Core Viewpoint - PDS Biotechnology Corporation has received a new patent in Japan for PDS0101, enhancing its intellectual property portfolio and providing market exclusivity for the product into the 2040s [2][4]. Group 1: Patent and Intellectual Property - The Japan Patent Office has issued Patent No. 7783866 for PDS0101, granting broad composition of matter and methods of use claims [2]. - This new patent expands previously granted patents in Japan and adds to the company's existing patents in the United States, China, Australia, and Hong Kong [2]. - The company has additional patent applications pending in several other countries, reinforcing its global intellectual property position [4][5]. Group 2: Market Context and Product Development - The incidence of HPV16-related cancers is rapidly increasing in the US and Europe, which highlights the potential market for PDS0101 [3]. - PDS0101 is currently being studied in a Phase 3 trial in combination with pembrolizumab for HPV16-positive recurrent/metastatic head and neck cancer [3][6]. - The company aims to advance broad intellectual property protections for PDS0101 and its other investigational agents in development [5].

Core Insights - BriaCell Therapeutics Corp. is advancing its Phase 3 clinical study for Bria-IMT, having screened over 230 patients and enrolled over 160, with topline data expected in the first half of 2026 [1][9] Group 1: Clinical Study Progress - The Phase 3 study is evaluating Bria-IMT in combination with an immune checkpoint inhibitor against physician's choice therapy in patients with metastatic breast cancer [2][4] - An interim analysis will be conducted once 144 patient events (deaths) occur, focusing on overall survival as the primary endpoint [5][9] - The enrollment pace has exceeded expectations, indicating strong engagement from clinical sites and interest from patients [3][9] Group 2: Regulatory Status - The Bria-IMT combination regimen has received FDA Fast Track designation, which may facilitate its approval process [5][9] - Positive results from the study could lead to full approval and marketing authorization for Bria-IMT in metastatic breast cancer patients [2][5] Group 3: Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing novel immunotherapies aimed at transforming cancer care [7]

Core Insights - BriaCell Therapeutics Corp. is advancing its Phase 3 clinical study for Bria-IMT in metastatic breast cancer, having screened over 230 patients and enrolled over 160, with topline data expected in the first half of 2026 [1][9]. Group 1: Clinical Study Details - The pivotal Phase 3 study evaluates Bria-IMT combined with an immune checkpoint inhibitor against physician's choice therapy in advanced metastatic breast cancer [2][4]. - An interim analysis will occur once 144 patient events (deaths) are recorded, focusing on overall survival as the primary endpoint [5][9]. - The study has received FDA Fast Track designation, which may expedite the approval process for Bria-IMT if positive results are obtained [5][9]. Group 2: Company Statements and Expectations - Dr. William V. Williams, President & CEO, highlighted the strong engagement from clinical sites and patient interest, indicating that enrollment has exceeded expectations [3][9]. - The company is committed to sharing Phase 3 data with the U.S. FDA in the coming months, aiming to provide hope to patients with metastatic breast cancer [3][9].

Core Viewpoint - Immutep Limited and Dr. Reddy's Laboratories have entered into a strategic collaboration and exclusive licensing agreement for the development and commercialization of Eftilagimod Alfa (efti) outside of North America, Europe, Japan, and Greater China, marking a significant milestone for both companies [1][6]. Group 1: Collaboration Details - The agreement allows Immutep to retain global manufacturing rights for efti and supply the product to Dr. Reddy's in the licensed markets while keeping all rights in key pharmaceutical markets [3][6]. - Immutep will receive an upfront payment of USD 20 million (approximately AUD 30.2 million) and is eligible for potential regulatory development and commercial milestone payments of up to USD 349.5 million (approximately AUD 528.4 million), along with double-digit royalties on commercial sales [4][8]. Group 2: Product Information - Eftilagimod Alfa is a first-in-class immunotherapy that activates the immune system to combat cancer, currently under evaluation in a Phase III trial for advanced or metastatic non-small cell lung cancer (NSCLC) and other indications such as head and neck cancer, breast cancer, and soft tissue sarcoma [2][8]. - The product has received Fast Track designation from the FDA for first-line treatment in both HNSCC and NSCLC, indicating its potential as a new standard of care in combination therapies [9]. Group 3: Strategic Importance - The collaboration is seen as a way to leverage Dr. Reddy's market access and expertise to maximize the impact of efti, aiming to serve a large patient population globally [5][6]. - This partnership allows Immutep to capture significant value in the licensed markets while maintaining a strong position for future value creation in key markets [6].

MIAMI, Dec. 08, 2025 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (Nasdaq: SABS), a clinical-stage biopharmaceutical company developing human anti-thymocyte immunoglobulin (hATG) for type 1 diabetes (T1D) and other autoimmune diseases, today announced that the Company will give several oral presentations at the 2nd Asian Conference on Innovative Therapies for Diabetes Management (ATTD-Asia) being held December 9-11, 2025, in Singapore. Data to be presented will highlight the progress of SAB BIO’s lead prog ...

