This Week in Biotech #13
Catch up on the latest biotech breakthroughs and upcoming trends (Sept 20-24).
Welcome to the Wednesday edition of This Week in Biotech by Biotech Blueprint!
MARKET UPDATES
🔹❗ Corbus Pharmaceuticals’ (CRBP) stock plunged 60% on Friday, Sept. 20, after disappointing data from Novo Nordisk’s phase 2 trial of an oral weight loss drug, monlunabant. Corbus is developing a similar obesity drug, CRB-913, which is still in the preclinical stage. The company also has two early-stage cancer drug candidates. The market reaction reflects concerns over CRB-913’s potential, given the setback with Novo’s similar compound. On the contrary, Viking Pharmaceuticals (VKTX) and Structure Therapeutics (GPCR), who are also developing oral weight loss drugs saw their stocks rise. On Monday, Mizuho recommended buying Corbus, arguing that the market’s reaction was overblown, as the company’s valuation is primarily driven by its lead asset, CRB-701, which delivered positive phase 1 results, rather than CRB-913.
🔹 Skye Bioscience saw its stock rally 22% on Monday after highlighting the advantages of its obesity treatment candidate, nimacimab, in contrast to monlunabant. Skye emphasized that nimacimab, a large-molecule CB1 inhibitor, had no reported neuropsychiatric adverse events in its phase 1 studies, and preclinical data indicated minimal brain accumulation, offering a safer alternative. The company is currently conducting a phase 2 study for nimacimab.
🔹 Capricor Therapeutics’ shares surged by over 50% after the company announced plans to seek FDA approval for its lead candidate, deramiocel (CAP-1002), this year. The San Diego-based biotech intends to file a biologics license application this October, targeting approval for deramiocel in treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD).
BIOTECH NEWS
🔹 On Sept. 24, Bavarian Nordic announced it has received a $63M contract from the U.S. Biomedical Advanced Research and Development Authority (BARDA) for the production and supply of additional JYNNEOS mpox vaccines. This funding will help replenish the bulk inventory used during the 2022 mpox outbreak and support the manufacture of one million freeze-dried doses, scheduled for delivery in 2026.
🔹 Vaccine startup Vicebio has secured $100M in series B financing, led by TCGX, with support from investors like Goldman Sachs and venBio. The funds will accelerate the development of next-generation vaccines for respiratory viruses using Vicebio’s proprietary Molecular Clamp technology. This technology stabilizes viral proteins to elicit strong immune responses and is applied to viruses like RSV, hMPV, and more. The financing will support a phase 1 trial for VXB-241, a bivalent vaccine targeting RSV and hMPV, with initial results expected in mid-2025.
🔹 On Sept. 23, Innate Pharma announced FDA clearance of its investigational new drug (IND) application for IPH4502, an ADC drug targeting nectin-4 in solid tumors. The upcoming phase 1 clinical study will evaluate the safety, tolerability, and preliminary efficacy of IPH4502.
🔹 On Sept. 20, the European Medicines Agency recommended expanding Regeneron/Sanofi’s Dupixent (dupilumab) approval to treat eosinophilic esophagitis in children as young as 1 year old. This decision is based on a phase 3 trial showing significant histological remission in children compared to placebo.
🔹 On Sept. 20, Zevra Therapeutics announced the FDA’s approval of Miplyffa (arimoclomol) as the first treatment for Niemann-Pick Disease Type C (NPC), a rare and fatal neurodegenerative disease. Miplyffa, combined with miglustat, is approved for treating NPC’s neurological symptoms in patients aged 2 and older. The approval is based on clinical trials showing Miplyffa’s effectiveness in slowing disease progression.
CLINICAL TRIAL UPDATES
🔹 On Sept. 24, Biogen and UCB announced positive topline results from the phase 3 study of dapirolizumab pegol, an investigational treatment for moderate-to-severe systemic lupus erythematosus (SLE). The study met its primary endpoint, showing significant clinical improvement compared to placebo, along with positive outcomes in key secondary measures related to disease activity and flares.
🔹 On Sept. 23, AstraZeneca and Daiichi Sankyo announced final results of their TROPION-Breast01 phase 3 trial for datopotamab deruxtecan (Dato-DXd) in patients with metastatic HR-positive, HER2-low or negative breast cancer. While the treatment demonstrated improvement in progression-free survival, it did not achieve statistical significance in overall survival compared to chemotherapy.
🔹 On Sept. 23, Black Diamond Therapeutics announced promising initial phase 2 data for BDTX-1535, showing a 42% objective response rate in patients with recurrent EGFR-mutant non-small cell lung cancer (NSCLC) resistant to previous treatments. The drug was well-tolerated with no new safety signals, and encouraging durability, with the first three patients showing a duration of response of approximately eight months.
🔹 On Sept. 23, IDEAYA Biosciences announced positive interim phase 2 data for darovasertib in neoadjuvant uveal melanoma, showing promising tumor shrinkage and eye preservation rates. IDEAYA plans to launch a phase 3 trial, targeting ~400 patients.
🔹 On Sept. 23, Biohaven announced positive results from a 3-year study of troriluzole for treating spinocerebellar ataxia. Troriluzole met the primary endpoint, showing a significant reduction in disease progression across multiple genotypes. Biohaven plans to submit a new drug application to the FDA in late 2024, with priority review eligibility due to orphan drug and fast-track designations.
🔹 On Sept. 20, it was announced that Novo Nordisk’s phase 2a trial for monlunabant, an oral CB1 receptor inverse agonist, showed significant weight loss in people with obesity. The 10 mg dose led to a 7.1 kg reduction after 16 weeks, compared to 0.7 kg with placebo. However, the company reported neuropsychiatric effects like anxiety, irritability, and sleep disturbances, which were dose-dependent. A phase 2b trial will begin in 2025 to explore optimal dosing and safety.
Happy Wednesday and thanks for reading Biotech Blueprint!
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DISCLOSURE: I have no business relationships with any company mentioned in this article.