JENKINTOWN, Pa., July 16,
2024 /PRNewswire/ -- SFA Therapeutics, Inc., a
clinical-stage biopharmaceutical company developing oral
small-molecule biosynthetic compounds for the treatment of
inflammatory diseases, today announced the appointment of
James Kirwin, MBA, as Chief
Operating Officer. In this role, Mr. Kirwin will lead the
identification and negotiation of clinical trial study agreements,
collaboration with CMC and regulatory teams, and the development of
GMP clinical trial materials with Contract Development and
Manufacturing Organizations.
Mr. Kirwin is a seasoned biopharmaceutical clinical operations
leader with over 20 years of experience in directing research and
innovation at global pharmaceutical companies as well as emerging
biotechnology start-ups. Mr. Kirwin's wealth of expertise spans
across multiple managerial and operational functions, including
research and development of pre-clinical and clinical assets and
the management of complex, high-performing teams.
"As we advance SFA-002 and other therapeutic candidates through
the clinic, Jim will be an integral member of our team in managing
all aspects of Clinical Development Operations. With his
exceptional ability to execute strategy with cross-functional teams
across a variety of diseases, Jim will bring organizational
excellence to SFA Therapeutics as Chief Operating Officer," said
Dr. Ira Spector, Chief Executive
Officer of SFA Therapeutics. "Jim's strategic direction will be
essential to contributing to SFA's mission to bring safe and
effective drugs to patients suffering from inflammatory and
immunologic conditions."
"As Chief Operating Officer of SFA Therapeutics, I look forward
to applying my clinical operations and managerial skillsets to
develop industry-leading operations in order to execute clinical
trials of SFA-002 and other therapeutic candidates. SFA
Therapeutics' novel platform has the potential to tailor many
biosynthetic compounds with target-specific adjuvants, and I
welcome the chance to help drive this disruptive science through
the clinic to patients in need of safer, more efficacious
treatments," commented James Kirwin,
Chief Operating Officer of SFA Therapeutics.
Most recently, Mr. Kirwin served as the Executive Director,
Global Head of Clinical Operations at Arvinas, where he designed
and built the clinical operations organization and initiated
clinical programs in breast and prostate cancer as well as
neuromuscular diseases. He ensured the smooth transition of the
Vepdegestrant breast cancer program to Pfizer in a collaborative
development agreement. Prior to this, Mr. Kirwin was the Vice
President, Clinical Development Operations and Clinical Alliances
at Iterum Therapeutics where he oversaw the anti-infectives global
clinical trial program which consisted of three Phase III studies
across 240 sites and 2,000 patients. Mr. Kirwin has also held
senior positions at Intercept Pharmaceuticals, Taiho Oncology,
Medtronic Spine and Biologics, Intrexon Corporation, Pfizer, Wyeth
Pharmaceuticals, and AstraZeneca.
Mr. Kirwin received his undergraduate degree in Microbiology and
Molecular Biology from Pennsylvania State
University and his MBA from the University of Delaware.
About SFA Therapeutics
SFA Therapeutics, Inc. is a clinical-stage biopharmaceutical
company developing oral small-molecule biosynthetic compounds for
the treatment of inflammatory diseases. Based on breakthrough
research licensed from Temple
University, SFA Therapeutics' platform has the potential to
develop safer and more efficacious treatments for a number of
chronic inflammatory diseases by uniquely tailoring the effects of
patented formulations with target-specific adjuvants. Its lead
asset, SFA-002, an HDAC inhibitor in immune cells, is approaching
Phase 2 clinical trials and has shown promising Phase 1a and Phase
1b results for the treatment of
psoriasis. SFA Therapeutics has also received clearance of its
Investigational New Drug (IND) application from the U.S. Food and
Drug Administration (FDA) to investigate SFA-001N in patients with
metabolic dysfunction-associated steatohepatitis (MASH), also known
as non-alcoholic steatohepatitis (NASH), with or without fibrosis.
SFA Therapeutics has an Orphan Disease Designation from the FDA for
SFA-001 in the treatment of hepatocellular carcinoma, the most
prevalent form of liver cancer.
SFA Therapeutics is headquartered in Jenkintown,
Pennsylvania. Please
visit www.sfatherapeutics.com to learn more.
Company Contact
Ira Spector, Ph.D.
SFA Therapeutics, Inc.
+1 267-584-1080
Media Contacts
Tony Russo, Ph.D.
Russo Partners, LLC
Tony@RussoPR.com
Maddie Stabinski
Russo Partners, LLC
Madeline@RussoPR.com
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SOURCE SFA Therapeutics, Inc.