The Phase 1/2 trial will assess the safety and
clinical activity of IMC-R117C, as a monotherapy and in combination
with standards of care, in patients with advanced cancers
expressing PIWIL1
First immunotherapy program to target PIWIL1, a
cancer-testis antigen overexpressed in a range of cancers,
including colorectal cancer
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn.
& ROCKVILLE, Md., US, 17 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 treated in the
Phase 1/2 trial of its novel ImmTAC candidate, IMC-R117C, targeting
PIWIL1 in colorectal and other gastrointestinal cancers.
IMC-R117C is Immunocore’s fifth ImmTAC candidate
to enter the clinic. PIWIL1 is overexpressed in multiple
malignancies, including colorectal cancer (CRC), and is associated
with aggressive tumor growth and poor patient survival.i Despite
the development and approval of novel therapeutics, there remains a
significant unmet medical need in patients with these cancers,
especially in advanced colorectal cancer that is refractory to or
has relapsed following standard chemotherapies and targeted
therapies.
The Company believes IMC-R117C is the first
PIWIL1-targeted immunotherapy and estimates that there are up to
20,000 colorectal cancer patients globally that are positive for
both PIWIL1 and HLA-A*02:01.
“We are proud to bring forward the first
immunotherapy program to target PIWIL1, through our novel ImmTAC
candidate, IMC-R117C,” said Mohammed Dar, Senior Vice
President, Clinical Development and Chief Medical Officer of
Immunocore. "PIWIL1 is expressed across all major subsets
of colorectal cancer – including microsatellite-stable CRC, which
has historically been insensitive to immunotherapy.”
The trial will evaluate the safety and clinical
activity of IMC-R117C in HLA-A*02:01-positive patients with select
advanced solid tumors. In addition to evaluating IMC-R117C as a
single agent, the trial will also test combinations with standards
of care.
###
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 Phase 1/2 trial of
IMC-R117C
IMC-R117C-1004 is a Phase 1/2, multicenter,
open-label, first-in-human trial of IMC-R117C in
HLA-A*02:01-positive patients with advanced cancers that express
PIWIL1. This trial is designed to assess the safety, tolerability,
pharmacokinetics (PK), immunogenicity, pharmacodynamics, and
clinical activity of IMC-R117C as monotherapy and in combination
with other therapies.
About colorectal cancer
Colorectal cancer (CRC) is one of the most
prevalent forms of cancer affecting the colon and rectum. Most
patients with CRC are diagnosed at an early stage, but survival
rates remain low for those with advanced or metastatic disease.
Despite advancements in CRC treatment, there is a significant need
for new therapies that enhance first-line response rates and extend
the duration of response, particularly for patients who do not
respond to initial treatments. Early detection through regular
screening is crucial for improving outcomes associated with
CRC.
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, scope and results of
Immunocore’s existing and planned clinical trials, including the
Phase 1/2 trial of IMC-R117C in patients with advanced cancers
expressing PIWIL1; the ability of IMC-R117C to target PIWIL in
colorectal and other gastrointestinal cancers; and the value
proposition of Immunocore’s product candidates, including
IMC-R117C, including expectations regarding the significant unmet
need for patients with colorectal cancer and the potential market
opportunity of IMC-R117C. 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 inflation, interest rates and unfavorable general
market conditions, and the impacts thereon of war in Ukraine,
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 Securities and Exchange
Commission. 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 Relations
Clayton Robertson, Head of Investor RelationsT:
+1 (215) 384-4781E: ir@immunocore.com
i Sun, Rui, Chun-li Gao, Dong-hai Li, Bo-jun Li,
and Yan-hong Ding. 2017. “Expression Status of PIWIL1 as a
Prognostic Marker of Colorectal Cancer.” Disease Markers
2017:1204937. https://doi.org/10.1155/2017/1204937
Immunocore (NASDAQ:IMCR)
Historical Stock Chart
From Nov 2024 to Dec 2024
Immunocore (NASDAQ:IMCR)
Historical Stock Chart
From Dec 2023 to Dec 2024
