RemeGen said China’s FDA expanded the label of ADC disitamab vedotin by granting conditional approval to treat HER2-expressing, locally advanced or metastatic urothelial carcinoma.
The agency had already granted the ADC conditional approval in June 2021 for gastric cancer. Seagen paid $200 million upfront in August to obtain most global rights to disitamab vedotin, which the partners believe uses a mAb with higher HER2 affinity than Herceptin trastuzumab.
Sutro Biopharma provided a clinical update from its ongoing, fully enrolled, dose-expansion Phase 1 study of STRO-002, a folate receptor alpha (FolRα)-targeting ADC, for patients with advanced ovarian cancer. A 33% ORR was observed in 33 RECIST evaluable patients across all FolRα expression levels and both dose levels. The dose response was observed, with a 47% ORR in 17 patients who started at the 5.2 mg/kg dose level. Emerging safety profile was generally consistent with prior STRO-002 data, with no new safety signals observed, including the absence of keratopathy.
FDA granted priority review to the sBLA for Enhertu fam-trastuzumab deruxtecan-nxki to treat unresectable or metastatic HER2 positive breast cancer in adults who received a prior anti-HER2-based regimen, setting a PDUFA date in 2Q22. Jointly developed by AstraZeneca and Daiichi Sankyo, Enhertu is a HER2 directed antibody drug conjugate which is approved for breast cancer patients who have received two or more prior anti-HER2-based regimens, and for locally advanced gastric or gastroesophageal junction adenocarcinoma patients who have received a prior trastuzumab-based regimen.
Ahead of expected interim readout for STRO-002, Sutro Biopharma has granted Tasly Biopharmaceuticals rights in Greater China to the ADC targeting FOLR1, which is in Phase 1 testing to treat ovarian and endometrial cancers. Sutro received $40 million up front, and is eligible for $345 million in milestones, plus royalties.
British ADC company Iksuda Therapeutics will take LCB14, a HER2 ADC, into Phase 1 having licensed it from Korea’s LegoChem Biosciences. LegoChem is eligible for development, regulatory and commercial milestone payments, as well as royalties on commercial sales, but amounts were not disclosed. Iksuda’s rights to LCB14 are global, excluding Greater China and South Korea. The company has partnered with LCB previously, and its Korean investor base contributed to a $47 million series A last June.
Genmab has licensed the GlycoConnect, HydraSpace and toxSYN technologies of Synaffix for a single drug target, with the option for worldwide development and commercialization of any resulting ADCs. Genmab has an option to exercise exclusive research and commercial licenses for more targets. Synaffix received $4.5 million up front and is eligible for milestone payments for a total potential deal value of $415 million plus tiered, mid-single digit royalties.
Nine months after securing accelerated approval from FDA for Zynlonta loncastuximab tesirine-lpyl to treat relapsed or refractory large B cell lymphoma, ADC Therapeutics has partnered with Mitsubishi Tanabe Pharma in a deal giving the Japanese pharma local rights to the antibody-drug conjugate targeting CD19. ADC will receive $30 million up front in the deal and is eligible for $205 million in milestones, plus double-digit royalties.
