New data from Adamis Pharmaceuticals Corp., of San Diego, suggest higher doses of intramuscular naloxone, an opioid antagonist, could be useful in combating overdoses from potent synthetic opioids. In a study, monkeys received doses of carfentanil, a synthetic opioid 10,000 times stronger than morphine and 100 times more potent than fentanyl, then followed by different doses of naloxone. The monkeys were examined using positron emission tomography imaging to observe the number of brain receptors bound with naloxone. The study found higher doses of naloxone resulted in an increased number of naloxone-bound brain receptors, lowering the number of brain receptors bound with the opioid. A higher level of naloxone, similar to levels produced by Adamis’ Zimhi product candidate, displaced more carfentanil bound to receptors compared to lower naloxone levels typically observed with current lower-dose marketed naloxone products, the company said.
Alimera Sciences Inc., of Atlanta, said it received about $1.8 million from the U.S. government under the Paycheck Protection Program, which provides for loans to qualifying businesses for amounts up to 2.5 times the average monthly U.S. payroll costs of the qualifying business. It also provides a mechanism for forgiveness of up to the full amount borrowed as long as the borrower uses the loan proceeds during the eight-week period after the loan origination for eligible purposes, including payroll costs, certain benefits costs, rent and utilities costs, and maintains its employment and compensation levels, subject to certain other requirements and limitations. Alimera is developing ophthalmic pharmaceuticals.
Annovis Bio Inc., of Berwyn, Pa., published data demonstrating the therapeutic efficacy of inhibiting the translation of amyloid precursor protein (APP) and its fragments in an Alzheimer’s disease model. Translational inhibition of APP by ANVS-401 has been shown to reduce APP and its fragments in cell culture, animal models and mildly cognitively impaired patients. The company said its Parkinson’s disease studies lowered levels of alpha-synuclein and normalized gut motility in two transgenic animal models. ANVS-401 treatment normalized impairments in spatial working memory, contextual fear learning and synaptic function in APP/presenilin-1 mice, without affecting their visual activity, motor skills or motivation, and without affecting wild-type mice. ANVS-401 was shown in human and animal studies to lower APP/amyloid-beta, tau/phospho-tau and alpha-synuclein, the neurotoxic proteins that impair axonal transport and lead to inflammation and cell death.
Audax Medical Inc. of Concord, Mass., secured an exclusive worldwide license from Northeastern University for an advanced nanomolecular technology addressing development of therapies for COVID-19 and other viruses. The company said research studies show the company's self-assembled nanomolecule exhibits strong antimicrobial properties, while also displaying favorable cytotoxicity and anti-inflammatory attributes. Additional development efforts will target related biochemical and biophysiological testing of COVID-19 and other like viral molecules, the company said.
Privately held artificial Intelligence firm Biovista Inc., of Charlottesville, Va., said it identified four treatments – two prescription drugs and two over-the-counter compounds — to counter key symptoms of COVID-19. The first drug could reduce viral replication, limit inflammatory events and help protect against acute lung injury, the company said. The second drug has the potential to reduce viral load, improving the primary acute respiratory distress syndrome component of the disease and reducing the cytokine storm in COVID-19, the company added. The two over-the-counter compounds would be adjunct treatments.
Cassava Sciences Inc., of Austin, Texas, said it received a $2.5 million research grant award from the NIH to support ongoing clinical evaluation of PTI-125, the company’s lead investigational drug. PTI-125 is designed to improve neurodegeneration and neuroinflammation in Alzheimer’s disease patients. In March, Cassava initiated an open-label, multicenter clinical study of PTI-125 at 100 mg twice-daily for 12 months. The target enrollment is about 100 patients with mild to moderate Alzheimer’s disease.
Epimab Biotherapeutics Inc., of Shanghai, and the QIMR Berghofer Medical Research Institute, a nonprofit research organization based in Brisbane, Australia, disclosed a research collaboration and license agreement to evaluate novel target combinations for their application using Epimab’s bispecific antibody format, Fabs-In-Tandem Immunoglobulin. Under the terms of the agreement, Epimab will be granted an exclusive license to Berghofer’s target combinations to develop bispecific antibodies. Those will be tested in Berghofer’s preclinical models. Financial details were not disclosed.
Fujifilm Diosynth Biotechnologies U.K. Ltd., of Billingham, U.K., disclosed a partnership with Oxgene Genetics Ltd., of Oxford, U.K. The tie-up will enable Diosynth to deliver gene therapy products to clients with an approximate 25% lead-time reduction. Diosynth has licensed Oxgene’s adeno-associated virus (AAV) system for commercial use to support biotech companies engaged in gene therapy development and manufacture. The AAV system consists of Helper, Rep/Cap and Gene of Interest plasmids, used in combination with a clonal suspension a HEK293 cell line.
