A phase II/III study sponsored by Assistance Publique - Hopitaux de Paris testing the combination of Kevzara (sarilumab, Regeneron Pharmaceuticals Inc./Sanofi SA) with azithromycin and hydroxychloroquine vs. sarilumab alone in patients with moderate or severe pneumonia associated with COVID-19 was suspended for futility on the recommendation of the data safety monitoring board, according to clincaltrials.gov.
ARTMS Products Inc., of Vancouver, British Columbia, and Telix Pharmaceuticals Ltd., of Melbourne, Australia, signed a development collaboration agreement to employ ARTMS’ production of Gallium-68 (68Ga) for the manufacture of Telix’s prostate cancer imaging product, TLX591-CDx (68Ga-PSMA-11 injection), for the imaging of prostate cancer with positron emission tomography. ARTMS’ flagship product, the Quantm Irradiation System (QIS) provides decentralized, local production of important medical isotopes, including 68Ga, and the firm has recently presented data demonstrating multicurie production of 68Ga following less than two hours of cyclotron irradiation time. Under the terms of the agreement, ARTMS’ cyclotron technology will be used to produce high-activity 68Ga which will then be validated for use with Telix’s production process for TLX591-CDx. Terms were not disclosed.
Avectas Ltd., of Kildare, Ireland, said it exclusively licensed from Onk Therapeutics Ltd., of Galway, Ireland, a chimeric antigen receptor-directed natural killer (CAR NK) cell therapy incorporating Onk’s death receptor TRAIL variant for the treatment of B-cell malignancies. Onk will be responsible for progressing the potential therapy to a phase I trial. The candidate will be engineered using Avectas' nonviral cell engineering platform, Solupore. Avectas will retain worldwide development and commercialization rights to the therapy. Onk will receive up-front fees, development and commercial milestones and royalties. Avectas has also, through a holding company, acquired a minority share of Onk.
Berg LLC, of Framingham, Mass., disclosed a collaboration with Boehringer Ingelheim GmbH, of Ingelheim, Germany, to study the drivers of inflammatory disease. The potential outcomes of the partnership, which begins with a pilot program, could lead to a broader understanding of the etiology of potential candidate biomarkers, the companies said. Berg has previously collaborated with multiple pharmaceutical companies and applied its Interrogative Biology platform to diverse datasets to address major clinical unmet needs.
Chromadex Corp., of Los Angeles, disclosed the results of several new studies, which have uncovered new findings regarding its Niagen (nicotinamide riboside, or NR) cellular nutrient, paving the way for continued research. Through its research program, Chromadex provides the patented nicotinamide NR ingredient to research institutions and universities at no cost. Newly published clinical research in the American Journal of Clinical Nutrition examined NR supplementation at 1 gram per day for six weeks in healthy overweight or obese men. NR modestly improved body composition and acetyl carnitine concentrations in skeletal muscle and increased metabolic rate during sleep.
Cortexyme Inc., of South San Francisco, disclosed the publication of research further documenting the ability of the pathogen Porphyromonas gingivalis to invade neurons and trigger Alzheimer’s disease-like neuropathology. The findings are to be published in the June 2020 issue of the Journal of Alzheimer’s Disease. An early version of the paper is available online.
Dongwha Pharmaceutical Co. Ltd., of Seoul, South Korea, said it plans to conduct clinical trials using a new drug candidate, DW-2008, to treat COVID-19. DW-2008 is an extract of the water willow plant (Justicia procumbens). In vitro antiviral experiments performed at the Institut Pasteur Korea against COVID-19 demonstrated that DW-2008 had 1.7, 3.8 and 4.7 times higher antiviral activity compared to chloroquine, Foster City, Calif.-based Gilead Sciences Inc.’s remdesivir, and Kaletra (lopinavir/ritonavir, Abbvie Inc.) respectively, the company said.
