Immunocore Holdings plc 6-K, filed Feb 22, 2023
Immunocore Holdings plc (IMCR)
6-K
2023-02-22
For: 2023-02-22
View Original
Added on
April 07, 2026
About this 6-K
Immunocore Holdings plc filed this 6-K on February 22, 2023.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the Month of February 2023
Commission File Number: 001-39992
Immunocore Holdings plc
(Translation of registrant’s name into English)
92 Park Drive
Milton Park
Abingdon, Oxfordshire OX14 4RY
United Kingdom
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
☒ Form 20-F ☐ Form 40-F
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
INCORPORATION BY REFERENCE
This Report on Form 6-K (this “Report”) of Immunocore Holdings plc (the “Company”), excluding Exhibits 99.1 and 99.2 attached hereto, shall be deemed to be incorporated by reference into the
Company’s registration statement on Form F-3ASR (File No. 333-264105) and the Company’s registration statements on Form S-8 (File Nos. 333-255182 and 333-265000) and to be a part thereof from the date on which this Report is filed, to the extent
not superseded by documents or reports subsequently filed or furnished.
Exhibits 99.1 and 99.2 to this Report are being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject
to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act.
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
Press Release
On February 22, 2023, the Company issued a press release announcing its presentation at the 30th Conference on Retroviruses and Opportunistic Infections (“CROI
2023”) of initial safety and activity data from the Phase 1 portion of the Company’s Phase 1/2 clinical trial of IMC-M113V, a bispecific soluble TCR therapy built on the Company’s ImmTAX® technology which is being developed for the treatment of
people living with human immunodeficiency virus (“PLWH”). A copy of the press release is furnished as Exhibit 99.1 to this Report.
Initial Phase 1 Data of IMC-M113V STRIVE Trial Presented at the CROI 2023 Conference
The Company announced initial Phase 1 data from its first-in-human, Phase 1/2 clinical trial of IMC-M113V, which is referred to as the IMC-C103C-101 trial. The initial data was presented at CROI
2023. IMC-M113V is a new class of bispecific protein immunotherapy being developed for the treatment of patients with human immunodeficiency virus (“HIV”) infection. The trial is designed to identify a safe and biologically active dose in
HLA-A*02:01 positive PLWH receiving suppressive antiretroviral therapy for less than or equal to seven years. The secondary objectives of the trial are to characterize pharmacokinetic (“PK”) and pharmacodynamic (“PD”) profiles, including serum
cytokines (IL2, IL6, IL8, IL10, IFNγ, TNFα, and IP10) pre- and less than or equal to 24 hours post-dosing. A greater than four-fold rise in IL6 was prespecified as indicative of PD activity.
In the single ascending dose (SAD) portion of the Phase 1 clinical trial, three dose levels of IMC-M113V, given as a single IV infusion, were evaluated: a starting dose of 1.6 mcg, based on the
minimum anticipated biological effect level (n=1), 5 mcg (n=1) and 15 mcg (n=10). All doses were observed to be well tolerated. There were no serious adverse events observed, nor any significant changes in hematology or chemistry. There were also
no reports of cytokine release syndrome or neurotoxicity.
Plasma viral load remained suppressed throughout trial dosing and follow-up. In addition, transient, dose-dependent increases in serum IL6 occurred eight-24 hours post-infusion. Five out of the ten
participants in the trial who received the 15-mcg dose showed a greater than 4-fold rise in IL6, which had been prespecified as indicative of pharmacodynamic activity based on prior experience from clinical trials with the Company’s approved
product, KIMMTRAK (tebentafusp).
Patient enrollment in the multiple ascending dose (MAD) portion of the trial has started, and the Company plans to enroll up to 28 participants with PLWH.
Also on February 22, 2023, the Company updated its corporate presentation with the slides reflecting the data presented at CROI 2023. The updated corporate presentation is available in
the “Investors/Media” section of the Company’s website at www.immunocore.com. The Company intends to use this presentation in meetings with analysts, investors and others from time to time. A copy of
the new slides added to the corporate presentation is being furnished as Exhibit 99.2 to this Report.
