CLINICAL AND REGULATORY
European Commission approved Padcev for locally advanced or metastatic urothelial cancer
Astellas and Seagen announced that the European Commission has approved Padcev (enfortumab vedotin) as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a PD-1/L1 inhibitor. The EC approval is supported by data from the global phase 3 EV-301 trial that demonstrated an OS benefit compared with chemotherapy.
Enhertu granted Priority Review in US for previously treated HER2-mutant metastatic NSCLC
AstraZeneca and Daiichi Sankyo have received notification of acceptance of the sBLA of ADC Enhertu for the treatment of adult patients in the US with unresectable or metastatic NSCLC whose tumors have a HER2 mutation and who have received a prior systemic therapy. The application has also been granted Priority Review. The PDUFA date, the FDA action date for their regulatory decision, is during the third quarter of 2022. The Priority Review follows Breakthrough Therapy designation by the FDA for Enhertu in this cancer type in May 2020.
DEALS AND FINANCING
GeneQuantum and Aimed Bio will collaborate on first in class ADC
Chinese GeneQuantum Healthcare signed an agreement with a Korean biotech Aimed Bio to co-develop a first-in-class therapeutic ADC. Aimed Bio, a spin-off company from Samsung Medical Center, is focusing on developing innovative antibody-centric drugs for brain diseases with few treatment options. GeneQuantum focuses on next generation ADC development. Taking advantage of the proprietary Ligase Dependent Conjugation technology platform, which allows a site-specific conjugation of cytotoxins or other type of payloads to antibodies, the company has developed a pipeline with more than 10 assets, with several at or approaching clinical stage. The collaborating ADC is a first-in-class asset with highly differentiated antibody against a unique target, a stable linker design and a novel payload with a strong by-stander killing effect. The resulting ADC is expected to treat brain and other cancers. The new drug is expected to enter IND in 2023.
Antibody and ADC developer Remegen raised $410 million in Shaghai IPO
Less than a year after winning approval in China for the first domestically developed ADC, Remegen raised ¥2.6 billion ($410 million) and picked up a listing on the Shanghai STAR market to support further work on its monoclonal antibodies and ADCs.