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Anixa Biosciences Announces Commencement of US FDA Approved IND Transfer to Support Upcoming Phase 2 Breast Cancer Vaccine Trial
Prnewswire· 2025-08-04 12:45
Core Insights - Anixa Biosciences has initiated the transfer of the Investigational New Drug (IND) application for its breast cancer vaccine, which is currently held by Cleveland Clinic, to advance to a Phase 2 clinical trial [1][2][4] - The Phase 1 clinical trial has shown promising results, with over 70% of patients exhibiting immune responses, indicating the vaccine's potential effectiveness [2][4] - The breast cancer vaccine targets α-lactalbumin, a protein associated with lactation that re-emerges in many breast cancer forms, suggesting both therapeutic and preventive benefits [3][4] Company Overview - Anixa Biosciences is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a portfolio that includes an ovarian cancer immunotherapy program developed in collaboration with Moffitt Cancer Center [5] - The company is developing vaccines for breast and ovarian cancer, as well as other cancers, utilizing technologies that target proteins expressed in certain cancer forms [5] - Anixa's business model involves partnerships with leading research institutions to explore and commercialize emerging technologies in cancer treatment [5]
BioNTech Announces Second Quarter 2025 Financial Results and Corporate Update
Globenewswire· 2025-08-04 10:45
Core Insights - BioNTech reported significant advancements in its oncology strategy, including collaborations and acquisitions aimed at enhancing its product pipeline and capabilities [2][6][30] - The company experienced a substantial increase in revenues for the second quarter of 2025, driven primarily by its COVID-19 vaccine collaboration [3][4] - BioNTech's financial position remains strong, with substantial cash reserves and expected cash inflows from strategic partnerships [10][11][14] Financial Performance - Revenues for Q2 2025 reached €260.8 million, up from €128.7 million in Q2 2024, while total revenues for the first half of 2025 were €443.6 million compared to €316.3 million in the prior year [3][4] - The net loss for Q2 2025 was €386.6 million, a significant reduction from a net loss of €807.8 million in Q2 2024, with a total net loss of €802.4 million for the first half of 2025 compared to €1,122.9 million in the same period last year [7][8] - Basic and diluted loss per share improved to €1.60 for Q2 2025 from €3.36 in Q2 2024, and for the first half of 2025, it was €3.33 compared to €4.67 in the prior year [8][41] Research and Development - R&D expenses for Q2 2025 were €509.1 million, down from €584.6 million in Q2 2024, with total R&D expenses for the first half of 2025 at €1,034.7 million compared to €1,092.1 million in the previous year [4][5] - The company is focusing on its oncology pipeline, including the development of BNT327, a bispecific antibody candidate, and has initiated several clinical trials for various cancer treatments [6][23][27] Strategic Developments - BioNTech entered a collaboration with Bristol Myers Squibb (BMS) for the co-development of BNT327, which includes an upfront cash payment of $1.5 billion and potential milestone payments totaling up to $7.6 billion [10][11][12] - The acquisition of CureVac is expected to enhance BioNTech's capabilities in mRNA technology, complementing its existing product offerings [2][6][30] - The company has received approval for a new variant-adapted COVID-19 vaccine, with preparations for launch underway [6][22] Financial Guidance - BioNTech reaffirmed its revenue guidance for the full year 2025, expecting revenues to be between €1,700 million and €2,200 million, with a focus on late-stage development and commercialization in oncology [14][16] - Planned expenses for 2025 include R&D expenses of €2,600 million to €2,800 million and SG&A expenses of €650 million to €750 million [15][16]
Radiopharm Theranostics Receives IND approval from US FDA to Initiate Phase I Therapeutic Clinical Study to target B7H3 with Betabart (RV-01)
Globenewswire· 2025-07-28 12:00
Lu177-B7H3 monoclonal antibody is first in class targeted radiopharmaceutical in development against the 4lg subtype of B7-H3 On track to initiate first-in-human study of RV-01 in solid tumors in 4Q25 "The high affinity and selectivity of RV-01 for the 4Ig isoform of B7H3 allows the antibody to bypass the soluble 2Ig isoform in the blood, boost binding of the radiopharmaceutical to tumor targets and avoid the formation of immune complexes in circulation," noted David Piwnica-Worms, M.D., Ph.D., Professor, M ...
