Aerpio Pharmaceuticals Inc., of Cincinnati, and the U.S. government’s Medical Technology Enterprise Consortium will evaluate razuprotafib in a randomized trial to prevent and treat acute respiratory distress syndrome in adults with moderate to severe COVID-19. The consortium will provide up to $5.1 million toward the clinical trial, and Aerpio will kick in $2.8 million. The consortium was established as an enterprise partnership including industry and academia to facilitate research and development activities. The partnership will provide resources to support a second COVID-19 phase II trial with razuprotafib, which is being investigated for its potential to prevent and treat the severe respiratory distress in COVID-19 patients.
Alterity Therapeutics Ltd., of Melbourne, Australia, said new clinical and experimental pharmacology data for its lead drug candidate, ATH-434 (formerly PBT-434), have been selected for presentation at the 2020 International Congress of Parkinson's Disease and Movement Disorders and the American Neurological Association's annual meeting. Results from an experiment testing ATH-434 in an animal model of multiple system atrophy independently confirm and extend previous findings demonstrating that the drug reduces alpha-synuclein pathology, preserves neurons and improves motor performance. ATH-434 is an orally bioavailable, brain penetrant, small-molecule inhibitor of alpha-synuclein aggregation.
Aveo Pharmaceuticals Inc. (Aveo Oncology), of Boston, said it earned a $2.8 million development milestone payment from partner Kyowa Kirin Co. Ltd., of Tokyo, following acceptance by the Japanese PMDA of an IND application for VEGF tyrosine kinase inhibitor tivozanib in a non-oncology indication. Kyowa Kirin regained certain non-oncology rights in 2019.
Beroni Group Ltd., of Sydney, provided an update on the development of the previously disclosed potential medical solution utilizing nanobody technology for detection and treatment of COVID-19 in collaboration with Tianjin University in China. After identifying the 24 specific nanobodies with high affinity to the new coronavirus N-protein and S-protein antigens through high-throughput screening in May, the scientific team has used structural biology, computational biology and biophysical methods to further analyze and improve the properties of those nanobodies. Out of the 24 nanobodies, 16 deal with the S-protein and can be used as antiviral therapeutics, and the other eight deal with the N-protein for use as a marker in diagnostic assays. The scientists have successfully established a prokaryotic expression and purification system for nanobodies in vitro, the company said.
Integrated CROs Caprion-Histogenex, of Montreal, and Viroclinics-DDL, of Rotterdam, the Netherlands, said they formed a strategic partnership to expand their global capabilities to address emerging needs for therapeutic and prophylactic solutions to target infectious diseases, including COVID-19. The companies said they will offer a suite of services ranging from preclinical and in vitro research models to deployment of custom-developed and off-the-shelf functional assays to monitor efficacy in vaccine and antiviral studies at sites in the Netherlands, North America, Belgium, the U.K., Australia and China. The partnership also will provide access to a network of clinical sample processing facilities across the globe, along with operational and logistical services, including sample management and sampling kits.
Celularity Inc., of Florham Park, N.J., said it was awarded a $750,000 COVID-19 Project grant by the California Institute for Regenerative Medicine. The grant supports California institutions participating in the phase I/II trial of human placental hematopoietic stem cell-derived natural killer cells for treating adults with COVID-19. The University of California, Irvine is the first California site to open for patient enrollment. Celularity said it will evaluate the antiviral activities of its cryopreserved investigational product, CYNK-001, in underserved and disproportionately affected populations with COVID-19.
Fresh preclinical data from Cocrystal Pharma Inc., of Bothell, Wash., showed that 3C-like protease inhibitors block coronavirus replication in vitro and improve survival in MERS-CoV-infected mice. The optimized compounds were effective against several human coronaviruses, including MERS-CoV, SARS-CoV and SARS-CoV-2 in an enzyme assay and in cell-based assays using Huh-7 and Vero E6 cell lines. Two selected compounds showed antiviral effects against SARS-CoV-2 in cultured primary human airway epithelial cells. In a mouse model of MERS-CoV infection, administration one day after virus infection increased survival from 0% to 100% and reduced lung viral titers and lung histopathology.
