Immunocore Holdings plc operates as a commercial stage biotechnology company.
The company is pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases, and autoimmune diseases. Leveraging the company’s proprietary, flexible, off-the-shelf ImmTAX (Immune mobilizing monoclonal TCRs Against X disease) platform, it is developing a deep pipeline in multiple therapeutic areas, including clinical stage programs in on...
Immunocore Holdings plc operates as a commercial stage biotechnology company.
The company is pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases, and autoimmune diseases. Leveraging the company’s proprietary, flexible, off-the-shelf ImmTAX (Immune mobilizing monoclonal TCRs Against X disease) platform, it is developing a deep pipeline in multiple therapeutic areas, including clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and earlier pre-clinical programs across three therapeutic areas.
In 2022, the company received approval for its lead product, KIMMTRAK, for the treatment of unresectable or metastatic uveal melanoma (‘mUM’) from the FDA, the European Commission and other health authorities. KIMMTRAK is approved in 39 countries for the treatment of unresectable or mUM. In 2024, the company launched KIMMTRAK in 14 additional countries (including Australia, Spain, Poland, and the United Kingdom excluding Scotland, and reached price agreements with England's National Institute for Clinical Excellence (‘NICE’), with further commercial launches planned in additional territories where KIMMTRAK is approved.
KIMMTRAK is the lead product from the company’s ImmTAX platform and was the first approved therapy in mUM. As of December 31,2024, the company has treated over 2,000 cancer patients with KIMMTRAK, tebentafusp, and its other ImmTAX product candidates. The company’s clinical programs are being conducted with patients with a broad range of cancers including melanoma, ovarian, lung, and colorectal, among others. The company is progressing three late-stage clinical programs within its ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) portfolio, including KIMMTRAK and the PRAME-targeted brenetafusp.
KIMMTRAK is manufactured at facilities located in Denmark and Germany, with final packaging completed in the Netherlands. The company is supporting the appropriate use of KIMMTRAK in the United States and Europe through a well-equipped and fit-for-purpose trained commercial team that includes commercial, medical, sales, and value access team members. The company utilizes a hybrid commercialization model that includes an in-house sales force in the United States and contracted resources in the United States and Europe. To support the company’s commercialization efforts, it has entered into an exclusive multi-regional agreement with Medison Pharma Ltd. (‘Medison’) to help seek regulatory authorization and commercialize KIMMTRAK in Canada, Australia, New Zealand, Israel, Central and Eastern Europe, South and Central America, and the Caribbean.
Unlike antibody targeted immunotherapies that has a relatively small target pool, the company’s approach relies on the power of TCRs, which are naturally occurring receptors found on the surface of T cells that has the ability to target nearly all of the human proteome. Natural TCRs give T cells the ability to scan for abnormalities in nearly any cell in the body that are presented as protein fragments, or antigens, by human leukocyte antigen (‘HLA’), on the cell surface. The company’s ImmTAX platform builds upon these natural TCRs to engineer soluble targeted and high-affinity TCRs. By engineering these TCRs through the company’s ImmTAX platform, it is developing off-the-shelf, bispecific therapeutics, which are able to precisely target a wide range of proteins uniquely expressed by unhealthy and abnormal cells that cannot be targeted by antibody-based immunotherapies.
The company’s ImmTAX bispecific therapeutics couple the targeting power of these engineered TCRs on one end with the other end displaying pre-optimized effector functions, which has the ability to drive a desired immune response at the site of the disease. This combination is designed to provide the company with significant flexibility as it is able to engineer and tailor the company’s ImmTAX therapeutics to target proteins that are specific to the disease it is trying to treat and then modulate the corresponding immune response by either boosting or inhibiting the immune system.
The company will also continue pioneering immunotherapy and unlocking the full potential of its platform to generate transformative treatments for patients, by using different targeting mechanisms and immune effectors for next-generation bispecific therapies.
Pipeline
The company is leveraging its platform within three therapeutic areas: cancer, infectious diseases, and autoimmune diseases. Its oncology portfolio includes numerous pre-clinical to late-stage programs, including KIMMTRAK in advanced cutaneous melanoma and adjuvant uveal melanoma, brenetafusp in a Phase 3 clinical trial in first-line advanced cutaneous melanoma, and in a Phase 1/2 clinical trial in multiple tumor types. Additionally, IMC-R117C (PIWIL-1) is in a Phase 1/2 clinical trial for advanced solid tumors, including colorectal cancer, and IMC-P115C (PRAME-HLE-A02) is in a Phase 1 clinical trial for patients with tumors that express PRAME. In 2024, the company submitted a clinical trial application (CTA) for IMC-T119C (PRAME-A24).
