Immunocore Holdings plc 6-K, filed Nov 14, 2022
Immunocore Holdings plc (IMCR)
6-K
2022-11-14
For: 2022-11-14
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Added on
April 07, 2026
About this 6-K
Immunocore Holdings plc filed this 6-K on November 14, 2022.
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 November 2022
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”), excluding Exhibit 99.1 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Nos. 333-226457 and 333-265000) and to be a part thereof from the date on which this Report is filed, to the extent not superseded by documents or reports subsequently filed or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.
Exhibit 99.1 to this Report is 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 November 11, 2022, Immunocore Holdings plc (the “Company”) issued a press release announcing the presentation of new findings from a biomarker analysis of KIMMTRAK
(tebentafusp-tebn) in patients with metastatic uveal melanoma (“mUM”) at the Society for Immunotherapy of Cancer (“SITC”) 37th Annual Meeting. The first poster presentation is titled
“Molecular features in tumors at time of progression on tebentafusp associated with overall survival (OS)”. The second poster presentation is titled “Tebentafusp induced T and B cell epitope spread in patients with advanced melanoma”. A copy of the press release is furnished as Exhibit 99.1 to this Report on Form 6-K.
New Biomarker Analysis of KIMMTRAK (tebentafusp-tebn) in Patients with mUM Presented at SITC 37th Annual Meeting
The data presented at the SITC 37th Annual Meeting was a biomarker analysis of tumors biopsies collected from 18 patients with metastatic uveal melanoma (“mUM”) shortly after radiographic
progression. These tumors were analyzed by immunohistochemistry (n=18) or by RNAseq (n=14) for expression of full-length gp100 protein, and for expression of components of the antigen processing machinery (“APM”) including HLA-A, the HLA that
presents the gp100 peptide recognized by KIMMTRAK.
The key highlights of the presentations included the observation that the expression of gp100 protein, the target of KIMMTRAK, remained relatively unchanged relative to baseline in biopsies at the
time of tumor progression and was not associated with overall survival (“OS”). However, it was observed that patients in the analysis with longer OS, despite achieving radiographic progression, were able to retain higher expression of the APM
required to ensure recognition by KIMMTRAK, including HLA, and higher levels of T cells, compared to those with shorter OS.
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, implied and
express statements regarding the therapeutic potential and clinical benefits of KIMMTRAK. 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 and 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 November 11, 2022.
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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:
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November 14, 2022
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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 presents new biomarker analysis for KIMMTRAK (tebentafusp-tebn) in metastatic uveal melanoma at the SITC 2022 Annual Meeting
Expression of gp100 protein, the target of KIMMTRAK, is unchanged relative to baseline in biopsies at time of tumor progression
Patients with radiographic progression who retain expression of the antigen processing machinery have long survival
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 11 November 2022) 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 today
presented new translational data on KIMMTRAK (tebentafusp-tebn) in patients with metastatic uveal melanoma at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting.
“We previously showed that some patients with radiographic progression can still have long survival on KIMMTRAK. In this analysis, we demonstrate that patients with longer survival retain expression of the antigen
processing machinery required to ensure recognition by KIMMTRAK,” said Koustubh Ranade, Ph.D., Head of Translational Medicine at Immunocore. “Downregulation of the antigen processing machinery is a known
mechanism of resistance for all T cell therapies, including checkpoint inhibitors. We also demonstrate that gp100 protein remains unchanged even in patients who had disease progression.”
Biopsies were obtained in up to 18 metastatic uveal melanoma patients shortly after radiographic progression. These tumors were analyzed by immunohistochemistry (n=18) or by RNAseq (n=14) for full-length gp100, and
for components of the antigen processing machinery (APM) including HLA-A, the HLA that presents the gp100 peptide recognized by KIMMTRAK. The expression of gp100 protein was unchanged relative to baseline and was not associated with overall
survival (OS). However, patients with longer OS, despite radiographic progression had higher expression of the APM, including HLA, and higher levels of T cells, compared to those with shorter OS. HLA downregulation has previously been reported as
a mechanism of resistance to immune checkpoint inhibitors, including anti-PD(L)1 (Zaretzky et. Al. N. Engl J Med 2016; 375:819-829).
Poster Details
Title: Molecular features in tumors at time of progression on tebentafusp associated with overall survival (OS)
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Poster #: 620
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Author: Emma Leach
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Location: Poster Hall C
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Date & Time: Friday, 11 November, 9:00 AM ET
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Title: Tebentafusp induced T and B cell epitope spread in patients with advanced melanoma
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Poster #: 619
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Author: Adel Benlahrech
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Location: Poster Hall C
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Date & Time: Thursday, 10 November , 9:00 AM ET
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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. Immunocore’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 (mUM) in the United States, European Union, Canada, Australia and the United Kingdom, having
demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in mUM, a cancer that has historically proven to be insensitive to other immunotherapies.
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.
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,” 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 and expected clinical
benefits of KIMMTRAK for melanoma, including its potential to be an effective treatment even for patients with advanced malignant melanoma regardless of disease progression and overall survival benefit. 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 the Company’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 the
Company’s business, strategy, clinical trials and 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 the COVID-19 pandemic, war in Ukraine or global geopolitical tension; Immunocore’s ability to obtain and maintain
regulatory approvals for 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
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 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 rising inflation and interest rates and general
market conditions, and the impacts thereon of the COVID-19 pandemic, 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; 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