Core Viewpoint - BriaCell Therapeutics Corp. is presenting clinical data from its pivotal Phase 3 study of Bria-IMT™ for metastatic breast cancer, emphasizing the role of specific biomarkers in predicting patient responses to treatment [1][5]. Group 1: Clinical Data and Biomarkers - The Phase 3 study (BRIA-ABC) supports the use of biomarkers to predict clinical responses, potentially improving patient outcomes such as response rates and survival benefits [2][7]. - Early Phase 3 biomarker data indicates that positive delayed-type hypersensitivity (DTH) and a favorable Neutrophil-to-Lymphocyte Ratio (NLR) are linked to longer progression-free survival (PFS) [7][8]. - Kaplan Meier analysis of early clinical data (n=62) shows a median PFS of 3.67 months across all study arms [6]. Group 2: Treatment Efficacy and Safety - Positive DTH is associated with better PFS (4.5 months vs 2.5 months, p = 0.001), while specific NLR values correlate with lower median PFS [8]. - The Bria-IMT regimen has demonstrated a favorable safety profile, with no treatment discontinuations related to Bria-IMT, indicating excellent tolerability [9]. Group 3: Study Design and Future Prospects - The multicenter randomized open-label study compares the Bria-IMT regimen combined with a checkpoint inhibitor against physician's choice in advanced metastatic breast cancer patients [10]. - Interim data will be analyzed upon reaching 144 patient events, with positive results potentially leading to full approval and marketing authorization for Bria-IMT [11].

Financial Data and Key Metrics Changes - Total revenues for Q3 2020 were $1.1 billion, with year-to-date revenues of $1.6 billion [21] - Product sales reached $267 million in Q3, with year-to-date product sales of $706 million [21] - Collaboration revenues significantly increased to $758 million in Q3, compared to $18 million in the same period of 2019 [22] - The company ended Q3 with $1.7 billion in cash and investments, bolstered by $725 million in upfront payments from Merck [25][26] Business Line Data and Key Metrics Changes - ADCETRIS sales were $163 million in Q3, a 3% decrease from Q3 2019, attributed to the pandemic's impact on new diagnoses [16][18] - PADCEV sales were $62 million in Q3, an 8% increase over Q2 2020, indicating strong adoption in both academic and community settings [19] - TUKYSA generated $42 million in net product revenues in its first full quarter since launch, with strong adoption and reimbursement coverage exceeding expectations [20] Market Data and Key Metrics Changes - The pandemic has led to a 15% decrease in new Hodgkin lymphoma diagnoses, impacting ADCETRIS sales [16][18] - The company is seeing a shift in site of care that negatively affected gross to net pricing for ADCETRIS [17] - The collaboration with Merck is expected to enhance global reach and patient access for TUKYSA and LV [10] Company Strategy and Development Direction - The company aims to invest in clinical development for ADCETRIS, PADCEV, and TUKYSA, while advancing late-stage pipeline products [12] - Strategic collaborations with Merck are focused on co-developing LV and TUKYSA, enhancing the company's market position [10][12] - The company plans to continue expanding its international infrastructure to support TUKYSA's launch in Europe [9] Management's Comments on Operating Environment and Future Outlook - Management expressed concern over the long-term impact of COVID-19 on cancer patient diagnoses and treatment [48][49] - The company remains optimistic about maintaining market share despite the pandemic's challenges [49] - Future guidance for ADCETRIS has been adjusted to $650 million to $660 million due to fewer new patient diagnoses [26] Other Important Information - The company is pursuing legal action against Daichi Sankyo for patent infringement related to a breast cancer drug [13] - Upcoming R&D Day is scheduled for November 16, where the company will discuss its pipeline and development activities [12] Q&A Session Summary Question: Can you comment on ADCETRIS market dynamics and diagnosis rates? - Management noted that product sales have increased year-over-year, but the pandemic has led to fewer patients starting treatment, which is concerning for future diagnoses [48][49] Question: What is the outlook for PADCEV's growth? - Management indicated that the launch has been strong, and while there may be a slight slowdown in growth, they are maintaining guidance and expect significant developments ahead [54][56] Question: Can you provide details on TUKYSA's launch and adoption hurdles? - The company reported strong uptake in both community and academic settings, with ongoing efforts to enhance awareness and access despite COVID-19 challenges [72][73] Question: How does the cash influx from Merck affect capital allocation? - Management emphasized that the priority is to drive existing products into blockbuster status while exploring new drug opportunities and maintaining innovation [89][92]

