LONDON – New figures underline the devastating effect the pandemic is having on cancer clinical research, with recruitment to U.K. studies falling by 60%. A total of 27,734 patients were recruited in 2020/21, compared to an average of 67,057 in the three years previously. Over those three years, recruitment had been on the rise, going from 61,810 in 2017/18 to 71,709 in 2019/20, according to figures compiled by the Institute of Cancer Research in London.
Shanghai Henlius Biotech Inc.’s self-developed Hanbeitai (bevacizumab biosimilar) has received marketing approval from China’s NMPA. It was approved for the treatment of metastatic colorectal cancer and unresectable, locally advanced, recurrent, or metastatic non-squamous non-small-cell lung cancer.
It’s been more than six years since the FDA’s first approval of an oncolytic virus – Amgen Inc.’s melanoma drug Imlygic (talimogene laherparepvec) – and it’s easy to argue that progress in the field has been overshadowed by success with other immunotherapy types such as checkpoint inhibitors. Though the FDA hasn’t approved any more oncolytic viruses since then, Phoenix-based Oncomyx Therapeutics Inc. is one of several companies trying to change that.
Life sciences VC Apple Tree Partners has launched its first U.K.-based portfolio company, providing $53 million in series A funding for immunology specialist Adendra Therapeutics Ltd.
LONDON – Europe’s latest antibody-drug conjugate (ADC) specialist, Emergence Therapeutics AG, will be going head to head with pioneer Seagen Inc.’s approved ADC, Padcev, after raising €87 million (US$97.9 million) in a series A round.
Odyssey Therapeutics Inc. launched with a whopping $218 million series A round, the year’s second-largest, to fuel work by almost 100 employees recruited in the past few months, mostly from big pharma firms.
Milan-based Recordati SpA has proposed acquiring the global specialty pharma Eusa Pharma Ltd., a specialist in rare and niche oncology, for about €724 million (US$817.5 million) net of around €26 million in debt Eusa held at last report, midyear. The transaction offers Recordati a "great growth opportunity" while giving it the chance to "build scale in a new-for-us and very attractive and underserved therapeutic area," thus providing further diversification for Recordati's existing rare diseases business, said Chairman Andrea Recordati.
Shares in Isofol Medical AB dropped by 27% on Dec. 6 as the company informed investors that its ongoing phase III trial of arfolitixorin in metastatic colorectal cancer would not reach the predefined number of events needed to demonstrate a statistically significant effect on progression-free survival (PFS) based on the study’s present statistical plan.
Tot Biopharm International Co. Ltd.’s self-developed Pusintin (bevacizumab), a biosimilar to Roche Holding AG’s Avastin, has won marketing approval from China’s NMPA. It was approved for the treatment of patients with advanced, metastatic, or recurrent non-squamous non-small-cell lung cancer and those with metastatic colorectal cancer.
Beyondspring Pharmaceuticals Inc. said it received a complete response letter from the FDA regarding the NDA for plinabulin, the company’s lead asset. The FDA said results of a phase III registrational trial were strong enough to show benefit but a second trial is needed to satisfy the agency.
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