Erytech Pharma SA, of Lyon, France, said it will be part of Evidence, a public-private consortium supported by the EU in the framework of the Horizon 2020 program. The consortium, consisting of leading experts in the field of red blood cell research, will explore how red blood cells are influenced by their extracellular environment. Specifically, it will investigate the behavior of red blood cells under physiological flow conditions, i.e. under conditions that are as close to reality as possible, to gain a better understanding of diseases and to develop improved diagnostic techniques and devices.
Immunoprecise Antibodies Ltd., of Victoria, British Columbia, said its lab has leased a high-throughput, label-free Octet HTX biosensor from Fortebio Analytics Co. Ltd., of Shanghai. The analytical tool addresses Immunoprecise's need for increased speed and sample throughput when characterizing large panels of therapeutic antibody candidates, the company said. Octet HTX offers time savings for researchers studying the binding interactions of hundreds of drug candidates by producing data supported with analysis tools allowing data-driven decisions to be made with confidence, Immunoprecise said.
Intract Pharma Ltd., of London, and Elasmogen Ltd., of Aberdeen, Scotland, disclosed an agreement to collaborate on developing orally delivered protein therapeutics, incorporating proprietary technologies developed by each of the partners. The collaboration combines Elasmogen’s Solomer technology, small (11 kDa) single-chain binding domains that can be rapidly reformatted to generate super-neutralizers (bivalent, biparatropic), with Intract’s Soteria and Phloral technologies for oral delivery of biologics targeted to the lower gastrointestinal tract. Terms were not disclosed.
Magenta Therapeutics Inc., of Cambridge, Mass., and Avrobio Inc., of Toronto, entered a research and clinical collaboration to evaluate MGTA-117, Magenta’s antibody-drug conjugate for conditioning patients before receiving one of Avrobio’s investigational lentiviral gene therapies. Magenta will retain all commercial rights to MGTA-117 while Avrobio retains all commercial rights to its gene therapies and will be responsible for clinical trial costs. MGTA-117 is designed to deplete hematopoietic stem and progenitor cells. Preclinical data, the company said, show it may be capable of clearing space in bone marrow to support long-term engraftment and rapid recovery in humans. Magenta plans to complete IND-enabling studies in 2020.
With its acquisition of Soluble Therapeutics Inc., Predictive Oncology Inc., of Eagan, Minn., will use its vaccine technology to develop a COVID-19 vaccine. The technology is based on its self-assembling nanoparticle, Non Specific Protein 10, using another self-assembling protein, ferritin, an iron storage protein. The ferritin platform is currently used by the NIH in its exploration of a universal flu vaccine.
Promis Neurosciences Inc., of Cambridge, Mass., and Toronto, said it identified antagonists against the receptor for activated protein kinase C 1 (RACK1) that prevent the formation of dysfunctional protein aggregates and act to restore normal function. Promis said RACK1 gives insights into the mechanisms involved in the pathogenesis of neurodegenerative diseases, including amyotrophic lateral sclerosis. The antagonists against RACK1 are designed to prevent normal brain protein from forming clumps that impair proper neuronal functioning and lead to disease.
Proteogenix SA, of Strasbourg, France, said it has the first human immune COVID-19 library for discovering antibodies against SARS-CoV-2. The library was created with blood samples from dozens of recovered COVID-19 patients, is adapted for screening with phage display and strives to meet the rising demands for effective antibodies for a broad range of applications. The library’s diversity (1.2 x 1010 different clones) is intended to fast-track discovery of antibodies with the strongest affinity, specificity and viral blocking activity, the company said.
Santhera Pharmaceuticals Holding Co., of Prattein, Switzerland, said it signed agreements with Rutgers, The State University of New Jersey as part of its program to advance gene therapy research for the treatment of LAMA2-deficient congenital muscular dystrophy (LAMA2 MD or MDC1A). Santhera gains rights to intellectual property developed at Rutgers on certain gene constructs that will be studied under a collaboration agreement. The gene therapy strategy uses two linker proteins composed of domains derived from extracellular matrix proteins agrin, laminin and nidogen. In animal models for LAMA2 MD, the approach led to restoration of muscle fiber basement membranes, recovery of muscle force and size, increased overall body weight and markedly prolonged survival, the company said.
