Pharma COVID Roundup: News from Moderna, Sanofi, and GSKBy
The latest on manufacturing and potential treatments for COVID-19 with news from Moderna, Sanofi, GSK, Abbott, Roche, Gilead, Novartis, Daiichi Sankyo, and others.
Moderna in Talks to Supply Japan with 40 M Doses of COVID-19 Vaccine
Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, is engaged in discussions with the Ministry of Health, Labour and Welfare of Japan for the Japanese government to potentially purchase 40 million or more doses of the company’s vaccine candidate against COVID-19, mRNA-1273.
Under the agreement, the vaccine would be supplied by Moderna and distributed in Japan by Takeda beginning in the first half of 2021 if the vaccine receives regulatory approval.
Sanofi, Regeneron End Development of Arthritis Drug Kevzara for COVID-19
Sanofi and Regeneron Pharmaceuticals, a Tarrytown, New York biopharmaceutical company, have decided to stop further clinical development of Kevzara (sarilumab), a drug for treating moderately to severely active rheumatoid arthritis, for treating COVID-19 following disappointing Phase III results.
Sanofi reported that a Phase III trial that evaluated Kevzara in severely or critically ill patients hospitalized with COVID-19 did not meet its primary endpoint and key secondary endpoint when Kevzara was compared to placebo added to usual hospital care.
The 420-patient randomized trial was conducted outside the US in Argentina, Brazil, Canada, Chile, France, Germany, Israel, Italy, Japan, Russia, and Spain (86 in a placebo arm, 161 in a 200-mg dose arm, and 173 in a 400-mg dose arm).
Serious adverse events were experienced by 26-29% of Kevzara patients and 24% of placebo patients. The incidence of adverse events leading to death was approximately 10% in all three treatment arms. Serious infections (including COVID-19 pneumonia) were observed in 11-13% of Kevzara patients and 12% of placebo patients.
Sanofi, GSK Initiate Phase I/II Trial of COVID-19 Vaccine
Sanofi and GlaxoSmithKline (GSK) have started a Phase I/II clinical trial for their adjuvanted COVID-19 vaccine. The vaccine candidate, developed in partnership by Sanofi and GSK, uses the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines with GSK’s pandemic adjuvant technology.
A total of 440 healthy adults are being enrolled in the trial across 11 investigational sites in the US. The companies say they anticipate first results in early December 2020, which will support the initiation of a Phase III trial in December 2020. If data are sufficient for a licensure application, the plan is to request regulatory approval in the first half of 2021.
Sanofi is leading the clinical development and registration of the COVID-19 vaccine. Preclinical results will be published later this year (as reported on September 3, 2020). In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant with the target of producing up to one billion doses of the vaccine in 2021.
In July 2020, Sanofi and GSK announced a collaborative effort with the US government to supply up to 100 million doses of vaccine for Operation Warp Speed, a US government initiative for accelerating the development of vaccines and treatments against COVID-19. The US government has a further option to discuss the purchase of up to 500 million doses longer term. Both companies also agreed (subject to final contract) with the UK government to supply up to 60 million doses of the vaccine.
The companies say they plan to supply a portion of total global available supply in 2021/2022 to COVAX, the vaccines pillar of the ACT-Accelerator (Access to COVID‐19 Tools), a global collaboration of leaders of governments, global health organizations, businesses, and philanthropies to accelerate development, production, and equitable access to COVID-19 tests, treatments, and vaccines.
GSK, Vir Biotechnology Start Phase II/III Study of COVID-19 Drug
GlaxoSmithKline (GSK) and Vir Biotechnology, a San Francisco-based clinical-stage biopharmaceutical company, have dosed the first patient in a Phase II/III study for the companies’ monoclonal antibody (VIR-7831, also known as GSK4182136) for the early treatment of COVID-19 in patients who are at high risk of hospitalization.
The companies formed a collaboration earlier this year (April 2020), which included a $250-million equity investment in Vir by GSK, to research and develop treatments for COVID-19.
