DAY301 / MabCare Therap, Servier - LARVOL DELTA

Servier completes the acquisition of Day One Biopharmaceuticals (Canada Newswire) - "Acquisition expands Servier's position in oncology with tovorafenib marketed as OJEMDA in the U.S. in pediatric low-grade glioma; Transaction also includes a strong oncology pipeline of clinical stage assets in rare cancers with high unmet needs; Transaction represents total equity value of approximately $2.5 billion....The transaction also strengthens Servier's oncology pipeline from early clinical to Phase 3. In addition to tovorafenib, which is being investigated in additional indications, Day One's pipeline includes Emi-Le (emiltatug ledadotin), a novel antibody drug conjugate (ADC) and DAY301, a targeted therapy in rare cancers."

M&A • Adenoid Cystic Carcinoma • Glioma • Low Grade Glioma • Solid Tumor

Phase 1 dose escalation and expansion study of the PTK7-targeted antibody-drug conjugate DAY301 in patients with locally advanced or metastatic solid tumors (AACR 2025) - P1 | "Based on the totality of data from phase 1b, a recommended phase 2 dose for future clinical studies will be determined. Recruitment for the trial started in December 2024, with the aim of a maximum of 84 patients to be enrolled in phase 1a and 116 patients in phase 1b."

ADC • Clinical • First-in-human • Metastases • P1 data • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • PTK7

Servier and Day One Biopharmaceuticals announce acquisition to expand Servier's rare oncology portfolio (PRNewswire.co.uk) - "Servier...and Day One Biopharmaceuticals, Inc...announced that they have entered into a definitive agreement for Servier to acquire Day One for $21.50 per share in cash, representing a total equity value of approximately $2.5 billion. The transaction remains subject to customary closing conditions and is expected to close in the second quarter of 2026...It strengthens Servier's portfolio and expands its oncology pipeline with programs ranging from early stage to phase 3."

M&A • Adenoid Cystic Carcinoma • Glioma

2026 Corporate Priorities and Key Milestones:…PIPELINE (GlobeNewswire) - "(i) Advance Emi-Le program by delivering Phase 1 clinical data by mid-2026 and progressing toward registration; (ii) Provide initial data from the Phase 1a clinical trial for DAY301, a PTK7-targeted antibody drug conjugate (ADC), in the second half of 2026."

P1 data • Solid Tumor

De novo secondary central nervous system lymphoma: A real-world cohort study over two decades (ASH 2025) - "CNS-targeting treatment included intrathecal methotrexate (IT MTX) 31.8% (n=21), intravenous methotrexate (IV MTX) 25.8% (n=17) combination IT MTX and IT cytarabine (ARA-C) 18.2% (n=12), and both IV and IT MTX 13.6% (n=9). De novo SCNSL demonstrated favourable outcomes with median OS of more than 20 years. Further studies on optimal CNS-targeting regimens are warranted."

Clinical • Real-world • Real-world evidence • B Cell Lymphoma • Burkitt Lymphoma • CNS Disorders • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • Secondary Central Nervous System Lymphoma • T Cell Non-Hodgkin Lymphoma

Investigation of Hepatitis B Reactivation Risk in Psoriasis Patients with Prior HBV Exposure Under Immunosuppressive Therapy (EADV 2025) - "Treatment options include conventional agents such as Methotrexate (MTX), Cyclosporine, and Acitretin, as well as biologics targeting cytokines like TNF-alpha, IL-12/23, IL-17, and IL-23...The current treatments used by the patients included: Ixekizumab (22.4%), Secukinumab (19.4%), MTX (15.3%), Risankizumab (13.3%), Ustekinumab (10.2%), Guselkumab (10.2%), Adalimumab (7.1%), Cyclosporine (1.0%), and Certolizumab (1.0%)...Reactivation rates by drug were: MTX 13.3% (n=2), Guselkumab 10.0% (n=1), Ixekizumab 4.5% (n=1), Secukinumab 5.3% (n=1); no reactivation was observed in patients on other treatments... Previous studies investigating HBV reactivation under immunosuppressive therapy have reported rates ranging from 0% to 14.8%. In our study, this rate was 5.1%, which may vary depending on the patient's HBV serological status, the immunosuppressive agent used, and the duration of therapy. HBV screening, monitoring, and prophylaxis, when necessary, are essential during..."

Clinical • Dermatology • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Failure • Psoriasis • IL12A • IL17A • IL23A • TNFA

Day One Reports Fourth Quarter and Full Year 2024 Financial Results and Corporate Progress (GlobeNewswire) - "Program Highlights:...DAY301, our PTK7-targeted ADC, cleared the first dose cohort (a single-patient accelerated titration cohort) in the Phase 1a portion of the Phase 1a/b clinical trial."

Trial status • Solid Tumor

Day One Reports Preliminary 2024 OJEMDA Net Product Revenue and Highlights 2025 Corporate Priorities (GlobeNewswire) - "The Company expects to complete enrollment of FIREFLY-2 in the first half of 2026; 2025 Upcoming Priorities and Milestones: Advance the existing pipeline, including the FIREFLY-2 Phase 3 clinical trial with tovorafenib in the front-line setting, and DAY301 in the Phase 1a/b trial."

Trial status • Brain Cancer • Glioma • Solid Tumor

To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=200 | Recruiting | Sponsor: Day One Biopharmaceuticals, Inc.

New P1 trial • Oncology • Solid Tumor

Day One Reports Third Quarter 2024 Financial Results and Corporate Progress - "Strong growth in OJEMDA net revenue with $20.1M in the third quarter of 2024, representing a 145% increase over the second quarter of 2024; Quarterly prescriptions (TRx) grew to 619 in the third quarter of 2024, representing a 159% increase over the second quarter of 2024; Day One expects to dose the first patient in the Phase 1a portion of the Phase 1a/b clinical trial of DAY301 by the end of 2024 or in the first quarter of 2025...Upcoming Events: Two posters on health-related quality of life and drug holiday from the registrational Phase 2 FIREFLY-1 trial investigating tovorafenib in patients with BRAF-altered, relapsed or progressive pLGG will be presented at the Society for Neuro-Oncology Annual Meeting on November 22, 2024."

New P1 trial • P2 data • Sales • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor

Day One Expands Pipeline with Potential First-in-Class Clinical-Stage Antibody Drug Conjugate (ADC) Targeting PTK7 in Solid Tumors for Adult and Pediatric Cancers (GlobeNewswire) - "Day One Biopharmaceuticals...announced it has entered into an exclusive licensing agreement...with MabCare Therapeutics (MabCare) for MTX-13...Day One has exclusive rights to develop, manufacture, and commercialize MTX-13 worldwide, excluding Greater China...'Our priorities for 2024 are to successfully launch OJEMDA.'...DAY301 targets PTK7...that is overexpressed in multiple adult cancers, including esophageal, ovarian, lung, and endometrial cancer, as well as pediatric cancers such as neuroblastoma, rhabdomyosarcoma and osteosarcoma....Under the terms of the licensing agreement, MabCare will receive $55 million upfront, and is eligible to receive an additional $1.152 billion in development, regulatory and commercial success-based milestones, plus low-to-mid single-digit royalties on net sales outside of Greater China. Day One expects the first patient to be dosed in the Phase I study in the fourth quarter of 2024 or first quarter of 2025."

Launch • Licensing / partnership • New P1 trial • Endometrial Cancer • Esophageal Cancer • Gynecologic Cancers • Lung Cancer • Neuroblastoma • Oncology • Osteosarcoma • Ovarian Cancer • Rhabdomyosarcoma • Solid Tumor