Latest news with #HPV-negative
Yahoo
03-06-2025
- Business
- Yahoo
Transgene to Host Webcast on Positive TG4050 Head and Neck Cancer Data Presented at ASCO 2025
Strasbourg (France), June 3, 2025, 8:00 a.m. CET – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today 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 (see press release here). The webcast will take place on June 6, 2025 at 9:00 a.m. ET / 3:00 p.m. CET, and will feature Transgene's management together with Prof. Christian Ottensmeier, MD, PhD, FRCP (University of Liverpool, La Jolla Institute for Immunology). 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. Webcast link to English language conference call: Please log in to the following link to obtain your personal telephone IDs: A replay of the call will be available on the Transgene website ( following the live event. *** About TransgeneTransgene (Euronext: TNG) is a biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. The Company's clinical-stage programs consist of a portfolio of viral vector-based immunotherapeutics. TG4050, the first individualized therapeutic vaccine based on the myvac® platform is the Company's lead asset, with demonstrated proof of principle in patients in the adjuvant treatment of head and neck cancers. The portfolio also includes other viral-vector-based immunotherapies: TG4001 for the treatment of HPV-positive cancers, as well as BT-001 and TG6050, two oncolytic viruses based on the viral backbone. The Company also conducts innovative discovery and preclinical work, aimed at developing novel viral vector-based modalities. With Transgene's myvac® platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The myvac® approach allows the generation of a virus-based immunotherapy that encodes patient-specific mutations identified and selected by Artificial Intelligence capabilities provided by its partner its proprietary platform Transgene is building on its viral vector engineering expertise to design a new generation of multifunctional oncolytic information about Transgene is available at: us on social media: X (formerly Twitter): @TransgeneSA — LinkedIn: @Transgene — Bluesky: @Transgene Contacts Media: Investors & Analysts: Caroline Tosch Lucie Larguier Corporate and Scientific Communications Manager Chief Financial Officer (CFO) +33 (0)3 68 33 27 38 Nadege Bartoli communication@ Investor Relations Analystand Financial Communications Officer MEDiSTRAVA +33 (0)3 88 27 91 00/03 Frazer Hall/Sylvie Berrebi investorrelations@ + 44 (0)203 928 6900 transgene@ DisclaimerThis press release contains forward-looking statements, which are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. The occurrence of any of these risks could have a significant negative outcome for the Company's activities, perspectives, financial situation, results, regulatory authorities' agreement with development phases, and development. The Company's ability to commercialize its products depends on but is not limited to the following factors: positive pre-clinical data may not be predictive of human clinical results, the success of clinical studies, the ability to obtain financing and/or partnerships for product manufacturing, development and commercialization, and marketing approval by government regulatory authorities. For a discussion of risks and uncertainties which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors ('Facteurs de Risque') section of the Universal Registration Document, available on the AMF website ( or on Transgene's website ( Forward-looking statements speak only as of the date on which they are made, and Transgene undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future. Attachment 20250603_Transgene_Webcast_ENError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
29-05-2025
- Business
- Yahoo
Morgan Stanley Maintains Buy Rating on Bicara (BCAX) After the Ficerafusp Alfa Trial Update
On May 23, Judah Frommer from Morgan Stanley maintained a Buy rating on Bicara Therapeutics Inc. (NASDAQ:BCAX) while keeping the price target at $36. This comes after the company released its interim data from Phase 1/1b trial of Ficerafusp alfa, which is the company's lead asset and a first-in-class bifunctional antibody. Close-up of a scientist in a lab conducting tests on a humanized immunoglobulin G1. Bicara Therapeutics Inc. (NASDAQ:BCAX) is a clinical-stage biopharmaceutical company that develops innovative bifunctional antibody therapies for solid tumors. Ficerafusp alfa is being tested for enhanced tumor penetration and to overcome the immunosuppressive tumor microenvironment, which has historically limited treatment efficacy in solid tumors. The recent data from the Phase 1/1b study has shown promising results in treating HPV-negative patients who have head and neck squamous cell carcinoma. The analyst highlighted that the trial reported a median overall survival exceeding 20 months, including an 18-21% complete response rate. Frommer believes this is a significant improvement compared to standard care, suggesting that approval of Ficerafusp alfa could be a breakthrough in a challenging therapeutic area. While we acknowledge the potential of BCAX as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than BCAX and that has 100x upside potential, check out our report about the . READ NEXT: and . Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
26-05-2025
- Business
- Yahoo
Stifel Reaffirms Buy Rating on BCAX After Promising ASCO Data for HPV-Negative Patients
