TG4050 / Transgene, NEC Corp - LARVOL DELTA

Profiling of the neoantigen-specific T cell response after adjuvant TG4050 individualized therapeutic vaccination in a randomized phase I trial for locally advanced resected HPV-negative HNSCC (SITC 2025) - P1/2 | "All participants provided written, informed consent before taking part. France: Comité de Protection des Personnes Ile de France 5 ID: 35725 (EUCT 2023-508561-33) Initial approval on 01 Oct 2019 UK: South Central - Oxford A Research Ethics Committee ID: 19/SC/0500 (EudraCT 2018-003267-58) Initial approval on 26 Mar 2020 US: Mayo Clinic Institutional Review Boards ID: 20-007421 Initial approval on 19 Feb 2021"

Clinical • Metastases • P1 data • Tumor-specific neoantigens • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck • CD8 • CX3CR1 • GZMB • IFNG • PRF1

Transgene to Present New Immunological Data from Phase I Trial of Individualized Therapeutic Cancer Vaccine, TG4050, at SITC 2025 (GlobeNewswire)

P1 data • Squamous Cell Carcinoma of Head and Neck

Transgene Completes Initial Patient Screening in Phase II Part of TG4050 Trial in Operable Head and Neck Cancer (GlobeNewswire) - "Transgene...announced the completion of initial patient screening in the randomized multicenter Phase II part of its Phase I/II clinical trial with TG4050, an individualized neoantigen therapeutic vaccine, as a single agent in the adjuvant treatment of HPV-negative squamous head and neck cancers (NCT04183166)....Transgene expects to complete randomization of all patients in the Phase II part by the end of 2025, following a second screening of patients conducted after surgery and adjuvant (chemo)radiotherapy....First immunogenicity data from the Phase II part of the trial are expected to be available in H2 2026, and preliminary efficacy data are expected in H2 2027....'Consequently, Transgene is starting initial preparations for a new Phase I trial in a second, undisclosed indication in an early treatment setting, with the aim to initiate the trial in Q4 2025'."

New P1 trial • P2 data • Trial status • Squamous Cell Carcinoma of Head and Neck

TG4050.02: A Clinical Trial Evaluating TG4050 in Head and Neck Cancer (clinicaltrials.gov) - P1/2 | N=80 | Active, not recruiting | Sponsor: Transgene | Recruiting ➔ Active, not recruiting

Enrollment closed • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Randomized phase I trial of adjuvant personalized cancer vaccine TG4050 in resected locally advanced (LA) head and neck squamous cell carcinoma (HNSCC) patients (pts). (ASCO 2025) - P1/2 | "TG4050 is safe and induces immune responses in pts with resected LA HNSCC. No relapse occurred in the vaccine arm as opposed to 19% in the control arm. With the evolution of the landscape, adjuvant anti-PD1 therapy may become standard in resected LA HNSCC."

Clinical • IO biomarker • Metastases • P1 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Transgene to Host Webcast on Positive TG4050 Head and Neck Cancer Data Presented at ASCO 2025 (GlobeNewswire) - "Transgene...announced it will host a live webcast to discuss the latest positive clinical data from its individualized neoantigen cancer vaccine, TG4050, presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting....They will discuss the new findings, the unmet medical need and the current treatment landscape and perspectives for early-stage HPV-negative head and neck cancer."

Clinical data • Head and Neck Cancer

Transgene and NEC Present Durable Disease-Free Survival and Sustained T Cell Responses at 24 Months with Individualized Cancer Vaccine TG4050 (The Manila Times) - P1/2 | N=80 | NCT04183166 | Sponsor: Transgene | "All patients in the treatment arm remain disease-free after a minimum of 2-year follow-up in the randomized Phase I trial in resected HPV-negative locally advanced head and neck cancer - Demonstrating clinical proof of principle for TG4050, Single agent TG4050 induced long-lasting neoantigen-specific CD8+ T cell responses...Treatment was well-tolerated with no unexpected safety signals...The Phase II part of the trial, aimed at confirming the encouraging results in a larger patient population and evaluating both immunological and clinical outcomes, is currently underway. All patients are expected to be randomized by Q4 2025."

