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Transgene Successfully Completes a Fundraising of c. €105 Million
Globenewswire· 2025-11-26 22:33
Core Points - Transgene successfully raised approximately €105 million through a fundraising initiative involving private placements and retail offerings at a price of €1.02 per share [1][6][10] - The funds will primarily support the development of the myvac® platform, which focuses on individualized therapeutic vaccines for cancer treatment [4][5][7] - The fundraising included participation from specialized healthcare investors and existing shareholders, indicating strong institutional interest [2][21] Fundraising Details - The fundraising consisted of a private placement and a public offering via the PrimaryBid platform, with a total of 141,433,349 new ordinary shares issued, representing 106.5% of the company's current share capital [9][10] - The subscription price of €1.02 per share reflects a 25% discount compared to the closing price prior to the fundraising [10] - A reserved capital increase of €39,262,015.44 was also conducted for TSGH, utilizing amounts advanced under a current account advance agreement [3][12] Use of Proceeds - Approximately 70% of the net proceeds will be allocated to accelerate the myvac® program, including ongoing Phase 2 trials and the launch of new indications [7][5] - About 20% will be directed towards R&D costs related to the myvac® program and other clinical trials [7] - The remaining funds will cover general administrative expenses and recurring cash consumption [7] Expected Milestones - Key milestones include the completion of the ongoing Phase 2 trial in head and neck cancers, with results anticipated by late 2027 or early 2028 [4][15] - The company plans to launch a Phase 1 trial in a new indication and prepare for pivotal trials by the end of 2027 [15][4] Share Capital and Ownership Structure - Post-fundraising, the company's share capital will amount to €82,256,012.70, divided into 274,186,709 ordinary shares [18] - TSGH will hold 78.29% of the capital, while SITAM Belgium will hold 3.55%, with other shareholders comprising 18.16% [18][21] Trading and Regulatory Information - Trading of Transgene's shares on Euronext Paris was suspended during the fundraising and is set to resume on November 27, 2025 [23][24] - The new shares will be fungible with existing shares and will carry the same rights [25]
Correction: Transgene Announces the Temporary Suspension of Trading of its Shares on Euronext Paris
Globenewswire· 2025-11-25 20:43
Core Points - Transgene has requested a suspension of trading for its shares on Euronext Paris starting November 26, 2025, pending the announcement of its capital increase results [1] - Trading is expected to resume on November 27, 2025, at market opening [1] Company Overview - Transgene is a biotechnology company focused on developing immunotherapy products for cancer treatment, with a portfolio that includes several viral vector-based immunotherapies in clinical development [2] - The lead candidate, TG4050, is the first individualized treatment from the myvac® platform, showing clinical proof of concept in patients with head and neck cancer [2] - Other candidates in development include BT-001, an oncolytic virus based on the patented invir.IO® platform [2] Technology and Innovation - The myvac® platform integrates tumor mutations identified through artificial intelligence into a viral vector, marking a step into precision medicine [3] - The invir.IO® platform allows for the design of multifunctional oncolytic viruses, showcasing Transgene's expertise in viral vector engineering [3]
Transgene Announces the Temporary Suspension of Trading of its Shares on Euronext Paris
Globenewswire· 2025-11-25 19:42
Core Points - Transgene has requested a suspension of trading for its shares on Euronext Paris pending the publication of results from its capital increase [1] - Trading is expected to resume on November 27, 2025, at the market opening [1] Company Overview - Transgene is a biotechnology company focused on developing immunotherapy products for cancer treatment [2] - The company's lead candidate, TG4050, is an individualized treatment that has shown clinical proof of concept in patients with head and neck cancer [2] - Transgene is also developing other candidates, including BT-001, which is based on a patented oncolytic virus [2] Technology Platforms - The myvac® platform allows for patient-specific immunotherapy by integrating tumor mutations identified through artificial intelligence [3] - The invir.IO® platform enables the design of multifunctional oncolytic viruses, showcasing Transgene's expertise in viral vector engineering [3]
Transgene Announces the Temporary Suspension of Trading of its Shares on Euronext Paris
Globenewswire· 2025-11-25 19:42
Core Viewpoint - Transgene has requested a suspension of trading for its shares on Euronext Paris pending the announcement of its capital increase results, with trading expected to resume on November 27, 2025 [1] Company Overview - Transgene is a biotechnology company focused on developing immunotherapy products for cancer treatment, with a portfolio that includes several viral vector-based immunotherapies currently in clinical development [3] - The lead candidate, TG4050, is the first individualized treatment from the myvac® platform, showing clinical proof of concept in patients with head and neck cancer [3] - Other candidates in development include BT-001, an oncolytic virus based on the patented invir.IO® platform [3] Technology and Innovation - The myvac® platform integrates tumor mutations identified through artificial intelligence into a viral vector, marking a step into precision medicine [4] - The invir.IO® platform allows for the design of a new generation of multifunctional oncolytic viruses, showcasing Transgene's expertise in viral vector engineering [4]
