On January 5, 2024 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, reported its strategic priorities for 2024 and announced the addition of two new pre-clinical candidates for autoimmune diseases to its pipeline (Press release, Immunocore, JAN 5, 2024, View Source [SID1234639012]).
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"We continue the global commercial roll out of KIMMTRAK, now launched in 10 countries, and are pursuing future growth opportunities for KIMMTRAK with two registrational trials in advanced cutaneous melanoma and in adjuvant uveal melanoma," said Bahija Jallal, Chief Executive Officer of Immunocore. "We are advancing our PRAME ImmTAC including our first Phase 3 clinical trial in melanoma and expect to present clinical data from our Phase 1/2 clinical trial in melanoma, ovarian, and lung cancer throughout 2024. Today we add two new autoimmune candidates to our pipeline, expanding the potential of our platform to a third therapeutic area."
Key Strategic Priorities 2024
Our strategic priorities are to bring transformative medicines to patients with cancer, infectious diseases, and autoimmune diseases. In 2024, our priorities will be:
Growing sales of KIMMTRAK (tebentafusp-tebn) in the United States and globally in patients with HLA-A*02:01-positive metastatic uveal melanoma, and expanding KIMMTRAK beyond its initial approved indication with the registrational trials for advanced (second-line or later) cutaneous melanoma (TEBE-AM) and adjuvant uveal (or ocular) melanoma (ATOM).
Advancing our PRAME franchise in multiple solid tumors and broadening the addressable population. Randomization is expected to begin in the first quarter of 2024 in the registrational trial for IMC-F106C in first-line advanced cutaneous melanoma (PRISM-MEL-301), and we expect to present data from the Phase 1/2 clinical trial monotherapy and combination cohorts throughout 2024. We further expect to submit investigational new drug (IND) applications or clinical trial applications (CTA) for IMC-P115C (PRAME HLA-A2 Half-Life-Extended) and IMC-T119C (PRAME HLA-A24) candidates in 2024.
Bringing novel ImmTAC candidates to the clinic, leading with IMC-R117C, a first-in-class ImmTAC candidate targeting PIWIL1 with focus on colorectal and gastrointestinal cancers.
Evaluating the potential for a functional cure in infectious diseases with lead candidates for human immunodeficiency virus (HIV) and hepatitis B virus (HBV).
Initiating CMC manufacturing for the Company’s first two autoimmune candidates – including the first in class, tissue-specific, TCR bispecific PD1 agonist for type 1 diabetes and a novel non-HLA restricted (universal) PD1 agonist for dermatological diseases.
KIMMTRAK expansion strategy
In 2024, the Company plans to expand access to KIMMTRAK to more patients in the United States, Europe and globally, as it continues to establish the therapy as standard of care for the first line treatment for metastatic uveal melanoma in countries where it is launched. As of 2023 year-end, KIMMTRAK has been launched in ten countries and is approved in 38 countries.
The Company also continues to enroll patients into a Phase 2/3 clinical trial (TEBE-AM) to investigate the potential of KIMMTRAK in advanced cutaneous melanoma, with randomization expected to be completed in the Phase 2 portion during the third quarter of 2024. Topline data from the Phase 2 portion of the trial is expected to be available by the fourth quarter of 2024.
In addition, in 2023, the Company signed an agreement for a European Organisation for Research and Treatment of Cancer (EORTC)-sponsored trial to study KIMMTRAK as adjuvant therapy for uveal (or ocular) melanoma (ATOM). The Company anticipates that the EORTC will randomize the first patient in the second half of 2024.
PRAME franchise
PRISM-MEL301 – First PRAME Phase 3 clinical trial with IMC-F106C in first-line advanced cutaneous melanoma
In August 2023, the Company announced plans to start a registrational Phase 3 trial with IMC-F106C in cutaneous melanoma. The trial will randomize patients with HLA-A*02:01-positive, first-line advanced cutaneous melanoma to IMC-F106C + nivolumab versus a control arm of either nivolumab or nivolumab + relatlimab, depending on the country where the patient is enrolled. The Company plans to randomize the first patient in this trial in the first quarter of 2024.
