Abata Therapeutics Announces FDA Clearance of Investigational New Drug Application for Clinical Evaluation of ABA-101 in Progressive Multiple Sclerosis
July 09 2024 - 6:00AM
Abata Therapeutics, a company focused on translating the biology of
regulatory T cells (Tregs) into transformational medicines for
patients living with severe autoimmune and inflammatory diseases,
today announced that the U.S. Food and Drug Administration (FDA)
has cleared the company’s Investigational New Drug (IND)
application to initiate the first-in-human (FIH) Phase 1 study of
ABA-101 in patients with progressive multiple sclerosis (MS).
“We are excited to have reached IND clearance for our first
product candidate, ABA-101, a tissue-specific TCR-Treg cell therapy
for progressive MS. This represents not only an important milestone
for Abata but also a significant advancement in the field as one of
the first tissue-targeted Treg cell therapies for autoimmune
disease,” said Samantha Singer, M.S., M.B.A., president and chief
executive officer of Abata. “In preclinical studies, ABA-101 was
shown to be safe and demonstrated tissue-specific trafficking,
persistence, and robust suppression of inflammation, supporting its
potential therapeutic effect. The quality of the data package,
including a cutting-edge precision medicine trial design for MS,
supported rapid clearance of our IND in less than a month. We look
forward to initiating our Phase 1 study later this year in patients
and evaluating the potential impact of ABA-101 on this progressive,
devastating disease.”
“Across the MS treatment landscape, there are no effective
therapies that address the CNS-compartmentalized inflammation
driving progressive multiple sclerosis. ABA-101 is uniquely
positioned to directly ameliorate this progressive pathology as
well as promote repair and clinical improvement, offering
life-changing benefits to those living with this disease today,”
said Richard M. Ransohoff, M.D., co-founder and advisor of Abata
and venture partner at Third Rock Ventures. “Receiving IND
clearance for ABA-101 validates our unique approach of leveraging
the natural role of Tregs in the immune system to treat autoimmune
diseases where current treatments are either insufficient or
non-existent.”
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 translating the biology of Tregs into transformational
medicines for patients with 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 by the end of 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 ElevateBio, Lightspeed Venture Partners,
Invus, Samsara BioCapital, Eurofarma, the JDRF T1D Fund, and
Biogen. 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