CLINICAL AND REGULATORY
FDA approved Enhertu for earlier use in metastatic breast cancer
AZ and Daiichi’s Enhertu (trastuzumab deruxtecan) has been approved in US for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy. Enhertu is a specifically engineered HER2-directed ADC. The FDA approval was based on positive results from the DESTINY-Breast03 Phase 3 trial that showed Enhertu reduced the risk of disease progression or death by 72% versus T-DM1.
FDA accepted BLA for mirvetuximab soravtansine in ovarian cancer with Priority Review
Immunogen announced that FDA has accepted and filed the BLA for mirvetuximab soravtansine monotherapy in patients with FRα-high platinum-resistant ovarian cancer who have been previously treated with 1 to 3 prior systemic treatments. The application has been granted Priority Review designation and FDA has set a PDUFA action date of November 28, 2022.
Springworks falls on weak data of combination of its nirogacestat with ADC Blenrep
SpringWorks Therapeutics fell 40% after new data to be presented at the 2022 ASCO meeting showed that in the Phase 1/2 DREAMM-5 study, the combination of low-dose BCMA-targeted ADC Blenrep plus SpringWorks’ nirogacestat led to ORR of 38% in late-stage multiple myeloma patients vs. 50% for the Blenrep monotherapy arm. The combo did achieve its stated aim of demonstrating a lower rate of ocular toxicity with the combination, with 7% of patients having grade 3 ocular toxicity vs. 50% in the Blenrep monotherapy cohort.
DEALS AND FINANCING
Zymeworks rejected unsolicited non-binding proposal
Zymeworks announced that its Board of Directors, after thorough consultation with its financial and legal advisors, unanimously determined that the unsolicited, opportunistic, non-binding proposal from an activist shareholder, All Blue Falcons FZE, and its affiliates to purchase Zymeworks for $10.50 per share substantially undervalues Zymeworks and is not in the best interest of the Company and its shareholders. In addition, Zymeworks commented that the proposal lacks credibility by offering no information regarding potential sources of funding or any details on their ability to consummate such a transaction. Zymeworks also said it will continue to execute on developing its pipeline, including a HER2-targeted bispecific antibody and ADC against same target.
Turning Point gets rights to anti Claudin18.2 ADC from LaNova Medicines
Turning Point Therapeutics has entered into license agreement with LaNova Medicines to develop and commercialize a novel ADC targeting Claudin18.2 LM-302 globally, excluding Greater China and South Korea. LM-302, which going forward will be identified as TPX-4589, is currently in Phase 1 clinical trials in both US and China. LaNova will receive an upfront payment of $25 million and will be eligible to receive up to an additional $195 million in milestones.
Tubulis closed €60 million Series B financing to accelerate its ADC pipeline
Tubulis announced the successful completion of a €60 million ($63 million) Series B financing led by Andera Partners with participation from new investors Evotec and Fund+. All existing investors also participated. The new capital will be used to advance Tubulis’ proprietary pipeline of uniquely assembled ADCs, towards clinical evaluation as well as introduce programs addressing a range of solid tumor indications.