Altimmune Inc., of Gaithersburg, Md., signed an agreement with Vigene Biosciences Inc., of Rockville, Md., to manufacture AdCOVID, Altimmune’s single-dose intranasal vaccine candidate for COVID-19. Vigene, a contract development and manufacturing organization, specializes in viral vectors. Following recent positive preclinical data, Altimmune plans to start a phase I trial with the candidate in the fourth quarter of this year.
Amag Pharmaceuticals Inc., of Waltham, Mass., signed an exclusive licensing agreement with Norgine BV, of Amsterdam, to develop and commercialize ciraparantag in Europe, Australia and New Zealand. Ciraparantag is in development for use in patients treated with direct oral anticoagulants and low-molecular-weight heparin when reversal of the anticoagulant effect of those products is needed for emergency surgery, urgent procedures or due to life-threatening or uncontrolled bleeding. The deal brings a $30 million up-front payment to Amag with the potential for $260 million if development and commercial milestones are reached, plus royalties.
Ampio Pharmaceuticals Inc., of Englewood, Colo., disclosed the publication of a paper in Clinica Chimica Acta, titled "Insights into pediatric multi-system inflammatory syndrome and COVID-19." The newly described syndrome in children resembles Kawasaki disease and exhibits signs, symptoms and pathology that could be treated by intravenous Ampion, either alone or in combination with intravenous immunoglobulins, the company said. Ampio continues to evaluate the potential use of Ampion in that condition as a safe, effective and alternative/addition to existing therapies, the company said. Ampion is a low-molecular-weight fraction of human serum albumin being developed for the treatment of pain due to osteoarthritis of the knee.
Amyris Inc.. of Emeryville, Calif., and the Infectious Disease Research Institute (IDRI) signed a binding term sheet for a planned COVID-19 RNA (ribonucleic acid) vaccine technology program. The program combines IDRI's expertise against infectious diseases with Amyris' fermentation platform technology, with the goal to create semisynthetic squalene-based adjuvants at scale. IDRI's RNA vaccine platform is expected to offer significant differentiated advantages over other RNA vaccines currently in development and will be further enhanced by a scalable Amyris adjuvant, the company said.
Arcturus Therapeutics Holdings Inc., of San Diego, said it entered a binding term sheet with the Israeli Ministry of Health to supply its COVID-19 vaccine candidate, LUNAR-COV19. A plan to finalize a supply agreement is expected within 30 days. Delivery to Israel of doses of the vaccine candidate is contingent upon achievement of near-term clinical and regulatory milestones and other conditions to be set forth in the definitive supply agreement. The government of Israel will be responsible for distributing the vaccine to its citizens subject to approval by the country’s Ministry of Health.
Astellas Pharma Inc., of Tokyo, was awarded a grant from the U.S. NIH to help fund two phase I studies to evaluate the safety and efficacy of ASP-8062, an oral small-molecule GABA B receptor-positive allosteric modulator as an add-on maintenance therapy for opioid use disorder. Astellas has continued research and development to explore new therapeutic possibilities for the opioid crisis and submitted the grant application based on supportive preclinical studies utilizing ASP-8062 in various models of substances of abuse, such as the self-administration reduction effect of opioids by ASP-8062. Those data are highly consistent with other scientific literature, Astellas said
Bavarian Nordic A/S, of Copenhagen, signed an agreement with Adaptvac, of Horsholm, Denmark, a joint venture established by ExpreS2ion Biotechnologies and Nextgen Vaccines, spun out of the University of Copenhagen, to license Adaptvac’s capsid virus-like particle technology for coronaviruses, including the COVID-19 indication. The parties signed a heads of agreement in May and have now concluded a license agreement that provides Bavarian Nordic the global commercialization rights to the COVID-19 vaccine. Under the terms, Bavarian Nordic will make an up-front payment of €4 million (US$4.6 million) to Adaptvac, in addition to payments related to potential future development and sales milestones and tiered royalties.