On May 24, analysts at Stifel reaffirmed their Buy rating and price target of $48 for Bicara Therapeutics Inc. (NASDAQ:BCAX). This follows the American Society of Clinical Oncology (ASCO) releasing abstracts after the market's close, which sparked debates regarding competing approaches to treating 1L SCCHN. The company's abstract provided a number of encouraging results for HPV-negative patients. These included an improved complete response (CR) rate, currently at 21%, a 12-month duration of response and overall survival (OS) of 60/61%, alongside a median overall survival (mOS) of more than 20 months. However, analysts pointed out that Merus, a market rival, also provided impressive full ASCO data that included both HPV-positive and HPV-negative patients. That said, Stifel analysts cautioned that it may be unreliable to draw competitive conclusions from non-randomized patient groups. In light of this, Stifel advises investors to purchase BCAX stock on any price weakness and to wait for more thorough information from Bicara at the next ASCO meetings. While we acknowledge the potential of BCAX to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than BCAX and that has 100x upside potential, check out our report about the cheapest AI stock. Read More: and . Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Insider
23-05-2025
- Business
- Business Insider
Bicara Therapeutics publishes updated data from Phase 1/1b trial of Ficerafusp
The company states: 'Bicara Therapeutics (BCAX) announced the publication of an abstract with updated interim data from the company's Phase 1/1b clinical trial of ficerafusp alfa in combination with pembrolizumab in patients with first line recurrent/metastatic head and neck squamous cell carcinoma on the 2025 American Society of Clinical Oncology Annual Meeting website. The company will host a conference call on Sunday, June 1, 2025 at 3:00 p.m. CT / 4:00 p.m. ET to present the fulsome dataset, including overall survival and duration of response data, following an oral presentation of the data at the ASCO Annual Meeting. Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration by breaking barriers within the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers. Specifically, ficerafusp alfa combines two clinically validated targets: an epidermal growth factor receptor directed monoclonal antibody with a domain that binds to human transforming growth factor beta.' 'We are pleased to present the fulsome dataset from our Phase 1/1b trial of ficerafusp alfa in patients with recurrent/metastatic head and neck squamous cell carcinoma during our upcoming oral presentation at ASCO,' said David Raben, MD, Chief Medical Officer of Bicara Therapeutics. 'The interim data featured in the ASCO abstract demonstrate encouraging signals that represent a meaningful improvement over historical benchmarks in patients with HPV-negative disease, a population with high unmet need and worse survival outcomes than those with HPV-positive disease. Notably, we're encouraged to see how ficerafusp alfa, specifically designed to drive tumor penetration within the tumor microenvironment, is leading to deep, and now, durable responses that appear to be translating to prolonged overall survival.'
Yahoo
22-05-2025
- Health
- Yahoo
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
24-month follow-up data from randomized Phase I part of the Phase I/II trial of TG4050 in resected locally advanced head and neck cancer selected for rapid oral presentationat ASCO on June 1st, 2025 Strasbourg, France, May 22, 2025, 5:45 p.m. CET – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, 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. TG4050 is a viral vector-based immunotherapy based on Transgene's myvac® platform and powered by NEC's cutting-edge AI capabilities designed to optimize antigen is being evaluated in a randomized multicenter Phase I/II trial as a single agent in the adjuvant treatment of HPV-negative head and neck cancers (NCT04183166). Based on promising Phase I data, Transgene and partner NEC have advanced the joint development of TG4050 in this indication with a Phase II extension of the trial, which is currently enrolling patients. Key data to be presented include: Safety in locally advanced HPV-negative resectable head and neck squamous cell carcinoma (HNSCC), Disease free survival after 2-year follow-up, Updated immunogenicity data. Prof. Le Tourneau, MD, PhD, Head of the Department of Drug Development and Innovation (D3i) at Institut Curie, and Principal Investigator commented: 'It is a privilege to present these study data which are based on the highly promising myvac® platform for individualized cancer vaccines. This oral presentation at ASCO offers an opportunity to highlight both the strength of the clinical data and the collaborative efforts of everyone involved in the trial.' Dr. Emmanuelle Dochy, MD, Chief Medical Officer of Transgene, added: 'We are pleased to have our latest findings on TG4050 selected for presentation among so many high-quality submissions to ASCO. This recognition reflects the dedication of our teams and the significance of our work in advancing medical science and patient care for those suffering from cancer. The Phase II part of our trial is currently enrolling patients internationally, as we continue to evaluate TG4050's potential in this setting.' The rapid oral presentation will take place on June 1st at 1:30 p.m. CDT during ASCO 2025 and will also be available to view on Transgene's website. 