Adare Pharmaceuticals Inc., of Lawrenceville, N.J., said it has acquired Orbis Biosciences Inc., of Lenexa, Kan. The transaction will enhance Adare’s pharmaceutical technologies business, which develops and manufactures products for global pharmaceutical, animal health and over-the-counter markets, the company said. The acquisition was finalized on April 30 for an undisclosed amount. Orbis Biosciences will maintain its operations in Lenexa and integration of the companies will start immediately.
Anixa Biosciences Inc., of San Jose, Calif., which is focused on the treatment, prevention and diagnosis of cancer and infectious diseases, said that, together with partner Ontochem GmbH, of Halle, Germany, it has identified its first therapeutic candidate against COVID-19, and has advanced the compound into biological testing. The candidate was identified from their research to evaluate more than 1.2 billion molecules through an in silico study to identify potential therapies for patients infected by SARS-CoV-2. The compound is expected to disrupt the interaction of the virus's endoribonuclease with a host human protein that is necessary for the virus to replicate upon infection.
Applied Biomath Inc., of Concord, Mass., said it is continuing its collaboration with Zymeworks Inc., of Vancouver, British Columbia, and will design and deliver a systems pharmacology model for a therapeutic platform Zymeworks has in development. The model will evaluate the pharmacokinetic and pharmacodynamic parameters of several variations of Zymeworks' platform with the goal of selecting a lead design with the widest therapeutic window. The model will then be used to predict the optimal properties of a potential drug candidate as well as to guide dosing strategy for pivotal preclinical models. Financial terms were not disclosed.
Applied DNA Sciences Inc., of Stony Brook, N.Y., with its COVID-19 vaccine development partner, Takis Biotech Srl, of Rome, Italy, said the first injections of DNA vaccine candidates against the Spike protein (product of the S gene) of the SARS-CoV-2 virus have produced neutralizing antibodies in test animals. The studies were completed at the Lazzaro Spallanzani National Institute for Infectious Diseases in Rome. Initial results were obtained using plasmids (the templates for Applied DNA’s LinearDNA platform) to baseline results. Applied DNA’s linear DNA dose-response trials begin this week.
Biomarin Pharmaceutical Inc., of San Rafael, Calif., signed a preclinical collaboration and license agreement with Dinaqor AG, of Pfäffikon, Switzerland, to develop gene therapies to treat rare genetic cardiomyopathies. Dinaqor will receive an undisclosed up-front payment and is eligible to receive development, regulatory and commercial rewards based on product sales as well as tiered royalties on worldwide sales. Biomarin reiterated its 2020 GAAP net income guidance of $20 million to $80 million, inclusive of this collaboration.
Brainstorm Cell Therapeutics Inc., of New York, said new data highlighting the immunomodulatory effects of Nurown on B and T regulatory function appeared in an online supplement to Neurology. The abstract was originally planned for presentation at the recently canceled 2020 American Academy of Neurology annual meeting. Nurown consists of autologous mesenchymal stem cells induced in culture to secrete high levels of neurotrophic factors.
Destiny Pharma plc, of Brighton, U.K., disclosed the publication of a new paper in Trends in Microbiology, titled “Assessing the potential for Staphylococcus aureus to evolve resistance to XF-73.” The author, from the University of Oxford, concludes that data published to date support the unique target profile of XF-73 and its potential to address the threat of antimicrobial resistance. The review looked at data from a number of established microbiology models that were used to evaluate the action of XF-73 in killing S. aureus that were carried out previously by Destiny.
Domain Therapeutics SA, of Strasbourg, France, signed a collaboration and licensing agreement with Merck KGaA, of Darmstadt, Germany, to explore the potential of adenosine inhibition in the development of immuno-oncology agents. Merck called the new generation of adenosine receptor antagonists “an important addition.” The companies plan to investigate new compounds as combo immunotherapies for cancer.
Eagle Pharmaceuticals Inc., of Woodcliff Lake, N.J., provided an update on its pilot study to assess the characteristics of its fulvestrant product candidate, EA-114, which has the potential to enhance estrogen receptor inhibition and improve patient outcomes. The firm has had two meetings with the FDA and will request another meeting to discuss those data. Eagle is developing the drug for hormone receptor-positive advanced breast cancer,
Galecto Inc., of Copenhagen, Denmark, said new data describing the preclinical and clinical evidence for antifibrotic activity of its lead compound, GB-0139 (formerly TD-139), are contained in an abstract for the Experimental Biology 2020 conference. Galecto is developing GB-0139 to treat most forms of lung fibrosis with an initial focus on idiopathic pulmonary fibrosis (IPF). The poster presentation, available online as the conference was canceled due to COVID-19, described results from preclinical studies investigating galectin-3 in vitro and in vivo in naïve and bleomycin‐treated mice. Results showed that GB-0139 was highly effective in the bleomycin model, including pharmacodynamic evidence with reduction of galectin-3. It had a direct link to clinical evidence in IPF patients after 14 days of treatment, including targeting alveolar macrophage with extended lung retention providing duration of action and reducing extracellular galectin-3 in a dose-dependent fashion. There was a reduction in a number of fibrosis biomarkers and those were the same as in the mouse model, demonstrating a link between the model and patient effects.
