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.
Airway Therapeutics Inc., of Cincinnati, filed with the National Institute of Allergy and Infectious Diseases to evaluate AT-100, a recombinant human surfactant protein D (rhSP-D), as a potential therapy for COVID-19. The company is advancing the candidate primarily for the prevention of bronchopulmonary dysplasia in very preterm infants, but "research has demonstrated that rhSP-D plays a key role in the clearance of numerous bacteria and viruses across a range of serious respiratory diseases," said Airway's president and CEO, Marc Salzberg.
Athenex Inc., of Buffalo, N.Y., provided an update in light of the coronavirus pandemic, stating that its operational plans remain on track and its current assessment is that the NDA submission for oral paclitaxel and prelaunch preparations for oral paclitaxel and tirbanibulin ointment should not be affected. While the company’s China operations in Chongqing were impacted by the coronavirus situation, it reported that operations resumed in the first week of March.
Aytu Bioscience Inc., of Englewood, Colo., said it concluded an exclusive distribution agreement for the right to commercialize a clinically validated and commercially used coronavirus 2019 (COVID-19) IgG/IgM rapid test licensed from L.B. Resources Ltd., of Hong Kong, which previously licensed North American rights from product developer Zhejiang Orient Gene Biotech Co. Ltd., of Huzhou, China. The point-of-care test, which was validated in a 113-patient trial and received CE marking, is a solid phase immunochromatographic assay used for rapid, qualitative and differential detection of IgG and IgM antibodies to COVID-19 in human whole blood, serum or plasma, delivering results in two to 10 minutes. Sensitivity of the lgM test was 87.9% (87/99) and specificity was 100% (14/14) when compared to RT-PCR, and sensitivity of the lgG test was 97.2% (35/36) and specificity was 100% (14/14) during the convalescence period of trial participants. The agreement grants Aytu the exclusive right to distribute the product in the U.S. for three years, with additional three-year autorenewals. Aytu plans to seek U.S. regulatory clearance under the FDA's emergency use authorization.
Brii Biosciences, of Beijing, has agreed to fund New York-based Columbia University to facilitate creating a framework for forming strategic collaborations focused on the treatment, prevention and diagnosis of COVID-19 and other coronavirus-linked illnesses. Columbia intends to disseminate the results of the project's research.
Chembio Diagnostics Inc., of Hauppauge, N.Y., said it formed a global strategic partnership with Lumiradx Ltd., of London, to develop point-of-care diagnostic tests on the platforms of both companies to detect the COVID-19 virus and IgM and IgG antibodies. Financial terms were not disclosed.
Clearside Biomedical Inc., of Alpharetta, Ga., said Arctic Vision Shanghai Biotechnology Co. Ltd., of Shanghai, acquired an exclusive license to commercialize and develop Xipere (triamcinolone acetonide) in China, Hong Kong, Macau, Taiwan and South Korea. Clearside is set to receive up to $35.5 million in development and sales milestones, including $4 million up front and additional payments for achieving specified events prior to and including receipt of FDA approval of Xipere. Clearside also will be entitled to tiered royalties of 10% to 12% based on annual net sales of Xipere in greater China and South Korea. The suspension formulation of the corticosteroid triamcinolone acetonide for suprachoroidal administration with Clearside’s SCS microinjector is in development as a targeted treatment of macular edema associated with uveitis. Arctic Vision also gained the right to pursue development and commercialization of Xipere for additional ophthalmic indications in its licensed territory, with Clearside’s consent.
Correvio Pharma Corp., of Vancouver, British Columbia, said it established an exclusive agreement through wholly owned subsidiary Correvio International Sàrl with Hong Kong Teson Pharma Ltd., of Hong Kong, to commercialize Aggrastat (tirofiban hydrochloride) in mainland China (excluding Taiwan and Hong Kong) and Macau. The GP IIb IIIa antagonist is approved to reduce thrombotic cardiovascular events in individuals with acute coronary syndrome. Correvio agreed to a one-time up-front payment of $3 million from Teson and is eligible to receive up to another $500,000 upon Teson's first receipt of product, expected to occur in the third quarter of 2020. Teson gained exclusive rights to commercialize Aggrastat in the territories at its own expense. Additional terms were not disclosed.
