Pharma COVID Roundup: News from J&J, Takeda, Amgen, RegeneronBy
The latest on manufacturing, potential treatments, and testing for COVID-19 with news from J&J, Takeda, Amgen, UCB, Regeneron, Novavax, Roche, Inovio, and Kaneka.
Manufacturing and supply of COVID-19 vaccines and drugs
Covaxx in $2.8-Bn Worth of Supply Deals for COVID-19 Vaccine
Covaxx, a Hauppauge, New York-based company and a division of United Biomedical, focusing on antibody diagnostics and vaccine development, has announced advanced purchase commitments of more than 140 million doses of its COVID-19 vaccine, UB-612, totaling over $2.8 billion, to deliver vaccines in multiple countries, including Brazil, Ecuador, and Peru.
These public and private commitments follow the start of human trials in Taiwan and a September (September 2020) agreement with Diagnosticos da America, a Brazil-based clinical diagnostic company, to conduct Phase II/III clinical trials and distribute vaccines within Brazil.
Covaxx is currently completing Phase I clinical trials of UB-612, a peptide-based vaccine, in Taiwan and has an agreement with the University of Nebraska Medical Center, home of the National Pandemic Center, to also conduct trials in the US. Last month (October 2020), Covaxx announced a global logistics partnership with Maersk, a Copenhagen, Denmark-based shipping and integrated logistics provider, for all transportation and supply-chain services that will be needed to deliver its UB-612 globally.
Inovio in Mfg Pact with Kaneka for COVID-19 Vaccine
Inovio, a Plymouth Meeting, Pennsylvania-based biopharmaceutical company developing DNA-based immunotherapies for cancer and infectious diseases, has entered into an agreement with Kaneka Eurogentec, an affiliate of Kaneka Corporation, a Tokyo-headquartered chemical manufacturer, to manufacture Inovio’s COVID-19 vaccine candidate, INO-4800, at its plasmid production scales.
Kaneka Eurogentec joins existing partners Thermo Fisher Scientific, Richter-Helm BioLogics, a Hamburg, Germany-based CDMO, and Ology Biosciences, an Alachula, Florida-based CDMO, in Inovio’s global manufacturing consortium. The company says each CDMO that has been selected to join the consortium is capable of supporting future large-scale global manufacturing across its portfolio of DNA medicines and vaccines.
Inovio is conducting a Phase II segment of its planned Phase II/III clinical trial for INO-4800. The US government has agreed to provide funding for both the Phase II and Phase III segments of the clinical trial in addition to the $71 million of funding previously announced in June (June 2020) for the large-scale manufacture of the company’s proprietary smart device, Cellectra 3PSP, and the procurement of Cellectra 2000 devices.
SAB Awarded $57.5 by US Gov’t for Manufacture of its COVID-19 Drug
SAB Biotherapeutics, a Sioux Falls, South Dakota-based clinical-stage biopharmaceutical company, has been awarded $57.5 million by the US government for the manufacturing of the company’s clinical-stage drug candidate for treating COVID-19, SAB-185, a human polyclonal antibody therapeutic.
SAB-185 is being tested as a COVID-19 therapeutic in an ongoing Phase I trial in healthy volunteers and an ongoing Phase Ib trial in patients with mild-or-moderate COVID-19.
Source: SAB Biotherapeutics
Updates on COVID-19 treatments and vaccines
EMA Starts Rolling Review of J&J’s COVID-19 Vaccine
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has started a rolling review of Johnson & Johnson’s Janssen’s vaccine candidate (Ad26.COV2.S) against SARS-CoV-2, the virus that causes COVID-19.
The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies and early clinical studies in adults. These studies suggest that the vaccine triggers the production of antibodies and immune cells that target SARS-CoV-2.
The company is currently conducting trials in people to assess safety and immunogenicity, and effectiveness. EMA will evaluate data from these and other clinical trials as they become available. The rolling review will continue until enough evidence is available for a formal marketing authorization application.
Source: European Medicines Agency
Novavax Provides Update on Phase II/III Trials for COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has reported that two of the three planned late-stage efficacy trials for its COVID-19 vaccine candidate, NVX-CoV2373, are fully enrolled, and more than 20,000 participants have been dosed.
In the UK, Novavax completed enrollment of 15,000 participants in a Phase III clinical trial. The company says interim data are expected as soon as early first quarter of 2021 although the timing depends on the overall COVID-19 rate in the region. The company also says these data are expected to serve as the basis for licensure application in the UK, the European Union, and other countries.
