Immunocore announces clinical trial collaboration and supply agreement with Bristol Myers Squibb to evaluate IMC-F106C (PRAME HLA-A02) in combination with nivolumab in its registrational Phase 3 first-line advanced cutaneous melanoma trial
22 Febbraio 2024 - 1:00PM
Immunocore announces clinical trial
collaboration and supply agreement with Bristol Myers Squibb to
evaluate IMC-F106C (PRAME HLA-A02) in combination with nivolumab in
its registrational Phase 3 first-line advanced cutaneous melanoma
trial
IMC-F106C is Immunocore’s first-in-class
bispecific TCR ImmTAC candidate targeting PRAME HLA-A02; nivolumab
is manufactured by Bristol Myers Squibb
The clinical trial collaboration relates to
Immunocore’s PRISM-MEL-301 registrational Phase 3 clinical trial in
first-line advanced cutaneous melanoma, evaluating IMC-F106C in
combination with nivolumab versus a control arm of either nivolumab
or the fixed-dose combination of nivolumab and relatlimab
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE,
Md., US, 22 February 2024) Immunocore Holdings plc (Nasdaq: IMCR)
(“Immunocore” or the “Company”), a commercial-stage biotechnology
company pioneering and delivering transformative immunomodulating
medicines to radically improve outcomes for patients with cancer,
infectious diseases and autoimmune diseases, today announced that
it has entered into a clinical trial collaboration and supply
agreement with Bristol Myers Squibb (NYSE:BMY) to investigate
Immunocore’s ImmTAC bispecific TCR (T cell receptor) candidate
targeting PRAME HLA-A02, IMC-F106C, in combination with Bristol
Myers Squibb’s nivolumab, in first-line advanced cutaneous
melanoma.
Under the terms of the collaboration, Immunocore will sponsor
and fund the registrational Phase 3 clinical trial of IMC-F106C in
combination with nivolumab in first-line advanced cutaneous
melanoma (PRISM-MEL-301), and Bristol Myers Squibb will provide
nivolumab.
The PRISM-MEL-301 trial will randomize HLA-A*02:01+ first-line
advanced cutaneous melanoma patients to IMC-F106C + nivolumab
versus a control arm of either nivolumab or the fixed-dose
combination of nivolumab and relatlimab, depending on the country
where the patient is enrolled. Immunocore plans to randomize the
first patient in this trial in the first quarter of 2024.
##
About PRISM-MEL301 – Phase 3 trial with IMC-F106C (PRAME
HLA-A02) in 1L advanced cutaneous melanoma
The Phase 3 registrational trial (NCT06112314) will randomize
patients with previously untreated, HLA-A*02:01 positive, advanced
melanoma to IMC-F106C + nivolumab versus nivolumab or the
fixed-dose combination of nivolumab and relatlimab, depending on
the country where the patient is enrolled. The trial will initially
randomize to three arms: two IMC-F106C dose regimens (40 mcg and
160 mcg) and control arm and will discontinue one of the F106C dose
regimens after an initial review of the first 60 patients
randomized to the two experimental arms (90 patients randomized
total). The primary endpoint of the trial is progression free
survival (PFS) by blinded independent central review (BICR), with
secondary endpoints of overall survival (OS) and overall response
rate (ORR), as well as safety.
About Immunocore
Immunocore is a commercial-stage biotechnology company
pioneering the development of a novel class of TCR bispecific
immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs
Against X disease – designed to treat a broad range of diseases,
including cancer, autoimmune, and infectious disease. Leveraging
its proprietary, flexible, off-the-shelf ImmTAX platform,
Immunocore is developing a deep pipeline in multiple therapeutic
areas, including five clinical stage programs in oncology and
infectious disease, advanced pre-clinical programs in autoimmune
disease and multiple earlier pre-clinical programs. The Company’s
most advanced oncology TCR therapeutic, KIMMTRAK has been approved
for the treatment of HLA-A*02:01-positive adult patients with
unresectable or metastatic uveal melanoma in the United States,
European Union, Canada, Australia, and the United Kingdom.
Forward Looking Statements
This press release contains “forward-looking statements” within
the meaning of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Words such as “may”, “will”,
“believe”, “expect”, “plan”, “anticipate” and similar expressions
(as well as other words or expressions referencing future events or
circumstances) are intended to identify forward-looking statements.
