Lisata Therapeutics embarks on cancer-fighting campaign

Basking Ridge-based Lisata Therapeutics is making strides against cancer using innovative technology to develop treatments that weaken tumors and potentially enhancing the delivery of drugs.

The clinical-stage pharmaceutical company was formed from the merger of Caladrius Biosciences and Cend Therapeutics , with New Jersey native David

as president and CEO. The longtime pharma and biotech executive’s career started with some of the Garden State’s biggest pharmaceutical companies, such as Merck and Roche, and took him all over the world before returning to New Jersey where he has remained the last nearly 30 years.

Mazzo recently spoke to NJBIZ about his career, Lisata, doing business in New Jersey and more. He lauded the state for its talent and location, which is why he said he moved his last several ventures that were originally headquartered elsewhere to New Jersey.

'It made sense' to be in NJ

“This is still the medicine cabinet of the United States and maybe of the world, in so many respects,” told NJBIZ. “So, it made sense to be here, especially since we’re looking to bring products to market.”

While he noted the bona fides of areas such as Cambridge and San Francisco as hotbeds of innovation and early discovery and development, nonetheless emphasized the strengths New Jersey boasts in terms of getting products out the door. “If you really want to bring things over the finish line and get products to market and get products to patients, which is really what we want to do,” explained. “It just made sense to be here in New Jersey.”

Mazzo also pointed to state incentives that have helped the company, such as the Net Operating Loss program. “Because it’s not an inexpensive place to live. And it’s not an inexpensive place to do business,” he explained. “But they’ve got some programs in place that make it a bit more user-friendly, especially for technology companies like ours. And we’ve taken full advantage of them. I just hope that some of these programs remain in place because they do help us significantly.”

Lisata has existed in its current configuration since September 2022. “But our predecessor company, Caladrius Biosciences, was also based here in New Jersey and had been around for some time. We ended up purchasing a small private company that had the technology that we felt we could exploit in a positive sense,” explained. “By exploit, I mean, we were better positioned to develop appropriately. So, we orchestrated that acquisition and at the time, that represented a change in our focus from really cardiovascular ischemic disease with cell therapies into this oncology asset and working on the solid tumors.”

At that point, the company changed its name to Lisata.

A difficult area of focus

On that oncology note, the company has focused its attention on some of the most difficult cancers to treat such as pancreatic and brain. explained that two of the main issues with treating solid tumors are the structure where a barrier of cells akin to a shower cap can form over the tumor and prevent drugs from getting into it and that they excrete and produce an immunosuppressive micro-environment that helps the tumor hide from the immune system.

“You’ve got to overcome both of these things to really treat solid tumors effectively,” he explained. “Up until now, the main way of dealing with this has been, to a great extent, brute force. You pump a lot more drug in, usually chemotherapy. You force a greater concentration gradient and you hope that that’s going to push more drug into the tumor. And it does to a certain extent.”

But that’s why these drugs come with so many side-effects, says, because they are essentially poisons and you have lots of off-target adverse events. “We’ve got a technology that really is focused on targeting tumors, specifically, so we could try to avoid these off-target effects and finding a way to penetrate the tumors in a more effective way with the chemo and immunotherapies that are co-administered with our product,” said . “And at the same time, alter the microenvironment to make it less immunosuppressive or make it immune-receptive.

Some people ask us sort of incredulously why’d you pick the hardest. Well, we picked them because they are the hardest cancers. If they weren’t the hardest cancers they’d already have good treatments for them.

David , president and CEO, Lisata Therapeutics

“In other words, remove or at least poke holes in the invisibility cloak to let your innate immune system and any externally administered immunotherapies recognize this as something that should be attacked.”

Lisata’s lead product in this effort is certepetide , which has shown promise in preclinical and clinical studies demonstrating favorable safety, tolerability and activity. stressed that it has also not shown any inherent toxicities.

“It’s fairly benign as a standalone agent but it has the properties of doing the things we want it to do, both in terms of targeting and penetration enhancement; as well as tumor microenvironment modification,” he explained. “And we are developing certepetide across a wide variety of different solid tumor types because any tumor that has a stromal barrier should benefit from a co-administration with certepetide.”

“Some people ask us sort of incredulously why’d you pick the hardest. Well, we picked them because they are the hardest cancers,” he said. “If they weren’t the hardest cancers they’d already have good treatments for them.”

These cancers represent the highest unmet medical need. “And because, mechanistically they are perfectly suited to the products and the technology that we’ve developed,” said , pointing to the necessity to find ways to treat pancreatic cancer, for example, which is projected to become the second-leading cause of cancer-related deaths by 2030. “That’s what we’re after. And the treatments have really not changed for the last 25, 30 years.”

Encouraging early results

And the early results have been encouraging. “The Phase 1b/2a study that was done in pancreatic cancer showed remarkable improvement in the survival rate of people with pancreatic cancer when certepetide was added to their chemotherapy,” said . “By remarkable, I mean that overall survival was increased by 55% and progression-free survival by 76%. Those were noted by the physicians who were involved in doing the studies. These are their words. They were saying these are breakthrough kind of improvements, unprecedented improvements that we haven’t seen in these types of cancers for decades.”

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That has now led to a Phase 2b trial. “In oncology, if the Phase 2b results are truly compelling in a cancer where there are limited available successful treatment options you have an opportunity, not a guarantee, to receive a conditional approval and get the product out to patients commercially much earlier than having to go through the entire Phase 3 process and approval process in the traditional sense,” explained. “So, we’ve designed our Phase 2b trial to give us the maximum probability of being eligible for that assuming the data is as compelling as 1b/2a data.”

That Phase 2b trial is complete with more than 150 patients enrolled in a randomized, double-blind, placebo-controlled setting. Lisata is a few months away from being able to report the data from that trial.

“That will be seminal for the company and the product, at least in pancreatic cancer,” said , who is hopeful about the results the study will yield. “We’ll have that definitive answer before the end of the year and that will be really, really important.”

In the meantime, said that Lisata is doing work across the different types of solid tumor cancers while building out the organization as it continues its efforts in this important, potentially life-saving work.

“I really do think that we have the opportunity to change the paradigm of treatment for solid tumor cancers,” said . “And what makes this so great for physicians and, of course, for investors is that their existing product is not competing with the existing or newly developed standards of care because it gets combined with it.”

Mazzo stressed that the goal is to get this product to the finish line whether by Lisata itself or through a purchase by a larger pharma company, which could integrate it into their pipeline.

“The whole goal here is to get this product out to as many people suffering from cancer as possible and we’ll do that in whatever way makes the most amount of sense.”

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