With 11 approved therapeutics in a diversity of targets and indications, antibody-drug conjugates (ADCs) have proved their clinical mettle. But they have not yet reached their full clinical potential, which, in the opinion of Astrazeneca plc’s Kenneth Thress, could transform patient care. The strength of ADCs, he told the audience at an educational session at the 2022 annual meeting of the American Association for Cancer Research (AACR 2022), is that it can turn anything into a targeted therapy.
The quixotic course of the cancer therapy Ontak continues with new top-line data from Citius Pharmaceuticals Inc. The company’s phase III study of I/Ontak (E-7777), a reformulation of previously FDA-approved oncology treatment Ontak (denileukin diftitox), was consistent with the prior formulation. No new safety signals were identified in treating persistent or recurrent cutaneous T-cell lymphoma.
Shanghai Allist Pharmaceuticals Co. Ltd.’s third-generation EGFR tyrosine kinase inhibitor, furmonertinib, met its primary endpoint in a phase III trial, demonstrating longer progression-free survival vs. first-generation EGFR TKI Iressa (gefitinib, Astrazeneca plc) as first-line therapy for locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer.
Preclinical data on two newly designed mRNA molecules from Sunshine Biopharma Inc., of Montreal, showed they are effective at killing cancer cells grown in culture. Tests were performed on a variety of cancer cells, including multidrug-resistant breast cancer cells, ovarian adenocarcinoma cells and pancreatic cancer cells, while toxicology studies using normal human cells showed that the mRNA molecules had little or no cytotoxic effects.
Still reeling from the impact COVID-19 has had on its research activities and funding, Cancer Research UK is to launch a new organization combining all its drug discovery expertise in a single team, with a single portfolio, later this month.
A patient’s death has prompted the FDA to place a partial clinical hold on Curis Inc.’s phase I/IIa study of emavusertib in leukemia. The patient, who had relapsed or refractory acute myeloid leukemia, experienced several conditions. One of them was rhabdomyolysis, a dose-limiting toxicity of emavusertib. Rhabdomyolysis is a breakdown of muscle fibers in the blood.
Gilead Sciences Inc. said it is increasing manufacturing capacity to match an anticipated increase in demand for its CAR T-cell therapy, Yescarta (axicabtagene ciloleucel), which gained FDA approval for a wider group of lymphoma patients late last week.
Biosion Inc. has out-licensed ex-China rights for its anti-Siglec-15 monoclonal antibody BSI-060T and additional preclinical assets with the same target to Pyxis Oncology Inc. for $10 million up front and potential milestone payments of up to $222.5 million, plus single to low double-digit royalties on commercial sales.
Clovis Oncology Inc. is trying to claw its way into ovarian cancer relevance against vastly larger competitors Astrazeneca plc and Glaxosmithkline plc with positive top-line phase III data from its study of PARP inhibitor Rubraca (rucaparib). The study’s monotherapy arm of Rubraca as a first-line maintenance treatment of ovarian cancer hit the primary endpoint of significantly improved investigator-assessed progression-free survival (PFS) compared to placebo. The median PFS was 20.2 months for Rubraca compared to 9.2 months for placebo in the intent-to-treat group.
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