Abata Therapeutics Receives FDA Fast Track Designation for ABA-101 for the Treatment of Progressive Multiple Sclerosis
August 22 2024 - 7:00AM
Abata Therapeutics, a company focused on transforming lives with
Treg therapies for severe autoimmune and inflammatory diseases,
today announced that the U.S. Food and Drug Administration (FDA)
has granted Fast Track designation for ABA-101 for the treatment of
patients with progressive multiple sclerosis (MS). The FDA recently
cleared ABA-101’s Investigational New Drug (IND) application, and
initiation of a first-in-human (FIH) Phase 1 study is imminent.
“There are no effective treatments for progressive MS, and
rapidly advancing new therapies is critical for patients and their
families. 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,” said Samantha Singer, M.S., M.B.A., president
and chief executive officer of Abata. “We are focused on initiating
our Phase 1 study this year in patients and evaluating the
potential impact of this important new therapy.”
The FDA grants Fast Track designation to facilitate the
development and expedite the review of drugs to treat serious
conditions and fill an unmet medical need, with the ultimate goal
of getting important new drugs to patients earlier. A drug that
receives Fast Track designation may be eligible for more frequent
meetings and communications with the FDA and rolling review of any
application for marketing approval, which may lead to earlier drug
approval and access for patients. A drug receiving Fast Track
designation also may be eligible for Accelerated Approval and
Priority Review if relevant criteria are met.
About ABA-101 and Progressive Multiple
SclerosisABA-101 is Abata’s autologous Treg therapy in
development for the treatment of progressive multiple sclerosis. It
was specifically designed for MS patients with progressive disease
who have imaging evidence of ongoing inflammatory tissue injury and
are HLA-DRB1*15:01 positive – an estimated patient group of about
45,000 in the U.S. today. ABA-101 is created by engineering a
patient’s own Tregs to express a T cell receptor (TCR) that
specifically recognizes immunogenic myelin fragments in the CNS.
This approach was designed to offer a strong safety profile and a
highly localized anti-inflammatory effect at the site of
disease. In in vivo preclinical studies, ABA-101 was
well-tolerated and demonstrated antigen-dependent Treg
functionality, anti-inflammatory cytokine production, suppression
of the production of inflammatory cytokines and therapeutic
effect.
About Abata TherapeuticsAbata Therapeutics is
dedicated to transforming lives with Treg therapies for severe
autoimmune and inflammatory diseases. Founded by pioneers in Treg
biology, TCR and antigen discovery, disease pathogenesis, and
molecular and imaging biomarkers, Abata has developed a
differentiated product engine to create engineered Treg cell
therapies that are tissue-specific, robust, and durable. Abata’s
lead program in progressive MS is on track to initiate a Phase 1
study in 2024, and its second program in type 1 diabetes is in
IND-enabling studies. Both indications are tissue-specific
autoimmune diseases with substantial unmet need, supporting a
strong rationale for Abata’s Treg approach. The company was
launched in 2021 by Third Rock Ventures, and today is supported by
a diverse syndicate of investors, including Lightspeed Venture
Partners, Biogen, Bristol Myers Squibb, ElevateBio, Eurofarma,
Invus, Samsara BioCapital, and T1D Fund (formerly JDRF T1D Fund).
Abata is based in Watertown, Mass. Please
visit abatatx.com or follow us on X (formerly known
as Twitter) or LinkedIn for more information.
Media ContactCory TrombleeScient
PRcory@scientpr.com
Investor ContactCourtney MogerleyPrecision
AQCourtney.Mogerley@precisionAQ.com