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OS Therapies Terminates Equity Line of Credit
Newsfile· 2025-08-26 01:51
Core Viewpoint - OS Therapies has terminated its Equity Purchase Agreement with Square Gate Capital Master Fund, effective August 26, 2025, and has successfully raised $4.2 million through a warrant exercise inducement and exchange offering to fund operations into mid-2026 [1][2]. Group 1: Financial Developments - The termination of the Equity Purchase Agreement (ELOC) with Square Gate Capital Master Fund is effective August 26, 2025 [1]. - The company raised $4.2 million in gross proceeds from a recent warrant exercise inducement and exchange offering, which will support operations through mid-2026 [2]. Group 2: Clinical Trials and Product Development - The treatment phases of the Phase 2b OST-HER2 clinical trial in osteosarcoma and the Phase 1b OST-504 clinical trial in prostate cancer are now complete, leading to a projected monthly burn rate in the second half of 2025 that is significantly lower than in the first half [3]. - OS Therapies plans to allocate capital primarily to drive towards approval for OST-HER2 in osteosarcoma while analyzing data from OST-504 for future development steps [3]. Group 3: Company Overview and Product Pipeline - OS Therapies is focused on developing treatments for osteosarcoma and other solid tumors, with its lead asset, OST-HER2, leveraging immune-stimulatory effects to target the HER2 protein [4]. - OST-HER2 has received multiple designations from the U.S. FDA, including Rare Pediatric Disease Designation and Fast-Track designation, and the company plans to submit a Biologics Licensing Application (BLA) for OST-HER2 in 2025 [4]. - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced delivery of therapeutic payloads [5].
Anixa Biosciences Announces Treatment of Second Patient in Fourth Cohort of Ovarian Cancer CAR-T Clinical Trial
Prnewswire· 2025-08-18 13:00
Core Insights - Anixa Biosciences is conducting a Phase 1 clinical trial for its CAR-T therapy targeting recurrent ovarian cancer, with the second patient in the fourth dose cohort treated successfully [1][3] - The fourth cohort is receiving a dose of three million CAR-positive cells per kilogram, a 30-fold increase from the initial dose, with no dose-limiting toxicities observed to date [2][4] - The CAR-T program targets the follicle-stimulating hormone receptor (FSHR), which is selectively expressed on ovarian cells and certain cancer cells, indicating a potential for targeted therapy [3][4] Company Overview - Anixa is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a proprietary CAR-T program developed in collaboration with Moffitt Cancer Center [5] - The CAR-T technology is differentiated by its use of the natural ligand of the FSHR receptor, FSH, which binds directly to tumor cells rather than using an antibody fragment [5] - Anixa's vaccine portfolio includes collaborations with Cleveland Clinic to develop vaccines for breast and ovarian cancer, as well as other cancers, focusing on immunizing against specific proteins expressed in cancer [5]
TuHURA Biosciences, Inc. Reports Second Quarter 2025 Financial Results and Provides a Corporate Update
Prnewswire· 2025-08-14 20:15
Core Insights - TuHURA Biosciences has completed the acquisition of Kineta, Inc. and its VISTA inhibiting monoclonal antibody, now named TBS-2025, with plans to initiate a Phase 2 trial in relapsed/refractory NPM1-mutated Acute Myeloid Leukemia (AML) in the second half of 2025 [1][4] - The company has initiated a Phase 3 accelerated approval trial of IFx-2.0 as an adjunctive therapy with Keytruda® for advanced and metastatic Merkel cell carcinoma (MCC), under a Special Protocol Assessment (SPA) agreement with the FDA [1][3] Corporate Highlights - TuHURA completed a $12.5 million equity financing transaction and received an additional $3 million from warrant exercise proceeds [2][5] - The company was included in the Russell 3000® and Russell 2000® Indexes as of June 27, 2025 [4] Clinical Development - The Phase 3 trial of IFx-2.0 is a single randomized placebo-controlled trial that could potentially meet the requirements for both accelerated and full approval without the need for a post-accelerated approval confirmatory trial [3] - A Phase 1b/2a trial has been initiated for IFx-2.0 as an adjunctive therapy in first-line treatment of checkpoint-naïve patients with MCC of unknown primary origin, targeting newly diagnosed patients with metastatic tumors [3] Financial Performance - Research and development expenses for the second quarter of 2025 were $4.9 million, compared to $2.8 million for the same period in 2024 [7] - Net cash outflows from operating activities for the first half of 2025 were ($10.9) million, compared to ($8.9) million for the same period in 2024 [7] Upcoming Milestones - The company plans to advance TBS-2025 into a randomized Phase 2 trial in the second half of 2025 [6] - TuHURA anticipates providing updates on enrollment progress in its Phase 3 trial of IFx-2.0 by the end of 2025 and topline results from the Phase 1b/2a trial in Q1 2026 [12]
Anixa Biosciences Announces Dr. Robert Wenham will speak about Immunotherapy in surviving Ovarian Cancer at the 13th Annual Ovarcoming Cancer Conference
Prnewswire· 2025-08-08 13:15
Core Insights - Anixa Biosciences, Inc. is advancing its CAR-T therapy for ovarian cancer, with Dr. Robert Wenham as the principal investigator for the ongoing Phase 1 clinical trial [1][4] - Dr. Wenham will present at the 13th Annual Ovarcoming Cancer Conference, discussing advancements in ovarian cancer research and therapies, including Anixa's CAR-T therapy [2] Company Overview - Anixa is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a therapeutic portfolio that includes an ovarian cancer immunotherapy program developed in collaboration with Moffitt Cancer Center [4] - The company utilizes a novel CAR-T technology known as chimeric endocrine receptor-T cell (CER-T) technology, which differentiates itself by using the natural ligand of the FSHR receptor [4] - Anixa's vaccine portfolio includes collaborations with Cleveland Clinic to develop vaccines for breast and ovarian cancer, as well as other cancers [4] Conference Details - The Ovarcoming Cancer Conference aims to unite survivors, caregivers, and medical professionals to learn from experts in the ovarian cancer field [3] - Dr. Wenham's presentation is scheduled for September 18, 2025, from 12:05 PM to 12:30 PM CT [2]
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
Core Insights - The FDA has granted clearance for Radiopharm Theranostics to initiate a first-in-human Phase 1 clinical trial of RV-01, a Lu177-B7H3 monoclonal antibody targeting the 4Ig isoform of B7-H3, which is overexpressed in tumors [1][2] - RV-01 is expected to provide a novel treatment option for patients with aggressive solid tumors, with the first patient dosing anticipated later in 2025 [2][5] Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs, listed on ASX (RAD) and NASDAQ (RADX) [6] - The company has a diverse pipeline that includes distinct technologies such as peptides, small molecules, and monoclonal antibodies, with ongoing clinical trials for various solid tumors [6] Product Details - RV-01 is the first radiopharmaceutical therapeutic agent developed through a joint venture with MD Anderson Cancer Center, demonstrating tumor shrinkage and prolonged survival in preclinical studies [5] - The unique hepatic clearance of RV-01 may minimize adverse effects compared to other radiotherapeutics, which often have renal excretion pathways associated with higher toxicity risks [2][3] Scientific Significance - B7-H3 is an immune checkpoint molecule linked to tumor aggressiveness and poor clinical outcomes, making it a compelling target for antibody-based cancer immunotherapy [4] - The high affinity of RV-01 for the 4Ig isoform allows for enhanced targeting of tumors while avoiding immune complex formation in circulation [3][4]
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].