In infectious diseases, the company is evaluating two candidates, IMC-M113V and IMC-I109V, in Phase 1 clinical trials for a potential functional cure in human immunodeficiency virus (HIV) and hepatitis B virus (HBV), respectively. The company has expanded the ImmTAX platform into autoimmune diseases with the addition of two potential first-in-class new bispecific candidates entering the pipeline: IMC-S118AI, for which it plans to submit a CTA or Investigational New Drug application (IND) in the second half of 2025, and IMC-U120AI, for which it plans to submit a CTA or IND in 2026.
ImmTAC Platform (Oncology)
Within its ImmTAC platform, the company’s KIMMTRAK is approved in 39 countries for HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM), and it is being evaluated in late-stage trials for adjuvant uveal melanoma and advanced cutaneous melanoma. Brenetafusp, a PRAME-targeted candidate, is being evaluated in an ongoing Phase 3 registrational trial, PRISM-MEL-301, in first-line advanced cutaneous melanoma, after the company randomized the first patient in the second quarter of 2024, and it is enrolling patients in multiple expansion arms of the Phase 1/2 clinical trial. Additionally, the company has initiated a Phase 1/2 trial with IMC-R117C in advanced gastrointestinal cancers, and a Phase 1 trial with IMC-P115C (PRAME-HLE-A02) in patients with tumors that express PRAME. Finally, the company submitted a CTA for IMC-T119C (PRAME-A24). The pipeline also includes additional undisclosed pre-clinical programs.
The company’s ImmTAC product candidates are bispecific, soluble TCR molecules featuring an antigen-specific targeting module based on its high-affinity, highly specific TCR system and its proprietary cluster of differentiation 3 (CD3) effector module for T cell recruitment, engagement, and activation.
The company’s ImmTAC programs include:
KIMMTRAK (tebentafusp), the company’s ImmTAC molecule targeting an HLA-A*02:01 gp100 antigen, is its first approved product. The FDA and the European Commission has approved KIMMTRAK (tebentafusp-tebn and tebentafusp, respectively) for the treatment of HLA-A*02:01-positive adult patients with unresectable or mUM. KIMMTRAK is approved in 39 countries. As of December 31, 2024, the company had commercially launched KIMMTRAK in 24 countries, including the United States, with further commercial launches underway in additional territories where it has received regulatory approval.
KIMMTRAK is also being evaluated for the treatment of 2L+ advanced cutaneous melanoma (‘CM’). The company is enrolling patients in a randomized Phase 3 clinical trial (TEBE-AM) to investigate the potential of tebentafusp as a monotherapy or in combination with an anti-PD(L)1 therapy. This trial is enrolling patients with advanced CM, excluding only uveal melanoma, who has progressed on an anti-PD1, received prior ipilimumab and, if applicable, received a prior targeted therapy (BRAF mutant). The Phase 2/3 trial was converted into a registrational Phase 3 clinical trial in May 2024.
KIMMTRAK is also being evaluated for the treatment of adjuvant therapy for uveal (or ocular) melanoma in the ATOM registrational Phase 3 trial. Randomization of the first patient in this trial, led by the European Organisation for Research and Treatment of Cancer (‘EORTC’), began in December 2024. The company signed the agreement for this EORTC-sponsored trial in 2023.
Brenetafusp, the first PRAME x CD3 ImmTAC bispecific molecule, is being evaluated in patients with first-line advanced CM in the company’s registrational PRISM-MEL-301 Phase 3 clinical trial in combination with nivolumab with a primary endpoint of progression-free survival (‘PFS’). PRISM-MEL301, the first Phase 3 clinical trial with brenetafusp, is randomizing patients with HLA-A*02:01-positive, first-line advanced CM to brenetafusp + nivolumab versus a control arm of either nivolumab or nivolumab + relatlimab, depending on the country where the patient is enrolled. The trial was designed based on the company’s analysis of the ongoing Phase 1 data in previously treated CM which demonstrated monotherapy clinical activity including partial responses (‘PR’), durable tumor reduction, disease control (PR and stable disease), PFS and circulating tumor DNA (‘ctDNA’) reduction (consistent with prior reported data for brenetafusp and tebentafusp). Additional rationale includes safety in combination with checkpoints (from the ongoing Phase 1 data and prior experience with tebentafusp) and evidence from across the platform for increased clinical activity in earlier line patients compared to later line. The first patient was randomized in this trial in June 2024.