Phase 1/2 clinical trial of IMC-F106C targeting PRAME-A02 in multiple solid tumors
In addition to progressing IMC-F106C into a registrational trial in cutaneous melanoma, the Company is continuing to enroll patients in the monotherapy and combination arms of the Phase 1/2 clinical trial across multiple tumor types, including expansion arms for patients with advanced ovarian, non-small cell lung carcinoma, endometrial, and melanoma. In August 2023, the Company provided an updated analysis of the original 18 melanoma patients (initially presented at ESMO (Free ESMO Whitepaper) in September 2022), which continued to show promising durability of the clinical activity (range of duration of partial response from 6 months to 17 months). The Company expects to report clinical data from the ongoing monotherapy and combination cohorts throughout 2024 including cutaneous melanoma (expected in Q2 2024), ovarian (expected by Q3 2024), and non-small cell lung carcinoma (expected by Q4 2024).
IMC-P115C (PRAME-A02 Half-Life Extended) & IMC-T119C (PRAME-A24)
The Company is expanding the PRAME franchise with two new PRAME ImmTAC candidates, IMC-P115C (PRAME-A02 HLE) and IMC-T119C (PRAME-A24) for solid tumors, which are both on track for investigational new drug (IND) or clinical trial application (CTA) submissions for IMC-P115C in the second quarter of 2024 and the second half of 2024 for IMC-T119C.
IMC-R117C (PIWIL1) for colorectal and other gastrointestinal cancers
The Company has leveraged its proprietary peptidomic (ImmSPECT) database to validate a novel target, PIWIL1. 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 gastrointestinal and pancreatic cancers. PIWIL1 is also reported to be a negative prognostic marker and the Company believes IMC-R117C is the first PIWIL1-targeted immunotherapy. The Company submitted a CTA to regulatory authorities in December 2023, and expects the trial to start this year.
Enrolling ImmTAV candidates for a functional cure in infectious diseases
The Company continues to enroll people living with HIV in the multiple ascending dose (MAD) part of a Phase 1 clinical trial with IMC-M113V, to identify a safe and tolerable dosing schedule. This study will also test whether IMC-M113V could lead to reduction in the viral reservoir and, after stopping all therapies (antiretroviral therapies and IMC-M113V), delay or prevent HIV rebound (known as functional cure). The MAD part of the trial will enroll up to 28 participants. The Company expects to present a data update from the Phase 1 clinical trial in the second half of 2024.
In 2023, the Company amended the design of the ongoing Phase 1 trial with IMC-I109V for people living with HBV to include HBV-positive hepatocellular carcinoma. The Company continues to enroll patients into the trial in 2024.
Tissue-specific down modulation of the immune system for autoimmune diseases
The Company is expanding its platform into autoimmune with two first in class new bispecific candidates entering the Company’s pipeline. The key differentiator of the ImmTAAI platform is tissue-specific down modulation of the immune system. When tethered to the tissue of interest, the new candidates supress pathogenic T cells via PD1 receptor agonism.
The first candidate, IMC-S118AI (PPIxPD1), is targeted specifically to the pancreatic beta-cell and is intended for disease-modifying treatment in type 1 diabetes. IMC-S118AI recognizes a peptide from pre-proinsulin presented by HLA-A*02:01 on beta-cells.
The second target is present in the skin and intended to treat inflammatory dermatological diseases. The candidate is an antigen presenting cell (APC) tethered ImmTAAI and is not HLA restricted (e.g. universal for all populations).
Preliminary Year-End 2023 cash position
Preliminary unaudited cash and cash equivalents is approximately $443 million USD as of December 31, 2023.
42nd Annual J.P. Morgan Healthcare Conference
The Company has updated its corporate presentation to reflect these business and strategic updates. Additionally, the Immunocore management team will discuss these updates during a live and webcast presentation at the 42nd Annual J.P. Morgan Healthcare Conference, on Wednesday January 10, 2024, at 9:00 a.m. Pacific Standard Time (PST). The presentation and webcast will be available in the ‘Investors/Media’ section of Immunocore’s website at www.immunocore.com. A replay of the presentation will be made available for a limited time.