Merck provides update on phase 3 KEYFORM-007 trial evaluating investigational fixed-dose combination of favezelimab and pembrolizumab for patients with previously treated PD-L1 positive microsatellite stable metastatic colorectal cancer
- The Phase 3 KEYFORM-007 trial did not meet its primary endpoint of overall survival (OS) for patients with previously treated PD-L1 positive microsatellite stable (MSS) metastatic colorectal cancer (mCRC).
- The fixed-dose combination of favezelimab and pembrolizumab did not show an improvement in OS compared to standard of care treatments (regorafenib or TAS-102).
- The safety profile was consistent with previous studies, with no new safety signals observed.
- Merck will continue to evaluate KEYTRUDA-based combinations and novel candidates for colorectal cancer.
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MesoPher cell therapy increases 2-year RFS rate in resected pancreatic cancer by 50%
- Amphera announces phase II trial results in the Journal of Clinical Oncology.
- The trial included 38 patients with resected pancreatic cancer who had completed standard-of-care chemotherapy.
- The primary endpoint was met with a 2-year recurrence-free survival rate of 64%, compared to an expected 40%.
- The 2-year overall survival rate was 83%, with low-grade side effects.
- MesoPher received Orphan Designation from both the FDA and EMA for pancreatic cancer.
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PolTREG starts preclinical CAR-Treg development for neuroinflammatory autoimmune diseases
- PolTREG has launched a preclinical study with CAR-Treg cells in a humanized mouse model of neuroinflammatory disease.
- The study will measure safety and efficacy, with data expected by March 30, 2025.
- CAR-Treg cells are derived from PTG-007, a polyclonal Treg cell therapy with over a decade of clinical data.
- PolTREG plans to initiate the first-in-human trial for MS and ALS as early as next year, pending successful preclinical results.
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IntraBio announces U.S. FDA approval of AQNEURSA for the treatment of Niemann-Pick disease type C
- The U.S. FDA has approved AQNEURSA (levacetylleucine) for treating neurological manifestations of Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing ≥15 kg.
- Approval is based on the IB1001-301 clinical trial, which showed significant improvement in neurological symptoms and functional benefits within 12 weeks.
- AQNEURSA is the only FDA-approved stand-alone therapy for NPC, addressing a significant unmet medical need.
- IntraBio plans to develop AQNEURSA for other rare and common neurodegenerative and neurodevelopmental disorders.
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BioAge Labs announces pricing of upsized initial public offering
- BioAge Labs priced its upsized IPO at $18.00 per share, offering 11,000,000 shares.
- The gross proceeds are expected to be $198.0 million before deductions.
- Shares will trade on the Nasdaq Global Select Market under the ticker symbol 'BIOA' starting September 26, 2024.
- The offering is expected to close on September 27, 2024, subject to customary conditions.
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Guardian Pharmacy Services announces pricing of upsized initial public offering
- Guardian Pharmacy Services priced its upsized IPO of 8,000,000 shares of Class A common stock at $14.00 per share.
- An additional 1,200,000 shares may be purchased by underwriters within 30 days.
- Shares will trade on the NYSE under the symbol 'GRDN' starting September 26, 2024.
- The offering is expected to close on September 27, 2024, subject to customary conditions.
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Enveric Biosciences presents data on lead product candidate, EB-003, at 7th Neuropsychiatric Drug Summit
- Enveric Biosciences presented data on EB-003, a non-hallucinogenic DMT analog, at the 7th Neuropsychiatric Drug Summit.
- EB-003 showed positive outcomes in preclinical models of anxiety and depression.
- The presentation highlighted key preclinical data, including effectiveness in reducing anxiety and depression in two mouse models.
- Enveric plans to file an IND application for EB-003 by Q3 2025 and initiate clinical development by the end of 2025.
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