After a difficult start, there’s been more progress in PIK3 drug class, with FDA approval of Novartis AG’s Vijoice (alpelisib) for the rare condition PIK3CA-related overgrowth spectrum (PROS).
Biosion Inc. has out-licensed ex-China rights for its anti-Siglec-15 monoclonal antibody BSI-060T and additional preclinical assets with the same target to Pyxis Oncology Inc. for $10 million up front and potential milestone payments of up to $222.5 million, plus single to low double-digit royalties on commercial sales.
Biosion Inc. has out-licensed ex-China rights for its anti-Siglec-15 monoclonal antibody BSI-060T and additional preclinical assets with the same target to Pyxis Oncology Inc. for $10 million up front and potential milestone payments of up to $222.5 million, plus single to low double-digit royalties on commercial sales.
Just nine months after a $55 million series B fundraising round, Billiontoone Inc. delivered an oversubscribed series C of $125 million. Demand for the company’s Unity prenatal test, which can assess fetal risk for common recessive conditions and aneuploidies using one maternal blood sample, tripled over the last year.
A patient’s death has caused the FDA to place a partial clinical hold on Alpine Immune Sciences Inc.’s phase I study NEON-2 in adults with advanced malignancies.
Microbiotica Ltd. of Cambridge, U.K., has raised £50 million ($67 million) in series B funding as the company aims to test its microbiome-based technology in early cancer and ulcerative colitis trials. The funding was co-led by new investors Tencent and Flerie Invest, with British Patient Capital on board along with existing investors Cambridge Innovation Capital, IP Group and Seventure. With response rates to checkpoint inhibitors still very low, Microbiotica’s scientists think that the way to improve the immune system’s response to these drugs is by modifying the bacteria present in the gut.
Tot Biopharm International Co. Ltd.’s self-developed Pusintin (bevacizumab), a biosimilar to Roche Holding AG’s Avastin, has won marketing approval from China’s NMPA. It was approved for the treatment of patients with advanced, metastatic, or recurrent non-squamous non-small-cell lung cancer and those with metastatic colorectal cancer.
Continuing its downward trend, BioWorld’s Cancer Index (BCI) has fallen by 19.16% this year, a stark contrast with the broader Nasdaq Biopharmaceutical Index and the Dow Jones Industrial Average, both of which are tracking up by 4.49% and 19.03%, respectively. Two-thirds of the 21 stocks that make up BCI are showing losses so far this year, and everything from disappointing sales, strong competition, clinical holds and safety issues are to blame.
Antengene Corp. Ltd. has formed a partnership with Legochem Biosciences Inc. to jointly develop new antibody-drug conjugates (ADCs) primarily for cancer. The partners will integrate antibodies from Antengene with Legochem’s ADC technology.
It looks like Shanghai Miracogen Inc.’s antibody-drug conjugate (ADC) partnership with Synaffix BV is paying off as MRG-004A, an ADC designed to treat solid tumors, has entered a U.S. phase I/II trial to treat solid tumors.
