The China NMPA’s Center for Drug Evaluation accepted Lepu Biopharma Co. Ltd.’s new drug application (NDA) for anti-PD-1 antibody candidate HX-008 (pucotenlimab). That comes after the company filed for an IPO in Hong Kong.
Researchers from The Hong Kong Polytechnic University (PolyU) said they have used two-dimensional nanosheets (FePSe3) to develop a biomimetic nanosheet that can monitor tumor development, treat tumors and monitor the treatment progress in real-time. With positive results from mice, the team hopes to further test it on larger animals, then move on to clinical studies.
In reporting positive data from a phase III study of sugemalimab in treating stage III non-small-cell lung cancer (NSCLC), Cstone Pharmaceuticals Co. Ltd. and Eqrx Inc. have the first anti-PD-L1 monoclonal antibody demonstrating progression-free survival in patients with concurrent or sequential chemoradiotherapy.
DUBLIN – Numab Therapeutics AG has moved closer to the front rank of European antibody developers by raising CHF100 million (US$111 million) in a series C financing round to accelerate the development of NM21-1480, a trispecific antibody that acts both as a PD-L1 inhibitor and 4-1BB (CD137) agonist. It also contains a human serum albumin recognition group, to extend its circulatory half-life.
Nantkwest Inc. and privately held Immunitybio Inc. trotted out positive early interim results from their advanced metastatic pancreatic cancer studies showing median survival rates more than double the historic rates: eight month’s survival compared to only three. “Anything beyond three months has an impact,” Patrick Soon-Shiong, Immunitybio’s CEO and Nantkwest’s executive chairman, told BioWorld, with understatement about one of the toughest to manage indications in medicine.
Dublin – IO Biotech ApS raised €127 million (US$154.7 million) in a series B round to fund a potentially pivotal trial of its combination of cancer vaccines in first-line metastatic melanoma. The Copenhagen, Denmark-based company is one of a number of firms fueling a mini-resurgence in immuno-oncology in the early weeks of the new year, as new data and new insights are prompting additional investments in an area that some had thought was already oversubscribed.
Gastric cancers were the focus of the final plenary session of the European Society for Medical Oncology’s Virtual Congress 2020. Results from the Checkmate-649, ATTRACTION-4, and Keynote-590 studies showed that advanced gastroesophageal tumors can benefit from first-line treatment with PD-1 checkpoint blockers in addition to chemotherapy, staving off progression and death by a few months.
HONG KONG – Following FDA approval of its IND, Israel-based Kahr Medical Ltd. is set to start a phase I/II trial of lead product DSP-107, a second-generation CD47- and 41BB-targeting compound. The move puts Kahr among a number of companies working on drugs against checkpoint molecule CD47.
Bolstered by the success of CTLA4 and PD-(L)1 antibodies, companies are exploring new targets to encourage the immune system to attack tumors. "While these agents have demonstrated efficacy in a proportion of cancer patients, there clearly is room for improvement to lift the tail of the curve," Michele Teng, associate professor at the QIMR Berghofer Medical Research Institute, told the audience at the clinical trials plenary session of the American Association for Cancer Research Virtual Annual Meeting II, where researchers presented data from a pair of immunotherapies looking to build on the success targeting PD-(L)1.
Targeting glycosylated PD-1 immune checkpoint may be a promising new cancer immunotherapeutic strategy, according to a collaborative study led by Taiwanese researchers, which was reported online in Cancer Research.