Core Insights - Medicenna Therapeutics Corp. presented updated clinical data for MDNA11, a long-acting IL-2 super-agonist, at the 2025 AACR Annual Meeting, highlighting its potential in treating advanced solid tumors, particularly in patients resistant to immune checkpoint inhibitors [1][2][10] Clinical Activity - Ten patients achieved an objective response (5 confirmed) with MDNA11 alone or in combination with KEYTRUDA, showing an objective response rate (ORR) of 36% (5 of 14) in all tumor types and 31% (4 of 13) in cancers planned for the Phase 2 combination expansion cohort [1][5] - In the monotherapy dose expansion, patients treated at ≥ 60 µg/kg had an ORR of 29.4% (5 of 17) across all tumor types and 40% (4 of 10) in the Phase 2 monotherapy expansion cohort [1][7] - The highest ORR of 50% was observed among MSI-H patients receiving MDNA11 monotherapy and endometrial cancer patients receiving the combination treatment [1][6] Safety Profile - MDNA11 demonstrated an acceptable safety profile, with over 90% of treatment-related adverse events being Grade 1-2 and transient, and no dose-limiting toxicities observed at doses up to 120 µg/kg [3][5] Immunodynamics - The study showed robust expansion of immune effector cells in both monotherapy and combination settings, with notable increases in critical T cell populations necessary for sustained anti-tumor responses [6][9] Future Directions - Enrollment in the Phase 2 combination dose expansion arm is ongoing, with the recommended dose for expansion established at 90 µg/kg every 2 weeks alongside KEYTRUDA [1][10] - Additional clinical data from the ABILITY-1 study is expected to be shared at future medical conferences throughout the year [2][8]

Core Insights - Compass Therapeutics, Inc. presented promising preclinical data on CTX-471, a CD137 agonist antibody, at the AACR Annual Meeting, indicating enhanced efficacy in models of immune checkpoint failure through simultaneous blockade of neo-angiogenesis [1][2][3] Company Overview - Compass Therapeutics is a clinical-stage biopharmaceutical company focused on developing proprietary antibody-based therapeutics for oncology, with a scientific emphasis on the interplay between angiogenesis, the immune system, and tumor growth [10] Product Development - CTX-471 is currently in a Phase 1b clinical trial for patients with solid tumors that have progressed after at least three months on approved PD-1 or PD-L1 inhibitors, showing partial responses in melanoma, small cell lung cancer, and mesothelioma [5] - The combination of CTX-471 with tovecimig has demonstrated significant anti-tumor efficacy in murine models resistant to conventional immune checkpoint inhibitors, suggesting a potential therapeutic regimen for patients who have failed checkpoint inhibitors [7][9] Mechanism of Action - The combination therapy appears to enhance innate and adaptive anti-tumor immunity, including increased tumor cell killing and interferon signaling, which may provide clinical benefits for patients previously unresponsive to standard treatments [3][7] Ongoing Trials - The ongoing COMPANION-002 trial is evaluating the efficacy of tovecimig in combination with paclitaxel for patients with previously treated, unresectable advanced metastatic or recurrent biliary tract cancers [9]

