Pharma COVID Roundup: News from Roche, Amgen, Lilly, Incyte, CSLBy
The latest from pharma companies on potential COVID-19 treatments and diagnostics with news from Roche, Amgen, Incyte, Lilly, Regeneron, CSL and others.
News from Roche, Amgen, Incyte, Regeneron, Lilly, and CSL
FDA OKs Emergency Use for Roche’s Antibody Test for COVID-19
Roche has received an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its new Elecsys Anti-SARS-CoV-2 antibody test. The test is designed to help determine if a patient has been exposed to the SARS-CoV-2 virus, the virus that caused COVID-19, and if the patient has developed antibodies against SARS-CoV-2.
Roche has started shipping (as of May 5, 2020) the new antibody test to laboratories globally and will ramp up production capacity to high double-digit millions per month to serve healthcare systems in countries accepting the CE mark, the authorization for in vitro diagnostic medical devices in the European Union, as well as in the US.
For countries with specific regulatory requirements, local approval timelines apply. In addition, there may be other country-specific regulations, such as import requirements, which will determine when the test becomes available locally. Roche says it will work closely with the respective regional representatives to ensure it appropriately supports local registration efforts.
An antibody test, also called a serology test, is used to determine whether a person might have gained immunity against a pathogen or not. The human body makes antibodies in response to many illnesses. In the current situation of the COVID-19 pandemic, antibody tests need to be able to specifically detect antibodies against SARS-CoV-2 with no cross-reactivity to other similar coronaviruses, which could generate a false positive result and thus wrongly indicate potential immunity. Roche says this antibody test has a specificity greater than 99.8% and 100% sensitivity.
Amgen To Evaluate Otezla as Potential COVID-19 Treatment
Amgen reports that it will evaluate Otezla (apremilast), an oral small-molecule drug for treating moderate-to-severe plaque psoriasis and psoriatic arthritis. as a potential immunomodulatory treatment in adult patients with COVID-19.
Amgen acquired Otezla in November 2019 for $13.4-billion from Celgene as part of a condition of the US Federal Trade Commission’s approval of Bristol-Myers Squibb’s $74-billion acquisition of Celgene, which was completed in November 2019.
Amgen provided an update of Otezla and other R&D activities for COVID-19 treatments and the impact of COVID-19 on its research activities in its-first-quarter 2020 earnings release issued on April 30, 2020.
In April (April 2020), Amgen and Adaptive Biotechnologies, a Seattle, Washington-based biopharmaceutical company, partnered to discover and develop fully human neutralizing antibodies targeting SARS-CoV-2, the virus that causes the novel coronavirus (COVID-19), to potentially prevent or treat COVID-19.
Amgen also provided an update on the impact of COVID-19 on its overall R&D activities. The company says study start-up activities are continuing, and study procedures are being implemented with recent guidance from regulators to maintain safety and data integrity. Amgen says it has paused enrollment in clinical trials where there is uncertainty around the ability of sites to ensure subject safety or data integrity.
Incyte Initiates Second Phase III Study of Jakafi for COVID-19
Incyte, a Wilmington, Delaware-based biopharmaceutical company, has initiated a second Phase III clinical trial in the US to evaluate the efficacy of Jakafi (ruxolitinib), a drug for treating myelofibrosis, a form of bone-marrow cancer, polycythemia vera, a form of bone-marrow cancer, and acute graft-versus-host disease, as a potential treatment with standard of care for treating COVID-19.
Last month (April 2020), Inctye and Novartis initiated a Phase III clinical trial to evaluate the efficacy and safety of ruxolitinib plus standard-of-care compared to standard of care therapy alone, in patients with COVID-19 associated cytokine storm. The collaborative study is sponsored by Incyte in the US and by Novartis outside of the US. Additionally, Incyte has launched an emergency expanded-access program in the US to allow eligible patients with COVID-19-associated cytokine storm to receive ruxolitinib.
The now second study, which Incyte reported on its first-quarter 2020 results issued on May 5, 2020, will evaluate COVID-19 patients on mechanical ventilation and who have acute respiratory distress syndrome, a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs.
Regeneron To Initiate Clinical Trial for Antibody Cocktail for COVID-19
Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, is advancing REGN-COV2, an investigational antibody “cocktail” treatment designed to prevent and treat SARS-CoV-2, the virus that causes COVID-19.
