Shares of Tscan Therapeutics Inc. (NASDAQ:TCRX) skyrocketed 126%, or $2.85, to trade midday at $5.10 on word of a multiyear collaboration with Amgen Inc. that will use Tscan’s target discovery platform, Targetscan, to identify the antigens recognized by T cells in patients with Crohn’s disease. Tscan banks $30 million up front and could earn more than $500 million in preclinical, clinical, regulatory and commercial milestone payments, plus tiered single-digit royalties. Amgen will evaluate a variety of modalities to create drugs based on targets discovered by Tscan, and will retain all global development and commercial rights. There’s an option to expand the deal into ulcerative colitis, too, under certain terms.

Zion Pharma in $680M Roche deal for its HER2 breast cancer drug

Roche AG acquired global rights to Zion Pharma Ltd.’s lead program, ZN-A-1041, an orally administered selective tyrosine kinase inhibitor that targets HER2 and is designed to penetrate the blood-brain barrier. It has potential in preventing or treating brain metastases in HER2-positive metastatic breast cancer patients. The deal includes up to $70 million in up-front and near-term milestone payments for Zion, plus up to $610 million upon achievement of certain development, regulatory and sales-based milestones. Zion also is entitled to tiered royalties on sales. Roche’s interest stems from its previous work in treating HER2-positive breast cancer. Hong Kong-based Zion is 5 years old and this is its first major deal after having raised about $75 million through venture capital.

Armed with new tools, US FDA picks up pace of accelerated approvals

Despite congressional concerns about accelerated approval, the U.S. FDA’s use of the pathway is not slowing down. If anything, it’s picked up pace since Congress gave the agency stronger authority last year to monitor drugs approved based on a surrogate endpoint and to ensure that confirmatory trials are progressing in a timely way. Of the 13 novel drugs the FDA approved from January through March, four, or nearly 31%, were granted accelerated approval. In comparison, the agency greenlighted only one novel drug for accelerated approval in the first quarter of 2022. While much of that has to do with the flow and timing of the drug pipeline, it does show the FDA isn’t reserving the accelerated pathway for a few isolated drugs.

COVID vaccine myocarditis is due to inflammation

By analyzing a cohort of adolescents that developed myocarditis or pericarditis after vaccination against SARS-CoV-2 vaccination, researchers from Yale University School of Medicine were able to pinpoint the underlying mechanism as an overly active innate immune response to the vaccine that led to broad activation of T cells and natural killer (NK) cells. Myocarditis “has been seen in other vaccine contexts, though is most common after viral infection,” Carrie Lucas, an associate professor of immunobiology at Yale University, told reporters at a press conference announcing the findings.

Et tu, Bruton? New approach in MS gains ground despite Merck partial hold

Watchers of the Bruton’s kinase (BTK) inhibitor space may be casting renewed skepticism in that direction after Merck KGaA disclosed April 12 that the U.S. FDA placed a partial clinical hold on the sign-up of more patients in work testing evobrutinib in relapsing multiple sclerosis (MS) – but BTK efforts in MS continue in various quarters.

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