Pharma COVID Roundup: News from Lilly, Pfizer, Amgen, AbbVie, TakedaBy
The latest on manufacturing and potential treatments for COVID-19 with news from Eli Lilly and Company, Pfizer, Amgen, AbbVie, Takeda, BioNTech, Novavax, and others.
Lilly Initiates Phase III Trial of Monoclonal Antibody for COVID-19
Eli Lilly and Company has initiated a Phase III trial in the US studying LY-CoV555, the company’s investigational monoclonal antibody for the prevention of SARS-CoV-2 infection and COVID-19, in residents and staff at long-term care facilities.
LY-CoV555 is the lead candidate from Lilly’s collaboration with AbCellera, a Vancouver, British Columbia, Canada-based biopharmaceutical company. It is a neutralizing antibody against SARS-CoV-2, the virus that causes COVID-19. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus and potentially preventing and treating COVID-19, according to information from Lilly.
The Lilly-sponsored study is being conducted in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, along with the NIAID’s COVID-19 Prevention Network, and several long-term care facility networks across the US. The study will enroll residents and staff who live or work at facilities that have had a recently diagnosed case of COVID-19 and who are now at a high risk of exposure. It will evaluate the efficacy of LY-CoV555 for the prevention of SARS-CoV-2 infection and COVID-19 by testing whether a single dose of LY-CoV555 reduces the rate of SARS-CoV-2 infection through four weeks as well as complications of COVID-19 through eight weeks. The study is expected to enroll up to 2,400 participants.
Lilly created customized mobile research units to support the on-site study. These units include a custom retrofitted recreational vehicle to support mobile labs and clinical trial material preparation, along with a trailer truck that will deliver all clinical trial supplies needed to create an on-site infusion clinic. Lilly says additional staff will be at the facilities to assist with the operations of the study. Lilly will deploy its mobile research unit fleet in response to outbreaks of the virus at long-term care facilities across the US.
Lilly has successfully completed dosing of LY-CoV555 in a Phase I study of hospitalized patients with COVID-19, and long-term follow-up is ongoing. A Phase II study in people recently diagnosed with COVID-19 in the ambulatory setting is ongoing. The company estimates that enrollment will be completed in September (September 2020), with initial data readout soon thereafter followed by full data in the fourth quarter of 2020.
Lilly says that large-scale manufacturing of this potential therapy continues, with the goal of having more than 100,000 doses available by the end of the year should LY-CoV555 prove to be a meaningful therapeutic option for COVID-19.
Source: Eli Lilly and Company
Pfizer, BioNTech Sign Pacts with Governments of Japan, Canada to Supply COVID Vaccine
Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, have formed separate agreements with the governments of Japan and Canada for the supply of BNT162, the companies’ mRNA-based vaccine candidate against SARS-CoV-2, the virus that causes COVID-19.
The agreement with Japan’s Ministry of Health, Labour and Welfare is to supply 120 million doses of BNT162. Financial details of both agreements were not disclosed, but the terms were based on the timing of delivery and the volume of doses. As requested by the government of Japan, deliveries of the vaccine candidate are planned for the first half of 2021. As requested by the government of Canada, deliveries of the vaccine candidate are planned for over the course of 2021.
The BNT162 program is based on BioNTech’s mRNA technology and supported by Pfizer’s vaccine development and manufacturing capabilities. The companies’ vaccine-development program is evaluating at least four vaccine candidates, each of which represents a unique combination of messenger RNA (mRNA) format and target antigen. Recently, two of the companies’ four vaccine candidates, BNT162b1 and BNT162b2, received fast track designation from the US Food and Drug Administration based on preliminary data from Phase I/II studies that are ongoing in the US and Germany as well as animal immunogenicity studies.
Late last month (July 2020), the companies selected the BNT162b2 vaccine candidate to move forward into a Phase II/III study. BNT162b2 encodes an optimized SARS-CoV-2 full length spike glycoprotein (S), which is the target of virus neutralizing antibodies. In the late-stage global trial, the companies will study a 30-µg dose level in a two-dose regimen in up to 30,000 participants aged 18–85 years.
Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review for BNT162b2 as early as October 2020, and, if regulatory authorization or approval is obtained, plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.
In addition to engagements with governments, Pfizer and BioNTech have provided an expression of interest for possible supply to the COVID-19 Vaccine Global Access (COVAX) Facility, a mechanism established by Gavi, a global public health partnership, the Coalition for Epidemic Preparedness Innovations, a public–private partnership focused on vaccine development against emerging infectious diseases, and the World Health Organization, which aims to provide governments with early access to a large portfolio of COVID-19 candidate vaccines using a range of technology platforms and produced by multiple manufacturers globally.
NIH Initiates Trial of Combo Therapy of Gilead, Merck KGaA Drugs for COVID-19
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has initiated a clinical trial to evaluate the safety and efficacy of a treatment regimen consisting of Gilead Sciences’ antiviral drug, remdesivir, plus Merck KGaA’s multiple sclerosis drug, Rebif (interferon beta-1a), in patients with COVID-19.
Investigators will evaluate whether time to recovery is shorter in patients receiving the combination therapy compared to those receiving only remdesivir. The study is anticipated to enroll more than 1,000 hospitalized adults with COVID-19 at as many as 100 sites in the US and abroad.
Interferon beta-1a has the same amino-acid sequence as a naturally occurring protein called interferon beta, which is part of a class of proteins called Type 1 interferons. Infected cells normally produce Type 1 interferons to help the immune system fight pathogens, especially viruses. Interferon beta has both antiviral and anti-inflammatory properties, according to information from the NIH.