The REGN-COV2 program is using a multi-antibody approach that targets different parts of SARS-CoV-2. Regeneron used the same platform to develop its coronavirus antiviral antibody that it used to develop an antibody treatment for Ebola.
In April (April 2020), Regeneron moved its neutralizing antibodies into preclinical and clinical-scale cell production lines and plans to begin clinical studies in June 2020. The company is working to scale up manufacturing and says it has a goal to have hundreds of thousands of doses available by the end of August 2020. The company provided an update in its first-quarter 2020 earnings release issued on May 5, 2020.
The company also announced an expanded agreement with the US Department of Health and Human Services to fund certain R&D activities related to COVID-19 treatments, including REGN-COV2 and the US study evaluating Kevzara (sarilumab), an antiviral compound, in patients hospitalized with severe COVID-19.
Regeneron is partnered with Sanofi for Kevzara, a human monoclonal antibody against the interleukin-6 receptor. Regeneron Pharmaceuticals and Sanofi developed the drug for treating rheumatoid arthritis, for which it was approved by US and European regulatory authorities. The companies are also evaluating the drug as a potential COVID-19 treatment. Last month (April 2020), an independent monitoring committee recommended continuing an ongoing Phase III trial only in a more advanced “critical” group of COVID-19 patients and discontinuing a study in the less advanced “severe” group of COVID-19 patients based on initial Phase II results.
Source: Regeneron Pharmaceuticals
Lilly, Junshi Biosciences To Co-Develop COVID-19 Antibody Therapies
Eli Lilly and Company and Junshi Biosciences, a Shanghai-based biopharmaceutical company, have formed an agreement to co-develop therapeutic antibodies for the potential prevention and treatment of COVID-19, the disease caused by the SARS-CoV-2 novel coronavirus.
At the beginning of the COVID-19 outbreak, Junshi launched an R&D program that focused on neutralizing antibodies to combat COVID-19. Within two months (as reported on May 4, 2020), the company completed preclinical studies, process development and production for a GLP toxicity study, and GMP production of clinical materials.
Junshi and Lilly say they are aiming to submit an investigational new drug (IND) application and initiate clinical studies in the US in the second quarter of 2020. Meanwhile, Junshi says it is communicating with the Center for Drug Evaluation of the National Medical Products Administration in China to initiate the IND application submission in China.
Under the agreement, Lilly will receive an exclusive license to conduct clinical development, manufacturing, and distribution of products outside of Greater China. Junshi will maintain all rights in Greater China.
Junshi’s S016 is a recombinant fully human monoclonal neutralizing antibody that is specific to the SARS-CoV-2 surface spike protein receptor binding domain and is designed to block the binding of viruses to the host-cell surface-receptor, angiotensin converting enzyme 2 (ACE2). The project is jointly developed by Junshi Biosciences and the Institute of Microbiology of the Chinese Academy of Science.
Source: Eli Lilly and Company
CSL To Develop Plasma-Derived COVID Treatment
CSL Behring Australia, a subsidiary of CSL Limited, will begin onshore development of an anti-SARS-CoV-2 plasma product with the potential to treat complications of COVID-19, particularly those whose illness is progressing toward the need for ventilation. SARS-CoV-2 is the virus that causes the novel coronavirus (COVID-19).
The investigational product, known as COVID-19 immunoglobulin, will be developed by CSL Behring Australia at its manufacturing facility in Broadmeadows, Victoria, Australia. CSL Behring says research will involve two phases: (1) producing a small batch of COVID-19 immunoglobulin to be used to develop tests to detect the presence of the antibodies that fight the SARS-CoV-2 virus that causes COVID-19, and (2) then using a larger batch of COVID-19 immunoglobulin in clinical trials in Australia’s hospitals to establish the safety of the product.
The company says the product will be developed in Australia using donations of plasma with high levels of antibodies by people who have recovered from COVID-19. The company estimates that up to 800 plasma donations will be required to produce sufficient COVID-19 immunoglobulin to treat 50–100 seriously ill people under the clinical trial.
If the clinical trial is successful, and subject to request by Australian governments, CSL Behring will seek to register COVID-19 immunoglobulin with the Therapeutic Goods Administration, the national pharmaceutical regulatory agency in Australia, to allow for its ongoing supply in Australia.