Core Insights - BriaCell Therapeutics Corp. is presenting positive data from its Phase 2 study of Bria-IMT™ in metastatic breast cancer and its preclinical Bria-OTS+ platform at the 2025 AACR Annual Meeting [1][2] - The company reports that Bria-IMT shows impressive survival and clinical efficacy in heavily treated patients who have failed multiple prior treatments [2][3] - The Phase 3 formulation of Bria-IMT has demonstrated a clinical benefit rate of 83% in evaluable patients [5][6] Phase 2 Study Findings - The Phase 2 study involved 54 metastatic breast cancer patients, with 37 receiving the Bria-IMT formulation currently used in the ongoing pivotal Phase 3 study [3] - Patients had a median of 6 prior treatments, including Antibody-Drug Conjugates (ADCs) and checkpoint inhibitors (CPIs) [3] - Overall survival (OS) for HR+ patients was reported at 17.3 months, while for triple-negative breast cancer (TNBC) patients, it was 11.44 months [6] Bria-OTS+ Platform - Bria-OTS+ is an enhanced immunotherapy platform that expresses multiple immune-activating cytokines and co-stimulatory molecules [8] - The platform aims to induce powerful and long-lasting immune activity against cancer [4][8] - The company anticipates that additional immune-activating factors will enhance the efficacy of the Bria-OTS+ platform [7] Future Developments - Phase 3 early biomarker data will be presented as a late-breaking abstract on April 30, 2025 [1][5] - The company plans to investigate Bria-BRES+ for breast cancer and Bria-PROS+ for prostate cancer in upcoming Phase 1/2a clinical studies [8]

Group 1: Core Insights - Portage Biotech Inc. reports confirmatory preclinical efficacy data for PORT-7, a selective adenosine A2B receptor inhibitor, demonstrating superior single-agent activity compared to anti-PD1 antibody in a murine mesothelioma model [1] - The combination of PORT-7 and anti-PD1 showed enhanced efficacy over either agent alone, indicating a favorable immune response with increased immune effector cells and the formation of tertiary lymphoid structures [1] - Portage is preparing to initiate a first-in-human clinical trial for PORT-7, addressing the need for novel treatments in aggressive mesothelioma [1] Group 2: Ongoing Developments - Portage is advancing the dose escalation of PORT-6, a selective A2A adenosine receptor inhibitor, with plans to co-administer it with PORT-7 in the ADPORT-601 trial [2] - This combination aims to achieve complete blockade of adenosine-induced immunosuppression in the tumor microenvironment, enhancing anti-tumor responses and broadening the impact of immunotherapy in solid tumors [2] Group 3: Company Overview - Portage Biotech is a clinical-stage immuno-oncology company focused on advancing a pipeline of novel biologics to enhance the immune system's ability to combat cancer [3]

Core Insights - BDC-3042 demonstrated a favorable safety profile and biological activity in a Phase 1 clinical study, with no dose-limiting toxicities or serious adverse events reported [1][4][5] - The drug showed signs of anti-tumor activity, particularly in non-small cell lung cancer (NSCLC) patients, with 80% of evaluable patients achieving stable disease or better [1][4] - Bolt Biotherapeutics is seeking a partnership to accelerate the development and commercialization of BDC-3042, highlighting its significant commercial potential [2][6] Clinical Study Findings - The Phase 1 study enrolled 17 patients across seven dose cohorts, with a median of four prior lines of therapy [3] - The recommended Phase 2 dose (RP2D) was established at 10 mg/kg every two weeks, with further exploration of other doses and schedules planned [3] - Evidence of target engagement was confirmed, with 100% of patient samples showing detectable dectin-2 staining [4] Safety and Efficacy - BDC-3042 was well tolerated, with no grade 4 or 5 drug-related adverse events reported [4] - The most common drug-related adverse events included fatigue, flatulence, and nausea, each occurring in 12% of patients [4] - The study indicated that patients previously treated with PD-(L)1 inhibitors may have improved outcomes due to higher dectin-2 expression [3][5] Company Overview - Bolt Biotherapeutics is focused on developing novel immunotherapies for cancer treatment, with BDC-3042 being a first-in-class agonist antibody targeting dectin-2 [6] - The company is also advancing BDC-4182, a next-generation immune-stimulating antibody conjugate, with clinical trials expected to begin in the second quarter of 2025 [6]