Baselaunch, a biotech venture accelerator and incubator in Basel, Switzerland, said that CSL Behring, a unit of Melbourne, Australia-based CSL Ltd., became the fifth partner in its phase II round supporting early stage biopharma venture companies. CSL joined Roche Holding AG, BB Pureos Bioventures, Roivant Sciences Ltd. and Bridge Biotherapeutics Inc. to support the phase II program, designed to provide funding of up to $500,000 per venture.
Daiichi Sankyo Co. Ltd., of Tokyo, said it formed a clinical trial collaboration with Astrazeneca plc, of Cambridge, U.K., to evaluate the combination of patritumab deruxtecan (U3-1402), its HER3-directed DXd antibody-drug conjugate, and Tagrisso (osimertinib), an EGFR tyrosine kinase inhibitor, in EGFR-mutated advanced or metastatic non-small-cell lung cancer (NSCLC). Daiichi is set to sponsor and conduct the multicenter, open-label, two-part phase I study evaluating the combination as first- and second-line treatment.
New data from Gigagen Inc., of South San Francisco, highlighted a new class of polyclonal antibody drugs, recombinant hyperimmunes, comprising thousands to tens of thousands of antibodies, the company said. The antibodies are derived from donor B cells and are produced recombinantly at large scale in mammalian cells. For applications such as GIGA-2050 to treat COVID-19, the result is similar to recombinant convalescent serum, which combines the advantages of recombinant antibodies such as purity, consistency and potency, with the advantages of plasma-derived antibodies such as proven efficacy, diversity, polyvalence and in vivo affinity maturation. Gigagen demonstrated consistent production of the GIGA-2050 drug candidate, a mixture of 12,500 anti-coronavirus antibodies and showed greater IgG purity than reference plasma-derived drugs.
Gilead Sciences Inc., of Foster City, Calif., released a statement Aug. 6 disclosing the multiple steps it has taken since January to ramp up production and rapidly build supply of investigational COVID-19 treatment remdesivir – branded Veklury – as it prepares for global demand at risk, in recognition of the lengthy manufacturing timeline. In addition to process improvements that have shortened the manufacturing timeline to six months, Gilead said it has expanded its global network of both internal manufacturing sites and external organizations, including partnering with industry peers, to add manufacturing capacity around the world. The Veklury manufacturing network now includes more than 40 companies in North America, Europe and Asia. In addition, Gilead said it has entered voluntary licensing agreements with nine generics manufacturers to further expand supply of remdesivir to 127 countries. The company’s statement followed a letter signed last week by Republic and Democratic attorneys general from 31 states, two territories and the District of Columbia, asking the U.S. federal government to march in on patents for remdesivir, citing limited supplies and pricing. In separate news, Pfizer Inc., of New York, signed a multiyear agreement with Gilead to manufacture and supply Gilead’s remdesivir, as one of multiple external manufacturing organizations supporting efforts to scale up supply of the investigational treatment for COVID-19. Pfizer will provide contract manufacturing services at its Kansas facility. Terms were not disclosed.
Huya Bioscience International LLC, of San Diego, said it obtained exclusive licensed worldwide rights, outside of China, to the SHP2 inhibitor HBI-2376 from Suzhou Genhouse Pharmaceutical Co. Ltd., of Suzhou, China. SHP2 is a RAS signaling pathway component leading to activation of ERK/MAPK pathways in a variety of cancer cells. SHP2 interaction with PD-L1 inhibits T-cell activity in the tumor microenvironment.
Ibio Inc., of New York, said IBIO-201 demonstrated an ability to elicit anti-SARS-CoV-2 immune response in preclinical studies. Anti-SARS-CoV-2 spike titers to IBIO-201 were observed 21 days after immunization. Titers continued to increase over the 42-day study. Distinct, favorable Th1 and Th2 immune profiles were observed. Ten distinct preclinical study arms for the IBIO-201 antigen-adjuvant combinations have been concluded, including combinations delivered via intramuscular and intranasal routes, and datasets are under evaluation, the company said.
