCs.

We’re proud to work together with Lisata to advance innovation in targeted therapeutics and expand treatment outcomes for patients worldwide.

🔗 Read the full press release here: https://ow.ly/ikPU50X8Fta

Today, we recognize World Cancer Research Day and the critical role of cancer research in improving prevention, early de...
09/24/2025

Today, we recognize World Cancer Research Day and the critical role of cancer research in improving prevention, early detection, and treatment for patients worldwide.

At Lisata Therapeutics, our CendR Platform® technology and lead drug candidate, certepetide, address the challenges in treating advanced solid tumors by enhancing drug delivery and modifying the tumor microenvironment.

We're proud to contribute to global cancer research through our clinical trials across multiple solid tumor indications, working toward better outcomes for patients.

Today, Lisata President and CEO, David J. Mazzo, Ph.D., participated in CEO Forums: An FDA Listening Tour to Engage Phar...
09/15/2025

Today, Lisata President and CEO, David J. Mazzo, Ph.D., participated in CEO Forums: An FDA Listening Tour to Engage Pharmaceutical and Biotech CEOs in Raleigh, NC.

During the forum, David advocated for the creation of a collaborative working group bringing together public and private sector stakeholders to harness the full potential of AI tools and technologies in drug development—while upholding the FDA's gold standard for safety, efficacy, and quality.

The future of pharmaceutical innovation lies in thoughtful collaboration between industry and regulators. Events like these are crucial for shaping policies that will accelerate breakthrough treatments for patients while maintaining the rigorous standards we all depend on.

In case you missed it, our population pharmacokinetic modeling study of certepetide was published in the American Colleg...
09/12/2025

In case you missed it, our population pharmacokinetic modeling study of certepetide was published in the American College of Clinical Pharmacology® journal earlier this year.

This analysis examined certepetide's pharmacokinetic profile in patients with metastatic pancreatic ductal adenocarcinoma and provides valuable insights to inform dose optimization in our ongoing clinical development programs.

Read the full publication: https://bit.ly/45GDoLN

How does certepetide work?Our lead investigational product targets alpha-v integrins primarily on tumor cells and vascul...
08/28/2025

How does certepetide work?

Our lead investigational product targets alpha-v integrins primarily on tumor cells and vasculature. When bound, it creates a CendR fragment that activates a novel uptake pathway, allowing anti-cancer drugs to pe*****te solid tumors more effectively while sparing healthy tissue. Certepetide also modifies the tumor microenvironment, enhancing immunotherapy effectiveness and inhibiting metastasis.

Watch our short film to learn more: https://www.youtube.com/watch?v=dd-SgaBoWac

08/22/2025

Lisata Therapeutics' certepetide pipeline targets advanced solid tumors across multiple indications through our CendR Platform® technology, which enables enhanced tumor-targeted delivery of anti-cancer agents.

Current clinical programs include:
🔬ASCEND trial in metastatic pancreatic cancer
🔬BOLSTER trial in cholangiocarcinoma
🔬 iLSTA trial in locally advanced, nonresectable PDAC
🔬CENDIFOX trial in pancreatic, colon, and appendiceal cancers
🔬Glioblastoma trial

Certepetide has received Fast Track designation and multiple Orphan Drug Designations from the FDA, recognizing significant unmet medical needs in these patient populations.

For more info on our ongoing clinical programs, visit: https://www.lisata.com/active-clinical-trials/

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Basking Ridge, NJ

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