Brenetafusp is also being tested in a Phase 1/2 trial in combination with non-platinum chemotherapies in platinum-resistant ovarian cancer (‘PROC’) and with bevacizumab or with platinum chemotherapy in earlier lines of platinum sensitive ovarian cancer (‘PSOC’). In the same trial, the company continues signal detection in metastatic non-small cell lung cancer (‘NSCLC’) cohorts, including brenetafusp in combination with docetaxel and with osimertinib in earlier-line NSCLC and additional solid tumors.
The company presented updated clinical data from the Phase 1/2 trial:
in patients with late-line CM, at the 2024 American Society of Clinical Oncology annual meeting, showing promising brenetafusp monotherapy disease control (partial response and stable disease), PFS, and ctDNA molecular response. In PRAME positive patients, the disease control rate (‘DCR’) was 58% and median PFS was 4.2 months. This analysis of the initial 18 uveal and cutaneous melanoma patients was an update of the initial data set presented at the 2022 European Society for Medical Oncology (‘ESMO’) Congress, which continued to show promising durability of the clinical activity (range of duration of patient response from 6 months to 17 months).
in patients with heavily pre-treated platinum-resistant high grade serous ovarian cancer, at the 2024 ESMO Congress, showing signals of activity in heavily pretreated, platinum-resistant patients. DCR was 58% in monotherapy patients and 69% for combination patients. Overall survival (‘OS’) was still maturing (73% 6 months OS rate in the monotherapy cohort). ctDNA molecular response rates were 31% and 82% in the monotherapy and combination cohorts, respectively, associated with longer progression PFS and OS.
IMC-P115C, the company’s half-life extended ImmTAC candidate is being tested in a Phase 1 dose escalation trial in HLA-A*02:01-positive patients with a range of advanced cancers expressing PRAME. This ImmTAC candidate was designed with the aim of improving patient convenience. IMC-P115C targets the same PRAME-A02 peptide, with the same CD3 effector and TCR, specificity as brenetafusp. The company started enrolling patients in this trial in December 2024.
IMC-R117C, the company’s ImmTAC candidate targeting an optimal HLA-A*02:01 PIWIL1, is being tested in a Phase 1/2 trial (first dose was administered in December 2024) for patients with advanced solid tumors, including colorectal cancer, as a single agent and in combination with standards of care. 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 other gastrointestinal cancers. PIWIL1 is also reported to be a negative prognostic marker
IMC-T119C, is an ImmTAC molecule targeting an optimal HLA-A*24 PRAME: The company submitted a CTA for IMC-T119C in the fourth quarter of 2024. HLA-A24 is an HLA-type that is estimated to be present in 60% of people in Japan and 15% - 20% in Western populations.
ImmTAV Platform (Infectious Diseases)
The company has two programs from its ImmTAV (Immune mobilizing monoclonal TCRs Against Virus) platform in the clinic. The company’s ImmTAV product candidates are bispecific soluble TCR molecules featuring its ImmTAX TCR-based targeting system with high specificity for low-expression viral antigens, combined with the proprietary anti-CD3 effector module for T cell engagement and activation that has been evidenced by its clinical oncology pipeline. The company is seeking to develop therapeutics that can provide a functional cure to chronic viral disease and are focusing initially on HIV and HBV.
The company’s ImmTAV programs include:
IMC-M113V, the company’s ImmTAV molecule targeting a human immunodeficiency virus gag antigen bispecific TCR molecule, is being evaluated in a Phase 1 clinical trial. Initial Phase 1 safety and pharmacodynamic activity data from the single ascending dose (‘SAD’), portion of the trial was presented at the Conference on Retroviruses and Opportunistic Infections (‘CROI’) in 2023. IMC-M113V was well tolerated at doses where the company observed biomarkers of T cell engagement. The company is enrolling up to 28 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, or functional cure. The company will present initial data from the MAD portion of the trial in the first quarter of 2025.
IMC-I109V, the company’s ImmTAV molecule targeting a conserved hepatitis B virus envelope antigen, is being evaluated in a Phase 1 clinical trial in patients with chronic HBV who are non-cirrhotic, hepatitis B e-Antigen negative, and virally suppressed on chronic nucleot(s)ide analogue therapy. In 2023, the company amended the trial design in the ongoing Phase 1 clinical trial with IMC-I109V for people living with HBV to include HBV-positive hepatocellular carcinoma. The company has completed patient enrollment in the SAD portion of the trial and plan to present data in the second half of 2025.