Bostongene Corp., of Waltham, Mass., and NEC Corp., of Tokyo, signed a collaboration to conduct cancer patient analysis under NEC's clinical trials. The collaboration brings together NEC's artificial intelligence-driven approach to cancer immunotherapy with Bostongene's analytical tools. The latter will perform tumor molecular profiling and microenvironment analysis for cancer patients identified in trials by NEC and or NEC affiliates across cancer types and disease stages.
Brainstorm Cell Therapeutics Inc., of New York, achieved its first milestone in developing an innovative exosome-based platform technology for the treatment of severe COVID-19 infection. Results from a study in a mouse model of lipopolysaccharide (LPS)-induced ARDS showed that intratracheal administration of Nurown-derived exosomes resulted in a statistically significant improvement in multiple lung parameters. Those included the clinically relevant factors of functional lung recovery, reduction in pro-inflammatory cytokines and attenuation of lung damage, Brainstorm said.
Cel-Sci Corp., of Vienna, Va., said it completed animal experiments using its LEAPS COVID-19 conjugate, which provides the basis for moving forward into animal challenge studies with live virus SARS-CoV-2 that will look to repeat the success of the animal challenge studies. The conjugates induced faster and much higher-than-expected antibody responses against a non-mutating region of the virus that causes COVID-19, after one injection. The company’s peptide technology can be used to construct immunotherapeutic peptides that exhibit both antiviral and anti-inflammatory properties at the same time.
Chugai Pharmaceutical Co. Ltd., of Tokyo, and Biofourmis Inc., a Boston-based digital therapeutics company, said they partnered to develop a digital solution for the objective assessment of pain associated with endometriosis.
Clarity Pharmaceuticals Ltd., of Sydney, and Imaginab Inc., of Los Angeles, signed a collaboration to develop new targeted theranostic products for a broad range of cancer types. Imaginab designs and engineers small, highly targeted proteins known as minibodies and cys-dibodies coupled with radioisotopes to image molecular targets using standard positron emission tomography. The pair will combine technologies to develop radiopharmaceutical products using Clarity's copper chelators to fully exploit the benefits of the theranostic pairing of copper-64 or copper-67.
Covaxx, a unit of United Biomedical Inc., of New York, said it is developing a multitope peptide-based vaccine against SARS-CoV-2 and will enter human trials next month. The vaccine comprises amino acid sequences of the SARS-CoV-2 receptor binding domain (RBD) further formulated with designer Th and CTL epitope peptides derived from the S2 subunit, membrane and nucleoprotein regions of SARS-CoV-2 structural proteins for induction of memory recall, T-cell activation and effector functions against SARS-CoV-2. Preclinical data have demonstrated exceptionally high immunogenicity and neutralizing titers against live virus as compared to published data from other vaccine candidates to date, the company said. In guinea pigs, the Covaxx vaccine generated anti-RBD titers of greater than 1 million as measured by ELISA, and neutralizing titers exceeding 8,120 (100% neutralization in cytopathic effect) assays. Those titers are about 400 times higher than those seen in patients’ convalescent plasma.
Daiichi Sankyo Co. Ltd., of Tokyo, and French institute Gustave Roussy entered a multiyear, multistudy research collaboration to further enable development of DS-1062 and patritumab deruxtecan (U3-1402), two of Daiichi Sankyo’s lead DXd antibody-drug conjugates (ADCs), in lung and breast cancer. The collaboration will focus on clinical and translational research, including potential combination strategies for DS-1062, a TROP2-directed DXd ADC, in patients with advanced non-small-cell lung cancer, and for patritumab deruxtecan, a HER3-directed DXd ADC, in patients with metastatic breast cancer. Daiichi Sankyo will provide funding and support.
Dynavax Technologies Corp., of Emeryville, Calif., and Medigen Vaccine Biologics Corp., of Taipei, Taiwan, plan to develop an adjuvanted vaccine candidate to protect against COVID-19. The collaboration is evaluating the combination of Medigen’s stable prefusion form of the SARS-CoV2 recombinant spike protein with Dynavax’s adjuvant, CpG 1018, which is in Dynavax’s FDA-approved adult hepatitis B vaccine. Preclinical studies demonstrated the vaccine candidate adjuvanted with CpG 1018 generated strong immune responses in animals, the companies said.
