AC Immune SA, of Lausanne, Switzerland, said presentations at the online AAT-AD/PD Focus meeting will describe proof-of-concept preclinical data for lead candidates in the company’s therapeutic and diagnostic programs targeting TDP-43 and alpha-synuclein. Antibody-mediated clearance of pathological TDP-43 and alpha-synuclein represent attractive strategies for therapeutic intervention, the company said. Its lead TDP-43 antibody candidate mitigated TDP-43 neuropathology in a mouse model of TDP-43 proteinopathies. Data for TDP-43 PET tracer will illustrate how the lead candidate was identified and optimized. The lead candidate, generated using the Morphomer platform, demonstrates binding to brain-derived pathological TDP-43 aggregates with high affinity and direct target engagement on patient brain tissue. Using the company’s Supraantigen platform, antibodies with high affinity for aggregated alpha-synuclein have been developed, which prevent the intercellular spreading of toxic alpha-synuclein species. Data demonstrate that lead candidate antibodies reduce the de novo formation of alpha-synuclein aggregates in vitro and significantly decrease spreading of alpha-synuclein pathology in a mouse model of human disease. A lead therapeutic candidate has been advanced into preclinical development to treat Parkinson’s disease and other synucleinopathies.
Advanz Pharma Corp. Ltd., of London, said it closed the acquisition of the rights to a portfolio of alprostadil products from UCB SA, of Brussels, paying $83 million, and a deposit for inventory of approximately $13 million, from its cash on hand. The alprostadil product portfolio consists of two established, niche, injectable prostaglandin E1 formulations for the treatment of erectile disfunction and peripheral arterial occlusive disease.
Aicuris Anti-infective Cures GmbH, of Wuppertal, Germany, said it is getting involved in the fight against SARS-CoV-2. In cooperation with partners, the company is levering its expertise, network and laboratories to support clinics in the region and the North Rhine-Westphalia Health Minister in the field of diagnostics to help fill the capacity gap. In addition, Aicuris is currently working to evaluate proprietary compounds to identify a possible active agent against COVID-19.
Amgen Inc., of Thousand Oaks, Calif., and Seattle-based Adaptive Biotechnologies Inc. said they will combine expertise to discover and develop fully human neutralizing antibodies targeting SARS-CoV-2 to potentially prevent or treat COVID-19. The collaboration combines Adaptive’s immune medicine platform for the identification of virus-neutralizing antibodies with Amgen’s expertise in immunology and antibody therapy development. The companies will begin work immediately and finalize financial details and terms in the coming weeks.
Ansun Biopharma Inc., of San Diego, reported preliminary data from an investigator-initiated trial of DAS-181, a recombinant sialidase with broad antiviral properties, for the treatment of severe COVID-19 infection. The study, conducted in collaboration with the Renmin Hospital of Wuhan University, evaluated a 10-day treatment regimen of nebulized DAS1-81 administered to four patients with severe bilateral viral pneumonia and hypoxemia. The researchers said the data demonstrate that DAS-181 may potentially help reduce or eliminate some of the most significant symptoms associated with COVID-19. The company also announced the initiation of an additional randomized, double-blind, placebo-controlled proof-of-concept trial to determine the safety and efficacy of DAS-181 for the treatment of severe COVID-19 pneumonia.
Apeptico Forschung und Entwicklung GmbH, of Vienna, signed, with the solnatide consortium, a grant agreement with the European Commission to accelerate the process of making the firm’s investigational medicinal product, solnatide, available for medical treatment of patients severely affected by COVID-19. Solnatide is being developed by Apeptico for the treatment of various forms of life-threatening acute pulmonary dysfunction and pulmonary edema in acute respiratory distress patients. In 2013, the company completed a phase I study in healthy subjects, proving the safety of solnatide.
Bioaegis Therapeutics Inc., of Morristown, N.J., building on intellectual property licensed from Harvard Medical School, said it believes that its lead product, recombinant human plasma gelsolin therapy (rhu-pGSN), should be considered as a viable therapeutic option for patients suffering from severe lung injury due to COVID-19. The firm is submitting requests to the FDA and other international regulatory authorities to accelerate a clinical trial. PGSN is a highly conserved human protein that is abundant in healthy individuals and a master regulator of the immune system, the company said.
