Lisata Therapeutics Announces First Patient Treated in the Second-line Cholangiocarcinoma Cohort of the BOLSTER Trial

Rhea-AI Summary

Lisata Therapeutics (Nasdaq: LSTA) has announced the treatment of the first patient in the second-line cholangiocarcinoma (CCA) cohort of the BOLSTER trial. This expansion follows the successful completion of enrollment in the first-line CCA cohort. The decision to initiate this cohort was based on recommendations from investigators in the first-line study. The BOLSTER trial is a Phase 2a, double-blind, placebo-controlled, randomized, multi-center study evaluating certepetide in combination with standard-of-care for first- or second-line CCA patients. This expansion aims to improve outcomes for patients who have progressed after first-line standard-of-care therapy alone.

Positive

• Expansion of BOLSTER trial to include second-line cholangiocarcinoma patients
• Successful completion of enrollment in first-line CCA cohort
• Potential to improve outcomes for patients who progressed after first-line therapy

Negative

• None.

Insights

Medical Research Analyst

The initiation of the second-line cholangiocarcinoma (CCA) cohort in the BOLSTER trial marks a significant expansion of Lisata Therapeutics' research efforts. This development, driven by investigator enthusiasm, suggests promising preliminary results from the first-line cohort. The inclusion of second-line patients broadens the potential application of certepetide, addressing an unmet medical need in a difficult-to-treat cancer.

The double-blind, placebo-controlled design of the BOLSTER trial adds robustness to the study, potentially increasing the value of its outcomes. If successful, this could position certepetide as a novel treatment option for CCA patients who have progressed after first-line therapy, potentially improving survival rates and quality of life in this patient population.

Oncology Doctor

The expansion of the BOLSTER trial to include second-line cholangiocarcinoma patients is a strategic move in oncology drug development. Cholangiocarcinoma, a rare and aggressive biliary tract cancer, has treatment options, especially after first-line therapy failure. The inclusion of this cohort could provide valuable data on certepetide's efficacy across different stages of CCA.

The combination approach of certepetide with standard-of-care therapy aligns with current trends in oncology, aiming to enhance treatment efficacy without significantly increasing toxicity. If successful, this could lead to a paradigm shift in CCA treatment, potentially offering a new option for patients who currently face a poor prognosis after first-line treatment failure.

Financial Analyst

The expansion of the BOLSTER trial to second-line CCA patients represents a potential value driver for Lisata Therapeutics (NASDAQ: LSTA). By broadening the target patient population, the company is increasing the market potential of certepetide, which could translate to higher revenue if the drug is approved. The enthusiasm from investigators suggests positive sentiment around the drug's potential, which may attract investor interest.

However, investors should note that this is still an early-stage trial and significant hurdles remain before potential commercialization. The company's ability to fund the expanded trial and potential future studies will be crucial. While this news is positive, it's important to consider Lisata's overall pipeline and financial position when assessing its long-term prospects.

Study arm initiated based upon enthusiasm and at the request of investigators who participated in first-line cholangiocarcinoma cohort

BASKING RIDGE, N.J., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced treatment of the first patient in the second-line cholangiocarcinoma (“CCA”) cohort of the BOLSTER trial. This follows the recently announced successful completion of enrollment in the first-line CCA cohort.

“We are pleased to announce the dosing of the first patient in the second-line cholangiocarcinoma cohort of the BOLSTER trial,” said Kristen K. Buck, M.D., Executive Vice President of Research and Development and Chief Medical Officer of Lisata. “Initiation of this cohort is based on the recommendation of investigators from our BOLSTER study’s first-line cholangiocarcinoma cohort to evaluate certepetide in patients who progressed after being treated with first-line standard-of-care therapy alone. We are excited to expand the evaluation of certepetide in this broadened cholangiocarcinoma population with the goal of improving outcomes for these patients in dire need.”

The BOLSTER trial is a Phase 2a, double-blind, placebo-controlled, randomized, multi-center study evaluating certepetide in combination with standard-of-care in subjects with first- or second-line CCA. For more information on the BOLSTER trial, including participating sites, please visit https://clinicaltrials.gov/study/NCT05712356.