Emergent Biosolutions Inc., of Gaithersburg, Md., agreed to provide contract development and manufacturing services for large-scale commercial drug substance manufacturing for Cambridge, U.K.-based Astrazeneca plc’s COVID-19 vaccine candidate, AZD-1222. The deal is valued at about $174 million through 2021 and follows an $87 million contract in June for development services, performance and process qualification, raw materials and an initial capacity reservation. The adenovirus vector-based vaccine candidate was co-invented by the University of Oxford and its spinout company, Vaccitech, and licensed by Astrazeneca.
Evotec SE, of Hamburg, Germany, said the U.S. Department of Defense awarded its Seattle-based subsidiary, Just-Evotec Biologics Inc., a contract valued up to $18.2 million to develop and manufacture monoclonal antibodies for treatment and/or prevention of COVID-19. Just-Evotec Biologics will design a manufacturing process for the production of clinical supplies of two monoclonal antibodies directed against SARS-CoV-2 antigens.
Fibrogenesis Inc., of Houston, disclosed data supporting use of its Pneumoblast cell therapy product in treating COVID-19. Using the widely accepted bleomycin model of lung scarring, company scientists demonstrated the administration and use of Pneumoblast induced a 51% reduction of lung fibrosis, which was statistically significant (p<0.005). When compared head to head with bone marrow-derived mesenchymal stem cells (BMSCs) for COVID-19, Pneumoblast was 221% more effective. In producing anti-inflammatory protein interleukin 1 receptor antagonist, which is believed to be the mechanism of scar tissue prevention by BMSC therapies currently in development, Pneumoblast was 192% more effective than BMSCs (p<0.005).
G1 Therapeutics Inc., of Research Triangle Park, N.C., created a license agreement for lerociclib with Eqrx Inc., of Cambridge, Mass., which gains exclusive rights for lerociclib in the U.S., Europe, Japan and all other global markets, excluding the Asia Pacific region, except Japan. G1 will receive $20 million cash up front and could receive development and commercial milestone payments of up to $290 million, plus tiered royalties ranging from mid-single digits to midteens based on annual net sales of lerociclib, a differentiated oral CDK4/6 inhibitor being developed for use in combination with other targeted therapies in certain breast and lung cancers.
Hansoh Pharmaceutical Group Co. Ltd., of Shanghai, signed a collaboration and licensing agreement with Eqrx Inc., of Cambridge, Mass., for almonertinib, a third-generation EGFR inhibitor. Eqrx is taking on the development and commercialization of almonertinib in the U.S., Europe, Japan and all other global markets outside of greater China, as Hansoh continues work in greater China. The pair will jointly conduct global studies with the compound as a monotherapy and in combination settings. Under the terms, Hansoh collects $100 million in an up-front payment as well milestones if development and regulatory targets are hit. More money is possible as commercial goals are achieved, plus royalties.
Humanetics Corp., of Minneapolis, said it received funding from the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, to conduct a study of BIO-300 in COVID-19 patients. The study will focus on patients treated for severe COVID-19 disease, many of whom were discharged from the hospital. The patients risk progressive complications that could lead to long-term impairment of lung function. BIO-300 is being developed by Humanetics as a medical countermeasure to protect the body from harm caused by ionizing radiation.
Immuron Ltd., of Melbourne, Australia, said IMM-124E, used to manufacture the company’s over-the-counter gastrointestinal and digestive health immune supplements Travelan and Protectyn, demonstrated neutralizing activity against SARS-CoV-2, the virus that causes COVID-19. All four production lots produced mean EC50 values of 40.5 to 91.9 ug/mL and inhibited viral replication at concentrations in which there was no observed cell toxicity. The concentration of IMM-124E at which virus replication was inhibited by 90% (EC90) produced mean EC90 values ranging from 48.7 to 155.4 ug/mL for all four lots tested again at concentrations at which there was no observed cell toxicity. A commercially available high protein milk powder product was used as a placebo in the studies and produced EC50 values greater than the observed cellular cytotoxicity concentration of >4,800 ug/mL.
Inflarx NV, of Jena, Germany, said, subject to regulatory approval, it plans to continue development of IFX-1, its monoclonal anti-human complement factor C5a antibody, for use in patients with severe COVID-19-induced pneumonia, with the start of a phase III study.
