Novavax targets approval for the COVID-19 vaccine in the US

Novavax is targeting a second-quarter FDA filing for emergency use of its COVID-19 vaccine. The aim hints the U.S. could join the U.K. on the list of countries to permit the vaccine in the first half of the year.

The vaccine’s success in a 15,000-subject U.K. phase 3 clinical trial proffers Novavax a clear path to a favorable decision by the Medicines and Healthcare products Regulatory Agency (MHRA). Nevertheless, the lack of data from another phase 3 trial, which only lately finished enrolling 30,000 subjects in the U.S. and Mexico, makes way for an FDA sanction less obvious. 

Novavax CEO Stanley Erck told CNBC said in a statement that the discussions with the FDA are going, and they hope the FDA will agree to review the U.K. data. If review happens, the vaccine could receive emergency use authorization in the United States in May.

Novavax will need to wait longer if the FDA needs the inclusion of data from the U.S.-Mexico trial. Erck informed that it would be a couple of months before final data are available from that trial, hinting that waiting on those results would push authorization in the U.S. back to the second half of the year.

Iktos announces collaboration with Pfizer for drug design

Virtual drug design tech firm Iktos has set up a new agreement with Big Pharma Pfizer to tap its artificial intelligence for its discovery work.

Pfizer will utilize the Paris-based company’s tech for de novo design to chosen Pfizer small-molecule discovery programs, although the duo neither apprises regarding specifics of the targets nor any financials for the compact.

Charlotte Allerton, head of medicine design at Pfizer, said that Big Pharma had an active interest in AI for de novo design, and they are happy to work with Iktos to use their AI technology on a number of their programs.

The use of AI is relatively wide, but these sorts of deals are designed to help seek out, model, and better predict small-molecule activities to benefit Pfizer know which targets are most likely to get to the finishing line return millions, if not billions, of dollars. 

Iktos, founded in 2016, has similar deals with Janssen, Almirall, Servier, Galapagos, and Pierre Fabre. Yann Gaston-Mathé, co-founder and CEO of Iktos, said that they are proud to work with Pfizer and to have their scientists use the software in the early discovery programs. 

AbbVie bags option to acquire Mitokinin for Parkinson’s prospect

AbbVie bought an exclusive right to take over San Francisco-based Mitokinin after the company finishes its Investigational New Drug (IND)-enabling studies on its lead program, PINK1, for Parkinson’s disease.

The company was based on tech that came out of co-founders Nicholas Hertz and Kevan Shokat’s labs at the University of California-san Francisco. They then moved into MBC BioLabs San Francisco in September 2017 with Series A funds from a syndicate led by Mission BioCapital that covered Pfizer Ventures.

PINK1 compounds selectively speed the activity of PINK1 that is a master regulator of mitochondrial quality control. It is genetically associated with Parkinson’s disease. The company hopes that increasing PINK1 activity can address the mitochondrial dysfunction associated with Parkinson’s.

Under the terms of the pact, AbbVie is paying an upfront payment while Mitokinin will continue to develop its PINK1 program through the completion of IND enabling studies for the lead compound. No financial details were revealed. Once, or if, IND-enabling studies are successful, AbbVie will have the option to buy the company.

Presage Biosciences inks new pact with Merck for cancer drug tests

Presage Biosciences landed two more biopharma partners in Merck and Maverick Therapeutics and raised another USD 13 million to extend its tumor microdosing technology. Its new partners will utilize that tech to evaluate new anti-cancer medicines in phase 0 trials, a stage in drug development designed to link preclinical and clinical work.

Of the financing, USD 6 million comes from new investors LabCorp Venture Fund, Bristol Myers Squibb, one of Presage’s pharma partners, and InHarv Partners. The remaining USD 6 million comes from Takeda Ventures, which is turning a convertible note into equity.

The funds will fund the expansion of Presage’s clinical sites in the U.S. and Australia and develop new devices for its microdosing technology, called Comparative In Vivo Oncology, or CIVO for short.

Presage and its partners are utilizing the CIVO technology for phase 0 studies, an idea the FDA introduced in 2006 to address animal models’ failure to predict how drugs will work in humans accurately. 

Presage CEO Rich Klinghoffer, Ph.D., said that this approach involves injecting people with microdoses of the experimental drug about 1/100 of the anticipated effective dose, but administering tiny doses systemically can make it challenging to measure efficacy.