Cobra Biologics, of Keele, U.K., and Combigene AB, of Lund, Sweden, disclosed the successful production and delivery, by Cobra, of the first DNA plasmid required to produce Combigene’s gene therapy drug candidate, CG-01, developed for the treatment of drug-resistant focal epilepsy. For the vital compounds of CG-01, Cobra has finalized production and delivery of the first of three key plasmids, enabling the downstream processes to be initiated. In addition to those plasmids, a specific type of cell, which Cobra is also producing, acting as the “factory” to produce CG-01 is necessary. After the production of the plasmids for CG-01, and the successful transfer of the production process to Cobra, an engineering run will be initiated, whereby the entire production process will be tested.
Cortexyme Inc., of South San Francisco, disclosed new data supporting the ability of the pathogen Porphyromonas gingivalis to invade brain cells and trigger characteristic Alzheimer’s disease (AD) pathology, including synaptic loss, ultrastructural changes and inflammation. The data are being presented this week as part of the Advances in Alzheimer’s and Parkinson’s Disease Focus Meeting 2020, which was converted to a virtual meeting due to the COVID-19 pandemic. Over the past several years, Cortexyme and scientists around the world have been publishing evidence on the role of P. gingivalis in AD, the company said.
Cytodyn Inc., of Vancouver, British Columbia, said the three-day effect of leronlimab in eight severely ill COVID-19 patients demonstrated a significant improvement in several important immunologic biomarkers. Patient test data reveal improvement in cytokines, interleukin-6 and a trend toward the normalization of the CD4/CD8 ratio. Leronlimab has been administered to 10 severely ill patients with COVID-19 in the New York City area under an emergency IND recently granted by the FDA.
Ennaid Therapeutics LLC, of Alpharetta, Ga., said it is advancing work on ENU-200 as a therapeutic to treat the up to 80% of asymptomatic, mild to moderate cases of COVID-19 viral infections. ENU-200 is a repurposed, patent-pending, orally deliverable antiviral drug that was previously approved by the FDA for a different indication. In silico modeling conducted by Ennaid has revealed the drug delivers specific antiviral activity against two SARS-CoV-2 proteins, S glycoprotein and Mpro, and Ennaid said its science suggests that simultaneous blockage may result in enhanced antiviral activity that could successfully and broadly treat COVID-19 and other coronaviruses.
ERS Genomics Ltd., of Dublin, and Axxam SpA, of Milan, Italy, signed a license agreement granting Axxam access to ERS’ CRISPR/Cas9 patent portfolio, to support Axxam's integrated discovery service platform. The application of the CRISPR/Cas9 platform is an addition to Axxam’s range of approaches for development of highly customized cell-based assays for relevant target classes and molecular pathways, the company said. The platform will be applied across Axxam’s integrated discovery services, in fields such as pharmaceuticals, crop protection, animal health, and food and beverages.
Evotec SE, of Hamburg, Germany, and Pancella Inc., of Toronto, entered a licensing and investment agreement. Evotec will receive a nonexclusive license to access Pancella's induced pluripotent stem (iPS) cell lines, which are genetically modified to prevent immune rejection of derived cell therapy products. Evotec will also have access to a new-generation cloaking technology known as hypoimmunogenic cells. The mechanism is designed to addresses potential tumor formation by residual undifferentiated cells. Evotec expects to develop iPSC-based, off-the-shelf cell therapies without using medication to suppress the patients' immune system.
Flugen Inc., of Madison, Wis., Bharat Biotech International Ltd., of Hyderabad, India, and the University of Wisconsin-Madison said an international collaboration of virologists has begun developing and testing a vaccine against COVID-19 called Coroflu. Work is designed to build on the backbone of Flugen’s flu vaccine candidate, M2SR, with research inserting gene sequences from SARS-CoV-2, the novel coronavirus that causes COVID-19, into M2SR so that the new vaccine will also induce immunity against the coronavirus. Refinement of the Coroflu vaccine concept and testing in laboratory animal models at UW-Madison is expected to take three to six months. Bharat Biotech will then begin production scale-up for safety and efficacy testing in humans. Coroflu could be in human trials by the fall of 2020.
Foamix Pharmaceuticals Inc., a wholly owned subsidiary of Menlo Therapeutics Inc., of Bridgewater, N.J., entered a settlement and license agreement to resolve remaining pending patent litigation involving Finacea Foam. Details of the settlement agreement are confidential and the settlement agreement is subject to FTC and U.S. Department of Justice review. Foamix is the owner of patents that have been licensed to Leo Pharma A/S, of Ballerup, Denmark, to market Finacea Foam, a topical prescription medicine for treating inflammatory papules and pustules of mild to moderate rosacea. The settlement concludes the litigation relating to Finacea Foam and comes after the settlements in October 2019 with an affiliate of Jerusalem-based Teva Pharmaceutical Industries Ltd. and in April 2019 with affiliates of Dublin’s Perrigo Co. plc.
