Gaining full rights to a bispecific antibody to treat atopic dermatitis, Johnson & Johnson is paying $1.25 billion to acquire Yellow Jersey Therapeutics, a wholly owned subsidiary of Numab Therapeutics AG. The subsidiary houses all assets related to NM-26, which targets IL-4Ra and IL-31, and was designed with Numab’s MATCH (Multispecific Antibody-based Therapeutics by Cognate Heterodimerization) technology platform. It is ready for phase II development for atopic dermatitis, although J&J intends to develop, manufacture and commercialize the drug globally for follow-on indications as well. “Yellow Jersey was recently incorporated as a subsidiary of Numab Therapeutics and will be demerged into an independent entity,” said Numab’s founder and CEO, David Urech, who added that the $1.25 billion payment is “all up front in cash, no contingent payments.”

Asahi Kasei seeks global pharma growth via $1.1B Calliditas buy

Japanese industrial conglomerate Asahi Kasei Corp. has made an offer to acquire Swedish rare diseases specialist Calliditas Therapeutics AB for SEK11.8 billion (US$1.1 billion). The offer, at an 83% premium to the closing share price of SEK113.60 on Monday, May 27, is recommended by the three biggest shareholders and the board of Calliditas, which said the company, which markets Tarpeyo (budesonide) for progressive kidney disease primary immunoglobulin A nephropathy, would benefit from “being part of a larger platform.” The combination of a specialist kidney disease therapy and an existing U.S. commercial operation also makes Calliditas a good fit for Asahi Kasei’s pharma business, which is in the midst of a strategic push to expand its footprint in the U.S., and has an existing nephrology franchise

Insmed stock soars on phase III lung disease data

Insmed Inc.’s phase III study of brensocatib in treating non-cystic fibrosis bronchiectasis hit its primary and multiple secondary endpoints, impressing investors with statistically significant results. Top-line data from the placebo-controlled Aspen study produced statistically significant reductions in the annualized rate of pulmonary exacerbations compared to placebo using the small-molecule, oral, reversible inhibitor of dipeptidyl peptidase 1. Insmed said it plans to file an NDA with the U.S. FDA in the fourth quarter of 2024. The company’s stock (NASDAQ:INSM) had more than doubled at midday, with shares up 109% to $45.86 each.

Innovent’s picankibart hits phase III plaque psoriasis endpoints

Innovent Biologics Inc.’s picankibart (IBI-112) met all primary endpoints and key secondary endpoints in the phase III registrational Clear-1 trial in Chinese subjects with moderate to severe plaque psoriasis. More than 80% of patients on picankibart achieved a 90% improvement from baseline using Psoriasis Area and Severity Index score after 16 weeks of treatment. Innovent of Suzhou, China and San Francisco, said it will submit an NDA for the recombinant anti-interleukin 23p19 subunit (IL-23p19) antagonist for psoriasis to China’s National Medical Product Administration. IBI-112 is also being studied in ulcerative colitis, Crohns disease, autoimmune disease, and enteritis. 

Inhibiting metabolic enzyme prevents EBV-driven disease

Treatment with indoleamine dioxygenase-1 (IDO1) inhibitors reduced both viremia and B-cell transformation in animal models of post-transplant lymphoproliferative disorder (PTLD), while IDO1 up-regulation occurred in patients who would go on to develop PTLD. The findings, which were reported in the May 24, 2024, issue of Science by researchers from the University of Basel and the University Hospital Basel, point to new ways to predict, prevent and treat complications of Epstein-Barr virus infection.

US Congress eyes FDA’s supply chain, recall issues

A recent hearing in the U.S. House of Representatives highlighted some of the issues Congress has with the agency’s performance, but there were questions as well about the FDA’s statutory authorities. One of these is the lack of statutory authority to require a recall for prescription drugs as well as the deadline for notifying the agency of device recalls, both of which are areas of legislative interest on the part of Congress.

Holiday notice

BioWorld’s offices were closed in observance of Memorial Day in the U.S. No issue was published Monday, May 27.

Also in the news

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