IMA401 / Immatics - LARVOL DELTA

IMA401 MAGEA4/8 Bispecific Phase 1a Data Summary (GlobeNewswire) - "Patients in three focus indications treated with ≥1 mg of IMA401 as a monotherapy or in combination with pembrolizumab demonstrated clinical activity: Head and neck cancer: cORR of 25% (2/8), disease control rate of 63% (5/8); Melanoma: cORR of 29% (2/7), disease control rate of 57% (4/7); Squamous non-small-cell lung cancer: 1 partial response at first scan for a heavily pre-treated, ICI-resistant patient, 1 patient with stable disease for >4 months and overall survival of approximately 16 months, 1 patient with progressive disease with shrinkage of liver target lesions."

P1 data • Head and Neck Cancer • Melanoma • Non Small Cell Lung Cancer

Novel pharmacokinetics (PK) and anti-drug antibody (ADA) assays for Immatics´ bispecific T cell engaging receptor (TCER®) clinical trial (CIMT 2025) - P1 | "Our ADA assays for IMA401 TCER® follow the classical tiered approach which consists of screening, confirmatory and characterization sub-assays. In summary, the in-house PK and ADA assay development and optimization has enabled Immatics to gain insights into drug exposure and immunogenicity, guiding decisions for the Immatics´ TCER® program."

Clinical • PK/PD data • Oncology • HLA-A • MAGEA4

Immatics Announces First Quarter 2025 Financial Results and Business Update (GlobeNewswire) - "IMA402 PRAME Bispecific: Phase 1a clinical trial in solid tumors ongoing with next data update at relevant dose levels planned in 2025....The next update on IMA401 Phase 1a data, with a focus on head and neck cancer, is expected in 2025, and the Company plans to share data with a focus on non-small cell lung carcinoma in 2026."

P1 data • Head and Neck Cancer • Non Small Cell Lung Cancer • Solid Tumor

TCER IMA401 (MAGEA4/8) (GlobeNewswire) - "The next update on IMA401 Phase 1a data, with a focus on head and neck cancer, is expected in 2025, and the Company plans to share data with a focus on non-small cell lung carcinoma in 2026."

P1 data • Trial status • Head and Neck Cancer • Non Small Cell Lung Cancer

IMA401-101: IMA401 TCER® in Recurrent and/or Refractory Solid Tumors, Alone or in Combination With a Checkpoint Inhibitor (clinicaltrials.gov) - P1 | N=95 | Recruiting | Sponsor: Immatics Biotechnologies GmbH | N=50 ➔ 95 | Trial completion date: Nov 2027 ➔ Dec 2029

Checkpoint inhibition • Enrollment change • Monotherapy • Trial completion date • Oncology • Solid Tumor • MAGEA4

Immatics Announces Third Quarter 2024 Financial Results, Business Update… (GlobeNewswire) - "Total revenue, consisting of revenue from collaboration agreements, was $56.7 million1 (€50.6 million) for the three months ended September 30, 2024, compared to $6.6 million1 (€5.9 million) for the three months ended September 30, 2023. The increase is mainly the result of a one-time revenue associated with the termination of the IMA401 collaboration by Bristol Myers Squibb during the three months ended September 30, 2024."

Commercial • Oncology • Solid Tumor

Initial safety, pharmacokinetics, and anti-tumor activity data of TCER IMA401, a MAGEA4/8-directed half-life extended TCR bispecific, in phase I dose escalation (ESMO 2024) - P1 | "IMA401 was well tolerated and its single-agent anti-tumor activity was demonstrated by durable objective responses and disease control. The prolonged half-life prompted a switch to treatment every 2 weeks already during dose escalation. The data of this ongoing Phase 1 dose escalation trial provide first clinical PoC for the next-gen half-life extended TCER® format and its potential in multiple solid tumors."

