PERTH, Australia – Engeneic Ltd. has begun a phase I trial of its nanocellular COVID-19 vaccine, which in preclinical animal studies stimulated a broad antiviral response against mutant strains of the virus, including the virulent Delta strain sweeping across Australia.
Chinese companies are finding that their COVID-19 vaccines are effective as booster shots and against variants of the virus, as data from more studies emerge. Those who have received the third dose of Sinovac Biotech Ltd.’s COVID-19 vaccine, Coronavac, showed 2.5-fold higher neutralizing potency against the Delta variant, compared to COVID-19 convalescents and two-dose vaccinees.
Given the ethics and feasibility of placebo-controlled COVID-19 vaccine trials, Access Consortium members are recognizing appropriately designed immunobridging studies as an acceptable approach for authorizing the vaccines, including those being developed to protect against SARS-CoV-2 variants.
While privately held Calcimedica Inc. posted positive top-line results from a phase II study of its lead candidate in treating patients with severe COVID-19 pneumonia, Redhill Biopharma Inc. took a tumble as preliminary top-line data from a phase II/III study of opaganib in treating hospitalized COVID-19 patients showed the endpoints failed to achieve statistical significance.
A fourth child has died after developing liver complications on a trial of Astellas Pharma Inc.’s gene therapy for rare neuromuscular disease, after FDA advisers noted the problems on the ASPIRO study in a discussion on gene therapy safety. Last week, Astellas announced that it had stopped dosing on ASPIRO after a safety issue involving liver function emerged in the trial of the gene therapy AT-132, aimed at the life-threatening rare disease X-linked myotubular myopathy.
The NIH and CDC granted researchers at the Feinstein Institutes for Medical Research at Northwell Health $700,000 to investigate an in-the-ear stimulator as a treatment for post-traumatic stress disorder (PTSD) in first responders to the attack on the World Trade Center 20 years ago. The researchers will enroll 30 World Trade Center first responders with chronic PTSD in a sham-controlled trial to test the effectiveness of a device that uses transcutaneous auricular stimulation of the vagus nerve, which has shown promise in preclinical studies.
The share price of Renovorx Inc. has spiked following FDA clearance for its Renovocath delivery system. Since the company announced the clearance, its stock (NASDAQ:RNXT) has climbed by more than 13%. Last month the company completed an IPO for approximately $16.6 million, issuing shares at $9-$11.
Shares of antibody drug conjugate developer Mersana Therapeutics Inc. (NASDAQ:MRSN) fell 39.1% to $8.56 on Sept. 10 after the company disclosed a second death from pneumonitis in the ongoing phase I trial testing its antibody drug conjugate, upifitamab rilsodotin against tumor types likely to express the sodium-dependent phosphate transport protein NaPi2b, such as ovarian cancer.
Apellis Pharmaceuticals Inc.’s win with one phase III trial and narrow miss with an identical one testing pegcetacoplan in geographic atrophy secondary to age-related macular degeneration caused Wall Street to punish the company while rewarding competitor Iveric Bio Inc.
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