Irbm SpA, of Rome, will collaborate with MSD, known as Merck & Co. Inc., of Kenilworth, N.J., in the U.S., to identify and develop peptide therapeutics active against different strains of coronavirus, including SARS-CoV-2. No financial terms were released. Irbm, which will leverage its previous SARS research in the collaboration, is a contract research organization.
Kaleido Biosciences Inc., of Lexington, Mass., said it initiated a controlled clinical study with Massachusetts General Hospital to evaluate Microbiome Metabolic Therapy (MMT) candidate KB-109 added to supportive self-care (SSC) for outpatients with mild to moderate COVID-19. It is the second clinical study Kaleido has initiated in that patient population. The non-IND study aims to include about 50 COVID-19-positive outpatients to be randomized 1-to-1 to either receive SSC (the control group) or SSC plus KB-109 for two weeks and then followed for three weeks. Patients will be evaluated for safety, physiologic effects, and gut microbiota structure and function. MMTs are designed to modulate the metabolic output and profile of the microbiome by driving the function and distribution of the gut’s existing microbes.
Lynk Pharmaceuticals, of Hangzhou, China, signed exclusive licensing agreements with Kobe University in Japan and with Riken Research Institute in Saitama, Japan, to develop RAS inhibitors with a novel mechanism of action. The agreement with Kobe also includes a joint collaboration which will continue to provide screening and structural support. Using the two parties’ early structural biology and screening outcome, Lynk will deploy its medicinal chemistry and drug design to target a broader range of undruggable RAS onco-drivers, the company said. and ultimately develop the compounds for clinical use.
Medicinova Inc., of La Jolla, Calif., and the Jasdaq Market of the Tokyo Stock Exchange disclosed an agreement with Biocomo Inc., of Mie, Japan, and Mie University for joint development of a COVID-19 vaccine using BC-PIV, a human parainfluenza virus type 2 vector developed by Biocomo and the university. Medicinova has been granted exclusive worldwide rights to use the vector for COVID-19 vaccine development. Terms were not disclosed.
A prospective study found potential utility of Haifa, Israel-based Memed Ltd.'s host immune technology for treating severe COVID-19. Initial data from the prospective study showed continuous and rapid measurements of IP-10, a biomarker associated with inflammatory disease including infectious diseases and immune dysfunction, can be a resource for predicting disease severity and progression, monitoring inflammatory status and personalizing treatment strategies for patients with severe COVID-19, Memed said.
Novavax Inc., of Gaithersburg, Md., entered a deal with Fujifilm Diosynth Biotechnologies (FDB), a contract development and manufacturing organization formed via the partnership of Fujifilm Holdings Corp., of Tokyo, and Mitsubishi Corp., also of Tokyo. The deal involves the manufacture of bulk drug substance for NVX-CoV2373, Novavax’s COVID-19 vaccine candidate. FDB’s site in Morrisville, N.C., has begun production of the first batch of NVX-CoV2373. The arrangement falls under Novavax’s $1.6 billion award from the federal government as part of Operation Warp Speed. Novavax is using the money to complete a pivotal phase III trial and hopes to deliver 100 million doses of NVX‑CoV2373 starting as early this year.
Noxopharm Ltd., of Sydney, reported preclinical data from two independent research groups confirming that idronoxil, the active ingredient in the company’s immuno-oncology drug candidate, and sphingosine-1-phosphate inhibitor, Veyonda, activate cancer-fighting immune cells and then enable their entry into microtumors. Noxopharm said other preclinical and clinical data, together with the new research data, leads the company to believe it is close to claiming the first drug capable of converting tumors from cold to hot across multiple cancer types in a well-tolerated way.
Onconova Therapeutics Inc., of Newtown, Pa., submitted an application for NIH funding to conduct human studies with rigosertib in COVID-19 disease patients. Recent preclinical studies conducted with rigosertib have shown inhibition of the virus’ replication in Vero cells when compared to controls, including agents currently being administered and studied in COVID-19 infection. Cancer-focused Onconova said it does not intend to pursue clinical development in the virus without additional, nondilutive funding.
