Biotechs Step Up Development Activities as U.S. Government Prioritizes Availability Of COVID-19 Vaccines

PALM BEACH, Fla., March 15, 2021 /PRNewswire/ -- The recent pandemic, in one way, is like the WWIII we were hoping would never come. The whole world is fighting…  not against each other, but against a common enemy. Never has there been a conflict where all nations are seeking to win, and where industry and governments are rising to the challenge. Billions of dollars and man hours are all focused on creating the 'atom bomb' that can end this war, once and for all. Researchers across the globe are working to develop a vaccine 24/7. Currently, as of March 11, 2021, there are 93 candidate vaccines and 25 candidate vaccines in stage 3 clinical trials. So far, 12 vaccines have been authorized across several countries. Vaccines are our atom bomb.  In the U.S. there are presently 3 vaccines being deployed. An update on WebMD said: "The FDA granted emergency use authorization to Pfizer/BioNTech's COVID-19 vaccine for people 16 years of age and older on Dec. 11, 2020. The push to distribute it to all 50 states began the following day in operation that was months in the making. A week later, the same authorization was granted to a vaccine by Moderna. In late February, 2021, Johnson & Johnson's vaccine became the third vaccine to get FDA approval."   Active biotech companies in the market this week include Johnson & Johnson (NYSE: JNJ), BioVaxys Technology Corp. (OTCPK: LMNGF) (CSE: BIOV), Pfizer Inc. (NYSE:PFE), Moderna, Inc. (NASDAQ: MRNA), Novavax, Inc. (NASDAQ: NVAX).

The WebMD article continued: "The CDC has recommended that health care workers and the elderly be the first to receive the vaccine. It could be spring or even summer before enough of the vaccine can be manufactured to help inoculate the general public.  Both the Pfizer and Moderna vaccines have shown over 90% efficacy and require two doses which are administered several weeks apart. Johnson & Johnson requires just one shot and is 85% effective. China and Russia have both developed their own vaccines which are being used in other countries."

BioVaxys Technology Corp. (OTCPK: LMNGF) (CSE: BIOV.CNQ) BREAKING NEWS:  BIOVAXYS ENTERS MAJOR BIOPRODUCTION AGREEMENT WITH WUXI BIOLOGICS (HONG KONG) LTD. TO SYNTHESIZE PROTEINS FOR ITS SARS-COV-2 VACCINE AND COVID-T™ IMMUNODIAGNOSTIC PROGRAMS - BioVaxys Technology Corp. ("BioVaxys") the world leader in haptenized protein vaccines for antiviral and cancer applications, announced today that it has entered into a major bioproduction agreement with WuXi Biologics Limited ("WuXi"), a leading global Contract Development and Research Organization ("CDMO") and business unit of Shanghai-based Wuxi AppTec, to produce SARS-CoV-2 s-proteins required by BioVaxys for BVX-0320, its COVID-19 vaccine candidate, and for its Covid-T™ immunodiagnostic program.

Under the terms of the March 11^th, 2021 agreement, WuXi will synthesize high yields of fully characterized, Good Laboratory Practice (GLP) grade SARS-CoV-2 s-protein for BioVaxys' preclinical safety study of its COVID-T™ diagnostic this spring. The recombinant s-protein will be constructed and expressed using WuXi Biologics' proprietary vector, with high yield protein production in a pilot plant bioreactor. By establishing its own source of s-protein, rather than depending upon a bulk commercial supplier, BioVaxys will be able to secure the level of purity, consistency and protein characterization required by the U.S Food and Drug Administration ("the FDA"), as well as the economics of sourcing its own protein supply, facilitating the future production of GMP-grade s-protein for human trials and future commercial-scale production.

Synthesized GMP-grade s-protein is used in both BioVaxys's Covid-T™ immunodiagnostic as well as in BVX-0320, the company's SARS-CoV-2 candidate vaccine which is also being prepared for a clinical study this year. BioVaxys will submit its pre-IND meeting request to the FDA for Covid-T early next month.

