TG6050 / Transgene - LARVOL DELTA

A Clinical Trial of TG6050 in Patients With Metastatic Non-Small Cell Lung Cancer (Delivir) (clinicaltrials.gov) - P1 | N=22 | Terminated | Sponsor: Transgene | N=36 ➔ 22 | Trial completion date: Oct 2025 ➔ Jun 2025 | Recruiting ➔ Terminated; Sponsor decision not related to safety

Enrollment change • Trial completion date • Trial termination • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • HER-2 • KRAS • PD-L1 • RET • ROS1

A Clinical Trial of TG6050 in Patients With Metastatic Non-Small Cell Lung Cancer (Delivir) (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Transgene | Trial completion date: Mar 2025 ➔ Oct 2025 | Trial primary completion date: Oct 2024 ➔ Apr 2025

Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • HER-2 • KRAS • PD-L1 • RET • ROS1

Transgene Reports Business, Pipeline and Financial Update for Q3 2024 (GlobeNewswire) - "The Phase I Delivir trial (NCT05788926), evaluating TG6050 in patients with advanced non-small cell lung cancer who have failed standard therapeutic options, completed the first two dose levels. Dose-limiting toxicity was observed in one patient in the third cohort and additional patients are being enrolled according to the protocol to complete this trial. Initial data are now expected in H1 2025."

P1 data • Non Small Cell Lung Cancer

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

TG6050, an oncolytic vaccinia virus encoding interleukin-12 and anti-CTLA-4 antibody, favors tumor regression via profound immune remodeling of the tumor microenvironment (CRI-ENCI-AACR ICIC 2024) - P1 | "TG6050 effectively delivers functional IL-12 and @CTLA-4 into tumor, resulting in a strong antitumor activity. The shift towards an inflamed TME correlated with a boost of the systemic antitumor T cells. The solid preclinical data, and favorable risk/benefit ratio paved the way for clinical evaluation of TG6050 in metastatic non-small cell lung cancer."

Biomarker • IO biomarker • Oncolytic virus • Tumor microenvironment • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • CTLA4 • IFNG • IL12A

Transgene - Preclinical Proof-of-Concept Data of Oncolytic Virus TG6050 Published in JITC (Transgene Press Release) - "Transgene...announces the publication in the Journal for ImmunoTherapy of Cancer (JITC) of a peerreviewed article which illustrates that TG6050 induces profound immune remodeling of the tumor microenvironment in animal models....The JITC paper reports that in addition to consistent multiplication and propagation of TG6050 in tumor cells, functional transgenes are expressed in the tumor with a sustained intratumoral accumulation of IL-12 and anti-CTLA-4 antibody....Upon intravenous administration in non-human primates for toxicology evaluation, it did not induce any of the IL-12 related adverse effectsthat are associated with systemic administration."

Preclinical • Solid Tumor

TG6050, an oncolytic vaccinia virus encoding interleukin-12 and anti-CTLA-4 antibody, favors tumor regression via profound immune remodeling of the tumor microenvironment. (PubMed, J Immunother Cancer) - P1 | "TG6050 effectively delivers functional IL-12 and @CTLA-4 into the tumor, resulting in strong antitumor activity. The shift towards an inflamed TME correlated with a boost in systemic antitumor T cells. The solid preclinical data and favorable benefit/risk ratio paved the way for the clinical evaluation of TG6050 in metastatic non-small cell lung cancer (NCT05788926 trial in progress)."

Biomarker • IO biomarker • Journal • Oncolytic virus • Tumor microenvironment • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • CTLA4 • IFNG • IL12A

Transgene anticipates significant progress from immunotherapy pipeline in 2024 and extends financial visibility until Q4 2025 (GlobeNewswire) - "Transgene has completed the enrollment of 86 patients in the ongoing randomized Phase II trial evaluating TG4001 in HPV-positive anogenital cancers (NCT03260023). Transgene confirms that top line readouts are expected in H2 2024....TG6050: Initial Phase I data expected in H2 2024, from this novel Invir.IO candidate administered intravenously....BT-001: Positive single agent data — Part B of the Phase I trial (combination with pembrolizumab) to deliver initial data in H2 2024."

