A Pittsburgh-based biotech startup announced it reached the next milestone in its pursuit of full U.S. Food and Drug Administration (FDA) approval for its drug that looks to aid cancer patients undergoing immunotherapy treatment.
This new clearance for CytoAgents Inc., which employs four people full-time, comes just days after the startup closed on a $7 million Series A2 equity-based funding round, which Pittsburgh-based PCG Capital led with support from BlueTree Allied Angels and a syndicate of local oncologists. It brings the startup's total funding to $20 million since its founding in 2018.
According to Teresa Whalen, CEO of CytoAgents, this "Study May Proceed" letter from the FDA is crucial as part of the development of its drug, CTO1681, which aims to treat Cytokine Release Syndrome (CRS), a medical condition that can occur when the body's immune system responds to infection or immunotherapy drugs more aggressively than it should.
Previously, CytoAgents was only permitted to conduct its trials with healthy human patients, but the startup can now move to aid those who could stand to benefit from the drug's potential most following the initiation from the FDA that CytoAgents can enter a U.S. Phase 1b/2a clinical trial under the FDA's Investigational New Drug application.
Whalen said it's estimated that up to 90% of patients receiving immunotherapy to fight lymphoma experience CRS as a side effect, which can be fatal.
"What's so important about receiving the letter 'Study May Proceed' from FDA is that they've authorized us to move forward in a trial and we're treating lymphoma patients receiving CAR T-Cell Therapy and [who are] at risk to this toxicity," Whalen said. "If we're successful, if we can perhaps prevent or treat Cytokine Release Syndrome altogether by reducing this life-threatening side effect, we can treat more and more patients with CAR T."
Whalen said these patients on average spend about two weeks in the hospital while undergoing their CAR T treatments, which could be reduced significantly should CTO1681 prove successful.
The "vast majority" of the capital raised from the startup's Series A2 will go toward the continued funding of these clinical trials, Whalen said.
"We now are in a position with FDA to make a real difference in this patient population, and we have the team to execute," Whalen said after noting that Dr. Stanley M. Marks, chairman of the UPMC Hillman Cancer Center, also serves as the chairman of CytoAgents' board. "This next year for CytoAgents, we're really turning the corner and it'll be a year of great growth and with positive data, [we're at] a very significant value inflection point."
Brian Shanahan, managing partner at PCG Capital, firmly believes in the startup's potential. It's why he lauded a $3.33 million investment into CytoAgents' most recent funding round and he expects to put even more capital in once the company reaches its next trial stage. It's also a different type of investment from the ones he's made in the past given his historical funding support for fintech-oriented startups and real estate development deals.
"This is an anomaly for now, and the reason why I chose to do it is because I was diagnosed with pancreatic cancer in August of 2020; I had like a 7% chance to live," Shanahan said. "When I saw this drug and I saw what it can do and because of my pancreatic journey I've been on, I saw the efficacy and the safety of this drug to help other cancer patients and anybody that has cancer or is struggling to live and fighting off this deadly disease, I'm all about supporting [that]…We put a bunch of money into this because we believe that we'll pay it forward and help a lot of cancer patients out there."
