CLINICAL AND REGULATORY
Enhertu significantly improved PFS and OS in patients with HER2-low metastatic breast cancer
First HER2-low metastatic breast cancer Phase 3 results for AstraZeneca and Daiichi Sankyo’s Enhertu offer potential to redefine how the disease is classified and treated. Positive high-level results from the pivotal DESTINY-Breast04 Phase III trial showed Enhertu demonstrated a statistically significant and clinically meaningful improvement in both PFS and OS in patients with HER2-low unresectable and/or metastatic breast cancer regardless of hormone receptor status versus physician’s choice of chemotherapy. Up to 55% of all patients with breast cancer have tumors with a HER2 IHC score of 1+, or 2+ in combination with a negative ISH test, a level of HER2 expression not currently eligible for HER2-targeted therapy. HER2-low expression occurs in both HR-positive and HR-negative disease. The HER2-targeted drug is approved to treat HER2-positive breast cancer and gastric cancer.
DEALS AND FINANCING
Synaffix inks $586 deal with MacroGenics to enable next generation ADCs
Synaffix entered a technology agreement with MacroGenics to use Synaffix’s GlycoConnect antibody conjugation technology, HydraSpace polar spacer technology, as well as select toxSYN linker-payloads. These will be combined with MacroGenics’ proprietary antibody and bispecific DART antibody platform technologies to generate next generation ADCs. Synaffix will be eligible to receive up to $586 million in payments spanning upfront and milestone payments across three programs plus royalties on commercial sales. The license rights of MacroGenics for each program will be designated as exclusive or non-exclusive to each program’s antibody target. The first program will commence at signature, with the option to expand the collaboration to a further two programs by March 2023. MacroGenics will be responsible for research, development, manufacturing, and commercialization of the ADCs. At the same time, Synaffix will support MacroGenics’ research activities and be responsible for the manufacturing of components that are specifically related to its proprietary GlycoConnect and HydraSpace technologies and the toxSYN linker-payloads.
Mersana announced research collaboration with Janssen to advance novel ADCs
Mersana announced a research collaboration and license agreement with Janssen Biotech to discover novel ADCs for three targets. Janssen will provide proprietary antibodies for three targets. Mersana will apply its expertise and its proprietary Dolasynthen platform to discover novel ADC product candidates. Mersana may leverage Synaffix’s GlycoConnect technology as its preferred site-specific ADC bioconjugation technology. Mersana will collaborate with Janssen on target candidates during preclinical development, with Janssen being solely responsible for clinical development and commercialization. Mersana will receive an upfront payment of $40 million. Mersana is eligible to receive reimbursement of certain costs as well as more than $1 billion in potential milestone payments, plus mid-single-digit to low double-digit percentage royalties on worldwide net sales of ADCs against the selected targets.
Lepu Biopharma raised $116 million to invest in ADC and PD-1/L1 drugs
Lepu Biopharma completed its IPO on Hong Kong stock exchange, raising HK$904 million ($115.9 million). The company plans to use more than half of the proceeds to support the R&D of its ADC candidates MRG-002 and MRG-003, anti-PD1 antibody HX-008 and anti-PD-L1 antibody LP-002. MRG-002 is HER2-targeting ADC currently evaluated in Phase 2 trial in HER2 over-expressing urothelial cancer. MRG-003 is and ADC targeting EGFR and is currently in Chinese Phase 2 trial for treatment of squamous HNC cancer. This year, the company plans to initiate a trial in the US.