About Cholangiocarcinoma

Cholangiocarcinoma, also known as bile duct cancer, is a cancer that forms in the bile ducts, a network of thin tubes that play a crucial role in digestion. Cholangiocarcinoma is a rare and serious cancer that is difficult to diagnose and often misclassified. According to the American Cancer Society, approximately 8,000 people in the United States are diagnosed with cholangiocarcinoma each year, however, the actual number is likely higher due to diagnostic challenges. The five-year survival rate for cholangiocarcinoma is under 5%, highlighting the urgent need for new and effective treatments.

About Certepetide

Certepetide is an investigational drug designed to selectively activate the C-end rule active transport mechanism in a tumor specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor. Additionally, certepetide has been shown to modify the tumor microenvironment, diminishing its immunosuppressive nature and inhibiting the metastatic cascade. Lisata and its collaborators have amassed significant non-clinical data demonstrating enhanced delivery of various existing and emerging anti-cancer therapies, including chemotherapies, immunotherapies and RNA-based therapeutics. To date, certepetide has also demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing clinical trials designed to demonstrate its ability to enhance the effectiveness of standard-of-care chemotherapy for pancreatic cancer as well as the combination of chemotherapy and immunotherapy in a variety of solid tumors. Certepetide has been awarded Fast Track designation (U.S.) and Orphan Drug Designation for pancreatic cancer (U.S. and E.U.) as well as Orphan Drug Designation for glioma, osteosarcoma, and cholangiocarcinoma (U.S.). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (U.S.).

About Lisata Therapeutics

Lisata Therapeutics is a clinical-stage pharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for the treatment of advanced solid tumors and other major diseases. Lisata’s product candidate, certepetide, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to selectively target and penetrate solid tumors more effectively. Lisata has already established noteworthy commercial and R&D partnerships based on its CendR Platform^® technology. The Company expects to announce numerous milestones over the next 1.5 years and believes that its projected capital will fund operations into early 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials. For more information on the Company, please visit www.lisata.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 the Company’s clinical development programs 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” and similar expressions and their variants, as they relate to Lisata or its management, may identify forward-looking statements. Examples of forward-looking statements include, but are not limited to, the potential efficacy of certepetide as a treatment for patients with cholangiocarcinoma and other solid tumors; statements relating to Lisata’s continued listing on the Nasdaq Capital Market; expectations regarding the capitalization, resources and ownership structure of Lisata; the approach Lisata is taking to discover and develop novel therapeutics; the adequacy of Lisata’s capital to support its future operations and its ability to successfully initiate and complete clinical trials; and the difficulty in predicting the time and cost of development of Lisata’s product candidates. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: results observed from a single patient case study are not necessarily indicative of final results and one or more of the clinical outcomes may materially change following more comprehensive reviews of the data and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the safety and efficacy of Lisata’s product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in Lisata’s clinical programs, Lisata’s ability to finance its operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of Lisata’s scientific studies, Lisata’s ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in Lisata’s markets, the ability of Lisata to protect its intellectual property rights; 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 Lisata’s Annual Report on Form 10-K filed with the SEC on February 29, 2024, and in other documents filed by Lisata with the Securities and Exchange Commission. Except as required by applicable law, Lisata 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.

Contact:

Investors:

Lisata Therapeutics, Inc.
John Menditto
Vice President, Investor Relations and Corporate Communications
Phone: 908-842-0084
Email: jmenditto@lisata.com

Media:

ICR Westwicke
Elizabeth Coleman
Senior Associate
Phone: 203-682-4783
Email: elizabeth.coleman@westwicke.com

FAQ

What is the latest development in Lisata Therapeutics' BOLSTER trial for cholangiocarcinoma?

Lisata Therapeutics has treated the first patient in the second-line cholangiocarcinoma cohort of the BOLSTER trial, expanding the study beyond the recently completed first-line cohort enrollment.

What is the design of the BOLSTER trial for LSTA's certepetide?

The BOLSTER trial is a Phase 2a, double-blind, placebo-controlled, randomized, multi-center study evaluating certepetide in combination with standard-of-care for first- or second-line cholangiocarcinoma patients.

Why did Lisata Therapeutics (LSTA) decide to include a second-line cholangiocarcinoma cohort in the BOLSTER trial?

The decision was based on recommendations from investigators in the first-line study, aiming to evaluate certepetide in patients who progressed after first-line standard-of-care therapy alone.

What is the potential benefit of expanding the BOLSTER trial for LSTA's certepetide to second-line cholangiocarcinoma patients?

The expansion aims to improve outcomes for cholangiocarcinoma patients who have progressed after first-line standard-of-care therapy, potentially addressing an unmet medical need in this population.