Core Viewpoint - Innate Pharma SA has announced its financial calendar for 2026, detailing key dates for financial statements and shareholder meetings [1] Financial Calendar Summary - March 26, 2026: Publication of 2025 financial statements [1] - May 13, 2026: Publication of revenue and cash position for Q1 2026 [1] - May 21, 2026: Annual General Shareholders Meeting [1] - September 17, 2026: Publication of half-year financial statements [1] - November 5, 2026: Publication of revenue and cash position for Q3 2026 [1]

Exelixis 2025 R&D Day Summary Company Overview - **Company**: Exelixis (NasdaqGS:EXEL) - **Focus**: Oncology, specifically solid tumor oncology Key Themes and Strategic Focus - **Multi-Compound, Multi-Franchise Strategy**: Exelixis aims to build a diverse pipeline of oncology products rather than focusing on single indications [4][5] - **Franchise Approach**: The company is prioritizing the development of franchise molecules and indications to enhance its market position and revenue potential [5][10] - **Patient-Centric Goals**: The overarching goal is to improve the standard of care for cancer patients, thereby benefiting both patients and shareholders [6][10] Financial Projections and Growth - **CABO Franchise Growth**: Projected cumulative growth of over 30% in CABO product revenues from 2023 to 2025, driven by new indications in the MET space [7] - **Zanza Development**: Zanza is positioned as a key molecule for future growth, with positive results from pivotal trials and an FDA filing based on the STELLAR-303 trial [8][9] Pipeline and Product Development - **Early-Stage Pipeline**: The pipeline includes three IND candidates (XB010, XB628, XB371) and new molecules like XB773 and XL557, which are advancing towards IND status [9] - **Focus Areas**: The company is concentrating on kidney cancer, neuroendocrine tumors, and colorectal cancer as primary targets for its pipeline [14] Clinical Trials and Research - **Ongoing Trials**: Exelixis has multiple ongoing or planned pivotal trials, including STELLAR-304 for non-clear cell renal cell carcinoma (RCC) and LITESPARK-033 for patients progressing after adjuvant Pembrolizumab [35][49] - **Zanza's Mechanism of Action**: Zanza is designed to target multiple pathways (MET, TAM kinases, VEGF) to combat resistance and improve patient outcomes [30][32] Unmet Medical Needs - **Non-Clear Cell RCC**: There is a significant unmet need in treating non-clear cell RCC, which has historically been underrepresented in clinical trials [20][24] - **Adjuvant Treatment Gaps**: The introduction of Pembrolizumab in the adjuvant setting has created a new patient population with unmet needs, which Exelixis aims to address with Zanza and HIF-2 inhibitors [49] Collaboration and Partnerships - **Expert Collaborations**: Exelixis collaborates with leading oncologists and institutions to enhance its research and development efforts, ensuring a strong focus on patient outcomes [60] Conclusion - **Commitment to Oncology**: Exelixis emphasizes its long-term commitment to advancing treatment options in oncology, particularly in renal cell carcinoma, with a focus on innovative therapies and patient care [61]

Core Viewpoint - The treatment landscape for advanced non-small cell lung cancer (NSCLC) is shifting towards a new class of therapies, specifically telomere-targeting agents, to address the unmet medical needs of patients without actionable mutations and those who are resistant to current therapies [1][4]. Industry Overview - Checkpoint inhibitors (CPIs) dominate the NSCLC treatment market, generating approximately $50 billion in global sales in 2024, with Merck's Keytruda accounting for $29.5 billion of that revenue [3][9]. - The NSCLC market is projected to grow from $34.1 billion to nearly $68.8 billion by 2033, indicating significant commercial opportunities for new therapies [7]. Company Insights - MAIA Biotechnology's ateganosine is positioned as a first-in-class telomere-targeting agent, designed to exploit telomerase activity found in over 80% of human tumors, offering a novel mechanism of action [5][12]. - The U.S. FDA has granted Fast Track Designation to ateganosine for treating NSCLC patients resistant to immunotherapy and chemotherapy, and a Phase 3 trial is set to begin [6]. Market Dynamics - The oncology market is expected to reward innovative therapies that fill existing treatment gaps, particularly in advanced NSCLC, which represents a significant unmet need [8][11]. - A significant portion of CPI sales, over 40%, is derived from NSCLC, highlighting the importance of this segment in the overall oncology market [9].