Forward-Looking Statements
This Report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements
regarding the safety, efficacy and clinical progress of IMC-M113V; and the clinical development of IMC-M113V, including the anticipated timing, anticipated patient enrollment, trial outcomes, expectations regarding the data that is being
presented and the expected timing of data releases and development. The words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,”
“predict,” “future,” “project,” “potential,” “continue,” “target” and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any
forward-looking statements in this Report are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from
those expressed or implied by any forward-looking statements contained in this Report, including, without limitation, risks associated with: the risk that the results of preclinical studies and early results from clinical trials may not be
predictive of future clinical trial results; the impact of worsening macroeconomic conditions and the ongoing and evolving COVID-19 pandemic, the war in Ukraine or global geopolitical tension on the Company’s business, strategy and anticipated
milestones, including the Company’s ability to conduct ongoing and planned clinical trials; the Company’s ability to obtain and maintain regulatory approval of its product candidates; the Company’s ability to obtain clinical supply of current
or future product candidates or commercial supply of KIMMTRAK or any future approved products, including as a result of supply chain disruptions; the Company’s ability and plans to launch, market and sell KIMMTRAK or any future approved
products, to continue to establish and expand a commercial infrastructure; the Company’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 the COVID pandemic, patient enrollment delays or otherwise; unexpected safety or efficacy data observed during preclinical studies or clinical trials and the Company’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; actions of regulatory agencies, which may
affect the initiation, timing and progress of clinical trials or future regulatory approval; the Company’s ability to obtain, maintain and enforce intellectual property protection for KIMMTRAK or any product candidates it is developing; the
Company’s need for and ability to obtain additional funding on favorable terms or at all, including as a result of worsening macroeconomic conditions such as rising inflation and interest rates, volatility in the capital markets and related
market uncertainty; and the success of the Company’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 the
Company’s filings with the Securities and Exchange Commission, including the Company’s most recent Annual Report on Form 20-F, as supplemented by its most recent filings that the Company has made or may make with the SEC in the future. Such
risks may be amplified by the COVID-19 pandemic and its potential impact on the Company’s business and the overall global economy. Any forward-looking statements represent the Company’s views only as of the date of this Report and should not be
relied upon as representing its views as of any subsequent date. The Company does not assume any obligation to update any forward-looking statements, except as may be required by law.
EXHIBIT INDEX
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Exhibit
No.
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Description
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Press Release dated February 22, 2023.
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Slides Added to Corporate Presentation.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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IMMUNOCORE HOLDINGS PLC
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Date: February 22, 2023
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By:
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/s/ Bahija Jallal, Ph.D.
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Name:
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Bahija Jallal, Ph.D.
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Title:
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Chief Executive Officer
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Exhibit 99.1
Immunocore announces initial Phase 1 safety and pharmacodynamic activity data with first soluble TCR therapy for people living with HIV
Data from the single ascending dose part of the Phase 1 trial shows IMC-M113V is well tolerated
Expected markers of T cell activation observed in half of participants at 15-mcg dose; plasma viral load remained suppressed throughout dosing and follow-up
The multiple ascending dose part of the trial is enrolling participants to identify safety and anti-viral activity
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 22 February, 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, autoimmune and infectious diseases, has presented at the Conference on Retroviruses and
Opportunistic Infection (CROI) the first safety and activity data with IMC-M113V, a bispecific soluble TCR therapy built on Immunocore’s ImmTAX® technology which is being developed for the treatment of people living with HIV (PLWH).
IMC-M113V is an immunotherapeutic approach designed to specifically eliminate CD4+ cells that are persistently infected with HIV (‘reservoirs’). IMC-M113V targets a peptide derived from the
Gag protein that is presented by HLA*A02 on the surface of HIV infected cells. Reduction in the number of these cells is one way to potentially achieve a state of viral suppression in the absence of anti-retroviral medications, or a ‘functional
cure.’
“IMC-M113V, which is designed to redirect T cells to eliminate HIV-infected cells, was well tolerated at doses where we observed biomarkers of T cell engagement,” said David Berman, Head of R&D of Immunocore. “We are now enrolling people living with HIV in the multiple ascending dose part of the trial where we will evaluate the active dosing schedules that could lead to
functional cure.”
Dr Linos Vandekerckhove, Laboratory director, HIV Cure Research Center, University Hospital Ghent, Belgium, said: “HIV continues to be a huge global health challenge. Although people living with HIV can control
their disease with antiretroviral therapies, lifelong treatment is needed as reservoirs of HIV infected cells persist. If a functional cure could be found this could significantly transform treatment of this chronic infectious disease and
decrease stigma of HIV.”
Initial Phase 1 trial data
In the single ascending dose part of the trial, three dose levels of IMC-M113V, given as a single IV infusion, were evaluated: a starting dose of 1.6 mcg, based on the minimum anticipated
biological effect level (n=1), 5 mcg (n=1) and 15 mcg (n=10). All doses were well tolerated. There were no serious adverse events, significant changes in hematology or chemistry, nor cytokine release syndrome or neurotoxicity.
