Acerus Pharmaceuticals Corp., of Toronto, announced that the Natesto Spermatogenesis Study results were accepted for publication in an upcoming issue of The Journal of Urology. The study, conducted at the University of Miami's Department of Urology, concluded that Natesto was found to be effective in restoring hypogonadal men to normal testosterone levels, and simultaneously improved both erectile function and quality of life. Gonadotropin hormones remained within normal ranges and semen parameters were preserved through six months of treatment in 95% of men.
Adamis Pharmaceuticals Corp., of San Diego, said its drug outsourcing facility, US Compounding Inc. (USC), has increased its product mix to provide additional drugs to assist in the ongoing fight against COVID-19. The FDA is allowing outsourcing facilities to compound certain medications in short supply that are not listed on FDA’s Drug Shortage List, and USC has begun manufacturing a variety of these products.
A consortium of health care companies announced the launch of the COVID-19 Research Database, a repository of HIPAA-compliant data sets made available to researchers to extract insights to help combat the COVID-19 pandemic. Collaborators include Advarra, Aetion Inc., AnalyticsIQ Inc., Arcadia, Berkeley Research Group LLC, Change Healthcare Inc., Datavant, Elsevier NV, Glooko Inc., Health Care Cost Institute Inc., Healthjump Inc., Helix, Medidata Solutions Inc., Mirador Analytics Ltd., Office Ally Inc., Parexel International Corp., Prognos Health Inc., Qiagen NV, Snowflake Inc., Sumitomo Dainippon Pharma Co. Ltd., Symphony Health, Veradigm and Verana Health Inc.
AIkido Pharma Inc., of New York, has executed a master license agreement with the University of Maryland, Baltimore, covering specific antiviral compounds discovered by UMB. The compounds seek to inhibit replication of multiple viruses, including influenza, SARS-CoV, MERS-CoV, Ebolavirus and Marburg virus. AIkido and UMB also executed a sponsored research agreement to support the development of the technology.
Allterum Therapeutics Inc., of Houston, closed a $2.9 million product development award by the Cancer Research and Prevention Institute of Texas (CPRIT) to support preclinical development of its 4A10 antibody therapy for the treatment of pediatric patients suffering from T-cell acute lymphoblastic leukemia. The technology was licensed from the National Cancer Institute. The funding will be used for preclinical development, including manufacturing scale-up already underway with Fujifilm Diosynth Biotechnologies.
Bayer AG, of Leverkusen, Germany, announced that Bayer Inc., of Mississauga, Ontario, is partnering with the Population Health Research Institute (PHRI) in launching a clinical research program to identify potential treatments for COVID-19. The studies will evaluate the safety and efficacy of different combination therapies including Bayer’s chloroquine and interferon beta-1b. Bayer will contribute CA$1.5 million (US$1.05 million) and will supply study drugs. Earlier in April 2020, PHRI committed CA$0.5 million.
Biogen Inc., of Cambridge, Mass., released its 2019 Corporate Responsibility Report that shows continuous progress across several environmental, social and governance metrics. The report details how Biogen has improved its absolute environmental performance across energy, water and waste metrics while growing the business in 2019, including the company remaining carbon neutral for six years in a row. The report noted that Biogen is committed to bring its climate programs in line with Intergovernmental Panel on Climate Change targets to keep the global temperature rise to below 1.5 degrees Celsius. Biogen advanced its health equity and diversity goals, and 46% of Biogen’s director-level positions and above are held by women. Additionally, the report highlighted Biogen’s efforts to advance health equity goals for its clinical trials and to increase diversity in the workplace, with nearly 1/3 of director-level positions and above held by people from racial and ethnic minority groups in the U.S.
Biosig Technologies Inc., of Westport, Conn., said its subsidiary Viralclear Pharmaceuticals Inc. has submitted an application for Vicromax (merimepodib) through the FDA’s Coronavirus Treatment Acceleration Program to administer the drug to hospitalized patients with COVID-19. Merimepodib has shown activity against a broad spectrum of RNA viruses and has demonstrated satisfactory safety data from over 300 patients treated for hepatitis C.
Cipher Pharmaceuticals Inc., of Oakville, Ontario, received a positive ruling on binding arbitration with Upsher-Smith Laboratories LLC, of Maple Grove, Minn. On Dec. 19, 2018, Cipher was notified that Upsher-Smith filed an abbreviated new drug application (ANDA) for a generic version of Absorica, a formulation of the active ingredient isotretinoin, prior to the expiration of certain U.S. patents, and Upsher-Smith subsequently filed a second ANDA. On Jan. 30, 2019, Galephar Pharmaceuticals Research Inc., Sun Pharmaceuticals Inc. and Cipher initiated a patent infringement lawsuit against Upsher-Smith, alleging it had infringed on at least one or more of their patents by filing an ANDA. The decision in the binding arbitration will delay Upsher-Smith's entry into the market until June 25, 2021.
