tipapkinogene sovacivec (TG4001) / Transgene - LARVOL DELTA

Randomized phase II trial evaluating the combination of TG4001, an HPV16 therapeutic vaccine, and avelumab (ave) in patients (pts) with immunotherapy-naïve recurrent and/or metastatic (R/M) HPV16-positive cervical or anogenital cancer. (ASCO 2025) - P1/2 | "TG4001 combined with ave did not improve PFS over ave alone in the whole patient population. Preplanned subgroup analysis in cervical cancer showed a positive efficacy signal in the combined arm. Avelumab was provided by the healthcare business of Merck KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009945)."

Clinical • IO biomarker • Metastases • P2 data • Cervical Cancer • Head and Neck Cancer • Hepatology • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • IL2 • PD-L1

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

Transgene Provides Update on Phase II Trial of Therapeutic Cancer Vaccine TG4001 in Recurrent or Metastatic HPV16-Positive Cervical and Anogenital Cancers (GlobeNewswire) - P1b/2 | N=150 | NCT03260023 | Sponsor: Transgene | "Transgene...announces that its randomized Phase II study to evaluate TG4001 in combination with avelumab versus avelumab alone in patients with recurrent or metastatic HPV16-positive cervical and anogenital tumors has not met the primary objective of the study (improvement in progression-free survival). The pre-planned subgroup analysis showed a positive efficacy trend in favor of the TG4001 containing regimen in cervical cancer patients, which requires further confirmation through additional analyses, including by PD-L1 status. These patients account for approximately half of the patients enrolled in the study. The treatment has been well tolerated. Adverse events are consistent with previous observations. Transgene is currently evaluating the full study results in detail to determine the best way forward for this program and will communicate further once this is completed."

P2 data • Cervical 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

Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers (clinicaltrials.gov) - P1/2 | N=150 | Active, not recruiting | Sponsor: Transgene | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Anal Carcinoma • Cervical Cancer • Gastrointestinal Cancer • Oncology • Penile Cancer • Solid Tumor • Squamous Cell Carcinoma • Vulvar Cancer

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

Phase Ib/II trial of tipapkinogene sovacivec, a therapeutic human papillomavirus16-vaccine, in combination with avelumab in patients with advanced human papillomavirus16-positive cancers. (PubMed, Eur J Cancer) - P1/2 | "TG4001 in combination with avelumab is safe, demonstrated antitumour activity in heavily pre-treated HPV16+ cancer patients, and is currently being evaluated in a randomised phase II trial in patients with incurable anogenital cancer and limited hepatic involvement."

Clinical • Combination therapy • Journal • Metastases • P1/2 data • Anal Carcinoma • Gastrointestinal Cancer • Hematological Disorders • Oncology • Solid Tumor • IFNG • IL2

Phase Ib/II trial of TG4001 (Tipapkinogene sovacivec), a therapeutic HPV16-vaccine, in combination with avelumab in patients with advanced HPV16-positive cancers (Eur J Cancer) - P1b/2 | N=150 | NCT03260023 | Sponsor: Transgene | "Forty-three patients, mainly heavily pre-treated (88%>1 previous line) were included in the safety analysis, with a majority of anal cancer (44%). No dose-limiting toxicities were reported, and DL2 (5x107 PFU) was selected as the RP2D. Treatment-related adverse events to TG4001 occurred in 93% of patients, mostly grade 1/2, with grade 3 anemias in one patient and no grade 4/5. ORR was 22% (8/36) and 32% (8/25) in all and patients without liver metastases, respectively. Median PFS and OS were 2.8 months (95%CI:1.4–5.6) and 11.0 months (95%CI:7.5–16.7) in the total population and 5.6 months (95%CI:1.6–9.6) and 13.3 months (95%CI:8.7–32.7) in patients without liver metastases."

P1/2 data • Anal Carcinoma • Cervical Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Oncology • Penile Cancer • Solid Tumor • Vulvar Cancer

Immunogenicity and clinical activity of tipapkinogen sovacivec (TG4001), an HPV-16 cancer vaccine: A randomized phase 2 study in advanced anogenital cancers. (ASCO 2023) - P1/2 | "Sponsored by Pharmaceutical/Biotech Company, Transgene SA, Avelumab was provided by the healthcare business of Merck KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009945), as part of an alliance between the healthcare business of Merck KGaA, Darmstadt, Germany and Pfizer. TG4001 can induce a de novo immune response against HPV-16 antigens E6 and E7 in advanced HPV-16 cancers. The data suggest that these IRs are associated with anti-tumor response and that TG4001 vaccination in combination with ICI has the potential to drive clinical benefit in R/M anogenital cancers. Clinical trial information: NCT03260023."

