Immunocore announces reimbursement agreement in
England for KIMMTRAK▼ for the treatment of HLA-A*02:01-positive
adults with unresectable or metastatic uveal melanoma
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn.
& GAITHERSBURG, Md., US, 03 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 announced that KIMMTRAK (tebentafusp)
has been recommended for funding through the National Health
Service (NHS) in England by the National Institute for Health and
Care Excellence (NICE).
NICE recommended KIMMTRAK within its marketing
authorization for the treatment of HLA-A*02:01-positive adults with
unresectable or metastatic uveal melanoma. The recommendation
overturns the initial negative decision by NICE in May 2023, which
the Company successfully appealed in December 2023.
“I am delighted for patients and their families
that NICE have now recommended tebentafusp as a treatment option
for HLA-A*02:01-positive metastatic or unresectable uveal
melanoma,” said Professor Paul Nathan, Consultant Medical
Oncologist at Mount Vernon Cancer Centre, UK. “Access to
the first therapy that improves survival for this rare and
threatening disease marks a major step forward. There remains much
work to be done to build upon this advance so that we can further
improve outcomes for all patients.”
“Today is a landmark day for the uveal melanoma
community, with NICE’s recommendation of the first treatment to
prolong survival in HLA-A*02:01-positive adults with metastatic or
unresectable uveal melanoma. Uveal melanoma is a very rare form of
melanoma which requires different clinical management. The option
to prescribe tebentafusp is a step change for patients and their
families, and we continue to support the process so that there is
reimbursement for the therapy across the UK for all eligible
patients,” said Susanna Daniels, CEO of Melanoma
Focus.
"The recommendation of tebentafusp by NICE is a
groundbreaking moment for individuals with metastatic uveal
melanoma. For the first time, HLA-A*02:01-positive patients with
this condition will have access to an effective treatment, which
offers new hope in the fight against this rare cancer,”
said Jo Gumbs, CEO and Founder of Ocular Melanoma
UK. “We are especially proud to have represented our
patient community in the appraisal process. This recommendation
highlights the power of collaboration between patients, advocates,
and medical experts. We remain committed to advancing care and
support for people with ocular melanoma and thank everyone who has
contributed to this monumental milestone.”“I am pleased that
patients in England can now have access to KIMMTRAK, marking our
13th launch this year,” said Ralph Torbay,
Immunocore’s Chief Commercial Officer.” This decision by
NICE, following two decades of pioneering research at our
laboratories in Oxford, underscores the strength of UK science in
transforming innovation into a medicine that benefits patients
worldwide.”
KIMMTRAK is now funded on the NHS in England as
of 02 December 2024.
About Uveal Melanoma
Uveal melanoma is a rare and aggressive form of
melanoma affecting the eye. Although it is the most common primary
intraocular malignancy in adults, the diagnosis is rare, and up to
50% of people with uveal melanoma will eventually develop
metastatic disease. Unresectable or metastatic uveal melanoma
typically has a poor prognosis and had no approved treatment until
KIMMTRAK.
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.
KIMMTRAK▼ (tebentafusp) is indicated as
monotherapy for the treatment of HLA-A*02:01-positive adult
patients with unresectable or metastatic uveal melanoma (mUM).
For more information, please see full Summary of
Product Characteristics (SmPC):
https://www.medicines.org.uk/emc/product/13842/smpc/print.
▼This medicinal product is subject to additional
monitoring. This will allow quick identification of new safety
information. Healthcare professionals are asked to report any
suspected adverse reactions. Side effects should be reported
directly via the Yellow Card Scheme:
https://yellowcard.mhra.gov.uk/.
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 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 the potential benefits and
advantages that KIMMTRAK will provide for patients, including
survival benefits. 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; 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, Head of Investor RelationsT: +1 (215) 384-4781E:
ir@immunocore.com
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