HONG KONG – Singapore-based Tessa Therapeutics Pte Ltd.’s CD30 CAR T-cell therapy has been granted a regenerative medicine advanced therapy (RMAT) designation by the U.S. FDA based on data from two independent phase I/II trials in patients with relapsed or refractory CD30-positive classical Hodgkin lymphoma.
Aivita Biomedical Inc.’s CEO, Hans Keirstead, just finished up a $12.5 million fundraiser and he’s prepping for another $12.5 million in a second effort. In the two months since he started raising the money, he has hired four more people and plans to hire four more by year-end, bringing the company’s headcount to 36 employees.
During a recent investor event related to early drug development, Basel, Switzerland-based Roche Holding AG touted research by the firm’s Genentech unit into the cancer target known as TIGIT, or T-cell immunoreceptor with Ig and ITIM domains, and the pharma giant is hardly alone in the sizzling space.
Citing what it called poor study design and execution coupled with a lack of follow-up data, the FDA’s Oncologic Drugs Advisory Committee voted 13-2 against recommending approval of Steba Biotech SA’s NDA for Tookad (padeliporfin dipotassium) for injection in men with localized early stage prostate cancer.
PERTH, Australia – Sydney-based Immutep Ltd. reported positive interim data for its phase II basket trial in non-small-cell lung cancer (NSCLC) and head and neck squamous cell carcinoma for its lead immunotherapy in combination with Merck & Co. Inc.’s anti-PD-1 therapy, Keytruda (pembrolizumab).
Updated results from IMV Inc.’s ongoing phase II trial of DPX-Survivac to treat advanced recurrent ovarian cancer show the company’s lead candidate was active and well-tolerated in patients.
Bicycle Therapeutics plc said Roche Holding AG's Genentech Inc. has agreed to pay $30 million up front for rights to develop and commercialize up to four potential immuno-oncology therapies using the company's bicyclic peptide platform. Bicycle will be responsible for all discovery and lead optimization, while Genentech will take up R&D beyond that.
DUBLIN – Advanced Biodesign SAS secured €9 million (US$9.8 million) in new funding commitments to take its lead drug candidate, ABD-3001, into a phase I trial in acute myeloid leukemia (AML). The Lyon, France-based firm is investigating a novel drug mechanism associated with cancer cell metabolism, which could have application across several cancer types.
BEIJING – Chinese biosimilar maker Bio-Thera Solutions Ltd., of Guangzhou, on Feb. 21 launched a pre-revenue listing on Shanghai’s STAR market, a Nasdaq-style tech board, to reap $241 million at a valuation of almost $2 billion. Its share price soared more than 83% during its first trading day.
Beyond every binary is a more complex reality. And so it is with driver and passenger mutations. The separation of tumor mutations into drivers and passengers underpins much progress in the development of targeted therapies. By looking at passenger mutations more carefully, though, researchers at Yale University have shown that passenger mutations, too, played a role in how tumors progressed.
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