Pharma COVID Roundup: News from Pfizer, J&J, Gilead, and Genentech
The latest on manufacturing and potential treatments for COVID-19 with news from Pfizer, J&J, Gilead Sciences, Genentech, Inovio, and Glenmark.
US DOJ OKs Info-Sharing on mAb Mfg Among Pharma Companies
The US Department of Justice (DOJ) says it will not challenge proposed efforts by Eli Lilly and Company, AbCellera Biologics, Amgen, AstraZeneca, Genentech, and GlaxoSmithKline to share formation about manufacturing facilities and other information that could enable them to expedite the production of monoclonal antibody (mAb) treatments that are determined to be safe and effective to treat COVID-19.
The companies had requested permission from the DOJ for sharing information about their manufacturing facilities, capacity, raw materials and supplies that could be used to produce COVID-19 mAb treatments. The companies have committed that they will not exchange information related to the prices of those treatments or the costs of inputs for or production of those treatments.
The DOJ provided its approval on the basis of two major points: (1) the demand for mAbs targeting COVID-19 is likely to exceed what any one firm could produce on its own and (2) waiting until regulators to approve specific treatments before scaling up manufacturing might delay access to these treatments by many months, which adversely could affect the US efforts to fight COVID-19.
The requesting parties submitted their business review request pursuant to the expedited, temporary review procedure detailed in the Joint Antitrust Statement Regarding COVID-19 issued on March 24, 2020 by both the DOJ and the Federal Trade Commission.
Source: US Department of Justice
Pfizer’s, BioNTech’s mRNA COVID-19 Vaccine Enters Phase II/III Trials
Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, have started a global (except for China) Phase II/III clinical study to evaluate their COVID-19 vaccine candidate.
The study is evaluating BNT162b2, a single nucleoside-modified messenger RNA vaccine candidate from their BNT162 mRNA-based vaccine program, at a 30-µg dose level in a two-dose regimen. BNT162b2, which recently received FDA fast-track designation, encodes an optimized SARS-CoV-2 full length spike glycoprotein (S), which is the target of virus-neutralizing antibodies.
During preclinical and clinical studies of four BNT162 RNA vaccine candidates, BNT162b1 and BNT162b2 emerged as strong candidates based on assessments of safety and immune response. Pfizer and BioNTech selected BNT162b2 as the candidate to progress to a Phase II/III study based on the totality of available data from its preclinical and clinical studies, including select immune response and tolerability parameters.
Overall, the companies say they expect to enroll 30,000 participants for the Phase II/Phase III study at approximately 120 clinical investigational sites around the world, including 39 states across the US and other countries, including Argentina, Brazil, and Germany.
If the Phase II/III trial is successful, Pfizer and BioNTech expect to be ready to seek emergency use authorization or some form of regulatory approval as early as October 2020. If authorization or approval is obtained, the companies currently aim to supply globally up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021.
The companies say that they are continuing to collect data from Phase I/II trials for all of their four vaccine candidates and expect to submit data on BNT162b2 for peer review and potential publication in the near future.
J&J’s COVID-19 Vaccine Candidate Advances to Phase I/IIa Trials
Johnson & Johnson’s (J&J) has reported promising data from preclinical studies for its COVID-19 vaccine candidate, Ad26.COV2.S, an adenovirus serotype 26 (Ad26) vector-based vaccine, has advanced the candidate to a Phase I/IIa clinical trial, and has plans to begin a Phase III trial in parallel in September (September 2020).
J&J reports that the data, published in Nature, show the vaccine candidate elicited a robust immune response as demonstrated by neutralizing antibodies and successfully prevented subsequent infection and provided complete or near-complete protection in the lungs from the virus in non-human primates in the preclinical study. Based on the data, a Phase I/IIa first-in-human clinical trial of Ad26.COV2.S in healthy volunteers, has now commenced in the US and Belgium.
