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]

Core Insights - The Phase 1 APOLLO study by Marker Therapeutics shows that lymphodepletion enhances the expansion and persistence of MAR-T cells, potentially improving anti-tumor activity [1][4][5] - The study is focused on MT-601, a MAR-T cell product for patients with lymphoma who have relapsed after or are not candidates for anti-CD19 CAR-T cell therapy [2][9] - The company has reported a significant increase in patient enrollment, surpassing the total from the previous year within the first five months of 2025 [5][7] Company Overview - Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company based in Houston, TX, specializing in T cell-based immunotherapies for hematological malignancies and solid tumors [11] - The company was founded at Baylor College of Medicine and has conducted clinical trials involving over 200 patients, demonstrating well-tolerated and durable clinical responses [11] Study Details - The APOLLO trial is a multicenter, open-label study evaluating the safety and efficacy of MT-601 in participants with relapsed or refractory lymphoma [9] - The primary objective is to assess the optimum dose, safety, and preliminary efficacy of MT-601, with an expected enrollment of approximately 30 participants across nine clinical sites in the U.S. [9] Clinical Data - In the APOLLO study, MT-601 was well tolerated with no dose-limiting toxicities reported, achieving objective responses in 7 out of 9 patients (78%), including 4 complete responses (44.4%) [2][4] - Preliminary data indicates that lymphodepletion supports the expansion and persistence of MT-601 in vivo, with higher levels observed in patients undergoing lymphodepletion compared to those who did not [3][4] Future Outlook - The company anticipates sharing more meaningful clinical data by the end of summer 2025, driven by the increased pace of patient enrollment and positive early clinical results [5][7]

Core Viewpoint - PDS Biotechnology Corporation is participating in the A.G.P. Virtual Annual Healthcare Company Showcase, highlighting its focus on immunotherapy for cancer treatment [1][2]. Company Overview - PDS Biotechnology is a late-stage immunotherapy company dedicated to transforming the immune system's ability to target and eliminate cancers [3]. - The company has initiated a pivotal clinical trial for its lead program, which targets advanced HPV16-positive head and neck squamous cell cancers [3]. - The lead investigational therapy, Versamune HPV, is being developed in combination with a standard immune checkpoint inhibitor and in a triple combination with PDS01ADC, an IL-12 fused antibody drug conjugate [3]. Event Details - The A.G.P. Virtual Annual Healthcare Company Showcase is scheduled for May 21, 2025, with a fireside chat featuring the CEO of PDS Biotech from 5:20 to 5:40 p.m. ET [2]. - An archived replay and transcript of the fireside chat will be available on the company's Investor Relations website following the event [2].

Core Insights - BriaCell Therapeutics Corp. has achieved significant milestones in its clinical studies, particularly in the Bria-IMT™ Phase 3 study and the Bria-OTS™ Phase 1/2 study, indicating potential transformative impacts on cancer treatment [1][4][5] Bria-IMT Pivotal Phase 3 Clinical Study - Bria-IMT™ is a targeted cell-based immunotherapy for metastatic breast cancer, currently being tested in combination with an immune checkpoint inhibitor [2] - Over 75 patients have been enrolled across 54 clinical sites in 15 states, including notable cancer centers [3] - Positive recommendations from the Data Safety Monitoring Board (DSMB) have been received, and successful completion of the study could lead to a fast-track application for drug approval [3][6] Bria-IMT Phase 2 Clinical Study - The Phase 2 study has shown survival data superior to the standard of care, with 83% of evaluable patients benefiting from the treatment [5][6] - The average survival for this patient population is under one year, highlighting the urgent need for effective therapies [6] Bria-OTS Phase 1/2 Clinical Study - Bria-OTS is a personalized immunotherapy platform that matches patients' human leukocyte antigens (HLA) to optimize treatment response [8] - A notable case reported 100% resolution of lung metastasis in a patient after two months of Bria-OTS monotherapy [9][10] Financing and Future Outlook - The company raised US$13.8 million through a public offering to support clinical programs and business advancement [13] - The company anticipates sharing further advancements in its clinical programs in the coming months [13][14]