P1 data • P1/2 data • Anal Carcinoma • Cervical Cancer • Melanoma • Merkel Cell Carcinoma • Non Small Cell Lung Cancer • Penile Cancer • Soft Tissue Sarcoma • Solid Tumor • Triple Negative Breast Cancer • Vulvar Cancer

Transgene Advances Its Innovative Immunotherapy Pipeline and Extends Financial Visibility Until the End of 2024 (Businesswire) - "The Phase I Delivir trial (NCT05788926) is evaluating TG6050 in patients with advanced non-small cell lung cancer who have failed standard therapeutic options. Completion of the trial is expected in H2 2024."

Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Clinical Trial of TG6050 in Patients With Metastatic Non-Small Cell Lung Cancer (Delivir) (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Transgene | Trial completion date: Dec 2024 ➔ Mar 2025 | Trial primary completion date: Jun 2024 ➔ Oct 2024

Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • HER-2 • KRAS • PD-L1 • RET • ROS1

Transgene - First Patient Dosed in Phase I Trial Evaluating TG6050, a Novel IL-12-Armed Oncolytic Virus Administered Intravenously, in Non-Small Cell Lung Cancer (Businesswire) - "Transgene...announced that the first patient has been dosed in Delivir, a Phase I clinical trial evaluating TG6050. This multi-mechanism oncolytic immunotherapy is administered intravenously in patients with recurrent metastatic advanced non-small cell lung cancer (NSCLC)....The Delivir trial will enroll up to 36 patients with advanced NSCLC who have failed standard therapeutic options, including immune checkpoint inhibitors....Completion of the trial is expected in H2 2024."

Trial completion date • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

TG6050 an oncolytic vaccinia virus armed with interleukin 12 and anti-CTLA4 antibody induces TME remodeling and strong anti-tumoral responses (AACR 2023) - "TG6050 is a novel oncolytic VACV designed for multiple routes of administration, and several tumor indications. Its strong impact on the TME, by massive infiltration of innate and adaptive immune cells, translated into very remarkable therapeutic activities in resistant tumors. This anti-tumor activity was further enhanced by combination with anti-PD-1."

IO biomarker • Oncolytic virus • Oncology • IL12A

A Clinical Trial of TG6050 in Patients With Metastatic Non-Small Cell Lung Cancer (Delivir) (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Transgene | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • HER-2 • KRAS • PD-L1 • RET • ROS1

Transgene - Preclinical Results Showing TG6050, a Novel Oncolytic Virus, induces Tumor Regression by Activating Innate and Adaptive immune responses presented at AACR (Businesswire) - "Transgene...presented promising preclinical data on its novel oncolytic virus TG6050, at the American Association for Cancer Research (AACR) Annual Meeting, April 14-19, 2023....mTG6050 treatment increased T cell responses capable of killing cancer cells....In several mice models, mTG6050 displayed a very strong anti-tumor activity....The Phase I Delivir trial has been initiated in 2023 and is currently enrolling patients with metastatic and recurring NSCLC."

Enrollment status • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Phase I Clinical Trial of TG6050 in Patients With Metastatic Non-Small Cell Lung Cancer. (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Transgene

Metastases • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • HER-2 • KRAS • PD-L1 • RET • ROS1

Transgene to Present Multiple Posters Highlighting the Potential of its Exciting Immunotherapy Pipeline at AACR 2023 (Businesswire) - "New Phase I data confirm high immunogenicity and promising efficacy profile of TG4050, an individualized neoantigen cancer vaccine developed by Transgene in collaboration with NEC Corporation...Transgene...will be presenting eight posters on its clinical and preclinical immunotherapies at the AACR (American Association for Cancer Research) Annual Meeting 2023, which will take place in Orlando, Florida, USA, April 14 – 19."

Clinical data • Preclinical • Trial status • Anal Carcinoma • Cervical Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Oncology • Ovarian Cancer • Penile Cancer • Solid Tumor • Vaginal Cancer • Vulvar Cancer

Transgene Receives Approval to Start a Phase I Trial of TG6050, a Novel IL-12-Armed Oncolytic Virus Given by Intravenous Administration (Businesswire) - "Transgene...announces it has received clinical trial application (CTA) approval from the French National Agency for the Safety of Medicines and Health Products (ANSM) to proceed with a Phase I clinical trial of TG6050, a novel oncolytic virus (OV) that will be administered intravenously in patients with advanced non-small cell lung cancer (NSCLC)....The first patient is expected to be enrolled in this multicenter trial in the first half of 2023."

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology