An update pointed to an article titled, "A Multivariate Model Combining Endpoint and Epitope-specific Antibody Responses as a Correlate of Protection to Ricin Toxin," that has been submitted to the peer-reviewed medical journal Vaccine.
The RiVax® vaccine candidate is being developed under the company's Public Health Segment and is a candidate for the prevention of death following exposure to a lethal dose of ricin toxin using a unique antigen that is completely devoid of the toxic activity of ricin. Studies thus far have shown the vaccine formulation to have enhanced thermostability. In addition, RiVax® also demonstrated up to 100% protection in mice and non-human primates (NHPs) subsequently exposed to lethal doses of ricin toxin either systemically or by aerosol.
Also in May,
Pushing Approval Through The "Animal Rule"
The tests are expected to facilitate potential approval of RiVax® under the FDA Animal Rule which requires the evaluation of efficacy in animals. Previous testing of RiVax® has demonstrated up to 100% protection in NHPs exposed to lethal aerosolized ricin. In human testing, the RiVax® antigen has been demonstrated to be well-tolerated in Phase 1 clinical studies. Also, immunogenicity correlated between animal models and humans. Companies that have successfully utilzed the "Animal Rule" pathway include
The FDA "Animal Rule" is applied to products where human testing in clinical efficacy trials would be unethical since it would require intentionally exposing subjects to the ricin toxin. In similar applications, the "Animal Rule" is generally appropriated with the approval of medical countermeasures for biodefense purposes. Data has shown the RiVax® vaccine candidate to be both protective and thermostable. It has also demonstrated that a reduced number of vaccinations may establish protection, potentially utilizing only two doses instead of three.
Notably, the RiVax® studies are supported by a contract award of up to
While RiVax® is in the headlines recently, data from the company's pivotal phase 3 trials are highly impressive.
Phase 3 Pipeline Adds More Firepower
The company's second trial is also adding to the value proposition.
Balance Sheet Funded To Advance Trials
As of
Despite the recent 20% rise in price, the stock may present a compelling value opportunity after factoring in the potential catalyst contributions during the remainder of 2020.
More data from its SGX301 trial, top-line results from its SGX942 study, and additional news related from its university collaborations and from the RiVax® program may each deliver its own catalyst event that can create individual value for long-term gains.
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