Takeda's Exkivity, rival to Johnson & Johnson's Rybrevant, wins FDA nod for EGFR exon 20-mutated non-small cell lung cancer. Another patient death in Astellas' neuromuscular disease gene therapy trial has led to an FDA clinical hold. China's Everest Medicines has licensed Providence Therapeutics’ mRNA COVID-19 vaccine candidates and other mRNA programs. And more.
After several setbacks in its Wave 1 pipeline, Takeda has finally chalked up a win, thanks to FDA’s conditional nod for Exkivity in previously treated non-small cell lung cancer with EGFR exon 20 insertion mutations. The oral med will compete with Johnson & Johnson’s bispecific antibody Rybrevant, which in May became the first FDA-approved therapy for this niche patient group.
An X-linked myotubular myopathy patient who experienced abnormal liver function while taking a low dose of Astellas’ investigational gene therapy AT132 in a clinical trial has died. Astellas earlier this month voluntarily paused the trial because of the liver safety signal, but now the FDA has intervened and slapped a clinical hold. The trial had previously seen three patient deaths in the now-abandoned high-dose cohort.
After a couple megarounds, China’s mRNA sector has recorded a licensing deal. China’s in-licensing specialist Everest Medicines is paying $50 million upfront to gain Asia emerging markets rights—including China—to Providence Therapeutics’ mRNA COVID-19 vaccine candidates plus another $50 million for a 50-50 collaboration on two more products leveraging the Canadian biotech’s mRNA platform.
Two cities near Tokyo reported white floating matter in vials of Pfizer and BioNTech’s COVID-19 vaccine. At a press conference, Pfizer’s Japanese unit said the material was likely vaccine ingredients that hadn’t been fully dissolved and wouldn’t affect the safety or efficacy of the vaccine. Altogether, 95 vials have reported floating matter through Sept. 5, the company said.
Through early studies, scientists at the Fred Hutchinson Cancer Research Center identified Takeda’s blood cancer drug Iclusig as a potential drug to control cytokine storm, which is a dangerous immune reaction in some COVID-19 patients. But Takeda told Fred Hutch it doesn’t have the budget to produce additional doses of the drug for a clinical trial to test out the theory, researchers say.
IASO Biotherapeutics has raised $108 million in series C funding to bankroll the global development and regulatory filings for several cell therapies, including the company’s lead candidate, an anti-BCMA CAR-T therapy for the treatment of multiple myeloma. It also has two autologous CAR-T drugs targeting CD19/22 and CD5 for blood cancers.
Merely two weeks after gaining an FDA nod for Waldenström’s macroglobulinemia, BeiGene’s Brukinsa has followed with an accelerated approval in relapsed or refractory marginal zone lymphoma. With the latest go-aheads and looming FDA filing in all-important chronic lymphocytic leukemia, the drug is turning up the heat against AbbVie and Johnson & Johnson’s blockbuster Imbruvica.
Other news of note: