"Pelareorep continues to deliver encouraging results in pancreatic cancer, where few effective treatments exist," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "In multiple studies, pelareorep has repeatedly demonstrated its ability to engage the immune system to attack pancreatic cancer tumors, which has the potential to improve outcomes for patients battling this difficult-to-treat cancer." Ongoing updates support potential of pelareorep combination therapies in one of t ...

Core Insights - BriaCell Therapeutics Corp. is set to present four clinical data presentations at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, highlighting its advancements in immunotherapy for cancer treatment [1][2]. Presentation Details - The first abstract titled "Update on phase III pivotal trial of Bria-IMT + CPI vs physician's choice in advanced metastatic breast cancer (BRIA-ABC)" will be presented on June 2, 2025, from 9:00 AM to 12:00 PM CDT, with the abstract number TPS1138 and poster board number 108a [2]. - The second abstract, "Bria-IMT + checkpoint inhibitor: Phase I/II survival results compared to benchmark trials in metastatic breast cancer," will also be presented on June 2, 2025, during the same time frame, with the abstract number 1096 and poster board number 75 [2]. - The third abstract, "Trial in progress: A study of Bria-OTS cellular immunotherapy in metastatic recurrent breast cancer," is scheduled for the same session, with the abstract number TPS1136 and poster board number 107a [2]. - A publish-only abstract titled "Impact of HLA Matching on Clinical Outcomes in a Phase 2 Trial of Bria-IMT™ Plus Anti PD1 in Advanced Breast Cancer" will be released on May 22, 2025, at 5:00 PM ET [2]. Company Overview - BriaCell Therapeutics Corp. is a clinical-stage biotechnology company focused on developing novel immunotherapies aimed at transforming cancer care [4].

Core Insights - BriaCell Therapeutics Corp. is conducting a pivotal Phase 3 clinical study for its lead candidate, Bria-IMT, in advanced metastatic breast cancer, with over 75 patients enrolled and more than 100 consented [1][2][9] - The company expects to complete patient enrollment by late 2025 or early 2026 and may report top-line data as early as the first half of 2026 [1][5] - The study is being conducted at 54 clinical sites across 15 states in the US, with a focus on evaluating overall survival compared to physician's choice treatment [4][5][9] Company Statements - Dr. William V. Williams, President & CEO, expressed optimism about the expanding patient enrollment and the potential of Bria-IMT to transform cancer care for metastatic breast cancer patients [3] - Dr. Giuseppe Del Priore, Chief Medical Officer, noted that the enrollment pace and clinical investigator interest are higher than previously observed, highlighting the dedication of clinical investigators and patients [3] Study Details - The primary endpoint of the study is overall survival, with interim data analysis planned once 144 patient events occur [5] - The Bria-IMT combination regimen has received FDA Fast Track designation, indicating its potential for expedited development and review [5] - Positive results from the Phase 3 study could lead to full approval and marketing authorization for Bria-IMT in metastatic breast cancer patients [5]

Core Insights - Pepinemab, a Semaphorin 4D blocking immunotherapy, shows promise in enhancing immune responses and improving survival in patients with metastatic melanoma and head and neck cancer [1][2][4] Company Overview - Vaccinex, Inc. is a clinical-stage biotechnology company focused on innovative treatments for cancer and Alzheimer's disease through the inhibition of Semaphorin 4D [2][8] - The lead drug candidate, pepinemab, is designed to block SEMA4D, which is believed to prevent immune cell infiltration in tumors and trigger inflammation in neurodegenerative diseases [7][8] Clinical Data and Presentations - New data on pepinemab's mechanism to enhance immune responses will be presented at the 2025 Annual Meeting of the American Association for Cancer Research (AACR) [2][3] - Pepinemab has been shown to enhance the maturity of tertiary lymphoid structures (TLS) and correlate with longer recurrence-free survival when combined with immune checkpoint inhibitors in metastatic melanoma patients [5][6] Mechanism of Action - Pepinemab facilitates immune cell interactions within organized centers of immunity, known as tertiary lymphoid structures, by blocking the SEMA4D inhibitory signal to dendritic cells [3][4] - The presence of TLS has been associated with clinical benefits and positive responses to immune checkpoint therapy, making pepinemab a potential solution for inducing TLS in "cold" tumors [4][5] Ongoing Studies - Evaluation of pepinemab in the neoadjuvant setting for head and neck cancer is ongoing, with results expected to be reported at upcoming scientific meetings [6]

