September 12, 2024 - 🧬 [nGram] Today’s Oncology Scoop: Sanofi's Radioligand Deal, Aura's Phase 2 Success, PIONeeR at ESMO

1. Sanofi, RadioMedix, and Orano Med announce licensing agreement on next-generation radioligand medicine for rare cancers

   • Sanofi has entered into an exclusive licensing agreement with RadioMedix and Orano Med to develop AlphaMedix, a radioligand therapy for neuroendocrine tumors (NETs).
   • AlphaMedix is a targeted alpha therapy (TAT) using lead-212 (212Pb) and has shown promising results in early clinical trials.
   • The FDA has granted AlphaMedix Breakthrough Therapy Designation for gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
   • Sanofi will handle global commercialization, while Orano Med will manage manufacturing. The agreement includes an upfront payment of €100 million and up to €220 million in sales milestones.
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2. ITM obtains exclusive worldwide license from Debiopharm for CA IX-targeted peptide-based radiopharmaceutical programs targeting solid tumors

   • ITM gains exclusive global development and commercialization rights to Debiopharm’s peptide-based theranostic pair, Debio 0228 ([177Lu]Lu-DPI-4452) and Debio 0328 ([68Ga]Ga-DPI-4452).
   • Debiopharm to receive approximately €300 million in upfront, development, and regulatory milestone payments, plus commercial milestones and low double-digit royalties on future sales.
   • The theranostic pair is currently being evaluated in the phase 1/2 GaLuCi™ clinical trial for Clear Cell Renal Cell Carcinoma (ccRCC), Pancreatic Ductal Adenocarcinoma (PDAC), and Colorectal Cancer (CRC).
   • ITM aims to rapidly advance the program through clinical evaluation to expand its radiopharmaceutical pipeline.
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3. Aura Biosciences reports positive phase 2 end of study results evaluating bel-sar as a first-line treatment for early-stage choroidal melanoma

   • Bel-sar demonstrated an 80% tumor control rate and 90% visual acuity preservation.
   • The Phase 2 study included 22 patients with early-stage choroidal melanoma.
   • No treatment-related serious adverse events were reported, and the safety profile was highly favorable.
   • Aura Biosciences is currently enrolling patients in the global Phase 3 CoMpass trial.
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4. The PIONeeR Project to present late-breaking results from its Phase Ib/IIa umbrella study at the ESMO Congress 2024

   • The PIONeeR Project will present its Phase Ib/IIa clinical trial results at the ESMO Congress 2024.
   • The trial addresses resistance to PD-1(L1) immune checkpoint inhibitors in advanced non-small cell lung cancer (NSCLC).
   • The study includes a biomarker program with over 400 biomarkers and an umbrella clinical trial with 4 ICI combinations.
   • The presentation will take place during the Presidential Symposium III: Eyes to the future on September 16, 2024.
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5. Cellworks biosimulation identifies which NSCLC patients will benefit from combining chemotherapy with immunotherapy

   • Cellworks' biosimulation platform accurately predicted overall survival (OS) and chemotherapy benefit in two real-world NSCLC patient cohorts.
   • The study was presented at the IASLC 2024 World Conference on Lung Cancer in San Diego, California.
   • The Cellworks TRI algorithm was trained on a cohort of 553 NSCLC patients and validated on an independent set of 710 advanced NSCLC patients.
   • Patients in the high TRI group showed no benefit from adding chemotherapy, while those in the low TRI group received an estimated incremental benefit in median OS of approximately 3 months.
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6. BPGbio presents phase 2b BPM31510 glioblastoma trial update at ESMO Congress 2024

   • BPGbio will present two posters on the ongoing phase 2 trial of BPM31510 in newly diagnosed glioblastoma multiforme (GBM) at ESMO Congress 2024.
   • The trial has enrolled 16 patients, with 7 having completed the study.
   • BPM31510, combined with Vitamin K and standard chemoradiation, is being tested in a single-arm Phase 2b trial across four U.S. sites, targeting 50 patients.
   • The quinomics assessment of BPM31510 shows its metabolic activity in an experimental glioma model and in the brain.
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7. Turbine achieves key milestone in collaboration with Ono Pharmaceutical

   • Turbine's AI-driven Simulated Cell platform identified multiple targets for Ono Pharmaceutical.
   • Turbine will lead in vitro validation of these targets in Ono's priority cancer biology domain.
   • The collaboration includes milestone payments for Turbine, with potential for additional payments based on progress.
   • Turbine's platform enables rapid identification and validation of novel therapeutic targets.
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