Biotech Insider – The US White House official briefing room recently released a statement dubbed “FACT SHEET: Consequences of Lack of Funding for Efforts to Combat COVID-19 if Congress Does Not Act”. In it, the Biden Administration recommended accelerating the creation of a next-generation, pan-COVID vaccine that would provide broad protection against a range of variants. Outside of the top two mRNA candidates, from Pfizer/BioNTech and Moderna, there are some serious new developments from other biotech innovators on the way from groups such as BioVaxys Technology Corp. (CSE:BIOV) (OTCQB:BVAXF), AstraZeneca PLC (NASDAQ:AZN), CureVac N.V. (NASDAQ:CVAC), GlaxoSmithKline plc (NYSE:GSK) and Johnson & Johnson (NYSE:JNJ).

Unlike the mRNA offerings that are currently available under an emergency use authorization, BioVaxys Technology Corp. (CSE:BIOV) (OTCQB:BVAXF) is working to develop its alternative flaghship vaccine candidate BVX-0320, a haptenized SARS-CoV-2 s-protein vaccine.

Their platform is based on the concept of haptenization, an idea that comes with a long history. The foundation of the concept began with the work of immunologist and Nobel laureate Dr. Karl Landsteiner. Today, BioVaxys uses this process which “teaches” a patient’s immune system to recognize and make target proteins more ‘visible’ as foreign, to stimulate a more intense immune response.

BVX-0320 comprises a portion of the SARS-CoV-2 spike protein that’s modified by the hapten, dinitrophenyl (DNP); hapten modification prevents ACE2 binding while retaining immunogenicity.

Now BioVaxys has recently demonstrated how their vaccine doesn’t bind to the Angiotensin Converting Enzyme-2 (ACE2) receptor—meaning this vaccine may not lead to the “rare” but serious myocarditis observed with mRNA vaccines.

A study published in the Journal of Hematological Oncology concludes that the Receptor Binding Domain (RBD) of the SARS-CoV-2 spike protein binds to the ACE2 receptor and that this binding of SARS-CoV-2 to ACE2 prevents the enzyme from converting angiotensin II, potentiating cardiac issues.

There have been several local and systemic adverse events associated with mRNA COVID-19 vaccines, with pericarditis, myocarditis and myocardial infarction as examples of cardiac complications related to these vaccines.

Currently available vaccines, whether comprised of either recombinant full-length or partial spike protein can result in rare, but life-threatening side effects, such as abnormal blood clotting or myocarditis.

Previous studies in mice showed that BioVaxys’ BVX-0320 not only stimulates a robust antibody and T cell response, but was also safe and well tolerated.

"This is the first peer-reviewed presentation of our work on BVX-0320 in mice,” said David Berd, MD, Chief Medical Officer of BioVaxys. “We expect it to be well received by the scientific community because it is novel and the data convincing."

The recently completed study on ACE2 binding inhibition by Millipore-Sigma was part of a bioproduction run of BVX-0320 contracted by BioVaxys last September, with the new batch is being used in ongoing pan-sarbecovirus vaccine collaboration with Ohio State University.

Millipore is a subsidiary of German-based Merck KGaA, one of the largest pharmaceutical companies in the world, with a market capitalization of US$95 billion.

After rough patches in 2021 that saw its vaccine permanently removed from Norway and removal from a US manufacturing facility, AstraZeneca PLC (NASDAQ:AZN) is making a comeback, this time for a Covid-19 drug instead of a vaccine.

While it may take a while to address tragic stories such as deaths ruled as Vaccine-Induced Thrombotic Thrombocytopenia (VITT) after taking their vaccine, AstraZeneca’s new Covid-19 drug is currently under review by Europe’s drug regulator.

Dubbed as “Evusheld”, AstraZeneca's antibody cocktail was already authorised in the US to prevent COVID-19 infections in individuals with weak immune systems or a history of severe side effects from coronavirus vaccines. In late February, the FDA revised its emergency use authorization for Evushield to change the initial dose for the authorized use as pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric patients.

Another vaccine maker that’s coming out of an up and down 2021 is Johnson & Johnson (NYSE:JNJ), which had to at least temporarily shut down the only plant in Africa making usable batches of its vaccine.

New data is suggesting that the JnJ vaccine is now preventing infections, hospitalization and deaths at least as well as the Pfizer-BioNTech and Moderna vaccines.

“We’ve been aware that JNJ has been kind of downgraded in people’s minds,” said Dr. Linda Gail-Bekker, Director of the Desmond Tutu H.I.V. Center at the University of Cape Town, who has studied the vaccine’s effectiveness in South Africa. “[But] it punches above its weight for a single-dose vaccine.”

The data were collected by the C.D.C. from 29 jurisdictions, representing 67 percent of the population.

Johnson & Johnson said in a statement: “The C.D.C. data adds to the growing body of evidence indicating the Johnson & Johnson Covid-19 vaccine provides durable protection against breakthrough infection and hospitalization.”

Working to help manufacture mRNA products for clients, CureVac N.V. (NASDAQ:CVAC) is launching an ‘RNA Printer’ subsidiary called CureVac RNA Printer GmbH. The unique tech provides an end-to-end solution for clients, as the RNA printer has been moved from the prototype stage to a fully functional facility located at CureVac’s German headquarters.

“We are convinced that the global mRNA pipeline will grow strongly over the next decade,” said CureVac’s CEO Dr. Franz-Werner Haas in a statement. “Providing access to flexible GMP manu-facturing solutions is expected to be a game-changer for the speed with which new mRNA products can be advanced from lab to clinic.”

Back in February 2021, CureVac and GlaxoSmithKline plc (NYSE:GSK) announced a partnership to develop next generation mRNA Covid-19 vacccines.

Now in 2022, the CureVac/GSK partnership was awarded a contract by Germany’s cabinet, as part of a plan for the country to spend up to $3.14 billion to ensure that Covid-19 vaccine makers have enough production capacity available to supply the country with shots in future outbreaks through 2029.

While not for Covid-19, back in February, CureVac and GSK dosed the first participant in Phase I study with a multivalent influenza vaccine candidate based on second-generation mRNA backbone.

“The global fight against COVID-19 continues, and we remain committed to making a difference with a safe and efficacious vaccine,” said Franz-Werner Haas, CEO of CureVac. “This goal has not changed, but the requirements to effectively address the virus and emerging variants have changed.”

Article Source: https://biotech-insider.com/the-small-biotech-company-that-all-the-majors-aspire-to-be/

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