Oramed JV, Oravax Medical, & India’s Premas Biotech to Develop Oral COVID-19 Vaccines

Jerusalem’s clinical-stage pharmaceutical company Oramed Pharmaceuticals  is forming a joint venture with Premas Biotech , a biotechnology firm based in Gurugram, India, to develop novel oral COVID-19 vaccine candidates. Oramed Pharmaceuticals specializes in making oral drug delivery systems. Premas has a technology platform called D-Crypt that is used to make a variety of “difficult to express” proteins in sizeable quantities efficiently. An oral Covid-19 Oravax is a vaccine candidate that harnesses and combines the true potential of the two unique platforms. The new joint venture company, called Oravax Medical Inc., uses the Oramed’s proprietary POD™ oral delivery technology combined with Premas Biotech’s novel vaccine technology.

“An oral COVID-19 vaccine would eliminate several barriers to rapid, widescale distribution, potentially enabling people to take the vaccine themselves at home,” said Oramed Pharmaceuticals’s Chief Executive Officer Nadav Kidron. “While ease of administration is critical today to accelerate inoculation rates, an oral vaccine could become even more valuable in the case that a COVID-19 vaccine may be recommended annually like the standard flu shot.”

Prabuddha Kundu, Co-founder and Managing Director, Premas Biotech, stated that an oral vaccine would significantly ease mass administration. “It would be like taking a vitamin pill and what I can disclose now is that we are more than 100% sure that the technology works and is promising. In a month we should have a scientific publication reporting our results.”

The COVID-19 vaccine candidate from Oravax is a virus-like particle (VLP) triple antigen vaccine targeting three structural proteins. According to the company, this design may make the vaccine a better candidate for protecting against emerging SARS-CoV-2 mutations. Additionally, oral delivery may make vaccination more acceptable and tolerable among the population at large, since it doesn’t involve needles or injection. Oral delivery could also mean easier distribution.

A clinical study using the combined technology for COVID-19 vaccine development is expected sometime during the second quarter of this year. The COVID-19 vaccine candidate has so far induced systemic immunity in a pilot animal study. The systemic immunity promoted from the vaccine occurred through immunoglobulin G and immunoglobulin A, the former of which represents the most common blood and bodily fluid antibody that works to combat viral infections.

Licenses for Premas Biotech’s COVID-19 vaccine, developed last year, were acquired from Akers Biosciences in March 2020. The novel coronavirus vaccine candidate was developed by Premas Biotech using the company’s genetically engineered S. cerevisiae platform D-Crypt™.

At the time of the announcement, the D-Crypt platform had recombinantly expressed over 30 proteins with similar major structural proteins of COVID-19. Because it uses genetically engineered baker’s yeast S. cerevisiae, the company says “D-Crypt™ is highly scalable into commercial production quantities.” The platform has also been previously used to produce several human and animal health vaccines candidates over a 10-year development period.

Oravax Medical will likely have to work hard to rival or come close to the efficacy and safety demonstrated by authorized and up-and-coming COVID-19 vaccine candidates. Currently authorized COVID-19 vaccines in the U.S. include those from Moderna and Pfizer-BioNTech.

AstraZeneca may also be coming close to receiving authorization in the U.S. after recent news of a U.S. Phase III trial reported that the company’s vaccine candidate AZD1222 was 79% effective at preventing symptomatic COVID-19. Additionally, the trial found the AstraZeneca COVID-19 vaccine demonstrated 100% efficacy at preventing severe disease and hospitalization.

In addition to joining the global fight against COVID-19, Oramed Pharmaceuticals is also placing focus on developing an oral insulin capsule for the treatment of type 2 diabetes. Late last year, the company launched a Phase III trial to study the oral insulin candidate ORMD-0801.

“ORMD-0801 is the first oral insulin capsule to achieve the requisite efficacy and safety data enabling us to run the world’s first FDA Phase III oral insulin trial,” Kidron said.

Last week, Oramed Pharmaceuticals said it had reached 25% randomization of the planned 675 patients in the late-stage oral insulin trial. This is one of Oramed Pharmaceuticals’s two Phase III studies being conducted under U.S. Food and Drug Administration approved protocols.

About Oramed Pharmaceuticals

Oramed Pharmaceuticals Inc  (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that it has entered into definitive agreements to form a joint venture focused on the development of novel oral COVID-19 vaccines. The new company, Oravax Medical Inc., is based on Oramed’s proprietary POD™ oral delivery technology and Premas Biotech Pvt. Ltd.’s novel vaccine technology.

Source: BioSpace Mar 22, 2021 https://www.biospace.com/article/oramed-forms-joint-venture-company-to-develop-oral-covid-19-vaccines/

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