Generex Biotechnology Corp., of Miramar, Fla., said it submitted a contract proposal to the U.S. Biomedical Advanced Research and Development Authority to develop a vaccine against the SARS-CoV-2 coronavirus and began manufacturing synthetic peptides to SARS-CoV-2 epitopes predicted by computational vaccinology algorithms. The peptide epitopes, which contain target amino acid sequences from the virus, will be screened against blood samples collected from COVID-19 convalescent patients to select peptides that activate the immune system to fight the coronavirus infection. The blood screening program incorporates T-cell assays, B-cell assays, antibody and virus neutralization tests and an in vitro cytokine storm cellular assay to identify peptide vaccines most likely to stimulate the T-cell (CD4 and CD8) response, modulate appropriate immune system responses to minimize potential for dysregulated cytokine-related inflammation, stimulate a neutralizing antibody response and provide broad-spectrum coverage for the vast majority of people, the company said.
Hebrew University of Jerusalem said its researchers developed an injectable antibiotic with a new mode of action that could impact the morbidity rate for pandemics such as COVID-19. Mupirocin, a topical antibiotic, was reformulated by Hebrew University researchers for intravenous delivery and new properties to fight drug-resistant bacteria were created, the university said. According to the European Antibiotic Resistance Organization, 700,000 people die every year from resistant infections and if no significant improvement is made in the field, that number will rise to 10 million by 2050.
Researchers at Utrecht University, Erasmus Medical Center and Harbour Biomed Therapeutics Ltd., of Cambridge, Mass., said they identified a fully human monoclonal antibody that prevents the SARS-CoV-2 virus from infecting cultured cells. The antibody could alter the course of infection in the infected host, support virus clearance or protect an uninfected individual that is exposed to the virus, the researchers said. The antibody binds to a domain that is conserved in both SARS-CoV and SARS-CoV-2, explaining its ability to neutralize both viruses, they concluded.
Ipsen SA, of Paris, said it entered an option agreement with the Institute for Research in Immunology and Cancer (IRICoR) and the Université de Montréal in which Ipsen would acquire an exclusive license for the worldwide rights to a high-value oncology program. Under the leadership of Université de Montréal’s drug discovery unit based at the IRICoR, the program, currently at lead optimization stage, will focus on advancing the current lead molecules to the development candidate stage. Université de Montréal/IRICoR will be responsible for conducting and financing the research program until the option to license is exercised. If Ipsen decides to exercise the option, it would assume all development activities and commercialize the drug candidate globally. Financial terms, including research, development, commercial milestones and royalties, have not been disclosed.
Junshi Biosciences Co. Ltd., of Shanghai and Eli Lilly and Co., of Indianapolis, said they will co-develop therapeutic antibodies for COVID-19 prevention and treatment. At the beginning of the pandemic, Junshi launched R&D efforts to discover therapies to combat COVID-19. Multiple neutralizing antibodies have been engineered, with the lead asset poised to enter clinical testing in the second quarter. Lilly receives an exclusive license to conduct clinical development, manufacturing and distribution of products outside of greater China. Junshi will maintain all rights in greater China.
Kempharm Inc., of Celebration, Fla., could receive a regulatory milestone payment of $5 million within 30 days following FDA acceptance of the NDA for KP-415, its prodrug of d-methylphenidate, for attention deficit hyperactivity disorder. Partner Corium Inc., of Menlo Park, Calif., is to lead all commercialization activities.
Lifearc, an independent medical research charity, and London’s Medical Research Council said they are making £16 million (US$19.89 million) available to establish a network of centers offering clinical-grade viral vectors and translational and regulatory guidance to support academic-led patient trials of new gene therapies. The two will provide U.K.-based research organizations with grants for up to five years. The grants are designed to support the costs associated with expanding or repurposing existing viral vector production centers. The Medical Research Council funds research in universities, hospitals and a network of establishments across the U.K. and Africa.
Mediwound Ltd., of Yavne, Israel, said it expanded its Nexobrid European presence with distribution agreements granting Genfa Medica SA, of Le Grand-Saconnex, Switzerland, which already is its distributor in Russia, Ukraine and the Baltic countries, the exclusive right to market and distribute the topically administered biologic in France and Switzerland. Mediwound also granted to Specialty Therapeutics PC, of Athens, Greece, the exclusive right to market and distribute Nexobrid in Greece, Bulgaria, Malta and Cyprus. Financial terms were not disclosed. Nexobrid, currently approved in the European Union and other markets, is used to remove eschar in patients with deep partial and full-thickness thermal burns.
