Palm Beach, FL – August 4, 2020 – It seems lately, that news on a vaccine (or vaccines) for the global health crisis, project new possibilities moving quickly to the final solution. The number of vaccines in development seems to be growing daily. Recently, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, testified in Congress, saying that it was a definitely a possibility the United States would have an effective vaccine against COVID-19 by early next year. An article on his testimony from the Center for Infectious Disease Research and Policy added: “His optimism comes on the same day Operation Warp Speed, the US’s COVID-19 vaccine program, announced its biggest agreement yet: $2.1 billion to Sanofi Pasteur to supply the US government with 100 million doses of its experimental coronavirus vaccine. Sanofi is working with GlaxoSmithKline on a vaccine clinical trial planned for September.” Active biotech companies with recent developments include: Nascent Biotech, Inc. (OTCQB: NBIO), Novavax, Inc. (NASDAQ: NVAX), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), Moderna, Inc. (NASDAQ: MRNA), Gilead Sciences, Inc. (NASDAQ: GILD.
Fauci said he saw promising data on Moderna’s vaccine, which began its phase 3 trials on Monday. Moderna’s vaccine is also being funded in part by Operation Warp Speed, which has so far spent $8 billion on vaccine development… And in answering questions about China and Russia’s progress on a vaccine, Fauci seemed confident the United States would not have to rely on an international vaccine candidate. “I do not believe that there will be vaccines so far ahead of us that we will have to depend on other countries to get us vaccines,” he said. NPR reported additional statements from Fauci: “While it typically takes years to develop vaccines, new technologies, the lack of bureaucratic red tape and the human body’s robust immune response to COVID-19 have hastened the process, Dr. Anthony Fauci said.
Nascent Biotech, Inc. (OTCQB: NBIO) BREAKING NEWS: Nascent Biotech & Manhattan BioSolutions Participate In a Panel Discussion On The TB Vaccine Development For COVID-19 – Nascent Biotech (the “Company” or “Nascent”), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat cancers and viral infections, has participated in the recent expert panel discussion entitled “BCG: a therapeutic modality for COVID-19 and cancers” hosted by the Bioidea Group (https://bioidea.co/2020/07/13/bcg-covid-19/). The virtual session featured distinguished clinicians and scientists working on the TB / BCG vaccine for COVID-19 and cancer. The event was moderated by Dr Navpaul Singh, Chief Medical Consultant from Nascent Biotech, Inc and live streamed to social media platforms. Live stream recording is available on YouTube: https://www.youtube.com/watch?v=SumCzJOn0nc.
Manhattan BioSolutions, Inc. founder and CEO, Dr. Boris Shor, who also participated in the discussion, highlighted the recent collaboration agreement with Nascent Biotech and ongoing objectives between the two companies. Dr. Shor reasserted that Manhattan BioSolutions is focused on the discovery of the next-generation therapies for the treatment of cancer and inflammatory diseases, and that its unique oncology programs could also be applied towards the discovery of novel agents against COVID-19 to significantly impact the current and/or future viral outbreaks. The two companies signed the research agreement in May of this year and have since initiated a vaccine program for the potential prevention of COVID-19 or other viral infections. This effort will augment Nascent’s current development plans to investigate the utility of its monoclonal antibody Pritumumab for the treatment of COVID-19, as announced earlier in March.
Dr. Boris Shor reiterated “Manhattan BioSolutions has a longstanding commitment to advance the basic research of immunotherapies and we are excited to be working with Nascent Biotech on constructing a vaccine to prevent COVID-19 around the world. The latest literature revealed a correlation showing that countries with higher rates of Bacille Calmette-Guérin (BCG) vaccinations had lower peak mortality rates from COVID-19. These beneficial effect of BCG (TB vaccine) against viral infections are proposed to be mediated by the stimulation of innate immune mechanisms, also termed trained immunity. Clinical trials around the world are underway to investigate the protective effects of BCG against COVID-19. Our novel platform will be based on the recombinant BCG, genetically engineered to express selected SARS-CoV-2 proteins. The new design addresses major limitation of old-generation unmodified BCG to stimulate the human immune system broadly: a lack of specificity to SARS- CoV-2. Together, we will be in a strong position to advance the discovery and development of an innovative vaccination platform against coronaviruses.” Read this entire press release and more news for NBIO at: https://www.financialnewsmedia.com/news-nbio
Other industry developments from around the markets include:
Novavax, Inc. (NASDAQ: NVAX) and FUJIFILM Diosynth Biotechnologies (FDB), a world leading contract development and manufacturing organization (CDMO) for biologics, viral vaccines and gene therapies, recently announced an agreement to manufacture bulk drug substance for NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. FDB’s site in Morrisville, North Carolina has begun production of the first batch of NVX-CoV2373.
This arrangement falls under Novavax’ recent $1.6 billion award by the federal government as part of Operation Warp Speed (OWS), a U.S. government program that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 to the U.S. population. The OWS funding is being used by Novavax to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX‑CoV2373 beginning as early as late 2020. NVX-CoV2373 consists of a stable, prefusion protein made using Novavax’ proprietary nanoparticle technology and includes Novavax’ proprietary Matrix‑M™ adjuvant. The batches produced at the FDB site in North Carolina will be utilized in a future pivotal Phase 3 clinical trial of up to 30,000 subjects which is expected to begin in the fall of 2020 and which will determine the safety and efficacy of NVX-CoV2373.
Moderna, Inc. (NASDAQ: MRNA) recently announced that the Phase 3 study of its mRNA vaccine candidate (mRNA-1273) against COVID-19 has begun dosing participants. The Phase 3 study, called the COVE (Coronavirus Efficacy) study, is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
“We are pleased to have started the Phase 3 COVE study,” said Stephane Bancel, CEO at Moderna. “We are grateful to the efforts of so many inside and outside the company to get us to this important milestone. We are indebted to the participants and investigators who now begin the work of the COVE study itself. We look forward to this trial demonstrating the potential of our vaccine to prevent COVID-19, so that we can defeat this pandemic.”
Inovio Pharmaceuticals, Inc. (NASDAQ: INO) recently announced that its COVID-19 DNA vaccine INO-4800 targeting SARS-CoV-2 was effective in protecting non-human primates (NHPs; specifically rhesus macaques) from live virus challenge 13 weeks after the last vaccination. These protective results were mediated by memory T and B cell immune responses from INO-4800 vaccination.
These results, submitted to a peer-reviewed journal and also published today on the non-peer reviewed online preprint site bioRxiv, demonstrate that INO-4800 reduced viral load in both the lower lungs and nasal passages in macaques that received two doses of INO-4800 (1 mg) four weeks apart and then were challenged with live virus 13 weeks after the second dose (study week 17). The reduced viral loads following exposure to SARS-CoV-2 infection at this timeframe demonstrate an important durable impact mediated by INO-4800. This is the first time a vaccine protection in non-human primates was reported from memory immune responses as previously reported monkey vaccine challenge studies were conducted at the time near their peak immune responses (1-4 weeks from their last vaccination).
Gilead Sciences, Inc. (NASDAQ: GILD) recently announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tecartus™ (brexucabtagene autoleucel, formerly KTE-X19), the first and only approved chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). The approval of this one-time therapy follows a priority review and FDA Breakthrough Therapy Designation and is based on results of ZUMA-2, a single-arm, open-label study in which 87 percent of patients responded to a single infusion of Tecartus, including 62 percent of patients achieving a complete response (CR). Among patients evaluable for safety, 18 percent experienced Grade 3 or higher cytokine release syndrome (CRS) and 37 percent experienced Grade 3 or higher neurologic toxicities.
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