Immunocore announces strategic priorities
and pipeline expansion ahead of 42nd
Annual J.P. Morgan Healthcare Conference
presentation
Increasing commercial access to KIMMTRAK
(tebentafusp-tebn) globally, and pursuing future growth
opportunities with two registrational trials in advanced cutaneous
melanoma and adjuvant uveal melanoma
Multiple clinical readouts expected to start in
2Q 2024 for IMC-F106C (PRAME HLA-A02) from Phase 1/2 clinical trial
monotherapy and combination arms; IMC-P115C (PRAME HLA-A02 HLE) and
IMC-T119C (PRAME HLA-A24) ImmTAC candidates on track for expected
CTA/IND submission in 2024
Submitted clinical trial applications (CTA) for
IMC-R117C, a first-in-class ImmTAC targeting PIWIL1 for colorectal
and other gastrointestinal cancers
Data from IMC-M113V Phase 1 clinical trial in
people living with HIV expected in the second half of 2024
Advancing novel TCR bispecific candidates for
autoimmune diseases
Company to present at 42nd Annual J.P. Morgan
Healthcare Conference on Wednesday, January 10, 2024 at 9:00 AM
P.T. / 5:00 PM GMT
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn.
& ROCKVILLE, Md., US, 05 January, 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 sets out its strategic priorities for 2024 and announced the
addition of two new pre-clinical candidates for autoimmune diseases
to its pipeline.
“We continue the global commercial roll out of KIMMTRAK, now
launched in 10 countries, and are pursuing future growth
opportunities for KIMMTRAK with two registrational trials in
advanced cutaneous melanoma and in adjuvant uveal melanoma,” said
Bahija Jallal, Chief Executive Officer of
Immunocore. “We are advancing our PRAME ImmTAC including
our first Phase 3 clinical trial in melanoma and expect to present
clinical data from our Phase 1/2 clinical trial in melanoma,
ovarian, and lung cancer throughout 2024. Today we add two new
autoimmune candidates to our pipeline, expanding the potential of
our platform to a third therapeutic area.”
Key Strategic Priorities
2024Our strategic priorities are to bring transformative
medicines to patients with cancer, infectious diseases, and
autoimmune diseases. In 2024, our priorities will be:
- Growing sales of KIMMTRAK
(tebentafusp-tebn) in the United States and globally in patients
with HLA-A*02:01-positive metastatic uveal melanoma, and expanding
KIMMTRAK beyond its initial approved indication with the
registrational trials for advanced (second-line or later) cutaneous
melanoma (TEBE-AM) and adjuvant uveal (or ocular) melanoma
(ATOM).
- Advancing our PRAME franchise in
multiple solid tumors and broadening the addressable population.
Randomization is expected to begin in the first quarter of 2024 in
the registrational trial for IMC-F106C in first-line advanced
cutaneous melanoma (PRISM-MEL-301), and we expect to present data
from the Phase 1/2 clinical trial monotherapy and combination
cohorts throughout 2024. We further expect to submit
investigational new drug (IND) applications or clinical trial
applications (CTA) for IMC-P115C (PRAME HLA-A2 Half-Life-Extended)
and IMC-T119C (PRAME HLA-A24) candidates in 2024.
- Bringing novel ImmTAC candidates to
the clinic, leading with IMC-R117C, a first-in-class ImmTAC
candidate targeting PIWIL1 with focus on colorectal and
gastrointestinal cancers.
- Evaluating the potential for a
functional cure in infectious diseases with lead candidates for
human immunodeficiency virus (HIV) and hepatitis B virus
(HBV).
- Initiating CMC manufacturing for
the Company’s first two autoimmune candidates – including the first
in class, tissue-specific, TCR bispecific PD1 agonist for type 1
diabetes and a novel non-HLA restricted (universal) PD1 agonist for
dermatological diseases.
KIMMTRAK expansion strategyIn
2024, the Company plans to expand access to KIMMTRAK to more
patients in the United States, Europe and globally, as it continues
to establish the therapy as standard of care for the first line
treatment for metastatic uveal melanoma in countries where it is
launched. As of 2023 year-end, KIMMTRAK has been launched in ten
countries and is approved in 38 countries.
The Company also continues to enroll patients
into a Phase 2/3 clinical trial (TEBE-AM) to investigate the
potential of KIMMTRAK in advanced cutaneous melanoma, with
randomization expected to be completed in the Phase 2 portion
during the third quarter of 2024. Topline data from the Phase 2
portion of the trial is expected to be available by the fourth
quarter of 2024.
In addition, in 2023, the Company signed an
agreement for a European Organisation for Research and Treatment of
Cancer (EORTC)-sponsored trial to study KIMMTRAK as adjuvant
therapy for uveal (or ocular) melanoma (ATOM). The Company
anticipates that the EORTC will randomize the first patient in the
second half of 2024.
