Further Development of Advanced COVID-19 Diagnostic Testing Continues

PALM BEACH,  Fla., March 18, 2021 /PRNewswire/ --  While most of the world press has been focused on the vaccine development and implementation, that is not the whole story. Numerable collaborations between governments, test developers, public health organizations, and private laboratories have been diligently working to accelerate the expansion of testing capacities. Moreover, these testing programs are set to pave way for the travel industry to gear up, creating a favorable environment for the entities operating in the market. The tourism and travel industries have been most affected during this pandemic outbreak, which has led to an upsurge in COVID-19 testing initiatives post August 2020, particularly in tourism-based countries and regions. This is also expected to propel the PoC testing market penetration as these tests are able to overcome the limitations associated with traditional testing. The demand for COVID-19 diagnostic products is set to propel further with the increasing number of coronavirus-infected patients, particularly post the ease of lockdown across the globe. Despite the gradual decline expected in the number of positive patients in 2021, integration of COVID-19 tests in routine diagnostic protocols is expected to maintain the market growth. Transitioning focus of new entrants toward at-home testing and integration of advanced software has been witnessed in the past few months. This is expected to increase patient convenience in regard to time-consuming laboratory-based testing.   Active biotech companies in the market this week include Johnson & Johnson (NYSE: JNJ), BioVaxys Technology Corp. (OTCPK: LMNGF) (CSE: BIOV), Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP), Savara Inc. (NASDAQ: SVRA), Onconova Therapeutics, Inc. (NASDAQ: ONTX).

A report from Grand View Research has projected that the global COVID-19 diagnostics market size, estimated at USD 84.4 billion in 2020 was expected to expand at a compound annual growth rate (CAGR) of 3.1% from 2021 to 2027.  The report said that the market is driven by the rising government initiatives targeted toward the implementation of mass testing… Additionally, increased traction gained by mobile testing market space is expected to open new avenues for market expansion.  "The services segment is estimated to dominate the market with a revenue share of 48.34% in 2020. Service providers are boosting their testing capabilities by expanding technological footprints in existing labs and diagnostic centers as well as by launching new, high-capacity laboratories, which has contributed to the segment growth… The reagents and kits segment is expected to register the fastest CAGR of 3.8% from 2021 to 2027. The accelerated approval process is a major factor contributing to the significant growth of this segment. In response to the pandemic, companies are implementing various strategic initiatives, such as new product development and collaborations."

BioVaxys Technology Corp. (OTCPK: LMNGF) (CSE: BIOV.CNQ) BREAKING NEWS:  BIOVAXYS ENTERS AGREEMENT WITH INOTIV TO CONDUCT PRECLINICAL TOXICITY STUDIES FOR ITS COVID-T™ IMMUNODIAGNOSTIC PROGRAM - BioVaxys Technology Corp. ("BioVaxys"), the world leader in haptenized protein vaccines for antiviral and cancer applications, announced today that it has entered into an agreement with Bioanalytical Systems, Inc. d/b/a Inotiv ("Inotiv"), a global Contract Research Organization ("CRO"), to conduct  preclinical toxicology studies for its Covid-T™ immunodiagnostic.  Headquartered in West Lafayette, IN, Inotiv, provides contract research services and monitoring instruments to emerging pharmaceutical companies and some of the world's leading drug development companies and medical research organizations.

Covid-T™ is a low-cost, easy-to-administer, and accurate tool to test for the presence of T cells against SARS-CoV-2, and to evaluate the effectiveness of any SARS-CoV-2 vaccine candidate in stimulating T cell immunity.  Covid-T™ uses Delayed-Type Hypersensitivity ("DTH"), which is known to be a measure of T cell immunity and has been used for many years for other infectious diseases including tuberculosis, fungal diseases, and mumps.  The test is performed by placing a small amount of synthesized test material, e.g., SARS-Cov-2 spike protein, intradermally and inspecting the site for mild localized reddening and hardening of the skin ~24 hours later.

Under the terms of the March 15th, 2021, agreement, Inotiv will evaluate the safety, tolerability, and toxicity of purified SARS-CoV-2 s-protein in an intradermal research model, which will include a battery of clinical pathology, immunology, and histopathology evaluations.  The fully characterized, Good Laboratory Practice (GLP) grade SARS-CoV-2 s-protein will be synthesized by WuXi Biologics and is a core element of the Covid-T immunodiagnostic.  BioVaxys anticipates that the preclinical toxicity study results will be available early summer, with the successful completion of the study a critical step towards the initiation of a pivotal human trial of Covid-T later this year, subject to FDA approval. BioVaxys intends to submit its pre-IND meeting request to the FDA for Covid-T early next month.

