Five Prime Therapeutics Inc. said it's licensing a family of monoclonal antibodies to Seattle Genetics Inc. for inclusion in an unspecified number of new cancer-killing antibody-drug conjugates, all directed to a single target. The deal holds $5 million up front for Five Prime, plus up to $525 million in milestone payments for the first two candidates. South San Francisco-based Five Prime's shares (NASDAQ:FPRX) rose about 13% on the news, which interim CEO William Ringo said allow it "to realize value from our preclinical pipeline while prioritizing our clinical investments based on upcoming data readouts."
DUBLIN – Neotx Therapeutics Ltd. raised $45 million in a series C round to continue clinical development of an immuno-oncology agent that already has a long clinical history behind it. Its lead molecule, naptumomab estafenatox, is a fusion protein comprising an antibody fragment that recognizes the tumor-associated antigen 5T4 and a bacterial “super-antigen” comprising a modified version of the Staphylococcal enterotoxin A. It is designed to unleash a powerful antibacterial immune response against cancer cells and is currently undergoing a phase Ib dose-escalation trial in patients with solid tumors, in combination with the PD-L1 inhibitor Imfinzi (durvalumab).
A lot of development dollars are shed when the FDA withdraws approval or requests that a drug be withdrawn from the market because new potential risks have come to light. And it’s not just the brand company that feels the loss. When Eisai announced last week that it was withdrawing its weight-loss drug Belviq (lorcaserin) due to FDA concerns about cancer risks, the news hit several drug companies that have been developing lorcaserin generics for nearly a decade, said Brandon Boyd, director of market strategy, biopharma & generics at Clarivate Analytics. Those companies have invested millions of dollars in development programs referencing Belviq and in patent litigation.
Parkinson’s disease (PD) is a neurodegenerative disorder. But not just. And it may not start that way. There is increasing evidence that a-synuclein, the protein whose aggregates eventually destroy midbrain dopaminergic neurons in PD (and that are the cause of other diseases collectively known as the synucleinopathies), first aggregates “in enteric neurons, the neurons that control gastrointestinal function,” Collin Challis told BioWorld. In the Feb. 17, 2020, issue on Nature Neuroscience, Challis, who was a postdoctoral scholar at the California Institute of Technology at the time of the study, and his colleagues have shown that increased peripheral expression of the enzyme glucocerebrosidase – better known for its role in the lysosomal storage disorder Gaucher’s disease – could reverse some of the effects of peripheral a-syn aggregates.
What with the lawsuits, declining prescriptions and approval hurdles that seem to be the U.S. answer to a nationwide opioid epidemic, drug companies have to think long and hard before spending the resources to develop yet another opioid drug. And patients are paying the price.
HYDERABAD, India – India could play a key role in driving down the exorbitant cost of emerging cell and gene therapies, with a combination of comparatively cheap labor and efficient manufacturing, international experts said during the annual BioAsia conference. “There is lot of potential to make CAR T therapy cheaper by making it in India,” said Carl June, a professor at the University of Pennsylvania and the first scientist to successfully treat a patient – a young girl in the U.S. in 2012 – with CAR T.
The FDA approved Durham, S.C.-based Coimmune Inc.’s IND, clearing the way for a phase IIb trial using CMN-001 to treat advanced metastatic renal cell carcinoma (mRCC). The drug is a dendritic cell-based immunotherapy that is tailored to each patient’s medical indication. It is designed to capture both mutated and variant antigens unique to each tumor. Primarily poor risk mRCC patients will be recruited for the trial. Coimmune is also developing a clinical-stage CAR T therapy to treat acute lymphoblastic leukemia in pediatric and adult patients. In January, Coimmune merged with Formula Pharmaceuticals Inc. and swiftly followed up with a $6 million investment to fund its upcoming phase I in lymphoblastic leukemia.
The articles from BioWorld’s ongoing coverage of the COVID-19 coronavirus outbreak are available at www.bioworld.com/coronavirus. The collection includes breaking research, clinical, regulatory and business development news on coronaviruses reaching back to 1991. Featured topics: vaccines and diagnostics in development, the science underpinning the virus, comparison to previous outbreaks such as Severe acute respiratory syndrome (SARS) and Middle Eastern respiratory syndrome coronavirus (MERS-CoV), global regulatory factors and the business news underpinning the research including development collaborations and investment trends.
Adamis, AGTC, Assertio, Astellas, Aveo, Caribou, Catalyst, Cellectis, Coimmune, Delmar, Enclear, Enzo, Eton, Genentech, Genprex, Immutep, Incyte, Jangobio, Kowa, Lidds, Matinas, Merck, Mereo, Molecular Templates, Orgenesis, Palatin, Reneuron, Restorbio, Retrotope, Revolution, Ribomic, Seattle Genetics, Servier, Terns, Vivus, Zelira