Assertio Therapeutics Inc., of Lake Forest, Ill., and Zyla Life Sciences Inc., of Wayne, Penn., signed a merger agreement under which Zyla stockholders will be entitled to receive 2.5 shares of common stock of a newly formed holding company for each share of Zyla common stock held, and the newly combined company will retain the Assertio name, trading on Nasdaq under the ASRT ticker. The boards of both companies have approved the deal, which is expected to close in the second quarter of 2020, subject to approval by shareholders of both firms.
Aurinia Pharmaceuticals Inc., of Vancouver, British Columbia, established its U.S. commercial center of operations in Rockville, Md. The new site will support Aurinia’s plans for growth as it prepares for the potential approval and launch of voclosporin for the treatment of lupus nephritis in 2021, the company said.
Avivagen Inc., of Ottawa, Ontario, accelerated plans for commercial launch of its OxC-Beta product as a supplement for human use in response to the COVID-19 pandemic. OxC-beta is a patent protected product that first launched commercially in livestock applications to help remove antibiotics as growth promoters from the food chain, subsequently launched in the companion animal market as a supplement, and is now being readied to launch in the U.S. market, initially for human use as a health supplement. Avivagen’s OxC-beta technology is derived from the firm’s discoveries about beta-carotene and other carotenoids. Through support of immune function, the technology provides a non-antibiotic means of promoting health and growth, the company said.
Bloom Science Inc., of San Diego, received a $500,000 grant from The ALS Association. Bloom is leveraging its GOLD (Genetically Optimized Living Drugs) platform in combination with preclinical data to advance a new generation of therapeutics aimed at managing microbiota, or the spectrum of bacteria that naturally populate the human gut. The grant is made available from the amyotrophic lateral sclerosis group’s Lawrence and Isabelle Barnett Drug Development Program.
Cellenkos Inc., of Houston, said it submitted a clinical development proposal to the U.S. Biomedical Advanced Research and Development Authority (BARDA) to start a phase I/II trial with CK-0802 for treatment of COVID-19-mediated acute respiratory distress syndrome (CoV-ARDS). Cellenkos will leverage its clinical experience with CK-0802 for other inflammatory disorders, including amyotrophic lateral sclerosis, and will fast track development of CK-0802 to treat respiratory complications caused by COVID-19 infection. CK-0802 is an allogenic cell therapy, consisting of Treg cells derived from clinical-grade umbilical cord blood units.
Celltex Therapeutics Corp., of Houston, has begun active discussions with the FDA regarding a study using mesenchymal stem cells (MSCs) against COVID-19-type symptoms. Celltex has researched safety and efficacy from the use of MSCs for those suffering from injuries, pain and maladies associated with autoimmune, vascular and other debilitating diseases, including inflammatory lung conditions, pneumonia and chronic obstructive pulmonary disease. Celltex’s intellectual property portfolio encompasses more than 1,500 clients, who have received more than 9,000 MSC therapies for various diseases without incurring any adverse events.
Cognition Therapeutics Inc., of New York, disclosed the publication of an article, titled “The Clinical Promise of Biomarkers of Synapse Damage or Loss in Alzheimer’s Disease,” in Alzheimer’s Research & Therapy that reviews the foundational role of synapses in cognitive function and discusses available and experimental biomarkers that are designed to indicate synapse injury and loss in such neurological diseases. The ability to measure synapse damage or loss would facilitate diagnosis of a broad range of neurological diseases and the clinical development of therapeutics against the conditions, Cognition noted.
Engeneic Ltd., of New York, said a paper, published in Cancer Cell, describes how the company’s dream vector (EDV) technology stimulates both an innate and an adaptive immune response and creates a dual method of action that could result in long-term survival. The EDVs activate macrophages, natural killer cells and dendritic cells with a subsequent adaptive immune response resulting from recruitment of specific CD8+ tumor killing T cells into the tumor microenvironment. This work, the company said, paves the way for treatment of drug-resistant, end-stage cancers across many tumor types with little or no toxicity, and for a fraction of the cost compared to other immunotherapies capable of treating only a limited number of cancer indications. Clinical trials are underway in Australia evaluating EDV in multiple cancer indications, including pancreatic cancer patients with stage IV disease who have exhausted curative treatment options.
Everest Medicines Inc., of New York, said it formed a strategic partnership with Jiashan National Economic and Technological Development Zone and Jiashan SDIC to develop, manufacture and commercialize drugs in oncology, infectious diseases, cardiorenal diseases and autoimmune diseases. Jiashan SDIC will invest $100 million in Everest Medicines to support several clinical trials for registration and to build GMP manufacturing and good storage practice facilities in the Jiashan National Economic and Technological Development Zone.
