by Jakub Jarolím, Business Intelligence Department
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Sotio Biotech
6/3/2023
January 2023 Biotechnology: Review of news from the most innovative therapeutic areas and the business development transactions
Market
Biotech is looking for signs of improvement in 2023, but fundraising will still be difficult
News of layoffs and restructuring have evoked concerns that 2023 could be a year of attrition that will push companies to prioritize key candidates and hold onto their finances.
While there will be some exceptions, fundraising and IPOs will be difficult for most. NBI remained flat during January.
Antibody-Drug Conjugates
Amgen and Hummingbird to use technologies from Synaffix to develop novel ADCs
Mersana Therapeutics announced the initiation of patient dosing in its Phase 1 clinical trial of XMT-2056, the company’s lead Immunosynthen product candidate.
Interleukin-15 and Interleukin-2
Nemvaleukin awarded Innovation Passport Designation from MHRA UK
Alkermes announced that its nemvaleukin alfa has been granted an Innovation Passport for the treatment of mucosal melanoma under the Innovative Licensing and Access Pathway (ILAP) by the Medicines and Healthcare products Regulatory Agency (MHRA), the regulatory body of the UK.
Cell Therapies
BMS’ Breayanzi met its primary endpoint in Phase 1/2 in multiple myeloma
BMS said CAR T therapy Breyanzi lisocabtagene maraleucel met the primary endpoint of complete response rate compared with historical controls in the Phase 1/2 TRANSCEND CLL 004 study to treat relapsed or refractory chronic lymphocytic leukemia or small lymphocytic leukemia.
Other Innovative Treatment Areas
CStone’s sugemalimab meets in esophageal squamous cell carcinoma
CStone Pharmaceuticals is readying an sNDA for submission to China’s NMPA after Cejemly sugemalimab met the primary endpoints of PFS and OS in combination with chemotherapy to treat locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma, compared with placebo.
Oncology Transactions
Huadong to commercialize CAR-T from CARsgen in China for $30 million upfront
CARsgen and Huadong Medicine announced a collaboration for the commercialization of CARsgen's BCMA CAR-T product CT053 in mainland China.
CT053, zevorcabtagene autoleucel (zevor-cel), is CARsgen's lead drug candidate and an autologous CAR T-cell product treating relapsed/refractory multiple myeloma. CT053 NDA was submitted to NMPA in October 2022.
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