Bayer announces positive topline results for Nubeqa from Phase III trial in men with metastatic hormone-sensitive prostate cancer
- The Phase III ARANOTE trial met its primary endpoint of radiological progression-free survival (rPFS).
- Nubeqa plus ADT showed a statistically significant and clinically meaningful increase in rPFS compared to placebo plus ADT.
- Results were consistent with Nubeqa’s established safety profile with no new signals observed.
- Bayer plans to present detailed results at a forthcoming scientific congress and discuss data with the U.S. FDA for regulatory approval.
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Phase III ARANOTE trial of darolutamide in combination with androgen deprivation therapy meets primary endpoint
- The Phase III ARANOTE trial met its primary endpoint, significantly increasing radiological progression-free survival (rPFS) with darolutamide + ADT compared to placebo + ADT.
- Safety analysis shows darolutamide plus ADT to be comparable to placebo plus ADT, reconfirming the established tolerability profile.
- Darolutamide plus ADT now has positive data both with and without docetaxel based on two pivotal phase III studies in metastatic hormone-sensitive prostate cancer (mHSPC).
- Bayer plans to present the pivotal data at a forthcoming scientific congress and prepare for submission with health authorities globally to extend the indication of darolutamide.
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FDA grants orphan drug designation to 7MW3711
- Mabwell's novel B7-H3-targeting ADC, 7MW3711, received Orphan Drug Designation from the FDA for small cell lung cancer.
- Orphan Drug Designation provides benefits like aid with medication development, tax credits, and seven years of market exclusivity upon approval.
- 7MW3711 is characterized by its stable structure, high purity, and better tumor-killing effects in multiple animal models.
- The ADC has shown good safety and pharmacokinetic properties in animal safety evaluations.
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Full-Life Technologies and SK Biopharmaceuticals enter licensing agreement for novel therapeutic targeting multiple solid tumors
- Full-Life Technologies and SK Biopharmaceuticals have entered a $571.5 million licensing agreement for the FL-091 radiopharmaceutical compound.
- SK Biopharmaceuticals gains exclusive worldwide rights for clinical research, development, manufacturing, and commercialization of FL-091.
- FL-091 targets neurotensin receptor 1 (NTSR1) positive cancers, including colorectal, prostate, and pancreatic cancers.
- SK Biopharmaceuticals also has the right of first negotiation for other pre-selected RDC programs from Full-Life.
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SELLAS announces U.S. FDA rare pediatric disease designation granted to SLS009 for the treatment of pediatric acute myeloid leukemia
- The U.S. FDA has granted Rare Pediatric Disease Designation (RPDD) to SLS009 for treating pediatric acute myeloid leukemia (AML).
- This is SELLAS' second RPDD, following the designation for acute lymphoblastic leukemia last month.
- Enrollment for pediatric AML patients in the ongoing Phase 2 clinical trial has been opened.
- RPDD provides eligibility for SLS009 to receive a Priority Review Voucher (PRV) upon marketing approval, which can be transferred or sold.
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Anagenex announces first programs in synthetic lethal oncology franchise
- Anagenex has nominated PRMT5 and MAT2A as its first two preclinical programs.
- PRMT5 is essential for cell survival, and MAT2A inhibition leads to PRMT5 inhibition.
- Both targets leverage MTAP deletion, a gene lost in 15% of all solid tumors.
- Anagenex aims to nominate a development candidate by 2H 2025.
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