Novartis Gains FDA Approval for Earlier Use of Pluvicto in Prostate Cancer, Mar. 28, 2025
Novartis’ radioligand therapy Pluvicto has received FDA approval for earlier use in treating PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) after prior androgen receptor pathway inhibitor therapy, but before chemotherapy. This expanded label significantly broadens the patient pool and brings Novartis closer to its $5 billion-plus sales target for the drug. The approval follows positive Phase 3 PSMAfore trial results, showing a 57% reduction in disease progression or death risk.
Full Article: Novartis Gains FDA Approval for Earlier Use of Pluvicto in Prostate Cancer
Asgard Therapeutics Appoints Shane Olwill as Chief Development Officer, Mar. 28, 2025
Asgard Therapeutics has appointed Shane Olwill as Chief Development Officer to lead the company’s clinical development strategy. Olwill brings over 20 years of oncology drug development experience, having held leadership roles at ONK Therapeutics and Pieris Pharmaceuticals. His expertise is expected to advance Asgard’s development of in vivo personalized cancer immunotherapies based on its TrojanDC platform.
Full Article: Asgard Therapeutics Appoints Shane Olwill as Chief Development Officer
IO Biotech Secures €57.5M Venture Debt from EIB to Advance Cancer Vaccine Pipeline, Mar. 27, 2025
IO Biotech has secured up to €57.5 million in venture debt financing from the European Investment Bank (EIB) to support cancer vaccine research and development. The investment will fund the clinical progress of IO102-IO103, an immune-modulating cancer vaccine, and accelerate pipeline expansion in line with EIB’s mission to foster innovation in European biotech.
Full Article: IO Biotech Secures €57.5M Venture Debt from EIB
Maxion Therapeutics Raises £34M in Series A to Advance KnotBody Platform, Mar. 27, 2025
British Patient Capital has invested £10 million in Maxion Therapeutics as part of a £34 million Series A financing round. The funds will support the advancement of Maxion’s KnotBody platform, targeting ion channels and GPCRs for the treatment of autoimmune and hard-to-drug diseases. The round was led by Monograph Capital and will move the company’s preclinical assets closer to clinical development.
Full Article: Maxion Therapeutics Raises £34M in Series A to Advance KnotBody Platform
Nanobiotix Reports Positive Phase 1 Data for NBTXR3 in Re-irradiated NSCLC, Mar. 27, 2025
Nanobiotix announced positive results from the dose escalation phase of a Phase 1 trial of radiotherapy-activated NBTXR3 (JNJ-1900) in NSCLC patients eligible for re-irradiation. Conducted by MD Anderson, the study showed no dose-limiting toxicities and determined a recommended Phase 2 dose. Efficacy results included 12-month LPFS of 64% and OS of 83%, positioning NBTXR3 as a potential treatment for patients with limited options.
Full Article: Nanobiotix Reports Positive Phase 1 Data for NBTXR3 in NSCLC
CureVac Wins Key Patent Ruling in BioNTech Dispute Over mRNA Technology, Mar. 27, 2025
The European Patent Office has upheld CureVac’s patent EP 3 708 668 B1, with amendments, in its ongoing litigation with BioNTech. The patent covers CureVac’s split poly-A tail mRNA technology and was largely defended against BioNTech's opposition. This decision strengthens CureVac’s position ahead of a July 2025 infringement hearing and reinforces its role in early mRNA innovation.
Full Article: CureVac Wins Key Patent Ruling in BioNTech Dispute
Vaximm Reports Positive Phase 2a Results for Oral Vaccine VXM01 in Glioblastoma, Mar. 26, 2025
Vaximm AG announced final positive results from a Phase 2a open-label trial evaluating its oral anti-VEGFR-2 vaccine VXM01 in combination with avelumab for recurrent glioblastoma (GBM). The therapy was well tolerated with no serious adverse events attributed to VXM01. An objective response rate of 12% was observed in non-resected patients, and median overall survival reached 11.1 months. Biomarker analysis also suggested promising pharmacodynamic activity, supporting further development.
Full Article: Vaximm Reports Positive Phase 2a Results for Oral Vaccine VXM01 in Glioblastoma
Immutep Doses First Patient in Pivotal Phase III TACTI-004 Lung Cancer Trial, Mar. 26, 2025
Immutep has dosed the first patient in its Phase III TACTI-004 trial evaluating eftilagimod alfa, a first-in-class MHC Class II agonist, in combination with KEYTRUDA® and chemotherapy for advanced/metastatic non-small cell lung cancer (NSCLC). The study marks a significant milestone for the late-stage immunotherapy company as it advances its lead asset into potential registration-enabling development.
Full Article: Immutep Doses First Patient in Phase III TACTI-004 Lung Cancer Trial
Pleco Therapeutics Advances AML Drug PTX-252 Following Positive FDA Pre-IND Meeting, Mar. 26, 2025
Pleco Therapeutics announced positive feedback from the FDA following a Pre-IND meeting for its AML drug candidate PTX-252. The IV formulation, designed to enhance chemotherapy response by removing toxic heavy metals, received Orphan Drug Designation. The agency provided guidance to support clinical advancement, with development co-led by Hyloris Pharmaceuticals.
