The week that just passed by saw the White House selecting vaccine candidates to Operation Warp Speed; new entrants in the COVID-19 drug development space; AstraZeneca’s multi deals to produce and supply its vaccine and INOVIO’s trials and tribulations, among others.
1. Lilly Begins Phase I Antibody Drug Trial For COVID-19
Eli Lilly and Co. (LLY), which has been collaborating with privately-held Canadian biotech AbCellera to develop LY-CoV555, an antibody treatment for the novel coronavirus, on Monday, began its phase I trial in patients hospitalized with COVID-19.
The phase I trial, which assesses the safety and tolerability of LY-CoV555, represents the world’s first study of a potential COVID-19 antibody treatment in humans. The results from the study are anticipated by the end of June.
If the phase I results show the antibody can be safely administered, Lilly will initiate a phase II proof of concept study to assess efficacy in vulnerable populations.
Lilly is also collaborating with China’s Shanghai Junshi Biosciences Co. Ltd. to develop an antibody treatment for COVID-19. A clinical trial of the investigational antibody is expected to be initiated this month, according to reports.
LLY closed Friday’s trading at $149.21, down 1.00%.
2. White House Selects Famous Five To ‘Operation Warp Speed’
The White House, on Wednesday, selected 5 COVID-19 vaccine candidates to ‘Operation Warp Speed’, the national program aiming to get a vaccine ready against the novel coronavirus by January 2021.
The selected candidates are:
Moderna Inc.’s (MRNA) vaccine candidate mRNA-1273, which is under a phase II study, with phase III study expected to be initiated in July.
AstraZeneca PLC’s (AZN) COVID-19 vaccine candidate AZD1222, being developed in partnership with Oxford University’s Jenner Institute, which is under a phase II/III trial at multiple sites in the UK.
Johnson & Johnson’s (JNJ) COVID-19 vaccine candidate Ad26 SARS-CoV-2, which is expected to enter human clinical trial this September.
Pfizer Inc. (PFE)/BioNTech (BNTX) BNT162 vaccine program, which is under a phase I/II trial in Germany.
Merck (MRK) SARS-CoV-2 vaccine candidate, which is currently in preclinical development, with clinical studies expected to start later this year.
3. AstraZeneca Inks Multi Deals To Produce And Supply COVID-19 Vaccine
AstraZeneca PLC (AZN), which is developing COVID-19 vaccine candidate AZD1222, has inked landmark agreements with the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi the Vaccine Alliance, and the Serum Institute of India (SII) as a part of its efforts to bring the vaccine to low-and-middle-income countries and beyond.
AZD1222 is being developed in partnership with Oxford University’s Jenner Institute, and the vaccine is currently under a phase II/III trial at multiple sites in the UK.
AstraZeneca has reached a $750 million deal with CEPI and Gavi to support the manufacturing, procurement, and distribution of 300 million doses of the potential vaccine, with delivery starting by the end of the year.
The licensing agreement with Serum Institute of India is to ensure the supply of one billion doses for low-and-middle-income countries, with a commitment to provide 400 million before the end of 2020.
AstraZeneca has so far secured manufacturing capacity for two billion doses of the vaccine.
On Tuesday, the Brazilian Ministry of Health gave the clearance to conduct clinical trials with the AZD1222 vaccine in Brazil. About 2,000 volunteers will be tested in the country with the investigational COVID-19 vaccine.
AZN closed Friday’s trading at $53.85, down 0.04%.
4. INOVIO Begins Trial In South Korea, So Does Its Tribulation
INOVIO (INO), on Thursday, announced that it is starting a phase I/II clinical trial of its COVID-19 vaccine INO-4800 in South Korea.
The International Vaccine Institute (IVI) and Seoul National University Hospital are collaborating with the Company to start this trial, which is the first clinical study of the COVID-19 vaccine in Korea. The 2-stage trial of INO-4800 will assess the safety, tolerability, and immunogenicity of the candidate vaccine in 40 healthy adults aged 19-50 years, and will further expand to enroll an additional 120 people aged 19-64 years.
A phase I clinical trial evaluating the safety profile and immunogenicity of INO-4800, which was initiated in April of this year in the U.S. is underway, with data expected this month. The Company plans to begin phase II/III trials in mid-summer.
In other news, INOVIO on Friday sued VGXI Inc., a wholly-owned subsidiary of GeneOne Life Science, its contract manufacturer for the supply of the INO-4800 vaccine, as the supplier has informed INOVIO that apparently it won’t be able to meet the Company’s need for 1 million doses of the vaccine by this year-end.