The aim of the study, which will enroll approximately 1,300 patients globally who have early symptomatic infection, is to assess whether VIR-7831, as a single-dose monoclonal antibody, can prevent hospitalization due to COVID-19. Initial results may be available before the end of 2020 (as reported on August 31, 2020), with complete results expected in the first quarter of 2021, and potentially early access to the antibody treatment as soon as the first half of 2021.
The clinical development program for VIR-7831 also includes two additional planned trials: one for the treatment of severely ill hospitalized patients and another for the prophylaxis of symptomatic infection. Later this year, the companies expect to start a Phase II trial of their other investigational SARS-CoV-2 neutralizing antibody, VIR-7832, which shares the same characteristics as VIR-7831 but may in addition also function as a therapeutic and/or prophylactic T-cell vaccine.
Abbott’s Rapid COVID-19 Test Gets FDA Emergency Use Authorization
Abbott has been issued emergency use authorization (EUA) by the US Food and Drug Administration (FDA) for its rapid test to detect COVID-19.
The BinaxNOW COVID-19 Ag Card test can be used to identify people who are currently infected and who should isolate themselves to help prevent the spread of the disease. It is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2, the virus that causes COVID-19, in nasal swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. The test is portable (about the size of a credit card) and provides results in 15 minutes to identify infection. Abbott says it will sell this test for $5.
Abbott says it will ship tens of millions of tests in September (September 2020) and ramp up to 50 million tests a month at the beginning of October (October 2020). The company has invested in two new US facilities to manufacture the test at massive scale.
The test is for use by healthcare professionals and can be used in point-of-care settings that are qualified to have the test performed and are operating under a CLIA (clinical laboratory improvement amendments) certificate of waiver, certificate of compliance, or certificate of accreditation. Within these settings, the test can be performed by doctors, nurses, school nurses, medical assistants and technicians, pharmacists, employer occupational health specialists, and more with minimal training and a patient prescription.
Abbott will also launch a complementary mobile app, for iPhone and Android devices, to allow people who test negative to display a temporary digital health pass that is renewed each time a person is tested through their healthcare provider together with the date of the test result. Organizations will be able to view and verify the information on a mobile device to facilitate entry into facilities along with hand-washing, social distancing, enhanced cleaning and mask-wearing.
Roche To Launch SARS-CoV-2 Rapid Test in Europe; Plans FDA Filing
Roche plans to launch a SARS-CoV-2 Rapid Antigen Test, in late September (September 2020), for markets accepting the CE Mark, which is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area. Roche says it also intends to file for emergency use authorization (EUA) to the US Food and Drug Administration (FDA).
The test is for use in point-of-care settings for both symptomatic and asymptomatic people to identify infection of SARS-CoV-2, the virus that causes COVID-19, in people suspected to carry the virus with results typically ready in 15 minutes. In addition, it serves as an initial screening test for individuals that have been exposed to SARS-CoV-2 infected patients or a high-risk environment. At launch, Roche says there will be 40 million SARS-CoV-2 Rapid Tests available, per month. Roche says capacity will increase more than two-fold at the end of this year (2020).
The launch is a partnership with SD Biosensor, a global bio-diagnostic company, with whom Roche has a global distribution agreement and had also launched a rapid antibody test in July (July 2020).
The test is the tenth addition to Roche’s diagnostic portfolio for COVID-19, which includes molecular, serology and digital tests and systems to diagnose and manage COVID-19.
FDA Expands Emergency Use Authorization for Gilead’s COVID-19 Drug Remdesivir
The US Food and Drug Administration (FDA) has expanded emergency use authorization (EUA) for Gilead Sciences’ investigational COVID-19 treatment, Veklury (remdesivir), to include hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease.
In May (May 2020), the FDA had provided EUA for remdesivir for the treatment of hospitalized adult and pediatric patients with severe COVID-19.
Multiple ongoing international Phase III clinical trials are evaluating the safety and efficacy of Veklury for treating SARS-CoV-2 infection, the virus that causes COVID-19, in different patient populations, formulations, and in combination with other therapies.
