SKB-571

The FDA's approval for Yuhan's J&J-partnered Lazcluze, Merck and Kelun's revised ADC deal, and U.S. lawmakers' scrutiny of clinical trials run at Chinese military hospitals made our news this week. Yuhan's Lazcluze, licensed by Johnson & Johnson, has made history as the first Korea-developed novel cancer drug to be approved by the FDA. Merck has optioned in on one Kelun Biotech antibody-drug conjugate but returned another. A few U.S. lawmakers have asked the FDA to examine clinical trials involving sites at Chinese military hospitals. And more. 1. Targeting AZ's Tagrisso, Johnson & Johnson's Rybrevant combo wins key FDA nod in first-line lung cancerThe FDA has approved Johnson & Johnson’s Rybrevant and Lazcluze for newly diagnosed EGFR-mutant non-small cell lung cancer. The combo will compete with AstraZeneca’s Tagrisso. J&J in-licensed Lazcluze, a third-generation EGFR tyrosine kinase inhibitor, from Korea’s Yuhan in 2018. The drug is now the first Korea-developed novel anti-cancer therapy to be approved by the FDA.2. Merck & Co. bags one Kelun ADC for $37.5M, boots out another asset as pipeline tinkering continuesMerck and Kelun Biotech have reworked their multi-asset ADC deal. The New Jersey pharma has decided to return the CLDN18.2-directed SKB315. Although no reason was offered, the CLDN18.2 space has become very crowded with multiple firms exploring various modalities. Merck also agreed to pay $37.5 million to take up an option on a new candidate, a bispecific ADC coded SKB571, although the exact drug target remains unclear.3. Lawmakers urge FDA to investigate clinical trials run in tandem with China's militaryLawmakers on the House Select Committee on the CCP are asking the FDA to scrutinize clinical trials conducted at Chinese military hospitals. The lawmakers questioned the trustworthiness of data generated at those sites and potential risks for U.S. intellectual property. Trials of Eli Lilly’s Alzheimer’s disease drug Kisunla and Pfizer’s cancer med Inlyta were raised as examples. 4. Despite looming BIOSECURE threat, pharma contracting giant WuXi Bio scoops up new projectsMeanwhile, as the House is reportedly gearing up for a vote on the BIOSECURE Act in September, WuXi Biologics said it had added 61 new projects in the first six months of 2024, half of which came from the U.S. Fifty-two of the new projects are for preclinical candidates and five for early clinical work. The number of new projects compares favorably to the company’s haul during the same period last year.5. FDA allows BioNTech-MediLink ADC trial to resume with lower, safer dosesAfter a safety scare in mid-June, the FDA has allowed MediLink Therapeutics to restart a phase 1 trial of its BioNTech-partnered HER3-directed ADC. Before the halt, the trial had recorded three deaths across two dose cohorts. Now, BioNTech said it will focus solely on doses no higher than 3mg/kg as MediLink “had observed a dose level-dependent trend of treatment-related adverse events.”6. Denmark's Adcendo signs $1B biobuck deal for Multitude’s anti-TF ADCDenmark’s Adcendo has signed a $1 billion biobucks deal to get ex-China rights to a preclinical ADC from Sino-American biotech Multitude Therapeutics. The candidate, coded ADCE-T02, targets tissue factor. A phase 1 trial of the drug is scheduled to start in Australia in the fourth quarter, and Adcendo is planning to get FDA’s green light to launch a U.S. study “in the near future.”7. Eisai, Biogen's Leqembi nabs UK nod, but reimbursement remains elusiveThe U.K. has approved Eisai and Biogen’s Leqembi for early-stage Alzheimer’s disease but excluded patients with two copies of the ApoE4 gene out of safety concerns. Still, the National Institute for Health and Care Excellence has tentatively denied coverage of the drug under Britain’s taxpayer-funded insurance program. The drug cost watchdog cited Leqembi’s “relatively small benefits” and high costs.Other News of Note: 8. Astellas employee held in China indicted by China’s prosecutors9. Insulet unveils $200M insulin delivery device production site in Malaysia10. Pathalys raises $105M series B to prepare Japan-approved kidney disease drug for FDA11. FDA rebukes another troubled Eugia production site with a warning letter12. Korea’s Bridge Biotherapeutics, China’s HitGen sign drug discovery pact for cancer (release)13. Pfizer pulls smoking cessation drug Champix from Korean market (Korea Biomedical Review)