AKL Research and Development Ltd., of Stevenage, U.K., reported results from experiments testing its osteoarthritis drug, APPA, at the Osteoarthritis Research Society International Virtual World Congress. APPA reduced inflammation-derived tissue turnover in human cartilage explants. The drug also inhibited RANKL-mediated osteoclastogenesis and bone resorption by human osteoclasts. In human articular chondrocytes, APPA significantly reduced gene expression induced by inflammatory cytokines IL-1beta of IL-8, TNF-alpha and cartilaginous degrading enzymes MMP-13 and MMP-3. In human cartilage explants stimulated with IL-1beta, APPA increased the level of proteoglycans in the intermedial layer.
Alkermes plc, of Dublin, said it reached an agreement with Sarissa Capital Management LP, a beneficial owner of about 5% of the company's outstanding ordinary shares, pursuant to which Sarissa Capital has the right to designate a director to the company's board. The company said the agreement follows “constructive dialogue between the parties related to the company's strategic priorities and ongoing board refreshment efforts.”
Centivax Inc., of San Francisco, said it launched on Jan. 1, 2021, as a company developing broad-spectrum therapeutics and a vaccines portfolio, including indications in COVID-19, multidrug-resistant bacteria, influenza, antivenom and oncology. The company said its portfolio programs benefit from governmental and institutional nondilutive funding and support, including from the Bill and Melinda Gates Foundation, the Naval Medical Research Center, Walter Reed Army Institute of Research and the U.S. NIH.
Ibsa Pharma Inc., of Parsippany, N.J., reported data at the Pediatric Endocrine Society meeting detailing potency and stability of liquid formulations of levothyroxine and advantages of its Tirosint-SOL version. Results of the new study demonstrate that unlike extemporaneously compounded formulations of liquid levothyroxine, which are packaged in a variety of containers, Tirosint-SOL demonstrated consistent and predictable product potency. Levothyroxine is used to treat hypoparathyroidism.
Mereo Biopharma Group plc, of London, and Cancer Focus Fund LP, a venture capital fund established in collaboration with The University of Texas MD Anderson Cancer Center to provide funding and clinical expertise to advance cancer therapies, said they are partnering to evaluate Mereo’s lead anti-TIGIT therapeutic antibody candidate, etigilimab, in clear cell ovarian cancer, a rare cancer that accounts for about 5% to 10% of all ovarian carcinomas in North America. The partnership will support a phase Ib/II trial testing etigilimab in combination with an anti-PD-1 antibody. The study will be financed by Cancer Focus Fund, in exchange for up-front consideration of $1.5 million of Mereo shares and additional payments based on the achievement of certain milestones.
Nicox SA, of Sophia Antipolis, France, said Fera Pharmaceuticals LLC, of Locust Valley, N.Y., has been reviewing opportunities for the development of naproxcinod in a number of indications, with preclinical development work in models of both COVID-19 infections and sickle cell disease. Taking into consideration data to date in COVID-19 models and the environment for development of COVID-19 therapeutics, Fera decided to no longer continue in COVID-19. Going forward, work will focus solely on development in sickle cell disease. Fera gained U.S. rights to naproxcinod, a cyclooxygenase-inhibiting nitric oxide-donating naproxen, in December 2015, with the deal amended in September 2018 and again in December 2020. Nicox retains all rights outside the U.S.
Novavax Inc., of Gaithersburg, Md., reported in a U.S. SEC filing that the company’s funding available for payment and allotted through the Operation Warp Speed agreement was increased by $147.3 million. That brings the total amount of funding through the project to about $1.7 billion.
Scipher Medicine Inc., of Waltham, Mass., launched Scipher Therapeutics, which will focus on developing drugs for patients not responding to existing approved therapies. The unit will use Scipher’s Spectra platform and clinico-genomic data to identify patients most likely to respond to the therapies.
Sola Biosciences LLC, of Boston, reported preclinical data at the MDA Insight in Research Investor Summit for Neuromuscular Disease from a study testing gene therapy SOL-257 in mice. SOL-257 targets pathogenic TDP-43, which is found in about 97% of amyotrophic lateral sclerosis patients. In the NEFH-hTDP-43ΔNLS mouse model, which expresses a doxycycline-repressible form of human TDP-43 lacking a nuclear localization signal, mice treated with control gene therapy (placebo) started dying three weeks after pathogenic TDP-43 expression, and by five weeks, 100% of male mice died. In contrast, all male mice treated with SOL-257 gene therapy survived.