Novartis, African Union Partner in Supply of COVID-19-Related Medicines
Novartis and the African Union (AU) through the Africa Medical Supplies Platform (AMSP) have formed a new collaboration to facilitate the supply of medicines from the Novartis Pandemic Response Portfolio to AU member states and the Caribbean Community (Caricom), a regional grouping of Caribbean countries.
The AMSP portal is an online marketplace that enables the supply of COVID-19-related critical medical equipment in Africa. It was developed under the AU Special Envoy, Strive Masiyiwa, a Zimbabwean businessman and philanthropist, and Janngo, an Abidjan, Cote D’Ivoire-based company that builds start-ups, on behalf of the Africa Centres for Disease Control and Prevention (Africa CDC). The platform was also developed in partnership with the African Export–Import Bank and the United Nations Economic Commission for Africa.
This collaboration aims to alleviate supply and logistical constraints by ensuring efficient and rapid access to Novartis’ pandemic medicines portfolio to African and Caricom governments. The portfolio consists of 15 medicines from Sandoz, the generics and biosimilars arm of Novartis: amoxicillin, ceftriaxone, clarithromycin, colchicine, dexamethasone, dobutamine, fluconazole, heparin, levofloxacin, loperamide, pantoprazole, prednisone, prednisolone, salbutamol, and vancomycin. The portfolio was launched in July 2020 and sells medicines at zero-profit to governments, non-governmental organizations, and other institutional customers in up to 79 eligible countries to address needs of low-and lower-middle-income countries for medicines to be used for symptomatic treatment at various stages of COVID-19. Eligible countries must be included on the World Bank’s list of low-income and lower-middle-income countries.
Japan’s Gov’t Selects Daiichi’s COVID-19 Vaccine for Development
Daiichi Sankyo has been selected by Japan’s Agency for Medical Research and Development (AMED) for AMED’s drug-discovery support program for its mRNA vaccine for COVID-19, DS-5670.
DS-5670 is an mRNA vaccine for COVID-19 using nucleic-acid delivery technology discovered by Daiichi Sankyo. Daiichi Sankyo says it will proceed with preparations for the start of clinical studies around March 2021 in collaboration with the University of Tokyo’s Institute of Medical Science.
AMED’s drug-discovery support program, named the Development of a Vaccine for COVID-19 Vaccines, aims to support the development of a vaccine against COVID-19 and early commercialization of vaccines.
Source: Daiichi Sankyo
Additional news from Starpharma, Q BioMed, BioCryst, Sound Pharma, Covaxx
Starpharma Develops Nanoparticle Formulation of Gilead’s Remdesivir
Starpharma, a Melbourne, Australia-based drug-delivery company specializing in dendrimers, has developed a long‑acting, water soluble version of remdesivir, an antiviral drug, currently being developed by Gilead Sciences to treat COVID-19.
Current formulations of remdesivir are required to be administered intravenously due to the drug’s low solubility, with each infusion taking up to two hours and requiring daily administration for either 5 or 10 days.
Starpharma says its dendrimer-based platform applied to remdesivir is a highly water-soluble nanoparticle formulation with controlled-release properties, which would potentially allow for less frequent dosing and use in a non-hospital setting, such as aged-care facilities, as well as enable subcutaneous injection rather than intravenous infusion, thereby allowing for outpatient treatment.
Q BioMed Initiates Production of COVID-19 Therapeutic for Clinical Trial Program
Q BioMed, a New York, New York-based commercial-stage biomedical development company has initiated a production contract with its technology partner, Mannin Research, a Toronto, Canada-based biopharmaceutical company focused on vascular diseases, for MAN-19, a clinical grade therapeutic intended to treat complications caused by COVID-19.
The Phase I clinical trial is slated to begin patient enrollment in February 2021. Development is being supported in part by funding from the Canadian and German governments under various R&D incentive and COVID-19 response initiatives.