Hansoh Pharmaceutical Group Co. Ltd., of Shanghai, and Nikang Therapeutics Inc., of Wilmington, Del., disclosed a collaboration focused on development and commercialization of NKT-1992, a small molecule in preclinical development, for viral infection in China, Taiwan, Hong Kong and Macau. Nikang is eligible to receive an up-front collaboration fee and additional payments contingent on certain development, regulatory and commercial milestones, potentially totaling more than $100 million, plus tiered royalties on net sales. Hansoh Pharma will be responsible for leading development and commercialization of NKT-1992 in greater China.
Hemogenyx Pharmaceuticals plc, of London, is deploying its research and technologies to develop potential treatments for COVID-19. Using its humanized mice, called the Advanced peripheral blood Hematopoietic Chimera, which were developed to model blood and autoimmune diseases and to test treatments, Hemogenyx will seek to discover human neutralizing antibodies that could be used. Prior to the appearance of COVID-19, Hemogenyx had been working independently and with a number of pharmaceutical company partners to utilize the exceptional features of the mice to identify and isolate human neutralizing antibodies for use as antiviral therapies.
Hope Biosciences Stem Cell Research Foundation in Houston said it has completed the first 10 treatments for immune support against COVID-19. This is the first of three FDA-approved clinical trials targeting COVID-19 that the foundation is executing. The first study is providing autologous, adipose-derived mesenchymal stem cells to patients who have already banked their stem cells with Hope, the foundation said.
Insmed Inc., of Bridgewater, N.J., said it will provide funding and clinical drug supply for the STOP-COVID19 (Superiority Trial of Protease inhibition in COVID-19) trial, an investigator-initiated study of brensocatib (formerly known as INS-1007) in up to 300 hospitalized patients with COVID-19 sponsored by the University of Dundee in Scotland. The study is expected to begin enrollment in May 2020. Brensocatib is an oral, reversible inhibitor of dipeptidyl peptidase 1 being developed by Insmed for the treatment of bronchiectasis and other inflammatory diseases.
Medincell SA, of Montpellier, France, said it has designed, tested and selected with the support of the Bill & Melinda Gates Foundation the candidate formulation which can now enter preclinical development. The company has demonstrated in vivo the feasibility of a contraceptive based on its BEPO (Bioresorbable diblock mPEG-PDLLA and triblock PDLLA-PEG-PDLLA) technology, administered by subcutaneous injection, fully bioresorbable and active for six months. The Gates grant of $19 million over four years will fund preclinical activities and an initial clinical study.
Menlo Therapeutics Inc., of Bridgewater, N.J., said its wholly owned subsidiary, Foamix Pharmaceuticals Ltd., entered a licensing agreement with specialty pharmaceutical company Cutia Therapeutics (HK) Ltd., of Hong Kong, an affiliate of Cutia Therapeutics, for Amzeeq (minocycline) topical foam, 4%, as well as its other topical minocycline product candidates, once approved, on an exclusive basis in greater China. Under the terms, Cutia will have an exclusive license to obtain regulatory approval of and commercialize Amzeeq and, if approved in the U.S., FMX-103 and FCD-105 in the greater China territory. Foamix will supply the finished licensed products to Cutia for clinical and commercial use. Foamix will receive an up-front cash payment of $10 million and will be eligible to receive an additional $1 million payment upon the receipt of marketing approval in China of the first licensed product. Foamix will also receive royalties on net sales of any licensed products.
Moleculin Biotech Inc., of Houston, said it entered an agreement with Imquest Biosciences Inc., of Frederick, Md., to expand in vitro and in vivo testing of WP-1122, Moleculin's lead drug candidate for the treatment of COVID-19.
Nascent Biotech Inc., of San Diego, said it has initiated tests to assess the possibility that its lead asset, monoclonal antibody pritumumab (PTB), could be used as a potential therapy against SARS-CoV-2. As specifically mentioned in a 2016 article in The Journal of Biological Medicine, cell-surface vimentin (recognized by PTB), is implicated in the entry of SARS-CoV-2, into the cells it infects. The company said it has engaged independent third-party consultants to conduct the tests, with initial results forthcoming.
NEC Corp., of Tokyo, disclosed analysis results in bioRxiv from efforts using AI prediction platforms to design blueprints for SARS-CoV-2 vaccines that can drive potent T-cell responses in the majority of the global population. The initiative, led by NEC Oncoimmunity in collaboration with NEC Laboratories Europe, involved the analysis of thousands of sequences from the SARS-CoV-2 virus and identified epitopes for the 100 most frequent HLA alleles in the global population.