Source: CSL Behring
News from CEPI, Inovio, Vir Biotechnology, and Alnylam Pharmaceuticals
CEPI in COVID-19 Vaccine Pact; CEPI Funds Mfg for Inovio’s Vaccine
The Coalition for Epidemic Preparedness Innovations (CEPI), a public–private coalition that seeks to derail epidemics by speeding up the development of vaccines, and the Australian subsidiary of Clover Biopharmaceuticals, a Chengdu, China-based biopharmaceutical company, have formed a $3.5-million partnering pact for COVID-19 vaccine research and development.
This initial CEPI investment will support Clover Australia in its efforts to initiate a Phase I clinical trial in Australia of its COVID-19 S-Trimer vaccine candidate. This vaccine candidate is based on Clover Biopharmaceutical’s proprietary Trimer-Tag vaccine technology platform, a way to produce the spike proteins of the COVID-19 virus in a native trimeric form for use in a vaccine. If successful in clinical trials, Clover Biopharmaceuticals has the capacity to scale up the production of the vaccine using its in-house biomanufacturing capabilities.
This is CEPI’s ninth worldwide collaboration to develop a COVID-19 vaccine and brings CEPI’s total investment in supporting COVID-19 vaccine R&D to $39.6 million. To date (as of April 28, 2020) CEPI has provided initial support and funding to several organizations and companies to support COVID-19 R&D: CureVac, a German company specializing in therapies based on messenger RNA; Inovio, a US company developing immunotherapies for infectious diseases and cancer; Moderna, a US biopharmaceutical company specializing in messenger RNA; Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company; the University of Hong Kong; the University of Oxford in the UK; the University of Queensland in Australia; and a consortium led by Institut Pasteur, a French research institute.
CEPI funds manufacturing for Inovio’s COVID-19 vaccine candidate
In a separate development, Inovio has entered into an agreement to expand its manufacturing partnership with the German contract manufacturer, Richter-Helm BioLogics GmbH & Co. KG, to support large-scale manufacturing of Inovio’s investigational DNA vaccine, INO-4800. The agreement is being partly funded by an initial grant of $1.3 million from CEPI, which brings CEPI’s total support to date (as of April 30, 2020) for the development of INO-4800 to $17.2 million.
INO-4800 is currently in Phase I clinical testing in the US for COVID-19 with potential to advance to Phase II/III efficacy trials this summer (summer of 2020). Inovio says it plans to produce one million doses of INO-4800 by the end of 2020, and additional capacity provided by Richter-Helm will expand manufacturing of this DNA vaccine candidate.
Richter-Helm Biologics is using manufacturing technology developed by VGXI, a contract manufacturer of DNA plasmids based in The Woodlands, Texas and a wholly owned subsidiary of GeneOne Life Science, a South Korean biopharmaceutical company. VGXI is Inovio’s contract manufacturer for early-stage clinical trial supply. Richter-Helm BioLogics will transfer and scale up the current production process for the INO-4800 DNA plasmid from VGXI. Richter-Helm BioLogics and VGXI already share a long-term partnership.
Vir, Alnylam Identify RNAi Therapeutic as a Potential COVID-19 Treatment
Vir Biotechnology, a San Francisco-based clinical-stage biopharmaceutical company, and Alnylam Pharmaceuticals, a Cambridge, Massachusetts-based biopharmaceutical company focused on RNA interference (RNAi) therapeutics, announced the selection of a development candidate, VIR-2703, an investigational RNAi therapeutic targeting the SARS-CoV-2 genome, with plans to advance VIR-2703 as an inhalational formulation for the potential treatment and/or prevention of COVID-19.
The companies plan to meet with the US Food and Drug Administration and other regulatory authorities to discuss a potential accelerated path for filing an Investigational new drug (IND) application or IND-equivalent application at or around year-end 2020. With this selection, Vir and Alnylam will work to generate the data required to enable beginning clinical studies.
In addition to the development candidate targeting the SARS-CoV-2 genome, the companies will use Alnylam’s recent advances in lung delivery of siRNAs for widespread silencing of gene targets in the respiratory tract in multiple cell types, including cells in the respiratory tract that may be the targets for SARS-CoV-2 infection. In addition, the companies will use Vir’s infectious-disease expertise and capabilities to bring forward up to three additional host factor-targeting development candidates to treat COVID-19 and potentially other coronavirus diseases.