Fierce Pharma Asia—Takeda's lung cancer nod; 4th death in Astellas' gene therapy trial; Everest's mRNA play

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Takeda's FDA approval for Exkivity, another FDA clinical hold on Astellas' gene therapy trial and Everest Medicines' mRNA licensing deal made our news this week. (Asiamap)(Google)

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.

1. Ready to rival J&J, Takeda's growth plan bears fruit with FDA nod for niche lung cancer drug Exkivity

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.

2. Another death blights Astellas' $3B Audentes buy as FDA slaps clinical hold on the test

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.

3. Everest bags COVID-19 program in bid to conquer Chinese mRNA market

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.

4. Floating material found in Pfizer COVID-19 vaccine vials in Japan, but company says it's not contamination

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.

5. Fred Hutch researchers tout Iclusig's potential to tame cytokine storm in COVID but can't get Takeda on board

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.

6. China's IASO nets $108M to advance cell therapies, antibodies for cancer, autoimmune disease

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.

7. BeiGene's Brukinsa turns up heat against Imbruvica with latest lymphoma nod

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:

8. Takeda eyes vaccine business growth amid COVID-19 partnerships and dengue progress, CEO says

9. Sinovac, Numolux in talks to build vaccine facility in South Africa: report

10. Haisco to pay $140M to get the ball rolling on Biosplice's phase 3 osteoarthritis drug in China

11. Jubilant Cadista recalls combination birth control pills after failed dissolution test