ABUS Up On HBV Trial Data, VIR’s COVID-19 Therapies On Track, All Eyes On DVAX

Today’s Daily Dose brings you news about positive results from Arbutus’ HBV trial; encouraging phase I results of Moderna’s COVID-19 vaccine candidate; biotech stocks hitting new highs and Vir Biotechnology’s progress in the battle against the novel coronavirus.

Read on…

Shares of Arbutus Biopharma Corp. (ABUS) jumped more than 50% in extended trading on Monday, following positive follow-up data from a Phase 1a/1b clinical trial of a single subcutaneous injection AB-729 in patients having a chronic Hepatitis B Virus infection.

According to the results, at week 12, the 60 mg single-dose of AB-729 achieved equivalent reductions in HBsAg, the surface antigen of the hepatitis B virus, as the 180 mg single-dose.

The Company is also exploring an additional 90 mg single-dose cohort, with results anticipated in the second half of 2020.

ABUS closed Monday’s trading at $1.87, down 10.95%. In after-hours, the stock was up 53.48% at $2.87.

Dynavax Technologies Corporation (DVAX) will be providing an update on its early-stage collaborations regarding the potential development of a vaccine for COVID-19 tomorrow, May 19, 2020.

The Company’s potential COVID-19 vaccine candidate contains the proprietary toll-like receptor 9 agonist adjuvant CpG-1018 (“CpG-1018”), the adjuvant used in the HEPLISAV-B product.

Dynavax’ HEPLISAV-B is a Hepatitis B Vaccine for the prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

DVAX closed Monday’s trading at $4.86, up 6.81%. In after-hours, the stock was up 41.56% at $6.88.

Shares of Moderna Inc. (MRNA) hit an all-time high on Monday, following positive interim clinical data from a phase I study of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2).

According to the Company, after two doses all participants in the phase I study evaluated to date across the 25 µg and 100 µg dose cohorts developed detectable antibodies in the blood against the novel coronavirus at or above levels seen in convalescent sera.

The mRNA-1273 vaccine candidate elicited neutralizing antibody titer levels in all eight initial participants across the 25 µg and 100 µg dose cohorts, reaching or exceeding neutralizing antibody titers generally seen in convalescent sera, the Company noted. Neutralizing antibodies interferes with a virus/pathogen’s ability to infect a cell.

The phase I study was led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

A phase II study of mRNA-1273 is being conducted by Moderna. Based on the interim Phase 1 data, the Moderna-led Phase 2 study will be amended to study two dose levels, 50 µg, and 100 µg, with the aim of selecting a dose for pivotal studies.

The NIAID-led Phase 1 study is being amended to include a 50 µg dose level cohort. Moderna anticipates the dose for the Phase 3 study, which is expected to be initiated in July, to be between 25 µg and 100 µg.

Later in the day, Moderna announced that it has commenced an underwritten public offering of $1.25 billion in shares of common stock, with underwriters having a 30-day option to purchase up to an additional $187.5 million in shares of common stock.

MRNA touched an all-time high of $87 in intraday trading on Monday, before closing at $80.00, up 19.96%.

Shares of Novavax Inc. (NVAX) closed Monday’s trading at a two-year high of $56.96, up 30.55% on no company-specific news. The stock has gained 215% so far this month, thanks to the progress in the Company’s COVID-19 vaccine program and the funding it has been receiving for the vaccine development.

NVX-CoV2373, the Company’s COVID-19 vaccine candidate, is under phase I portion of the phase I/II trial. The preliminary immunogenicity and safety results from the phase I portion of the NVX-CoV2373 vaccine trial are expected in July.

The top-line data from a phase IIb clinical trial of Serum Institute of India’s malaria vaccine candidate, being conducted in Burkina Faso, in West Africa, are expected this quarter. Novavax’s Matrix-M vaccine adjuvant is a key component of this malaria vaccine candidate.

Novavax has the rights to sell and distribute the Serum Institute of India-manufactured vaccine in high-income countries, primarily in the travelers and military vaccine markets.

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NVAX closed Monday’s trading at $56.96, up 30.55%.

Sorrento Therapeutics Inc. (SRNE) touched a new 52-week intraday high of $10 in Monday’s trading before closing at $6.50.

The Company is also developing potential coronavirus antiviral therapies and vaccines.

In preclinical experiments, STI-1499, one of the antibodies identified by the Company, completely blocked SARS-CoV-2 infection of healthy cells and neutralized the virus infectivity at a very low antibody dose.

Sorrento is planning to generate an antibody cocktail product that would act as a “protective shield” against SARS-CoV-2 coronavirus infection and remain effective even if virus mutations render a single antibody therapy less effective over time.

Given the impressive results, the Company has chosen STI-1499 as the first antibody in the antibody cocktail (COVI-SHIELD) it is developing. STI-1499 is also expected to be developed as a stand-alone therapy, (COVI-GUARD) because of the high potency it has exhibited in experiments to date.

SRNE closed Monday’s trading at $6.50, down 3.85%. In after-hours, the stock was up 8.92% at $7.08.

Sophiris Bio Inc. (SPHS.OB), a late-stage clinical biopharmaceutical company, is all set to shut down operations as the Company has not been able to find a partner or raise capital to support its operations.

The Company’s shares were delisted from The Nasdaq Stock Market on March 12, 2020, due to non-compliance with the minimum $2.5 million stockholders’ equity requirement.

The lead asset of Sophiris is Topsalysin, which has completed two Phase 2 clinical trials for the focal treatment of localized prostate cancer and one Phase 3 study for the treatment of the lower urinary tract symptoms of benign prostatic hyperplasia (BPH).

Commenting on the developments, Randall Woods, president, and CEO said, “We have conducted an extensive year-long process with the assistance of an experienced financial advisor to identify potential strategic buyers and partners to support the continued development of topsalysin. During the process, we had contacts with more than 70 strategic and financial parties including biopharma companies, healthcare investment funds, and strategic financing companies. We held discussions, including management presentations and more extensive due diligence, with many of these parties and the process regrettably did not result in any actionable transaction.”

Vir Biotechnology Inc. (VIR) is advancing two clinical development candidates, VIR-7831 and VIR-7832, as potential therapeutics for COVID-19, in collaboration with GlaxoSmithKline plc (GSK).

VIR-7831 and VIR-7832 are based on S309, an antibody isolated from a patient who recovered from severe acute respiratory syndrome (SARS) in 2003, which has been shown to prevent SARS-CoV-2 live virus infection of cells.

Since the S309 antibody likely covers the entire family of related coronaviruses, even as SARS-CoV-2 continues to evolve, it may be quite challenging for it to become resistant to the neutralizing activity of S309, said Herbert “Skip” Virgin, Chief Scientific Officer of the Company.

VIR-7831 and VIR-7832 are expected to enter clinical testing this summer.

VIR closed Monday’s trading at $40.10, up 32.13%.

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