PRAME franchise
PRISM-MEL301 – First PRAME Phase 3 clinical
trial with IMC-F106C in first-line advanced cutaneous melanoma
In August 2023, the Company announced plans to
start a registrational Phase 3 trial with IMC-F106C in cutaneous
melanoma. The trial will randomize patients with
HLA-A*02:01-positive, first-line advanced cutaneous melanoma to
IMC-F106C + nivolumab versus a control arm of either nivolumab or
nivolumab + relatlimab, depending on the country where the patient
is enrolled. The Company plans to randomize the first patient in
this trial in the first quarter of 2024.
Phase 1/2 clinical trial of IMC-F106C targeting
PRAME-A02 in multiple solid tumors
In addition to progressing IMC-F106C into a
registrational trial in cutaneous melanoma, the Company is
continuing to enroll patients in the monotherapy and combination
arms of the Phase 1/2 clinical trial across multiple tumor types,
including expansion arms for patients with advanced ovarian,
non-small cell lung carcinoma, endometrial, and melanoma. In August
2023, the Company provided an updated analysis of the original 18
melanoma patients (initially presented at ESMO in September 2022),
which continued to show promising durability of the clinical
activity (range of duration of partial response from 6 months to 17
months). The Company expects to report clinical data from the
ongoing monotherapy and combination cohorts throughout 2024
including cutaneous melanoma (expected in Q2 2024), ovarian
(expected by Q3 2024), and non-small cell lung carcinoma (expected
by Q4 2024).
IMC-P115C (PRAME-A02 Half-Life Extended) &
IMC-T119C (PRAME-A24)
The Company is expanding the PRAME franchise with two new PRAME
ImmTAC candidates, IMC-P115C (PRAME-A02 HLE) and IMC-T119C
(PRAME-A24) for solid tumors, which are both on track for
investigational new drug (IND) or clinical trial application (CTA)
submissions for IMC-P115C in the second quarter of 2024 and the
second half of 2024 for IMC-T119C.
IMC-R117C (PIWIL1) for colorectal and
other gastrointestinal cancers
The Company has leveraged its proprietary
peptidomic (ImmSPECT) database to validate a novel target, PIWIL1.
PIWIL1 is believed to play a role in tumor progression and is
expressed across a range of tumors, including colorectal which is
historically insensitive to immune checkpoints, as well as
gastrointestinal and pancreatic cancers. PIWIL1 is also reported to
be a negative prognostic marker and the Company believes IMC-R117C
is the first PIWIL1-targeted immunotherapy. The Company submitted a
CTA to regulatory authorities in December 2023, and expects the
trial to start this year.
Enrolling ImmTAV candidates for a
functional cure in infectious diseases
The Company continues to enroll people living
with HIV in the multiple ascending dose (MAD) part of a Phase 1
clinical trial with IMC-M113V, to identify a safe and tolerable
dosing schedule. This study will also test whether IMC-M113V could
lead to reduction in the viral reservoir and, after stopping all
therapies (antiretroviral therapies and IMC-M113V), delay or
prevent HIV rebound (known as functional cure). The MAD part of the
trial will enroll up to 28 participants. The Company expects to
present a data update from the Phase 1 clinical trial in the second
half of 2024.
In 2023, the Company amended the design of the ongoing Phase 1
trial with IMC-I109V for people living with HBV to include
HBV-positive hepatocellular carcinoma. The Company continues to
enroll patients into the trial in 2024.
Tissue-specific down modulation of the
immune system for autoimmune diseases The Company is
expanding its platform into autoimmune with two first in class new
bispecific candidates entering the Company’s pipeline. The key
differentiator of the ImmTAAI platform is tissue-specific down
modulation of the immune system. When tethered to the tissue of
interest, the new candidates supress pathogenic T cells via PD1
receptor agonism.
The first candidate, IMC-S118AI (PPIxPD1), is
targeted specifically to the pancreatic beta-cell and is intended
for disease-modifying treatment in type 1 diabetes. IMC-S118AI
recognizes a peptide from pre-proinsulin presented by HLA-A*02:01
on beta-cells.
The second target is present in the skin and
intended to treat inflammatory dermatological diseases. The
candidate is an antigen presenting cell (APC) tethered ImmTAAI and
is not HLA restricted (e.g. universal for all populations).
Preliminary Year-End 2023 cash
positionPreliminary unaudited cash and cash equivalents is
approximately $443 million USD as of December 31, 2023.
42nd
Annual J.P. Morgan Healthcare Conference
The Company has updated its corporate
presentation to reflect these business and strategic updates.
Additionally, the Immunocore management team will discuss these
updates during a live and webcast presentation at the 42nd Annual
J.P. Morgan Healthcare Conference, on Wednesday January 10, 2024,
at 9:00 a.m. Pacific Standard Time (PST). The presentation and
webcast will be available in the ‘Investors/Media’ section of
Immunocore’s website at www.immunocore.com. A replay of the
presentation will be made available for a limited time.
