Group 1 - Adlai Nortye Ltd. announced topline results from its Phase III BURAN trial evaluating buparlisib (AN2025), a PI3K inhibitor, in combination with paclitaxel for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) [1] - The study did not meet the primary endpoint of improving overall survival compared to paclitaxel alone [1] - The safety profile of buparlisib was consistent with previous findings, with no new safety signals observed [1] Group 2 - Detailed results from the Phase III trial will be presented at an upcoming medical conference [2] - AN8025 is a next-generation tri-specific antibody fusion protein derived from an approved PD-L1 antibody, optimized for PD-1-based immunotherapy [2] - Preclinical studies have demonstrated that AN8025 enhances both the quantity and quality of antigen-presenting cells (APCs) while inducing robust PD-L1-dependent T cell activation and anti-tumor efficacy in vivo [3] Group 3 - The company plans to submit the IND application for AN8025 in mid-2025 [3] - AN9025 is an in-house developed oral small molecule pan-RAS(ON) inhibitor designed to target a broad spectrum of RAS mutations across various tumor types [3] - Preclinical studies have shown that AN9025 effectively inhibits RAS-mutant cancers, including pancreatic, lung, and colorectal adenocarcinomas, with potent and durable efficacy [4] Group 4 - The company plans to submit an IND application for AN9025 in the second half of 2025 [4] - AN4005 is an orally available small-molecule PD-L1 inhibitor that demonstrates antitumor activity by blocking PD-1/PD-L1 interaction [4] - Preliminary results from the Dose-Escalation Phase presented at SITC 2024 demonstrated that AN4005 exhibits favorable safety and tolerability in patients with advanced tumors [5]

Core Viewpoint - Corvus Pharmaceuticals, Inc. is actively engaging with investors at the 2025 Jefferies Global Healthcare Conference, highlighting its innovative approach in immunotherapy and its lead product candidate, soquelitinib [1][3]. Company Overview - Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on ITK inhibition as a novel immunotherapy strategy for various cancers and immune diseases [3]. - The company's lead product candidate, soquelitinib, is an investigational oral small molecule drug that selectively inhibits ITK [3]. - Corvus is developing additional clinical-stage candidates targeting a range of cancer indications [3]. Event Details - The leadership team will present a corporate overview and conduct one-on-one meetings with investors at the conference in New York on June 5, 2025, from 9:20 to 9:50 am ET [1]. - A live webcast of the presentation will be available for 90 days post-event, accessible through the investor relations section of the Corvus website [2].

Core Insights - Vaccinex, Inc. is presenting new data on pepinemab, a monoclonal antibody targeting SEMA4D, which enhances immune responses in neoadjuvant settings for head and neck cancer [2][5][6] - The upcoming presentation at the ASCO conference will detail how pepinemab treatment correlates with improved pathologic responses by inducing mature lymphoid structures [4][6] Company Overview - Vaccinex, Inc. is focused on innovative treatments for cancer and neurodegenerative diseases through the inhibition of SEMA4D [8] - The lead drug candidate, pepinemab, is designed to block SEMA4D, which is implicated in immune cell infiltration and activation in tumors [7][9] Clinical Research and Development - Pepinemab is being evaluated in combination with other immunotherapies, such as KEYTRUDA and BAVENCIO, in various clinical trials for head and neck cancer and pancreatic adenocarcinoma [9][10] - Previous studies indicate that pepinemab can enhance immune cell interactions and improve treatment outcomes in patients with "cold" tumors, which are typically resistant to standard immunotherapy [5][6] Upcoming Events - The ASCO conference presentation is scheduled for June 1, 2025, focusing on the neoadjuvant biomarker trial of pepinemab in resectable head and neck cancer [4][5]

Core Insights - Immutep Limited's investigator-initiated EFTISARC-NEO Phase II trial has successfully met its primary endpoint, demonstrating a significant increase in tumour hyalinization/fibrosis in patients with resectable soft tissue sarcoma (STS) when treated with eftilagimod alfa (efti) combined with radiotherapy and KEYTRUDA® [1][7]. Company Overview - Immutep is a late-stage biotechnology company focused on developing innovative immunotherapies for cancer and autoimmune diseases, particularly leveraging the Lymphocyte Activation Gene-3 (LAG-3) pathway [7]. - The company is pioneering the understanding and advancement of therapeutics related to LAG-3, aiming to provide novel treatment options for patients and maximize shareholder value [7]. Trial Details - The EFTISARC-NEO trial showed a median of 50% tumour hyalinization/fibrosis in a preliminary analysis of 21 patients, significantly exceeding the prespecified median of 35% [3]. - The trial is primarily funded by a grant from the Polish government, with a total enrollment of 40 patients completed in January 2025 [3][4]. Medical Significance - Tumour hyalinization/fibrosis serves as an early surrogate endpoint linked to improved overall survival and recurrence-free survival in STS patients [2]. - STS is classified as an orphan disease with a high unmet medical need and poor prognosis, with an estimated 13,520 new cases and 5,420 deaths in the U.S. in 2025 [4]. Eftilagimod Alfa (efti) Profile - Efti is a proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity, enhancing the immune response against cancer [5]. - Efti is under evaluation for various solid tumours, including non-small cell lung cancer and head and neck squamous cell carcinoma, and has received Fast Track designation from the FDA for certain indications [6].