Summary of Medicenna Therapeutics Update - December 10, 2025 Company Overview - **Company**: Medicenna Therapeutics (OTCPK:MDNA.F) - **Focus**: Clinical stage immunotherapy company developing next-generation superkines, specifically engineered cytokines to treat serious cancers [3][5] Key Industry Insights - **Clinical Study**: ABILITY-1 study evaluating MDNA-11, a next-generation IL-2 superagonist, both as a monotherapy and in combination with pembrolizumab (Keytruda) [2][10] - **Target Indications**: Advanced refractory solid tumors, including cutaneous melanoma, MSI-high tumors, and other difficult-to-treat cancers [10][12] Core Findings and Data Clinical Data Highlights - **Safety Profile**: MDNA-11 demonstrated a manageable safety profile with over 90% of treatment-related adverse events being grade one or two, typically resolving within 48 hours [13][14] - **Efficacy**: - Objective response rate (ORR) of approximately 38% in secondary immune checkpoint inhibitor-resistant cutaneous melanoma [17] - In patients treated immediately after progression on checkpoint inhibitors, ORR was 42% with a disease control rate (DCR) of 83% [17] - Notable individual cases included a patient with MSI-high pancreatic cancer in remission for over 21 months and a cutaneous melanoma patient with over seven months of remission [16][32] Mechanistic Insights - **Mechanism of Action**: MDNA-11 is designed to preferentially activate CD8 T cells and NK cells while minimizing toxic immune overreactions associated with conventional IL-2 therapies [5][6] - **Pharmacodynamics**: Robust expansion of effector CD8 T cells and stem-like CD8 T cells observed, supporting the intended mechanism of action [26] Survival Data - **Overall Survival**: Patients achieving disease control had a median overall survival of approximately 120 weeks compared to 29 weeks for those without disease control [23][24] Strategic Development Plans - **Next Steps**: Continue enrollment in phase two eligible expansion cohorts and expand sample sizes in tumor types showing clinical efficacy [27][66] - **NeoCyte Study**: Collaboration to evaluate MDNA-11 in a neoadjuvant therapy context for high-risk resectable melanoma [27] Expert Opinions - **KOL Insights**: Experts highlighted MDNA-11's potential as a best-in-class IL-2 variant, particularly in refractory settings and its promising safety profile compared to historical IL-2 therapies [36][40] - **Combination Strategies**: Interest in combining MDNA-11 with existing checkpoint inhibitors like nivolumab and ipilimumab for enhanced efficacy [38][47] Additional Considerations - **Market Positioning**: MDNA-11 is positioned to address significant unmet medical needs in refractory cancer populations, particularly in melanoma and MSI-high tumors [30][34] - **Future Directions**: Potential for MDNA-11 to replace traditional IL-2 therapies in various treatment settings, including earlier lines of therapy as data matures [48][55] This summary encapsulates the critical insights and data presented during the Medicenna Therapeutics update, focusing on the company's innovative approach to cancer treatment and the promising results from the ABILITY-1 study.

Core Insights - Kazia Therapeutics announced promising data from the 2025 San Antonio Breast Cancer Symposium, highlighting the efficacy of paxalisib in treating HER2-positive metastatic breast cancer and triple-negative breast cancer (TNBC) [1][2]. Group 1: Clinical Findings - The first patient in the TNBC Phase 1b trial showed a 76% reduction in tumor volume and significant decreases in circulating tumor cells (CTC) and clusters [1]. - Paxalisib demonstrated a 42% reduction in single CTCs and a 78% reduction in CTC clusters, including large clusters associated with metastatic progression [6]. - Early biomarker data indicated that paxalisib has measurable biological activity after just one treatment cycle [5]. Group 2: Mechanistic Insights - Paxalisib disrupts aggressive CTC clusters and reverses resistance pathways, enhancing immune response by revitalizing exhausted T- and B-cell populations [2][8]. - The drug targets mesenchymal, metastatic, and epigenetically resistant CTC clusters, which are key drivers of metastasis [11]. - There is evidence of epigenetic reprogramming of CTCs towards less aggressive phenotypes, confirmed through digital pathology [7]. Group 3: Broader Implications - The findings suggest that paxalisib's effects are relevant across multiple breast cancer subtypes, not just TNBC, indicating a potential for broader therapeutic applications [9]. - Kazia's research points to a unifying biology across breast cancer subtypes, suggesting that paxalisib could address unmet needs in current treatment paradigms [9]. - The company is exploring combination therapies with pembrolizumab and PARP inhibitors, which may enhance treatment efficacy in various breast cancer contexts [12].