Gemoab GmbH, of Dresden, Germany, said preclinical data published in Nature Scientific Reports provides proof of concept for a universal off-the-shelf cellular therapeutic based on UniCAR-modified NK-92 cells retargeted to GD2-expressing tumors by GD2-specific targeting modules. Redirected UniCAR-NK-92 cells induced specific and effective killing of GD2-expressing cells in vitro and in vivo, associated with enhanced interferon-gamma production. Gemoab said the data, generated by researchers of the Helmholtz-Center Dresden-Rossendorf, provide further evidence of the flexibility of the UniCAR platform.
Innovation Pharmaceuticals Inc., of Wakefield, Mass., said under the terms of a material transfer agreement signed with a leading public health-focused U.S. university and top coronavirus expert, virologists plan to evaluate the potential antiviral properties of brilacidin, the company’s lead defensin-mimetic drug candidate, as a potential COVID-19 vaccine. The new research is independent of that being conducted on brilacidin at one of the U.S. 12 Regional Biocontainment Labs that is testing its potential inhibitory activity as a small-molecule drug against SARS-CoV-2.
Janssen Biotech Inc., part of New Brunswick, N.J.-based Johnson & Johnson, and digital medicine company Vivante Health are collaborating to develop digital predictive biomarkers for chronic diseases. The agreement, facilitated by Johnson & Johnson Innovation LLC, will focus on biomarkers for chronic inflammatory diseases and will expand the use of Vivante's digital platform beyond treatment, toward prediction and early interception. Financial terms of the deal were not disclosed.
Mannkind Corp., of Westlake Village, Calif., said it is adjusting research and development resources that were reserved for its pipeline of investigational products for treating serious lung diseases, with the goal of prioritizing work on new compounds that may have the potential to address the morbidity and mortality associated with respiratory viral infections, such as COVID-19. Specifically, the company has begun a collaboration with Los Angeles-based Immix Biopharma Inc. to prepare a dry powder formulation of a compound with the potential to treat acute respiratory distress syndrome, a complication of COVID-19. The immediate focus of that effort is to rapidly develop prototype powders, which will then be assessed for their potential to be used therapeutically. Other collaborations are being actively explored at this time, Mannkind said. Company shares (NASDAQ:MNKD) gained 21 cents, or 25%, to close March 17 at $1.05.
Microbiotix Inc., of Worcester, Mass., said it will receive up to $2.86 million from CARB-X, a consortium led by Boston University and funded by a global partnership. The nondilutive funding will be used to develop a new oral antibiotic to treat multidrug-resistant gonorrhea, a sexually transmitted disease caused by bacteria that have developed resistance to all but one existing antibiotic. If the project achieves certain development milestones, the company will be eligible for an additional $16 million in funding from CARB-X.
Moleculin Biotech Inc., of Houston, said it entered an agreement with the University of Texas Medical Branch at Galveston (UTMB) to conduct research on its portfolio of molecular inhibitors, including drug candidate WP-1122, for antiviral properties against a range of viruses, including coronavirus. Moleculin will supply the drug candidate and related inhibitors, as well as technical support and UTMB will begin testing those candidates against various viral disease models, including COVID-19, in connection with the UTMB Center for Biodefense and Emerging Infectious Diseases.
Neuren Pharmaceuticals Ltd., of Perth, Australia, said it will defer partnering ex-North American rights to trofinetide in its Acadia Pharmaceuticals Inc. deal to capture greater value by selecting the optimum commercial outcome after phase III trial results for Rett syndrome in the U.S., which are expected in 2021. Under Neuren’s license agreement with San Diego-based Acadia, Neuren has full and free access to use all U.S. data for registration and commercialization of trofinetide outside North America. Neuren said it will move forward with European regulatory authority meetings this year to discuss the Rett syndrome development program. The FDA recently granted Neuren and Acadia a rare pediatric disease designation for trofinetide, a synthetic analogue of the amino terminal tripeptide of IGF-1 designed to treat Rett syndrome’s core symptoms by reducing neuro-inflammation and supporting synaptic function. Neuren granted an exclusive license to Acadia for developing and commercializing trofinetide in North America, while retaining all rights outside North America. Worth up to $465 million, the deal makes Neuren eligible to receive one-third of the market value of any rare pediatric disease priority review voucher granted by the FDA.
Ose Immunotherapeutics SA, of Nantes, France, and Servier SAS, of Suresnes, France, said they amended the two-step global licensing option agreement for exclusive global rights to interleukin-7 receptor (IL-7R) antagonist OSE-127, specifically modifying the provisions regarding the option exercise modalities and associated financial conditions. Under the amendment, step two of the option agreement will make Ose eligible to receive a €5 million (US$5.5 million) milestone payment from Servier upon the enrollment of the first patient in the phase IIa study in Sjögren’s syndrome and an additional €15 million payment upon exercise option completion of both phase II trials, and in priority upon completion of the phase IIa study in Sjögren’s syndrome. The previous version of the agreement had the full €20 million milestone payment due upon completion of the phase II study in ulcerative colitis. The phase II studies are expected to start this year.
