Core Insights - SELLAS Life Sciences Group has entered into an agreement with IMPACT-AML to conduct a clinical study evaluating SLS009, a selective CDK9 inhibitor, for acute myeloid leukemia (AML) [1][3] Company Overview - SELLAS is a late-stage clinical biopharmaceutical company focused on developing novel therapies for various cancer indications, with its lead product candidate, GPS, targeting the WT1 protein [4] - SLS009 is positioned as a potentially first and best-in-class small molecule CDK9 inhibitor, showing high response rates in AML patients with unfavorable prognostic factors [4] Collaboration Details - The IMPACT-AML initiative is a pan-European project aimed at advancing innovative treatments for AML, involving major research and clinical institutions across Europe [2] - The collaboration allows SELLAS to leverage IMPACT-AML's infrastructure for efficient patient enrollment and access to multiple European clinical sites [2][3] Clinical Study Plans - The clinical study will evaluate SLS009 in combination with azacitidine and venetoclax (AZA/VEN) in approximately 40 newly diagnosed AML patients with high-risk features [3][6] - Enrollment at U.S. sites is expected to begin in Q1 2026, followed by European sites in Q2 2026, pending regulatory and site readiness [3][6]

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Core Insights - Compass Therapeutics is advancing multiple first-in-class bispecific antibodies and expects to achieve major data-driven milestones in 2026 [2] - The company has strengthened its management team with the addition of Arjun Prasad as Chief Commercial Officer and Cynthia Sirard as Chief Medical Officer [2] Pipeline Highlights - Key survival analyses for tovecimig in late Q1 2026 could transform treatment for patients with biliary tract cancer [3] - The ongoing Phase 2/3 COMPANION-002 study of tovecimig is on track for late Q1 2026, focusing on progression-free survival (PFS) and overall survival (OS) [5] - CTX-8371 has shown robust responses in patients with solid and hematologic malignancies, with cohort expansions now open for enrollment in triple negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC) [5][11] - Initial data from the Phase 1 study of CTX-10726 is expected in H2 2026, with the study initiation anticipated in Q1 2026 [5][11] Financial Position - As of December 31, 2025, Compass Therapeutics reported an estimated $209 million in cash and marketable securities, providing a cash runway into 2028 [12]

Acquisition Overview - Johnson & Johnson (J&J) has completed the acquisition of Halda Therapeutics for $3.05 billion in cash, enhancing J&J's oncology portfolio with Halda's Regulated Induced Proximity Targeting Chimera (RIPTAC) platform [1][2] Product Pipeline - The acquisition includes HLD-0915, a clinical-stage, once-daily oral therapy for prostate cancer, which utilizes the RIPTAC platform for precision targeting of cancer cells [2] - The deal also adds early-stage candidates for breast, lung, and other tumor types to J&J's pipeline, leveraging RIPTAC technology [2] Financial Impact - J&J anticipates earnings dilution in the fourth quarter of 2025 and into 2026, with an expected total impact on adjusted earnings per share of around $0.20, split equally between the two years [3] Strategic Vision - J&J's innovative medicine worldwide chairman emphasized the strategic importance of this acquisition in redefining cancer treatment and expressed excitement about the collaboration with Halda's team [4] - The focus will be on advancing the potential of the new pipeline and utilizing the RIPTAC platform to discover additional oncology molecules [4]

Core Insights - Processa Pharmaceuticals' shares surged 122.3% following a positive clinical update on its mid-stage study of NGC-Cap for advanced or metastatic breast cancer [1][6] Clinical Study Overview - NGC-Cap, a combination of PCS6422 and Roche's Xeloda (capecitabine), is the lead asset in Processa Pharmaceuticals' pipeline, with 19 patients enrolled in the phase II study [2] - The preliminary analysis includes data from the first 16 patients, indicating a pharmacokinetic advantage of NGC-Cap over Xeloda monotherapy [3][4] Efficacy and Safety Profile - Preliminary phase II data show significantly higher exposure to active metabolites in patients treated with NGC-Cap, suggesting improved antitumor activity [4] - The pharmacologic profile indicates that NGC-Cap allows for greater delivery of effective components of Xeloda without worsening tolerability [5][6] - Early results suggest that increased exposure to active metabolites did not lead to more severe toxicity compared to Xeloda, with manageable tolerability despite higher pharmacologic activity [7] Side Effects and Tolerability - Patients on NGC-Cap experienced about ten times lower exposure to the toxic metabolite FBAL, associated with dose-limiting toxicities, leading to similar incidence of hand-foot syndrome (HFS) across treatment groups, but with milder symptoms in the NGC-Cap arm [8] - These findings support a differentiated safety profile for NGC-Cap, which could be appealing if sustained in later analyses [9] Future Expectations - Processa Pharmaceuticals aims to complete enrollment of the 20-patient cohort for the phase II interim analysis by the end of Q1 2026, with full results expected in early 2026 [9] - The company also has another investigational candidate in mid-stage development for rare kidney diseases [10]

