Immunocore announces upcoming
presentation and posters at ASCO 2024
Phase 1 expansion data in immune
checkpoints pre-treated cutaneous melanoma for brenetafusp
(IMC-F106C targeting PRAME) to be presented during oral abstract
session
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn.
& ROCKVILLE, Md., US, 24 April 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,
will present Phase 1 expansion data for brenetafusp (IMC-F106C),
the first off-the-shelf ImmTAC therapy targeting PRAME, in patients
with late-line cutaneous melanoma, all previously treated with
anti-PD1 and the vast majority having received ipilimumab, at the
2024 American Society of Oncology (ASCO) Annual Meeting commencing
on 31 May.
The Company will also present four posters,
including one trial-in-progress poster of the Phase 3 PRISM-MEL301
trial with brenetafusp in combination with nivolumab versus
standard nivolumab regimens in HLA-A*02:01+ patients with
first-line advanced melanoma, and three posters sharing clinical
and translational data about KIMMTRAK in metastatic uveal
melanoma.
Presentation and poster
details
Title: Phase 1 safety and efficacy of IMC-F106C,
a PRAME×CD3 ImmTAC bispecific, in post-checkpoint cutaneous
melanomaPresenting author: Omid HamidSession: Oral Abstract Session
– Melanoma/Skin Cancers, Friday 31 May 2024; 2:45-5:45 p.m. CT /
1:45-4:45 p.m. ET
Title: A Phase 3 trial of IMC-F106C (PRAME ×
CD3) plus nivolumab versus standard nivolumab regimens in
HLA-A*02:01+ patients with previously untreated advanced melanoma
(PRISM-MEL-301)Presenting author: Georgina LongSession: Poster
Session – Melanoma/Skin Cancers, Saturday 1 June 2024, 1:30-4:30
p.m. CT / 12:30-3:30 p.m. ET
Title: Stable disease with confirmed tumor
reduction has a similar clinical outcome as RECIST partial response
for tebentafusp in metastatic uveal melanomaPresenting author:
Alexandra IkeguchiSession: Poster Session – Melanoma/Skin Cancers,
Saturday 1 June 2024, 1:30-4:30 p.m. CT / 12:30-3:30 p.m. ET
Title: Association between clinical and disease
characteristics and detectable or undetectable baseline ctDNA in
patients with metastatic uveal melanomaPresenting author: Paul
NathanSession: Poster Session – Melanoma/Skin Cancers, Saturday 1
June 2024, 1:30-4:30 p.m. CT / 12:30-3:30 p.m. ET
Title: Baseline and serial ctDNA dynamics
predicts outcomes in patients treated with first-line tebentafusp
including those who were and were not treated beyond
progressionPresenting author: Ryan SullivanSession: Poster Session
– Melanoma/Skin Cancers, Saturday 1 June 2024, 1:30-4:30 p.m. CT /
12:30-3:30 p.m. ET
Conference CallImmunocore will
host an investor and analyst event and webcasted conference call on
Friday 31 May 2024 at 6:15 p.m. CT with Dr. Diwakar Davar. The
webcast will be available under ‘News & Events’ in the Investor
Relations section of Immunocore Holdings’ website at
www.immunocore.com.
##
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 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 PRISM-MEL301 – Phase 3 trial with
brenetafusp (IMC-F106C, PRAMExCD3) in 1L advanced cutaneous
melanoma
The Phase 3 registrational trial will randomize
patients with previously untreated, HLA-A*02:01-positive, advanced
melanoma to IMC-F106C + nivolumab versus nivolumab or nivolumab +
relatlimab, depending on the country where the patient is enrolled.
The study 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 IMC-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).
About the IMC-F106C-101 Phase 1/2 trial
IMC-F106C-101 is a first-in-human, Phase 1/2
dose escalation trial in patients with multiple solid tumor cancers
including non-small cell lung cancer (NSCLC), small-cell lung
cancer (SCLC), endometrial, ovarian, cutaneous melanoma, and breast
cancers. The Phase 1 dose escalation trial was designed to
determine the maximum tolerated dose (MTD), as well as to evaluate
the safety, preliminary anti-tumor activity and pharmacokinetics of
brenetafusp (IMC-F106C), a bispecific protein built on Immunocore’s
ImmTAC technology, and the Company’s first molecule to target the
PRAME antigen. The Company has initiated patient enrollment into
four expansion arms in cutaneous melanoma, ovarian, NSCLC, and
endometrial carcinomas. The IMC-F106C-101 trial is adaptive and
includes the option for Phase 2 expansion, allowing for
approximately 100 patients treated per tumor type in the Phase 1
and 2 expansion arms. Dose escalation continues in additional solid
tumors as well as plans for combination arms with
standards-of-care, including checkpoint inhibitors, chemotherapy,
and tebentafusp.
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 expected clinical benefits of
KIMMTRAK, brenetafusp and the Company’s other product candidates,
including progression free survival and extended overall survival
benefit; expectations regarding receipt of regulatory approvals and
completion of related procedures; the value proposition of
Immunocore’s products and product candidates, including KIMMTRAK
and brenetafusp; future development plans of Immunocore’s products
and product candidates, including KIMMTRAK and brenetafusp;
expectations regarding the design, progress, timing, scope and
results of Immunocore’s existing and planned clinical trials,
including the Phase 3 PRISM-MEL301 trial with brenetafusp plus
nivolumab versus standard nivolumab in 1L advanced cutaneous
melanoma and the Phase 1/2 dose escalation trial with brenetafusp
in patients with multiple solid tumor cancers including non-small
cell lung cancer (NSCLC), small-cell lung cancer (SCLC),
endometrial, ovarian, cutaneous melanoma, and breast cancers . 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 the 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 between Hamas
and Israel, 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 the worsening macroeconomic conditions, including
inflation, 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. 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
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