Pfizer Inc., of New York, and Mainz, Germany-based Biontech SE plan to co-develop and distribute, excluding China, an mRNA-based coronavirus vaccine for preventing COVID-19 infection. The two intend to develop Biontech’s mRNA vaccine program, BNT-162, which is expected to enter the clinic in April. Agreement details, including financial terms, and all development activities related to development, manufacturing and potential commercialization, will be finalized in the next few weeks, the companies said.
Pluristem Therapeutics Inc., of Haifa, Israel, said the Israeli Ministry of Health approved Pluristem’s request to seek approvals to treat COVID-19 coronavirus patients under Israel’s per-patient compassionate use framework. The ministry may approve proposed treatments on a per-patient basis for the use of PLX cell therapy, including intramuscular administration of PLX-PAD for the proposed treatment of severe pneumonia resulting from COVID-19 and preventing the deterioration of patients from acute respiratory distress syndrome and sepsis. PLX cells are allogeneic mesenchymal-like cells that induce the immune system’s natural regulatory T cells and M2 macrophages, designed to prevent or reverse immune system overactivation. PLX cells may potentially reduce the incidence and/or severity of COVID-19 pneumonia and pneumonitis, the company said.
Pneumagen Ltd., of St. Andrews, Scotland, initiated a new program to prevent and treat coronavirus COVID-19 infections using its carbohydrate binding modules (mCBMs). Pneumagen's lead mCBM, Neumifil, is being developed for universal treatment of respiratory tract infections, including influenza virus, respiratory syncytial virus and coronaviruses including COVID-19. Neumifil's mechanism is designed to mask glycan receptors in patients' airways to prevent the virus’ entry to the body. The company is a University of St Andrews spinout.
In its effort to find and develop a multi-antibody cocktail as prophylaxis or treatment of SAR-CoV-2, Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., said it isolated hundreds of virus-neutralizing, fully human antibodies from humans who have recovered from COVID-19. From that candidate pool, Regeneron said it will select the top two antibodies for a cocktail treatment based on potency and binding ability to the SARS-CoV-2 spike protein.
Ribomic Inc., of Tokyo, said it signed a license agreement with Korean firm Aju Pharm Co. Ltd. for RBM-007 in exudative age-related macular degeneration (AMD) in the territory of Korea and Southeast Asia (Singapore, Philippines, Thailand, Vietnam, Indonesia, Malaysia, Cambodia and Myanmar). Upon execution of the agreement, Aju will obtain the exclusive license to develop and sell RBM-007 in that territory, in exchange for an up-front payment of $1 million. Ribomic also is eligible for potential development milestone payments of up to $5 million and will supply the product to Aju at product supply prices, which includes royalties. RBM-007 is currently being evaluated in a phase II study in patients with exudative AMD.
Roche Holding AG, of Basel, Switzerland, said it began shipping the first allotment of its cobas SARS-CoV-2 test for COVID-19 to a network of 30 hospital and reference laboratories across the U.S. for automated, high-volume patient testing. Shipping of the initial 400,000 test kits began March 13 and will be completed this week. Roche plans to ship an additional 400,000 tests per week to the laboratory testing sites across the nation that are set up to run the test immediately under the FDA’s Emergency Use Authorization guidelines. The test uses nasopharyngeal or oropharyngeal swab samples taken from the back of the nose or throat.
Senti Biosciences Inc., of South San Francisco, entered a clinical supply and manufacturing collaboration with Roosterbio Inc., of Frederick, Md., to accelerate the clinical translation of Senti’s gene-modified cell therapies for ovarian cancer and other solid tumor indications. The collaboration will leverage Roosterbio’s human mesenchymal stem/stromal cell (hMSC) bioprocess systems, rapid product and process development platform, and cGMP-compliant, hMSC-focused manufacturing capabilities. Financial terms were not disclosed.
Signpath Pharma Inc., of Salt Lake City, said it is exploring opportunities to expedite the opportunities for utilizing Lipocurc, its intravenous formulation of liposomal curcumin, in clinical settings for the treatment of patients afflicted with COVID-19 and other viral diseases which cause harm via the cytokine storm mechanism.
Vaxxas Pty Ltd., of Brisbane, Australia, said it received a $5 million grant to conduct initial human clinical studies using its High Density Microneedle Array Patch (HD-MAP) for measles and rubella vaccination. The funding is provided by the Bill & Melinda Gates Foundation and builds on an earlier grant by the foundation of $4.5 million focused on preclinical development. In separate news, Vaxxas said preclinical data published in PLoS Medicine indicated the broad immunological and commercial potential of HD-MAP. Using influenza vaccine, the clinical study demonstrated significantly enhanced immune response compared to vaccination by needle/syringe. It marked the largest microarray patch clinical vaccine study ever performed, the company said.