A US Government Interagency Group Defines Three Classes Of SARS-Cov-2 Variants

PALM BEACH, Fla., March 24, 2021 /PRNewswire/ -- While the world has reason to become optimistic about seeing a light at the end of the tunnel, due to the development of vaccines to fight and rein in the current global pandemic, more concerns arise if the current vaccines will also tame the ever increasing variants on the virus. Concern about new coronavirus variants has grown quickly in recent months. First, scientists in the United Kingdom spotted a more contagious coronavirus strain that spread like wildfire through the London area. Then, researchers in South Africa spotted one that appears to evade the immune system. Next, another variant was flagged in Brazil because it looked like it could infect people who had already been infected once before… And now there has been a flurry of reports about homegrown variants in the United States. An article from NPR.org asked: "What's going on? How worried do we really need to be about them?" They answer that the short answer is, "worried but probably not panicked. The virus is doing what viruses do: evolving to find new ways to continue to infect people."   Active biotech companies in the market this week include AstraZeneca Plc's (NASDAQ: AZN), BioVaxys Technology Corp. (OTCPK: LMNGF) (CSE: BIOV), Sorrento Therapeutics, Inc. (NASDAQ: SRNE), Novavax, Inc. (NASDAQ: NVAX), Moderna, Inc. (NASDAQ: MRNA).

The Centers For Disease Control and Prevention (CDC) has recently devised a classification to label and follow the variants in the U.S. These classifications include definitions and attributes of the variants. There are 3 categories. Variants of Interest, Variants of Concern and Variants of High Consequence.  Learn more about these 3 categories by clicking here.  The NPR article continued with: "It's something we should keep an eye on and make sure that we continue to monitor the situation," says Kristian Anderson, a scientist at the Scripps Research Institute. But that doesn't mean it will turn out to be a serious problem, he adds. "There's a lot of things we need to keep eyes on, and then we keep our eyes on it, and then it turns out to not be important. In fact, the vast majority of situations [are] exactly that."

BioVaxys Technology Corp. (OTCPK: LMNGF) (CSE: BIOV.CNQ) BREAKING NEWS:  BIOVAXYS EXPANDS INTELLECTUAL PROPERTY PORTFOLIO - PATENT FILING TO ADDRESS EMERGING SARS-COV-2 VARIANTS NATIONAL PHASE FILINGS FOR CANCER VACCINE - BioVaxys Technology Corp. ("BioVaxys"), the world leader in haptenized antigen vaccines for antiviral and cancer applications, announced today that it is expanding its intellectual property portfolio with the filing of an international patent application through the Patent Cooperation Treaty ("PCT") for its haptenized viral antigen vaccine platform, including new claims for a multivalent version of BVX-0320, its SARS-CoV-2 vaccine candidate. The planned multivalent version of the BioVaxys vaccine is a combination of the haptenized spike protein subunits from each newly emerging, highly transmissible, SARS-CoV-2 variants, including United Kingdom (B.1.1.7 lineage), South Africa (B.1.351 lineage), and Brazil (P.1 lineage), that are of high concern to worldwide governments, healthcare practitioners, and infectious disease researchers.  

The provisional patent application covering the Company's haptenized viral antigen vaccine platform was filed with the US Patent and Trademark Office ("USPTO") last year and has now been converted to an International PCT Application, which is a patent treaty with more than 150 member countries. The PCT makes it possible to seek patent protection for an invention simultaneously in a large number of countries by filing a single "international" patent application instead of filing several separate national or regional patent applications.

In developments related to BVX-0918A, its ovarian cancer vaccine, Biovaxys has entered the National Phase with its bihaptenized tumor antigen platform patent application, most recently filed in 2019 as an International PCT Application. The granting of patents remains under the control of the national or regional patent offices in what is called the "National Phase". Once filed as a PCT, a patent application owner can start to pursue the grant of its patents directly before the national (or regional) Patent Offices of the countries in which they want to obtain them. Entering the National Phase, BioVaxys is pursuing expanded patent protection to include the major pharmaceutical markets of US, European Union (including the UK and Turkey), Australia, Canada, China, India, Japan, Russia, Brazil, and South Korea. 