Immvira Group Co., of Shenzhen, China, and Shanghai Pharmaceuticals Holding Co. Ltd., of Shanghai, said they signed a clinical collaboration and exclusive license agreement for Immvira's MVR-T3011 intratumoral oncolytic virus program for the commercialization of novel immunotherapies to treat solid malignant tumors. As part of the agreement, Shanghai Pharma will receive an exclusive license and gain access to MVR-T3011 for clinical development, manufacturing and commercialization within certain fields of use in mainland China, Hong Kong, Macau and Taiwan. Immvira and Shanghai Pharma will collaborate on clinical trials in China with exclusive commercial rights for intratumoral therapies developed under the agreement assigned to Shanghai Pharma for the greater China region. Immvira retains full development and commercialization rights for regions outside of greater China.
IMV Inc., of Dartmouth, Nova Scotia, said Canadian government agencies agreed to contribute up to CA$4.75 million (US$3.58 million) to advance phase I development of its vaccine candidate, DPX-COVID-19, to prevent COVID-19 infection. The company is set to receive CA$4.15 million in advisory services and funding from the National Research Council of Canada industrial research assistance program (NRC IRAP), Atlantic Canada Opportunities Agency and Next Generation Manufacturing Canada to support rapid scale-up of the DPX-COVID-19 manufacturing process and its evaluation in a phase I trial. IMV also received CA$600,000 from the NRC IRAP innovation assistance program. The phase I trial in Canada is expected to begin in the third quarter, with a phase II trial expected to start in the U.S. and Canada by year-end 2020. DPX-COVID-19 is a peptide-based vaccine formulated with IMV’s DPX liposome delivery technology.
Innovation Pharmaceuticals Inc., of Wakefield, Mass., said an experiment in a human lung epithelial cell line with the live (or wild-type) virus showed that brilacidin, a polymer-based antibiotic, inhibited SARS-CoV-2 when administered post-infection. The results complement earlier experiments in the same lung cell line that showed brilacidin, when directly incubated with the live virus, exhibited potent inhibition, the company said.
Merck & Co. Inc., of Kenilworth, N.J., and Hanmi Pharmaceutical Co. Ltd., of Seoul, South Korea, said they forged an exclusive licensing agreement to develop, manufacture and commercialize efinopegdutide (formerly HM-12525A), Hanmi’s once-weekly glucagon-like peptide-1/glucagon receptor dual agonist, to treat nonalcoholic steatohepatitis. Merck received an exclusive license to develop, manufacture and commercialize efinopegdutide in the U.S. and globally in return for an up-front payment of $10 million to Hanmi, which also is eligible for up to $860 million in development, regulatory and commercialization milestone payments and double-digit royalties. Hanmi retained an option to commercialize efinopegdutide in Korea. Rights to the candidate, previously in development to treat severely obese individuals with and without diabetes, were returned to Hanmi in 2019 by Janssen Pharmaceutical NV, a unit of Johnson & Johnson, of New Brunswick, N.J.
To guarantee early access to a COVID-19 vaccine, the Swiss government said it concluded an agreement for 4.5 million doses of Cambridge, Mass.-based Moderna Inc.’s mRNA-1273 vaccine. The government also said it is in talks with other vaccine companies. If two doses per person are needed, the amount would vaccinate 2.25 million people. Moderna dosed the first of what could be as many as 30,000 healthy volunteers on July 27 as it began its phase III COVID-19 vaccine trial.
Partnering with Monopar Therapeutics Inc., of Wilmette, Ill., and Northstar Medical Radioisotopes LLC, of Beloit, Wis., Isotherapeutics Group LLC, of Arlington, Texas, will develop and manufacture a radio-immuno-therapeutic (RIT) for treating severe COVID-19. Isotherapeutics will modify Monopar’s urokinase plasminogen activator receptor (uPAR)-targeted antibody, MNPR-101, by making conjugates allowing attachment of therapeutic radioisotopes supplied by Northstar to create a platform of uPAR-targeted RIT candidates to be evaluated as treatments for severe COVID-19. Isotherapeutics plans to advance a clinical candidate identified from the platform through GMP manufacturing for Monopar and Northstar to take into first-in-human trials.