Transgene to Showcase Potential of Proprietary VacDesignR® Computational Tool to Optimize Individualized Therapeutic Cancer Vaccines
Globenewswire· 2025-11-06 07:30
Core Insights - Transgene is set to present its proprietary computational tool, VacDesignR®, at the ESMO AI & Digital Oncology 2025 conference, which enhances the design and production of recombinant Modified Vaccinia Ankara (MVA)-based vectors for individualized neoantigen therapeutic vaccines [1][2][5] Group 1: VacDesignR® Tool - VacDesignR® optimizes recombinant plasmid architecture for MVA vectors, improving production reliability and vector quality by minimizing unwanted homologous recombination and intelligently selecting peptide sequences [3] - Future versions of VacDesignR® will integrate AI components to enhance performance and scalability, aligning with Transgene's strategy to expedite production timelines for individualized therapeutic vaccines [4] Group 2: Clinical Development - The individualized immunotherapies developed through the myvac® platform are currently in a Phase I/II clinical trial (NCT04183166), utilizing the VacDesignR® tool for their design [2] - TG4050, the first individualized therapeutic vaccine based on the myvac® platform, is designed to treat HPV-negative head and neck cancers following surgery and adjuvant therapy [4][8] Group 3: Company Overview - Transgene focuses on designing and developing virus-based immunotherapies for cancer treatment, with a portfolio that includes viral vector-based immunotherapeutics [8] - The myvac® platform allows for the creation of personalized immunotherapies that encode patient-specific mutations, utilizing advanced AI technologies [9]
New Phase I Immunological Data Presented at SITC 2025 Support TG4050’s Potential Role in Preventing Cancer Relapse
Globenewswire· 2025-11-04 16:45
Core Insights - TG4050 demonstrates the ability to induce neoantigen-specific cytotoxic CD8+ T cell responses, which can target and eliminate tumor cells, potentially reducing the risk of cancer relapse [1][3][4] Company Overview - Transgene is a biotech company focused on developing virus-based immunotherapies for cancer treatment, with TG4050 being its lead asset [9][12] - TG4050 is an individualized therapeutic vaccine based on the myvac® platform, designed to stimulate the immune system to recognize and destroy tumor cells [10][12] Clinical Development - TG4050 is currently being evaluated in a Phase I/II clinical trial for patients with HPV-negative head and neck cancers, with the first immunogenicity data from the Phase II part expected in the second half of 2026 [14] - The trial includes a randomized study design, assessing the treatment benefits of TG4050 in patients at risk of relapse [14] Immunological Data - New immunological data presented at the SITC Annual Meeting confirm TG4050's mechanism of action and its potential for sustained prevention of cancer relapses [4][5] - CD8+ T cells induced by TG4050 exhibit an effector phenotype and persist for up to two years post-treatment, indicating long-term immune response capabilities [8][5] Collaboration and Technology - Transgene collaborates with NEC Corporation, leveraging NEC's AI-driven platform to enhance the development of individualized neoantigen therapeutic vaccines [5][12] - NEC's Neoantigen Prediction System utilizes advanced AI to identify and select the most immunogenic sequences for the vaccine [15][12]
Transgene to Present New Immunological Data from Phase I Trial of Individualized Therapeutic Cancer Vaccine, TG4050, at SITC 2025
Globenewswire· 2025-10-03 15:45
Core Insights - Transgene will present a detailed analysis of the neoantigen-specific T cell response from the Phase I trial of its individualized therapeutic cancer vaccine, TG4050, at the upcoming SITC Annual Meeting [1][3] - TG4050 is being developed for solid tumors, specifically targeting HPV-negative head and neck cancers, utilizing Transgene's myvac® technology and NEC's AI capabilities [3][5] - The Phase I trial results showed that all patients receiving TG4050 remained disease-free after a minimum of 2-year follow-up, contrasting with a 19% relapse rate in the observational arm [4] Company Overview - Transgene is a biotechnology company focused on developing targeted immunotherapies for cancer treatment, with a portfolio of viral vector-based immunotherapeutics [5] - TG4050 is the lead asset of the company, representing the first individualized therapeutic vaccine based on the myvac® platform, demonstrating proof of principle in head and neck cancer treatment [5][6] - The company is also advancing other viral vector-based assets, including BT-001, which is in clinical development [5] Clinical Development - TG4050 is currently being evaluated in a randomized multicenter Phase I/II clinical trial as a single agent in the adjuvant treatment of HPV-negative head and neck cancers [3] - A Phase II extension of the trial is ongoing, with patient enrollment currently in progress [4]
