Latest news with #immunotherapy
Medscape
7 hours ago
- Health
- Medscape
Darzalex Monotherapy OK'd for Smoldering Multiple Myeloma
At its June 2025 meeting, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended extending the indications for Darzalex (daratumumab) solution for injection as monotherapy to the treatment of adult patients with smoldering multiple myeloma at high risk of developing multiple myeloma. Darzalex is a monoclonal antibody used to treat adults with multiple myeloma and light chain amyloidosis. Good Response to Treatment Daratumumab attaches to the CD38 protein, found in large amounts on abnormal white blood cells in multiple myeloma and light chain amyloidosis. By attaching to CD38 on these cells, daratumumab activates the immune system to kill the abnormal white blood cells. Darzalex as monotherapy was investigated in two main studies involving multiple myeloma patients whose disease relapsed after, or was refractory to, at least two previous treatments, including a proteasome inhibitor and an immunomodulatory medicine. Response to treatment was measured by the disappearance of, or at least a 50% reduction in, protein produced by multiple myeloma cells. In the first study, around 29% of the patients who received daratumumab responded to treatment. In the second study, 36% of patients responded. In these studies, daratumumab was not compared with any other treatment. Full Indications The CHMP highlighted that the full indications for Darzalex solution for injection for will now be: For multiple myeloma: In combination with lenalidomide and dexamethasone or with bortezomib, melphalan, and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant In combination with bortezomib, lenalidomide, and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma In combination with bortezomib, thalidomide, and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy In combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide-refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy As monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy For smoldering multiple myeloma: As monotherapy for the treatment of adult patients with smoldering multiple myeloma at high risk of developing multiple myeloma For light chain (AL) amyloidosis: In combination with cyclophosphamide, bortezomib, and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain amyloidosis The indications for Darzalex concentrate for solution for infusion remained unchanged, the CHMP said. Rob Hicks is a retired UK National Health Service doctor. A well-known TV and radio broadcaster, he has written several books and has regularly contributed to national newspapers, magazines, and online publications.
Yahoo
11 hours ago
- Business
- Yahoo
Anixa Biosciences to Host an Investor Webcast on June 26, 2025
SAN JOSE, Calif., June 20, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that it will host an investor webcast presentation on June 26, 2025 at 2:00 PM EDT. During the webcast, Dr. Amit Kumar, Anixa's Chairman and CEO, will conduct an introductory presentation that will cover key aspects of Anixa's business including an overview of the Company's therapeutic portfolio, its business strategy, market opportunity and near-term milestones. After the formal presentation, investors will have an opportunity to ask relevant questions through an interactive Q&A portal. To listen to the webcast or to ask questions during the live event, please pre-register at the following link: An archived version of the webcast and presentation will be available on the Company's website, About Anixa Biosciences, Inc. Anixa is a clinical-stage biotechnology company focused on the treatment and prevention of cancer. Anixa's therapeutic portfolio consists of an ovarian cancer immunotherapy program being developed in collaboration with Moffitt Cancer Center, which uses a novel type of CAR-T, known as chimeric endocrine receptor-T cell (CER-T) technology. This technology is differentiated from other cell therapies as the natural ligand of the FSHR receptor, FSH, binds to the FSHR receptor on the tumor cell instead of an antibody fragment. Moffitt is a world leader in cancer immunotherapy treatments, pioneering next-generation cell therapies such as CAR-T, and tumor infiltrating lymphocytes (TILs) to harness the power of the immune system. The Company's vaccine portfolio includes vaccines being developed in collaboration with Cleveland Clinic to treat and prevent breast cancer and ovarian cancer, as well as additional cancer vaccines to address many intractable cancers, including high incidence malignancies in lung, colon, and prostate. These vaccine technologies focus on immunizing against "retired" proteins that have been found to be expressed in certain forms of cancer. The breast and ovarian cancer vaccines were developed at Cleveland Clinic and exclusively licensed to Anixa. Cleveland Clinic is entitled to royalties and other commercialization revenues from the Company related to these vaccine technologies. Anixa's unique business model of partnering with world-renowned research institutions on all stages of development allows the Company to continually