In South Africa, the Phase IIb trial to evaluate safety and provide an early indication of efficacy is now fully enrolled. As in the UK, availability of efficacy data depends on the illness rate in South Africa and may be available as soon as the first quarter of 2021. The trial is being conducted in collaboration with Professor Shabir Mahdi and Wits University in Witwatersrand, Johannesburg, South Africa and is funded in part by the Bill & Melinda Gates Foundation. The Coalition for Epidemic Preparedness Innovations, a public–private partnership focused on vaccine development against emerging infectious diseases, funded the manufacturing of doses of NVX-CoV2373 for this Phase IIb clinical trial.
Additionally, Novavax expects its Phase III clinical trial in the US and Mexico to begin in the coming weeks (as reported on November 30, 2020). The company reports that preliminary blinded data on NVX-CoV2373 in older adults needed to proceed to Phase III has previously been positively reviewed by the US Food and Drug Administration (FDA). Novavax says it will use vaccine material produced at commercial scale for this trial. The company has been working with the FDA to complete trial-initiation gating activities related to its commercial-scale production at Fujifilm Diosynth Biotechnologies’ facility in Research Triangle Park, North Carolina.
Novavax was awarded $1.6 billion in funding from the US government to meet its goals for Operation Warp Speed, an US government initiative to speed the development and delivery of COVID-19 vaccines and treatments. The award is funding the US and Mexico Phase III trial and manufacturing scale-up.
Amgen, Takeda, UCB Launch Study for COVID-19 Drugs
Amgen, Takeda, and UCB have launched an adaptive platform trial to evaluate therapeutic candidates to be studied in hospitalized COVID-19 patients.
The COMMUNITY trial (COVID-19 Multiple Agents and Modulators Unified Industry Members) was designed and launched by members of the COVID R&D Alliance, a group of more than 20 pharmaceutical and biotech companies that are engaged the development of potential therapies, novel antibodies, and anti-viral therapies for COVID-19 and its related symptoms. The companies say the trial will onboard global sites in the US, Brazil, Mexico, Russia, South Africa, and other countries to allow the trial sites to be active when cases spike locally.
Initial therapies entering into the trial were selected based upon their potential to suppress or control the immune response or the resulting inflammation. These therapies include: (1) Amgen’s Otezla (apremilast), which is approved to treat certain types of psoriasis and psoriatic arthritis, is being evaluated in the COVID-19 study to see if it may suppress immune-response inflammation; (2) Takeda’s investigational intravenous administration of lanadelumab, which modulates the kallikrein-kinin system and suppresses production of bradykinin and potentially lessens inflammation; and (3) UCB’s zilucoplan, an investigational medicine that may reduce overactivation of the immune system that contributes to acute respiratory distress syndrome.
Otezla entered trials this week (as reported on November 20, 2020), and the companies expect lanadelumab and zilucoplan will enter in the coming weeks (as reported on November 30, 2020). Other anti-viral, immunomodulating and vascular agents may enter in the coming months.
Regeneron in Pact for AAV Delivery of COVID-19 Antibody Cocktail
Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, has formed a research collaboration with the University of Pennsylvania (Penn) to investigate whether Regeneron’s investigational antibody cocktail consisting of casirivimab and imdevimab can prevent COVID-19 infection when delivered intranasally via adeno-associated virus (AAV) vectors.
Regeneron’s antibody cocktail is being studied in clinical trials for the treatment and prevention of COVID-19 and was granted an emergency use authorization last month (November 2020) by the US Food and Drug Administration (FDA) in certain high-risk patients with mild-to-moderate COVID-19.
Based on data from Regeneron’s preclinical studies showing that the antibody cocktail can prevent infection in animal models, the study will evaluate whether introducing the therapy via a single dose of AAV will be able to produce similar protection for potentially a longer duration.
Source: University of Pennsylvania
News on COVID-19 testing
Roche Gets FDA EUA for COVID-19 Antibody Test
Roche has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its Elecsys anti-SARS-CoV-2 S antibody test.
The serology (blood) test can be used to measure the level of antibodies in people who have been exposed to the SARS-CoV-2 virus. The EUA in the US follows the launch of the Elecsys anti-SARS-CoV-2 S antibody test in September (September 2020) for markets accepting the CE Mark, which indicates that a product has been assessed by the manufacturer and deemed to meet European Union safety, health and environmental protection requirements.
The new test targets antibodies that are directed against the region of the novel coronavirus known as the spike protein, specifically the area that enables the virus to bind to a host cell receptor, which is required for the virus to enter the host cell. In addition to helping measure a patient’s immune response, the company says the test may help guide the allocation of plasma donations from recovered COVID-19 patients to current patients by identifying donors that have antibodies to SARS-CoV-2 virus.