Core Insights - BriaCell Therapeutics Corp. announced positive survival and clinical benefit data from its Phase 2 Bria-IMT™ study, which outperformed FDA-approved therapies in metastatic breast cancer patients [1][2][6] - The company will present these findings at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting [1] Clinical Data Summary - The Phase 2 study showed a median overall survival (OS) of 9.9 months and a progression-free survival (PFS) of 3.6 months for the overall cohort, with a clinical benefit rate (CBR) of 55% and an objective response rate (ORR) of 10% [5][9] - In the ongoing pivotal Phase 3 study, the selected formulation of Bria-IMT demonstrated improved OS of 13.4 months and PFS of 3.6 months, with a CBR of 61% and an ORR of 14% [5][8][10] - These results were achieved in a more heavily pre-treated patient population compared to comparator trials, highlighting Bria-IMT's strong anti-cancer activity [10] Comparative Analysis - Bria-IMT's outcomes were compared to two pivotal Phase 3 studies: ASCENT and TROPiCS-02, where ASCENT reported an OS of 11.8 months and TROPiCS-02 reported 14.4 months [7][8] - The CBR for Bria-IMT (61%) exceeded that of ASCENT (40%) and TROPiCS-02 (34%), while the ORR of 14% matched or exceeded the treatment of physician's choice (TPC) arms in both studies [9][10] Future Outlook - Successful completion of the pivotal Phase 3 study may support a Biologics License Application, Priority Review, Full Approval, and Commercialization of Bria-IMT [6][10] - The company is optimistic about confirming results in the ongoing pivotal Phase 3 study and addressing unmet needs in metastatic breast cancer [2][10]

Core Insights - Oncolytics Biotech Inc. presented new data on pelareorep's mechanism of action in pancreatic ductal adenocarcinoma (PDAC) at the 2025 ASCO Annual Meeting, highlighting its ability to stimulate immune responses and prime tumors for treatment [1][2] Group 1: Mechanism of Action - Pelareorep initiates a pro-inflammatory tumor microenvironment (TME) and induces both innate and adaptive immune responses, allowing circulating tumor-infiltrating lymphocytes (TILs) to attack tumors [1] - The treatment expands anti-reovirus T cells and upregulates chemokines that facilitate the expansion of pre-existing TIL clones in the blood, which can return to the tumor and reduce its size [2] - The presence of TIL clones in the blood before treatment and their expansion post-treatment correlate with favorable clinical responses [4] Group 2: Clinical Trial Insights - The GOBLET study is a Phase 1/2 trial evaluating pelareorep in combination with other therapies for advanced or metastatic gastrointestinal tumors, focusing on objective response rate (ORR) and disease control rate [3] - Efficacy results from GOBLET Cohort 1 showed a 62% overall response rate, an 85% disease control rate, and a 45% 12-month survival rate in first-line metastatic PDAC patients [4] Group 3: Combination Therapies - Pelareorep is being tested in combination with atezolizumab, gemcitabine, and nab-paclitaxel for advanced/metastatic pancreatic cancer, as well as in other cancer types such as MSI-high metastatic colorectal cancer and anal cancer [5][12] - The company is advancing towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA [9]

Core Insights - PDS Biotechnology Corporation is advancing its lead immunotherapy program, Versamune HPV, in combination with pembrolizumab for the treatment of recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) [2][8] Group 1: Clinical Trial Results - In Phase 2 trials, the median overall survival (mOS) for patients with a Combined Positive Score (CPS) ≥20 is reported at 39.3 months, while for CPS ≥1, it is 30.0 months [1][6] - The ongoing Phase 3 trial (VERSATILE-003) is currently enrolling patients, with a total of 351 patients expected to be accrued [5][6] - The VERSATILE-002 trial shows promising results, with a median follow-up of 18.4 months, indicating one of the longest follow-up periods for this patient population [6] Group 2: Presentation and Publication - Three abstracts summarizing Versamune HPV studies will be presented at the 2025 ASCO Annual Meeting, scheduled for May 30-June 3, 2025 [2][4] - The VERSATILE-002 trial results will be presented by Dr. Jared Weiss, while Dr. Katharine Price will present the ongoing VERSATILE-003 trial details [6] Group 3: Company Overview - PDS Biotechnology is focused on transforming cancer treatment through immunotherapy, particularly targeting HPV16-positive cancers [8] - The company is also developing a triple combination therapy that includes PDS01ADC, an IL-12 fused antibody drug conjugate, alongside standard immune checkpoint inhibitors [8]

