CSPC Pharmaceutical Group Ltd.’s antibody-drug conjugate SYS-6045 has been granted clearance by China’s National Medical Products Administration (NMPA) to enter clinical trials.
Strong interim safety and efficacy data from Hoth Therapeutics Inc.’s phase IIa study of HT-001 helped boost the company’s stock (NASDAQ:HOTH) on Jan. 7 as shares rose 178% to close at $2.28 each.
Tanvex Biopharma Inc. said its U.S. subsidiary, Tanvex Biopharma U.S.A. Inc., received an FDA complete response letter (CRL) on Jan. 3 for its TX-05 BLA, a biosimilar that references Roche AG’s Herceptin (trastuzumab). The CRL cites unnamed issues that need to be addressed by the downstream manufacturer of TX-05, which is a third-party service provider of Tanvex U.S. for its drug product.
Roche Holding AG kicked off the new year (again) with a potential $1 billion deal, including $80 million up front, for exclusive rights to Innovent Biologics Inc.’s IBI-3009, a DLL3-targeting antibody-drug conjugate (ADC) candidate that recently entered a phase I study.
The curtain is coming down on one of Europe’s longest-established biopharmas, with Novartis AG announcing it is to shut Morphosys AG’s facilities, following its 2024 acquisition of the one-time antibody pioneer for $2.9 billion. The closure of sites in the U.S. and Germany by the end of 2025 will affect 330 employees.
The antibody-drug conjugate (ADC) arena continues to ring up deals, as Avenzo Therapeutics Inc. signed an exclusive license agreement with Duality Biotherapeutics Inc., whereby Avenzo will develop, manufacture and commercialize AVZO-1418/DB-1418, described as a potential best-in-class EGFR/HER3 bispecific ADC, globally (excluding greater China).
Artificial intelligence (AI)-based models developed by a team of international researchers were able to identify ovarian cancer in ultrasound images more accurately than humans. Results from a study published in Nature Medicine showed that the AI models achieved an accuracy rate of 86.3%, compared to 82.6% for the experts and 77.7% for the non-expert examiners.
C-C chemokine receptor-like 2 (CCRL2) is a chemokine receptor involved in inflammation activation and is usually expressed in differentiated myeloid cells. CCRL2 is overexpressed in acute erythroid leukemia (AEL) cells compared to healthy cells. Antibody-drug conjugates (ADCs) against CCRL2 in AEL were developed and tested in the preclinical setting.
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