Oragenics Inc., of Tampa, Fla., said the U.S. NIH-created stabilized pre-fusion spike protein (CoV-2 S-2P) licensed by the company has generated neutralizing antibodies in mice during immunization against SARS-CoV-2, the virus that causes COVID-19. The study shows that the spike protein, adjuvanted with the TLR4-agonist Sigma Adjuvant System (a TLR4 agonist that induces T-cell activation), generates neutralizing antibody titers in both a pseudovirus neutralization assay and a plaque reduction neutralization titer assay. Immunization also produced a balanced Th1/Th2 response. Results are reported BioRxiv.
PDS Biotechnology Corp., of Florham Park, N.J., said its COVID-19 vaccine candidate, Versamune-CoV-2 (PDS-0203), appeared to induce "highly active and potent virus-specific CD8 killer and CD4 helper T-cells within 14 days of treatment" in a preclinical study. The candidate pairs the company's T-cell activating Versamune platform with a recombinant protein recognized by the human immune system that is derived from SARS-CoV-2. Preclinical work continues on PDS-0204, a COVID-19 vaccine candidate that combines Versamune with a recombinant fusion protein of SARS-CoV-2 developed by Ribeirão Preto, Brazil-based Farmacore Biotecnologia Limitada.
Pfizer Inc., of New York, and Biontech SE, of Mainz, Germany, agreed with the U.K. to supply 30 million doses of the BNT-162 mRNA-based vaccine candidate against SARS-CoV-2, which is in development, subject to clinical success and regulatory approval. Financial details were not disclosed, but terms were based on delivery timing of delivery dosage volumes. The BNT-162 program is based on Biontech’s mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities.
Researchers from Singapore-MIT Alliance for Research and Technology, MIT's research enterprise in Singapore, said they've found "a practical way to induce a strong and broad immunity to the dengue virus based on proof-of-concept studies in mice." The study is reported in a paper published in NPJ Vaccines. Investigators will aim to test the sequential immunization in humans in the near future, they said.
Sorrento Therapeutics Inc., of San Diego and Boston, said it signed a letter of intent to acquire Smartpharm Therapeutics Inc., a gene-encoded therapeutics company developing nonviral DNA and RNA gene delivery platforms for COVID-19 and rare diseases, with potential application in enhancing antibody-centric therapeutics, including those against COVID-19. The transaction is expected to close in August. Financial terms were not disclosed. Sorrento and Smartpharm, of Cambridge, Mass., have been in an R&D collaboration to encode and express in vivo Sorrento's SARS-CoV-2 neutralizing monoclonal antibodies using Smartpharm's plasmid nanoparticle platform.
Therapeutics Solutions International Inc., of Oceanside, Calif., said it has discovered the combination of Quadramune, a nutritional supplement, and diabetes drug metformin could potentially treat COVID-19-associated lung damage in preclinical models. At a mechanistic levels, it was shown that metformin increased the ability of Quadramune to increase the number of M2 macrophages, augment production of anti-inflammatory and regenerative proteins and suppress production of pathological inflammatory proteins. The company said it is preparing to conduct a 500-person study to test the protection from COVID-19 in those at high risk of infection.
The U.K. government increased its COVID-19 investment by £100 million (US$127.45 million) to fund a cell and gene therapy catapult manufacturing innovation center to accelerate mass production of a COVID-19 vaccine. The Braintree, U.K., center will open in December 2021 with capacity to produce millions of doses each month. The initiative upgrades an existing facility, complementing the Vaccines Manufacturing and Innovation Centre under construction in Oxfordshire, U.K.
Valneva SE, of Saint-Herblain, France, confirmed its participation in the U.K. government’s COVID-19 vaccine response program. Valneva said it reached agreement in principle with the U.K. government to provide up to 100 million doses of its SARS-CoV-2 vaccine candidate, manufactured at its facilities in Livingston, Scotland. The U.K. government is expected to contribute to U.K. study costs and is negotiating funding to expand Valneva’s Scottish facility. As part of its broader COVID-19 response, Valneva plans to increase its investment in the Livingston manufacturing facility and in its facility in Solna, Sweden.