Lisata Therapeutics Inc (NASDAQ:LSTA) CEO David Mazzo joined Proactive to discuss the company’s strategic collaboration with GATC Health, a leader in artificial intelligence-driven drug discovery.
Mazzo explained that GATC’s technology will be used to analyze Lisata’s lead candidate certepetide and identify potential new drug combinations.
Proactive: Hello, you're watching Proactive. I'm joined by Lisata Therapeutics CEO, David Mazzo. David, very good to speak with you again. You've seen progress with your strategic collaboration with GATC Health. Tell us about this partnership and what it's aimed at.
David Mazzo: Good morning, and thank you again for having us on. We're very excited about the collaboration with GATC Health. As we announced in the press release, they are one of the pre-eminent artificial intelligence groups working in the field of new drug discovery. Today, in fact, I'll use the term validated—but they've certainly been noted for their prowess by the fact that Lloyd’s of London has chosen them as part of their new system to provide clinical trial insurance.
GATC Health does all the risk assessments and essentially acts as the actuary in these insurance schemes. So, they are counting heavily on the ability of GATC’s technology to predict the probability of success in drug discovery and development. Our association with them capitalizes on that ability by applying it to certepetide, allowing us to further our two-pillar development approach. This means not only optimizing our plans for completing developments in pancreatic cancer but also expanding the possible uses of certepetide. This could include combinations with other anti-cancer agents or even with drugs outside of cancer.
What we like about GATC, besides them being clearly brilliant, is that they work at what I call the “Lisata speed.” Maybe they call it “GATC speed,” but mutually, we're both highly responsive. Things don't take days—they take hours. Their technology can perform billions of calculations simulating human biology in silico very rapidly. This should speed up drug development, de-risk it, and ultimately reduce costs. We’re very excited about this.
The first step of the collaboration is that they're going to analyze certepetide on their advanced technology platform. Then beyond that, you're going to be identifying other drugs that you can use in combination with certepetide. Is that right?
That is correct. They regularly identify drugs independent of their collaboration with us. These include both existing drugs and new chemical entities that they are patenting, which can be applied to various therapeutic areas. The hope is that in the future, not only might we collaborate on combining some of these new discoveries with certepetide, but also on projects that don’t involve certepetide at all. This could enrich Lisata’s pipeline, as we stated in the press release.
They also see value in our expertise in translational medicine and drug development, just as we see value in their ability to generate highly de-risked drug development proposals.
You recently reported your full-year 2024 results, highlighting progress with your clinical pipeline and encouraging preliminary data from the Phase 2b pancreatic cancer trial. How will this collaboration support your development strategy going forward?
It will help on several fronts. As we previously discussed, we have ongoing studies in pancreatic ductal adenocarcinoma (PDAC), non-resectable pancreatic cancer, and cholangiocarcinoma, both first- and second-line. Additionally, we have exploratory studies in colon cancer, appendiceal cancer, and early work in metastatic melanoma—all using certepetide in cancer indications we’ve identified.
What we expect from GATC is not only prioritization of resources and optimization of development schemes—such as selecting the best endpoints—but also identification of new areas we haven’t yet considered. These could be more de-risked and have a higher probability of yielding positive results in the shorter term. Additionally, the collaboration could expand our work into non-cancer indications as well.
As this collaboration gets underway, what does 2025 hold in store for Lisata?
As I mentioned in our conference call, 2025 is a data-rich year for us. We've already reported cohort A from the ASCEND trial, which showed positive indications and corroborated previous therapeutic effects. We had four complete responses in the certepetide treatment group and none in the standard-of-care group, with a clear indication of separation in overall survival.
We expect to report overall survival (OS) data from cohort B in the coming months, along with full cohort B data. The limiting factor here is that we have an agreement with our academic collaborators to release this data at a major scientific meeting before issuing a press release. We're currently working to identify which meeting that will be.
Beyond ASCEND, we may have data from the BOLSTER trial and other studies, including iLSTA, which has already shown preliminary results. These indicate that certepetide, in combination with gemcitabine and durvalumab (a checkpoint inhibitor), enhances responses in non-resectable pancreatic cancer. This could increase interest in certepetide in combination with immunotherapy.
We will also have discussions with regulatory agencies regarding the next steps in pancreatic ductal adenocarcinoma development, as well as ongoing discussions with potential partners to further maximize the value of certepetide.
Quotes have been lightly edited for clarity and style