Immunocore announces first patient dosed in the
Phase 1 trial of IMC-P115C, a half-life extended (HLE) ImmTAC
candidate in patients with tumors that express PRAME
IMC-P115C (PRAME-HLE-A02) targets the same
peptide and has the same CD3 effector and TCR specificity as
brenetafusp, and is designed with extended
half-life
The Phase 1 trial will assess the safety and
clinical activity of IMC-P115C in HLA-A*02:01-positive patients
with advanced solid tumors that express PRAME
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn.
& GAITHERSBURG, Md., US, 23 December 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 announces that the first patient has
been dosed in the Phase 1 trial of IMC-P115C (PRAME-HLE-A02), which
is a half-life extended ImmTAC candidate.
IMC-P115C was developed to improve patient
convenience by reducing the frequency of treatment administration.
It is Immunocore’s first half-life extended candidate, and sixth
ImmTAC candidate to enter the clinic. IMC-P115C is a PRAME x CD3
ImmTAC bispecific protein, with the same CD3 and targeting the same
HLA-A*02:01 PRAME (PReferentially expressed Antigen in MElanoma)
peptide as brenetafusp.
“I am very proud of the Immunocore team who have
worked diligently with the clinical sites to start the Phase 1
trial with IMC-P115C – our half-life extended PRAME-targeted
candidate,” said Mohammed Dar, Senior Vice President,
Clinical Development and Chief Medical Officer of
Immunocore. “With brenetafusp, we have the largest Phase
1/2 PRAME data set, which served as the basis for starting the
first Phase 3 trial with a PRAME therapy. We look forward to the
data from this Phase 1 trial, which will add to the understanding
of the potential of our PRAME candidates.”
The Phase 1 dose escalation trial will evaluate
the safety, pharmacokinetics and clinical activity of IMC-P115C in
HLA-A*02:01-positive patients with a range of advanced cancers
expressing PRAME.
About ImmTAC®
molecules for cancer
Immunocore’s proprietary T cell receptor (TCR)
technology generates a novel class of bispecific biologics called
ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) molecules
that are designed to redirect the immune system to recognize and
kill cancerous cells. ImmTAC molecules are soluble TCRs engineered
to recognize intracellular cancer antigens with ultra-high affinity
and selectively kill these cancer cells via an anti-CD3
immune-activating effector function. Based on the demonstrated
mechanism of T cell infiltration into human tumors, the ImmTAC
mechanism of action holds the potential to treat hematologic and
solid tumors, regardless of mutational burden or immune
infiltration, including immune “cold” low mutation rate tumors.
About the IMC-P115C Phase 1
trial
IMC-P115C-1005 is a first-in-human, Phase 1
trial in patients with advanced solid tumors expressing PRAME. The
dose escalation portion of the trial is designed to evaluate the
safety, preliminary anti-tumor activity and pharmacokinetics of
IMC-P115C, a bispecific protein built on Immunocore’s ImmTAC
technology, and the Company’s first half-life extended
molecule.
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 diseases and infectious
diseases. Leveraging its proprietary, flexible, off-the-shelf
ImmTAX platform, Immunocore is developing a deep pipeline in
multiple therapeutic areas, including nine active clinical and
pre-clinical programs in oncology, infectious diseases, and
autoimmune diseases. 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 Immunocore’s expectations
regarding the design, progress, timing, enrollment, randomization,
scope, expansion, funding, and results of its existing and planned
clinical trials; including the Phase 1 trial of IMC-F106C-101; and
the expected clinical benefits of IMC-P115C and the Company’s other
product candidates. 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 the Company’s control. These risks and
uncertainties include, but are not limited to, the impact of
worsening macroeconomic conditions on the Company’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 in the Middle
East or global geopolitical tension; Immunocore’s ability to obtain
and maintain regulatory approval of its 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 in the Middle East, 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. 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 10-K for
the year ended December 31, 2023 filed with the Securities and
Exchange Commission on February 28, 2024, as well as discussions of
potential risks, uncertainties, and other important factors in the
Company’s subsequent filings with the SEC. All information in this
press release is as of the date of the release, and the Company
undertakes no duty to update this information, except as required
by law.
Contact Information
Immunocore Sébastien Desprez,
Head of CommunicationsT: +44 (0) 7458030732E:
sebastien.desprez@immunocore.comFollow on Twitter: @Immunocore
Investor RelationsClayton
Robertson / Morgan WareniusT: +1 (215) 384-4781E:
ir@immunocore.com
Immunocore (NASDAQ:IMCR)
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