Sirnaomics Ltd. went five for five in its study of treating cutaneous basal cell carcinoma. Five of five patients in a cohort of the open-label, dose-escalation phase II study of STP-705, composed of two sIRNA oligonucleotides targeting transforming growth factor beta 1 and cyclooxygenase-2, had a 100% complete response.
How to get reasonable efficacy in cancer without toxicity – problematic especially in older patients – is a dilemma made ever more poignant by the advent of CAR T therapies and bispecific antibodies, which have been showing overall response rates of about 70%, but with side effects that can severely limit their use. Invariant natural killer T cells may provide an answer, and New York-based Mink Therapeutics Inc. aims to find out.
Japan’s Healios K.K. is in discussions with Japan’s Pharmaceutical and Medical Devices Agenc about the regulatory path forward for its Multistem somatic stem cell products, for which it conducted phase II/III trials in ischemic stroke and a phase II trial in acute respiratory distress syndrome.
With financings, U.S. FDA approvals and mergers and acquisitions all tracking behind last year, why would clinical data be any different? According to BioWorld research, clinical trial reports are down by 16.2% this year. The number of efforts targeting the COVID-19 pandemic, as well as the proportion of data focused on infectious diseases, are also dropping.
As Novartis AG works to streamline the company and finalized a long-considered plan to separate its Sandoz Inc. business by creating a standalone company, it temporarily stopped dosing in a study of branaplam for treating Huntington’s disease. Several findings from the phase IIb study suggested the presence of peripheral neuropathy in some participants. An independent data monitoring committee recommended the dosing halt but fell short of recommending the study be terminated. The VIBRANT-HD steering committee agreed with the committee’s recommendation.
Interim analysis of a phase III trial testing a single dose of Pfizer Inc.'s bivalent respiratory syncytial virus (RSV) vaccine candidate, RSVpreF, in older adults has revealed efficacy good enough to support a planned BLA submission for the vaccine to the U.S. FDA in fall 2022, the company said. Preparation for further submissions to other regulatory agencies are underway.
As the PDUFA date looms for Bristol Myers Squibb Co. with its candidate, deucravacitinib, for psoriasis, others – notably Dice Therapeutics Inc. – strive for new solutions to the skin disease, which has remained problematic for many patients despite approvals of multiple drugs in various classes.
Treating mice with butyrate, a short-chain fatty acid that is normally produced by beneficial gut microbes, prevented anaphylactic shock in allergic mice when they were exposed to peanuts after treatment. It also reduced inflammation in animals with colitis.
Cumulus Neuroscience Ltd. published a study demonstrating its home use electroencephalogram (EEG) can turn in more precise results than supervised laboratory-based assessments.
Nuvectis Pharma Inc. has been in business for barely two years, but thanks to a business model involving in-licensing promising late preclinical drug candidates, it has already begun a trial with a molecule targeting a little-known pathway that cancer cells depend on for protection. The firm is also close to the clinic with a drug that could give a new twist to tyrosine kinase inhibition after a $16 million financing round in early August.
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