Lisata Therapeutics Inc (NASDAQ:LSTA) shares were reacting positively this week after the company announced further developments for its lead investigational drug candidate, certepetide.
The company announced the completion of patient enrollment in the Phase 1b/2a CENDIFOX trial, evaluating its iRGD cyclic peptide, certepetide, with FOLFIRINOX-based therapies for pancreatic, colon, and appendiceal cancers.
This comes after the company last week announced a significant partnership and license agreement with Kuva Labs that expands its focus on solid tumor treatments into cancer diagnosis. The agreement gives Kuva Labs, a subsidiary of Mi2 Holdings, access to certepetide as a targeting and delivery agent for their NanoMark platform to develop novel imaging agents for the detection of solid tumor cancers.
What is certepetide?
Certepetide is Lisata’s lead investigational drug which was designed to improve the delivery of anti-cancer therapies in solid tumors. It works by activating a tumor-specific transport mechanism that enhances the penetration and retention of co-administered therapies within tumors while not impacting normal tissues.
Certepetide also modifies the tumor microenvironment, making it less immunosuppressive and more supportive of immune cell activity.
Clinical trials have shown its potential to boost the effectiveness of standard-of-care chemotherapy, particularly for pancreatic cancer, with a favorable safety and tolerability profile.
Recognized with Fast Track and Orphan Drug designations from the US Food and Drug Administration (FDA) for several cancers, including pancreatic cancer and osteosarcoma, certepetide is currently being studied in clinical trials to explore its ability to enhance a range of cancer treatments.
Why is it important?
Lisata is focused on solid tumors, including pancreatic cancer, glioblastoma, and cholangiocarcinoma.
These cancers pose significant challenges to effective treatment with current therapies because solid tumors are characterized by a dense and complex microenvironment that hinders the delivery and penetration of anti-cancer drugs and reduces the effectiveness of standard treatments like chemotherapy and immunotherapy.
Additionally, the immunosuppressive nature of the tumor microenvironment limits the ability of the immune system to target and destroy cancer cells.
The CENDIFOX trial is a study where researchers are testing how safe and effective it is to combine certepetide with a standard chemotherapy treatment called neoadjuvant FOLFIRINOX. They are also looking at whether adding another drug, panitumumab, makes a difference.
The study focuses on three types of cancer: pancreatic, colon, and appendiceal (appendix) cancers.
Essentially, the trial aims to see if adding certepetide—and possibly panitumumab—can improve outcomes for patients receiving chemotherapy before surgery.
In addition to assessing safety and efficacy, the trial will provide critical tumor tissue data for immune profiling and insights into long-term patient outcomes. It is funded by the KU Cancer Center, with Lisata supplying certepetide.
Next steps
With patient enrollment now complete in the Phase 1b/2a CENDIFOX trial, Lisata Therapeutics will turn its attention to analyzing the safety, efficacy, and immune profiling data collected from the study to validate certepetide’s potential in treating advanced solid tumors.
Results from the trial are anticipated in 2025.
Management says
“The successful enrollment of all three cohorts in the CENDIFOX trial is another significant milestone, bringing us closer to validating certepetide’s potential as a transformative treatment for advanced solid tumors,” said Dr Kristen Buck, Lisata’s chief medical officer.
On the partnership with Kuva Labs, Dr Buck added: “This license agreement exemplifies certepetide’s broad versatility, extending its application beyond our current focus on solid tumor treatments and into the realm of cancer diagnosis.”