Novavax Inc., of Gaithersburg, Md., and Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, agreed to develop, manufacture and commercialize NVX-CoV2373, a COVID-19 vaccine candidate, in Japan. NVX‑CoV2373 is a stable, prefusion protein made using Novavax’s recombinant protein nanoparticle technology and includes Novavax’s Matrix‑M adjuvant. Takeda will receive funding from Japan’s Ministry of Health, Labor and Welfare to support the technology transfer, infrastructure establishment and manufacturing scale-up. Takeda anticipates the capacity to manufacture more than 250 million doses of the vaccine annually. Novavax also entered a license agreement with Serum Institute of India Private Ltd. to develop and commercialize NVX‑CoV2373 in low- and middle-income countries and India. The agreement excludes major upper-middle and high-income countries, for which Novavax continues to retain rights. Serum, of Puna, India, will be responsible for regulatory submissions and marketing authorizations while Novavax will provide the antigen and adjuvant. The two will split the revenue.
Novocellbio Co. Ltd., of Incheon, South Korea, said the autologous NK cell treatment agent NOVO-NK killed the human-derived COVID-19 coronavirus. Monkey kidney cells (VeroE6 cells) infected with the COVID-19 coronavirus (SARS-CoV-2) were treated with NOVO-NK cell and the therapy agent was successful in decreasing COVID-19’s effects in various controlled time periods, and the COVID-19 coronavirus was almost killed within six hours, the company said. NOVO-NK also increases a patient’s immunity, reducing the risk of reinfection arising from viruses’ or cancer cells’ mutation, the company added.
Partner Therapeutics Inc., of Lexington, Mass., said it inked a $35 million milestone-based other transaction agreement (OTA) with the U.S. Department of Defense to fund two studies of inhaled Leukine (sargramostim, rhu-granulocyte macrophage-colony stimulating factor) in people with COVID-19-associated acute hypoxemia. The firm fixed price agreement with the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense will fund the phase II studies to evaluate the effect of Leukine in improving outcomes, including oxygenation and percent of patients intubated. The first study, conducted under a U.S. IND application, is expected to begin in August, supplementing data from more than 60 participants who completed treatment in the ongoing SARPAC (sargramostim in patients with acute hypoxic respiratory failure due to COVID-19) trial at five hospitals in Belgium. Funding from the OTA also will support regulatory filings and expansion of production capacity to meet increased demand.
Recce Pharmaceuticals Ltd., of Sydney, reported activity against Helicobacter pylori bacteria in rats treated with its broad-spectrum synthetic polymer antibiotic candidate, RECCE-435. Five groups of 10 rats each were observed. In the three groups treated with the study drug (250 mg/kg, 500 mg/kg and 1,000 mg/kg), dose-dependent efficacy was seen at all doses, with significant reduction in bacterial load. No signs of toxicity were observed at any dosage. In an additional independent safety study, RECCE-435 doses of up to 500 mg/kg were administered to groups of five mice each twice daily for seven days vs. water, and data indicated their feeding habits were not affected by the drug.
Sab Biotherapeutics Inc., of Sioux Falls, S.D., said it was awarded an additional $35.6 million in expanded scope for its Diversitab Rapid Response Antibody Program contract with the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense Joint Project Lead for Chemical, Biological, Radiological and Nuclear Defense Enabling Biotechnologies. With this follow-on award, Sab has three awards totaling $72 million for its rapid response capability and development of its COVID-19 therapeutic candidate, SAB-185, since March 2020.
Som Biotech SL, of Barcelona, Spain, said it received €340,000 (US$403,741) from the Center for Industrial Technological Development to initiate clinical trials for developing an eravacycline-based drug to treat SARS-CoV-2. Eravacycline is an antibiotic, from the tetracycline family, that inhibits the main protease of SARS-CoV-2 and the replication of the virus. The company said eravacycline is the most promising of the three drug candidates it has validated in vitro as new therapies for treating COVID-19 in collaboration with the Department of Pharmacy and Pharmaceutical Sciences at Ewha University Womans University in South Korea. The clinical trial is planned to begin in the second half of 2020 in the U.S. and Europe.