Core Insights - Elicio Therapeutics has granted inducement awards to its newly appointed Chief Strategy and Financial Officer, Preetam Shah, and two additional employees as part of their employment agreement [1][2] - The inducement awards consist of 191,624 stock options for Dr. Shah and a total of 21,000 stock options for the other two employees, with an exercise price of $4.98 per share [2] - The stock options will vest over four years, with 25% vesting on the first anniversary of the respective start dates and the remainder vesting monthly thereafter [3] Company Overview - Elicio Therapeutics is a clinical-stage biotechnology company focused on developing novel immunotherapies for high-prevalence cancers, including mKRAS-positive pancreatic and colorectal cancers [4] - The company aims to leverage its Amphiphile ("AMP") technology to enhance the activation of cancer-specific T cells, promoting durable cancer immunosurveillance [4] - Elicio's lead program, ELI-002, targets common KRAS mutations found in approximately 25% of all solid tumors and is currently in a randomized clinical trial for patients with mKRAS-positive pancreatic cancer [4]

Industry Overview - The cancer market is experiencing significant growth due to rising demand for targeted and less toxic cancer medicines, with new cancer cases in the U.S. expected to exceed 2 million for the first time in 2024, leading to increased global spending on cancer treatments [1][3] - Innovative cancer treatments such as immunotherapy, targeted therapies, and personalized vaccines are emerging, utilizing the body's immune system and focusing on specific genetic mutations to provide more effective and less harmful alternatives to traditional chemotherapy [2][3] Company Developments - Major pharmaceutical companies like Novartis, AstraZeneca, Pfizer, AbbVie, and Eli Lilly are actively developing new cancer therapies, including antibody-drug conjugates and immune-oncology agents, while smaller biotech firms are also making significant advancements [4] - Verastem Oncology is seeking FDA approval for its combination regimen of avutometinib and defactinib for treating KRAS mutant recurrent low-grade serous ovarian cancer, with a decision expected by June 30, 2025 [6][7] - Relay Therapeutics has reported positive interim data for its RLY-2608 breast cancer program, leading to plans for a pivotal study in mid-2025 [9][10] - Pyxis Oncology is focused on developing next-generation therapeutics, with its lead candidate showing significant tumor regression in patients with recurrent and metastatic head and neck squamous cell carcinoma, and has received Fast Track Designation from the FDA [12][13][14]

Core Insights - PDS Biotechnology Corporation announced that preclinical immune response data for a novel Infectimune-based flu vaccine will be presented at the American Association of Immunologists' IMMUNOLOGY2025™ Annual Meeting [1] - The presentation will focus on broadly protective immunity against influenza and opportunities for universal influenza vaccines [2] - PDS Biotech is advancing its lead program in advanced HPV16-positive head and neck squamous cell cancers through a pivotal clinical trial [3] Presentation Details - Title of the presentation: Broadly Protective Immunity against Influenza and Opportunities for Universal Influenza Vaccines [2] - Session Type: Guest Symposium at the International Society of Influenza and Other Respiratory Viruses (ISIRIV) Symposium [2] - Date and Time: May 4, 2025, from 8:30 to 10:30 a.m. HST [2] - Presenter: Andrea Sant, Ph.D., Professor of Microbiology and Immunology at the University of Rochester Medical Center [2] Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on transforming immune responses to target and kill cancers [3] - The company is developing its lead investigational targeted immunotherapy, Versamune HPV, in combination with standard-of-care immune checkpoint inhibitors [3] - PDS Biotech is also exploring a triple combination therapy that includes PDS01ADC, an IL-12 fused antibody drug conjugate, along with standard-of-care immune checkpoint inhibitors [3]

