Acerus Pharmaceuticals Corp., of Toronto, said it started litigation against Recipharm Ltd., a wholly owned subsidiary of Recipharm AB, a pharmaceutical contract development and manufacturing organization based in Stockholm, in the Commercial Court of London. The company alleges that the suspension of Recipharm’s manufacturing license in August 2018, in contravention of its contractual obligations to Acerus, led to a shortage of Estrace, an oral, plant-derived 17-beta estradiol therapy indicated for symptomatic relief of menopausal symptoms, in Canada. The product generated sales revenues of $4.2 million but, due to the shortage, revenues and Acerus’ market share have decreased substantially each year since the shortage began.
Achilles Vaccines srl, of Siena, Italy, has received an investment from the EU Malaria Fund (EUMF) that will support development of a novel malaria vaccine produced on its technology platform designed to transform bacteria into an efficient delivery system of bio antigenic molecules to produce low-cost, safe and self-adjuvanting fit-for-purpose vaccines. The funding, with support from Fondazione TLS, will also be used to advance the company’s project to develop a human monoclonal antibody against COVID-19.
Adamis Pharmaceuticals Corp., of San Diego, said an article, titled “Higher naloxone dosing in a quantitative systems pharmacology model that predicts naloxone-fentanyl competition at the opioid mu receptor level,” has been published in PLOS One. It describes an opioid receptor quantitative systems pharmacology model, which was developed to predict the effects of different IM doses of naloxone (2 mg, 5 mg and 10 mg) in response to different levels of fentanyl exposure (low, medium and high). The model defined a successful reversal as lowering the amount of opioid bound to the brain receptors to less than 50% within 10 minutes. For the lowest and middle levels of fentanyl exposure, the model predicted that the 2-mg IM naloxone resulted in successful resuscitations within 10 minutes, but more rapid reversal was observed with the 5-mg and 10-mg doses. However, at the highest level of naloxone exposure, the model predicted that the 2-mg IM (and 4-mg IN) doses of naloxone did not result in a successful reversal. In contrast, the 5-mg and 10-mg doses of naloxone successfully reversed opioid toxicity.
Assembly Biosciences Inc., of South San Francisco, said it is regaining worldwide rights to all microbiome gastrointestinal programs licensed under its collaboration agreement with North Chicago-based Abbvie Inc. following the pharma’s decision to terminate the research, development, collaboration and license agreement inked with Allergan plc in 2017. Allergan was acquired by Abbvie. Assembly notes that the move was not based on any efficacy, safety or other data related to the collaboration programs. As a result, it brings back in-house all microbiome candidates subject to the collaboration, including ABI-M201, which is in a phase Ib trial in patients with mild to moderate ulcerative colitis, and ABI-M301, a preclinical program for Crohn’s disease.
Catalyst Biosciences Inc., of South San Francisco, presented preclinical data at the World Federation of Hemophilia Virtual Summit, showing gene therapy CB 2679d-GT in hemophilia B mice demonstrated a fourfold reduction in blood loss and an eightfold reduction in bleeding time when compared with the same dose of the Padua variant of FIX. Furthermore, when packaged in a proprietary chimeric AAV capsid, CB 2679d-GT demonstrated a clear dose response of high stable FIX levels across the three dose levels in hemophilia B mice, the company said. A pilot nonhuman primate study comparing the expression and tolerability of CB 2679d-GT in the chimeric capsid KP1 with the LK03 capsid demonstrated that CB 2679d-GT was well-tolerated with high FIX expression that stabilized to about 25% to 50% FIX above baseline levels at the six-week interim data cutoff. The novel chimeric capsid had differentiated and superior response to anti-capsid neutralizing antibodies than that observed for the LK03 comparator during the screening of nonhuman primates for the study.
Hemostemix Inc., of Calgary, Alberta, said its motion for a Replevin Order (return of assets) in its litigation with Aspire Health Science LLC, of Orlando, Fla., was not heard by the Court of Queen’s Bench, Alberta. Instead the court determined that Hemostemix will have to bring a Replevin Action in Florida because the computers with the electronic records that Hemostemix wants were located in Florida.
Immuron Ltd., of Melbourne, Australia, said it entered a research agreement with Australia’s national science agency, CSIRO, to produce a new therapeutic against Campylobacter and entero-toxigenic Escherichia coli (ETEC) for clinical evaluation by the U.S Department of Defense. CSIRO has been engaged to produce a hyperimmune bovine colostrum product using vaccines developed by the Naval Medical Research Center (NMRC), with which the company entered a research collaboration last October. In addition, NMRC submitted a pre-IND information package to the FDA and it expects to receive written comments on the nonclinical information within 30 days regarding its planned drug application to treat moderate to severe campylobacteriosis and ETEC infections.
Kane Biotech Inc., of Winnipeg, Manitoba, said its proposal, titled “DispersinB, the missing link in wound care – Clinical evaluation of DispersinB to treat biofilm mediated antimicrobial resistance in non-healing chronic wound,” has received the Department of Defense’s Medical Technology Enterprise Consortium Research Project Award. The award will provide about $2.7 million in nondilutive funding for the continued clinical development of the product. It consists of a naturally occurring enzyme produced by an oral bacterium Aggregatibacter actinomycetemcomitans, which is associated with juvenile periodontitis.
Merck & Co. Inc., of Kenilworth, N.J., completed the acquisition of Themis Bioscience GmbH, of Vienna. The Federal Trade Commission has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and Merck has received merger control clearance from the Austrian Federal Competition Authority. Themis is now a wholly owned subsidiary of Merck. An initial focus of the agreement is acceleration of the development of a measles vector-based COVID-19 vaccine candidate. Clinical studies are planned to start later in 2020.
Oncolys Biopharma Inc., of Tokyo, executed a patent assignment agreement with Kagoshima University, and will initiate development of therapeutic drug for COVID-19. Masanori Baba at the university identified compounds having a strong antiviral activity and obtained experimental data using an in vitro assay showing more powerful antiviral activity on SARS-CoV-2 virus replication at a concentration that has no effect on host cells, compared to some already approved drugs. Oncolys plans to conduct toxicological and pharmacokinetic studies and to manufacture investigational drugs for a clinical trial.
Oryzon Genomics SA, of Madrid, Spain, started a precision medicine collaboration with the Institute of Medical and Molecular Genetics of the La Paz University Hospital in Madrid in patients with Phelan-McDermid syndrome, a genetic disorder that involves a deletion or mutation of the end of chromosome 22 by an alteration of the SHANK3 gene. It is believed that the inability of the single functioning copy of SHANK3 to produce sufficient Shank3 protein for normal functioning may be responsible for most of the neurologic symptoms associated with that disorder. Eighty percent of people with the condition have an autism spectrum disorder.
Tiziana Life Sciences plc, of London, said the U.S. Patent and Trademark Office granted a patent covering the company’s platform technology for the oral administration of foralumab, its fully human monoclonal antibody, and all other anti-CD3 monoclonal antibodies. The patent will be issued June 23, 2020. The company also recently demonstrated that nasally-administered foralumab was not only well-tolerated but also produced a desirable immunological response.