Amgen Inc.’s pioneering lung cancer drug, Lumykras (sotorasib), is set to become available to NHS patients in England, after cost-effectiveness body NICE recommended financing from the Cancer Drugs Fund (CDF) in final draft guidance.
Ahead of U.S. President Joe Biden’s State of the Union address March 1 in which he gave a shoutout to his cancer moonshot initiative, the FDA released a trio of final guidances aimed at speeding the development of new cancer drugs. First launched in 2016 with the goal of doubling the rate of progress against cancer by making a decade worth of advances in five years, the moonshot was reignited last month with a new target following setbacks in cancer screenings and treatments during the COVID-19 pandemic. Now, Biden’s catch phrase is “ending cancer as we know it.”
LONDON – Epsilogen Ltd. has raised £30.8 million (US$41.5 million) in an oversubscribed series B, after its lead immunoglobulin E (IgE) program delivered positive results in a phase I in advanced solid tumors. The money is to fund a phase Ib trial of the product, Mov18 IgE – the first and only IgE antibody to have made it to the clinic – in platinum-resistant ovarian cancer.
Adagene Inc. has announced a research collaboration with Sanofi SA, to find “masked” monoclonal and bispecific antibodies that are safer than marketed drugs in oncology, in a deal worth up to $2.5 billion plus royalties. San Diego and Suzhou, China-based Adagene will generate masked versions of Sanofi antibodies, taking responsibility for early stage research activities using its Safebody technology. Sanofi will be responsible for later-stage research and all clinical, product development and marketing activities.
After years of turbulent development that included a clinical hold, a COVID-19 stumble, a withdrawn approval application and an extended PDUFA date, the FDA has approved CTI Biopharma Corp.’s Vonjo (pacritinib) for treating the bone marrow cancer myelofibrosis.
Reports of two patient deaths prompted Celyad Oncology SA to voluntarily pause a phase Ib trial testing its allogeneic CAR T-cell therapy, CYAD-101, in combination with Keytruda (pembrolizumab, Merck & Co. Inc.) in patients with refractory metastatic colorectal cancer (mCRC), the latest safety hitch among efforts to advance the promise of CAR T beyond the first approvals in hematological malignancies.
LONDON – Antibody-drug conjugate specialist Heidelberg Pharma AG has secured a route into Asia and a fresh injection of much-needed capital, in a licensing and equity deal with Huadong Medicine Co. Ltd. worth up to €930 million (US$1.1 billion).
Odeon Therapeutics Inc. has acquired rights to two cancer candidates from Obi Pharma Inc. in a deal worth up to $200 million. The transaction gives Shanghai-based Odeon rights to develop, register, and commercialize the antibody-drug conjugate OBI-999 and a therapeutic cancer vaccine OBI-833 in mainland China, Hong Kong, and Macau.
Jubilant Therapeutics Inc. started 2022 with an IND clearance for JBI-802, its oral, selective dual inhibitor of lysine-specific demethylase 1 (LSD1) and HDAC6, setting up a year that could be important for LSD1 in the hands of others as well.
Biontech SE and Medigene AG have signed a three-year research collaboration to develop T-cell receptor (TCR) based immunotherapies against cancer. Medigene will receive €26 million ($29.5 million) up front and could receive hundreds of millions of euros per drug in milestone payments from the deal, which will also covers research funding for the period of the collaboration.