The company says human observational and genetic studies, as well as animal models of endothelial dysfunction collectively suggest that by targeting Tie2 receptor, MAN-19 may be effective in the treatment of a number of complications associated with viral infections such as COVID-19 and the seasonal flu.
Source: Q BioMed
BioCryst Receives $47 M from US Gov’t for COVID-19 Antiviral Drug
BioCryst Pharmaceuticals, a Durham, North Carolina-based company that develops small molecule medicines for rare diseases, has been awarded additional funding, a new $44-million contract and an additional $3 million to an existing contract, by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to support the development of galidesivir, an antiviral drug, for treating COVID-19.
The company says that drug has demonstrated broad-spectrum activity in vitro against more than 20 RNA viruses in nine different families, including the coronaviruses that cause MERS and SARS.
The additional funds under these performance-based contracts support the following: (1) the completion of Parts 1 and 2 of an ongoing clinical trial of galidesivir in Brazil; (2) conducting a Phase II clinical trial of galidesivir in non-hospitalized COVID-19 patients at high risk for developing severe disease and complications of COVID-19; (3) conducting a clinical pharmacology trial of galidesivir to determine appropriate dosing in patients with renal impairment; and (4) increasing the supply of galidesivir.
The review of data from an ongoing Phase I trial to assess the safety, clinical impact, and antiviral effects of galidesivir in patients with COVID-19 and a decision to choose a dose and advance into Part 2 of the trial are expected to occur in the fourth quarter of 2020.
The galidesivir development program is substantially funded with federal funds from NIAID and by Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services. Since March 2015, BARDA has supported the galidesivir development program under a contract for the continued development of galidesivir as a potential broad-spectrum antiviral treatment for filoviruses. In addition to the new contract award from NIAID, there is currently approximately $27 million remaining on the existing BARDA contract.
Source: BioCryst Pharmaceuticals
Sound Pharmaceuticals Advances Small Molecule Ebselen for COVID-19
Sound Pharmaceuticals, a Seattle, Washington-based company developing therapeutics for hearing loss, has received approval from the US Food and Drug Administration for two Phase II studies to evaluate ebselen, an anti-inflammatory drug recently shown to inhibit nCoV2 activity and viral replication, in COVID-19 patients.
Ebselen is a small-molecule drug that mimics and induces the activity of glutathione peroxidase (GPx) in the inner ear, retina, brain, lung, and kidney. The investigational drug is entering Phase III trials for the treatment of Meniere’s Disease and is currently in a Phase IIb study involving Cystic Fibrosis patients with acute respiratory infections receiving IV antibiotics.
Source: Sound Pharmaceuticals
Covaxx Plans Phase I Trials for Peptide-Based COVID-19 Vaccine
Covaxx, a Hauppauge, New York-based company in antibody diagnostics and vaccine development, reports it is developing a multitope peptide-based vaccine (MPV) against SARS-CoV-2, the virus that causes COVID-19, with plans to enter human trials.
The company says it is planning to begin Phase I human trial in Taiwan. Covaxx is also filing an investigational new drug application with the US Food and Drug Administration to initiate clinical trials this fall (fall 2020) in the US in collaboration with the University of Nebraska Medical Center as its core site for its Phase I/II trial.
Covaxx says it plans to manufacture and deliver up to 100 million doses of the vaccine to patients in the first quarter of 2021 and up to 1 billion doses by the end of 2021. The company will use its existing internal manufacturing in delivering high volumes of the vaccine. As part of Covaxx’s roadmap for delivering its first 100 million doses, the company is establishing a Vaccine Prioritization Advisory Group composed of ethicists, regulators, virologists, epidemiologists, and economists to advise the company on criteria and guidelines for prioritizing the deployment of vaccine doses.
The B-cell and T-cell vaccine designed to activate both arms of the patient’s humoral and cellular immune responses and is constructed off a peptide-based vaccine platform first deployed by United Biomedical, Covaxx’s parent company. The vaccine is comprised of amino acid sequences of the SARS-CoV-2 receptor binding domain 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.