Edesa Biotech Inc., of Toronto, and Light Chain Bioscience, a brand of Geneva-based Novimmune SA, signed a strategic agreement to develop treatments for COVID-19 pneumonia and other disorders. Edesa obtains an exclusive worldwide license to develop and commercialize two phase II-ready biologic drug candidates for all therapeutic and diagnostic applications. The licensed monoclonal antibodies block certain signaling proteins, known as TLR4 and CXCL10.
Forma Therapeutics Inc., of Watertown, Mass., announced that it will present an electronic poster at the American Association for Cancer Research taking place virtually. The poster will include preclinical data from a selective inhibitor of CBP/p300, a known co-activator of the androgen receptor (AR) and a driver of metastatic castration-resistant prostate cancer. The data demonstrate antitumor activity of FT-6876, a CBP/p300 inhibitor in AR-dependent breast cancer cell lines and highlight the possible role of CBP/p300 in proliferation and survival of AR-dependent tumors.
Innovation Pharmaceuticals Inc., of Wakefield, Mass., said that, based on molecular screening of 11,552 compounds comprising already FDA-approved drugs and those in clinical testing, brilacidin, the company’s defensin-mimetic drug candidate targeting COVID-19, was identified as one of the most promising potential inhibitors of SARS-CoV-2, the novel coronavirus responsible for COVID-19. Researchers said the compounds should be further evaluated in experimental assays and clinical trials to confirm their actual activity against the disease. Findings were published in Chemrxiv.
Merck & Co. Inc., of Kenilworth, N.J., said it is taking steps to support patients in the U.S. who may have lost their jobs and insurance coverage. The firm will continue to ensure access to Merck medicines at no cost for eligible patients through its Merck Patient Assistance Program. The program is making a number of changes to help patients who have lost their job or cannot get into their doctor’s office during the crisis, including assessing patients’ real-time financial situations, providing assistance with expiring enrollments, and offering new options to collect signatures on enrollment forms, Merck said.
Mogrify Ltd., of Cambridge, U.K., and Sangamo Therapeutics Inc., of Brisbane, Calif., started a collaboration and exclusive license agreement for Sangamo to develop allogeneic cell therapies from Mogrify’s induced pluripotent stem cells and embryonic stem cells (ESCs) and Sangamo’s zinc finger protein gene-engineered chimeric antigen receptor regulatory T-cell (CAR-Treg) technology. The deal provides Sangamo with access to Mogrify’s cell conversion technology, which will diversify options as the firms develop off-the-shelf allogeneic CAR-Treg cell therapies, Sangamo said. Sangamo will pay Mogrify an up-front payment. Mogrify is also eligible to receive potential additional payments related to development and regulatory milestones, and product sales. Exact terms were not disclosed.
Novan Inc., of Morrisville, N.C., engaged H.C. Wainwright & Co. LLC to assist the company in exploring and evaluating a range of strategic and financial alternatives. The firm has advanced several late-stage development programs in the field of dermatology, including lead product candidate SB-206, in phase III trials for molluscum contagiosum, a primarily pediatric contagious skin infection. In addition, Novan has started several early stage programs in women’s health and gastrointestinal disorders as well.
Opgen Inc., of Gaithersburg, Md., disclosed the start of an investigator-initiated collaboration with Karolinska Institutet in Sweden, to identify bacterial co-infections in patients admitted to the intensive care unit for COVID-19 pneumonia using the Unyvero HPN panel. High-risk COVID-19 patients, especially in intensive care units and on ventilation, many of whom may be elderly or have preexisting conditions that compromise their immune system, are at a higher risk of acquiring bacterial co-infections that pose severe life-threatening complications, the company noted. Karolinska Institutet previously evaluated the Unyvero system and the HPN panel and has now been provided with additional Unyvero Analyzers for increased throughput and additional HPN cartridges to enable testing of specimens.