P1 data • Trial status • Squamous Cell Carcinoma of Head and Neck

Transgene to Present 24-month Disease-Free Survival Data from All Patients in Phase I Part of Trial of Individualized Cancer Vaccine, TG4050, at ASCO 2025 (GlobeNewswire) - "Transgene...today announces that it will present two-year disease-free survival (DFS) data from all patients in the randomized Phase I part of the trial of its individualized neoantigen therapeutic cancer vaccine TG4050. The data will be shared during a rapid oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago from May 30 to June 3, 2025....In addition, Transgene will present a poster at ASCO on TG4001, presenting randomized Phase II data in combination with avelumab in a cervical cancer subgroup."

P1 data • P2 data • Cervical Cancer • Head and Neck Cancer

Transgene to Provide Updated Phase I Data in a Rapid Oral Presentation on Individualized Therapeutic Cancer Vaccine TG4050 at ASCO 2025 (GlobeNewswire) - "Transgene...will be delivering a rapid oral presentation of randomized Phase I trial data of individualized neoantigen therapeutic cancer vaccine TG4050 in head and neck cancer at the 2025 American Society of Clinical Oncology (ASCO)....The company will also present a poster on randomized Phase II data of TG4001 in combination with avelumab in the cervical cancer subgroup."

P1 data • P2 data • Cervical Cancer • Squamous Cell Carcinoma of Head and Neck

A Trial Evaluating TG4050 in Ovarian Carcinoma. (clinicaltrials.gov) - P1 | N=64 | Completed | Sponsor: Transgene | Active, not recruiting ➔ Completed | N=23 ➔ 64 | Trial completion date: Dec 2025 ➔ Oct 2024

Enrollment change • Trial completion • Trial completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Randomized phase I trial of adjuvant individualized TG4050 vaccine in patients with locally advanced resected HPV-negative head and neck squamous cell carcinoma (HNSCC) (SITC 2024) - P1/2 | "All participants provided written, informed consent. •France: Name: Comité de Protection des Personnes Ile de France 5 ID: 35725 (EUCT 2023-508561-33) •UK: Name: South Central - Oxford A Research Ethics Committee ID: 19/SC/0500 (EudraCT 2018-003267-58) •US: Name: Mayo Clinic Institutional Review Boards ID: 20-007421."

Clinical • IO biomarker • Metastases • P1 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8

Transgene and NEC Present New Data Confirming Clinical Proof of Principle for Neoantigen Cancer Vaccine, TG4050, in Head & Neck Cancer at SITC 2024 (GlobeNewswire) - P1/2 | N=80 | NCT04183166 | Sponsor: Transgene | "Transgene...announced 24.1-month median follow-up data from the ongoing randomized Phase I trial of TG4050...all 16 patients who received TG4050 as adjuvant immunotherapy after completion of adjuvant standard of care remain disease-free and have not relapsed. Out of the 16 patients in the control observation arm, 3 patients have relapsed. There remains a high medical need for these head and neck cancer patients, as approximately 30% of them are expected to experience a relapse within 24 months after standard surgery and adjuvant chemoradiotherapy...All treatment-related adverse events continue to be mild to moderate...Building on these promising data, the randomized Phase I trial has been expanded to a randomized Phase I/II trial in the adjuvant setting of head and neck cancer (NCT04183166), which is currently enrolling patients in the Phase II part."