Compugen to Present a Pooled Analysis of COM701 Phase 1 trials in Platinum Resistant Ovarian Cancer at ESMO 2025
Prnewswire· 2025-07-28 11:00
Core Insights - Compugen Ltd. is set to present a pooled analysis of data from three Phase 1 trials of COM701 for treating heavily pretreated platinum-resistant ovarian cancer patients at ESMO 2025 in Berlin [1][2] Company Overview - Compugen is a clinical-stage cancer immunotherapy company that utilizes AI/ML for predictive computational drug target discovery [2] - The company has two proprietary product candidates in Phase 1 development: COM701, an anti-PVRIG antibody, and COM902, an antibody targeting TIGIT for solid tumors [2] - Compugen's pipeline includes early-stage immuno-oncology programs aimed at activating the immune system against cancer [2] - The company is headquartered in Israel with additional offices in San Francisco, CA, and its shares are listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN [2]
Compugen to Release Second Quarter 2025 Results on Wednesday, August 6, 2025
Prnewswire· 2025-07-23 11:00
Company Overview - Compugen Ltd. is a clinical-stage cancer immunotherapy company specializing in predictive computational drug target discovery using AI/ML technologies [3] - The company is headquartered in Israel and has an office in San Francisco, CA, with shares listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN [3] Upcoming Financial Results - Compugen will release its second quarter 2025 financial results on August 6, 2025, before U.S. financial markets open [1] - A conference call and webcast will be held at 8:30 AM ET to review the results and provide a corporate update [1] Product Pipeline - Compugen has two proprietary product candidates in Phase 1 development: COM701, an anti-PVRIG antibody, and COM902, an antibody targeting TIGIT for solid tumors [3] - Rilvegostomig, a PD-1/TIGIT bispecific antibody, is in Phase 3 development by AstraZeneca under a licensing agreement [3] - GS-0321, a high affinity anti-IL-18 binding protein antibody, is also in Phase 1 development and licensed to Gilead [3] Research Programs - The company has a therapeutic pipeline focused on early-stage immuno-oncology programs aimed at activating the immune system against cancer through new mechanisms [3]
Anixa Biosciences Announces Issuance of Additional U.S. Patent for Ovarian Cancer Vaccine Technology
Prnewswire· 2025-07-09 12:00
Core Viewpoint - Anixa Biosciences has announced the issuance of a key patent for its ovarian cancer vaccine technology, which is expected to enhance the company's position in the cancer treatment market [1][4]. Group 1: Patent and Technology - The United States Patent and Trademark Office (USPTO) will issue U.S. Patent Number 12,357,593 on July 15, 2025, covering methods related to eliciting an immune response targeting anti-Müllerian hormone receptor, type II (AMHR2) [1]. - The patent includes methods for administering an immunogenic composition that encodes the AMHR2 polypeptide, specifically targeting the extracellular domain of human AMHR2 [3]. - Anixa holds exclusive worldwide rights to the patent, which was issued to Cleveland Clinic [3]. Group 2: Collaboration and Development - The ovarian cancer vaccine is being developed in collaboration with Cleveland Clinic and the National Cancer Institute, focusing on high-risk populations such as those with BRCA mutations [2]. - Anixa's therapeutic portfolio includes an ovarian cancer immunotherapy program utilizing chimeric endocrine receptor-T cell (CER-T) technology, which is distinct from traditional CAR-T therapies [4]. - The company is also developing additional cancer vaccines in collaboration with Cleveland Clinic to address various cancers, including breast, lung, colon, and prostate cancers [4].