Core Insights - New data from the INSIGHT study indicates that the VeriStrat Host Immune Classifier can predict overall survival in non-small cell lung cancer patients treated with immunotherapy [1][2] - The presentation of this data will occur at the 2025 ASCO Annual Meeting, highlighting the significance of the findings [1] Group 1: Study Findings - The VeriStrat test categorizes patients' immune responses as either Hot (VeriStrat Good) or Cold (VeriStrat Poor) [2] - Statistically significant improvement in overall survival was observed in patients with a VeriStrat Poor result when treated with immunotherapy combined with chemotherapy, compared to those receiving immunotherapy alone [2] - The two-year survival rate for patients receiving the combination treatment was over three times higher than for those on immunotherapy alone [2] Group 2: Clinical Implications - The VeriStrat test may assist oncologists in evaluating treatment benefits and risks, potentially guiding decisions on treatment escalation or de-escalation [3] - Preliminary results from another ongoing study suggest that the VeriStrat test may also be applicable for other solid tumors, with data expected to be published later in 2025 [3] Group 3: Company Overview - Biodesix is a leading diagnostic solutions company focused on improving clinical care and outcomes for patients, particularly in lung disease [4] - The company offers diagnostic tests such as Nodify Lung® Nodule Risk Assessment and IQLung™ Cancer Treatment Guidance to support personalized care [4]

Core Insights - The investigational drug shows promise in treating advanced cutaneous squamous cell carcinoma, with a patient experiencing no detectable cancer after 12 weeks of treatment [1][2][3] - The incidence of cutaneous squamous cell carcinoma has tripled over the past three decades, highlighting the growing burden of this disease [7] Company Insights - HonorHealth Research Institute is conducting a clinical trial for a new drug designed to activate in the tumor microenvironment, offering hope for patients with limited treatment options [1][4][5] - Werewolf Therapeutics is pioneering the development of therapeutics that stimulate the immune system, utilizing its proprietary PREDATOR® platform to create conditionally activated molecules [11] Industry Insights - Approximately 1 million Americans are diagnosed with cutaneous squamous cell carcinoma annually, with nearly 7,000 fatalities occurring when the disease becomes advanced or metastatic [6] - Current treatment options for advanced cases are limited, particularly for patients who do not respond to checkpoint inhibitors [6][9]

Financial Data and Key Metrics Changes - The company has a strong balance sheet with $17 million in cash, providing a runway of approximately 2.5 years, which is considered ample in the current industry context [6][9][13] - Historical cash burn averages between $5 million and $7 million per year, indicating a capital-efficient business model [8][15] Business Line Data and Key Metrics Changes - The company is advancing two lead clinical programs: a breast cancer vaccine and an ovarian cancer CAR T therapy, both currently in Phase 1 clinical trials with promising clinical data [3][16] - The breast cancer vaccine is funded by a U.S. Government grant, which helps keep cash burn low [17][34] Market Data and Key Metrics Changes - The breast cancer market is large and well-known, while the ovarian cancer market, though smaller, presents a significant unmet medical need with poor outcomes [5] - The company is targeting both neoadjuvant and primary prevention markets for its breast cancer vaccine, indicating a broad market strategy [40] Company Strategy and Development Direction - The company leverages partnerships with top-tier academic institutions like Moffitt Cancer Center and Cleveland Clinic to enhance its research capabilities without incurring high costs [4][10] - The strategy focuses on advancing clinical programs through early stages and partnering with pharmaceutical companies for later-stage development and commercialization [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical data being generated, particularly regarding the safety and efficacy of the ovarian cancer CAR T therapy, with encouraging survival rates observed in treated patients [27][28] - The company aims to present final data from the Phase 1 trial of the breast cancer vaccine at the San Antonio Breast Cancer Symposium in December, indicating a proactive approach to sharing results [39] Other Important Information - The company has maintained consistent insider buying over the years, reflecting management's confidence in the business [7] - There are no outstanding warrants, preferred stock, or debt, which positions the company favorably for future financing [13] Q&A Session Summary Question: What is the current status of the ovarian cancer CAR T therapy? - The therapy is in Phase 1 trials, with encouraging safety profiles and overall survival rates observed in treated patients [27][28] Question: How is the breast cancer vaccine funded? - The breast cancer vaccine is fully funded by a U.S. Government grant, which helps minimize cash burn [17][34] Question: What are the next steps for the breast cancer vaccine program? - The company plans to present final data from the Phase 1 trial at the San Antonio Breast Cancer Symposium in December and is preparing for a Phase 2 trial [39][40]