Clinical • Metastases • P2 data • Anal Carcinoma • Cervical Cancer • Gastrointestinal Cancer • Immune Modulation • Infectious Disease • Oncology • Penile Cancer • Solid Tumor • IFNG

Transgene to Present Data on its Two Therapeutic Cancer Vaccines at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Businesswire) - "Presentations include new data further demonstrating the immune responses induced by TG4001 and recently updated results from the adjuvant Phase I trial of neoantigen vaccine TG4050 in head and neck cancer...Transgene...announced two poster presentations at the 2023 American Association of Clinical Oncology (ASCO) annual meeting to be held in Chicago, IL (June 2-6)."

Clinical data • P2 data • Head and Neck Cancer • Oncology • Solid Tumor

Transgene Presents Immunological Data Demonstrating that TG4001, a Novel Therapeutic Cancer Vaccine, Can Induce T-cell Responses Against HPV16 Antigens in the Ongoing Phase II Trial at ASCO 2023 (Businesswire) - P1/2 | N=150 | NCT03260023 | Sponsor: Transgene | "Transgene...announced that new data will be presented today on TG4001. These data confirm the ability of this novel investigational therapeutic cancer vaccine to induce immune responses against HPV16 antigens, that are associated with anti-tumor response. These results have been presented in a poster at the ongoing American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL....58% of patients receiving TG4001 + avelumab showed an increase of immune responses against HPV antigens versus 9% in the avelumab arm. At baseline, immune responses against HPV antigens were limited to 4/46 patients. The occurrence of an immune response was detected at day 43 and tended to gain in intensity at day 85....Transgene anticipates that the last patient will be randomized in the current Phase II clinical study in the first half of 2024. Final results will be communicated in 2024."

P1/2 data • P2 data • Trial status • Oncology • Solid Tumor

A randomized phase II trial of TG4001 plus avelumab versus avelumab alone in recurrent/metastatic (R/M) human papilloma virus (HPV)-16 positive anogenital cancers (AACR 2023) - P1/2 | "Secondary endpoints include overall survival, objective response rate according to RECIST1.1, duration of response, disease control rate. Exploratory endpoints comprise analyses of blood-based parameters and tumor-based proteins and RNA expression and their impact on clinical outcomes."

Clinical • IO biomarker • Metastases • P2 data • Anal Carcinoma • Cervical Cancer • Gastrointestinal Cancer • Oncology • Penile Cancer • Solid Tumor • IL2

Transgene: 2022 Full-year Results and Business Update (Businesswire) - "Summary of key ongoing clinical trials:...(i) TG4001 - Recurrent/metastatic anogenital HPV16-positive - 1st (patients ineligible for chemotherapy) and 2nd lines: Final results to be communicated in 2024; (ii) BT-001 - Solid tumors: Part A data to be communicated in H1 2023...Start of part B of the Phase I trial in H2 2023."

P1 data • P2 data • Trial status • Oncology • Solid Tumor

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

[VIRTUAL] TG4001 (Tipapkinogene sovacivec) and avelumab for recurrent/metastatic (R/M) Human Papilloma Virus (HPV)-16+ cancers: clinical efficacy and immunogenicity (SITC 2020) - P1/2 | "Conclusions Our study suggests that immunotherapeutic combination of TG4001 and avelumab shows valuable tumor activity in pts with previously treated advanced HPV-16+ cancers. These results warrant validation in a larger cohort of patients."

Clinical • IO biomarker • Late-breaking abstract • Liver Cancer • Oncology • Vaginal Cancer • IFNG

Transgene Announces Positive Interim Analysis Results of Phase II Trial Evaluating TG4001 + Avelumab vs Avelumab in HPV-Positive Anogenital Cancers (Businesswire) - P1b/2 | N=150 | NCT03260023 | Sponsor: Transgene | "Transgene...announces that following an interim analysis of its randomized controlled Phase II clinical study comparing TG4001 in combination with avelumab to avelumab alone in patients with HPV16-positive anogenital tumors (NCT: 03260023), the Independent Data Monitoring Committee (IDMC) has recommended the study continue. Based on positive signals observed in the interim analysis, the trial is now expected to enroll an additional 66 patients, for a total trial size of 120 patients compared to the previously announced target of 150 patients. Transgene anticipates the last patient to be randomized in the trial in H1 2024....To date, the treatment has been well tolerated. Adverse events are consistent with previous observations made in the Phase Ib/II trial."

DSMB • Enrollment change • P1/2 data • Trial status • Genito-urinary Cancer • Oncology • Solid Tumor

Phase Ib/II trial of TG4001 (Tipapkinogene sovacivec), a therapeutic HPV-vaccine, and Avelumab in patients with recurrent/metastatic (R/M) HPV-16+ cancers (ESMO 2019) - P1/2; "The combination of TG4001 and avelumab is safe and provides anti-tumor activity in HPV-16+ cancer patients. The treatment induces immune changes in patients with poor baseline immune contexture. The combination is being evaluated in the ongoing Ph II part."

