AbbVie/Roche's Venclexta wins fourth approval; WuXi, fellow CRO Altasciences ink deal
→ AbbVie and Roche’s blood cancer drug, Venclexta, has notched a fourth approval. On Wednesday, AbbVie $ABBV said the drug was approved in combination with Genentech’s Gazyva for treatment-naive patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). “The approval is based on findings from the CLL14 trial in which patients received a 12-month treatment regimen. The majority of patients receiving Venclexta in the trial remained progression-free at two years,” said Michael Severino, AbbVie’s vice chairman and president, in a statement. Venclexta was first approved in 2016 by the FDA under the accelerated approval pathway for use in certain patients with CLL — it is now sanctioned for use in more than 50 countries and generated $344 million in global sales last year.
→ Well-connected China-based CRO WuXi has joined forces with a Canadian CRO, Altasciences. The Laval, Quebec-based company will support WuXi AppTec’s Investigational New Drug (WIND) platform — no financial details of the deal were disclosed. “The partnership is an excellent complement for WuXi to help our global collaborators to expedite the R&D process from pre-IND to clinical stages and bring better therapies to patients far faster,” said Edward Hu, Co-CEO at WuXi AppTec, in a statement. Meanwhile, Wuxi’s biologics arm kicked off the construction of a 1.3 million sq. ft. manufacturing center in Chengdu — one of the largest cities in Southwest China — on Thursday.
→ Oncology drug developer Cellectar Biosciences $CLRB has unveiled a $10 million offering— with institutional investors buying $5 million in a registered direct offering of 1,982,000 common shares, and the remaining $5 million coming from a concurrent private placement of 2,018,000 common shares. The announcement comes days after the company’s lead drug — CLR 131 — was granted fast track status by the FDA for fourth-line or later treatment of relapse/refractory multiple myeloma, and one day after the treatment induced a positive response in an ongoing Phase I multiple myeloma study.