Moderna and its manufacturing partner have identified the foreign particles in their COVID-19 vaccines in Japan as stainless steel. Astellas' Audentes Therapeutics buy took another hit as a gene therapy trial was paused for a second time thanks to safety concerns. Takeda's Wave 1 pipeline plan also suffered a setback as pevonedistat failed in a phase 3 blood cancer trial. And more.
After Japan put over 2 million doses of Moderna’s COVID-19 vaccine on hold because of contamination reports, the company’s contract manufacturer, Spain’s Rovi Laboratories, has concluded that the particulates discovered in the vials are stainless steel. The particles likely came from friction between two pieces of metal on a manufacturing line, Moderna said. In a joint statement, Moderna, Rovi and the shot’s Japanese distributor, Takeda, said the metal impurity may cause local reaction during an injection but “does not pose an undue risk to patient safety.”
It wasn’t long ago that Astellas’ gene therapy AT132, obtained from the $3 billion acquisition of Audentes Therapeutics, survived an FDA clinical hold after three deaths related to liver failure were recorded among patients with a rare neuromuscular disease who got the high dose. Now, Astellas has voluntarily paused dosing new trial participants in response to abnormal liver function findings in a patient who got the low dose.
Takeda’s late-stage pipeline just took a hit. Pevonedistat, a NEDD8-activating enzyme inhibitor, failed to move the needle in a phase 3 blood cancer trial. Adding the drug on top of Bristol Myers Squibb’s Vidaza didn’t offer additional benefit in slowing disease progression or death when used for newly diagnosed patients with high-risk myelodysplastic syndromes, chronic myelomonocytic leukemia and low-blast acute myeloid leukemia.
The two co-founders of Taiwanese company JHL Biotech have pleaded guilty to stealing trade secrets from Roche’s Genentech and wire fraud. They hired Genentech insiders—who have been convicted via separate guilty pleas—to steal confidential material to accelerate JHL’s development of biosimilars to Avastin, Herceptin, Rituxan and Pulmozyme.
SK Biosciences is launching a phase 3 trial of its COVID-19 vaccine candidate, GBP510, which uses GlaxoSmithKline’s adjuvant. The trial aims to enroll about 4,000 subjects around the world, and it will pit the nanoparticle vaccine against AstraZeneca’s University of Oxford-partnered shot, Vaxzevria.
BeyondSpring recently reported that a combination of its plinabulin and docetaxel significantly prolonged the lives of patients with previously treated non-small-cell lung cancer over docetaxel alone. Now, Jiangsu Hengrui Pharmaceuticals is paying $30 million upfront and committing to another $170 million in milestones for Greater China rights to the drug.
China’s Jacobio Pharmaceuticals led a $53 million series A round in HebeCell. The two will collaborate to develop off-the-shelf pluripotent stem cell-CAR-NK therapy for cancer, viral infection and autoimmune diseases. HebeCell said its approach is different from other players because it has a 3D platform to mimic the lymph nodes in which NK cells develop.
Chinese biotech Lynk Pharmaceuticals has raised $50 million in a series B, led by Lilly Asia ventures. The company has got the green light to run clinical trials for three drugs in the U.S. and China. These include a triple-kinase inhibitor dubbed LNK01002 that just entered phase 1 in primary and secondary myelofibrosis.
Hong Kong-based Insilico Medicine has penned a deal with 4B Technologies to design drugs for neurodegenerative diseases, with an initial focus on amyotrophic lateral sclerosis. Insilico will use its artificial intelligence software to help 4B find drugs that can enhance neuroprotection and suppress inflammation.