New investment to advance Abata’s T-cell therapy for progressive MS
Candidate treatment ABA-101 also given fast-track designation by FDA
Abata Therapeutics has received an investment from Bristol Myers Squibb to support the development of its experimental regulatory T-cell (Treg) therapies for severe autoimmune and inflammatory diseases, including progressive multiple sclerosis (MS).
The new equity investment from the global biopharmaceutical company follows last week’s green light from the U.S. Food and Drug Administration (FDA) allowing Abata to test ABA-101, its treatment candidate for progressive MS, in clinical trials. Abata plans to launch a Phase 1 trial later this year to evaluate that therapy in certain people with progressive MS.
“Given [the company’s] leadership in cell therapy, immunology, and neuroscience, we’re honored to have Bristol Myers Squibb as an investor,” Samantha Singer, Abata’s president and CEO, said in a company press release. “This investment highlights both the potential of our product engine and a shared belief in the transformational potential of … Treg cell therapies for the treatment of autoimmune and inflammatory diseases.”
ABA-101 also recently received FDA’s fast-track designation for progressive MS treatment, which is meant to speed the development of potentially important therapies for serious conditions with unmet medical needs. It gives Abata access to perks including more frequent meetings with the agency and potential priority review status upon filling of a regulatory application.
“There are no effective treatments for progressive MS, and rapidly advancing new therapies is critical for patients and their families,” Singer said in a separate press release. “We are very pleased that the FDA granted us Fast Track designation as it will enable us to expedite our efforts to bring ABA-101 to patients.”
Abata’s pipeline includes ABA-101, its most advanced program, and ABA-201, its investigational Treg cell therapy for type 1 diabetes, an autoimmune disease marked by high blood sugar levels.
Bristol Myers Squibb investing in Abata’s Treg therapies program
Both of these treatment candidates are based on Tregs, a type of immune cells that work to dampen inflammatory and immune responses in the body — including the abnormal responses that drive MS autoimmune diseases like MS.
ABA-101 specifically involves the collection of Tregs from patients and their modification in the lab to carry a cell surface receptor that recognizes fragments of myelin. That protective coating around nerve fibers is progressively damaged and lost in MS.
The engineered Tregs are then infused back into the patient, where they are expected to suppress inflammatory and immune responses at sites where they recognize myelin fragments, which in MS patients are indicative of myelin damage due to autoimmunity. Activated Tregs also are thought to release molecules that promote myelin repair.
ABA-101 is being specifically developed for MS patients with progressive MS, with imaging evidence of ongoing inflammatory tissue injury, and a particular genetic mutation known as HLA-DRB1*15:01. This genetic variation affects the immune system’s ability to identify the body’s healthy tissue and is a risk factor for developing MS.
The support of Bristol Myers Squibb adds not only capital, but also expertise as we advance our two lead programs, ABA-101 for the treatment of progressive multiple sclerosis and ABA-201 for the treatment of type 1 diabetes.
Since the launch of Abata in 2021, the company’s development of Treg-based therapies has been supported by a range of investors, such as Lightspeed Venture Partners, Biogen, Elevatebio, Eurofarma, Invus, Samsara Biocapital, and T1D Fund, previously known as JDRF T1D Fund. Bristol Myers Squibb has now joined this group, but the amount invested has not been disclosed.
“The support of Bristol Myers Squibb adds not only capital, but also expertise as we advance our two lead programs, ABA-101 for the treatment of progressive multiple sclerosis and ABA-201 for the treatment of type 1 diabetes,” Singer said.
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