Anixa Biosciences Initiates Dosing in Fourth Cohort in its Ovarian Cancer CAR-T Clinical Trial
Prnewswire· 2025-06-23 12:00
Core Insights - Anixa Biosciences has initiated dosing for the first patient in the fourth dosage cohort of its Phase 1 clinical trial for CAR-T therapy targeting recurrent ovarian cancer, marking a significant advancement in the study [1][2] - The fourth cohort will receive a dose of three million CAR-positive cells per kilogram, which is thirty times higher than the initial cohort dose, indicating a strategic escalation in dosage to assess safety and efficacy [2][4] Company Overview - Anixa is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a specific emphasis on ovarian cancer immunotherapy developed in collaboration with Moffitt Cancer Center [4] - The company's CAR-T technology targets the follicle-stimulating hormone receptor (FSHR), which is exclusively expressed on ovarian cells and certain cancer cells, positioning it uniquely in the oncology landscape [3][4] - Anixa's business model involves partnerships with leading research institutions, allowing for the exploration of emerging technologies in cancer treatment [4]
Anixa Biosciences to Host an Investor Webcast on June 26, 2025
Prnewswire· 2025-06-20 11:30
Core Viewpoint - Anixa Biosciences, Inc. is set to host an investor webcast on June 26, 2025, to discuss its business strategy, therapeutic portfolio, market opportunities, and upcoming milestones [1][2]. Company Overview - Anixa is a clinical-stage biotechnology company focused on cancer treatment and prevention [4]. - The company is developing an ovarian cancer immunotherapy program in collaboration with Moffitt Cancer Center, utilizing a novel CAR-T technology called chimeric endocrine receptor-T cell (CER-T) technology [4]. - Anixa's vaccine portfolio includes vaccines for breast and ovarian cancer developed with Cleveland Clinic, as well as additional vaccines targeting high incidence malignancies in lung, colon, and prostate cancers [4]. - The company partners with renowned research institutions to explore emerging technologies for development and commercialization [4]. Webcast Details - The webcast will feature an introductory presentation by Dr. Amit Kumar, Anixa's Chairman and CEO, followed by a Q&A session for investors [2]. - Interested participants must pre-register to listen to the webcast and ask questions during the live event [3].
Teva and Fosun Pharma Enter into a Strategic Partnership to Develop Novel Anti-PD1-IL2 Therapy (TEV-56278) in Immuno-Oncology
Globenewswire· 2025-06-16 12:30
Core Viewpoint - Teva Pharmaceutical Industries Ltd. and Shanghai Fosun Pharmaceutical have formed a strategic partnership to develop TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy, aimed at enhancing cancer treatment efficacy while minimizing toxicity [1][2][3] Company Overview - Teva Pharmaceutical Industries Ltd. is a global biopharmaceutical leader with over 120 years of experience, focusing on innovative drug development and the production of generics and biologics [6] - Shanghai Fosun Pharmaceutical, founded in 1994, is a leading innovation-driven global healthcare company with a strong presence in pharmaceuticals and healthcare services, actively implementing its "4IN" strategy [9][10] Partnership Details - The agreement allows Fosun Pharma exclusive rights to develop, manufacture, and commercialize TEV-56278 in specific regions, while Teva retains rights in the rest of the world, facilitating global data generation [2][8] - This collaboration aims to leverage both companies' strengths, combining Teva's innovative drug development capabilities with Fosun Pharma's oncology expertise and market access in China [4][8] Product Information - TEV-56278 is designed to selectively deliver IL-2 to PD-1+ T cells, enhancing anti-tumor activity and reducing systemic toxicities, and is currently in Phase 1 trials for various cancers [5][8] - Preclinical data indicates that TEV-56278 may lead to tumor regression and improved T-cell responses, showcasing its potential as a novel cancer immunotherapy [5][8]
FDA Removes Partial Clinical Hold on TuHURA Biosciences' Phase 3 Accelerated Approval Trial for IFx-2.0 in Advanced or Metastatic Merkel Cell Carcinoma
Prnewswire· 2025-06-09 12:00
Core Viewpoint - TuHURA Biosciences, Inc. is set to initiate its Phase 3 accelerated approval trial for IFx-2.0 in combination with Keytruda® for advanced and metastatic Merkel cell carcinoma, following the removal of a partial clinical hold by the FDA [1][3] Group 1: Trial Details - The Phase 3 trial will evaluate IFx-2.0 as an adjunctive therapy administered weekly for three weeks alongside Keytruda®, compared to Keytruda® plus placebo [3] - The trial is expected to enroll 118 participants across approximately 22 to 25 U.S. sites, with a randomization ratio of 1:1 [3] - The primary endpoint is Overall Response Rate (ORR), with a key secondary endpoint of Progression Free Survival (PFS) [3] Group 2: Financial Aspects - The resolution of the partial clinical hold allows the company to unlock the second tranche of funding from a $12.5 million PIPE financing, triggering an additional payment of $2.23 million [1][3] - The company had previously announced this financing on June 3, 2025 [1] Group 3: Company Overview - TuHURA Biosciences focuses on developing novel technologies to overcome resistance to cancer immunotherapy, addressing primary and acquired resistance [4][5] - The lead product candidate, IFx-2.0, is designed to enhance the efficacy of checkpoint inhibitors [5]