Immunocore presents initial multiple
ascending dose data for HIV functional cure candidate in an oral
presentation at CROI 2025
IMC-M113V was well tolerated, with no
dose-limiting toxicities
Signals of dose-dependent reduction in
active reservoir, and viral control after complete antiretroviral
treatment interruption in some PLWH
Enrollment in MAD portion of the trial
continues with higher doses being evaluated
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn.
& GAITHERSBURG, Md., US, 10 March 2025) 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,
has today shared initial data from the multiple ascending dose
(MAD) portion of its Phase 1/2 STRIVE trial of IMC-M113V, its
functional cure candidate for human immunodeficiency virus
(HIV).
The data, presented in an oral session at the
Conference on Retroviruses and Opportunistic Infections (CROI)
2025, in San Francisco, shows that IMC-M113V – the first T
cell receptor bispecific therapy to target HIV in the clinic – is
well tolerated and shows signals of dose-dependent viral control
after antiretroviral treatment (ART) is interrupted. The MAD
portion of the trial continues and is evaluating higher doses, to
be followed by expansion cohorts at one or more doses.
“I am encouraged by the safety profile and
initial signals of anti-viral activity of IMC-M113V in the Phase
1/2 trial. It is uncommon to be able to interrupt ART for 12 weeks
or longer, with the vast majority of people showing viral rebound
by 4 weeks,” said Dr. Beatriz Mothe, Associate
Investigator, HIV Unit, Infectious Diseases Department,
IrsiCaixa, Hospital Germans Trias i Pujol, Barcelona. “I look
forward to further data from the trial at higher doses, as part of
wider efforts to find solutions that could enable people with HIV
to remain healthy without lifelong antiretroviral treatment.”
Initial MAD data
The MAD portion of the Phase 1/2 dose escalation
trial, reported at CROI, included 16 people living with HIV (PLWH)
who were stable on ART. Enrollment excluded individuals who had
started ART less than 12 weeks after acquiring HIV. While
continuing ART, three sequential cohorts evaluated weekly IV
infusions of IMC-M113V up to doses of 60 mcg (n=5), 120 mcg (n=5),
and 300 mcg (n=6) administered over 12 weeks, followed by
analytical treatment interruption (ATI) for up to 12 weeks, after
which participants resumed their prior ART regimen.
All doses were well tolerated and no serious
adverse events (AEs) or dose limiting toxicities were observed.
Mild (Grade 1) cytokine release syndrome, consisting of fever alone
that resolved within 4 hours, was observed in five of the six PLWH
in the 300 mcg cohort when receiving their first 300 mcg dose.
There were no discontinuations due to AEs. One person withdrew
prior to completing the dose schedule in the 300 mcg cohort for
reasons unrelated to IMC-M113V.
Dose-dependent increases in serum cytokines were
observed, consistent with the mechanism of action, with the highest
levels of T cell-derived cytokines at 300 mcg.
In the 15 evaluable PLWH, delayed viral rebound
and/or viremia control at any point during ATI was observed in 0 of
5 PLWH at 60 mcg, 1 of 5 at 120 mcg, and 2 of 5 at 300 mcg. The 3
PLWH with evidence of viral control had a viral load of
approximately 200 c/mL at week 8. The historical rate for this
observation is 5%1. Furthermore, 2 of these 3 PLWH remained off ART
for the entire 12 week ATI period that was pre-specified in the
protocol.
In the 3 PLWH with evidence of viral control,
the pattern consisted of initial viral rebound followed by viral
reduction to approximately 200 c/mL, including 1 PLWH at 300 mcg
who had initial viremia to >104 c/mL before subsequent decrease
to <50 c/mL at week 12. This observation of initial viremia
followed by control at week 12 is typically observed in <1% of
all PLWH1. Such ‘regained’ post-treatment control may be associated
with an immune response to the virus.
There was also a reduction in CD4+ T
cell-associated HIV Gag RNA in some PLWH during treatment,
indicating a reduction in the active virus reservoir, which was
quantified at weeks 1, 7 and 13. A trend of reduction in intact HIV
DNA was also observed post-treatment in a preliminary analysis of 6
people treated at the two highest doses.
IMC-M113V and the STRIVE
trial
IMC-M113V utilizes a T cell receptor that binds
to an HLA-A*02:01-Gag complex on HIV-infected immune cells. An
anti-CD3 effector arm of the molecule then recruits T cells to
destroy CD4+ cells containing integrated HIV DNA, known as the
reservoir.
The objectives of the first-in-human Soluble T
cell Receptors in Viral Eradication (STRIVE) Phase 1/2 trial are to
establish safe dose regimens administered alongside ART and to
quantify antiviral activity, measured through post-treatment viral
control (<200 c/ml) after ART withdrawal.
The Company presented initial Phase 1 safety and
pharmacodynamic activity data from the single-ascending dose
portion of the trial in February 2023. The data demonstrated
IMC-M113V was well tolerated with no serious adverse events.
Expected markers of T cell activation were observed in half of
people (n=10) who received a maximum dose of 15 mcg.
###
About ImmTAV®
molecules for infectious diseases
ImmTAV (Immune mobilizing monoclonal TCRs
Against Virus) molecules are novel bispecifics that are designed to
enable the immune system to recognize and eliminate virally
infected cells.
Immunocore is advancing clinical candidates to
achieve functional cure for 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 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 numerous 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”, “aim”,
“continue”, “target” 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 of Immunocore’s product candidates, including
IMC-M113V; and expectations regarding the design, progress, timing,
enrollment, randomization, scope, expansion, funding, and results
of Immunocore’s existing and planned clinical trials, including the
IMC-M113V STRIVE Phase 1/2 clinical trial and expansions into
additional cohorts. 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, 2024 filed with the Securities and
Exchange Commission on February 26, 2025, 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 LinkedIn: @Immunocore
Investor RelationsClayton
Robertson / Morgan Warenius T: +1 (215) 384-4781E:
ir@immunocore.com
1 Gunst, J.D., Gohil, J., Li, J.Z. et
al. Time to HIV viral rebound and frequency of post-treatment
control after analytical interruption of antiretroviral therapy: an
individual data-based meta-analysis of 24 prospective
studies. Nat Commun 16, 906 (2025).
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