BioVaxys President and Chief Operating Officer Ken Kovan stated, "Based on previous preclinical studies conducted with BVX-0320, and the fact that our SARS-CoV-2 vaccine candidate likewise incorporates synthetic s-protein, we have high expectations that this detailed toxicology study of the s-protein with Inotiv will confirm the safety profile of the diagnostic and lead to our planned pivotal clinical study later this year."

James Passin, BioVaxys CEO, stated "We are delighted to work with Inotiv, a leading CRO, to complete a toxicity study, further advancing Covid-T, our novel low cost and scalable skin test for T cell immunity to SARS-CoV-2, the virus that causes Covid-19. We believe that Covid-T will help to solve the world's most pressing public health policy crisis by enabling the rational distribution and allocation of vaccine resources, while preventing unnecessary and wasteful vaccination of people with demonstrable T cell immunity to Covid-19."  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:

Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP), a clinical-stage biopharmaceutical company, recently announced preliminary results following vaccination of non-human primates with TNX-1800 (modified horsepox virus, live vaccine), a live attenuated COVID-19 vaccine candidate engineered to express the SARS-CoV-2 (CoV-2) spike protein. Immunogenicity and protective efficacy of single-dose TNX-1800 were assessed at two dose levels (n=4 per group). At Day 41 after the vaccination, animals were challenged with live SARS-CoV-2 through intra-nasal and intra-tracheal routes. Protection was assessed at Day 47, six days after challenge. The research is part of an ongoing collaboration between Southern Research, the University of Alberta and Tonix.

"We are pleased that all eight animals vaccinated with TNX-1800 had undetectable SARS-CoV-2 in their upper and lower airways 6 days after challenge with SARS-CoV-2," said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. "Today's results are from the second phase of a study in which TNX-1800 vaccinated and control animals were challenged with SARS-CoV-2. Last Fall, we reported that all eight of animals vaccinated manifested 'takes', a skin reaction to horsepox vaccination which is a validated biomarker of functional T cell immunity, and that vaccination was associated with neutralizing antibodies in each case. The positive results of the protection from live CoV-2 challenge that we are reporting today validate the capacity for TNX-1800 to protect against COVID-19, and also validate the 'take' after TNX-1800 vaccination as a biomarker for functional T cell immunity."

Savara Inc. (NASDAQ: SVRA) recently announced the closing of its previously announced underwritten public offering of 57,479,978 shares of its common stock, including 11,694,150 shares sold pursuant to the exercise in full by the underwriters of their option to purchase additional shares, at a price to the public of $1.45 per share. In addition, in lieu of shares of common stock, Savara sold to certain investors pre-funded warrants to purchase an aggregate of 32,175,172 shares of common stock at a purchase price of $1.449 per warrant, which represents the per share public offering price for the common stock less the $0.001 per share exercise price for each pre-funded warrant. As a result of the underwriters' full option exercise, the aggregate gross proceeds of the offering to Savara, before deducting underwriting discounts and commissions and other offering expenses, were approximately $130.0 million.

Onconova Therapeutics, Inc. (NASDAQ: ONTX) recently announced financial results for the twelve months ended December 31, 2020 and provides a business update.  Highlights of the fourth quarter of 2020 and recent weeks include: ON 123300, Onconova's proprietary multi-kinase inhibitor, received clearance from the U.S. Food and Drug Administration (FDA) to begin Phase 1 studies; ON 123300 also received Institutional Review Board (IRB) approval at one U.S. clinical trial site; The Phase 1 solid tumor study with ON 123300 in China is ongoing and continues to enroll patients; Raised net proceeds of $35.2 million from two equity offerings; cash and cash equivalents as of February 28, 2021 were approximately $49.5 million; An independent investigator-initiated study with oral rigosertib in combination with a PD-1 inhibitor in advanced KRAS mutated non-small cell lung cancer is ongoing; and A Special Meeting of Stockholders to consider changes to the capital structure of the Company will reconvene on April 1, 2021

"The fourth quarter and recent weeks have been active and productive at Onconova as we continue to advance our lead product ON 123300 into the clinic," said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. "We submitted an Investigational New Drug application to the FDA for a Phase 1 study in advanced cancers including HR+/HER 2- metastatic breast cancer patients resistant to approved second-generation CDK 4/6 inhibitors. In December 2020, we received clearance from the FDA to begin the study, and have since received IRB approval at our first site. We expect the first patient to be enrolled in the second quarter of this year. Two further sites are in the study set-up process.

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.

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