by Jakub Jarolím, Business Intelligence Department
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SOTIO Biotech
18/6/2022
May 2022 Biotechnology: Review of news from the most innovative therapeutic areas and the business development transactions
Market
Biotech market remains low, and no oncology IPO was completed in last three months
April was the cruelest month for biotech so far and the stocks remain low. However, big pharma companies are still resisting temptation for biotech M&A spree until prices drop further. The IPO market is also dead, with only 12 IPOs completed this year and no oncology IPO in last three months.
Antibody-Drug Conjugates
FDA approved Enhertu for earlier use in 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.
Interleukin-15 and Interleukin-2
ImmunityBio submits BLA for N-803 + BCG for non-muscle invasive bladder cancer
ImmunityBio has submitted BLA to FDA for N-803, IL-15 superagonist, plus Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle invasive bladder carcinoma in situ with or without Ta or T1 disease.
Cell Therapies
Bayer is returning licensing rights to Atara’s mesothelin CAR-T therapies
CARsgen reported interim results of investigator-initiated trial of CT041 were reported in the Nature Medicine. The Phase 1 results of CLDN18.2-specific CAR-T in gastrointestinal cancers are from a multi-center, open-label trial conducted in China to explore the safety, efficacy and cellular pharmacokinetics of CT041 in patients with CLDN18.2-positive advanced gastrointestinal cancers.
Other Innovative Treatment Areas
New LAG3 data advance Merck cancer strategy behind Keytruda
Merck’s next class of checkpoint blockers took a step forward at ASCO with data suggesting anti-LAG3 antibody favezelimab plus Keytruda may be effective in indication where other immunotherapy combinations aren’t available.
In a pair of abstracts released ahead of ASCO, Merck reported that favezelimab plus Keytruda led to ORR of 73% in 30 PDL1-naive HL patients and an ORR of 31% in 29 patients with PDL1-refractory disease.
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