Emergent Biosolutions Inc., of Gaithersburg, Md., said it initiated development of candidates to treat and prevent COVID-19, using its hyperimmune platforms. COVID-HIG, manufactured from human plasma with antibodies to SARS-CoV-2, will be developed as a potential treatment for severe hospitalized patients and to protect at-risk individuals. In parallel, COVID-EIG, manufactured from plasma of immunized horses with antibodies to SARS-CoV-2, will be developed as a potential treatment for severe hospitalized patients. Emergent plans to use its existing infrastructure and capabilities it deployed for a recently completed phase II trial of influenza hyperimmune FLU-IGIV to treat individuals hospitalized with influenza A. In other news, Emergent said it is collaborating with Novavax Inc., also of Gaithersburg, Md., to develop and manufacture Novavax’s vaccine against the coronavirus that causes COVID-19. Emergent will be responsible for manufacturing the vaccine with a goal of starting a phase I trial within the next four months. Financial terms of the agreement weren't disclosed. Separately, Novavax said it was awarded $4 million to support development of the vaccine from the Coalition for Epidemic Preparedness.
GT Biopharma Inc., of Beverley Hills, Calif., and Cytovance Biologics LLC, of Oklahoma City, are collaborating to develop a treatment for COVID-19 using GT's Trike NK cell engager platform. Cytovance will be responsible for manufacturing the product using its E. coli-based Keystone Expression System. Financial terms of the agreement weren't disclosed.
Hitgen Inc., of Chengdu, China, said Tokyo-based Kaken Pharmaceutical Co. Ltd. has licensed for development a number of novel small-molecule leads for an undisclosed target identified by the company. Under the terms, Hitgen will grant exclusive rights to Kaken for further development and commercialization, and be eligible for preclinical and clinical milestone payments from Kaken as the project progresses, in addition to an up-front license fee. It's the second time Kaken has licensed candidates from Hitgen, the company said.
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.
Immunoprecise Antibodies Ltd., of Victoria, British Columbia, a therapeutic antibody discovery CRO, said its approach utilizing polytope monoclonal antibody therapy, from its discovery platforms and artificial intelligence capabilities with partner, Evqlv Inc., is being used in the development of a universal COVID-19 therapy.
Innovation Pharmaceuticals Inc., of Wakefield, Mass., said research procedures that one of the 12 U.S. regional biocontainment labs (RBLs) will follow when testing brilacidin, the company's lead defensin mimetic drug candidate, will be against SARS-CoV-2, the coronavirus responsible for COVID-19. Staff scientists at the RBL will evaluate brilacidin's potential inhibitory efficacy against SARS-CoV-2 in lung epithelial cell lines, as well as its potential inhibitory effect in viral replication of the alphavirus (with Venezuelan equine encephalitis virus as a prototype) in different cell lines. If brilacidin shows promise, testing will be expanded to include additional mechanism-of-action studies to determine brilacidin's specific inhibitory activity across the lifecycle of the SARS-CoV-2 virus – viral entry, viral RNA and viral release.
Kamada Ltd., of Rehovot, Israel, plans to start development of an anti-corona polyclonal immunoglobulin for the treatment of COVID-19. The product will be derived from plasma of donors who have recovered from the virus. Kamada also said it received a notice of allowance from the U.S. Patent and Trademark Office for a patent on the method of treatment for using polyclonal human immunoglobulins against the Zika virus.
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.
Mallinckrodt plc, of Staines-upon-Thames, U.K., said it is currently evaluating the limited published evidence suggesting a potential role for inhaled nitric oxide (iNO) as a supportive measure in treating those patients infected with coronavirus (SARS-CoV-2) and having associated pulmonary complications. The company indicated it has engaged with the FDA, the NIH and the Biomedical Advanced Research and Development Authority; however, the safety and efficacy of iNO for pulmonary complications associated with coronavirus have not been established. The company markets iNO as Inomax (nitric oxide) gas for inhalation in the U.S. for the treatment of term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension. While nitric oxide has not been specifically studied or used to treat COVID-19, in vitro it has demonstrated an inhibitory effect on the replication cycle of severe acute respiratory syndrome-related coronavirus (SARS-CoV).
Medicago Inc., of Quebec City, said it has produced a virus-like particle (VLP) of the coronavirus just 20 days after obtaining the SARS-CoV-2 gene. Production of the VLP is the first step in developing a vaccine for COVID-19, which will now undergo preclinical testing for safety and efficacy. Once that is completed, the company expects to discuss with the health agencies for the start of human trials by July or August. The company is also using its technology platform to develop antibodies against SARS-CoV-2 in collaboration with the Laval University’s Infectious Disease Research Centre headed by Gary Kobinger, who helped develop a vaccine and treatment for Ebola. Those SARS-CoV-2 antibodies could potentially be used to treat people infected by the virus.
Mesoblast Ltd., of New York, plans to test remestemcel-L in patients with acute respiratory distress syndrome caused by COVID-19. The company is in talks with various government and regulatory authorities, medical institutions and pharmaceutical companies to start the clinical trial.
