Backers of Boston-based Elicio Therapeutics Inc. may have jumped the gun as they ran away from the firm after data were made public from the phase II Amplify-7P study testing ELI-002 7P in adjuvant KRAS-mutation-driven pancreatic ductal adenocarcinoma (PDAC) following standard locoregional therapy. Wainwright analyst Robert Burns said the results are “more nuanced than they appear” and the sell-off represents “an attractive entry point” for investors. Shares (NASDAQ:ELTX) closed June 15 at $4.08, down $10.77, or 72%, in the wake of news that the trial missed the pre-specified primary endpoint of disease-free survival (DFS) in the intent-to-treat population.
The University of Oxford and Moderna Inc. have announced authorization by the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a phase I/II study of mRNA-4194, Moderna’s investigational mRNA-based cancer vaccine for Lynch syndrome.
The Coalition for Epidemic Preparedness Innovations (CEPI) will provide up to $9.7 million in additional funding to Pop Biotechnologies Inc. to advance the company’s Pop Bio SNAP (Spontaneous Nanoliposome Antigen Particle) protein vaccine platform into a phase I trial.
Nearly a year after Health and Human Services Secretary Robert Kennedy announced the U.S. was cutting off funding for Gavi, a global vaccine alliance, Secretary of State Marco Rubio said his department is reengaging with the organization in light of the ongoing Ebola outbreak in central Africa. In testifying before a June 2 Senate Foreign Relations Committee hearing, Rubio said the State Department made the decision to reengage a few weeks earlier with Gavi. He provided no detail of what that engagement looks like.
The Coalition for Epidemic Preparedness Innovations (CEPI) has announced funding and support to urgently accelerate development of three investigational vaccines targeting the Bundibugyo Ebola virus.
Moderna Inc. has announced an expanded collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI) to advance the development of a potential vaccine against Bundibugyo Ebola virus (BDBV), a cause of Ebola virus disease.
Landing on the right COVID-19 vaccine formulation for the coming season is becoming more complicated against a backdrop of low vaccination rates, young children with little to no immunization, declining surveillance data and a new SARS-COV-2 lineage slowly emerging.
Less than two weeks after the outbreak was officially declared, animal studies of a newly designed vaccine against the Bundibugyo Ebola virus are now underway in the U.S. and U.K., and the Serum Institute of India is standing ready to manufacture the vaccine for clinical trials. If the animal tests are positive, the vaccine will be ready for clinical trials in two to three months.
Eli Lilly and Co. has offered to buy three vaccine companies for up to $3.8 billion combined, including up to $1.55 billion for Vaccine Company Inc., whose in vivo nanoparticle (IVN) technologies are designed to enable antigens that elicit durable immune responses, much like virus-like particle (VLP) vaccines, but avoid the VLP manufacturing burden.
What would normally be a routine meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee May 28 may be more carefully watched given the overall turmoil surrounding vaccines in the U.S. The only task before the adcom is to recommend the COVID-19 vaccine formula for the upcoming season. That conversation will include looking at the effectiveness of the four FDA-approved vaccines currently in use in the U.S.
RSS
