(OXFORDSHIRE, England & CONSHOHOCKEN, Penn.
& ROCKVILLE, Md, 01 November 2023) Immunocore Holdings plc
(Nasdaq: IMCR), a commercial-stage biotechnology company pioneering
the development of a novel class of T cell receptor (TCR)
bispecific immunotherapies designed to treat a broad range of
diseases, including cancer, infectious diseases and autoimmune
conditions, will present data for KIMMTRAK (tebentafusp-tebn) in
metastatic uveal melanoma and cutaneous melanoma at the Society for
Immunotherapy of Cancer's (SITC) Annual Meeting (1st – 5th
November) and the Society for Melanoma Research (SMR) Congress (6th
– 9th November).
Across the two scientific conferences, the
company will present seven posters:
Presentation and poster details
Society for Immunotherapy of Cancer
Title: Molecular features associated with long
survival on tebentafusp in previously untreated metastatic uveal
melanoma in a phase 3 trial (abstract #30)Presenting
author: Marlana OrloffSession: Poster
Hall, Saturday November 4, 2023
Title: Novel regulators of ImmTAC-mediated
killing of melanoma cancer cells revealed by genome-wide
CRISPR-Cas9 screens (abstract #1108)Presenting
author: Aleksandra RaczkaSession: Poster
Hall, Saturday November 4, 2023
Society for Melanoma Research
Title: Propensity score analysis of the effect
of corticosteroids on survival from tebentafusp in metastatic uveal
melanoma (mUM) (poster #P-096)Presenting author:
Alexandra IkeguchiSession: Poster display, Monday
November 6, 2023 – Wednesday November 8, 2023
Title: Tumor microenvironment (TME) features
and serum cytokines in patients with metastatic uveal and cutaneous
melanoma treated with tebentafusp (poster #P-225)Presenting
author: Omid HamidSession: Poster
display, Monday November 6, 2023 – Wednesday November 8, 2023
Title: A Phase 2/3 trial in progress on
tebentafusp as monotherapy and in combination with pembrolizumab in
HLA-A*02:01+ patients with previously treated advanced non-uveal
melanoma (TEBE-AM) (poster #P-047)Presenting
author: Diwakar DavarSession: Poster
display, Monday November 6, 2023 – Wednesday November 8, 2023
Title: Evidence of tumor response in orbital
lesions treated with tebentafusp in metastatic uveal melanoma
patients (poster #P-089)Presenting author: Marcus
ButlerSession: Poster display, Monday November 6,
2023 – Wednesday November 8, 2023
Title: Early ctDNA reduction is associated with
better overall survival in the Ph 3 trial of tebentafusp in
previously untreated metastatic uveal melanoma (poster
#P-163)Presenting author: Ryan
SullivanSession: Poster display, Monday November
6, 2023 – Wednesday November 8, 2023
##
About ImmTAC®
molecules for cancerImmunocore’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 KIMMTRAK®KIMMTRAK is a
novel bispecific protein comprised of a soluble T cell receptor
fused to an anti-CD3 immune-effector function. KIMMTRAK
specifically targets gp100, a lineage antigen expressed in
melanocytes and melanoma. This is the first molecule developed
using Immunocore’s ImmTAC technology platform designed to redirect
and activate T cells to recognize and kill tumor cells. 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.
About Phase 3 IMCgp100-202 TrialIMCgp100-202
(NCT03070392) is a randomized pivotal trial that evaluated overall
survival (OS) of KIMMTRAK compared to investigator’s choice (either
pembrolizumab, ipilimumab, or dacarbazine) in HLA-A*02:01-positive
adult patients with previously untreated mUM. KIMMTRAK demonstrated
an unprecedented OS benefit with a Hazard Ratio (HR) in the
intent-to-treat population favoring KIMMTRAK, HR=0.51 (95% CI:
0.37, 0.71); p< 0.0001, over investigator’s choice (82%
pembrolizumab; 13% ipilimumab; 6% dacarbazine).
IMPORTANT SAFETY INFORMATION
Cytokine Release Syndrome (CRS), which may be serious or
life-threatening, occurred in patients receiving KIMMTRAK. Monitor
for at least 16 hours following first three infusions and then as
clinically indicated. Manifestations of CRS may include
fever, hypotension, hypoxia, chills, nausea, vomiting, rash,
elevated transaminases, fatigue, and headache. CRS occurred in 89%
of patients who received KIMMTRAK with 0.8% being grade 3 or 4.
Ensure immediate access to medications and resuscitative equipment
to manage CRS. Ensure patients are euvolemic prior to initiating
the infusions. Closely monitor patients for signs or symptoms of
CRS following infusions of KIMMTRAK. Monitor fluid status, vital
signs, and oxygenation level and provide appropriate therapy.
Withhold or discontinue KIMMTRAK depending on persistence and
severity of CRS.
Skin Reactions
Skin reactions, including rash, pruritus, and cutaneous edema
occurred in 91% of patients treated with KIMMTRAK. Monitor patients
for skin reactions. If skin reactions occur, treat with
antihistamine and topical or systemic steroids based on persistence
and severity of symptoms. Withhold or permanently discontinue
KIMMTRAK depending on the severity of skin reactions.
Elevated Liver Enzymes
Elevations in liver enzymes occurred in 65% of patients treated
with KIMMTRAK. Monitor alanine aminotransferase (ALT), aspartate
aminotransferase (AST), and total blood bilirubin prior to the
start of and during treatment with KIMMTRAK. Withhold KIMMTRAK
according to severity.
Embryo-Fetal ToxicityKIMMTRAK may cause fetal
harm. Advise pregnant patients of potential risk to the fetus and
patients of reproductive potential to use effective contraception
during treatment with KIMMTRAK and 1 week after the last dose.
The most common adverse reactions (≥30%) in patients who
received KIMMTRAK were cytokine release syndrome, rash, pyrexia,
pruritus, fatigue, nausea, chills, abdominal pain, edema,
hypotension, dry skin, headache, and vomiting. The most common
(≥50%) laboratory abnormalities were decreased lymphocyte count,
increased creatinine, increased glucose, increased AST, increased
ALT, decreased hemoglobin, and decreased phosphate.
For more information, please see full Summary of Product
Characteristics (SmPC) or full U.S. Prescribing Information
(including BOXED WARNING for CRS).
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. Immunocore’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 (mUM) in the United States, European Union, Canada,
Australia and the United Kingdom, having demonstrated an overall
survival benefit in a randomized Phase 3 clinical trial in mUM, a
cancer that has historically proven to be insensitive to other
immunotherapies.
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,” “can,” “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 therapeutic potential and expected clinical benefits of our
product candidates, including overall survival benefit of
tebentafusp; and expectations that ctDNA reduction from tebentafusp
is strongly associated with overall survival benefit. Any
forward-looking statements are based on management’s current
expectations of future events and are subject to a number of risks
and uncertainties that could cause actual 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, strategy, financial position 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 the COVID-19 pandemic, war in Ukraine 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 pre-clinical studies or
clinical trials; actions of regulatory agencies, which may affect
the initiation, timing and progress of Immunocore’s 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 COVID-19
pandemic, war in Ukraine and global geopolitical tension;
Immunocore’s ability to obtain, maintain and enforce intellectual
property protection for KIMMTRAK or any product candidates it is
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 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: Immunocore
Sébastien Desprez, Head of CommunicationsT: +44 (0) 7458030732 E:
sebastien.desprez@immunocore.com Follow on Twitter and LinkedIn:
@Immunocore
Investor Relations Clayton Robertson,
Head of Investor RelationsT: +1 (215) 384-4781E:
clayton.robertson@immunocore.com
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