##
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 ImmTAV molecules and infectious
diseasesImmTAV (Immune mobilising monoclonal TCRs Against
Virus) molecules are novel bispecifics that, like ImmTAC (Immune
mobilising monoclonal TCRs Against Cancer) molecules, are designed
to enable the immune system to recognize and eliminate virally
infected cells.
Immunocore is advancing clinical candidates to
cure patients with HIV and hepatitis B virus (HBV). The Company
aims to achieve sustained control of HIV after patients stop
anti-retroviral therapy (ART), without the risk of virological
relapse or onward transmission. This is known as ‘functional cure’.
For the treatment of HBV, the Company aims to achieve sustained
loss of circulating viral antigens and markers of viral replication
after stopping medication for people living with chronic HBV.
About ImmTAAI molecules and autoimmune
diseases ImmTAAI (Immune mobilising monoclonal TCRs
Against Autoimmune) molecules are novel bispecifics that are
designed for tissue-specific down modulation of the immune system.
When tethered to the tissue of interest, ImmTAAI candidates supress
pathogenic T cells via PD1 receptor agonism. The Company is
currently advancing two candidates for autoimmune conditions,
including Type 1 Diabetes and inflammatory dermatological
diseases.
About PRISM-MEL301 – Phase 3 trial with
IMC-F106C (PRAMExCD3) in 1L advanced cutaneous melanomaThe
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
TrialIMC-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
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 TEBE-AM - Phase 2/3 trial with
tebentafusp (gp100xCD3) in second-line or later cutaneous
melanomaThe trial is randomizing patients with second-line
or later cutaneous melanoma who have progressed on an anti-PD1,
received prior ipilimumab and, if applicable, received a BRAF
kinase inhibitor. Patients will be randomized to one of three arms
including tebentafusp, as monotherapy or in combination with an
anti-PD1, and a control arm. The Phase 2 portion of the trial will
include 40 patients per arm.
About the ATOM Phase 3 trial
The EORTC-led Phase 3 clinical trial will include sites in 10 EU
countries and the United States and will randomize patients with
HLA-A*02:01-positive high-risk primary uveal melanoma after
definitive treatment, by surgery or radiotherapy, and no evidence
of metastatic disease on imaging. The trial is expected to enroll a
total of 290 patients who will be randomized 1:1 to one of two
arms: KIMMTRAK as monotherapy or observation. The primary endpoint
of the trial is relapse-free survival (RFS), with secondary
objectives of overall survival and safety and tolerability of
tebentafusp. Exploratory objectives include the comparison of the
health-related quality of life between the treatment arms and the
evaluation of the role of circulating tumor DNA as a biomarker for
the presence of residual disease.
About Uveal MelanomaUveal
melanoma is a rare and aggressive form of melanoma, which affects
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 recognise and kill tumour 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.
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 KIMMTRAKConnectImmunocore
is committed to helping patients who need
KIMMTRAK obtain access via our KIMMTRAKConnect program. The program
provides services with dedicated nurse case managers who provide
personalized support, including educational resources, financial
assistance, and site of care coordination. To learn more, visit
KIMMTRAKConnect.com or call 844-775-2273.
About ImmunocoreImmunocore 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 commercial performance of KIMMTRAK, including expanded access
to KIMMTRAK to more patients in the United States, Europe and
globally; the potential benefits and advantages KIMMTRAK will
provide for patients; expectations regarding the design, progress,
timing, enrollment, scope, expansion, and results of the Company’s
existing and planned clinical trials, those of the Company’s
collaboration partners or the combined clinical trials with the
Company’s collaboration partners; the timing and sufficiency of
clinical trial outcomes to support potential approval of any of the
Company’s product candidates or those of, or combined with, its
collaboration partners; the Company’s goals to develop and
commercialize product candidates based on its KIMMTRAK platform
alone or with collaboration partners; the expected submission of
investigational new drug applications or clinical trial
applications; the potential regulatory approval, expected clinical
benefits and availability of the Company’s product candidates; the
Company’s preliminary unaudited cash and cash equivalents; sales,
marketing, manufacturing and distribution requirements; and
potential growth opportunities and trends, including in connection
with future product launches. 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
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 worsening macroeconomic
conditions, including changes inflation and 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 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 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. In addition, as the reported cash and cash equivalents in
this press release are preliminary, have not been audited and are
subject to change pending completion of the Company’s audited
financial statements for the year ended December 31, 2023, it is
possible that the Company or its independent registered public
accounting firm may identify items that require the Company to make
adjustments to the amount included in this release, and such
changes could be material. Additional information and disclosures
would also be required for a more complete understanding of the
Company’s financial position and results of operations as of
December 31, 2023.
CONTACT: Immunocore
Sébastien Desprez, Head of CommunicationsT: +44 (0) 7458030732E:
sebastien.desprez@immunocore.com Follow
on Twitter: @Immunocore
Investor Relations Clayton Robertson,
Head of Investor RelationsT: +1 215-384-4781E:
ir@immunocore.com
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