Enrollment status • P1 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Transgene to Present a Poster on Updated Data for TG4050 at SITC 2024 (GlobeNewswire) - "Transgene...will present a poster highlighting median 24-month follow up from the ongoing randomized Phase I trial of its individualized therapeutic cancer vaccine, TG4050 at the 39th Society for ImmunoTherapy of Cancer (SITC) annual meeting. This presentation will emphasize efficacy and disease-free survival outcomes in patients with head and neck cancers. SITC annual meeting will take place in Houston, Texas, USA, from November 6 to 10, 2024....Transgene and NEC are continuing the joint development of TG4050 in this indication with a Phase II extension of the trial, which is currently enrolling patients."

Enrollment status • P1 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Transgene to Report Major Clinical Data before the end of 2024 – Confirmed Financial Visibility until Q4 2025 (GlobeNewswire) - "Neoantigen therapeutic cancer vaccine: TG4050...The Phase II part started enrolling patients in Q2 2024 within the framework of an extended collaboration between Transgene and NEC. Patient enrollment is progressing at a good pace...Additional data on the 24-month median follow-up of Phase I patients will be reported in Q4 2024...In H1 2024, Transgene has completed the enrollment of 90 patients in the ongoing randomized Phase II trial evaluating TG4001 in HPV-positive anogenital cancers (NCT03260023) in combination with an immune checkpoint inhibitor. Transgene confirms that topline readouts are expected in Q4 2024....The Phase I Delivir trial (NCT05788926) is evaluating TG6050 in patients with advanced non-small cell lung cancer who have failed standard therapeutic options. Initial data from the trial is expected in Q4 2024."

Clinical data • Enrollment status • Anal Carcinoma • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Transgene - First Patient Enrolled in Phase II Part of Randomized Phase I/II Trial Evaluating Lead Cancer Vaccine TG4050 in Head and Neck Cancer (Transgene Press Release) - "Transgene...announces that the first patient has been enrolled in the Phase II part of the randomized Phase I/II clinical trial of the individualized therapeutic cancer vaccine, TG4050, in the adjuvant treatment of head and neck cancer. Patient screening and enrollment are active, with the aim of enrolling 80 patients internationally in the overall Phase I/II trial....Last patient enrollment for Phase II part expected in Q4 2025."

Enrollment status • Head and Neck Cancer

Transgene provides business and financial update for Q1 2024 (GlobeNewswire) - "Transgene...today provides a business update, including its financial position as of March 31, 2024...Preliminary work to launch additional Phase I trial...2024."

New P1 trial • Oncology • Solid Tumor

A Clinical Trial Evaluating TG4050 in Head and Neck Cancer (clinicaltrials.gov) - P1/2 | N=80 | Recruiting | Sponsor: Transgene | Trial completion date: Dec 2027 ➔ Dec 2028

Metastases • Trial completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Clinical Trial Evaluating TG4050 in Head and Neck Cancer (clinicaltrials.gov) - P1/2 | N=80 | Recruiting | Sponsor: Transgene | Phase classification: P1 ➔ P1/2 | N=30 ➔ 80 | Trial completion date: Nov 2024 ➔ Dec 2027 | Trial primary completion date: Nov 2023 ➔ Dec 2027

Enrollment change • Metastases • Phase classification • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Personalized vaccine TG4050 induces polyepitopic immune responses against private neoantigens in resected HPV negative head and neck cancers (AACR 2024) - "TG4050 design and manufacturing was feasible in Head and Neck cancers. Vaccination was safe and induced polyclonal immune responses against vaccine targets alone or during concurrent treatment with immunotherapy. The association of vaccine treatment with lower rates of relapse warrants further clinical confirmation in this indication."

IO biomarker • Late-breaking abstract • Tumor-specific neoantigens • Head and Neck Cancer • Oncology • Oral Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8 • IFNG

Transgene and NEC’s cancer vaccine shows promise in head and neck cancer (Clinical Trials Arena) - P1 | N=30 | NCT04183166 | Sponsor: Transgene | "French Biotech Transgene and Japanese NEC Corporation have released follow-up data from the Phase I trial of its individualised cancer vaccine, TG4050, in patients with head and neck cancers....The companies also announced plans to start a randomised Phase II extension of the Phase I trial, which is slated for start in Q2 this year....After a median follow-up of 18.6 months, all 16 patients in the TG4050 treatment group were disease-free while three out of the 16 patients in the control observation arm relapsed. Specific cellular responses were seen in 16 out of 17 patients who received TG4050, the additional patient who received TG4050 was one of the relapsed participants from the control group."