VGXI has also refused to divulge the manufacturing and material-handling process that would allow another manufacturer to use its methods. So INOVIO has alleged that “VGXI is holding the vaccine and world health hostage”.
INO closed Friday’s trading at $11.93, up 0.42%.
5. Russia Approves First Drug To Treat COVID-19
Avifavir, developed by the Russian Direct Investment Fund (RDIF) in partnership with ChemRar Group, has been included in Russia’s list of nationally recommended drugs for the treatment of COVID-19.
The drug will be available to Russian hospitals from June 11, 2020.
Commenting on the development, Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said, “Avifavir is also the first drug against coronavirus registered in Russia, having demonstrated efficacy in clinical trials”.
6. Resverlogix To Foray Into COVID Space
Canadian biotech Resverlogix Corp. (RVX.TO) is planning to test its lead compound Apabetalone in the treatment of COVID-19.
Apabetalone is a first-in-class, small molecule that is a selective BET (bromodomain and extra-terminal) inhibitor. This selective inhibition of Apabetalone is said to have potentially important benefits for patients with high-risk cardiovascular disease, diabetes mellitus, chronic kidney disease, end-stage renal disease, neurodegenerative disease, Fabry disease, peripheral artery disease, and other orphan diseases, according to the Company.
The first step of investigating whether Apabetalone treatment of human cells susceptible to 2019 novel coronavirus (2019-nCoV) infection will impact the replication cycle of the virus has been initiated by the Company.
7. No RECOVERY For Hydroxychloroquine
A clinical trial, dubbed RECOVERY, testing various potential drugs for COVID-19, including Hydroxychloroquine, in the U.K has found that there is no beneficial effect of Hydroxychloroquine in patients hospitalized with COVID-19.
According to a statement, released Thursday, by Professor Peter Horby and Professor Martin Landray, chief investigators of the RECOVERY Trial, there was no significant difference in the primary endpoint of 28-day mortality in the patients treated with Hydroxychloroquine and those given usual care alone.
Against this backdrop, the enrollment of participants to the Hydroxychloroquine arm of the RECOVERY trial is stopped with immediate effect.
8. King’s College Repurposing Novartis Drug For COVID-19
King’s College London and Guy’s and St Thomas’ NHS Foundation Trust have launched a trial that will evaluate the potential of Novartis Pharma’s Ruxolitinib in reducing complications in deteriorating COVID-19 patients, the need for intensive care and death rate.
Ruxolitinib, sold under the brand name Jakafi in the U.S., and as Jakavi elsewhere in the world, is used to treat adults with myelofibrosis or polycythemia vera, and for the treatment of graft versus host disease in adults and children at least 12 years old.
The first phase of the trial will enroll 19 patients. Upon successful completion, the study will advance to the second phase, which will involve 59 patients, according to King’s College London.
9. AbbVie & Team To Develop Antibody Therapeutic For COVID-19
AbbVie Inc. (ABBV), on Friday, announced that it is teaming up with Harbour BioMed, Utrecht University and Erasmus Medical Center to develop a novel antibody therapeutic to prevent and treat COVID-19.
The foursome will focus on advancing the fully human, neutralizing antibody 47D11 discovered by Utrecht University, Erasmus Medical Center, and Harbour BioMed that targets the conserved domain of the spike protein of SARS-CoV-2.
AbbVie will support the preclinical activities, while simultaneously undertaking preparations for later stage preclinical and clinical development work. The Company will receive an option to exclusively license the antibody from the three parties for therapeutic clinical development and commercialization worldwide. Financial terms were not disclosed.
The collaboration comes after Abbvie’s marketed HIV-drug combo Kaletra (Aluvia) failed to demonstrate any improvement in the clinical outcome of patients hospitalized with mild-to-moderate COVID-19 in a clinical trial in April of this year.
ABBV closed Friday’s trading at $93.85, up 0.87%.
10. Sun Pharma To Test Plant-based Drug For COVID-19
India’s Sun Pharmaceutical Industries Ltd., on Friday, launched a phase II clinical trial of AQCH, a plant-derived drug for the treatment of COVID-19.
In ‘in vitro’ studies, AQCH, which is being developed for dengue, has had a strong antiviral effect and therefore is being tested as a possible treatment option for COVID-19, according to the Company.
The clinical trial of AQCH for COVID-19 will be conducted across 12 centers in India, with 210 patients being treated for a duration of 10 days. The results of the clinical trial are expected to be released by October 2020.
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