Immunocore NASDAQ: IMCR executives highlighted the company’s T-cell receptor (TCR) platform, commercial momentum for KIMMTRAK, and several upcoming clinical milestones during a presentation at the Needham Healthcare Conference.
Platform focus: soluble TCRs and intracellular targets
Management described Immunocore as founded on a TCR platform designed to produce “high-affinity, off-the-shelf soluble TCRs” that can recognize intracellular cancer antigens presented via HLA. The company said this approach expands the addressable target space beyond membrane-bound proteins.
Company representatives said the platform can access “greater than 90% of the proteome,” contrasting it with standard antibodies and many bispecific antibodies that rely on extracellular targets. They also described the platform as modular, with potential applications across oncology, infectious disease, and autoimmune disease, including the ability to either engage T-cells against tumors and infections or “down-modulate the immune system in a tissue-specific manner” for autoimmunity.
KIMMTRAK commercial execution and durability trends
In discussing KIMMTRAK’s performance in uveal melanoma, the company said it sold “just over $400 million” last year and is entering its fifth year on the market as standard of care across major markets. Management attributed the launch to “the people and the product,” pointing to an experienced commercial team and what it called a strong overall survival benefit and a “predictable and manageable safety profile” in a high unmet-need setting.
Executives cited KIMMTRAK’s overall survival data, including an OS hazard ratio of 0.51, and noted that prior to its approval, no product had been approved for uveal melanoma for roughly 40 years. They said growth drivers differ by geography:
- U.S.: increased duration of therapy over time and continued penetration into community centers.
- Outside the U.S.: additional country launches and broader patient access; Immunocore said KIMMTRAK has been approved in 39 countries and launched in 30.
On treatment duration, management said real-world duration has exceeded clinical trial experience, with duration now “about 14 months” in the commercial setting versus “closer to around 10 months” in the clinic. The company also said it continues to see duration trends improve as it launches in newer countries.
Treatment beyond progression and competitor context
Chief Medical Officer Mohammed Dar addressed questions about treatment beyond progression, saying the practice originated from investigator observations during phase I development and was then incorporated into the pivotal trial. Dar said that even among patients whose best response was progressive disease, that subgroup had better survival versus controls when comparing “progressors to progressors.” He added that in real-world use, treatment beyond progression has been even longer, which he attributed in part to the absence of cumulative toxicity seen with chemotherapy, targeted therapies, and some checkpoint inhibitors.
Asked about potential future positioning if other therapies enter the market, Dar emphasized that KIMMTRAK’s approval is in HLA-A*02:01-positive patients and that randomized OS data “always trumps single-arm data.” He said factors to watch for other agents include survival, toxicity profile, and durability of response.
Management also previewed additional KIMMTRAK data the company expects to present, including five-year overall survival data “next month at AACR” in an oral presentation. The company referenced French real-world registry data presented previously at ESMO showing “a 28-month overall survival,” and said it expects additional real-world evidence data outside the U.S. later this year.
On expanding beyond HLA-A*02:01 in uveal melanoma, Dar said the company has not pursued other HLA types there due to epidemiology—management estimated 90% to 95% of uveal melanoma cases occur in Caucasians, where HLA-A*02:01 is the largest allele—while it has considered other HLA subtypes in programs such as PRAME and HBV where relevant to target populations.
Key pipeline milestones: TEBE-AM, ADaM, PRAME, and earlier-line strategies
Dar framed the upcoming TEBE-AM readout in cutaneous melanoma as targeting patients who have failed approved therapies—post PD-1, with prior CTLA-4 exposure and, where applicable, BRAF-targeted therapy. He said there is currently “no treatment that has shown a survival benefit in a randomized trial” in this setting, and described overall survival as the endpoint for TEBE-AM. He contrasted an off-the-shelf infusion approach with tumor-infiltrating lymphocyte (TIL) therapy, which he characterized as applicable to a narrower subset of patients who can undergo resection, manufacturing time, and conditioning regimens.
