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Immatics Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for ACTengine® IMA203 TCR-T Monotherapy
RMAT designation granted by FDA CBER for IMA203 cell therapy in multiple PRAME-expressing tumors including cutaneous and uveal melanoma, ovarian cancer and other cancer types Regulatory activities underway with an initial focus on a registration-directed trial in melanoma as step one to leverage the full breadth of PRAME Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today announced that its IMA203 TCR-T program has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA Center for Biologics Evaluation and Research (CBER) in multiple relapsed and/or refractory HLA-A*02:01-positive and PRAME-expressing cancers, including cutaneous melanoma, uveal melanoma, endometrial carcinoma, synovial…
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Moderna and Immatics Announce Strategic Multi-Platform Collaboration to Develop Innovative Oncology Therapeutics
Collaboration combines leading technologies to develop breakthrough, mRNA-enabled in vivo expressed TCER® molecules Companies to leverage Immatics’ XPRESIDENT® target discovery platform and Moderna’s mRNA technology for the development of novel cancer vaccines Collaboration to include evaluation of Immatics’ investigational IMA203 PRAME TCR-T in combination with Moderna’s investigational PRAME mRNA cancer vaccine Immatics to receive $120 million upfront cash payment plus research funding with the potential for additional milestone and royalty payments Moderna, Inc. (NASDAQ: MRNA, “Moderna”) and Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today announced a strategic research and development collaboration to pioneer novel and transformative therapies for cancer patients with…
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Moderna und Immatics geben strategische Multi-Plattform-Kollaboration zur Entwicklung innovativer Onkologie Therapeutika bekannt
Kollaboration kombiniert führende Technologien zur Entwicklung bahnbrechender, in vivo exprimierter mRNA TCER®-Moleküle Die Unternehmen werden zur Entwicklung neuartiger Krebsimpfstoffe Immatics Target-Discovery-Plattform XPRESIDENT® und Modernas mRNA-Technologie nutzen Die Kollaboration umfasst die Untersuchung von Immatics TCR-T-Zelltherapiekandidat IMA203, der gegen die Zielstruktur PRAME gerichtet ist, in Kombination mit Modernas PRAME-mRNA-Krebsimpfstoffkandidat Immatics wird eine Vorauszahlung von 120 Millionen US-Dollar sowie Forschungsfinanzierung erhalten, mit der Option auf zusätzliche Meilenstein- und Tantiemenzahlungen Moderna, Inc. (NASDAQ: MRNA; „Moderna“) und Immatics N.V. (NASDAQ: IMTX; „Immatics“), ein Unternehmen, das sich auf die Entwicklung und Herstellung von T-Zell-basierten Immuntherapien für die Behandlung von Krebs fokussiert, gaben heute eine strategische Forschungs- und Entwicklungskollaboration bekannt, um gemeinsam neuartige und transformative Therapien für Krebspatienten mit hohem medizinischem Bedarf voranzubringen. Diese…
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Immatics Announces Second Quarter 2023 Financial Results and Business Update
Phase 1/2 clinical trial initiated evaluating Immatics’ second next-generation half-life extended TCR Bispecific program, TCER® IMA402 targeting PRAME ACTengine® IMA203 TCR-T monotherapy against PRAME showed 67% confirmed ORR in an interim clinical update on 11 heavily pre-treated patients in Phase 1b dose expansion Cohort A with median duration of response not reached at a median follow-up time of 8.5 months at data cut-off; next update in 4Q 2023 Bristol Myers Squibb exercised first opt-in into 2019 cell therapy collaboration ($15 million option fee received) and made a $35 million equity investment Cash and cash equivalents as well as other financial assets not including the recent equity investment by Bristol Myers…
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Immatics Initiates Phase 1/2 Clinical Trial to Evaluate PRAME TCR Bispecific IMA402 in Patients with Advanced Solid Tumors
TCER® IMA402 is the first next-generation, half-life extended TCR Bispecific targeting PRAME to enter the clinic Patient enrollment for IMA402 Phase 1/2 trial underway The trial will evaluate safety, tolerability, and anti-tumor activity of IMA402 in patients with recurrent and/or refractory solid tumors First clinical data expected in 2024 Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today announced the initiation of a Phase 1/2 clinical trial with its proprietary Bispecific T cell engaging receptor (TCER®) IMA402. IMA402 is the second product candidate in Immatics’ TCER® pipeline of next-generation, half-life extended bispecific molecules to enter clinical development. It targets…