examine emerging technologies in complementary fields for further development and commercialization. To learn more, visit or follow Anixa on Twitter, LinkedIn, Facebook and YouTube. Forward-Looking StatementsStatements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect Anixa's current expectations concerning future events and results. We generally use the words "believes," "expects," "intends," "plans," "anticipates," "likely," "will" and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in "Item 1A - Risk Factors" and other sections of our most recent Annual Report on Form 10-K as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release. Contact:Mike CatelaniPresident, COO & CFOmcatelani@ View original content to download multimedia: SOURCE Anixa Biosciences, Inc. Error in retrieving data Sign in to access your portfolio Error in retrieving data
Yahoo
2 days ago
- Business
- Yahoo
Transgene Completes Initial Patient Screening in Phase II Part of TG4050 Trial in Operable Head and Neck Cancer
Phase I part showed 100% Disease-Free Survival (DFS) after a minimum of 2-year follow-up – providing clinical proof of principle for TG4050 Randomization of all patients expected to be completed by end 2025 First immunogenicity data of Phase II part expected in H2 2026 Preliminary efficacy data expected in H2 2027Strasbourg, France, June 19, 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 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). TG4050, Transgene's lead asset, is based on its proprietary myvac® platform and powered by NEC's cutting-edge AI capabilities designed to optimize antigen selection for individual patients. All patients treated with TG4050 in the Phase I part of the trial remained disease-free after a minimum of two years of follow-up, confirming clinical proof of principle. Translational data showed sustained T cell responses at 24 months in these patients. The results, which met all trial endpoints including safety, feasibility, immune activation and disease-free survival (DFS, defined as survival without recurrence or death for any cause), were presented in an oral presentation at the recent American Society of Clinical Oncology (ASCO 2025) annual meeting. 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. These screenings represent key steps during which patients are evaluated to determine whether they meet the eligibility criteria to participate in the clinical trial. In total, approximately 80 patients with a complete response to adjuvant therapy are anticipated to be enrolled and subsequently randomized in the Phase I/II trial. 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. Dr. Emmanuelle Dochy, MD, Chief Medical Officer of Transgene added: 'Timely completion of first patient screening of the Phase II part of our Phase I/II trial is an important milestone for Transgene and brings us one step closer to providing a new treatment option for patients living with operable squamous head and neck cancer. With meaningful data readouts expected over the next two years, we are preparing to deliver important data for TG4050 and at the same time explore its wider potential. We are grateful to the patients, their families, investigators, and clinical staff whose commitment made this achievement possible.' Dr. Alessandro Riva, CEO of Transgene commented: 'The positive results from the Phase I part of our TG4050 trial support the strong potential of our myvac® platform. The successful completion of the first screening of the randomized Phase II part in less than a year and ahead of schedule underscores the investigators' commitment to rapidly advance the development of TG4050. In the ongoing Phase II part of the trial, we have been able to scale efficiently, strengthen our manufacturing capabilities and operate with the agility needed to lead in a highly competitive and fast-moving myvac® individualized cancer vaccine platform can be applied across a range of solid tumors where in many cases a significant unmet medical need remains. 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.' *** 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 a clinical stage 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. Positive data have been generated in the adjuvant setting of head and neck cancer (NCT04183166). A Phase II part is ongoing, Transgene is preparing an additional trial in a second indication, with aim to initiate the trial in Q4 2025. 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 ongoing internationally. Overall approximately 80 patients will be randomized in the trial. 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 20250619_Completion_EN
Zawya
2 days ago
- Health
- Zawya
Mayo Clinic researchers identify new immunotherapy target for ovarian cancer