Novelstem International Corp., of Boca Raton, Fla., disclosed two collaborations to apply the technology platform of its Israel-based affiliate, Newstem Ltd., one to research a potential cancer immunotherapy drug and another to research genes responsible for COVID-19. Novelstem also announced the identification and completion of analysis of resistance to a dozen standard-of-care cancer treatments. Under the COVID-19-focused deal, the Azrieli Center for Stem Cells and Genetic Research at Hebrew University used Newstem’s haploid human embryonic stem cell platform technology and genome-wide screening methodologies, with research initiated for identifying genes that regulate the pathogenicity of the SARS-CoV-2 virus. Work is intended to help develop methods to generate resistance to SARS-CoV-2 and enable new ways to find therapies. The immunotherapy agreement involves an undisclosed Nasdaq-listed biopharma company and will focus on development of a potential new biopharmaceutical in the field of cancer immunotherapy as well as to pursue the potential discovery of new drug targets. Should the research progress to support a successful immunotherapy, Newstem would be entitled to further milestone payments as well as royalties based on sales.
Ocean Biomedical Inc., of Providence, R.I., said Nature published findings from a Brown University research team providing insights into the way malaria regulates infection levels within its host, and new possibilities for a broadly effective vaccine and a new class of antimalarial medications. Ocean is developing that discovery to accelerate the timetable for clinical availability of a new vaccine and related medicines. In addition to the potential malaria treatments, Ocean said it plans to expand the development platform that led to that discovery to facilitate breakthroughs in other critical areas, including addressing novel coronaviruses, such as SARS-CoV-2.
Prothera Biologics Inc., of Providence, R.I., and Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, said they entered a global licensing agreement to develop a plasma-derived IAIP (Inter-alpha Inhibitor Proteins) therapy for the treatment of acute inflammatory conditions. IAIP are naturally occurring proteins that circulate in the blood, and extensive research at Prothera has shown that those proteins play an essential role in human health by controlling inflammation. Under the agreement, the firms will work together on IND-enabling activities, with development led by Takeda's Plasma Derived Therapies R&D organization. The collaboration will also explore the development of companion diagnostics with the goal of personalizing patient treatment and maximizing real-world outcomes. Takeda will assume responsibility for funding all development and commercialization activities. Specific financial terms were not disclosed.
Recce Pharma Ltd., of Sydney, reported preclinical data showing in vivo antibacterial activity against methicillin-resistant Staphylococcus aureus (MRSA superbug) in rats with topical burns treated with its lead compound, Recce 327. The study met its primary endpoints, showing a reduction in bacterial load in wound and percentage of wound contraction, evaluated on the fourth day following dosing.
Sengenics Pte Ltd., of Singapore, said it launched a KREX-based array, the Immukyne protein array, in a bid to enhance and accelerate effective response for COVID-19 by understanding whether autoantibodies play a role in progression to severe disease in COVID-19 patients, using advanced antibody profiling assays.
Shenzhen Hepalink Pharmaceutical Group Co. Ltd., of Shenzhen, China, said its subsidiary, Cytovance Biologics, signed a collaboration agreement with Akshaya Bio Inc., of Edmonton, Alberta, to provide rapid access to clinical materials using Akshaya’s Chimigen platform technology for vaccine development for COVID-19 and hepatitis B virus (HBV) The companies will focus on using Chimigen to execute bulk drug products of both COVID-19 and HBV vaccines to be used in phase I trials. Akshaya utilizes the platform to develop therapeutic vaccines for patients with chronic viral infections as well as prophylactic vaccines to prevent infections. Cytovance will scale up production using its GMP insect cell microbial manufacturing platform for evaluation of Chimigen in both indications.
Soleno Therapeutics Inc., of Redwood City, Calif., said a paper published in Genes showed that agonizing the ATP-sensitive potassium channel in hyperphagic obesity results in a range of therapeutically relevant responses, including reducing appetite, improving satiety, reducing fat mass, decreasing circulating and liver fat, and improving insulin sensitivity. The publication illustrates that those responses have been observed in numerous animal models of hyperphagic obesity and have also been seen in diazoxide chloride-controlled release (DCCR)-treated patients with Prader-Willi syndrome (PWS), a rare genetic form of hyperphagic obesity. Soleno is testing DCCR in a phase III trial in PWS.
Valneva SE, of Saint-Herblain, France, and Dynavax Technologies Corp., of Emeryville, Calif., said they are collaborating to initiate a vaccine program targeting COVID-19 leveraging Valneva’s Ixiaro, a cell-derived vaccine for Japanese encephalitis, and Dynavax’s Toll-like receptor 9 agonist adjuvant, CpG 1018, which is used in hepatitis B vaccine Heplisav-B. Valneva and Dynavax said they will work with regulatory authorities to align on the optimal strategy to execute an expedited clinical development path, with the goal to initiate clinical trials before the end of 2020.