Kite Pharma Inc., of Santa Monica, Calif., and Teneobio Inc., of Newark, Calif., entered a license and collaboration agreement in which Kite will receive exclusive rights to certain antibodies directed to B-cell maturation antigen. The fully human variable heavy chain of one such antibody is currently undergoing clinical evaluation in a chimeric antigen receptor (CAR) format for the treatment of patients with multiple myeloma in a phase I trial at the National Cancer Institute. Kite and Teneobio will also collaborate on the discovery of antibodies directed to four additional targets, using Teneobio’s platform, to be used in CAR T-cell therapies for multiple myeloma and other cancers. Teneobio will receive an undisclosed up-front payment and will be eligible to receive additional payments based on achieving certain clinical and regulatory milestones, as well as royalties on future potential sales.
La Jolla Pharmaceutical Co., of San Diego, said it is providing Giapreza (angiotensin II) for emergency use in patients with septic shock due to COVID-19 at Guy’s and St Thomas’ NHS Foundation Trust in London. Giapreza was recently approved by the European Commission but is not yet commercially available in Europe. According to English law, authorized medicines can be made available prior to commercial availability in order to fulfill special patient needs. In December 2017, Giapreza was approved by the FDA as a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock. In August 2019, it was approved by the European Commission to treat refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies. Giapreza mimics the body’s endogenous angiotensin II peptide, which is central to the renin-angiotensin-aldosterone system, which regulates blood pressure.
Merrimack Pharmaceuticals Inc., of Cambridge, Mass., received $2.25 million from selling certain assets from its preclinical nanoliposome programs to Ewing, N.J.-based Celator Pharmaceuticals Inc. Merrimack will not receive any further contingent consideration or royalties. Celator also reimbursed Merrimack for certain specified expenses and assumed certain liabilities regarding the assets. The transaction continues Merrimack’s strategy of extending its cash runway into 2027 and preserving its ability to capture the potential $450 million of remaining Onivyde (liposomal irinotecan)-related contingent milestone payments from its 2017 asset sale to Ipsen SA, of Paris, as well as the potential $54.5 million of remaining contingent milestone payments resulting from its 2019 sale of certain programs to New York-based Elevation Oncology Inc., formerly known as 14ner Oncology Inc.
Due to lack of FTC approval, Basel, Switzerland-based Novartis AG and Aurobindo Pharma USA Inc., of East Windsor, N.J., mutually agreed to terminate sale of Sandoz US generic oral solids and dermatology portfolio to Aurobindo. Sandoz will continue to operate its oral solids and dermatology business as part of the Sandoz US business, according to Novartis.
Noxopharm Co., of New South Wales, Australia, said it identified a clinical trial opportunity that could help reduce the mortality rate of COVID-19. Preclinical research from the Hudson Institute of Medical Research in Melbourne found the active ingredient in Noxopharm’s Veyonda, idronoxil, inhibits a range of cytokines, including interleukin-6 (IL-6), that are involved in cytokine response syndrome. Cytokine storm is associated with an excessive and abnormal inflammatory response and is believed to be responsible for most deaths in patients with COVID-19 infection. Noxopharm said it will pursue a clinical study to evaluate the use of idronoxil in patients considered to be at risk of developing COVID-19-associated acute respiratory distress syndrome and multi-organ failure.
Paratek Pharmaceuticals Inc., of Boston, said the Biomedical Advanced Research and Development Authority (BARDA) has initiated funding to support all of the U.S. FDA postmarketing requirements associated with the approval of antibiotic Nuzyra (omadacycline), including pneumonia and pediatric studies as well as the five-year postmarketing bacterial surveillance study. The reimbursement cost for those postmarketing commitments is projected to total about $77 million.
Persephone Biosciences Inc., of San Diego, said it is developing an immune-boosting microbiome therapeutic to help prevent and fight the novel coronavirus (SARS-CoV-2) as well as a potential stool-based diagnostic designed to help predict which patients are at highest risk for developing severe complications and mortality from COVID-19. The company said its therapeutic is envisioned to be used to prevent infection, taken at the onset of symptoms or with a vaccine or antiviral drug to mount an effective immune response with long-lasting immunity and boost the immune system of those exposed to the virus as is the case with first responders. That may promote rapid elimination of the virus, preventing the life-threatening symptoms that occur with extreme COVID-19 cases.
