Morphosys AG is to acquire Constellation Pharmaceuticals Inc., financed by gambling a huge chunk of its income on the U.S. firm’s BET inhibitor pipeline drug – an approach that has to date produced mixed results in cancer.
Amgen Inc.’s Merdo Gordon, head of commercial global operations, said just-approved Lumakras (sotorasib) is “priced very well compared to other targeted medicines available in the market” for cancers driven by specific mutations. “Just characterizing the launch broadly, look, it’s really hard to tell because of the variability of our reach to customers right now” – a result of the COVID-19 pandemic.
Little more than two months after inking a $2 billion-plus commercialization deal with Swiss oncology specialist Helsinn Group around the fibroblast growth factor receptor (FGFR) inhibitor infigratinib, Bridgebio Pharma Inc.'s subsidiary, QED Therapeutics Inc., has won accelerated FDA approval for the therapy, to be marketed as Truseltiq. Approval for the oral medicine covers the treatment of patients with previously treated locally advanced chemotherapy-resistant bile duct cancer (cholangiocarcinoma) harboring an FGFR2 fusion or rearrangement as detected by an FDA-approved test.
Well ahead of the assigned Aug. 16 PDUFA date, Amgen Inc. bagged accelerated clearance from the FDA for Lumakras (sotorasib), the first targeted therapy for adults with KRAS G12C-mutated locally advanced or metastatic non-small-cell lung cancer (NSCLC), as determined by an FDA-approved test.
In reporting positive data from a phase III study of sugemalimab in treating stage III non-small-cell lung cancer (NSCLC), Cstone Pharmaceuticals Co. Ltd. and Eqrx Inc. have the first anti-PD-L1 monoclonal antibody demonstrating progression-free survival in patients with concurrent or sequential chemoradiotherapy.
Engine Biosciences Pte. Ltd., a Singapore and Silicon Valley-based company using machine learning, combinatorial genetics and other technologies to hasten the discovery of gene interactions and biological networks underlying disease, has raised $43 million in series A financing. Polaris Partners led the round, which the company said would help it expand its portfolio of precision oncology therapeutics, prepare for its first clinical programs, and scale its technology platform.
The Research to Accelerate Cures and Equity for Children Act is leading to deep changes in pediatric cancer research. Passed in 2017 and fully implemented in 2020, the RACE Act requires companies to investigate targeted drugs for adult cancers in pediatric cancers as well “when the molecular target of the drugs are substantially related to a pediatric cancer.”
Locust Walk Acquisition Corp. CEO and biotech veteran Chris Ehrlich said his firm sifted through more than 90 prospects before setting on a merger with Effector Therapeutics Inc., focused on selective translation regulation inhibitors (STRIs) in cancer.
HONG KONG – Mitoimmune Therapeutics Inc., a company that earlier this year completed a ?27.5 billion (US$24.41 million) series B financing led by Korea Development Bank, has received investigational new drug approval in the U.S. for MIT-001, its anti-inflammatory and anti-necrotic agent, moving the company a step closer to entering the clinic.
San Diego-based Biotheryx Inc. has raised $92 million in series E financing led by Farallon Capital Management to advance multiple molecular glues, proteolysis-targeting chimeras and monovalent degraders toward the clinic. Its first molecular glue program, BTX-1188, is expected to enter the clinic by the end of this year.
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