Abcellera Biologics Inc., of Vancouver, British Columbia, and Eli Lilly and Co., of Indianapolis, agreed to co-develop antibody products for treating and preventing COVID-19. The collaboration will leverage Abcellera's pandemic response platform and Lilly's global capabilities for developing, manufacturing and distributing therapeutic antibodies. Within one week of receiving a blood sample from one of the first U.S. patients who recovered from COVID-19, Abcellera screened more than 5 million immune cells looking for ones that produced functional antibodies that helped the patient neutralize the virus and recover from the disease and identified more than 500 unique fully human antibody sequences. The next step is to screen those antibodies to find the ones most effective in neutralizing SARS-CoV-2.
Can-Fite Biopharma Ltd., of Petach Tikva, Israel, will collaborate with the Lewis Katz School of Medicine at Temple University in Philadelphia, to explore antiviral activity of piclidenoson on coronavirus viral load in a mammalian cell model system. Piclidenoson is an A3 adenosine receptor agonist small-molecule, orally bioavailable drug under development for treating autoimmune inflammatory diseases. It is being evaluated in a phase III study as a first-line treatment, to replace methotrexate, to treat rheumatoid arthritis and in a phase III study to treat moderate to severe psoriasis.
I-Mab Biopharma Co. Ltd., of Rockville, Md., and Shanghai, is initiating TJM2 development to treat cytokine storm in severe and critically ill patients with COVID-19. TJM2 is a neutralizing antibody against human granulocyte-macrophage colony stimulating factor (GM-CSF), a cytokine that plays a role in acute and chronic inflammation. The company said development will start following FDA acceptance of I-Mab’s IND, and the study will commence in the U.S. with plans to expand into other hardest-hit countries. Cytokine storm is characterized by surging inflammatory cytokines and is an overreaction of the immune system. Recent studies revealed high levels of GM-CSF, along with a few other cytokines, are associated with severe clinical complications in COVID-19 patients.
La Jolla Pharmaceutical Co., of San Diego, is providing Giapreza (angiotensin II) in Italy for compassionate use in patients with septic shock associated with COVID-19. According to Italian law, authorized medicines for life-threatening and rare illnesses can be made available prior to commercial availability under a compassionate use program. Giapreza was recently approved by the European Commission, but is not yet commercially available in Europe. In December 2017, it was approved by the FDA as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. The drug mimics the body’s endogenous angiotensin II peptide, which is central to the renin-angiotensin-aldosterone system, which in turn regulates blood pressure.
Lattice Biologics Ltd., of Belgrade, Mont., plans to evaluate its amniotic fluid concentrate, Amnioboost, in patients with acute respiratory distress syndrome (ARDS), the principal cause of death in COVID-19 infection. The company said Amnioboost is believed to have immunomodulatory properties to counteract the inflammatory processes implicated in several diseases by down-regulating production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.
Lexicon Pharmaceuticals Inc., of The Woodlands, Texas, presented additional data on Xermelo’s (telotristat ethyl) antiproliferative effects in patients with carcinoid syndrome at the European Neuroendocrine Tumor Society meeting in Barcelona, Spain. Xermelo is approved for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy, but is not currently approved for any other use. Data from a retrospective, pre- and post-design chart review of 200 metastatic neuroendocrine tumor patients who were on standard background therapies and received the drug for an average of 12 months in U.S. clinical practice demonstrated that most patients had no tumor progression at six, 12 and 18 months following the start of Xermelo, with a median time to tumor progression of 39.8 months.
Neuexcell Therapeutics Inc., of State College, Pa., disclosed the publication of research demonstrating proof of principle for the company’s gene therapy, which generated functional new neurons in animal models of Huntington’s disease (HD). The results, published in the current issue of Nature Communications, show that the therapy led to improvement in HD symptoms and extension of lifespan in validated mouse models, indicating a promising approach to treating HD and other serious central nervous system disorders. A research team led by Gong Chen, Neuexcell’s founder and chief scientific officer, developed an adeno-associated virus-based gene therapy to regenerate functional new neurons in the brains of mice with HD-like symptoms. The mice treated with that gene therapy exhibited improved motor skills and an increased rate of survival compared to untreated mice.
Pharmamar SA, of Madrid, reported positive results from in vitro studies of Aplidin (plitidepsin) on the human coronavirus HCoV-229E, which has a multiplication and propagation mechanism similar to COVID-19. The results confirm the company’s hypothesis that the therapeutic target of Aplidin, EF1A, is key to the multiplication and spread of the virus. Pharmamar said it plans to contact regulatory authorities to analyze the possibilities of studies on COVID-19 patients.
Qiagen NV, of Hilden, Germany, said it will develop a new Qiastat-Dx test kit to differentiate the novel SARS-CoV-2 coronavirus from 21 other serious respiratory infections and will receive advanced development support from the U.S. Department of Health and Human Services. Accelerated development of the kit further expands Qiagen’s global mobilization for the emergency, which already includes an increase in production of components for a full range of U.S. and international testing protocols, the company said. The kit will be a molecular testing panel designed to aid in the diagnosis of patients with respiratory syndromes in about one hour.
Redx Pharma plc, of Cheshire, U.K., said it was in receipt of a further private approach from Yesod Bio-Sciences Ltd., of London, that may lead to a possible cash offer for the entire issued and to be issued share capital of the company at a price of 15 pence (US19 cents) per share. The board is giving careful consideration to the approach, including discussions with Moulton Goodies Ltd., the company's largest shareholder, and bearing in mind the commitments made in relation to funding from entities controlled by Redmile Group LLC.
Roche Holding AG, of Basel, Switzerland, said the FDA has issued an emergency use authorization for the cobas SARS-CoV-2 test that is intended for the qualitative detection of the virus that causes COVID-19 disease, in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria for testing. Hospitals and reference laboratories can run the test on the company’s fully automated cobas 6800 and cobas 8800 systems. The CE-IVD test is also available in markets accepting the CE mark for patients with signs and symptoms of COVID-19 disease and living in affected areas where the SARS-CoV-2 virus is known to be present.
Sengenics UK Ltd., of Cambridge, U.K., a precision medicine company, said it is making full-length, correctly folded and functional COVID-19 antigens available for purchase for both research and vaccine development purposes. The company’s used its Krex technology to discover autoantibody biomarker signatures for prediction of drug response and severe immune-related adverse events. It can also be used to identify autoantibody biomarkers that may be used to diagnose cancer, autoimmune or neurodegenerative conditions.
Verastem Inc., of Boston, in its year-end financial report, said its new strategic direction embraces the accelerated development for KRAS-mutant solid tumors. Earlier this year, the company licensed exclusive global development and commercialization rights to CH-5126766 (VS-6766), an inhibitor of the RAF/MEK signaling pathway. The combination of the compound and defactinib is being investigated in a phase I study and expansion cohorts in patients with KRAS-mutant advanced solid tumors, including low-grade serous ovarian cancer, non-small-cell lung cancer and colorectal cancer. This month, the company also completed a $100 million private placement offering.