The COVID-19 clinical trial program, including the Phase I/IIa clinical trial and a Phase III clinical trial program, will evaluate both one- and two-dose regimens of Ad26.COV2.S in parallel studies. The Phase I/IIa trial will evaluate the safety, reactogenicity (expected reactions to vaccination, such as swelling or soreness), and immunogenicity of Ad26.COV2.S in over 1,000 healthy adults aged 18 to 55 years, as well as adults aged 65 years and older. Planning is also underway for a Phase IIa study in the Netherlands, Spain and Germany and a Phase I study in Japan.
The company says as it plans its COVID-19 Phase III clinical development program, discussions are underway with partners with the objective to start a Phase III clinical trial of the single vaccine dose versus placebo in September (September 2020), pending the interim data of the Phase I and II trials and approval of regulators. Simultaneously, the company also is planning to start a parallel Phase III clinical trial of a two-dose regimen versus placebo.
The company says it continues to increase manufacturing capacity of its vaccine, is in active discussions with global strategic partners to support worldwide access, and aims to meet its goal to supply more than one billion doses globally through the course of 2021, provided the vaccine is safe and effective.
Source: Johnson & Johnson
European Commission, Gilead Sign Pact for Supply of Remdesivir
The European Commission (EC) has signed a contract with Gilead Sciences to secure treatment doses of Veklury, the brand name for remdesivir, an investigational antiviral for the treatment of COVID-19.
The Commission says as early as August (August 2020), in order to meet immediate needs, batches of Veklury will be made available to European Union member states and the UK, with the coordination and support of the EC.
The EC’s Emergency Support Instrument will finance the contract, worth a total of EUR 63 million ($74 million), to ensure the treatment of approximately 30,000 patients presenting severe COVID-19 symptoms. The EC says the contract will help to cover the current needs over the next few months (as reported on July 29, 2020) while ensuring a fair distribution at the EU level based on an allocation key that takes into account the advice from the European Centre for Disease Prevention and Control.
The EC is also preparing a joint procurement plan for further supplies of the medicine, which is expected to cover additional needs and supplies from October (October 2020) onwards.
Earlier this month (July 2020), remdesivir was granted conditional marketing authorization in the EU. Gilead has been requested to submit the final reports of remdesivir studies to the European Medicines Agency by December 2020 as part of the conditions to be fulfilled to move from a conditional marketing authorization to a full marketing authorization. Further data on the effectiveness and safety of the medicine is expected to be submitted by August 2020 in order to finalize this process.
Source: European Commission
Gilead Provides $1 M to Study Racial Health Inequities Associated with COVID-19
Gilead Sciences and the Satcher Health Leadership Institute at the Morehouse School of Medicine in Atlanta, Georgia are working together to develop a comprehensive health-equity data platform to help address the impact of COVID-19 and other diseases on communities of color.
Gilead says the tool will provide the ability to collect and study the demographic disparities associated with COVID-19 with the goal of using this data to help create actionable, evidence-based policy changes to attain health equity and ensure that disproportionately impacted communities receive resources and support. The database will also examine co-morbidities associated with COVID-19, including asthma, diabetes, heart disease, cancer, obesity, sickle-cell anemia and depression.
Gilead will initially provide $1 million for the project and to support the creation of a Black Health Equity Alliance, composed of national thought leaders, community representatives, scholars, researchers, and policymakers, which will help coordinate COVID-19 education, training, information exchange and dissemination, and policy analysis.
The data map will go live and be available to the public in the fourth quarter of 2020.
Source: Gilead Sciences
Genentech Reports Disappointing Phase III Results of Arthritis Drug for COVID-19
Roche’s Genentech reports that a Phase III study of Actemra (tocilizumab), a drug to treat certain forms of arthritis, did not meet its primary endpoint of improved clinical status in hospitalized adult patients with severe COVID-19 associated pneumonia.
The study evaluated the safety and efficacy of intravenous Actemra added to standard-of-care treatment and compared to treatment with placebo plus standard of care. In addition, the key secondary endpoints, which included the difference in patient mortality at week four, were not met. The company says, however, there was a positive trend in time to hospital discharge in patients treated with Actemra. The study did not identify any new safety signals for Actemra.
The trial was conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.
