by Jakub Jarolím, Business Intelligence Department
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SOTIO Biotech
28/7/2022
July 2022 Biotechnology: Review of news from the most innovative therapeutic areas and the business development transactions
Market
The NBI added 2 % during July; there were some initial signs of a pickup in M&A activity
Biotech stocks, as measured by the NBI, reported a mild growth of 4 % in July. There were some initial signs of a pickup in M&A activity in June and July. This can be viewed as a sign that the sell-off in stock markets has gone too far and that the biotechnology sector is currently undervalued.
Antibody-Drug Conjugates
FDA granted Priority Review to Enhertu for treatment of HER2-low breast cancer patients
FDA granted Priority Review and assigned a PDUFA date in 4Q22 to an sBLA for Enhertu fam-trastuzumab deruxtecan-nxki from AstraZeneca and Daiichi Sankyo to treat patients with HER2-low breast cancer who have received a prior line of therapy in the metastatic setting.
Interleukin-15 and Interleukin-2
FDA accepted BLA for N-803 for treatment of muscle-invasive bladder cancer in situ
FDA accepted for review a BLA from ImmunityBio for its antibody cytokine fusion protein as a treatment for patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ with or without Ta or T1 disease.
ImmunityBio filed the BLA based on positive results from a series of studies of the investigational treatment, including the ongoing QUILT 3.032 trial. The PDUFA target action date is May 23, 2023.
Other Innovative Treatment Areas
Akeso wins NMPA approval for dual immune checkpoint inhibitor
Akeso announced that China’s NMPA approved its PD-1xCTLA-4 antibody Kaitanni (cadonilimab), for the treatment of patients with relapsed or metastatic cervical cancer whose disease has progressed on or after platinum-based chemotherapy.
Oncology Transactions
Two Claudin18.2 targeting ADCs from CSPC and Kelun involved in billion dollar deals
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