Merck KGaA is contributing 3,000 units of Rebif for the study. The contribution is in addition to a previously announced donation of up to 300,000 units of Rebif to international trials sponsored by the French INSERM institute (Institut National de la Santé et de la Recherche Médicale) and the World Health Organization.
Novavax Reports Positive Phase I Data for COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has reported promising results from its Phase I trial of its COVID‑19 vaccine candidate, NVX CoV2373.
NVX‑CoV2373 is a recombinant vaccine candidate adjuvanted with the company’s proprietary adjuvant, Matrix-M. The company reported that the vaccine adjuvanted with Matrix-M was generally well-tolerated in healthy adults 18-59 years of age and elicited robust antibody responses numerically superior to that seen in human convalescent sera. The data have been submitted for peer review to a scientific journal and to an online preprint server at medRxiv.org. No serious adverse events were reported, and safety follow-up continues.
The trial was supported by funding from the Coalition for Epidemic Preparedness Innovations, a public–private partnership focused on vaccine development against emerging infectious diseases, and was conducted at two sites in Australia.
AbbVie, Amgen, Takeda Enroll First Patients in COVID Trial
Three members of the COVID R&D Alliance (AbbVie, Amgen, and Takeda) have enrolled the first patients in a clinical trial to evaluate Amgen’s Otezla (apremilast), a drug for treating psoriasis, Takeda’s Firazyr (icatibant) a drug for treating hereditary angioedema, and AbbVie’s cenicriviroc, an investigational drug for treating nonalcoholic steatohepatitis (NASH), a liver disease, in hospitalized COVID-19 patients who require high-flow oxygen.
The COVID R&D Alliance is composed of more than 20 biopharmaceutical and life-science companies working to speed the development of potential therapies, novel antibodies, and antiviral therapies for COVID-19 and its related symptoms. Members are investigating marketed and late-stage therapies indicated for other disease states, which, based on their mechanisms of action, may have a potential treatment effect in COVID-19 patients.
The study is a collaboration between members of the COVID R&D Alliance, Quantum Leap Healthcare Collaborative, a non-profit organization advancing the clinical-development process, and the US Food and Drug Administration. The trial will use Quantum Leap’s adaptive platform trial design, which is intended to increase trial efficiency by minimizing the number of participants and time required to evaluate potential treatments.
The therapies under investigation were selected based on their potential to impact the immune-system response of COVID-19 patients who need respiratory support. Based on the respective mechanisms of action, Otezla may suppress inflammation resulting from an immune response, Firazyr may ameliorate bradykinin-driven pulmonary edema, and cenicriviroc acts by blocking monocytes trafficking to tissues, features that may help to reduce or mitigate the severity of acute respiratory distress syndrome response in severely ill COVID-19 patients.
Zydus Cadila Advances COVID Vaccine to Phase II Trials
Zydus Cadila, an Ahmedabad, India-based pharmaceutical company, reports that its plasmid DNA vaccine to prevent COVID-19, ZyCoV-D, was found to be safe and well tolerated in a Phase I clinical trial. The company will begin Phase II clinical trials on August 6, 2020.
Source: Zydus Cadila
FDA OKs Antibody Tests for COVID-19
The US Food and Drug Administration has authorized the first two COVID-19 serology tests that display an estimated quantity of antibodies present in an individual’s blood.
Both tests, the ADVIA Centaur COV2G and Atellica IM COV2G, from Siemens, a process automation company, are what are known as “semi-quantitative” tests, meaning that they do not display a precise measurement, but estimate the quantity of a patient’s antibodies produced against infection with the virus that causes COVID-19.
The FDA emphasizes that serology tests should not be used to diagnose an active infection as they only detect antibodies the immune system develops in response to the virus, not the virus itself.
Source: US Food and Drug Administration
NIH Launches Center to Apply AI in COVID-19 Imaging and Personalized Therapies
The National Institutes of Health (NIH) has launched the Medical Imaging and Data Resource Center (MIDRC) to apply artificial intelligence and medical imaging for early detection and personalized therapies for COVID-19. The multi-institutional collaboration will be led by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), part of the NIH. The MIDRC will facilitate collection, analysis, and dissemination of imaging and associated clinical data.
Source: National Institutes of Health
Partner Therapeutics Gets $35-M Contract with US Gov’t for COVID-19 Therapy
Partner Therapeutics, a Boston, Massachusetts-based biopharmaceutical company focused on cancer, has announced a $35-million milestone-based agreement with the US Department of Defense (DOD) to fund two clinical studies of inhaled Leukine (sargramostim), a granulocyte macrophage-colony stimulating factor, in patients with COVID-19-associated acute hypoxemia, a below-normal level of oxygen in the blood.
The study will evaluate the effect of Leukine in improving clinical outcomes, including oxygenation and percent of patients intubated. The first of two Phase II clinical studies will be initiated this month (August 2020) in centers in the US and will be conducted under an investigational new drug (IND) application, which was approved by the US Food and Drug Administration (FDA) in May (May 2020). Leukine is FDA-approved for the treatment of acute radiation syndrome and is held in the Strategic National Stockpile.
The DOD funding will be used for the two Phase II studies to assess the benefits of Leukine in the treatment of patients with acute hypoxemia due to COVID-19. Funding will also support regulatory filings for a potential emergency use authorization and expansion of production capacity. The first of the two clinical studies will begin in August 2020 and will supplement data from more than 60 patients who have completed treatment in a clinical trial, which is currently underway at five hospitals in Belgium.
Source: Partner Therapeutics