Lisata Therapeutics Inc (NASDAQ:LSTA) CEO David Mazzo joined Proactive to discuss a recent milestone for the company: the completion of patient enrollment in the pancreatic cancer cohort of its Phase 1b/2a CENDIFOX trial.
The trial is evaluating the safety and efficacy of certepetide (formerly LSTA1) in combination with FOLFIRINOX-based therapies for pancreatic, colon, and appendiceal cancers.
Mazzo explained to Proactive that this trial combines the company’s lead program, certepetide with a standard of care treatment, providing crucial data on the drug's efficacy in enhancing immune cell infiltration in tumors.
Proactive: You've completed patient enrollment for the pancreatic cancer cohorts in your phase 1b/2a clinical trial. That's another milestone for the trial.
David Mazzo: Yes, we're very pleased to have made that announcement for a number of reasons. This is one of the trials where we're combining certepetide formerly known as LSTA1, with another standard of care treatment typically used in pancreatic cancer. This is the first trial where we'll have real data combining certepetide with this standard of care treatment.
This trial, conducted in conjunction with a university cancer center, allows us to see pre- and post-treatment biopsies of the tumors. This provides us with physiological and quantitative information regarding cytotoxic T cell infiltration of the tumors. It corroborates in humans what we've previously seen in animals and anecdotally in other studies – that certepetide improves immune cell infiltration into the tumor microenvironment. We're very excited about this milestone and look forward to reporting the data in the coming quarters.
You still have to complete enrollment in the remaining two cohorts. Can you explain what these are?
Yes. In general, we're looking at the combination of certepetide with various products in different tumor types. In this study, we're examining the effects of certepetide in combination with standard care treatments in colorectal cancer and other tumor types. The specifics of the protocol are available for anyone interested.
These two cohorts will provide the first glimpses of certepetide’s ability to assist with these tumor types when combined with different chemo or immunotherapy regimens. Both cohorts are progressing well in terms of enrollment. Although these patients are rarer in terms of enrollment criteria, we expect to complete enrollment by the end of this year.
Are you encouraged by the progress of the trial so far?
Very much so. This is essentially a single-center trial, pulling in patients from the Kansas City area. Given the competition for these patients, the enthusiasm and progress we've seen are very encouraging. It corroborates what we're seeing in our other trials, many of which are enrolling according to plan or ahead of plan. Investigators, even though most trials are blinded, are seeing encouraging results, suggesting the treatment is effective. This motivates us to keep going.
When would you expect to report the results of the trial?
I'm hoping to have top-line results by the end of this year, depending on how quickly all the biopsies can be processed by external laboratories. If all goes well, we should be able to report some data by the end of the year.
Quotes have been edited for clarity and style