By GREGORY ZELLER //
In a potentially huge breakthrough in the struggle against seasonal influenza mutations, Codagenix Inc. is preparing to release data demonstrating “multi-season efficacy” for its frontline flu vaccine – meaning the vaccine could prevent flu-related sicknesses even after the virus mutates.
According to the Farmingdale-based clinical-stage startup, in multiple studies involving pigs and ferrets, CodaVax-H1N1 – Codagenx’s live-attenuated Influenza A vaccine – induced “a robust immune response to multiple seasonal strains of influenza,” making it a potential silver bullet against “seasonally drifted strains” of the common, often serious virus.
The biotech has now developed an intranasal version of the influenza vaccine that works at “ultra-low doses” compared to contemporary flu vaccinations, which can be on the order of six magnitudes stronger and only allow the host to build a resistance against a particular strain.
“Current commercial influenza vaccines still use an egg-grown, inactivated virus that requires a high dose of antigen,” noted Codagenix cofounder and Chief Scientific Officer Steffen Mueller. “Using an inactivated virus requires continual updates to the vaccine each season – and as we know, this can lead to vaccines that aren’t matched to the circulating virus or have very low efficacy against the circulating virus.
“Our goal is to make a vaccine that won’t require updating each year, but rather one that can provide multi-season protection with improved efficacy.”
In the new data set, Codagenix demonstrates that CodaVax-H1N1 promoted a strong immune response against both the 2016 and 2017 influenza strains, demonstrating unprecedented multi-season potential. Currently, there is no commercially available vaccine that can protect against flu mutations over multiple seasons.
The Broad Hollow Bioscience Park resident – launched in 2012 by Mueller, a Stony Brook University assistant research professor, and Farmingdale State College biology professor J. Robert Coleman – will officially unveil its data at the J.P. Morgan 35th Annual Healthcare Conference, a four-day international life sciences lollapalooza scheduled for Jan. 9-12 in San Francisco.
The conference, one of the world’s most-attended annual life sciences conferences, is the perfect place to trumpet the impressive multi-season data set, according to Coleman.
“We are making this release so that it coincides with the biotech conference,” the Codagenix COO told Innovate LI. “In San Francisco, we will be meeting with five potential partners, clinical collaborators and possible future investors.”
Those potential partners may want to jump on board fast. Codagenix – which has already begun the first live-host tests of its potential Zika virus vaccine and is knee-deep in studies and trials pitting its proprietary, synthetic biology-based vaccine-design platform against Foot and Mouth Disease Virus and swine flu – has already manufactured the necessary “clinical trial material” and is ready to begin human testing of it intranasal CodaVax-H1N1 vaccine.
Patient “recruitment and dosing” for Phase I and II clinical trials is sCagenicheduled to commence in the first quarter of 2017, the company said in a statement.
Noting the biotech’s “disruptive” genome-recoding technology’s potential to “shake up the vaccine industry’s status quo,” Coleman said he and Mueller are “excited to demonstrate the potential” of their low-dose, multi-season influenza vaccine.
“The flu-vaccine industry is in need of a next-generation product that can provide improved efficacy across multiple seasons,” Coleman said Thursday. “We believe CodaVax-H1N1 is well positioned to disrupt the market and reduce the disease burden of influenza.”