Immunocore Holdings plc, 92 Park Drive, Milton Park, Abingdon, Oxon, OX14 4RY, UK
T: +44 (0)1235 438600 | www.immunocore.com
Registered in England no: 6456207 | VAT No. GB 939 6694 55
Plasma viral load remained suppressed throughout dosing and follow-up. In addition, transient, dose-dependent increases in serum IL6 occurred 8-24 hours post-infusion. Five out of the ten
participants who received the 15-mcg dose showed a >4-fold rise in IL6, which had been prespecified as indicative of pharmacodynamic activity based on prior experience from clinical trials with KIMMTRAK (tebentafusp), the Company’s first
ImmTAX therapy now approved for the treatment of metastatic or unresectable uveal melanoma.
Enrollment underway in next part of the trial
The Company has started enrolling people living with HIV in the multiple ascending dose (MAD) part of the trial, to identify a safe and tolerable dosing schedule that could lead to reduction
in the viral reservoir and control of HIV after stopping antiretroviral therapies (ART), or functional cure. The MAD trial will enroll up to 28 participants.
About the STRIVE (Soluble T cell Receptors In Virus Eradication) trial
The STRIVE trial (IMC-M113V-101) is a first-in-human, open-label Phase 1/2 trial, designed to identify a safe and biologically active dose in HLA-A*02:01 positive PLWH receiving suppressive
ART for ≤7 years. The trial’s secondary objectives are to characterize pharmacokinetic (PK) and pharmacodynamic (PD) profiles, including serum cytokines (IL2, IL6, IL8, IL10, IFNγ, TNFα, and IP10) pre- and ≤24 hours post-dosing. A ≥4-fold rise
in IL6 was prespecified as indicative of PD activity.
People living with HIV can remain healthy with antiretroviral therapies, but they must continue to take medication for life as virus reservoirs remain. IMC-M113V is an immunotherapeutic
approach designed to specifically eliminate CD4+ cells that are persistently infected with HIV (‘reservoirs’). IMC-M113V targets a peptide derived from the Gag protein that is presented by HLA-A*02 on the surface of HIV infected cells.
##
About ImmTAV molecules and infectious diseases
ImmTAV (Immune mobilising monoclonal TCRs Against Virus) molecules are novel bispecific molecules 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 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, 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,” “can,” “will,” “believe,”
“expect,” “plan,” “anticipate,” “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 ability of IMC-M113V to eliminate CD4+ cells and to be an effective treatment for
patients with HIV infection; whether a reduction in the number of CD4+ cells will achieve a state of viral suppression in the absence of anti-retroviral medications; the expected clinical benefits of IMC-M113V, including its potential as a
“functional cure”; the Company’s plan for future development of IMC-M113V; the therapeutic potential and expected clinical benefits of Immunocore’s products and product candidates, including IMC-M113V; expectations regarding the development
and expansion of Immunocore’s pipeline and the design, progress, timing, enrollment, scope, expansion and results of Immunocore’s existing and planned clinical trials, including statements regarding the ongoing enrollment of patients in the
ongoing trial of IMC-M113V; and Immunocore’s ability to obtain and maintain regulatory approval for its products and product candidates; expectations regarding the potential market opportunity and potential commercial performance of
Immunocore’s product candidates, if approved. 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 and the ongoing and evolving COVID-19 pandemic on Immunocore’s business, strategy, clinical trials, financial position and anticipated milestones, including Immunocore’s ability to conduct ongoing and planned clinical
trials; results from earlier clinical or pre-clinical studies of Immunocore’s product candidates, including IMC-M113V, may not necessarily be predictive of the results from required later pre-clinical studies and future 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 supply chain disruptions, the COVID-19 pandemic, the war in
Ukraine or global geopolitical tension; Immunocore’s ability to obtain and maintain regulatory approvals for its product candidates; Immunocore’s ability to develop, manufacture and commercialize its product candidates; 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 the COVID-19 pandemic, 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 such as rising inflation and interest rates, volatility in the capital markets and related market uncertainty, the
COVID-19 pandemic, the 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; unexpected safety or
efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; 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, 2021 filed with the Securities and Exchange Commission on March 3, 2022, 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:
Immunocore
Sébastien Desprez, Head of Communications
T: +44 (0) 7458030732
E: sebastien.desprez@immunocore.com
Follow on Twitter: @Immunocore
Consilium Strategic Communications (corporate and financial)
Mary-Jane Elliott/ Chris Welsh/Jessica Hodgson
T: +44 (0)203 709 5700
E: Immunocore@consilium-comms.com
Investor Relations
Clayton Robertson, Head of Investor Relations
T: +1 215-384-4781
E: ir@immunocore.com
Exhibit 99.2