Core Insights - BriaCell Therapeutics Corp. presented positive Phase 2 survival and Phase 3 biomarker data at the 2025 San Antonio Breast Cancer Symposium, highlighting the potential of its Bria-IMT regimen in treating metastatic breast cancer [1][6]. Group 1: Clinical Data and Findings - The Bria-IMT regimen shows promise in addressing unmet needs in metastatic breast cancer treatment, particularly for patients with CNS metastasis who have undergone a median of 6 prior treatments [2][6]. - The Phase 3 study involves a randomized trial comparing Bria-IMT plus immune checkpoint inhibitors, Bria-IMT monotherapy, and Treatment of Physician's Choice, with a pooled interim analysis of 116 patients [4][6]. - The regimen demonstrated a favorable safety profile with no treatment-related discontinuations due to adverse events, and the most common adverse events were low grade [7]. Group 2: Biomarkers and Predictive Indicators - Biomarkers such as the Neutrophil-to-Lymphocyte Ratio (NLR) have shown potential as predictors of clinical benefit, with favorable NLR values correlating with longer progression-free survival (PFS) [7][8]. - Positive Delayed Type Hypersensitivity (DTH) was identified as a key predictor of clinical benefit, with median overall survival significantly higher in DTH+ patients compared to DTH- patients [10][11]. - Th1-biased cytokines and chemokines may serve as potential predictive biomarkers for clinical responses to the Bria-IMT regimen, indicating enhanced immune activation [14][16]. Group 3: Future Directions - Further evaluation of cytokine and chemokine biomarkers is planned to establish more personalized therapeutic strategies for metastatic breast cancer patients with limited treatment options [3][8]. - Ongoing analysis of the Phase 3 study aims to mature the understanding of overall survival data and the role of biomarkers in predicting patient response [11][12].

Core Insights - MDNA11 demonstrates durable anti-tumor activity in difficult-to-treat populations, exceeding objective response rate (ORR) benchmarks in immune checkpoint resistant melanoma, MSS endometrial cancer, MSI-H, and TMB-H cancers [1] - The monotherapy expansion cohorts show an ORR of 42% and a disease control rate (DCR) of 83% for patients treated with MDNA11 after progression on immune checkpoint inhibitors [1] - Combination therapy with KEYTRUDA shows an ORR of 50% and a DCR of 75% in MSS endometrial cancer, while MSS TMB-H tumors show an ORR of 25% and a DCR of 88% [1] Clinical Data - In monotherapy cohorts, ORR is 38% in melanoma and 22% in MSI-H tumors, with corresponding DCRs of 75% and 78% respectively [1] - Patients with disease control in monotherapy cohorts had a median overall survival (mOS) of 120.2 weeks compared to 28.6 weeks for those without disease control [7] - In combination cohorts, patients with disease control had a median OS that was not yet reached, compared to 26 weeks for those without disease control [10] Safety Profile - MDNA11 shows a manageable safety profile, with over 90% of treatment-related adverse events being Grade 1-2 and transient, resolving typically within 48 hours [4] - No dose-limiting toxicities were observed at doses up to 120 µg/kg in monotherapy or in combination with KEYTRUDA [4] Recommended Dose - The preliminary recommended dose for expansion for both monotherapy and combination arms is established at 90 µg/kg Q2W, with a biological effective dose range set at 60 to 120 µg/kg [5] Future Developments - Medicenna plans to share new and mature data from the ABILITY-1 study and additional studies in the coming weeks and months [3]