Genentech has initiated several studies to further investigate Actemra as a potential treatment for patients with COVID-19-associated pneumonia, including two Phase III clinical trials, and a Phase II trial.
Glenmark Reports Phase III Trial Results of Antiviral for COVID-19
Glenmark Pharmaceuticals, a Mumbai, India-headquartered pharmaceutical company, has announced top-line results from a Phase III clinical trial evaluating the antiviral drug, favipiravir, a generic form of Fujifilm Toyama Chemical’s Avigan, an antiviral drug being evaluated to treat COVID-19, in mild-to-moderate COVID-19 patients conducted across seven clinical sites in India.
The open-label randomized, multicenter clinical trial, conducted in 150 patients, evaluated the efficacy and safety of favipiravir plus standard supportive care, versus standard supportive care alone, in mild-to-moderate patients. Results from the Phase III trial showed numerical improvements for the primary efficacy endpoint with 28.6% faster viral clearance in the overall. Additionally, the company reports that favipiravir was well tolerated with no serious adverse events or deaths in the favipiravir treated arm.
Last month (June 2020), Glenmark announced that it received manufacturing and marketing approval from India’s drug regulator to launch FabiFlu, the brand name of Glenmark’s favipiravir. The manufacturing and marketing approval was granted as part of an accelerated approval process.
Glenmark is also conducting another Phase III clinical trial in India to evaluate the efficacy of a combination therapy of favipiravir and umifenovir, an antiviral treatment for influenza infection, in moderate hospitalized adult COVID-19 patients.
Source: Glenmark Pharmaceuticals
EMA Sets Up Infrastructure for Monitoring COVID Treatments and Vaccines
The European Medicines Agency (EMA) has set up an infrastructure to support the monitoring of the efficacy and safety of COVID-19 treatments and vaccines when used in day-to-day clinical practice.
The EMA has signed three contracts for observational research with academic and private partners over recent months in order to be ready to effectively monitor vaccines in the real world as soon as they are authorized and to support the safe and effective use of COVID-19 vaccines and medicines.
The latest contract was finalized in mid-July (July 2020) with Utrecht University and the University Medical Center Utrecht to collect data on the impact of COVID-19 in pregnancy in order to guide decision-making about vaccine indications, vaccination policies, and treatment options for COVID-19 in pregnant women.
In June (June 2020), the EMA contracted IQVIA, a contract research organization and business intelligence project, with a project to build a framework for the conduct of multi-center cohort studies with the European Health Data & Evidence Network consortium on the use of medicines in COVID-19 patients.
In May (May 2020), the EMA commissioned the ACCESS Project, a not-for-profit healthcare advocacy group, for preparatory research into data sources and methods that can be used to monitor COVID-19 vaccines in clinical practice, once authorized.
Source: European Medicines Agency
Inovio’s COVID-19 DNA Vaccine Shows Promising Preclinical Results
Inovio, a Plymouth Meeting, Pennsylvania-based biopharmaceutical company developing DNA-based immunotherapies for cancer and infectious diseases, reports that its COVID-19 DNA vaccine candidate, INO-4800, was effective in protecting non-human primates (NHPs; specifically, rhesus macaques) from live virus challenge 13 weeks after the last vaccination. These protective results were mediated by memory T and B cell immune responses from INO-4800 vaccination.
The company says that these results demonstrate that INO-4800 reduced viral load in both the lower lungs and nasal passages in macaques that received two doses of INO-4800 (1 mg) four weeks apart and then were challenged with live virus 13 weeks after the second dose (study week 17).
A separate NHP study evaluating the durability of INO-4800 at 12 months after vaccination is currently under way. INO-4800 also has been selected by US’ Operation Warp Speed, which seeks to accelerate the development of COVID-19 vaccines and treatments, for its COVID-19 NHP challenge study.
In May (May 2020), the peer-reviewed journal, Nature Communications, published an Inovio study showing that vaccination with INO-4800 generated robust binding and neutralizing antibody and T cell responses in mice and guinea pigs. The study was funded by a grant from the Coalition for Epidemic Preparedness Innovations, a public–private partnership focused on vaccine development against emerging infectious diseases.