Lisata Therapeutics, Inc. develops investigational therapies for advanced solid tumors and other serious diseases. Its principal product candidate, certepetide, is a proprietary iRGD cyclic peptide designed to activate an uptake pathway that can improve tumor targeting and penetration by co-administered or tethered anti-cancer agents.
Recurring Lisata news covers clinical and preclinical data involving certepetide, collaborations and license agreements tied to antibody-drug conjugates and other delivery technologies, development-rights changes for regional markets, financial results, business updates, and corporate matters affecting governance or capital structure.
Haystack Oncology, a Quest Diagnostics company, and Lisata Therapeutics (Nasdaq: LSTA) have announced a research collaboration to evaluate the efficacy of a pancreatic cancer therapy. Lisata will use Haystack's MRD™ technology to detect circulating tumor DNA (ctDNA) in a clinical study of certepetide plus chemotherapy for metastatic pancreatic cancer.
The collaboration is part of the FORTIFIDE study, which investigates certepetide's safety, tolerability, and efficacy in combination with standard treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC). Haystack's technology will measure serum ctDNA levels throughout the study as an exploratory endpoint to analyze certepetide's early therapeutic effect.
This collaboration aims to address the challenge of early response measurement in pancreatic cancer treatment development, potentially offering a more sensitive alternative to conventional imaging assessments.
Lisata Therapeutics (Nasdaq: LSTA) has announced the early completion of enrollment in its Phase 2a BOLSTER trial for certepetide, a potential treatment for first-line cholangiocarcinoma (CCA). The trial, which finished enrollment nearly six months ahead of schedule, is evaluating certepetide in combination with standard-of-care versus standard-of-care alone. Due to the rapid enrollment and urgent need for improved treatments, Lisata has added a second-line CCA arm to the trial, with the first patient expected to enroll by Q4 2024. Top-line data from the first-line cohort is now anticipated by mid-2025, potentially accelerating the development of this novel therapeutic approach for CCA.
Lisata Therapeutics announced promising preclinical results for its investigational candidate, certepetide, in treating intrahepatic cholangiocarcinoma. Presented by Dr. Dan G. Duda at the 2024 Cholangiocarcinoma Foundation Annual Conference, the study showed that certepetide combined with standard chemotherapy and immunotherapy improved survival in mice, reduced metastasis, and enhanced immune cell infiltration into tumors. Lisata is conducting a Phase 2a clinical trial (BOLSTER) to evaluate certepetide with standard chemotherapy as a first-line treatment and will soon add an arm to test it with chemoimmunotherapy. Results are expected in 2025.
Lisata Therapeutics announced the successful completion of patient enrollment for the pancreatic cancer cohort in their Phase 1b/2a CENDIFOX trial. This trial, conducted at the University of Kansas Cancer Center, is assessing the safety and efficacy of combining certepetide with FOLFIRINOX-based therapies for pancreatic, colon, and appendiceal cancers. A total of 51 patients will be enrolled, and the study will provide valuable pre- and post-treatment tumor tissue data for immune profiling. The trial is funded by the KU Cancer Center, with Lisata supplying certepetide. The company is looking forward to completing enrollment in the remaining cohorts and reporting results.
Lisata Therapeutics, a clinical-stage pharmaceutical company developing therapies for advanced solid tumors and other serious diseases, announced its participation in two key industry events in June 2024.
CEO David J. Mazzo will present at the BIO International Convention in San Diego on June 3 at 2:15 p.m. PT. The company will also participate in the virtual GCFF 2024 Bio Investing Conference on June 20 at 10:00 a.m. PT. Both events will feature presentations by Mazzo and opportunities for one-on-one meetings with attendees.
Lisata Therapeutics announced that the European Medicines Agency (EMA) has granted a Paediatric Investigation Plan (PIP) waiver for its lead investigational product, certepetide, in pancreatic cancer.
The waiver, recommended by the EMA's Paediatric Committee (PDCO), confirms that pediatric studies for certepetide are unnecessary as pancreatic cancer occurs only in adults.
This decision allows Lisata to avoid the significant clinical trial burden and costs associated with pediatric studies, focusing instead on expediting therapy development for adults with pancreatic cancer.
The waiver will not impact Lisata's commitment to evaluating certepetide in other pediatric solid tumors as required.
Lisata Therapeutics, Inc. reported strong first-quarter 2024 financial results and provided an update on its business activities. The company is anticipating pivotal data readouts from the Phase 2b ASCEND trial later in 2024, with transformative potential. They have received significant regulatory designations for their investigational drug certepetide in various cancer types. Lisata's financial management allows operations to be funded until early 2026. The company is executing multiple ongoing and planned clinical trials globally to advance their innovative therapies.
Lisata Therapeutics, Inc. (Nasdaq: LSTA) will participate in several industry and investor events in May 2024, including the Pharma Partnering U.S. Summit, BioNJ BioPartnering Conference, Pharma Partnering EU Summit, 10th Annual Oncology Innovation Forum, and the 2024 ASCO Annual Meeting. The Company aims to showcase its innovative therapies for advanced solid tumors and serious diseases, with key representatives like Tariq Imam and David J. Mazzo presenting at these events.
Lisata Therapeutics, Inc. (Nasdaq: LSTA) will release its financial results for the first quarter of 2024 on May 9, 2024. The company focuses on developing therapies for solid tumors and serious diseases. A conference call will follow the release, with a webcast available for replay on the company's website.
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