Redhill Biopharma Ltd., of Tel Aviv, Israel, said it completed its acquisition of global rights, excluding Europe, Canada and Israel, to Movantik (naloxegol) for the treatment of opioid-induced constipation (OIC) from Astrazeneca plc, of Cambridge, U.K. Movantik, an oral, peripherally acting mu-opioid receptor antagonist, was approved in the U.S. for OIC in 2014.
Relief Therapeutics Holding SA, of Geneva, said it closed the binding share exchange agreement for the acquisition of Sonnet Biotherapeutics Inc., of Princeton, N.J.
Serimmune Inc., of Goleta, Calif., said it received a research milestone payment from Merck & Co. Inc., of Kenilworth, N.J., under its ongoing discovery and development collaboration agreement. Under terms of the agreement, Serimmune applied its SERA platform to clinical and preclinical specimens provided by Merck, which will lead preclinical and clinical development and commercialization of candidates identified from the collaboration. Serimmune is eligible to receive research, development and regulatory milestone payments and tiered royalties on sales of any products resulting from the collaboration.
Sorrento Therapeutics Inc., of San Diego, said it initiated the next phase of its collaboration with Celularity Inc., of Warren, N.J., which said the FDA cleared the IND for use of its CYNK-001 in adults with COVID-19. Celularity also announced that it will immediately commence a phase I/II study including up to 86 patients with COVID-19. Celularity is preparing to launch CYNK-001 manufacturing at its new purpose-built cGMP/cGTP manufacturing facility in Florham Park, N.J., and Sorrento will make available to Celularity current existing capacity in Sorrento’s cGMP cell therapy manufacturing facilities in San Diego. The addition of Sorrento’s cGMP cell therapy manufacturing capacity is expected to facilitate rapid scale-up and sustained production, the companies said.
Tetra Bio-Pharma Inc., of Ottawa, said it launched a study to determine the levels of cannabinoid metabolites (e.g., 7-COOH-CBD), cannabinoid precursors (e.g., CBGA) and minor cannabinoids (e.g., CBN) in the plasma of humans. The study is important to the FDA and Health Canada to define the levels of those compounds in patients consuming cannabis and Tetra’s inhaled drugs Qixleef and Caumz, the company said.
The University Hospitals (UH) network in Cleveland said it will lead a clinical trial that involves the administration of an investigational drug, ARMS-I, to its caregivers working on the front lines of the COVID-19 pandemic. The trial, called the ARMS-I COVID Study, is designed to assess whether the drug helps prevent airborne transmission of coronavirus and whether it reduces the symptoms of health care providers who have tested positive for the virus. The study will be conducted by the UH Clinical Research Center. In laboratory studies, ARMS-I has been shown to kill enveloped viruses such as COVID-19.
UCB SA, of Brussels, said the acquisition of Ra Pharmaceuticals Inc., of Cambridge, Mass., has been completed, and the latter is now a wholly owned subsidiary of UCB. Ra shareholders received $48 in cash for each Ra share they held at closing. The deal, announced in October, valued Ra at about $2.5 billion.
Vir Biotechnology Inc., of San Francisco, and Alnylam Pharmaceuticals Inc., of Cambridge, Mass., said they expanded their broad multitarget collaboration for the development and commercialization of RNAi therapeutics for infectious diseases, including SARS-CoV-2, the virus that causes the disease COVID-19. The expansion includes up to three additional targets focused on host factors for SARS-CoV-2, including ACE2 and TMPRSS2, both of which are considered critical for viral entry, with the potential for an additional host target to emerge from Vir’s functional genomics work. Under the amended agreement, in addition to leading development of selected development candidates, Vir will lead commercialization of any products emerging from the collaboration that gain regulatory approval. At clinical proof of concept, Alnylam will have an option to share equally in any profits and losses associated with the development and commercialization of each coronavirus program. Alternatively, Alnylam may elect to earn development and commercialization milestones and royalties on net sales of any products resulting from the collaboration in amounts agreed upon for each coronavirus program. Those additional targets expand the companies’ collaboration and license agreement announced in 2017, and the subsequent amendment to that agreement announced in March, to now develop siRNAs for up to nine infectious disease targets in total, including hepatitis B virus in the Vir-2218 (ALN-HBV02) program currently in phase I/II studies.
Zealand Pharma A/S, of Copenhagen, said it completed its acquisition of substantially all the assets of Valeritas Holdings Inc., of Bridgewater, N.J., for the cash purchase price of $23 million and the assumption of certain liabilities. The deal adds Valeritas’ V-Go wearable insulin delivery device to Zealand’s diabetes portfolio.