Core Insights - BriaCell Therapeutics Corp. announced positive survival data from its Phase 2 study of Bria-IMT combined with checkpoint inhibitors, showing better outcomes than current ADC drugs for HR+ metastatic breast cancer patients [1][2][4] Clinical Study Results - In the Phase 2 study, 25 out of 37 patients with HR+ breast cancer treated with Bria-IMT had a median overall survival of 17.3 months, surpassing the 14.4 months seen with TRODELVY® [2][4] - For triple-negative breast cancer (TNBC) patients, the survival data with Bria-IMT was comparable to TRODELVY® but significantly higher (70%) than traditional chemotherapy [2][4] - The study included 54 heavily pre-treated metastatic breast cancer patients, with a median of 6 prior treatments [5] Company Statements - Dr. William V. Williams, President and CEO of BriaCell, expressed confidence in the survival benefit data and the tolerability of Bria-IMT, looking forward to further confirmation in the ongoing Phase 3 study [3][4] - Dr. Giuseppe Del Priore, Chief Medical Officer, highlighted the potential of Bria-IMT + CPI to meet the unmet medical needs of HR+ and TNBC patients, who have limited treatment options [3][4] Additional Information - No discontinuations related to Bria-IMT have been reported to date, indicating a favorable safety profile [4][5] - The ongoing pivotal Phase 3 study is listed on ClinicalTrials.gov as NCT06072612 [5]

Core Insights - Amgen's IMDELLTRA® (tarlatamab-dlle) has shown a substantial survival advantage over standard chemotherapy in patients with small cell lung cancer (SCLC) who have progressed after platinum-based chemotherapy, as demonstrated in the Phase 3 DeLLphi-304 clinical trial [1][2][3] Group 1: Clinical Trial Results - The DeLLphi-304 trial met its primary endpoint, showing statistically significant and clinically meaningful improvement in overall survival (OS) compared to local standard-of-care chemotherapy [1][3] - IMDELLTRA is indicated for adult patients with extensive-stage SCLC who have disease progression on or after platinum-based chemotherapy, with approval based on overall response rate and duration of response [5][6] Group 2: Drug Mechanism and Target Population - IMDELLTRA is a first-in-class immunotherapy that targets DLL3 on tumor cells and CD3 on T cells, leading to the destruction of DLL3-expressing SCLC cells [4][6] - DLL3 is expressed on approximately 85-96% of SCLC patients, making it a promising target for therapy [4][6] Group 3: Safety and Efficacy - The safety profile of IMDELLTRA was consistent with its known profile, and detailed data from the trial will be presented at an upcoming medical congress [2][3] - Serious adverse reactions occurred in 58% of patients, with cytokine release syndrome (CRS) being the most common [26][27] Group 4: Future Developments - Amgen is advancing a robust development program for tarlatamab, including multiple ongoing clinical trials evaluating its efficacy in various treatment settings for SCLC [8][9]

Core Viewpoint - BriaCell Therapeutics Corp. and its subsidiary BriaPro are advancing the development of novel high-affinity antibodies targeting B7-H3, a significant player in cancer progression, with plans for patent applications and multiple cancer indications [1][2][8]. Group 1: Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing innovative immunotherapies to transform cancer care [5]. - BriaPro is a pre-clinical stage immunotherapy company aiming to enhance the body's cancer-fighting capabilities [6]. Group 2: Technology Development - BriaPro is utilizing molecular modeling techniques to develop anti-B7-H3 antibodies, which are expected to be incorporated into the Bria-TILsRx™ platform designed to activate T cells in the tumor microenvironment [2][8]. - The B7-H3 target is overexpressed in various solid tumors, including prostate, lung, breast, pancreatic, and ovarian cancers, while showing limited expression in normal tissues, making it an ideal target for selective activation of tumor infiltrating lymphocytes [3][8]. Group 3: Market Potential - Antibodies targeting B7-H3 are in high demand among pharmaceutical and biotechnology companies, indicating a strong market interest [5]. - The development of anti-B7-H3 antibodies is expected to synergize with BriaCell's existing cell-based immuno-oncology platform, which includes novel cell-based immunotherapy approaches [5].