CLINICAL AND REGULATORY

Elahere to became standard of care in ovarian cancer

It showed that it led to a 35% risk reduction in disease progression or death versus chemotherapy in platinum-resistant FOLR1-positive patients in the confirmatory trial. With a survival benefit and a safety profile no worse than chemotherapy, Elahere is about to gain full FDA approval and is likely to become the new standard of care for treatment of FOLR1-positive platinum-resistant ovarian cancer.

FDA placed clinical hold on Mersana’s upifitamab rilsodotin

A partial clinical hold affecting enrollment in the Phase 3 UP-NEXT and Phase 1 UPGRADE-A trials, which are evaluating upifitamab rilsodotin to treat ovarian cancer, clipped shares of Mersana Therapeutics. The company said there appeared to be an imbalance in bleeding events in an aggregate safety report, including five fatal bleeding events among 560 patients dosed with the antibody-drug conjugate targeting SLC34A2.

A pair of TROP2-targeted ADCs showed progress in NSCLC during ASCO

AZ said that in the TROPION-Lung02 study, datopotamab deruxtecan plus Keytruda led to a 38% ORR in both untreated and previously treated patients. The ORR was 49% when chemo was added to the combination. Kelun and Merck & Co. also reported data from a partnered TROP2 ADC in the indication. In the Phase 2 KL264-01 study, SKB264 led to a 44% confirmed ORR in previously treated NSCLC patients. Dato-DXd was tested in a combination regimen, while SKB264 was tested as monotherapy.

Nearly two thirds of the patients in the Dato-DXd study were previously untreated, with no patients receiving more than two prior lines. In contrast, about 17% of the patients in the SKB264 study had received more than two lines of treatment, and no patients were treatment naïve. But while the patients in the Kelun and Merck study were more heavily pretreated, that trial included patients with EGFR mutations, which drove up the response rates for the overall study population.

DEALS AND FINANCING

Lonza expands ADC offering with Synaffix takeout

Lonza is adding a next-generation ADC platform to its development and manufacturing services via the €100 million ($107 million) acquisition of Dutch biotech Synaffix. Founded in 2010, Synaffix had raised just one undisclosed series A round, after which it relied on a series of out-licensing deals to finance the development of its ADC linker and payload technologies without developing its own in-house pipeline of programs.

The biotech has 12 disclosed partners, with three having ADC programs that had reached Phase 1 testing. In addition to the upfront, Synaffix investors are eligible for up to €60 million in performance-based milestones.

Lilly buys German ADC company Emergence Therapeutics

Eli Lilly announced that it has agreed to acquire Emergence Therapeutics, a Germany-based developer of ADCs. An announcement from Heidelberg Pharma said that the company had divested its stake in Emergence as Lilly acquired the biotech. Pontifax led Emergence’s $98 million series A round in December 2021; the company’s lead program is ETx-22, an ADC targeting PRR4.

Eisai backs Chinese Bliss Biopharmaceutical with Series B++ round

Eisai funded a series B++ round in Bliss Biopharmaceutical, which will use the money to advance its pipeline of ADCs. The size of the round was not disclosed. Last month, the two companies announced a collaboration agreement for Bliss’s lead ADC BB-1701, which targets HER2 to treat breast, gastric, urothelial and lung cancers, among others.

ADC company Escugen raises $14 million in its Series A+ round

Shanghai Escugen Biotechnology raised a RMB100 million ($14 million) A+ round for its pipeline of ADCs and monoclonal antibodies, three of which are now in the clinic. Those include ESG401, an ADC targeting TROP2 to treat solid tumors including those of the breast, lung and ovaries, and ESG206, a mAb to treat B cell lymphoid malignancies. Toposcend Capital led the round, with participation from Lotus Lake Ventures and Zhangke Herun.