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. Following the previously reported topline results from this study in the overall patient population (see press release here), Transgene is currently evaluating potential partnership opportunities to determine the best path forward for the program. *** Contacts Media: Investors & Analysts: Caroline Tosch Lucie Larguier Corporate and Scientific Communications Manager Chief Financial Officer (CFO) +33 (0)3 68 33 27 38 Nadege Bartoli communication@ Investor Relations Analystand Financial Communications Officer MEDiSTRAVA +33 (0)3 88 27 91 00/03 Frazer Hall/Sylvie Berrebi investorrelations@ + 44 (0)203 928 6900 transgene@ About TransgeneTransgene (Euronext: TNG) is a biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. The Company's clinical-stage programs consist of a portfolio of viral vector-based immunotherapeutics. TG4050, the first individualized therapeutic vaccine based on the myvac® platform is the Company's lead asset, with demonstrated proof of principle in patients in the adjuvant treatment of head and neck cancers. The portfolio also includes other viral-vector-based immunotherapies: TG4001 for the treatment of HPV-positive cancers, as well as BT-001 and TG6050, two oncolytic viruses based on the viral backbone. The Company also conducts innovative discovery and preclinical work, aimed at developing novel viral vector-based modalities. With Transgene's myvac® platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The myvac® approach allows the generation of a virus-based immunotherapy that encodes patient-specific mutations identified and selected by Artificial Intelligence capabilities provided by its partner its proprietary platform Transgene is building on its viral vector engineering expertise to design a new generation of multifunctional oncolytic information about Transgene is available at: us on social media: X (formerly Twitter): @TransgeneSA — LinkedIn: @Transgene — Bluesky: @Transgene About myvac®myvac® is a viral vector (MVA – Modified Vaccinia Ankara) based, individualized immunotherapy platform that has been developed by Transgene to target solid tumors. myvac®-derived products are designed to stimulate the patient's immune system to recognize and destroy tumors using their own cancer specific genetic mutations. Transgene has set up an innovative network that combines bioengineering, digital transformation, established vectorization know-how and unique manufacturing capabilities. Transgene has been awarded 'Investment for the Future' funding from Bpifrance for the development of its platform myvac®. TG4050 is the first myvac®-derived product being evaluated in clinical trials. Click here to watch a short video on myvac®. About TG4050TG4050 is an individualized immunotherapy being developed for solid tumors that is based on Transgene's myvac® technology and powered by NEC's longstanding artificial intelligence (AI) and machine learning (ML) expertise. This virus-based therapeutic vaccine encodes neoantigens (patient-specific mutations) identified and selected by NEC's Neoantigen Prediction System. The prediction system is based on more than two decades of expertise in AI and has been trained on proprietary data allowing it to accurately prioritize and select the most immunogenic is designed to stimulate the immune system of patients in order to induce a T-cell response that is able to recognize and destroy tumor cells based on their own neoantigens. This individualized immunotherapy is developed and produced for each patient. About the Phase I/II clinical trialTG4050 is being evaluated in a Phase I/II clinical trial for patients with HPV-negative head and neck cancers (NCT04183166). An individualized treatment is created for each patient after they complete surgery and while they receive adjuvant therapy. Half of the participants received their vaccine immediately after completing adjuvant treatment. The other half were given TG4050 as an additional treatment at the time of recurrence of the disease as an additional treatment to standard of care (SoC). This randomized study is evaluating the treatment benefits of TG4050 in patients who are at risk of relapse. In the Phase I part, thirty-two evaluable patients have been included. The Phase II part is currently enrolling patients internationally. DisclaimerThis press release contains forward-looking statements, which are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. The occurrence of any of these risks could have a significant negative outcome for the Company's activities, perspectives, financial situation, results, regulatory authorities' agreement with development phases, and development. The Company's ability to commercialize its products depends on but is not limited to the following factors: positive pre-clinical data may not be predictive of human clinical results, the success of clinical studies, the ability to obtain financing and/or partnerships for product manufacturing, development and commercialization, and marketing approval by government regulatory authorities. For a discussion of risks and uncertainties which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors ('Facteurs de Risque') section of the Universal Registration Document, available on the AMF website ( or on Transgene's website ( Forward-looking statements speak only as of the date on which they are made, and Transgene undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future. Attachment 20250522_ASCO_PR_Abstract_EN
