Eli Lilly’s market capitalisation hit the $1tn mark in the past week, becoming the first healthcare company in the world to join the exclusive club dominated by technology companies. Buoyed by unprecedented demand for its weight loss drugs, the US drugmaker hit the trillion-dollar mark for the total value of its shares on 21 November. Share price in Lilly closed at $1,059.70 on 21 November, reflecting a 27% increase since January 2025. By trading at market open 24 November, share prices retreated slightl ...

Core Viewpoint - PDS Biotechnology Corporation has completed the VERSATILE-002 Phase 2 trial for PDS0101 in combination with pembrolizumab, showing promising results that lead the company to seek an expedited approval pathway in the ongoing VERSATILE-003 Phase 3 trial [1][2][3]. Clinical Update - The VERSATILE-002 trial demonstrated a median overall survival (mOS) of 39.3 months for patients with CPS ≥ 1, with a 95% confidence interval lower limit of 23.9 months [4]. - Progression-free survival (PFS) was reported at 6.3 months for the same patient group [4]. - The company plans to amend the ongoing VERSATILE-003 trial to potentially reduce its size while maintaining statistical power, with mOS remaining the primary endpoint for full FDA approval [4][3]. Financial Results - For Q3 2025, the company reported a net loss of $9.0 million, or $0.19 per share, a decrease from a net loss of $10.7 million, or $0.29 per share, in Q3 2024 [5][16]. - Research and development expenses were $4.6 million, down from $6.8 million in the same quarter of the previous year, attributed to lower manufacturing and clinical expenses [6][16]. - General and administrative expenses increased to $3.6 million from $3.4 million year-over-year, primarily due to higher professional fees [7][16]. Cash Position - As of September 30, 2025, the company's cash balance was $26.2 million, a decrease from $41.7 million as of December 31, 2024 [8][15]. - The company raised approximately $5.3 million by selling 5,800,000 shares and accompanying warrants on November 12, 2025 [9]. Additional Clinical Developments - The National Cancer Institute presented new clinical data at the 2025 Society for Immunotherapy of Cancer Annual Meeting, highlighting the immunological properties of PDS0101 and PDS01ADC [4]. - Preliminary results from the colorectal cancer cohort of the Phase 2 clinical trial with PDS01ADC met the criteria for expansion to Stage 2, confirming at least 6 of 9 objective responses [4].

Core Insights - AIM ImmunoTech Inc. presented data from a Phase 2 clinical study on Ampligen for advanced recurrent ovarian cancer, showing promising results at the 40th Annual SITC Meeting [1][2] Study Results - The study involved 27 platinum-sensitive patients, with 24 evaluable for response; 5 achieved complete response and 7 had partial response, resulting in an Objective Response Rate (ORR) of 50% [2] - This ORR is significantly higher compared to previous studies, such as Keynote-100, which reported ORRs of 7.4% and 9.9% for pembrolizumab alone [2] Mechanism and Potential - AIM believes that Ampligen can act synergistically with checkpoint inhibitors, potentially benefiting patients who do not respond to these therapies alone [3] - The study's findings suggest that Ampligen may enhance traditional cancer treatments, improving immune responses and prolonging remission for patients with limited options [4] Intellectual Property - AIM holds several patents related to the use of Ampligen in combination with checkpoint inhibitors, with expiration dates ranging from 2039 to 2040 in various jurisdictions [5] Company Overview - AIM ImmunoTech Inc. focuses on developing therapeutics for cancers, immune disorders, and viral diseases, with Ampligen as its lead investigational drug [7]

Core Insights - Nurix Therapeutics, Inc. has appointed Dr. Roger Dansey to its board of directors, enhancing the company's expertise in research, drug development, and commercialization [1][2] - Dr. Dansey brings over two decades of leadership experience in hematology and oncology, having held significant roles at Pfizer and Seagen [1][2] - Nurix is focused on targeted protein degradation medicines, aiming to innovate treatment options for cancer and autoimmune diseases [3] Company Overview - Nurix Therapeutics is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of targeted protein degradation medicines [3] - The company's pipeline includes degraders of Bruton's tyrosine kinase (BTK) and inhibitors of Casitas B-lineage lymphoma proto-oncogene B (CBL-B), with a focus on improving treatment for various cancers and autoimmune diseases [3] - Nurix's partnered drug discovery pipeline features collaborations with Gilead, Sanofi, and Pfizer, retaining options for co-development and profit sharing in the U.S. [3] Leadership and Expertise - Dr. Dansey's previous roles include Chief Development Officer and Chief Oncology Officer at Pfizer Oncology, and Chief Medical Officer at Seagen, where he contributed to the development of breakthrough cancer therapies [2] - His experience includes leadership positions at Merck, Gilead, and Amgen, where he was involved in the registration efforts for Keytruda and the development of Xgeva [2] - Dr. Dansey's appointment is expected to guide Nurix in accelerating pivotal trials for its lead asset, bexobrutideg, in chronic lymphocytic leukemia [2]