ImmTAAI Platform (Autoimmune Diseases)
While the company’s ImmTAC and ImmTAV platforms attempt to provide therapeutic benefit by driving an immune response against targeted cells, its ImmTAAI (Immune modulating monoclonal TCRs Against AutoImmune disease) platform leverages the company’s ImmTAX platform to generate product candidates designed to provide precision tissue-specific downmodulation of the immune system for the treatment of autoimmune diseases. When tethered to the tissue of interest, the ImmTAAI candidates suppress pathogenic T cells via PD1 receptor agonism. With the company’s ImmTAAI platform, it plans to develop a portfolio of product candidates to treat autoimmune diseases with a high unmet medical need and provide significant benefit to patients.
The company’s ImmTAAI programs include:
IMC-S118AI is the company’s ImmTAAI molecule specifically targeted to the pancreatic beta-cells for disease modifying treatment in type 1 diabetes. The company plans to submit a CTA or IND for IMC-S118AI in the second half of 2025. IMC-S118AI recognizes a peptide from pre-pro-insulin presented by HLA-A2*01 on beta-cells coupled with a PD1 agonist effector arm. Type 1 diabetes is an autoimmune condition in which the patient’s immune system attacks and kills the beta-cells responsible for controlling glucose levels through the release of insulin. Progressive loss of beta cells leads to loss of glucose control requiring life-long monitoring and treatment with exogenous insulin.
IMC-U120AI is a CD1a-tethered PD1 agonist ImmTAAI therapy. It targets a non-HLA restricted or ‘universal’ target expressed on antigen presenting cells in the skin. CD1a is an HLA-like protein that is expressed on skin and mucosal antigen presenting cells, such as Langerhans cells. It plays an important role in triggering allergic inflammation in atopic dermatitis and potentially other immune diseases. The company plans to file a CTA or IND in 2026 for a Phase 1 trial in atopic dermatitis.
2025 Strategic Priorities
The company’s strategic priorities for 2025 include:
Building a melanoma franchise – reaching more mUM patients and delivering KIMMTRAK’s lifecycle management program through two ongoing registrational Phase 3 trials (TEBE-AM and the EORTC-sponsored ATOM trial). The company is also enrolling a third registrational trial, PRISM-MEL-301, evaluating brenetafusp in first-line melanoma.
Advancing the clinical portfolio – enrolling patients in multiple Phase 1 and 1/2 oncology trials with brenetafusp (PRAME-A02), IMC-P115C (PRAME-A02-HLE), IMC-R117C (PIWIL1-A02), and IMC-M113V in HIV.
Innovating for sustainable growth – planning to submit a CTA or IND for the company’s two autoimmune disease candidates: IMC-S118AI (PPI x PD1) by year end 2025 and IMC-U120AI (CD1a x PD1) in 2026.
ImmTAX Platform
The company’s therapeutic platform takes advantage of human TCRs through engineering of novel therapies known as Immune mobilizing monoclonal TCRs Against X disease (‘ImmTAX’). The company’s ImmTAX product candidates are bispecific therapeutics that are consists of two key elements—a TCR targeting system and an effector function—that, when combined, are designed to gives the company platform significant flexibility to treat a range of diseases.
Specifically, the company’s optimized ImmTAX bispecifics couple a high-affinity TCR targeting system with a range of effector functions tailored for the specific disease being addressed. TCRs are naturally found on the surface of T cells and are programmed to scan for abnormalities in the body through binding protein fragments presented by HLA on the surface of other cells. The company has been able to build upon the activity of natural TCRs to develop high-affinity TCRs, which allow for a precise targeting by its therapeutics of unhealthy and abnormal cells. The company’s TCR targeting system can be customized to target almost any protein within the human proteome, thereby increasing the potential for an on-target immune response. The company accomplishes this by identifying proteins that are specific to a disease and customizing the TCR domain of its ImmTAX molecules to target the HLA fragment presented by that specific protein.
The other component of the company’s ImmTAX molecules is an effector antibody fragment designed to mimic the body’s natural mechanisms for modulating the immune system, thereby allowing it to develop product candidates which are designed to generate a range of immune responses depending on the disease that is being treated.
While it has focused its initial efforts on oncology, the company is broadening its development efforts to infectious diseases and autoimmune conditions. The company has named each of these platforms according to their therapeutic area to distinguish the type of target recognized by the TCR targeting system and the selected effector function:
ImmTAC – Immune mobilizing monoclonal TCRs Against Cancer.