Core Viewpoint - Greenwich LifeSciences, Inc. has completed enrollment in the open label non-HLA-A*02 arm of its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][5]. Group 1: Trial Details - The Phase III trial includes approximately 500 HLA-A*02 patients randomized to receive either GLSI-100 or a placebo, and up to 250 non-HLA-A*02 patients treated with GLSI-100 in an open label arm [2][7]. - The non-HLA-A*02 patient group represents about 55% of the total patient population in FLAMINGO-01 [2]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis, with an interim analysis planned after 14 events [7]. Group 2: Company Insights - The CEO highlighted that the non-HLA-A*02 patient population could potentially double the number of eligible patients for GLSI-100 treatment in the US and Europe to approximately 88,000 new patients annually, with a market potential of $8-10 billion per year [3][5]. - The company believes that patent claims related to the use of GLSI-100 in the non-HLA-A*02 population are not subject to any licensing or royalty payments, potentially extending patent protection beyond 2040 [3][5]. Group 3: Clinical Observations - Preliminary data suggests that the immune response and safety profile of non-HLA-A*02 patients are trending similarly to the HLA-A*02 arms, with previous studies showing breast cancer recurrences reduced by up to 80% [5][6]. - The company is actively seeking regulatory approval to continue randomized enrollment of new non-HLA-A*02 patients with a control arm [5].

Core Insights - BioNTech and OncoC4 presented promising data for gotistobart (BNT316/ONC-392), a Treg depletion candidate, showing significant overall survival benefits in patients with metastatic squamous non-small cell lung cancer (sqNSCLC) compared to standard chemotherapy [1][4][5] Company Overview - BioNTech is a biopharmaceutical company focused on developing innovative therapies for cancer and other serious diseases, leveraging advanced immunotherapy techniques and a diverse oncology pipeline [9] - OncoC4 is a late clinical-stage biopharmaceutical company engaged in developing novel biologicals for cancer treatment, with a strategic collaboration with BioNTech for gotistobart [14] Clinical Trial Insights - The PRESERVE-003 trial is a two-stage Phase 3 study evaluating gotistobart as a monotherapy against standard chemotherapy in sqNSCLC patients who have progressed on prior treatments [5] - In the non-pivotal stage, 45 patients received gotistobart, while 42 received docetaxel, with a 12-month overall survival rate of 63.1% for gotistobart versus 30.3% for docetaxel [2][4] - The ongoing pivotal stage aims to enroll approximately 500 patients across multiple countries, focusing on overall survival as the primary endpoint [5] Treatment Efficacy - Gotistobart has not yet reached a median overall survival at nearly 15 months of follow-up, while docetaxel showed a median overall survival of 10 months [2][4] - The treatment with gotistobart reduced the risk of death by 54% compared to docetaxel, indicating a significant clinical advantage [2][4] Safety Profile - The safety profile of gotistobart was manageable, with 42.2% of patients experiencing grade ≥3 treatment-related adverse events compared to 48.8% in the docetaxel group [2][4] Regulatory Status - Gotistobart has received Fast Track Designation from the FDA for treating metastatic NSCLC patients whose disease progressed on prior anti-PD-(L)1 therapy, highlighting its potential as a novel treatment option [4][6]

As filed with the Securities and Exchange Commission on December 5, 2025. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CERO THERAPEUTICS HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 2836 81-4182129 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) 201 Haskins Way, Suite 230 Sout ...

As filed with the Securities and Exchange Commission on December 5, 2025. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT CERO THERAPEUTICS HOLDINGS, INC. (Exact name of registrant as specified in its charter) UNDER THE SECURITIES ACT OF 1933 Delaware 2836 81-4182129 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) 201 Haskins Way, Suite 230 Sout ...

Core Thesis - ImmunityBio, Inc. is positioned to address significant medical challenges related to immune exhaustion and lymphopenia, with its flagship therapy Anktiva showing promising results in clinical trials [2][4]. Company Overview - ImmunityBio's share price was $2.30 as of December 1st [1]. - The company focuses on enhancing immune function through innovative therapies, particularly targeting T-cell and NK-cell activation [2][3]. Product and Technology - Anktiva, an IL-15 agonist, has demonstrated durable lymphopenia reversal and significant survival benefits in clinical trials, with median overall survival often doubling compared to historical standards [2]. - The technology platform allows for the autonomous production of IL-15 by engineered NK cells, creating a self-sustaining immune response [3]. Clinical Trials and Collaborations - Ongoing clinical trials, such as QUILT-3.055 for non-small cell lung cancer and QUILT-88 for pancreatic cancer, have shown promising results [2]. - Collaborations with MiNK Therapeutics have yielded exceptional outcomes in pancreatic cancer, highlighting Anktiva's potential as a key component in next-generation immunotherapy [4]. Market Position and Future Potential - Despite a weak balance sheet, ImmunityBio's platform presents significant asymmetric upside potential, particularly in light of the growing recognition of immune system exhaustion as a global health crisis [4]. - The founder, Dr. Patrick Soon-Shiong, has a proven track record in biotech, which adds credibility to the company's future prospects [4].