Clinical • IO biomarker • P1/2 data • PD(L)-1 Biomarker • Oncology

R&D Day: Presentations to Highlight Transgene’s Competitive Positioning, Capabilities to Engineer Novel Immunotherapies for Patients with Cancer, and Update on Initial Clinical Data (Businesswire) - "The event, which features presentations by leading clinicians and scientists from around the world, as well as key members of the Transgene management team, provides insights on: TG4001, with updated data from the previous trial (Phase Ib/II) evaluating the combination of TG4001 and avelumab in HPV16-positive cancers; TG4050, with updated follow up data from the two Phase I trials in ovarian cancer and head and neck cancer; The progress of the Invir.IO platform, with a focus on a novel oncolytic virus vectorizing human IL-12 that has been designed to be administered intravenously."

P1 data • P1/2 data • Gynecologic Cancers • Head and Neck Cancer • Oncology • Ovarian Cancer

Positive Readouts for Transgene’s Clinical Stage Candidates Generated by its Two Innovative Platforms, with Further Clinical Data Expected in the Second Half of 2022 (Businesswire) - "TG4001 – Results from the interim analysis of the randomized Phase II trial in HPV-positive anogenital cancers to be released in Q4 2022; TG4050 (myvac® platform) – New positive Phase I data presented at AACR and ASCO - Additional data from the two Phase I trials to be communicated in H2 2022; TG6002 – Phase I data confirming the potential of the intravenous administration of Transgene’s Invir.IO™ oncolytic viruses will be presented at ESMO 2022 on September 11 at 12 pm CET; BT-001 (Invir.IO™ platform) – Initial Phase I data demonstrated good tolerability and first signs of antitumor activity - Phase Ib (BT-001 in combination with pembrolizumab) expected to start in the second half of 2022."

P1 data • P2 data • Anal Carcinoma • Gastrointestinal Cancer • Gynecologic Cancers • Head and Neck Cancer • Oncology • Ovarian Cancer • Solid Tumor

Transgene Confirms the Potential of Its Two Innovative Platforms and Expects Significant Clinical Results in 2022 (Businesswire) - "TG4050 (myvac): Additional data to be presented at AACR 2022 in April...TG4001: Interim analysis expected in Q4 2022.... BT-001 (Invir.IO): IND approval for Phase I/IIa trial in the US, ongoing enrollment in Europe...The next clinical update on the ongoing Phase I trial is expected in the second quarter of 2022...TG6002: End of Phase I expected in mid-2022....The Phase I trial evaluating TG6002 administered intravenously is expected to be completed by mid-2022. Comprehensive translational data will be presented in the fourth quarter of 2022."

IND • P1 data • P1/2 data • Anal Carcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

[VIRTUAL] TG4001 therapeutic vaccination combined with PD-L1 blocker avelumab remodels the tumor microenvironement (TME) and drives antitumor responses in human papillomavirus (HPV)+ malignancies (ESMO-IO 2020) - P1/2 | "57% of pts had “hot” TME profile at baseline versus 100% at D43. Conclusions TG4001 and PD-L1 blockade with avelumab led to the development of specific immunity and TME transformations in HPV+ cancer pts potentially leading to clinical benefit."

IO biomarker • Oncology • Vaginal Cancer • CD8 • IFNG • IL1R1

[VIRTUAL] TG4001 (Tipapkinogene sovacivec) and avelumab for recurrent/metastatic (R/M) Human Papilloma Virus (HPV)-16+ cancers: clinical efficacy and immunogenicity (SITC 2020) - P1/2 | "Conclusions Our study suggests that immunotherapeutic combination of TG4001 and avelumab shows valuable tumor activity in pts with previously treated advanced HPV-16+ cancers. These results warrant validation in a larger cohort of patients."

Clinical • IO Biomarker • Late-breaking abstract • Liver Cancer • Oncology • Vaginal Cancer • IFNG

Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers (clinicaltrials.gov) - P1/2; N=150; Recruiting; Sponsor: Transgene; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open • Anal Carcinoma • Cervical Cancer • Gastrointestinal Cancer • Oncology • Penile Cancer • Solid Tumor • Squamous Cell Carcinoma • Vulvar Cancer

Transgene: First Patient Enrolled in Expanded Phase II Clinical Trial of TG4001 + Avelumab Vs Avelumab Alone in Patients With HPV16-positive Anogenital Cancers (Businesswire) - "Transgene...today announces that a first patient has been enrolled in a randomized, controlled Phase II study evaluating the combination of TG4001 with avelumab versus avelumab monotherapy in patients with HPV16-positive anogenital tumors...An interim analysis will be performed after the enrollment of approximately 50 patients. Transgene expects to communicate interim analysis data around the end of 2022."

P2 data • Trial status • Anal Carcinoma • Cervical Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Penile Cancer • Vulvar Cancer