Transgene’s Individualized Neoantigen Therapeutic Cancer Vaccine TG4050 Delivers Positive Randomized Phase I Data Randomization to be Completed in Phase II Part in Q4 2025
Globenewswire· 2025-09-16 15:45
Core Insights - Transgene reported positive Phase I data for TG4050, showing 100% disease-free survival after a median follow-up of 30 months in operable head and neck squamous cell carcinoma (HNSCC) patients [3][4][8] - The company is progressing into Phase II trials for TG4050, with initial patient screening completed and randomization expected by the end of 2025 [6][7] - Transgene's financial position is stable, with funding secured until the end of December 2026, allowing for continued development of its lead asset [22][23] Financial Performance - Operating income for the first half of 2025 was €4.6 million, an increase from €3.4 million in the same period of 2024 [20] - Research and development expenses rose to €17.9 million from €15.4 million year-over-year, while general and administrative expenses decreased to €3.8 million from €4.6 million [20] - As of June 30, 2025, Transgene had €16.8 million in cash, slightly up from €16.7 million at the end of 2024, with a cash burn of €18.8 million in the first half of 2025 [21] Clinical Development - TG4050 is the first candidate from Transgene's myvac® platform, which aims to provide individualized therapeutic cancer vaccines [4][26] - The company is preparing to initiate a new Phase I trial for a second indication, expanding the myvac® platform's potential [9] - Additional immunological data from the Phase I study will be presented in Q4 2025, with first immunogenicity data from the Phase II trial expected in H2 2026 [5][8] Governance and Leadership - Simone Steiner joined Transgene as Chief Technical Officer in April 2025, bringing expertise in CAR-T cell therapies to enhance the manufacturing of myvac®-based immunotherapies [16] - Emmanuelle Quilès was appointed as an independent Board member in July 2025, contributing 25 years of experience in the pharmaceutical industry [17] Other Assets and Collaborations - Transgene is also developing BT-001, an oncolytic virus, with updated data to be presented at ESMO 2025 [10][11] - The company is evaluating TG4001 for HPV-positive cancers and TG6050 for advanced non-small cell lung cancer, with ongoing assessments of their clinical development paths [13][14][15]
Transgene Completes Initial Patient Screening in Phase II Part of TG4050 Trial in Operable Head and Neck Cancer
Globenewswire· 2025-06-19 06:00
Core Insights - Transgene's TG4050 has demonstrated 100% Disease-Free Survival (DFS) after a minimum of two years in the Phase I part of the clinical trial, confirming its clinical proof of principle [1][2] - The company is progressing with the Phase II part of the trial, expecting to complete patient randomization by the end of 2025, with initial immunogenicity data anticipated in H2 2026 and preliminary efficacy data in H2 2027 [3][4] Company Overview - Transgene is a biotechnology company focused on developing virus-based immunotherapies for cancer treatment, with TG4050 being its lead asset based on the myvac® platform [7][10] - The myvac® platform utilizes artificial intelligence from NEC to optimize antigen selection for individualized cancer treatment [8][10] Clinical Trial Details - The Phase I/II clinical trial for TG4050 targets HPV-negative squamous head and neck cancers, with approximately 80 patients expected to be enrolled and randomized [3][12] - The trial evaluates the efficacy of TG4050 as an adjuvant treatment following surgery and adjuvant therapy, with a focus on patients at risk of relapse [12] Future Developments - Transgene is preparing for a new Phase I trial in a second, undisclosed indication, aiming to initiate it in Q4 2025 [5][11] - The company is committed to advancing the development of TG4050 and enhancing its manufacturing capabilities to meet the demands of a competitive market [4][11]
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· 2025-05-22 15:45
Core Insights - Transgene will present two-year disease-free survival data from the Phase I part of the TG4050 trial at ASCO 2025 [1][3] - TG4050 is an individualized neoantigen therapeutic cancer vaccine developed using Transgene's myvac® platform and NEC's AI capabilities [2][10] - The Phase I/II trial is focused on HPV-negative head and neck cancers, with the Phase II part currently enrolling patients internationally [3][12] Company Overview - Transgene is a biotechnology company specializing in virus-based immunotherapies for cancer treatment [5][7] - The company’s lead asset, TG4050, is the first individualized therapeutic vaccine based on the myvac® platform [5][10] - Transgene is also developing other viral vector-based immunotherapies, including TG4001 for HPV-positive cancers [7] Clinical Trial Details - The Phase I/II trial evaluates TG4050 as a single agent in the adjuvant treatment of HPV-negative head and neck cancers [3][12] - The trial includes a randomized study design with 32 evaluable patients in the Phase I part [12] - The Phase II extension is currently enrolling patients, indicating ongoing development and potential for future data [3][12] Presentation and Recognition - The rapid oral presentation at ASCO will take place on June 1, 2025, highlighting the clinical data and collaborative efforts in the trial [1][3] - Transgene's findings on TG4050 were selected for presentation among numerous high-quality submissions, reflecting the significance of their work [3]