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.
Naya Biosciences Inc. has expanded its bifunctional antibody pipeline to include NY-500, a novel PD-1 x VEGF tetravalent bifunctional antibody for the treatment of hepatocellular carcinoma (HCC) and other solid tumors.