On commercialization, CFO David Berman said expansion into cutaneous melanoma would be “incremental” due to overlap with the current footprint, adding that about half of cutaneous melanoma patients are treated by physicians already familiar with KIMMTRAK.
In pricing discussions, Berman said the company’s philosophy is to price based on unmet need and patient value informed by data, and argued that demonstrating an OS benefit in the TEBE-AM population would support a meaningful pricing opportunity.
Dar also discussed the ADaM adjuvant uveal melanoma trial, which he said is the only active adjuvant uveal melanoma registrational phase III trial and is focused on high-risk patients with recurrence-free survival as the primary endpoint. He said the study rationale was supported by observations in a phase III frontline metastatic trial, noting a PFS hazard ratio of 0.68 in patients with smaller tumors (lesions less than 3 cm) versus 0.73 overall. Dar said the EORTC-run cooperative group study is expected to complete enrollment by 2028.
For the PRAME franchise, Dar described a frontline metastatic cutaneous melanoma study (PRISM-MEL-301) using a “composite hybrid control” of nivolumab or Opdualag based on country-level approvals, designed to reflect evolving real-world use of PD-1 combinations. He said enrollment is progressing, dose selection under Project Optimus was completed last year, and the company is aiming to complete enrollment by the end of 2027 or early 2028. While he declined to detail the statistical plan, he said a clinically meaningful and commercially relevant benefit in pivotal trials is generally “at least a 25% improvement relative to control.”
Infectious disease and autoimmunity: early clinical steps and partnering openness
In infectious disease, Dar said the company is pursuing a “functional cure” approach in HIV and characterized it as a “lofty goal.” He said the ongoing phase I multiple ascending dose escalation has shown “interesting signals,” including an impact on the viral reservoir and a delay in viral rebound after stopping therapy, with acceptable safety and no dose-limiting toxicity. The company’s goal this year is to escalate to higher doses to evaluate whether higher exposure improves viral reservoir and control outcomes, with the option to expand cohorts if signals are promising.
On cytokine release syndrome (CRS) in HIV studies, Dar said cases seen to date were generally grade one (fever) and resolved quickly within hours. He said potential grade two CRS at higher doses would need to be evaluated based on reversibility and benefit, and noted mitigations such as pre-medication (including steroids) are built into the study design.
In autoimmunity, Dar described a tissue-targeting approach enabled by the company’s peptide libraries, immunology and proteomics expertise, and protein engineering. He said the type 1 diabetes program has submitted a CTA, with the first patient expected to be dosed in the “next couple of weeks or a month or so.” He also cited a potential atopic dermatitis program targeting CD1a, with a goal of filing a CTA later this year.
Berman said the company is open to partnering in infectious disease and autoimmunity “as long as it’s at the right time,” noting Immunocore is “well capitalized” and can advance programs to key inflection points with relatively low capital before considering risk-sharing. He also said the company continuously evaluates inbound business development opportunities, primarily focused on oncology.
On financial position, Berman said Immunocore ended 2025 with “just over $860 million” in cash, and that KIMMTRAK revenue, combined with disciplined SG&A and data-driven R&D investment, supports funding “for the foreseeable future.”
About Immunocore NASDAQ: IMCR
Immunocore plc is a clinical‐stage biotechnology company focused on the development of novel immunotherapies that harness the body's own T‐cell response to treat cancer and infectious diseases. The company's proprietary ImmTAC (immune mobilising monoclonal T‐cell receptors against cancer) platform utilizes engineered, soluble T‐cell receptor (TCR) molecules designed to recognise intracellular peptide–HLA complexes. By redirecting and activating T cells against disease‐associated targets, Immunocore aims to address malignancies and persistent viral infections with high unmet medical need.
The company's most advanced candidate, tebentafusp, is a bispecific ImmTAC molecule that targets gp100, a melanoma‐associated antigen, and has received regulatory approval for the treatment of metastatic uveal melanoma.
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