Welcome to our dedicated page for Lisata Therapeutics news (Ticker: LSTA), a resource for investors and traders seeking the latest updates and insights on Lisata Therapeutics stock.
About Lisata Therapeutics Inc.
Lisata Therapeutics Inc. (Nasdaq: LSTA) is a clinical-stage pharmaceutical company headquartered in Basking Ridge, New Jersey. The company is dedicated to the discovery, development, and commercialization of innovative therapies aimed at addressing advanced solid tumors and other major diseases. Lisata leverages its proprietary CendR Platform® technology to enhance the delivery and efficacy of anti-cancer therapies, positioning itself as a key innovator in the biopharmaceutical landscape.
Core Product and Mechanism of Action
Lisata's lead product candidate, certepetide (formerly LSTA1), is an investigational cyclic peptide designed to activate a novel tumor-specific uptake pathway known as the C-end rule (CendR) mechanism. This unique pathway enhances the penetration and accumulation of co-administered or tethered anti-cancer drugs within solid tumors. Beyond improving drug delivery, certepetide modifies the tumor microenvironment by reducing its immunosuppressive nature and promoting immune cell infiltration, thereby increasing the efficacy of immunotherapies and chemotherapy regimens.
Clinical Development and Pipeline
Lisata is conducting multiple clinical trials across various cancer types, including pancreatic ductal adenocarcinoma (PDAC), cholangiocarcinoma, melanoma, glioblastoma, and other solid tumors. Key trials include:
- ASCEND Trial: A Phase 2 study evaluating certepetide with standard-of-care chemotherapy for metastatic pancreatic cancer.
- BOLSTER Trial: A Phase 2a double-blind trial assessing certepetide in combination with chemotherapy and immunotherapy for cholangiocarcinoma.
- CENDIFOX Trial: A Phase 1b/2a study investigating certepetide in neoadjuvant settings for pancreatic, colon, and appendiceal cancers.
- iLSTA Trial: A Phase 1b/2a trial examining certepetide with chemotherapy and immunotherapy for locally advanced non-resectable pancreatic cancer.
These trials aim to validate certepetide's ability to enhance treatment outcomes across a spectrum of solid tumors.
Strategic Partnerships and Collaborations
Lisata has established notable research and development collaborations to expand the applications of its technology. Key partnerships include:
- Collaboration with Valo Therapeutics to explore certepetide's synergy with immunotherapy platforms like PeptiCRAd.
- Partnership with Kuva Labs to integrate certepetide into advanced cancer diagnostic technologies.
- Research agreement with the University of Cincinnati to evaluate certepetide for non-oncology applications like endometriosis.
These collaborations highlight Lisata's commitment to innovation and its technology's versatility.
Regulatory Designations and Market Position
Certepetide has received multiple regulatory designations, including Fast Track and Orphan Drug Designations from the U.S. FDA and the European Union for indications such as pancreatic cancer, glioma, osteosarcoma, and cholangiocarcinoma. These designations underscore the potential of certepetide to address unmet medical needs in rare and aggressive cancers.
Business Model and Revenue Potential
Lisata operates on a business model centered around clinical innovation, strategic partnerships, and intellectual property development. The company generates value through licensing agreements, milestone payments, and potential future commercialization of its therapies. Its robust pipeline and proprietary technology platform provide a strong foundation for long-term growth in the oncology market.
Challenges and Competitive Landscape
As a clinical-stage company, Lisata faces challenges typical of the biopharmaceutical industry, including regulatory hurdles, high R&D costs, and competition from established players and emerging startups. However, its focus on solid tumors—a segment with significant unmet needs—provides a competitive edge. By combining innovative technology with strategic collaborations, Lisata aims to differentiate itself in a crowded market.
Conclusion
Lisata Therapeutics Inc. is at the forefront of developing next-generation cancer therapies. Its lead product, certepetide, and the underlying CendR Platform® technology represent significant advancements in targeted drug delivery and tumor microenvironment modification. With a strong clinical pipeline, strategic partnerships, and regulatory endorsements, Lisata is well-positioned to make a meaningful impact in oncology and beyond.
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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