Nanoviricides Inc., of Shelton, Conn., said it completed the synthesis of multiple nanoviricide drug candidates for testing following identification of virus-binding ligands associated with SARS-CoV-2. The company acquired and expanded two low-threat circulating coronaviruses in its BSL2 lab and expanded them to enable testing of drug candidates. One of those, NL63, uses the same ACE2 receptor on human cells as SARS-CoV-2 but does not cause similarly severe disease in humans. Effectiveness of test candidates in the cell culture studies against coronaviruses would provide a rationale for effectiveness against SARS-CoV-2, according to Nanoviricides. The company is seeking to establish collaborations to enable additional testing of its drug candidates against the current coronavirus. In the meantime, Nanoviricides expects to begin testing its drug candidates against the BSL2 coronavirus strains in its BSL2 virology lab. Despite the plummeting markets, on March 16 the company’s shares (NYSE American:NNVC) gained 6%, adding 42 cents to close at $7.28.
Nicox SA, of Sophia Antipolis, France, and Ocumension Therapeutics Ltd., of Shanghai, amended their licensing agreement for NCX-470, a nitric oxide-donating prostaglandin analogue, to include Korea and Southeast Asia in addition to Ocumension's license for the Chinese market. Ocumension will pay Nicox €15 million (US$16.9 million) in place of the milestones in the original agreement and will cover half of the cost of the Denali phase III trial of NCX-470 in patients with glaucoma. The companies will jointly manage the Denali trial in the U.S. and China. Nicox and Ocumension also amended their licensing agreement for Zerviate (cetirizine ophthalmic solution) to expand Ocumension's territory from the Chinese market to the majority of Southeast Asian region. Ocumension plans to file an IND with China's Center for Drug Evaluation for a clinical trial testing Zerviate in patients with allergic conjunctivitis, which is expected to start in the fourth quarter of 2020.
Novavax Inc., of Gaithersburg, Md., and Serum Institute of India (SII) inked a commercial license agreement for the use of Novavax’s Matrix-M vaccine adjuvant with SII’s malaria vaccine candidate. Under the terms, SII is granted rights to use Matrix-M in the vaccine in regions where the disease is endemic and will pay Novavax royalties on its market sales of the vaccine. Matrix-M will be manufactured and supplied to SII by Novavax AB, a wholly owned subsidiary of Novavax based in Uppsala, Sweden. Novavax also gained the rights to sell and distribute the SII-manufactured vaccine in high-income countries, primarily in the travelers and military vaccine markets. SII licensed the R21 malaria vaccine, which targets the most severe Plasmodium falciparum-induced malaria disease, from the Jenner Institute at Oxford University in 2017. Matrix-M is a key component in the malaria vaccine candidate, currently in a phase IIb sponsored by the Jenner Institute, with top-line data expected to be reported in the second quarter of 2020.
Olix Pharmaceuticals Inc., of Suwon, South Korea, said preclinical data published in Molecular Pharmaceutics indicated that L-type calcium channel blockers (CCBs) might have potential in augmenting RNAi therapeutics. Findings showed L-type CCBs increased the endocytic cellular uptake of cell-penetrating asiRNA (cp-asiRNA), and the small molecules substantially improved the potency of cp-asiRNAs, not only in vitro but also in vivo on rat skin.
Oncosec Medical Inc., of San Diego, received a research and development tax incentive cash rebate of $850,000 from the Australian Tax Office.
Pharmamar SA, of Madrid, said that in vitro studies of Aplidin (plitidepsin) on the human coronavirus HCoV-229E, which has a multiplication and propagation mechanism similar to the SARS-CoV-2 virus that causes COVID-19, were positive, with potency of the nanomolar order. The studies, performed at the National Biotechnology Centre of the Spanish National Research Council, confirmed the hypothesis that the therapeutic target of Aplidin, elongation factor 1 alpha 2, is key to the multiplication and spread of the coronavirus. Pharmamar plans to contact regulatory authorities to discuss the possibility of conducting studies of Aplidin, originally advanced to treat cancer, on individuals with COVID-19.
Pluristem Therapeutics Inc., of Haifa, Israel, signed a collaborative agreement with the BIH Center for Regenerative Therapy and the Berlin Center for Advanced Therapies at Charite’ University of Medicine Berlin to expand its existing framework and research agreement and conduct a joint project evaluating the therapeutic effects of Pluristem’s patented PLX cell product candidates for potential treatment of the respiratory and inflammatory complications associated with the COVID-19 coronavirus. PLX cells are allogeneic mesenchymal-like cells that have immunomodulatory properties that induce the immune system’s natural regulatory T cells and M2 macrophages, and thus may prevent or reverse the dangerous overactivation of the immune system. The collaboration with Charité researchers will allow the firm to expedite its program to potentially enable the use of PLX cells to treat patients infected with COVID-19 that have respiratory and immunological complications, Pluristem said.