The COVID-19 pandemic has Salt Lake City’s Polarityte Inc. reducing its operating expenses by cutting payroll, minimizing discretionary spending and managing its manufacturing capacities. The company said it adopted a 10% salary and wage reduction for at-will employees and what it called “key” executives effective April 19. Based on preliminary, unaudited financial results, the company estimates first quarter 2020 revenue from SkinTE, a human cellular and tissue-based product derived from a patient's own skin intended for the repair, reconstruction and replacement of skin tissue, will be in the range of $350,000 to $450,000, compared to $714,000 in the fourth quarter of 2019. The company said the reduction was due to a decrease in the average sizes of wounds treated in the first quarter, and also due to the impact in March of the COVID-19 pandemic, including but not limited to stay-at-home orders, declines in elective surgical procedures and overall disruptions to the health care system.
Redhill Biopharma Ltd., of Tel Aviv, Israel, and Raleigh, N.C., said it will provide its investigational drug RHB-107 (upamostat, WX-671), for testing in nonclinical studies for activity against SARS-CoV-2, the virus that causes COVID-19, to the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. RHB-107 is a serine protease inhibitor active against a number of human trypsins and several other related serine proteases. Inhibition of serine proteases, including trypsins, may inhibit viral attachment and replication and decrease lung damage from viral pneumonia. RHB-107 was selected by NIAID for in vitro testing, following evaluation by NIAID of data on the drug’s possible mechanism of action and potential activity against SARS-CoV-2.
Revive Therapeutics Ltd., of Toronto, said it entered into a sponsored research partnership agreement with the University of Wisconsin-Madison to evaluate novel formulations and drug delivery technology focused on psilocybin-based pharmaceuticals. The research program will be conducted at the Reed Research Group led by Dr. Jess Reed, professor of Animal Sciences at the university. He and his research team will evaluate psilocybin-based formulations and the patented tannin-chitosan composite drug delivery technology for psilocybin, in which the company has an exclusive license with the Wisconsin Alumni Research Foundation. The technology aims to deliver both synthetic and natural extract of psilocybin in a potential number of ways such as topical gels, creams or ointments, oral or transdermal patches, oral dosages and foams.
Suono Bio Inc., of Cambridge, Mass., said NGK Spark Plug made a strategic investment to help advance the company’s second-generation platform technology for the ultra-rapid, formulation-independent delivery of drugs, including biologics and gene therapies without the need for encapsulation of the therapeutic.
Twoxar Pharmaceuticals Inc., of Mountain View, Calif., said that two leads for the potential treatment of systemic lupus erythematosus, TXR-711 and TXR-712, demonstrated significant efficacy and excellent tolerability in preclinical studies. The data were accepted at the 12th European Lupus Congress and published in Lupus Science & Medicine. In validation studies in the MRL/l mouse model, the compounds demonstrated significant efficacy and acceptable tolerability, comparing favorably to cyclophosphamide, a treatment with safety limitations used for severe flares. Treatment also demonstrated improved renal function with decreased renal inflammation compared with control mice.
Vaxart Inc., of South San Francisco, Calif., said it obtained positive preclinical results for its COVID-19 vaccine candidates, with several generating immune responses in all tested animals after a single dose. In the first round of preclinical testing, all animals that received one of the Vaxart vaccines had IgG anti-SARS CoV-2 antibodies in serum two weeks after the first vaccination. Antibody responses in all vaccinated groups were statistically significant compared to the untreated controls, the company said. Vaxart plans to select one or more vaccine candidates for cGMP manufacturing and clinical testing based on the magnitude and the breadth of the immune response.
VBL Therapeutics, of Tel Aviv, Israel, said it received a nondilutive grant of up to ILS 3.175 million (US$900,000) from the Israel Innovation Authority. The funds will support the continued development of VBL's lead product candidate, VB-111, a targeted anticancer gene-therapy agent that is being evaluated in a phase III potential registration study to treat platinum-resistant ovarian cancer. VB-111 uses a dual mechanism to target solid tumors, combining a blockade of tumor vasculature with an antitumor immune response. VB-111 has received orphan designation for treating ovarian cancer from the E.C. and the FDA.
Viravaxx AG, of Vienna, said it launched a project for combating COVID-19 with the Medical University of Vienna to create an integrated immunodiagnostic and vaccination platform. The company said the platform allows high resolution mapping of antigenic determinants eliciting an immune response following infection. These vaccines will be tested for immunogenicity in animal models, and the immune response will be analyzed with a microarray and the neutralization ELISA.
Vivacelle Bio Inc., of Chicago, said it will make VBI-S, which is designed to redistribute nitric oxide that uses biophysical properties of phospholipid nanoparticles, available for use in COVID-19 patients. In early studies VBI-S, improved blood pressure and oxygenation of septic shock patients when all other measures had failed. Seventy percent of deaths of COVID-19 patients are due to septic shock.