BioVaxys President and Chief Operating Officer Ken Kovan stated that "Establishing a bioproduction method for a steady supply of purified and fully characterized s-protein from a validated process will enable us to quickly transition from having the GLP material for the upcoming Covid-T™ animal toxicity study to having a steady source the GMP-grade s-protein for clinical trials later this year. Now that we know the gene sequences, a further major benefit of our relationship with WuXi will be our ability to quickly source the s-protein of newly emerging SARS-CoV-2 variants for use in a planned multi-valent version of BVX-0320 and line extensions of Covid-T™."

James Passin, BioVaxys CEO, stated "We are delighted to execute a definitive agreement with WuXi Biologics, a leading China-based CDMO listed on the Hong Kong Stock Exchange under the symbol 2269, with a market capitalization of USD$45 billion.  The relationship with WuXi positions BioVaxys to accelerate the regulatory and commercial advancement of Covid-T™ and BVX-0320."  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:

The Israel Ministry of Health (MoH), Pfizer Inc. (NYSE: PFE) and BioNTech SE (BNTX) recently announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2), underscoring the observed substantial public health impact of Israel's nationwide immunization program. These new data build upon and confirm previously released data from the MoH demonstrating the vaccine's effectiveness in preventing symptomatic SARS-CoV-2 infections, COVID-19 cases, hospitalizations, severe and critical hospitalizations, and deaths. The latest analysis from the MoH proves that two weeks after the second vaccine dose protection is even stronger – vaccine effectiveness was at least 97% in preventing symptomatic disease, severe/critical disease and death. This comprehensive real-world evidence can be of importance to countries around the world as they advance their own vaccination campaigns one year after the World Health Organization (WHO) declared COVID-19 a pandemic.

Findings from the analysis were derived from de-identified aggregate Israel MoH surveillance data collected between January 17 and March 6, 2021, when the Pfizer-BioNTech COVID-19 Vaccine was the only vaccine available in the country and when the more transmissible B.1.1.7 variant of SARS-CoV-2 (formerly referred to as the U.K. variant) was the dominant strain. Vaccine effectiveness was at least 97% against symptomatic COVID-19 cases, hospitalizations, severe and critical hospitalizations, and deaths. Furthermore, the analysis found a vaccine effectiveness of 94% against asymptomatic SARS-CoV-2 infections. For all outcomes, vaccine effectiveness was measured from two weeks after the second dose.

Moderna, Inc. (NASDAQ: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, recently announced that the first participants have been dosed with the Company's modified COVID-19 vaccines, designed to address the potential need for booster vaccine candidates, in an amendment to the ongoing Phase 2 clinical study.

mRNA-1273.351 encodes for the prefusion stabilized Spike protein of the SARS-CoV-2 variant B.1.351, first identified in the Republic of South Africa, and is being assessed as a booster vaccine to increase the breadth of response to emerging variants with key-receptor-binding domains (RBD) mutations. mRNA-1273.211 is a multivalent candidate which combines mRNA-1273, Moderna's authorized vaccine against ancestral strains, and mRNA-1273.351 in a single vaccine, designed to elicit a broad immune response as both a primary series and when administered as a boost to those who have previously received mRNA-1273.

Johnson & Johnson (NYSE: JNJ) recently announced that the World Health Organization (WHO) has issued Emergency Use Listing (EUL) for its single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), to prevent COVID-19 in individuals 18 years of age and older.

Data from the Phase 3 ENSEMBLE study showed that the Johnson & Johnson COVID-19 vaccine was well tolerated and demonstrated a 67 percent reduction in symptomatic COVID-19 disease in participants who received the vaccine in comparison to participants given the placebo. The onset of protection was observed from day 14 and was maintained 28 days post-vaccination.

The data also demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death across countries with different variants, beginning 28 days after vaccination.¹ Variants observed in an ongoing analysis in the ENSEMBLE study included the B.1.351 variant which was identified in 95 percent of the COVID-19 cases in South Africa.

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.

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