ImmTAV – Immune mobilizing monoclonal TCRs Against Viruses.
ImmTAAI – Immune modulating monoclonal TCRs Against AutoImmune disease.
Sales and Marketing
As of December 31, 2024, the company had launched KIMMTRAK in 24 countries, including the United States, Germany, France and a number of other countries, and it is focused on driving increasing awareness and adoption of KIMMTRAK as a treatment for mUM. The company’s focus is to utilize its commercial capabilities to continue to meet patient demand in the company’s major markets, and to launch in further markets in 2025.
Medison is the exclusive distribution partner for KIMMTRAK in Canada, Australia, New Zealand, Israel, Central and Eastern Europe, South and Central America, and the Caribbean.
Manufacturing and Drug Supply
For KIMMTRAK, the company contracts with the following well-established third-party manufacturers:
AGC Biologics A/S, headquartered in Copenhagen, Denmark; and
Simtra Biopharma Solutions, headquartered in Halle/Westfalen, Germany.
AGC Biologics A/S and Simtra Biopharma Solutions are positioned to provide longer term commercial manufacture of KIMMTRAK, with the storage, global distribution, packaging and labelling operations being provided by Deutsche Post DHL Group in the Netherlands.
Competition
The company faces competition from segments of the pharmaceutical, biotechnology and other related markets that pursue the development of TCR-based therapeutics to address unmet needs in cancer, including Adaptimmune Therapeutics plc, Immatics Biotechnologies GmbH (‘Immatics’), Adaptive Biotechnologies Corporation (‘Adaptive’), pure MHC, LLC, BioNTech SE, Genentech, Inc. (‘Genentech’), Matterhorn Biosciences AG, Enara Bio Limited, Boehringer Ingelheim International GmbH, and Regeneron Pharmaceuticals, Inc. (‘Regeneron’), who are also seeking to identify peptide HLA targets and develop product candidates; Immatics, Anocca AB, T-Knife GmbH, Adaptive, 3T Biosciences, Inc., MediGene AG, Regeneron, Takara Bio Inc., Bristol-Myers Squibb Company (‘BMS’), GSK plc, Kite Pharma, Inc., Lion TCR Pte. Ltd., TCRCure Biopharma Ltd., Corregene Biotechnology Co. LTD, and TScan Therapeutics, Inc. (‘TScan’) who are developing TCR-based cell therapies; and F. Hoffmann-La Roche Ltd, Amgen, Inc., Genmab, Inc., Molecular Partners AG, 3T Biosciences, Inc., Crossbow Therapeutics, Inc., and CDR-Life Inc. are developing CD3-based TCR bispecific compounds or TCR mimetic antibodies.
Intellectual Property
As of December 31, 2024, the company’s global portfolio consisted of over 600 patents and pending applications, including at least 25 issued U.S. patents and more than 300 ex-U.S. patents. The majority of the company’s patents and patent applications are solely owned. The portfolio includes solely owned patents and patent applications directed to the company’s commercial TCR product (KIMMTRAK), its product candidates (including brenetafusp, IMC-M113V, IMC-I109V, IMC-P115C, IMC-R117C, IMC-T119C, IMC-S118AI and IMC-U120AI), and the company’s platform technology used to identify and generate its therapeutic candidates, novel targets, formulations and methods of treatment.
KIMMTRAK (tebentafusp)
As of December 31, 2024, the company owned granted patents and patent applications covering the composition of matter of its commercial product KIMMTRAK (tebentafusp). The patents include claims that cover the specific sequence of KIMMTRAK, as well as claims that cover TCR variants with similar biological properties. Granted patents has been obtained in major territories including two in the United States and 28 in foreign jurisdictions, including Europe (including United Kingdom, France, Germany, Italy, Spain, Ireland, Denmark and the Netherlands), Australia, Canada, China, Hong Kong, Japan, Mexico, Eurasia and South Africa. These granted patents are set to expire in 2030. In the United States, a patent term extension (‘PTE’) application has been filed and is anticipated to extend the patent term such into the first quarter of 2035. Requests for supplementary protection certificates (‘SPC’) has been filed and granted in Australia and Canada, extending patent term through the second quarter of 2035 and 2032, respectively. SPCs has also been filed in Europe (with grants in at least 10 European territories) extending patent term through the second quarter of 2035. Further patent families has been filed including those directed to dosing regimen, formulation, and methods of treatment. If granted, these applications would provide possible additional upside protection to at least 2042.
