Immunocore announces first patient dosed in the Phase 1 trial of IMC-P115C, a half-life extended (HLE) ImmTAC candidate in patients with tumors that express PRAME
Immunocore (IMCR) has initiated the Phase 1 trial of IMC-P115C, its first half-life extended ImmTAC candidate, with the first patient now dosed. IMC-P115C targets PRAME (PReferentially expressed Antigen in MElanoma) and shares the same CD3 effector and TCR specificity as brenetafusp, but is designed with an extended half-life to improve patient convenience through reduced treatment frequency.
The Phase 1 dose escalation trial will evaluate safety, pharmacokinetics, and clinical activity in HLA-A*02:01-positive patients with advanced cancers expressing PRAME. This marks Immunocore's sixth ImmTAC candidate to enter clinical trials, building upon their existing PRAME dataset from brenetafusp's Phase 1/2 trials.
Immunocore (IMCR) ha avviato il trial di Fase 1 di IMC-P115C, il suo primo candidato ImmTAC con emivita prolungata, con il primo paziente già trattato. IMC-P115C si focalizza su PRAME (Antigene espresso in modo preferenziale nel melanoma) e condivide la stessa specificità CD3 ed TCR di brenetafusp, ma è progettato con un'emivita prolungata per migliorare la comodità dei pazienti riducendo la frequenza dei trattamenti.
Il trial di dose escalation di Fase 1 valuterà la sicurezza, la farmacocinetica e l'attività clinica in pazienti HLA-A*02:01-positivi affetti da tumori avanzati esprimente PRAME. Questo segna il sesto candidato ImmTAC di Immunocore ad entrare in trials clinici, costruendo sui dati esistenti di PRAME derivanti dai trials di Fase 1/2 di brenetafusp.
Immunocore (IMCR) ha iniciado el ensayo de Fase 1 de IMC-P115C, su primer candidato ImmTAC con vida media prolongada, con el primer paciente ya dosificado. IMC-P115C tiene como objetivo PRAME (Antígeno expresado preferentemente en melanoma) y comparte la misma especificidad de CD3 y TCR que brenetafusp, pero está diseñado con una vida media prolongada para mejorar la comodidad del paciente mediante la reducción de la frecuencia de tratamiento.
El ensayo de escalada de dosis de Fase 1 evaluará la seguridad, farmacocinética y actividad clínica en pacientes HLA-A*02:01-positivos con cánceres avanzados que expresan PRAME. Esto marca el sexto candidato ImmTAC de Immunocore en entrar en ensayos clínicos, apoyándose en su base de datos existente de PRAME proveniente de los ensayos de Fase 1/2 de brenetafusp.
Immunocore (IMCR)는 첫 번째 절반 생명 연장 ImmTAC 후보 물질인 IMC-P115C의 1상 임상을 시작했으며, 첫 번째 환자에게 투약이 완료되었습니다. IMC-P115C는 PRAME(피부 흑색종에서 선호적으로 발현되는 항원)를 목표로 하며, brenetafusp와 동일한 CD3 효과기 및 TCR 특성을 공유하지만, 치료 빈도를 줄여 환자의 편의를 증대시키기 위해 장기적인 절반 생명으로 설계되었습니다.
1상 용량 증량 임상 시험은 PRAME을 발현하는 진행성 암을 가진 HLA-A*02:01 양성 환자에서 안전성, 약동학 및 임상 활동성을 평가할 것입니다. 이는 Immunocore가 임상 실험에 진입하는 여섯 번째 ImmTAC 후보로, brenetafusp의 1/2상 시험에서의 기존 PRAME 데이터셋을 바탕으로 하고 있습니다.
Immunocore (IMCR) a lancé l'essai de phase 1 de IMC-P115C, son premier candidat ImmTAC à durée de vie prolongée, le premier patient ayant déjà été soumis au traitement. IMC-P115C cible PRAME (Antigène exprimé préférentiellement dans le mélanome) et partage la même spécificité CD3 et TCR que brenetafusp, mais est conçu avec une durée de vie prolongée pour améliorer le confort des patients grâce à une réduction de la fréquence des traitements.
L'essai de dose croissante de phase 1 évaluera la sécurité, la pharmacocinétique et l'activité clinique chez des patients HLA-A*02:01-positifs atteints de cancers avancés exprimant PRAME. Cela représente le sixième candidat ImmTAC d'Immunocore à entrer dans des essais cliniques, s'appuyant sur leur jeu de données PRAME existant provenant des essais de phase 1/2 de brenetafusp.
Immunocore (IMCR) hat die Phase-1-Studie zu IMC-P115C gestartet, seinem ersten ImmTAC-Kandidaten mit verlängerter Halbwertszeit, wobei der erste Patient bereits behandelt wurde. IMC-P115C zielt auf PRAME (bevorzugt exprimiertes Antigen bei Melanomen) ab und teilt die gleiche CD3-Effektor- und TCR-Spezifität wie Brenetafusp, ist jedoch mit einer verlängerten Halbwertszeit konzipiert, um den Patientenkomfort durch reduzierte Behandlungsfrequenz zu verbessern.
Die Phase-1-Dosiseskalationsstudie wird die Sicherheit, Pharmakokinetik und klinische Aktivität bei HLA-A*02:01-positiven Patienten mit fortgeschrittenen Krebsarten, die PRAME exprimieren, bewerten. Dies ist der sechste ImmTAC-Kandidat von Immunocore, der in klinische Studien eintritt und auf dem bestehenden PRAME-Datensatz aus den Phase-1/2-Studien von Brenetafusp aufbaut.