New P2 trial • P1 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Transgene anticipates significant progress from immunotherapy pipeline in 2024 and extends financial visibility until Q4 2025 (GlobeNewswire) - "Key events and upcoming milestones: Neoantigen therapeutic cancer vaccine (TG4050) - Additional data from the randomized Phase I trial in adjuvant head and neck cancer to be presented in H1 2024 The trial will be expanded in a randomized Phase I/II trial in the same indication. The Phase II part will start in Q2 2024....Transgene and its partner NEC plan to report updated data at AACR (poster presentation on April-10, 2024) and the additional data on the 24-month median follow up of patients in H2 2024. The randomized Phase I trial will be expanded to a randomized Phase I/II trial in the adjuvant setting of head and neck cancer. The Phase II part is expected to start enrolling patients in Q2 2024 within the framework of an extended collaboration between Transgene and NEC."

P1 data • Trial status • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Transgene, NEC, and BostonGene Expand Collaboration for Phase I/II Clinical Trial of Neoantigen Cancer Vaccine TG4050 (Yahoo Finance) - "Transgene..., NEC Corporation...and BostonGene Corporation...announced the expansion of their collaboration for the randomized Phase I/II trial of TG4050, an individualized therapeutic vaccine for patients with head and neck cancers. BostonGene is partnering with NEC and Transgene to continue performing tumor molecular profiling and microenvironment analysis and provide high-throughput sequencing services. The partnership with BostonGene will enable fast turnaround of next-generation sequencing (NGS) data, and sophisticated analytics will enable comprehensive profiling of patient immune contexture."

Diagnostic • Licensing / partnership • Head and Neck Cancer • Oncology

Transgene and NEC Extend their Collaboration to Continue Joint Clinical Development of Neoantigen Cancer Vaccine TG4050 (Yahoo Finance) - "Transgene...and NEC Corporation... have announced the signing of a further development collaboration agreement to continue the clinical evaluation of the individualized neoantigen cancer vaccine TG4050. TG4050 is currently being evaluated in a randomized multicenter Phase I trial as a single agent in the adjuvant treatment of HPV-negative head and neck cancers. Based on promising data obtained in the Phase I trial (NCT04183166), Transgene and NEC are preparing a randomized Phase I/II extension of this trial slated to start in 2024....Transgene and NEC expect to present additional immunological and clinical data from the Phase I trial at a scientific conference in the first half of 2024."

Licensing / partnership • New P1/2 trial • P1 data • Head and Neck Cancer

A Trial Evaluating TG4050 in Ovarian Carcinoma. (clinicaltrials.gov) - P1 | N=23 | Active, not recruiting | Sponsor: Transgene | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2024 ➔ Dec 2025 | Trial primary completion date: Sep 2023 ➔ Dec 2024

Enrollment closed • Trial completion date • Trial primary completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Solid Tumor

Transgene Advances Its Innovative Immunotherapy Pipeline and Extends Financial Visibility Until the End of 2024 (Businesswire) - "Key events and upcoming milestones:...(i) TG4050:...The last patient has been randomized in the head and neck cancer Phase I study. Transgene and its partner NEC plan to report updated data in H1 2024. Transgene and NEC intend to start a randomized Phase II trial in the adjuvant setting of head and neck cancer in 2024.... (ii) BT-001...Part B of the Phase I trial (combination with pembrolizumab) to start in H2 2023."

New P2 trial • P1 data • Trial status • Head and Neck Cancer • Oncology • Solid Tumor