Full Article: Pleco Therapeutics Advances AML Drug PTX-252 Following FDA Feedback
Nouscom Demonstrates Potent Immune Response with NOUS-209 in Lynch Syndrome, Mar. 25, 2025
Nouscom reported successful Phase Ib/II results for its off-the-shelf neoantigen immunotherapy NOUS-209 in Lynch Syndrome carriers. The vaccine induced neoantigen-specific T cell responses in all evaluable participants and demonstrated durable CD8/CD4 activity. The data support further development of NOUS-209 as a cancer interception approach, with a Phase 2/3 trial in planning.
Full Article: Nouscom Demonstrates Potent Immune Response with NOUS-209 in Lynch Syndrome
CEL-SCI Receives FDA Green Light for Registration Study of Multikine in Head & Neck Cancer, Mar. 25, 2025
CEL-SCI announced new data from its Phase 3 study showing up to 95% improvement in quality of life with Multikine in patients with resectable stage 3/4 head and neck cancer. Based on efficacy and safety data, the FDA has allowed initiation of a confirmatory registration study. Multikine may address an unmet need in patients with low PD-L1 expression and no lymph node involvement.
Full Article: CEL-SCI Advances Multikine for Head and Neck Cancer After Positive Phase 3 Data
Imunon Finalizes Phase 3 Design for Advanced Ovarian Cancer Therapy IMNN-001, Mar. 25, 2025
Imunon announced FDA alignment on the design of its Phase 3 pivotal trial OVATION 3, evaluating IMNN-001 in newly diagnosed advanced ovarian cancer. The IL-12 DNA immunotherapy showed a meaningful survival benefit in a prior Phase 2 trial. Site initiation is underway for the Phase 3 study.
Full Article: Imunon Finalizes Phase 3 Design for IMNN-001 in Ovarian Cancer
Aura Biosciences Presents Positive Phase 1 Data for Bel-Sar in NMIBC, Mar. 25, 2025
Aura Biosciences shared encouraging Phase 1 trial data for bel-sar (AU-011) in non-muscle invasive bladder cancer (NMIBC) at the 40th Annual European Association of Urology Congress. The data confirm the potential of bel-sar in early-stage bladder cancer and support further development in this difficult-to-treat patient group.
Full Article: Aura Biosciences Presents Positive Phase 1 Data for Bel-Sar in NMIBC
Tolremo Therapeutics Appoints Lung Cancer Expert to Scientific Advisory Board, Mar. 25, 2025
Tolremo Therapeutics has appointed Professor Pasi A. Jänne, a global leader in drug-resistant lung cancer, to its Scientific Advisory Board. Jänne's expertise will support development of TT125-802, a CBP/p300 bromodomain inhibitor designed to prevent non-genetic resistance to targeted therapies.
Full Article: Tolremo Therapeutics Appoints Lung Cancer Expert to SAB
Mural Oncology Halts Development of Nemvaleukin in PROC After Interim Analysis, Mar. 25, 2025
Mural Oncology has discontinued its Phase 3 ARTISTRY-7 trial of nemvaleukin alfa plus KEYTRUDA® in platinum-resistant ovarian cancer (PROC) following interim results showing no significant survival benefit. The company will cease development of nemvaleukin for this indication.
Full Article: Mural Oncology Halts Development of Nemvaleukin in PROC
Augustine Therapeutics Raises €77.7M Series A for CMT and Neurodegenerative Programs, Mar. 24, 2025
Augustine Therapeutics has raised €77.7 million in a Series A round co-led by Novo Holdings and Jeito Capital to advance AGT-100216 into Phase I for Charcot-Marie-Tooth disease. The company is also developing HDAC6 inhibitors for neurodegenerative and cardio-metabolic conditions.
Full Article: Augustine Therapeutics Raises €77.7M Series A
Pathios Therapeutics Appoints Dr. Sumeet Ambarkhane as CMO, Mar. 24, 2025
Pathios Therapeutics has named Dr. Sumeet Ambarkhane as Chief Medical Officer to lead development of PTT-4256, a GPR65 inhibitor currently in Phase 1/2 for advanced solid tumors. Dr. Ambarkhane brings experience from Alligator Bioscience and MorphoSys AG to support Pathios’ immuno-oncology strategy.
Full Article: Pathios Therapeutics Appoints Dr. Sumeet Ambarkhane as CMO
Entrada Therapeutics Receives UK Authorization to Initiate Phase 1/2 Trial for Duchenne Muscular Dystrophy, Mar. 24, 2025
Entrada Therapeutics has received UK MHRA authorization to initiate ELEVATE-45-201, a global Phase 1/2 study of ENTR-601-45 for Duchenne muscular dystrophy (DMD) patients with exon 45 skipping mutations. The randomized, placebo-controlled trial will assess safety, pharmacokinetics, and dystrophin production, with an open-label extension planned. ENTR-601-45, an Endosomal Escape Vehicle (EEV™)-conjugated PMO, aims to restore dystrophin production, with the study set to begin in Q3 2025.
Full Article: Entrada Therapeutics Receives UK Authorization to Initiate Phase 1/2 Trial for Duchenne Muscular Dystrophy