Protalix Biotherapeutics Inc., of Carmiel, Israel, said it agreed to conduct a feasibility study with Kirin Holdings Co. Ltd., of Tokyo, to evaluate production of a complex protein using its Procellex plant cell-based protein expression system. Kirin agreed to provide research funding for Protalix scientists to conduct cell line engineering and protein expression studies on the target protein. If the study succeeds, Kirin and Protalix expect to discuss a licensing agreement of Procellex to Kirin to continue the program’s development.
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.
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.
J.S. Cole and Associates will be the exclusive financial advisor for Austin, Texas-based TFF Pharmaceuticals Inc.’s partnering efforts in Japan. TFF’s platform is designed to improve solubility and absorption of poorly water-soluble drugs. The company’s two lead candidates are voriconazole and tacrolimus inhalation powders. It plans to increase its pipeline by collaborating with large pharmaceutical partners. J.S. Cole provides business development and marketing research guidance.
Tiziana Life Sciences plc, of London, is developing TZLS-501, a monoclonal antibody targeting interleukin-6 receptor, for treatment of patients infected with the coronavirus that causes COVID-19. Shares of Tiziana (NASDAQ:TLSA) shot up $1.90, or 93%, to close at $3.95 on March 11.
Twist Bioscience Corp., of South San Francisco, Calif., announced the availability of research-use only target enrichment next-generation sequencing panels for viral detection and characterization of samples from patients testing positive for SARS-CoV-2, which causes COVID-19. The panels can be used for environmental monitoring and surveillance testing, while also providing insight into full sequence information to track viral evolution and strain origin. The target enrichment panels are in three reaction sizes for various workflows, with synthetic double-stranded DNA probes covering the length of the SARS-CoV-2 virus. Next-generation sequencing offers high-throughput, specific identification of infections in several sample types, including blood, nasal swab and feces. For viral infections, obtaining genetic material sufficient for sequencing can be a challenge due to low levels of virus often present. For those infections, target enrichment using DNA-based hybridization probes to isolate specific sequences out of a mixed genomic sample can increase the sensitivity and specificity of NGS-based efforts.
Tyligand Bioscience Ltd., of Shanghai, and Context Therapeutics LLC, of Philadelphia, are collaborating to develop, manufacture, register and commercialize onapristone extended release. Tyligand will be solely responsible for designing and optimizing a manufacturing process to meet Context’s development and commercialization needs, and standards for quality, safety and cost. Upon completion of performance-based milestones, Tyligand will be granted the exclusive right and will be solely responsible for developing and commercializing onapristone extended release in China, Hong Kong and Macau. Context will be eligible to receive royalties on net sales in Macau. Context will retain rest of world commercialization rights. Onapristone extended release is being evaluated in patients with progesterone receptor-positive ovarian and endometrial cancers in the phase II ONWARD 220 trial.
Vir Biotechnology Inc., of San Francisco, is collaborating with the National Institute of Allergy and Infectious Diseases, Vaccine Research Center to develop monoclonal antibodies against coronaviruses, including SARS, MERS and SARS-CoV-2, the virus that causes COVID-19. Vir has already identified antibodies that bind to SARS-CoV-2 from individuals who recovered from a SARS infection. Shares of Vir (NASDAQ:VIR) jumped $3.86, or 12.9%, to close at $33.77 on March 11. In other new, Vir said it plans to collaborate with Cambridge, Mass.-based Biogen Inc. to develop and manufacture human monoclonal antibodies to treat COVID-19 patients. Subject to a final agreement, Biogen would continue cell line development, process development and clinical manufacturing to advance development of Vir’s antibodies. The company is conducting research to determine if its antibodies, or additional antibodies that it may be able to identify, can be effective as treatment and/or prophylaxis against SARS-CoV-2.
Earlier this year, Xavier Saelens (the VIB-UGent Center for Medical Biotechnology) said it discovered a single-domain antibody (VHH) capable of binding the SARS-CoV-2 spike protein of COVID-19. The lab team said it established that Fc fusions of the VHH can neutralize pseudotyped SARS-CoV-2 and that the neutralizing VHH can be produced in large-scale production processes common in the biopharmaceutical industry.
Xortx Therapeutics Inc., of Calgary, Alberta, is researching the use of XRx-101, a formulation of oxypurinol, to treat acute kidney and lung injury accompanying coronavirus infection and specifically for COVID-19 infection. The company, which reviewed recent studies characterizing the outbreak of COVID-19 in mainland China, reported illustrating that acute kidney injury and acute pulmonary injury are key factors in the most serious cases of COVID-19 hospitalization and death. Xortx said it plans to manufacture and submit INDs for XRx-008’s planned phase III trial in autosomal dominant polycystic kidney disease.