ImmTAX Pipeline
As of December 31, 2024, the company solely owned patent families covering the composition of matter of each of its oncology, infectious disease, and autoimmune pipeline candidates, including issued U.S. patents covering the composition of matter of brenetafusp, the company’s PRAME-A02 candidate. In each case, claims of the composition of matter patents or patent applications are directed to the therapeutic candidates and to variants with similar biological properties. The issued U.S. composition of matter patents for brenetafusp are estimated to expire in 2038, excluding any additional term for patent term adjustments or patent term extensions. Further patent applications have been filed relating to brenetafusp dosing regimens and methods of treatment.
The company’s ImmTAX platform
As of December 31, 2024, the company solely owned a number of patents and patent applications related to its ImmTAX platform. The oldest patent families relating to the company’s ImmTAX TCR bispecific format will expire starting in 2030. The company has filed further platform patent families relating to TCR bispecifics with improved therapeutic properties, including formats with extended in vivo half-life and improved anti-CD3 effector functions, as well as therapeutic formats for the treatment of autoimmune indications. Such pending patent applications, if granted, are expected to expire between 2039 and 2043, excluding any additional term for patent term adjustments or patent term extensions.
The company jointly owns in 50% equal share with Adaptimmune, platform patent families relating to methods and tools for selecting TCRs in the early pipeline. The latest of these will expire in 2036.
HLA Target Peptide Patent Applications
As of December 31, 2024, the company owned a number of patent families relating to novel HLA-restricted peptide targets and their use. Such patents and pending patent applications, if granted, are expected to expire between 2036 and 2037, excluding any additional term for patent term adjustments or patent term extensions.
Patent Term
Typically, the company files its priority applications at the U.K. Intellectual Property Office (‘UKIPO’), and/or at the U.S. Patent and Trademark Office (‘USPTO’). This is generally followed 12 months later by the filing of a patent application under the PCT claiming priority from the initial application(s), and/or national applications.
Trademarks
As of December 31, 2024, the company’s trademark portfolio contained registrations or registration applications related to its commercial and pipeline products, including KIMMTRAK, as well as for IMMUNOCORE, in the United States and other relevant jurisdictions. The company also has trademark registrations or registration applications relating to its platform technology, including ImmTAX, ImmTAC, ImmTAV and ImmTAAI in the United States and in certain foreign jurisdictions.
Collaborations and License Agreements
BMS Collaboration
In February 2024, the company entered into a clinical trial collaboration and supply agreement with BMS (the ‘BMS Agreement’) to investigate its ImmTAC bispecific TCR candidate targeting PRAME HLA-A*02:01 brenetafusp in combination with BMS’s nivolumab, in first-line advanced cutaneous melanoma.
Gadeta Collaboration
In December 2022, the company entered a collaboration, option and license agreement, (the ‘Gadeta Collaboration’), with Gadeta B.V., (‘Gadeta’) which was acquired by Clade Therapeutics, (‘Clade’) in October 2023.
Assignment and Exclusive License Agreement with Adaptimmune
In May 2013, the company entered into an assignment and exclusive license agreement (the ‘Adaptimmune License’) with Adaptimmune Limited, which is the U.K. subsidiary of Adaptimmune Therapeutics plc, relating to the joint ownership and licensing of certain patents, patent applications, rights in know-how and other intellectual property rights.
Government Regulation
The company is subject to the EU’s General Data Protection Regulation (‘EU GDPR’), the United Kingdom’s equivalent law (‘U.K. GDPR’) (collectively, ‘GDPR’), and the Health Insurance Portability and Accountability Act as amended (‘HIPAA’), in the United States, among others.
The company is subject to the U.S. Foreign Corrupt Practices Act of 1977, as amended (the ‘FCPA’), the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. Travel Act, the USA PATRIOT Act, the U.K. Bribery Act 2010 and the U.K. Proceeds of Crime Act 2002 and possibly other state and national anti-bribery and anti-money laundering laws in countries in which the company conducts activities, collectively, Anti-Corruption Laws. The company can also be held liable for the acts of its third-party agents under the FCPA, the U.K. Bribery Act 2010 and possibly other Anti-Corruption Laws.
Research and Development
For the year ended December 31, 2024, the company’s research and development expenses were $222.2 million.
History
Immunocore Holdings plc was founded in 1999. The company was incorporated in 2021.
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