Biotech stocks have continued to be market-leading targets for investors through the coronavirus stock market crash and rebound. Moderna, Inc. (NASDAQ: MRNA), Q BioMed Inc (OTC: QBIO) and Gilead Sciences (NASDAQ: GILD) are getting a lot of attention now.
Having been the first group to start testing a vaccine against SARS-CoV-2, Moderna inc (NASDAQ: MRNA) is now on the cusp of phase 2. With the FDA having completed its review of the IND, Moderna expects to start the 600-subject phase 2 “shortly.”
“The imminent Phase 2 study start is a crucial step forward as we continue to advance the clinical development of mRNA-1273, our vaccine candidate against SARS-CoV-2,” said Stephane Bancel, Moderna’s chief executive officer in a press release issued by the company on Thursday.
Moderna has a goal of starting a pivotal phase 3 study in the summer and could have its first biologics license application approved as soon as next year, Bancel’s statement said.
“We are accelerating manufacturing scale-up and our partnership with Lonza puts us in a position to make and distribute as many vaccine doses of mRNA-1273 as possible, should it prove to be safe and effective,” said Bancel.
Last month, Q BioMed inc (OTC: QBIO) announced that together with its technology partner, Mannin Research, they are accelerating the rapid development of novel drugs for the treatment of life-threatening complications caused by COVID-19 and other viral infections. This novel drug program is being evaluated by government programs for funding and accelerated development under various COVID-19 response initiatives. Q BioMed and Mannin hope to have at least one treatment in human trials this year.
The accelerated development is the result of a joint venture (JV) between Mannin, with its Tie2 based small molecule platform that addresses vascular leakage, and Cyclica, a Toronto, Canada based biotechnology company that has a proprietary AI-augmented drug discovery platform, Ligand Design and Ligand Express. The JV agreement will deploy Cyclica’s unique AI platform to accelerate the development of new treatments based on Mannin’s Tie2 based platform.
Gilead Sciences (NASDAQ: GILD) has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its antiviral drug remdesivir, under the brand name Veklury, to treat Covid-19 infection.
The decision falls under an exceptional approval pathway, which is similar to emergency use authorisation in the US.
Remdesivir is an experimental nucleotide analogue that showed broad-spectrum antiviral activity against various viral pathogens, including Ebola, Marburg, MERS and SARS, in-vitro and in-vivo in animal models.
In-vitro testing found that the drug is active against SARS-CoV-2, the novel coronavirus that causes Covid-19. The drug is currently being assessed in several Phase III clinical trials.