TME Pharma NV

Plus, news about Basilea, TME Pharma and Perceive Biotherapeutics: Septerna stops work on Phase 1: The newly public biotech ended a healthy volunteer trial for SEP-786, its hypoparathyroidism candidate, after “unanticipated events of elevated unconjugated bilirubin levels.” The company had been targeting a readout in the middle of this year, CEO Jeffrey Finer told Endpoints News at last month’s JP Morgan Healthcare Conference. The biotech now expects to select a follow-up candidate “to accelerate toward the clinic later this year to quickly regain momentum with our PTH1R program,” Finer said Tuesday. Multiple drugmakers are doing work in the rare endocrine disorder field, and Ascendis’ hypoparathyroidism drug was recently approved. Septerna’s stock $SEPN was down about 63% on Tuesday morning. — Kyle LaHucik FDA approves Sanofi’s Merilog: It’s the first FDA-approved, fast-acting insulin biosimilar to Novo Nordisk’s NovoLog, and is now the third insulin biosimilar approved by the agency to treat diabetes. — Alexis Kramer Basilea abandons MRSA drug ahead of clinic entry: The Swiss biotech decided not to exercise its option for its endolysin candidate, dubbed tonabacase, because it didn’t meet “stringent risk-return criteria.” Basilea licensed the option for tonabacase from iNtRON Biotechnology back in 2023 and did a preclinical assessment of the candidate last year. — Ayisha Sharma German cancer biotech has new eye focus: TME Pharma is planning to establish a “new entity” focused on the “rapid advancement” of NOX-E36 for ophthalmic indications, with support from private investors. The company said it has enough supply of the drug for initial preclinical and clinical studies. TME is also looking for a strategic partner for its lead asset, dubbed NOX-A12, for glioblastoma. — Ayisha Sharma Ophthalmology biotech reveals $15M Series A: Johnson & Johnson’s corporate venture arm, Deerfield Management and other investors are backing Perceive Biotherapeutics. The small molecule startup, a spinout of Perceive Pharma, is working on “neuroprotective therapeutics” for glaucoma and other eye conditions. — Kyle LaHucik

BERLIN--( BUSINESS WIRE )-- TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), announces its plan to externalize and monetize the company's second clinical stage asset NOX-E36 – an L-stereoisomer RNA aptamer inhibiting the CCL2 chemokine. This decision leverages the compound’s potential, as shown by clinical and preclinical data, to safely address significant unmet medical needs in ophthalmic diseases impacted by fibrosis. The presence of the target of NOX-E36, CCL2, has been shown to predict early failure of glaucoma surgical intervention in patients and inhibition of the pathway targeted by NOX-E36 in preclinical models of glaucoma surgery prevents fibrosis thereby prolonging the success of the intervention 1 . NOX-E36 has already been administered to 175 clinical trial participants with an excellent safety and tolerability profile and showing activity on its target, already derisking a number of steps in early clinical development. Fibrosis is a significant cause of treatment failure or increased severity in many clinically important eye diseases 2 with unmet needs such as diabetic retinopathy (9.6 million cases in the US, of which 1.84 million vision-threatening 3 ), age-related macular degeneration (20 million cases in the US, of which 1.5 million vision-threatening 4 ), and primary open angle glaucoma (>3 million cases in the US 5 ). Click here to read the full press release 1 Chong (2017) Invest Ophthalmol Vis Sci 58:3432 & Chong (2010) Ophthalmology 117:2353 2 Sorenson (2024) Frontiers in Ophthalmology 2024 Vol. 4 3 Lundeen (2023) JAMA Ophthalmol. 2023;141(8):747-754 4 Rein (2022) JAMA Ophthalmol. 2022;140(12):1202-1208 5 US National Eye Institute Glaucoma Tables, Link

BERLIN--( BUSINESS WIRE )-- TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), announced today that an abstract featuring results from the NOX-A12 GLORIA Phase 1/2 trial in first-line brain cancer (glioblastoma) has been selected for presentation at the European Society for Medical Oncology (ESMO) Congress taking place in Barcelona, Spain, September 13-17, 2024. The oral presentation will provide further analysis of the dual inhibition of NOX-A12 and bevacizumab in glioblastoma in the expansion arm of the GLORIA Phase 1/2 trial. The full abstract will be published online via the ESMO Congress website . 00:05 a.m. CEST on Monday, September 09, 2024. It will be available concurrently on the TME Pharma website. Title: Dual inhibition of postradiogenic angio-vasculogenesis in glioblastoma: Results of the phase 1/2 GLORIA trial Presenter: Dr. Frank A. Giordano, Chair of the Department of Radiation Oncology, University Medical Center Mannheim, Germany Session: Mini oral session: CNS tumors Time and Date: 08.30-8.35 a.m. CEST, Sunday, September 15, 2024 About TME Pharma TME Pharma is a clinical-stage company focused on developing novel therapies for treatment of the most aggressive cancers. The company’s oncology-focused pipeline is designed to act on the tumor microenvironment (TME) and the cancer immunity cycle by breaking tumor protection barriers against the immune system and blocking tumor repair.