Palm Beach, FL – August 26, 2020 – The worldwide response, both private and public, to finding a therapeutic and/or vaccine for the global pandemic has brought out the best in the global community. Contrary to historical comparable situations, it appears that this time a vaccine or vaccines may emerge in the very near future… an astronomical pace. Early in the COVID-19 pandemic, infectious disease experts said that developing a vaccine for the virus would take at least 12–18 months. Now, in their continued blitzkrieg against SARS-CoV-2, the novel coronavirus that causes COVID-19, several drug companies are keeping pace with their ambitious timelines, and some are moving even faster than they initially predicted. Recent articles have reflected this optimism. One such report said: “The pandemic is pushing drug companies to develop and test their wares at unparalleled speeds. “There is no reason you couldn’t speed up drug development if you really focused on it, and that’s what the pandemic has brought,” say a CEO of a life sciences consulting firm… Never have so many groups been working on vaccines and treatments for the same disease, said an, executive director of a medical research advocacy division of a well-known Institute. “(But) We have to be cautiously optimistic.” Active biotech and pharma companies in the markets this week include JanOne Inc. (NASDAQ: JAN), Moderna, Inc. (NASDAQ: MRNA), Sorrento Therapeutics, Inc. (NASDAQ: SRNE), iBIO, Inc. (NYSE: IBIO), INOVIO (NASDAQ:INO).
And its not just the private companies pushing the proverbial boulder up the hill… but the FDA is helping to make the slope a lower one for a faster conclusion. The Food and Drug Administration (FDA) has taken a number of steps to accelerate the development of COVID-19 therapeutics, from issuing guidance documents for product developers, to creating initiatives to facilitate regulatory review. We also continue to engage in public-private partnerships that prioritize evaluating potential therapeutics and vaccines in clinical trials and leveraging real-world data to better understand the natural history of COVID-19 infection. In this blog, we summarize the therapeutic landscape for COVID-19, describe the agency’s initiatives to support development, and outline lessons learned for modernizing the clinical research enterprise.
JanOne Inc. (NASDAQ: JAN) BREAKING NEWS: JanOne Advances its Potential Peripheral Artery Disease and Covid-19 Vascular Inflammation Treatment Towards Trial Readiness – JanOne Inc., a company focused on developing treatments for conditions that cause severe pain and drugs with non-addictive, pain-relieving properties, has successfully completed its initial engineering batch of JAN101. The JAN101 formulation is a patented sodium nitrite proprietary compound that demonstrated success in Phase 1 and Phase 2a trials for improving blood flow and vascular function, necessary in the treatment of Peripheral Artery Disease (PAD) and potentially for Covid-19 vascular complications that is believed to be the cause of severe vital organ and tissue damage.
According to Dr. Tony Giordano, JanOne’s chief scientific officer, “We are very fortunate to have had the foresight to initiate the manufacturing process this past February. Should we gain FDA approval for our Covid-19 study, we will be in a position to start patient trials immediately and still remain on track for our planned PAD phase 2b trials to begin in early 2021.”
The company expects to submit the investigational new drug (IND) for the treatment of Covid-19 vascular complications in the coming weeks and continues to advance plans to scale-up production of JAN101. The company has secured a partner for bottling and labeling, GMP batch production, including placebo batches. The company expects to deliver 250,000 doses within 30 days after start of manufacturing and have GMP batches of more than 20 million doses ready next year. Read this full release and more news for JAN at: https://www.financialnewsmedia.com/news-jan/
Other recent developments in the biotech industry include:
Moderna, Inc. (NASDAQ: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, recently announced that the Company has concluded advanced exploratory talks with the European Commission to supply 80 million doses of mRNA-1273, Moderna’s vaccine candidate against COVID-19, as part of the European Commission’s goal to secure early access to safe and effective COVID-19 vaccines for Europe. The potential purchase agreement with the European Commission of 80 million doses provides for an option for Member States to purchase an additional 80 million doses for a total of up to 160 million doses. The discussions are intended to ensure that Member States have access to Moderna’s vaccine.
The Phase 3 study of mRNA-1273 began on July 27 and enrollment of approximately 30,000 participants is on track to complete in September. Moderna is scaling up global manufacturing to be able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year, beginning in 2021. In Europe, the Company is working with its strategic manufacturing partners, Lonza of Switzerland and ROVI of Spain, for manufacturing and fill-finish outside of the United States. This is a dedicated supply chain to support Europe and countries other than the United States that enter into purchase agreements with Moderna.
Sorrento Therapeutics, Inc. (NASDAQ: SRNE) and SmartPharm Therapeutics, Inc. (“SmartPharm”) recently announced the signing of a merger agreement under which Sorrento will acquire SmartPharm, a gene-encoded therapeutics company developing non-viral DNA and RNA gene delivery platforms for COVID-19 and rare diseases with broad potential for application in enhancing antibody-centric therapeutics. As previously announced on July 24, 2020, Sorrento and SmartPharm entered into a letter of intent setting forth the terms and conditions by which Sorrento would acquire SmartPharm. In consideration for the acquisition, at closing, SmartPharm equity holders will receive up to an aggregate of $19.4 million of shares of Sorrento common stock, subject to certain adjustments, based on a price per share calculated in accordance with the merger agreement.
Sorrento and SmartPharm also previously announced a research and development collaboration to encode and express in vivo Sorrento’s proprietary SARS-CoV-2 neutralizing monoclonal antibodies utilizing SmartPharm’s Gene Mab plasmid nanoparticle platform.
iBIO, Inc. (NYSE American: IBIO), a biotechnology corporation and biologics contract manufacturing organization, recently provided an update on one of its proprietary vaccine candidates being designed to prevent infection from the SARS-CoV-2 virus. iBio is investigating an array of adjuvants in combination with iBio’s proprietary lichenase carrier molecule (“LicKMTM”) fused to a coronavirus subunit protein (“IBIO-201”) with the goal of producing a safe and effective vaccine for COVID-19 disease, and especially one for our most vulnerable populations, including the elderly.
Ten distinct preclinical study arms for the IBIO-201 antigen-adjuvant combinations have been concluded. These include combinations delivered via intramuscular and intranasal routes, and datasets are under evaluation. Anti-SARS-CoV-2 spike titers to IBIO-201were observed 21 days after immunization. Titers continued to increase over the 42-day study. Distinct, favorable Th1 and Th2 immune profiles were observed.
INOVIO (NASDAQ:INO), a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, 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).
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