Nanoviricides Inc., of Shelton, Conn., said it signed a confidential disclosure agreement with an unnamed leading pharmaceutical company in the Asian region to explore collaborating on the company’s COVID-19 program. Nanoviricides said it is developing an antiviral drug candidate specifically targeting the coronavirus SARS-CoV-2, with broad-spectrum activity against other coronaviruses.
Neuralis Inc., of San Diego, said the American Academy of Allergy, Asthma and Immunology presented results for ARS-1, a 1-mg intranasal epinephrine product using Intravail technology, showing treatment results in bioequivalent exposure to epinephrine injection given once and twice, as well as results in a more rapid absorption and onset of hemodynamic effects. ARS-1 is being investigated as a treatment for patients with severe allergic reactions (including anaphylaxis) to food, medications and insect bites that could lead to life-threatening anaphylaxis.
Oragenics Inc., of Tampa, Fla., said it acquired Noachis Terra Inc., of Gainesville, Fla., following its entry into a stock purchase agreement, to develop and commercialize TerraCoV2, a vaccine candidate that could provide specific immunity from the SARS-CoV-2 coronavirus. Noachis Terra holds a worldwide, nonexclusive license to the TerraCoV2 vaccine candidate from the National Institute of Allergy and Infectious Diseases, an institute within the U.S. NIH. As a result of the acquisition, Oragenics paid an aggregate of $1.925 million in cash, issued 9.2 million shares of its common stock and warrants to purchase 9.2 million shares and may be obligated to pay Joseph Hernandez, the founder and former sole shareholder of Noachis Terra, certain contingent cash consideration in the future.
Recce Pharmaceuticals Ltd., of Sydney, reported preclinical data showing significant antibacterial activity against Neisseria gonorrhoeae bacteria in mice treated with its lead compound, RECCE-327. The recognized vaginal infection model met its primary endpoint of a reduction in bacterial load compared to vehicle infected control evaluated on the seventh day following dosing. Three groups of 10 female mice each showed efficacy at different dose levels with significant reduction in bacterial load in the vaginal infection as compared to the vehicle control (p<0.05).
Surrozen Inc., of South San Francisco, said preclinical abstracts published for 2020 Digestive Disease Week highlight results from SWEETS (Surrozen Wnt signal enhancers engineered for tissue specificity), antibody-based molecules designed to enhance Wnt signaling. SWEETS-1, the firm’s hepatocyte-targeted SWEETS, demonstrated that hepatocyte-specific activation of Wnt target genes, such as Axin2, stimulated hepatocyte regeneration and restored liver function as measured by clotting time in a thioacetamide-induced mouse liver injury model.
Teva Pharmaceuticals USA Inc., of Parsippany, N.J., a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Celltrion Healthcare Co. Ltd., of Incheon, South Korea, said Truxima (rituximab-abbs), its biosimilar to Rituxan, is now available in the U.S. for treatment of rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis, following its January approval by the FDA. Truxima gained FDA approval initially in November 2018 for use in CD20-positive, B-cell non-Hodgkin lymphoma, and was launched for that indication a year later. The companies said Truxima is the only Rituxan biosimilar available for RA in the U.S. Earlier this year, the Centers for Medicare and Medicaid Services granted pass-through status for Truxima in the hospital outpatient setting. The wholesale acquisition cost (WAC) will be 10% lower than the reference product, and is expected to be available through primary wholesalers at a WAC of $845.55 per 100-mg vial and $4,227.75 per 500-mg vial.
Vaxxel SAS, of Lyon, France, said it acquired Strasbourg, France-based Transgene SA’s Duckcelt-T17 cell line. Terms were not disclosed, but through the agreement, Transgene becomes a shareholder of Vaxxel. Duckcelt-T17, initially developed and patented by Transgene, is an avian cell line grown in suspension. It is permissive to a variety of viruses, including influenza viruses and human metapneumoviruses. The cell line has a demonstrated capability to be used at industrial scale, the companies said.
VBL Therapeutics Ltd., of Tel Aviv, Israel, said preclinical data demonstrate the potential of MOSPD2 antibodies for multiple sclerosis (MS), with results showing that knockout of the MOSPD2 gene in mice essentially protected the animals from developing CNS disease in the well-established EAE model for MS. The firm’s anti-MOSPD2 antibodies that block monocyte migration without affecting T cells, were able to recapitulate that effect and profoundly reduced inflammation and tissue damage. VBL is advancing lead candidate antibody VB-601 toward a first-in-human study, which is expected in 2021.
Vir Biotechnology Inc., of San Francisco, and Alnylam Pharmaceuticals Inc., of Cambridge, Mass., said they selected a development candidate for VIR-2703 (also referred to as ALN-COV), an investigational RNAi therapeutic targeting the SARS-CoV-2 genome. The companies plan to soon meet with the FDA and other regulatory authorities to discuss a potential accelerated path for filing an IND or IND-equivalent application at or around year-end 2020. The companies said they plan to advance VIR-2703 as an inhalational formulation for the potential treatment and/or prevention of COVID-19.