Core Insights - Spherix Global Insights has launched its Market Dynamix™ service focusing on PD-1 Inhibition in Solid Tumors, providing analysis and advisory services for the immuno-oncology landscape as new PD-1 biosimilars and subcutaneous formulations approach market entry [1][2] Study Focus and Methodology - The 2025 edition of Market Dynamix™ will integrate quantitative insights from 100 U.S.-based oncologists, assessing current treatment algorithms and future expectations regarding the PD-1 inhibitor class [3] - The study will evaluate the impact of biosimilars and subcutaneous delivery formats on manufacturers, providers, and payers, delivering actionable intelligence for commercial planning and competitive positioning [3] - In 2026, the tracking will expand with RealTime Dynamix™: PD-1 Inhibition in Solid Tumors, providing quarterly updates on prescriber perceptions and competitive dynamics [3] Market Dynamics - The study will explore oncologist familiarity and perceived clinical equivalence of biosimilar PD-1 inhibitors, as well as adoption intent and expected impacts on practice economics and patient access [6] - It will also assess attitudes toward subcutaneous PD-1 formulations, focusing on convenience and anticipated shifts in site-of-care dynamics [6] - The analysis will include forecasts for PD-1 brand positioning and market share over the next 12 months, along with the influence of biomarker testing on treatment selection [6]

Core Insights - Summit Therapeutics Inc. reported progress on its lead drug candidate, ivonescimab, and its third-quarter financial results, with stock trading lower [1][7] Clinical Trial Results - The Phase 3 HARMONi-6 trial demonstrated that ivonescimab combined with chemotherapy reduced the risk of progression or death by 40% compared to BeOne Medicines' Tevimbra and chemotherapy for advanced squamous non-small cell lung cancer (NSCLC) [2] - The ivonescimab regimen extended the median time without tumor progression to 11.1 months, an increase of 4.2 months over the Tevimbra-based therapy [2] - The overall response rate (ORR) for ivonescimab plus chemotherapy was 75.9%, compared to 66.5% for tislelizumab plus chemotherapy, with a duration of response (DoR) of 11.20 months versus 8.38 months [3] Future Plans - Based on the HARMONi-6 results, the company plans to submit a Biologics License Application (BLA) for ivonescimab plus chemotherapy in Q4 2025 [4] - Summit is currently enrolling patients in the HARMONi-3 Phase 3 study to compare ivonescimab with Merck's Keytruda for first-line metastatic NSCLC, with expected completion of enrollment in the squamous cohort by H1 2026 [5] - A new Phase 3 HARMONi-GI3 study has been initiated for first-line unresectable metastatic colorectal cancer (CRC), with plans for further expansion of the ivonescimab clinical development program [6] Financial Position - As of September 30, 2025, the company reported cash and cash equivalents of $238.6 million [6]

Group 1 - Merck announced that the European Medicines Agency (EMA) endorsed an injectable version of its cancer therapy Keytruda (pembrolizumab) [3] - The endorsement comes from an expert panel within the EMA, specifically the Committee for Medicinal Products for Human Use (CHMP) [3] - This development is significant for Merck as Keytruda is a blockbuster drug in its portfolio [3]

Core Insights - PDS Biotechnology Corporation announced that its combination therapy of PDS0101 (Versamune HPV) and Keytruda (pembrolizumab) achieved a median overall survival (mOS) of 29.5 months in patients with low PD-L1 expression (CPS 1-19), significantly outperforming Keytruda alone (10.8 months) and Keytruda plus chemotherapy (12.3 months) [1][7] Group 1: Clinical Trial Results - The VERSATILE-002 Phase 2 clinical trial evaluated the efficacy of PDS0101 in combination with Keytruda for patients with HPV16-positive recurrent and/or metastatic head and neck squamous cell cancer [1][4] - Approximately 60% of the patients enrolled in the trial had low PD-L1 expression, indicating a challenging subset of the overall patient population [3] - The full study population reported an mOS of 39.3 months, with detailed data expected to be published later this year [3] Group 2: Expert Commentary - Prof. Kevin Harrington highlighted the significance of the results, noting the potential for a well-tolerated treatment option without chemotherapy for patients [2] - Dr. Kirk Shepard emphasized that the findings suggest PDS0101 may enhance survival outcomes for patients who typically have limited treatment options and poor prognosis [3] Group 3: Company Overview - PDS Biotechnology is focused on developing immunotherapy treatments that enhance the immune system's ability to target and kill cancer cells, with a pivotal clinical trial underway for advanced HPV16-positive head and neck squamous cell cancers [5] - The company is also exploring a triple combination therapy involving PDS01ADC, an IL-12 fused antibody drug conjugate, alongside standard immune checkpoint inhibitors [5]

