By M. Marin
Advantages include ease of storage & distribution, plus potential to overcome vaccine hesitancy
Oramed Pharmaceuticals Inc. (NASDAQ:ORMP) has announced the formation of a new joint venture with India-based Premas Biotech, Oravax Medical Inc., to advance an orally administered vaccine for the COVID-19 virus. Oramed is the largest shareholder of Oravax, which will leverage Oramed’s proprietary POD™ oral delivery technology and Premas Biotech’s novel vaccine technology. Oravax intends to launch and commercialize its oral COVID-19 vaccine following clinical trials.
In a preclinical study of its efficacy, the oral vaccine successfully produced antibodies after just one dose. It promoted systemic immunity through Immunoglobulin G (IgG), which is the most common antibody in the blood and bodily fluids protecting against viral infections, and through Immunoglobulin A (IgA), which are antibodies that are found in the lungs, sinuses, stomach, and intestines that protect the respiratory and gastrointestinal tracts against infection.
In addition to offering protection against current COVID-19 strains, Oramed also believes that the oral vaccine could protect against emerging coronavirus variants more than many other vaccines currently being administered because of its triple antigen targeting of three structural protein parts of the SARS CoV-2 virus: Spike (S), Membrane M, and coronavirus envelope E targets. Based on Premas’ novel technology, the Oravax pill is a virus-like particle (VLP) triple antigen vaccine. VLPs are molecules that are similar to viruses but are not infectious. According to News Medical, using VLPs is “a very effective way of creating vaccines.”
Moreover, given the difficulties involved in storing and distributing most COVID-19 vaccines currently being offered, the Oravax vaccine might also provide a more convenient way to provide wide-scale distribution and inoculation as, unlike most other vaccines that require freezing storage, the Oravax vaccine can be stored in standard refrigerators. A pill format would also enable people to fill a prescription and then take the pill vaccine in the comfort of their own homes, eliminating the inconvenience of seeking vaccine availability and then waiting at an external location to receive the dose.
In turn, this might enable health agencies to boost inoculation rates. Currently, about 14% of people nationwide in the U.S. and less than 1% globally have been fully vaccinated, according to the New York Times, with a “striking divide” from one country to another. With higher portions of the population inoculated against COVID-19, we would expect commercial activity to resume towards pre-pandemic levels.
The company believes that a pill is probably also a greener vaccine option than a single- or double-dose injection solution that produces needles that have to be discarded. Depending on packaging of the Oravax oral vaccine, this could be an important differentiating factor from an environmental, social and corporate governance (ESG) investing perspective. We believe ESG is an increasingly important component of overall investment decision making.
Overcoming Vaccine Hesitancy
It is also possible that a vaccine in pill form will help some people overcome vaccine hesitancy, or the fear of taking a relatively new vaccine. According to NCBI, vaccine hesitancy stems from a number of factors, including the lack of trust in public health agencies. Some people who are concerned about accepting a vaccine injection might be more willing to get a COVID-19 vaccine in oral pill format.
Oravax expects to begin clinical trials in 2Q 2021. The several positive takeaways from this development include that Oramed has expanded its potential addressable commercial market into COVID-19 and potentially other viruses and has also shown the potential versatility of the technology behind its oral delivery platform.
Other biotech companies such as Vaxart (NASDAQ:VXRT), are also researching and/or developing vaccines, including in oral format, as well as nasal sprays (Altimmune [NASDAQ:ALT]) and precision transdermal (TDS) patch formats. However, there is still a tremendous global need for COVID-19 vaccines. Given the relatively early stage of inoculations at this point, we believe there is ample demand for vaccines and Oravax will be able to enjoy early mover advantage. Moreover, many in the medical community believe that a COVID-19 vaccine is likely to be recommended annually just as the flu vaccine is, which further underscores the need for a greater number of vaccine manufacturers. Separately, Pfizer (NYSE: PFE) has indicated that it is pursuing early stage oral studies for a drug to treat the COVID-19 disease, not to inoculate against it.
Advancing Multiple Clinical Studies in 2021
The Oravax vaccine represents a successful expansion of Oramed’s POD™ oral protein delivery platform into the vaccine development market, as noted. Simultaneously, Oramed continues to pursue opportunities in its core diabetes space, as well. In 2021, in addition to focusing on moving the COVID-19 vaccine forward through Oravax, Oramed also continues to advance its Oral Insulin in dual concurrent Phase 3 studies.
The company recently announced that it has enrolled and randomized 25% of the 675 patients planned for its Phase 3 ORA-D-013-1 study of ORMD-0801, its oral insulin capsule to treat type 2 diabetes (T2D). Oramed has also screened the first patients in its ORA-D-013-2 study, the second of the two above-noted concurrent Phase 3 studies of ORMD-0801 for the treatment of T2D. The ORA-D-013-2 study is planned to enroll 450 T2D patients.
This dual study represents the world’s first pivotal Phase 3 oral insulin trial conducted through an FDA approved protocol. Oramed also remains focused on advancing its NASH study and has also screened the first patients in this global trial. The company also is developing an oral GLP-1 (Glucagon-like peptide-1) analog capsule, ORMD-0901 for the treatment of diabetes.
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