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Immatics Reports Interim Clinical Data from Ongoing Phase 1b Cohort A Monotherapy with ACTengine® IMA203 TCR-T Targeting PRAME
<ul type="disc"> <li>Update covers data from 11 heavily pre-treated, last-line patients in Phase 1b dose expansion Cohort A treated with IMA203 TCR-T monotherapy against PRAME</li> <li>Objective response rate (ORR): 64% (7/11) initial ORR at week 6 and 67% (6/9) confirmed ORR at month 3</li> <li>Median duration of response not reached at median follow-up time of 8.5 months at data cut-off</li> <li>Objective responses independent of solid tumor type at low, medium and high PRAME expression levels in checkpoint-refractory cutaneous melanoma, platinum-resistant ovarian cancer, uveal melanoma, head and neck cancer and synovial sarcoma</li> <li>Cohort A IMA203 monotherapy TCR-T treatment continues to show manageable tolerability with no high-grade CRS and no ICANS; no…
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Immatics Announces First Bristol Myers Squibb Opt-in of TCR-T Candidate from Ongoing Multi-target Strategic Collaboration
Bristol Myers Squibb exercised its first option and entered into a global license agreement with Immatics for the most advanced TCR-T product candidate from the companies’ ongoing collaboration to develop four TCR-based adoptive cell therapies targeting solid tumors Immatics to receive an option payment of $15 million and is eligible for additional up to $490 million in milestone payments in addition to tiered royalties on net sales of the product Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today announced that Bristol Myers Squibb (NYSE:BMY) has exercised its option and entered into an exclusive worldwide license for the first…
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Immatics Announces Full Year 2022 Financial Results and Corporate Update
ACTengine® IMA203 TCR-T monotherapy against PRAME showed 50% confirmed objective response rate (cORR) at or above target dose in different solid cancers in an interim clinical update in Phase 1a and Phase 1b in October 2022 ACTengine® IMA203 TCR-T clinical data update on all three ongoing IMA203 Phase 1b cohorts (Cohort A: 1st-gen monotherapy, Cohort B: combination with a checkpoint inhibitor, Cohort C: 2nd-gen monotherapy), and identification of most promising cohort to advance towards pivotal trials is planned for 2H 2023; prioritization of patient treatment with 1st and 2nd-generation monotherapy Expansion of cell therapy manufacturing capabilities with construction of an in-house GMP manufacturing facility for registration-directed and commercial production of ACTengine®…
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Immatics Announces Third Quarter 2022 Financial Results and Business Update
Interim clinical update on ACTengine® IMA203 TCR-T monotherapy targeting PRAME demonstrated high confirmed objective response rate (cORR) of 50% (6/12) at or above target dose across Phase 1a and Phase 1b; confirmed responses seen across different solid tumor types: cutaneous melanoma, ovarian cancer, head and neck cancer, uveal melanoma, and synovial sarcoma First patient treated with IMA203CD8, a 2nd generation ACTengine® TCR-T monotherapy product candidate targeting PRAME in Phase 1b expansion cohort C; patient treatment ongoing in all three Phase 1b expansion cohorts Next-generation TCR Bispecific, TCER® IMA402 targeting PRAME showed high anti-tumor activity in vivo, low T cell engager-associated toxicities and favorable pharmacodynamic characteristics in preclinical studies; Phase 1/2 clinical trial…
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Immatics Reports Interim Clinical Data Update on ACTengine® IMA203 TCR-T Monotherapy Targeting PRAME
Clinical validation of PRAME as multi-tumor target with large potential for TCR-based therapies: confirmed responses in different solid cancers, in patients with high and low PRAME expression Update covers data from 27 patients in completed Phase 1a dose escalation and first 5 patients in Phase 1b dose expansion (cohort A) treated with IMA203 monotherapy Confirmed objective response rate (cORR): 50% (6/12) at target dose or above with at least 1 billion infused TCR-T cells across Phase 1a and 1b; thereof 80% cORR (4/5) in Phase 1b patients alone with all responses ongoing at data cut-off Confirmed responses across different solid tumor types: cutaneous melanoma, ovarian cancer, head and neck cancer,…