Sinovac Biotech Ltd., of Beijing, said the first challenge study of its SARS-CoV-2 vaccine candidate on animals shows it induced SARS-CoV-2-specific neutralizing antibodies in mice, rats and nonhuman primates, specifically the rhesus macaque. The results, the company added, show the candidate offered safe and complete protection in rhesus macaques against SARS- CoV-2 strains. Sinovac said it received approval in April to conduct phase I/II studies on its inactivated vaccine candidate against COVID-19 in China. The company the phase I trial will involve 144 healthy adults, ages 18 to 59.
Tetra Bio-Pharma Inc., of Ottawa, said it completed modifications to the nonclinical safety program of PPP-003 to ensure the launch of a phase I trial in healthy volunteers later this year and that it will be able to initiate a phase II trial in patients with COVID-19 immediately after. Tetra's said PPP-003’s development program was adjusted to support a CTA in Canada and an IND in the U.S. for an intravenous sterile finished drug product. PPP-003 was shown in experimental models to decrease pro-inflammatory cytokines (IL-6 and TNF) in acute lung injury models similar to what occurs in sepsis, the company said. PPP-003, a specific CB2 agonist, also stops the efflux of inflammatory cytokines like TNF and IL-1beta in acute lung injury induced in other experimental models, the company added.
The Montreal Heart Institute said it received funding from the NIH for the institute’s clinical study of COVID-19. The COLCORONA study is one of the few contact-free current studies of treatment of COVID-19 infection in which non-hospitalized individuals can participate from their homes, the institute said, and is designed to determine whether colchicine has a preventive effect on the major inflammatory storm of the lungs observed in adults with serious COVID-19 complications. Colchicine, used to treat gout, may reduce severe inflammatory complications associated with COVID-19 and slow the diseases’ progression, the institute added. Several sites in Canada, the U.S. and Spain are participating.
Trovagene Inc., of San Diego, said it is changing its name to Cardiff Oncology Inc., with a new Nasdaq ticker, CRDF, to be effective at market open May 8. Mark Erlander will assume the role of CEO.
VBL Therapeutics Ltd., of Tel Aviv, Israel, reported new data at the Digestive Disease Week virtual meeting showing that treatment with anti-MOSPD2 antibodies was shown to decrease inflammation and fibrosis in a nonalcoholic steatohepatitis (NASH) model and significantly reduce disease activity in a colitis model. Data demonstrated that MOSPD2 plays a role in the pathogenesis of NASH and colitis by inhibiting the accumulation of monocytes in the affected tissue.
Xbrane Biopharma AB, of Solna, Sweden, and co-development partner Stada Arzneimittel AG, of Bad Vilbel, Germany, said they entered an exclusive licensing agreement with Bausch + Lomb, of Rochester, N.Y., the eye health business of Bausch Health Cos. Inc., to commercialize Xlucane, a Lucentis (ranibizumab, Roche Holding AG) biosimilar candidate, in the U.S. and Canada. The companies aim to obtain regulatory approval of all currently approved indications for Lucentis in both countries. Stada and Xbrane will be jointly responsible for finalizing development, and Xbrane will also provide commercial supply. Bausch + Lomb will be responsible for the sales, marketing and all other commercialization efforts for the biosimilar candidate following regulatory approval. Under the terms, Bausch + Lomb will make a mid-single-digit-million up-front payment and will pay further milestone payments subject to approval and launch of the product in the U.S. Xbrane and Stada will also be entitled to a share of gross profits from sales of the product by Bausch + Lomb. The two firms will share equally in the proceeds they receive from Bausch + Lomb.