Sonnet Biotherapeutics Holdings Inc., of Princeton, N.J., said it executed a letter of intent with New Life Therapeutics Pte. Ltd., of Singapore, to negotiate a license agreement for its SON-081 and SON-080 assets, both low-dose formulations of interleukin-6, to treat diabetic peripheral neuropathy (DPN) and chemotherapy-induced peripheral neuropathy (CIPN). The licensed territory is expected to include the ASEAN countries of Singapore, Malaysia, Indonesia, Thailand, the Philippines, Cambodia, Brunei, Vietnam, Myanmar and Laos. Sonnet received a $500,000 nonrefundable payment from New Life, with the letter of intent outlining an agreement that could provide Sonnet with up to $40 million in milestone payments and a 30% royalty on commercial sales. Upon execution of a definitive agreement, still to be negotiated, New Life will assume responsibility for a phase Ib/IIa pilot scale efficacy study with SON-081 in DPN, expected to initiate during the first half of 2021. Sonnet will conduct a pilot scale efficacy study with SON-080 in CIPN, also expected to begin during the first half of 2021.
Therapeutics Solutions International Inc., of Oceanside, Calif., said preclinical data suggested memory-protective effects related to Quadramune were seen in an animal model of inflammation-associated memory loss. Animals were treated with Quadramune for three days and exposed to lipopolysaccharide as an inflammatory stimulus before the animals were assessed for their ability to remember a submerged platform. Lipopolysaccharide administration resulted in approximately 57% reduction in memory, but animals that received Quadramune had restoration of memory activity. The study also showed that Quadramune reduced the presence of cytokine-related inflammation in the brain. Quadramune is a dietary supplement comprising green tea extract, pterostilbene, nigella sativa and sulforaphane that the company is assessing preclinically in combination with metformin to treat COVID-19-associated lung damage.
Tiziana Life Sciences plc, of London, said it signed agreements with four CROs to expedite development of TZLS-501, its fully human anti-interleukin-6 receptor monoclonal antibody designed to treat COVID-19. The company plans to initiate a study of the candidate, delivered as an aerosol to the lungs using a handheld nebulizer, in the first quarter of 2021, working with FHI Clinical Inc., of Durham, N.C.; STC Biologics Inc., of Newton, Mass.; Sciarra Laboratories Inc., of Hicksville, N.Y.; and ITR Laboratories Canada Inc., of Montreal.
Verrica Pharmaceuticals Inc., of West Chester, Pa., said it signed an option agreement with Torii Pharmaceutical Co. Ltd., of Tokyo, covering an exclusive license to develop and commercialize in Japan Verrica’s candidates, including VP-102 (cantharidin), to treat molluscum contagiosum and common warts. Torii agreed to pay $500,000 to secure the exclusive option, which it may exercise until the latter of six months following the effective date of the agreement or 10 business days after Verrica provides notification of FDA acceptance of its resubmission of the NDA for VP-102, a protein phosphatase 2A inhibitor. The license agreement, if exercised, calls for Torii to make an up-front payment of $11.5 million, up to $58 million in additional development, regulatory and sales milestone payments and tiered transfer price payments for product supply ranging from mid-30 to mid-40 percentage points of net sales. Torii assumed responsibility for development and regulatory activities in Japan. In July 2020, the FDA issued a complete response letter for VP-102, citing additional information regarding the chemistry, manufacturing and controls process for the drug/device combination product and human factors validation information.
Vistagen Therapeutics Inc., of South San Francisco, received the $5 million up-front license payment from Everinsight Therapeutics Inc., of Shanghai, as part of their licensing and collaboration agreement for the clinical development and commercialization of PH-94B.
Vyripharm International Inc., a subsidiary of Vyripharm Enterprises LLC, of Houston, said it executed a memorandum of understanding with National Yang-Ming University, of Taipei, Taiwan, to assess the biodistribution and targeting profile of its cannabinoid CB1 receptor antagonist, VYR-206, for the diagnosis and treatment monitoring of neurological disorders. Details of the agreement and financial terms were not disclosed.
Xortx Therapeutics Inc., of Calgary, Alberta, and the Icahn School of Medicine at Mount Sinai, New York are partnering to study the incidence of acute kidney injury and hyperuricemia in nearly 4,000 patients hospitalized with COVID-19.