Core Insights - MDNA11 demonstrates durable anti-tumor activity in difficult-to-treat populations, exceeding objective response rate (ORR) benchmarks in immune checkpoint resistant melanoma, MSS endometrial cancer, MSI-H, and TMB-H cancers [1] - The monotherapy expansion cohorts show an ORR of 42% and a disease control rate (DCR) of 83%, indicating the potential of MDNA11 in earlier lines of treatment [1] - Combination treatment with KEYTRUDA shows promising results, with an ORR of 50% and a DCR of 75% in MSS endometrial cancer [1][9] Clinical Data - In monotherapy expansion cohorts, ORRs are 38% in melanoma and 22% in MSI-H tumors, with corresponding DCRs of 75% and 78% respectively [1] - Patients treated with MDNA11 as the next treatment after immune checkpoint inhibitors had an ORR of 42% [8] - In MSS endometrial cancers, the ORR was 50% with a DCR of 75%, while TMB-H tumors showed an ORR of 25% and a DCR of 88% [9] Safety Profile - MDNA11 exhibits a manageable safety profile, with over 90% of treatment-related adverse events being Grade 1-2 and transient [4] - No dose-limiting toxicities were observed at doses up to 120 µg/kg, and Grade 3-4 events were mainly laboratory abnormalities without clinical sequelae [4] Overall Survival - In monotherapy cohorts, patients with disease control had a median overall survival (mOS) of 120.2 weeks compared to 28.6 weeks for those without disease control [7] - In combination cohorts, patients with disease control had a median OS that was not yet reached, compared to 26 weeks for those without disease control [10] Future Developments - Medicenna plans to share new and mature data from the ABILITY-1 study and additional studies in the coming weeks and months [3] - The NEO-CYT trial provides external validation of MDNA11's approach, suggesting its potential as a de-risked drug candidate for earlier stage cancer patients [3]

Core Insights - BriaCell Therapeutics Corp. presented positive Phase 2 survival and Phase 3 biomarker data at the 2025 San Antonio Breast Cancer Symposium, highlighting the potential of its Bria-IMT regimen in treating metastatic breast cancer [1][6]. Group 1: Clinical Data and Findings - The Bria-IMT regimen shows promise in addressing unmet needs in metastatic breast cancer treatment, particularly for patients with CNS metastasis who have undergone a median of 6 prior treatments [2][6]. - The Phase 3 study involves a randomized trial comparing Bria-IMT plus immune checkpoint inhibitors, Bria-IMT monotherapy, and Treatment of Physician's Choice, with a focus on safety, biomarker correlations, and progression-free survival (PFS) [4][6]. - The regimen demonstrated a favorable safety profile with no treatment-related discontinuations due to adverse events, and the most common adverse events were low grade [7]. Group 2: Biomarker Insights - Neutrophil-to-Lymphocyte Ratio (NLR) emerged as a potential predictive biomarker, with patients showing favorable NLR (0.7 – 2.3) experiencing longer PFS (4.4 months) compared to those with NLR <0.7 or >2.3 (2.6 months) [7][8]. - Positive Delayed Type Hypersensitivity (DTH) was identified as a key predictor of clinical benefit, with median overall survival significantly higher in DTH+ patients (11.3 months) compared to DTH- patients (4.7 months) [10][11]. - Th1-biased cytokines and chemokines may serve as potential predictive biomarkers for clinical responses to the Bria-IMT regimen, indicating enhanced T-cell activation and pro-inflammatory signaling [16][14]. Group 3: Future Directions - Further evaluation of cytokine and chemokine biomarkers is planned to establish more personalized therapeutic strategies for metastatic breast cancer patients with limited treatment options [3][11]. - Ongoing analysis will continue as enrollment progresses and overall survival data matures, reinforcing the potential clinical benefits of the Bria-IMT regimen [8][11].

Core Insights - Medicenna Therapeutics Corp. is hosting a live webinar on December 10, 2025, at 08:30 AM Eastern Time to discuss updated clinical data from the ABILITY-1 Phase 1/2 Study evaluating MDNA11 [1][2] Company Overview - Medicenna is a clinical-stage immunotherapy company focused on developing Superkines for cancer and autoimmune diseases, with a particular emphasis on long-acting IL-2 Superkine, MDNA11, which has superior affinity toward CD122 and preferentially stimulates cancer-killing T cells and NK cells [5] - The company is also developing MDNA113, a bispecific targeting PD-1 and IL-2 for solid tumors, utilizing proprietary BiSKITs™ and T-MASK™ platforms [5] - Bizaxofusp, an IL-4 Empowered Superkine, has been studied in five clinical trials with over 130 patients and has received FastTrack and Orphan Drug status from the FDA and EMA [5] Webinar Details - The webinar will feature presentations from Medicenna's executive and scientific advisory team, including Dr. Fahar Merchant, Dr. Arash Yavari, and Dr. André Mansinho, along with commentary from key opinion leaders and a live Q&A session [4][9]