Core Insights - CERo Therapeutics Holdings, Inc. is presenting a poster at the ASCO 2025 Annual Meeting, showcasing its innovative approach to engineered T cell therapeutics targeting cancer [1][2] - The poster details a first-in-human study of CER-1236, an autologous chimeric engulfment receptor T-cell therapy aimed at treating acute myeloid leukemia [2] - The study is a multi-center, open-label, Phase 1/1b trial focusing on safety and preliminary efficacy, with primary outcome measures including adverse events and overall response rates [2] Company Overview - CERo is focused on developing next-generation engineered T-cell therapeutics that integrate characteristics of both innate and adaptive immunity [3] - The company’s proprietary technology aims to redirect patient-derived T cells to eliminate tumors through phagocytic mechanisms, creating Chimeric Engulfment Receptor T cells (CER-T) [3] - CERo believes that CER-T cells will have broader therapeutic applications compared to current CAR-T therapies, potentially addressing both hematological malignancies and solid tumors [3]

Core Insights - AbbVie reported strong first-quarter results for 2025, exceeding expectations and indicating a solid start to the year, with a focus on pipeline advancements and strategic investments [2][3] Financial Performance - First-quarter diluted EPS was $0.72 on a GAAP basis, a decrease of 6.5%, while adjusted diluted EPS was $2.46, an increase of 6.5% [3][19] - Net revenues for the first quarter reached $13.343 billion, an increase of 8.4% on a reported basis and 9.8% on an operational basis [3][4] - The immunology portfolio generated global net revenues of $6.264 billion, up 16.6% on a reported basis and 18.1% operationally [3][4] - Skyrizi net revenues were $3.425 billion, reflecting a 70.5% increase on a reported basis, while Rinvoq net revenues were $1.718 billion, up 57.2% [4][19] - Humira net revenues decreased by 50.6% to $1.121 billion [4][19] - Neuroscience portfolio revenues were $2.282 billion, an increase of 16.1% [4][19] - Oncology portfolio revenues reached $1.633 billion, up 5.8% [4][19] - Aesthetics portfolio revenues were $1.102 billion, a decrease of 11.7% [4][19] Guidance and Outlook - AbbVie raised its 2025 adjusted diluted EPS guidance from $11.99 - $12.19 to $12.09 - $12.29, accounting for an unfavorable impact of $0.13 per share related to acquired IPR&D and milestones expense [3][9] Recent Developments - The European Commission granted marketing authorization to Rinvoq for treating giant cell arteritis in adults, marking the eighth approved indication for the drug in the EU [7] - AbbVie announced a collaboration with Xilio Therapeutics to develop novel immunotherapies for cancer [7] - A Biologics License Application was submitted to the FDA for trenibotulinumtoxinE for treating moderate to severe glabellar lines, which could be the first neurotoxin of its kind available [7][8]

Core Insights - BriaCell Therapeutics Corp. has confirmed the complete resolution of lung metastasis in a patient with metastatic breast cancer after treatment with its Bria-OTS immunotherapy, marking a significant milestone in the ongoing Phase 1/2a study [1][6][8] Group 1: Treatment Efficacy - The Bria-OTS monotherapy resulted in a 100% resolution of lung tumors in a 78-year-old female patient after two months of therapy, with confirmation of this resolution at the four-month follow-up [2][5] - The patient had extensive metastases prior to treatment and showed stable disease in other areas after receiving Bria-OTS injections [5][6] - The treatment was well-tolerated, and the patient remains in the study with stable disease elsewhere [6][8] Group 2: Study Details - Bria-OTS is currently being investigated in a Phase 1/2a dose escalation study for metastatic recurrent breast cancer, with a focus on safety and efficacy as a monotherapy [9] - This study represents a next-generation advancement of BriaCell's lead candidate, Bria-IMT™, which is in a pivotal Phase 3 study for metastatic breast cancer [9] Group 3: Industry Context - The results from the Bria-OTS study are particularly significant given the limited treatment options available for patients with hormone receptor-positive metastatic breast cancer, despite advancements in antibody-drug conjugates and immune checkpoint inhibitors [8] - The initial data from the Bria-OTS study demonstrates promising anti-tumor activity, providing early validation for BriaCell's personalized immunotherapy approach [8][9]