- First patient dosed in Phase 1 trial, marking clinical progress
- IMC-P115C designed to reduce treatment frequency, potentially improving patient compliance
- Builds on existing PRAME dataset from brenetafusp trials
- None.
Insights
A critical development in Immunocore's pipeline expansion with IMC-P115C represents a strategic enhancement of their PRAME-targeting platform. The half-life extended (HLE) modification is a significant technical advancement, potentially reducing the treatment burden from weekly to bi-weekly or monthly dosing schedules. This could translate to improved patient compliance and reduced healthcare resource utilization.
The trial builds upon Immunocore's existing PRAME program, leveraging data from brenetafusp's development. Key differentiators include:
- Identical TCR specificity and CD3 effector as brenetafusp, reducing development risk
- Enhanced half-life characteristics that could provide competitive advantages in the growing PRAME-targeted therapy space
- Potential for broader market penetration due to improved dosing convenience
With PRAME expression found in multiple tumor types, including melanoma, lung and ovarian cancers, the addressable market is substantial. The initiation of this Phase 1 trial, while early-stage, represents a calculated step in expanding Immunocore's commercial potential in the
This development positions Immunocore strategically in the competitive PRAME-targeting landscape. The company's approach of developing a half-life extended version while maintaining proven targeting mechanisms demonstrates sophisticated pipeline management. This could be particularly valuable considering:
- Reduced dosing frequency could provide a significant competitive advantage over other PRAME-targeting therapies in development
- The potential for improved patient compliance could lead to better real-world efficacy data
- Lower administration costs could positively impact pricing strategies and market access
The timing is important as several companies are advancing PRAME-targeted therapies. Immunocore's experience with brenetafusp provides a significant head start in understanding the target biology and safety profile, potentially accelerating development timelines and reducing clinical risk.
Immunocore announces first patient dosed in the Phase 1 trial of IMC-P115C, a half-life extended (HLE) ImmTAC candidate in patients with tumors that express PRAME
IMC-P115C (PRAME-HLE-A02) targets the same peptide and has the same CD3 effector and TCR specificity as brenetafusp, and is designed with extended half-life
The Phase 1 trial will assess the safety and clinical activity of IMC-P115C in HLA-A*02:01-positive patients with advanced solid tumors that express PRAME
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & GAITHERSBURG, Md., US, 23 December 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, today announces that the first patient has been dosed in the Phase 1 trial of IMC-P115C (PRAME-HLE-A02), which is a half-life extended ImmTAC candidate.
IMC-P115C was developed to improve patient convenience by reducing the frequency of treatment administration. It is Immunocore’s first half-life extended candidate, and sixth ImmTAC candidate to enter the clinic. IMC-P115C is a PRAME x CD3 ImmTAC bispecific protein, with the same CD3 and targeting the same HLA-A*02:01 PRAME (PReferentially expressed Antigen in MElanoma) peptide as brenetafusp.
“I am very proud of the Immunocore team who have worked diligently with the clinical sites to start the Phase 1 trial with IMC-P115C – our half-life extended PRAME-targeted candidate,” said Mohammed Dar, Senior Vice President, Clinical Development and Chief Medical Officer of Immunocore. “With brenetafusp, we have the largest Phase 1/2 PRAME data set, which served as the basis for starting the first Phase 3 trial with a PRAME therapy. We look forward to the data from this Phase 1 trial, which will add to the understanding of the potential of our PRAME candidates.”
The Phase 1 dose escalation trial will evaluate the safety, pharmacokinetics and clinical activity of IMC-P115C in HLA-A*02:01-positive patients with a range of advanced cancers expressing PRAME.
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 the IMC-P115C Phase 1 trial
IMC-P115C-1005 is a first-in-human, Phase 1 trial in patients with advanced solid tumors expressing PRAME. The dose escalation portion of the trial is designed to evaluate the safety, preliminary anti-tumor activity and pharmacokinetics of IMC-P115C, a bispecific protein built on Immunocore’s ImmTAC technology, and the Company’s first half-life extended molecule.
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 diseases and infectious diseases. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including nine active clinical and pre-clinical programs in oncology, infectious diseases, and autoimmune diseases. 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”, “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 Immunocore’s expectations regarding the design, progress, timing, enrollment, randomization, scope, expansion, funding, and results of its existing and planned clinical trials; including the Phase 1 trial of IMC-F106C-101; and the expected clinical benefits of IMC-P115C and the Company’s other product candidates. Any forward-looking statements are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual events or 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 on the Company’s business, 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 health epidemics or pandemics, war in Ukraine, the conflict in the Middle East or global geopolitical tension; Immunocore’s ability to obtain and maintain regulatory approval of 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 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 changes in inflation and interest rates and unfavorable general market conditions, and the impacts thereon of the war in Ukraine, the conflict in the Middle East, and global geopolitical tension; Immunocore’s ability to obtain, maintain and enforce intellectual property protection for KIMMTRAK or any of its product candidates it or its collaborators are 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 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission on February 28, 2024, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the SEC. 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 Information
Immunocore
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E: sebastien.desprez@immunocore.com
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Investor Relations
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FAQ
What is the purpose of Immunocore's IMC-P115C Phase 1 trial announced in December 2024?
How does IMCR's IMC-P115C differ from brenetafusp?
What milestone does IMC-P115C represent for Immunocore (IMCR)?
Which patient population is eligible for the IMCR IMC-P115C Phase 1 trial?