Core Insights - Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) stock surged by 130.95% to $6.94 following a clinical update on its Phase 2 study of NGC-Cap, a combination treatment for advanced or metastatic breast cancer [7]. Clinical Study Findings - The first 16 of 19 patients in the Phase 2 study showed that NGC-Cap significantly increases exposure to capecitabine metabolites without increasing side effects compared to standard Mono-Cap therapy [2]. - Patients were randomized to receive either NGC-Cap (150 mg twice daily) or standard-dose Mono-Cap (1,000 mg/m² twice daily), with preliminary findings suggesting NGC-Cap allows for greater exposure to effective cancer-killing components while avoiding increased severity of side effects [3]. Safety and Side Effects - Although patients receiving NGC-Cap experienced a higher total number of side effects related to capecitabine metabolites, the severity of these side effects was similar between the two treatment groups, indicating that increased activity did not lead to more severe toxicity [4]. - Patients on NGC-Cap had substantially lower exposure to FBAL, a catabolite metabolite associated with side effects like hand-foot syndrome (HFS), with exposure being up to ten times less than that of Mono-Cap [5]. - The incidence of HFS was similar between treatment groups, but symptoms in the NGC-Cap group were mild (Grade 1), while those on Mono-Cap experienced more severe symptoms (up to Grade 2) [6]. Future Plans - Processa anticipates completing enrollment for the final patient in the 20-patient interim analysis of the Phase 2 safety and efficacy study by the end of Q1 2026 [7].

2025 R&D Update and ASH Data Review December 11, 2025 © Genmab 2025 This presentation contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. All statements other than statements of historical facts included in this presentation, including, without limitation, those regarding our financial position, business strategy, plans and objectives of management for future operations (including development plans ...

Core Insights - Astellas Pharma is set to present new data on potential treatments for pancreatic and gastric/gastroesophageal junction (G/GEJ) cancer at the 2026 ASCO GI Cancers Symposium, highlighting advancements in precision oncology and the company's commitment to improving patient outcomes [1][2]. Company Developments - Astellas will showcase results from the Phase 2 ILUSTRO study, which evaluates the efficacy of zolbetuximab in combination with chemotherapy and immunotherapy for treating claudin 18.2-positive, HER2-negative, locally advanced or metastatic G/GEJ cancer [1][3]. - The company is also advancing ASP3082 (setidegrasib), a targeted protein degrader for KRAS G12D mutations, currently in Phase 1 trials for pancreatic cancer [1][4]. Presentation Details - Key presentations at the ASCO GI 2026 include: - Oral presentation of the Phase 2 ILUSTRO trial results on January 8, 2026, focusing on zolbetuximab plus mFOLFOX6 and nivolumab [3]. - Poster presentations on various topics, including biomarker testing and treatment selection for gastric or GEJ adenocarcinoma [3][4]. Product Information - VYLOY (zolbetuximab) is a first-in-class monoclonal antibody targeting claudin 18.2, currently the only approved treatment for CLDN18.2-positive (HER2-negative) gastric or GEJ cancer in several regions, including the U.S. and Europe [7][8]. - ASP3082 (setidegrasib) targets KRAS G12D mutations, which are present in approximately 40% of pancreatic ductal adenocarcinomas, and is being evaluated for its safety and efficacy in clinical trials [12].

Core Insights - Aprea Therapeutics, Inc. has entered into a securities purchase agreement to sell 2,623,023 shares of common stock and warrants to purchase an equal number of shares, raising approximately $3.1 million before expenses [2][3] Financing Details - The offering price for each share and accompanying warrant is set at $1.165, with warrants having an exercise price of $1.04 per share, exercisable immediately and expiring five years from the registration statement effectiveness date [2][3] - The gross proceeds from the offering are intended for general corporate purposes and research and development expenses, extending the company's cash runway into Q1 2027 [3] Company Overview - Aprea Therapeutics is focused on developing innovative cancer treatments that target specific vulnerabilities in cancer cells while minimizing harm to healthy cells, with applications across various cancer types including ovarian, endometrial, colorectal, prostate, and breast cancers [7] - The company's lead programs include APR-1051, an oral small-molecule inhibitor of WEE1 kinase, and ATRN-119, a small molecule ATR inhibitor, both in clinical development for solid tumor indications [8]

Core Viewpoint - Ascentage Pharma presented four-year follow-up data for Olverembatinib, demonstrating its long-term efficacy and safety in treating TKI-resistant/intolerant chronic-phase chronic myeloid leukemia (CML-CP) at the 67th ASH Annual Meeting [1][2][3] Group 1: Efficacy Results - Olverembatinib showed a median event-free survival (EFS) of 21.2 months compared to 2.9 months for the best available therapy (BAT) in patients with TKI-resistant/intolerant CML-CP [3][12] - For patients without the T315I mutation, Olverembatinib achieved an EFS of 11.9 months versus 3.1 months for BAT [3][12] - The complete hematologic response (CHR) rates were 85% for Olverembatinib compared to 35% for BAT, while complete cytogenetic response (CCyR) rates were 38% versus 19% [12] Group 2: Safety Profile - The safety profile of Olverembatinib was favorable, with a vascular occlusion incidence of 7% among patients [3][11] - No new safety signals were reported, and the study included patients with and without the T315I mutation [11] Group 3: Regulatory and Commercialization Status - Olverembatinib is the first third-generation BCR-ABL1 inhibitor approved in China for specific CML indications, and it is included in the China National Reimbursement Drug List (NRDL) [4][15] - Ascentage Pharma is conducting three global registrational Phase III studies for Olverembatinib in various indications, including newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and gastrointestinal stromal tumors (GIST) [4][15] Group 4: Clinical Significance - The data presented at ASH 2025 reinforces Olverembatinib's role in clinical practice for long-term treatment of CML-CP, providing confidence to physicians and patients [5][11] - The study's findings highlight the need for effective treatment options for patients resistant to or intolerant of first- and second-generation TKIs [8][12]