Merck’s Keytruda meets primary endpoint in head and neck cancer trial
- The Phase 3 KEYNOTE-689 trial evaluated Keytruda as a perioperative treatment for stage III or IVA resected, locally advanced head and neck squamous cell carcinoma.
- Keytruda showed a statistically significant improvement in event-free survival (EFS) and major pathological response (mPR) compared to adjuvant radiotherapy alone.
- The safety profile of Keytruda was consistent with previous studies, with no new safety signals identified.
- Results will be presented at an upcoming medical meeting and submitted to regulatory authorities.
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Ultragenyx receives breakthrough therapy designation for setrusumab in osteogenesis imperfecta
- Ultragenyx's setrusumab (UX143) received Breakthrough Therapy Designation from the FDA for treating osteogenesis imperfecta (OI) in patients aged 2 and older.
- The designation is based on positive results from the Phase 2 Orbit study, showing a significant decrease in fracture rates.
- Setrusumab has also been granted Orphan Drug Designation in the US and EU, and is part of the European Medicine Agency’s PRIME program.
- Ultragenyx and Mereo BioPharma are collaborating on the global development of setrusumab, focusing on pediatric and young adult patients.
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Adcendo receives FDA clearance for ADCE-D01 trial in soft tissue sarcoma
- Adcendo's IND application for the ADCElerate-01 trial of ADCE-D01 has been cleared by the US FDA.
- ADCE-D01 is a first-in-class ADC targeting the uPARAP receptor, overexpressed in mesenchymal cancers.
- The Phase I/II trial will assess safety, pharmacokinetics, and preliminary efficacy in metastatic/unresectable STS.
- Recruitment will occur in the US and Europe, with a CTIS submission planned in the EU.
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Boehringer receives U.S. FDA breakthrough therapy designation and initiates two phase III trials in MASH for survodutide
- Boehringer Ingelheim's survodutide receives FDA Breakthrough Therapy designation for treating non-cirrhotic MASH with moderate or advanced fibrosis.
- Two Phase III trials, LIVERAGE and LIVERAGE-Cirrhosis, are launched to evaluate survodutide's efficacy in MASH patients with fibrosis and cirrhosis.
- LIVERAGE will assess MASH improvement and fibrosis reduction over 52 weeks and long-term liver disease outcomes over seven years.
- LIVERAGE-Cirrhosis will focus on reducing liver disease outcomes in MASH patients with cirrhosis over four and a half years.
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Medilink announces global clinical trial collaboration and supply agreement on YL201 combination therapy
- MediLink and Amgen have entered a global clinical trial collaboration to evaluate YL201 and IMDELLTRAâ„¢ in extensive-stage small cell lung cancer (ES-SCLC).
- The Phase Ib study will assess safety, tolerability, pharmacokinetics, and efficacy of the combination therapy.
- IMDELLTRAâ„¢ has received FDA accelerated approval for ES-SCLC, contingent on confirmatory trials.
- MediLink's YL201 has shown promising results in Phase I/II trials for advanced solid tumors.
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Scholar Rock reports apitegromab meets primary endpoint in phase 3 SAPPHIRE study in patients with spinal muscular atrophy
- Scholar Rock announced positive results from the Phase 3 SAPPHIRE trial for apitegromab in spinal muscular atrophy (SMA).
- The trial met its primary endpoint, showing significant improvement in motor function compared to placebo.
- Apitegromab was well-tolerated with no new safety concerns, consistent with previous trials.
- Scholar Rock plans to submit regulatory applications to the FDA and EMA in Q1 2025.
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Airsupra shows significant reduction in severe asthma exacerbations in BATURA Phase III trial
- The BATURA Phase IIIb trial demonstrated that Airsupra (albuterol/budesonide) significantly reduced the risk of severe asthma exacerbations compared to albuterol alone.
- The trial included patients with intermittent or mild persistent asthma, using either SABA alone or with low-dose ICS or LTRA maintenance therapy.
- Airsupra's safety profile was consistent with previous findings, with no new safety concerns reported.
- Data from the trial will be presented at the ACAAI Annual Scientific Meeting and shared with health authorities.
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Cybrexa therapeutics doses first patient with CBX-12 in phase 2 ovarian cancer trial
- Cybrexa Therapeutics has initiated a Phase 2 trial for CBX-12 in platinum-resistant or refractory ovarian cancer.
- The trial follows positive Phase 1 results showing a 40% response rate in TOP1-naïve ovarian cancer patients.
- CBX-12 uses alphalex technology to deliver exatecan, a topoisomerase 1 inhibitor, directly to tumor cells.
- Future plans include additional Phase 2 studies in colorectal cancer and other solid tumors in 2025.
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Bayer and MOMA Therapeutics enter collaboration and license agreement in oncology
- Bayer and MOMA Therapeutics have partnered to develop and commercialize a small molecule oncology program.
- The collaboration leverages MOMA's KNOMATIC platform, which targets highly dynamic proteins in cancer treatment.
- Bayer will handle preclinical, development, and commercial activities, with MOMA receiving upfront and milestone payments.
- Financial terms of the agreement were not disclosed.
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Innovent and Ask Pharm announce strategic collaboration for limertinib, a third-generation EGFR TKI for the treatment of lung cancer
- Innovent Biologics and ASK Pharm have entered a strategic collaboration for limertinib, a third-generation EGFR TKI for lung cancer.
- Innovent will have exclusive commercialization rights in mainland China, while ASK Pharm will handle production and supply.
- Limertinib's NDAs are under review by China's NMPA for two indications in NSCLC with specific EGFR mutations.
- A Phase 3 trial showed limertinib met its primary endpoint, with detailed results to be presented at future conferences.
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