by Jakub Jarolím, Business Intelligence Department
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Sotio Biotech
31/1/2023
December 2022 Biotechnology: Review of news from the most innovative therapeutic areas and the business development transactions
Market
Inflation, rate hikes and geopolitical concerns led to worst year for stocks since 2008
December 30 marked the final day of trading in what has been a painful year for stocks. Major indexes suffered their worst year since 2008. High inflation and aggressive rate hikes from the Federal Reserve battered grow, geopolitical concerns and volatile economic data also kept markets on edge.
Antibody-Drug Conjugates
Padcev plus Keytruda under FDA Priority Review for urothelial cancer
Updated data from the Phase 3 DESTINY-Breast03 study of anti-HER2 ADC Enhertu fam-trastuzumab deruxtecan-nxki against HER2 ADC Kadcyla ado-trastuzumab emtansine are even stronger than the interim data that led to Enhertu’s approval in the second-line metastatic breast cancer setting.
Interleukin-15 and Interleukin-2
Nektar presented first positive Phase 1 data of NKTR-255 in multiple myeloma
Nektar presented two presentations of NKTR-255 at ASH. NKTR-255 was well tolerated in heavily pre-treated patients with hematologic malignancies (NHL and MuMy) in doses up to 12 μg/kg and in combination with daratumumab in doses up to 9 μg/kg.
Cell Therapies
Autolus announced its obe-cel met Phase 2 endpoint, reaching a $70 million milestone
FDA lifted a clinical hold and cleared an IND for BEAM-201, allowing Beam Therapeutics to proceed with a clinical study of the multiplex silenced, allogeneic CAR T therapy targeting CD7 to treat relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. The agency had placed the hold in early August.
Other Innovative Treatment Areas
Jemperli meets PFS endpoint in Phase 3 RUBY endometrial cancer trial
Anti-PD-1 antibody Jemperli dostarlimab from GSK showed significant improvement in PFS, the primary endpoint, in the first-line trial for adult patients with primary advanced or recurrent endometrial cancer.
Oncology Transactions
Kelun strikes third deal with Merck Co. for ADCs, this time with $175 million upfront
The Kite subsidiary of Gilead Sciences will pay an undisclosed amount for Tmunity, co-founded in 2015 by the University of Pennsylvania’s Carl June to develop CAR T therapies for solid tumors and blood cancers.
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