BioVaxys President and Chief Operating Officer Kenneth Kovan states that "Because of the time and expense associated with developing novel products, BioVaxys places considerable importance on obtaining patent protection for new technologies, uses, and processes.  The Company will file patent applications to protect inventions and improvements that are important to the development of our business and with respect to the application of our products and technologies to the treatment of a number of diseases."    For greater certainty, BioVaxys is not making any express or implied claims that it has the ability to treat the SAR-CoV-2 virus at this time.  Continued…. Read this full release and more news for BioVaxys Technology at:  https://www.financialnewsmedia.com/news-biov/     

Other recent developments in the biotech industry include:

AstraZeneca Plc's (NASDAQ: AZN) On March 23, the company said it will publish up-to-date results from its major U.S. COVID-19 vaccine trial within 48 hours after health officials publicly criticized the drugmaker for using "outdated information" to show how well the immunization worked.  The rare public rebuke marks the latest setback for the vaccine once hailed as a milestone in the fight against the COVID-19 pandemic but has since been dogged by questions over its effectiveness and possible side effects.

AstraZeneca said results it published on Monday in which the vaccine had demonstrated 79% efficacy were based on an interim analysis of data through Feb. 17, and it would now "immediately engage" with the independent panel monitoring the trial to share its full analysis.

Sorrento Therapeutics, Inc. (NASDAQ: SRNE) recently announced that the first patient has been treated in its Phase 1b Amyloid Light Chain (AL) Amyloidosis study of STI-6129, an ADC which uses STI-5171, a fully human monoclonal antibody (mAb) from Sorrento's G-MAB™ library. This study is being conducted as a multicenter, open-label, dose-escalation clinical trial in patients with advanced relapsed and/or refractory systemic amyloid light chain (AL) amyloidosis with a primary objective to identify a Phase 2 dose for STI-6129 based on its safety, preliminary efficacy and pharmacokinetic profile.

STI-6129 is an ADC with covalently bound duostatin tubulin inhibitors (Duostatin 5) using a proprietary site-specific C-LOCK™ chemical linker designed to reduce the premature systemic release of duostatin and avoid the potential for toxicity, particular ocular toxicity, seen with other ADCs, especially first-generation products. STI-6129 has demonstrated an improved therapeutic index in animal models, as compared to traditional non-selective conjugates. STI-6129 has the potential for being a first-line treatment for amyloidosis as well as second line in those patients who have developed daratumumab resistance, an anti-CD38 mAb alone. STI-6129 binds to different epitopes than daratumumab and the addition of the targeted delivery of the duostatin can potentially manage those patients who have become refractory to such treatments.

Novavax, Inc. (NASDAQ: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, recently announced final efficacy of 96.4% against mild, moderate and severe disease caused by the original COVID-19 strain in a pivotal Phase 3 trial in the United Kingdom (U.K.) of NVX–CoV2373, the company's vaccine candidate. The company also announced the complete analysis of its Phase 2b trial taking place in South Africa, with efficacy of 55.4% among the HIV- negative trial participants in a region where the vast majority of strains are B1.351 escape variants. Across both trials, NVX-CoV2373 demonstrated 100% protection against severe disease, including all hospitalization and death. Both studies achieved their statistical success criteria. Today's final analyses build on the successful interim results announced in January 2021, adding substantially more COVID-19 cases and statistical power.

Moderna, Inc. (NASDAQ: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, recently announced that the Philippines has secured 7 million additional doses of COVID-19 Vaccine Moderna through a new supply agreement, bringing its confirmed order commitment up to 20 million doses. The 7 million additional doses are secured through a partnership with the private sector. The COVID-19 Vaccine Moderna is not currently approved for use in the Philippines, and the Company will work with regulators to pursue necessary approvals prior to distribution.

"We appreciate the continued confidence demonstrated by the government of the Philippines through this new agreement, as well as the support of the private sector, resulting in 20 million doses secured for the country," said Stéphane Bancel, Chief Executive Officer of Moderna. "This agreement supports the ongoing efforts in the Philippines to secure access to a safe and effective COVID-19 vaccine and reflects Moderna's continued commitment to expanding access to its vaccine around the world."  The initial procurement by the Philippines of 13 million doses was announced on March 6, 2021. Under the terms of this agreement, deliveries would begin in mid-2021.

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