Clinical • P1 data • PK/PD data • Endocrine Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Melanoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • HLA-A • MAGEA4

Immatics Presents Clinical Proof-of-Concept Data from Ongoing Phase 1 Dose Escalation Trial with TCR Bispecific Molecule TCER IMA401 Targeting MAGEA4/8 at ESMO 2024 and Provides Development Update (GlobeNewswire) - P1a/1b | N=50 | NCT05359445 | Sponsor: Immatics Biotechnologies GmbH | "Immatics N.V...presented the proof-of-concept clinical data for the first candidate of its next-generation, half-life extended TCR Bispecifics platform, TCER IMA401...Initial data from the IMA401 Phase 1a first-in-human dose escalation basket trial in a broad range of heavily pretreated patients with recurrent and/or refractory solid tumors showed initial anti-tumor activity, durable objective responses, including confirmed responses ongoing at 13+ months, and a manageable tolerability profile...The next data update is expected in 2025...MA401 demonstrated an 'antibody-like' median half-life of over two weeks (16.9 days). This supported the switch to q2w dosing (once every two weeks) during dose escalation."

P1 data • Solid Tumor

Immatics Announces Upcoming Oral Presentation at ESMO Congress 2024 (GlobeNewswire) - "Immatics N.V...today announced that the first proof-of-concept clinical data for its next-generation, half-life extended TCR Bispecific molecule, TCER IMA401 (MAGEA4/8), will be presented during an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2024 on Monday, September 16, 2024 at 11:25 CEST....Full abstracts will be available on the ESMO website on Monday, September 9, 2024, at 00:05 CEST."

P1 data • PK/PD data • Oncology • Solid Tumor

IMA401 TCER® in Recurrent and/or Refractory Solid Tumors (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Immatics Biotechnologies GmbH | Phase classification: P1a/1b ➔ P1

Phase classification • Oncology • Solid Tumor • MAGEA4

Immatics Announces Third Quarter 2023 Financial Results and Business Update (GlobeNewswire) - "Immatics has recently received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for IMA203 GEN1 in multiple PRAME-expressing cancers, including cutaneous and uveal melanoma, and is now targeting a registration-enabling Phase 2 trial in cutaneous melanoma potentially bundled with uveal melanoma in 2024. Discussions with FDA to align on patient population, trial design and CMC aspects of the planned Phase 2 trial are ongoing. An update on the clinical development plan is expected in the first quarter of 2024....Research and Development Expenses: R&D expenses were €30.5 million ($32.3 million2) for the three months ended September 30, 2023, compared to €28.6 million ($30.3 million2) for the three months ended September 30, 2022. The increase mainly resulted from higher costs associated with the advancement of the clinical pipeline of ACTengine^® IMA203 and TCER^® IMA401 and IMA402 candidates."

Commercial • New P2 trial • Cutaneous Melanoma • Melanoma • Oncology • Skin Cancer • Solid Tumor

Immatics Announces Full Year 2022 Financial Results and Corporate Update (GlobeNewswire) - "ACTengine® IMA201 (MAGEA4/8) – The Phase 1a dose escalation cohort at target dose is ongoing. Immatics plans to discontinue this program after treatment of the remaining patients already enrolled in the clinical trial in order to focus on its TCR Bispecific program TCER^® IMA401 addressing the identical target peptide derived from MAGEA4/8 as IMA201."

Trial status • Oncology • Solid Tumor

IMA401 TCER® in Recurrent and/or Refractory Solid Tumors (clinicaltrials.gov) - P1a/1b | N=50 | Recruiting | Sponsor: Immatics Biotechnologies GmbH | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor • MAGEA4

Immatics Initiates Phase 1 Clinical Trial to Evaluate Lead TCR Bispecific IMA401 in Patients with Advanced Solid Tumors (GlobeNewswire) - "Immatics N.V...announced the initiation of a Phase 1 clinical trial with its T cell engaging receptor (TCER®) IMA401 for patients with recurrent and/or refractory solid tumors....The trial is planned to be conducted at up to 15 centers in Germany, with the first site already being initiated. The Phase 1 trial is designed to enroll approximately 50 patients...Immatics’ TCR Bispecific pipeline includes a second TCER® product candidate, IMA402, which targets PRAME. Manufacturing of the clinical IMA402 batch is planned for the second half of 2022 and initiation of the Phase 1 trial is planned in 2023."

