Immunocore’s Lead Asset Tebentafusp Gains Fast Track Designation for Metastatic Uveal Melanoma

OXFORD, England & CONSHOHOCKEN, Pa.–(BUSINESS WIRE)–Immunocore Limited, a leading T Cell Receptor (TCR) biotechnology
company, today announces that the U.S. Food and Drug
Administration (FDA) has granted Fast Track Designation for its
development program, the investigation of tebentafusp (IMCgp100) for the
treatment of patients who are HLA-A*0201-positive with previously
untreated, metastatic uveal melanoma (mUM).

The pivotal study IMCgp100-202 is a 2:1 randomized study of tebentafusp
compared with Investigator’s Choice (dacarbazine, ipilimumab or
pembrolizumab) in HLA-A*0201 positive adult patients with previously
untreated mUM. The primary endpoint is a comparison of overall survival.

“For patients with metastatic uveal melanoma, the prognosis is poor and
has not meaningfully changed in decades. Our goal is to test whether
tebentafusp can prolong survival for these patients.” comments David
Berman, Head of R&D of Immunocore. “We are delighted that
tebentafusp has been granted Fast Track Designation.”

The FDA’s Fast Track program is designed to facilitate the development,
and expedite the review of drugs to treat serious conditions and fill an
unmet medical need. A drug granted Fast Track Designation may be
eligible for several benefits, including more frequent meetings and
communications with the FDA and, if relevant criteria are met, the
potential for Accelerated Approval, Priority Review or Rolling Review of
a Biologics License Application (BLA) or New Drug Application (NDA).

Tebentafusp has previously been granted orphan drug designation for
melanoma by the US FDA and Promising Innovative Medicine designation
under UK Early Access to Medicines Scheme.

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About Immunocore

Immunocore, a leading T Cell Receptor (TCR) biotechnology company,
working to create first-in-class biological therapies that have the
potential to transform patients’ lives. The Company’s primary
therapeutic focus is oncology and it also has programs in infectious and
autoimmune diseases. Immunocore has a pipeline of proprietary and
partnered programs in development and the lead program, tebentafusp
(IMCgp100), has entered pivotal clinical studies as a treatment for
patients with metastatic uveal melanoma. Collaboration partners include
Genentech, GlaxoSmithKline, AstraZeneca, Lilly, and the Bill and Melinda
Gates Foundation. Immunocore is headquartered at Milton Park,
Oxfordshire, UK, with an office outside Philadelphia, USA. The Company
is privately held by a broad international investor base. For more
information, please visit www.immunocore.com.

About Tebentafusp

Tebentafusp is a novel bi-specific biologic T cell redirection therapy
that specifically targets the melanoma associated antigen gp100, and
which is now in pivotal studies for mUM.

Contacts

Immunocore
Louise Conlon, External Affairs and Brand
Communications Manager
T: +44 (0)1235 438600
E: [email protected]
Follow
on Twitter: @Immunocore

Consilium Strategic Communications (corporate and financial)
Mary-Jane
Elliott/Jessica Hodgson/Chris Welsh
T: +44 (0)203 709 5700
E: [email protected]