Core Insights - TuHURA Biosciences has completed the acquisition of Kineta, Inc. and its VISTA inhibiting monoclonal antibody, now named TBS-2025, with plans to initiate a Phase 2 trial in relapsed/refractory NPM1-mutated Acute Myeloid Leukemia (AML) in the second half of 2025 [1][4] - The company has initiated a Phase 3 accelerated approval trial of IFx-2.0 as an adjunctive therapy with Keytruda® for advanced and metastatic Merkel cell carcinoma (MCC), under a Special Protocol Assessment (SPA) agreement with the FDA [1][3] Corporate Highlights - TuHURA completed a $12.5 million equity financing transaction and received an additional $3 million from warrant exercise proceeds [2][5] - The company was included in the Russell 3000® and Russell 2000® Indexes as of June 27, 2025 [4] Clinical Development - The Phase 3 trial of IFx-2.0 is a single randomized placebo-controlled trial that could potentially meet the requirements for both accelerated and full approval without the need for a post-accelerated approval confirmatory trial [3] - A Phase 1b/2a trial has been initiated for IFx-2.0 as an adjunctive therapy in first-line treatment of checkpoint-naïve patients with MCC of unknown primary origin, targeting newly diagnosed patients with metastatic tumors [3] Financial Performance - Research and development expenses for the second quarter of 2025 were $4.9 million, compared to $2.8 million for the same period in 2024 [7] - Net cash outflows from operating activities for the first half of 2025 were ($10.9) million, compared to ($8.9) million for the same period in 2024 [7] Upcoming Milestones - The company plans to advance TBS-2025 into a randomized Phase 2 trial in the second half of 2025 [6] - TuHURA anticipates providing updates on enrollment progress in its Phase 3 trial of IFx-2.0 by the end of 2025 and topline results from the Phase 1b/2a trial in Q1 2026 [12]

Core Insights - Summit Therapeutics (SMMT) reported a second-quarter 2025 loss per share of $0.76, significantly wider than the Zacks Consensus Estimate of a loss of $0.10, and compared to a loss of $0.09 in the same period last year [1][7] - The company currently has no marketed products, resulting in no recorded revenues for the quarter [2] - Year-to-date, SMMT shares have increased by 58.3%, outperforming the industry average increase of 5.3% [2] Financial Performance - Adjusted research and development expenses reached $79.4 million, a 190.8% increase year-over-year, primarily due to higher costs for expanding clinical studies for ivonescimab [4] - Adjusted general and administrative expenses rose by 64.5% year-over-year to $10.2 million, driven by costs associated with developing infrastructure for ivonescimab [4] - As of June 30, 2025, the company had cash, cash equivalents, and short-term investments totaling $297.9 million, down from $361.3 million as of March 31, 2025 [5] Pipeline Developments - Summit's only pipeline drug, ivonescimab, is a first-in-class bispecific antibody targeting PD-1 and VEGF, currently undergoing three late-stage studies for non-small cell lung cancer (NSCLC) [8] - The phase III HARMONi study showed that ivonescimab plus chemotherapy reduced the risk of disease progression by 48% compared to chemotherapy alone, but did not achieve statistically significant overall survival benefits [9][10] - The company plans to file for approval of the ivonescimab-chemo combination for previously treated EGFR-mutated NSCLC, pending further discussions with the FDA regarding the need for statistically significant overall survival benefits [10] Recent Study Results - Positive results were reported from the Akeso-sponsored phase III HARMONi-6 study, where ivonescimab plus chemotherapy showed significant improvement in progression-free survival compared to BeiGene's PD-1 inhibitor [11] - The HARMONi-3 study is evaluating ivonescimab against Merck's Keytruda in first-line metastatic NSCLC patients [12] - The HARMONi-2 study previously demonstrated that ivonescimab outperformed Keytruda in patients with positive PD-L1 expression [13] Collaborations and Approvals - Akeso has secured approval for ivonescimab in a second indication for front-line PD-L1 positive advanced NSCLC based on HARMONi-2 results [14] - Summit has entered clinical trial collaborations with Pfizer and Revolution Medicines to evaluate ivonescimab in combination with their drugs across various solid tumor settings [15]