Baihua Pharmaceutical Hits Five Consecutive Daily Limit-Ups as Innovative Drug Out-Licensing Data Shines

Tempus announced an expanded, multi-year collaboration with Moderna and Merck to support the potential commercialization of intismeran autogene, also known as V940 or mRNA-4157, a potential first-in-class individualized neoantigen therapy being evaluated in combination with KEYTRUDA in patients with completely resected stage IIB-IV melanoma and other cancer types. Intismeran autogene is jointly developed by Moderna and Merck, known as MSD outside the United States and Canada, and the new collaboration builds on joint efforts initiated last year. Under the agreement, Tempus will manage the timely collection and transfer of tumor tissue and blood samples required for next-generation sequencing, and, subject to applicable regulatory approvals, will also provide NGS services to support the intismeran autogene design and manufacturing process. Financial terms of the collaboration were not disclosed. Moderna Chief Business Officer Said Francis said the partnership lets the company leverage Tempus's commercial footprint and advanced sequencing capabilities, while Jannie Oosthuizen, President of Global Oncology and MSD International, said such collaborations are helping build the infrastructure needed to bring individualized neoantigen therapies to patients at scale.

AbbVie announced that the U.S. Food and Drug Administration has granted two Breakthrough Therapy Designations for telisotuzumab adizutecan, known as Temab-A or ABBV-400, in colorectal cancer and non-small cell lung cancer. The first designation covers Temab-A in combination with bevacizumab for adults with refractory, metastatic colorectal cancer previously treated with fluoropyrimidine, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and, if indicated, anti-EGFR monoclonal antibody therapy. The second covers Temab-A as a monotherapy for adults with locally advanced or metastatic EGFR wild-type, c-Met protein-expressing, non-squamous non-small cell lung cancer who have previously received platinum-based chemotherapy and an anti-PD-(L)1 antibody therapy. These are the first Breakthrough Therapy Designations for Temab-A and bring AbbVie's antibody-drug conjugate portfolio to four such designations; they were primarily based on results from the first-in-human study M21-404. Temab-A is an investigational, next-generation, c-Met-directed antibody-drug conjugate with a novel topoisomerase 1 inhibitor payload and has not been approved by any global regulatory authority.

Genmab posted two fresh oncology trial readouts, including a Phase 3 win for epcoritamab in newly diagnosed diffuse large B cell lymphoma. The EPCORE DLBCL 2 trial, run with AbbVie, reported that epcoritamab plus R CHOP cut the risk of disease progression or death by 51% versus R CHOP alone in patients with higher risk DLBCL. Separately, the Phase 1/2 RAINFOL 01 study of rinatabartsesutecan, or Rina S, in platinum resistant ovarian cancer reported a 45.9% confirmed objective response rate in a heavily pretreated population, with a median duration of response of 12.1 months and no clear safety signals around eye toxicity, peripheral neuropathy, interstitial lung disease or stomatitis. The trial headlines arrive after a strong run in the shares, with the DKK2,482.0 price coming alongside a 31.18% 90 day share price return and a 23.67% year to date share price return, while the 5 year total shareholder return is down 8.75%.