New P1 trial • Trial status • Oncology • Solid Tumor

IMA401 TCER® in Recurrent and/or Refractory Solid Tumors (clinicaltrials.gov) - P1a/1b | N=50 | Not yet recruiting | Sponsor: Immatics Biotechnologies GmbH

New P1 trial • Oncology • Solid Tumor • MAGEA4

Immatics and Bristol Myers Squibb Enter Into Global Exclusive License for Immatics’ TCR Bispecific Program IMA401 (GlobeNewswire) - "Immatics N.V...and Bristol Myers Squibb (NYSE: BMY), today announced that they have entered into a license, development and commercialization agreement (the “agreement”) for Immatics’ TCR Bispecific candidate, IMA401. Under the terms of the agreement, Immatics will receive an upfront payment of $150 million as well as up to $770 million in development, regulatory and commercial milestone payments, in addition to tiered double-digit royalty payments on net sales of IMA401. Immatics retains the options to co-fund U.S. development in exchange for enhanced U.S. royalty payments and/or to co-promote IMA401 in the US."

Licensing / partnership • Oncology • Solid Tumor

Immatics Announces Third Quarter 2021 Financial Results and Provides Business Update (GlobeNewswire) - "IND submission for IMA203CD8 as part of the Phase 1b study expansion cohort is expected in the first half of 2022...TCER® IMA402...Production of GMP material for a Phase 1 clinical study is planned in 2022...R&D expenses were €21.2 million ($24.5 million1) for the three months ended September 30, 2021...The increase is mainly due to expanded clinical activities for the ACTengine® IMA200 series, as well as GMP manufacturing for the TCER® compound, IMA401."

Commercial • New P1 trial • Hematological Malignancies • Oncology • Solid Tumor

Immatics Announces Second Quarter 2021 Financial Results and Provides Business Update (GlobeNewswire) - ACTengine® IMA200 series: The next data update, which will cover safety, biological activity, and the assessment of anti-tumor activity across different cancer indications, including patients treated at higher dose levels (dose levels 2 and 3), will be provided by the company within the second half of 2021; IMA401 remains on track for submission of a CTA in the fourth quarter of 2021 and patient recruitment will be initiated in the first half 2022."

Enrollment status • P1 data • Regulatory • Oncology • Solid Tumor

Immatics Announces Full Year 2020 Financial Results and Corporate Update (GlobeNewswire) - “Adoptive Cell Therapy Programs: An additional Phase 1a read-out for IMA201 and IMA203 and initial Phase 1b data for IMA202 from the dose expansion cohort is planned for H2 2021. Submission of a clinical trial application (CTA) for the fourth IMA200 series program, IMA204, remains anticipated for H2 2021; TCR Bispecifics Programs: IMA401 –Submission of a CTA for IMA401 remains on track by the end of 2021; IMA402 – Immatics plans to announce preclinical proof-of-concept data for its second TCER® program, IMA402 in Q2 2021....Scientific Advisory Board Update...Patrick Hwu...will co-chair the SAB."

Clinical data • Preclinical • Regulatory • Oncology • Solid Tumor

Immatics Announces Third Quarter 2020 Financial Results and Business Update (GlobeNewswire) - "ACTengine® IMA204: Submission of an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for IMA204 remains anticipated for 2021; IMA401: Submission of the IMA401 IND/IMPD application remains expected by the end of 2021."

IND • Oncology

Immatics Presents Preclinical Proof-of-Concept Data for TCR Bispecifics Program IMA401 Targeting MAGEA4/8 (GlobeNewswire) - "Preclinical data highlights: IMA401 TCER™ targets a peptide derived from the melanoma-associated antigen 4 or 8 (“MAGEA4/8”); the target peptide is highly prevalent in several solid tumor types including squamous non-small-cell lung carcinoma (sq NSCLC), head and neck squamous cell carcinoma (HNSCC) bladder, uterine, esophageal and ovarian carcinomas, as well as melanoma, sarcoma subtypes and other solid cancer types, IMA401 TCER™ can kill tumor cells in vitro with MAGEA4/8 peptide levels similar to levels found in cancer patients."

Preclinical • Oncology • Solid Tumor