HONG KONG – Eisai Co. Ltd. has received not one, but two approvals from Japan’s Ministry of Health, Labour and Welfare (MHLW), for its anticancer agent Remitoro (denileukin diftitox) and multiple receptor tyrosine kinase inhibitor Lenvima (lenvatinib mesylate). Both approvals, each for a rare disease indication, were granted based on phase II trial results, instead after the usual phase III trials.
Suzhou-China based Cstone Pharmaceuticals Co. Ltd., which in-licensed RET inhibitor pralsetinib from Blueprint Medicines Corp. in 2018, has won Chinese approval for the drug to treat adult patients with locally advanced or metastatic RET fusion-positive non-small-cell lung cancer after platinum-based chemotherapy. Already approved as Gavreto in the U.S., the drug is Cstone’s first product approved in China and the country’s first selective RET inhibitor.
According to the BioWorld Cancer Financings Report, 2020 proved to be a record year in terms of capital raised by biopharmaceutical companies working on therapeutics for cancer indications.
DUBLIN – Step Pharma SAS closed a €35 million (US$41.5 million) series B round to move its first-in-class cytidine triphosphate synthase 1 inhibitor into clinical trials in patients with T-cell and B-cell malignancies.
Asher Biotherapeutics Inc. raised $55 million in a series A financing round to take forward a series of engineered cytokines designed to selectively activate T cells or other immune effector cells, in order to eliminate both the toxicities and the loss of efficacy that can result from indiscriminate activation.
HONG KONG - Bispecific antibody startup Epimab Biotherapeutics Inc. has completed a $120 million series C financing, bringing it closer to a potential IPO next year. The Shanghai-based company said the new funds would help it move its EGFR/cMET-targeted bispecific candidate, EMB-01, into phase II testing this year, as well supporting the advancement of other clinical candidates and an expansion of its pipeline.
Following a missed primary endpoint in its phase III study in treating anti-PD-1-refractory advanced melanoma, Idera Pharmaceuticals Inc. is considering stopping the registrational trial of its synthetic Toll-like receptor 9 (TLR9) agonist or pressing on toward the clinical trial’s second primary endpoint.
Aktis Oncology Inc. raised $72 million in a series A round and set out its stall as another contender with big ambitions in the rapidly developing field of targeted radiopharmaceuticals for solid tumor indications.
Libtayo (cemiplimab-rwlc) became the first PD-1 therapy to score a phase III win in cervical cancer, a pleasing development not only for investors in Regeneron Pharmaceuticals Inc. and partner Sanofi SA but for patients with the stubborn disease.
LONDON – Targeted protein degradation (TPD) specialist Amphista Therapeutics Ltd. has delivered yet another demonstration of investor interest in the field, closing a $53 million series B.
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