Dubai, United Arab Emirates — Mayo Clinic researchers have discovered a new immunotherapy target, a cryptic antigen, may be key in helping the immune system fight tumors in ovarian cancer. The study, published in Science Advances, could improve treatment approaches for this type of cancer. Because ovarian cancer has limited symptoms, it can go undetected until it has spread. At a later stage, it becomes challenging to treat and has had limited success from existing immunotherapies and checkpoint inhibitors. Cryptic antigens are part of a protein — known as epitopes — that are usually hidden or inaccessible to the immune system and may be present in tumor cells. By targeting these antigens, the immune system can be effectively mobilized to attack the cancer. "These findings underscore the need to look at alternate sources of target antigens for ovarian cancer," says Marion R. Curtis, Ph.D., senior author of the study and immunologist at Mayo Clinic Comprehensive Cancer Center. "Discovering tumor-associated antigens that T cells recognize is crucial for the success of immunotherapeutic approaches in ovarian cancer, where the growth of cells that form in the ovaries multiply quickly and can invade and destroy healthy body tissue." T cells are a critical component of the adaptive immune system. Their ability to recognize and respond to specific targets is fundamental to their function. They play a significant role in developing and treating cancer and are vital in the immune system's fight against infections. In this study, the researchers characterized tumor antigens generated from ovarian cancer using multi-omics approaches to determine their ability to trigger an immune response. Multi-omics encompasses using multiple 'omes' (i.e., genome, proteome, microbiome, epigenome) to better understand the mechanisms of disease processes, detection, potential prevention and more focused therapies. Researchers have previously focused on discovering newly formed antigens (neoantigens). However, a previous study revealed that neoantigens are rarely found in ovarian cancer samples, making them unattractive targets. The next steps involve preclinical testing and clinical trials to evaluate the safety and efficacy of new immunotherapies and vaccines that target these cryptic antigens. The researchers also plan larger-scale studies to determine the prevalence of cryptic antigen expression across various tumor types, potentially paving the way for broader applications of this immunotherapy approach. Review the study for a complete list of authors, disclosures and funding.
Yahoo
2 days ago
- Business
- Yahoo
Brenus Pharma and InSphero Have Developed 3D Tumor Spheroids Mimicking in vivo Human Colorectal Cancer Conditions and Confirming STC-1010's Efficacy
Presented at EACR 2025, promising results show the impact of Brenus Pharma and InSphero's collaboration in advancing translational immunotherapy through scalable 3D tumor models. LISBON, Portugal, June 19, 2025--(BUSINESS WIRE)--Brenus Pharma, a French biotech developing next-generation first-in-class immunotherapies, and InSphero, a Swiss leader in 3D cell-based assay technologies, presented promising data at the European Association for Cancer Research 2025 annual congress. These data confirm the use of 3D tumor spheroids for potency testing of STC-1010, Brenus' lead candidate for colorectal cancer. Funded through the EUROSTARS program, the collaboration led to vitrified 3D colorectal cancer spheroids using tumor cell lines co-cultured with fibroblasts. The vitrification method preserves morphology, stromal integrity, and viability after thawing, enabling realistic evaluation of STC-1010's therapeutic potential under conditions mimicking in vivo human tumors. Previous studies showed that STC-1010 antigens were effectively processed by monocyte-derived dendritic cells (mMo-DCs), activating CD8+ T cells. These T cells induced apoptosis in both 2D and 3D colorectal cancer models and released anti-tumor cytokines (IFNγ and Granzyme B). These data reinforce the therapeutic potential of STC-1010. "This collaboration has enabled us to assess the highly representative and scalable 3D model into our SGC platform. It's a major step forward in our ability to assess potency and accelerate the development of STC-1010 and future candidates." Benoit Pinteur, CSO of Brenus Pharma. "We are proud to support Brenus with our cryopreserved 3D tumor models. This work illustrates how advanced in vitro systems can bring immunotherapies closer to clinical reality." Jan Lichtenberg, CEO of InSphero. About Brenus Pharma Brenus Pharma unlocks the potential of immuno-oncology by generating first-in-class immunotherapies that initiate a multi-specific in vivo immune response against tumors. Their proprietary "off-the-shelf" Stimulated-tumor-Ghost-Cells (SGC) platform mimics patients' tumor cells and makes them visible to the immune system to anticipate, target, and destroy these cells as they appear. Brenus aims to shift the oncology paradigm by making patients active participants in their treatment. About InSphero InSphero sets the standard for in vitro drug discovery and safety testing with innovative 3D cell-based technology and comprehensive preclinical research solutions. Its reliable, scalable and reproducible suite of 3D InSight™ Platforms for Liver Safety, Liver Disease, Islet Biology, and Oncology & Immunology are used by the top pharmaceutical companies worldwide. Learn more at View source version on Contacts contact@ 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