All statements, other than statements of historical facts, included
in this press release are forward-looking statements. These
statements include, but are not limited to, statements regarding
the benefits of Immunocore’s collaboration with Bristol Meyers
Squibb; the risk that the Company may not realize the anticipated
benefits of its collaboration with Bristol-Meyers Squibb; and
expectations regarding the design, progress, timing, enrollment,
randomization, scope, expansion, funding, and results of the
PRISM-MEL301 registrational Phase 3 clinical trial of IMC-F106C
(PRAME- HLA-A02) in combination with nivolumab in first-line
cutaneous melanoma (PRISM-MEL-301). Any forward-looking statements
are based on management’s current expectations and beliefs of
future events and are subject to a number of risks and
uncertainties that could cause actual events or results to differ
materially and adversely from those set forth in or implied by such
forward-looking statements, many of which are beyond Immunocore’s
control. These risks and uncertainties include, but are not limited
to, the impact of worsening macroeconomic conditions on
Immunocore’s business, financial position, strategy and anticipated
milestones, including Immunocore’s ability to conduct ongoing and
planned clinical trials; Immunocore’s ability to obtain a clinical
supply of current or future product candidates or commercial supply
of KIMMTRAK or any future approved products, including as a result
of health epidemics or pandemics, war in Ukraine, the conflict
between Hamas and Israel, or global geopolitical tension; the
timing and sufficiency of clinical trial outcomes to support
potential approval of any of Immunocore’s product candidates or
those of, or combined with, its collaboration partners such as
IMC-F106C (PRAME-HLA A02); Immunocore’s ability to obtain and
maintain regulatory approval of its products and product
candidates, including KIMMTRAK; Immunocore’s ability and plans in
continuing to establish and expand a commercial infrastructure and
to successfully launch, market and sell KIMMTRAK and any future
approved products; Immunocore’s ability to successfully expand the
approved indications for KIMMTRAK or obtain marketing approval for
KIMMTRAK in additional geographies in the future; the delay of any
current or planned clinical trials, whether due to patient
enrollment delays or otherwise; Immunocore’s ability to
successfully demonstrate the safety and efficacy of its product
candidates and gain approval of its product candidates on a timely
basis, if at all; competition with respect to market opportunities;
unexpected safety or efficacy data observed during preclinical
studies or clinical trials; actions of regulatory agencies, which
may affect the initiation, timing and progress of clinical trials
or future regulatory approval; Immunocore’s need for and ability to
obtain additional funding, on favorable terms or at all, including
as a result of worsening macroeconomic conditions, including
changes in inflation and interest rates and unfavorable general
market conditions, and the impacts thereon of the war in Ukraine,
the conflict between Hamas and Israel, and global geopolitical
tension; Immunocore’s ability to obtain, maintain and enforce
intellectual property protection for KIMMTRAK or any of its product
candidates it or its collaborators are developing; and the success
of Immunocore’s current and future collaborations, partnerships or
licensing arrangements, including the risk that Immunocore may not
realize the anticipated benefits of its collaboration with Bristol
Myers Squibb. These and other risks and uncertainties are described
in greater detail in the section titled "Risk Factors" in
Immunocore’s filings with the Securities and Exchange Commission,
including Immunocore’s most recent Annual Report on Form 20-F for
the year ended December 31, 2022 filed with the Securities and
Exchange Commission on March 1, 2023, as well as discussions of
potential risks, uncertainties, and other important factors in
Immunocore’s subsequent filings with the Securities and Exchange
Commission. All information in this press release is as of the date
of the release, and Immunocore undertakes no duty to update this
information, except as required by law.
CONTACT: ImmunocoreSébastien
Desprez, Head of CommunicationsT: +44 (0) 7458030732E:
sebastien.desprez@immunocore.com Follow
on Twitter: @Immunocore
Investor Relations Clayton Robertson /
Morgan Warenius T: +1 215-384-4781E: ir@immunocore.com
Grafico Azioni Immunocore (NASDAQ:IMCR)
Storico
Da Gen 2025 a Feb 2025
Grafico Azioni Immunocore (NASDAQ:IMCR)
Storico
Da Feb 2024 a Feb 2025
