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The Week That Was: MRK Enters COVID Space, GSK's 1Bln Dose Target, Roche, GILD Team Up For REMDACTA

covid19 may29 lt

The safety of Hydroxychloroquine, the malaria drug that President Trump believed to be a "game-changer" in the fight against coronavirus, has been called into question and the WHO has now temporarily halted trials involving this drug in several countries.

According to data from the COVID-19 and Cancer Consortium (CCC19) registry, treatment with both Hydroxychloroquine and Azithromycin was also strongly associated with increased risk of death in patients with cancer and COVID-19.

The week that just passed by saw some big names joining the race to develop vaccines for COVID-19, a couple of deals to speed up the manufacture of the vaccine and promising trial results of one of the potential COVID-19 treatments.

Read on…

1. Novavax Initiates Phase I/II Trial of NVX-CoV2373 Vaccine

Novavax Inc. (NVAX) on Monday announced the initiation of phase I/II clinical trial of its coronavirus vaccine candidate, NVX-CoV2373.

NVX-CoV2373 contains Novavax' proprietary Matrix-M adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies.

The phase I portion of the trial is designed to enroll approximately 130 healthy participants 18 to 59 years of age at two sites in Australia. The preliminary immunogenicity and safety results from the phase I portion of the trial are expected in July 2020.

The phase II portion of the trial, which will immediately begin following the successful phase I portion, is expected to be conducted in multiple countries, including the United States, and would assess immunity, safety and COVID-19 disease reduction in a broader age range.

In a bid to expand its manufacturing capacity and achieve an annual capacity of over 1 billion doses of antigen starting in 2021 for NVX-CoV2373, Novavax on Thursday acquired Praha Vaccines in an all-cash transaction of approximately $167 million. The acquisition includes a biologics manufacturing facility and associated assets in Bohumil, Czech Republic.

NVAX closed Friday's trading at $46.04, up 2.68%.

2. Merck Jumps Into COVID Space

Merck & Co. Inc. (MRK) announced its foray into the COVID space on Tuesday by acquiring a private Austrian firm Themis and entering into collaboration with IAVI, a non-profit research organization, besides teaming up with Ridgeback Biotherapeutics LP.

Themis, which Merck has agreed to acquire, has a pipeline of vaccine candidates based on a measles vaccine vector technology called Themaxyn that was licensed from the Institut Pasteur in France. The two companies already have a partnership that was signed last August for the discovery and development of undisclosed vaccine candidates using Themis' measles virus vector-based platform.

Themis' COVID-19 vaccine candidate is in pre-clinical development, and clinical studies are planned to start later in 2020.

The second deal, which is a collaboration with IAVI, focuses on advancing rVSV, an IAVI-designed and engineered SARS-CoV-2 vaccine candidate. This vaccine is in preclinical development, and Merck will help move it in clinical studies, which are planned to start later in 2020.

The third deal, which is a collaboration with Ridgeback Biotherapeutics, will see Merck gaining exclusive worldwide rights to develop and commercialize the former's antiviral compound EIDD-2801 currently in early clinical development for the treatment of patients with COVID-19.

MRK closed Friday's trading at $80.72, up 2.13%.

3. Novartis Backs AAVCOVID Vaccine Program

The Massachusetts Eye and Ear and Massachusetts General Hospital's AAVCOVID vaccine program, which is working on a novel experimental gene-based COVID-19 vaccine, got a boost on Thursday with AveXis, a Novartis Company, joining hands.

The AAVCOVID vaccine program is a gene-based vaccine strategy that seeks to deliver genetic sequences of the SARS-CoV-2 using an AAV vector.

AveXis has agreed to contribute the use of its gene therapy manufacturing expertise to help produce and scale up the vaccine this month while AAVCOVID undergoes further safety and efficacy testing in preclinical studies taking place at academic medical institutions including Mass. Eye and Ear.

The clinical trials of the AAVCOVID vaccine are scheduled to begin in the second half of 2020.

NVS closed Friday's trading at $87.43, up 1.33%.

4. GSK To Produce 1Bln Doses Of Vaccine Booster For Partners

GlaxoSmithKline plc (GSK), which has been collaborating with companies and research groups across the world working on promising COVID-19 vaccine candidates by offering its innovative vaccine adjuvant technology, has now set itself a target to produce 1 billion doses of pandemic vaccine adjuvant in 2021 to support multiple COVID-19 vaccine collaborations.

An adjuvant is an ingredient used in certain vaccines that allows people receiving the vaccine to achieve a stronger immune response.

GSK's pandemic adjuvant is capable of reducing the amount of vaccine protein required per dose, which allows more vaccine doses to be produced, contributing to protecting more people. Additionally, an adjuvant can enhance the immune response and has been shown to create a stronger and longer-lasting immunity against infections.

The Company has started manufacture of the adjuvant and is in discussions with Governments and global institutions about funding for production and supply of the adjuvant.

In April of this year, GSK teamed up with Sanofi to combine innovative technologies to develop an adjuvanted COVID-19 vaccine, which is expected to enter clinical trials in the second half of 2020. If all goes well as planned, the vaccine could be available by the second half of 2021.

GSK closed Friday's trading at $41.92, up 0.91%.

5. AstraZeneca Seeks Oxford Biomedica's Support To Manufacture AZD1222

AstraZeneca UK Ltd has roped in Oxford Biomedica plc, a gene and cell therapy group, to manufacture the adenovirus vector-based COVID-19 vaccine candidate, AZD1222, which is under a phase II/III trial at multiple sites in the UK.

The follow up of healthy adult volunteers in a phase I trial of AZD1222, formerly known as ChAdOx1 nCoV-19, is currently ongoing.

As part of the Clinical & Commercial Supply Agreement, AstraZeneca will have access to Oxford Biomedica's new 7,800 m2 commercial manufacturing centre Oxbox, located in Oxford, UK.

AZN closed Friday's trading at $54.60, up 2.06%.

6. PureTech To Advance LYT-100 In Clinical Trial In COVID-19 Patients

PureTech Health plc (PRTC.L) is all set to advance its drug candidate LYT-100 in a clinical trial in non-critical COVID-19 patients with respiratory complications in the third quarter of this year.

The Company believes that LYT-100 has the potential to treat serious respiratory complications, including inflammation and fibrosis that persist following the resolution of SARS-CoV-2 (COVID-19) infection.

The trial is expected to enroll approximately 150 patients, with a primary endpoint measuring pulmonary function testing. The trial will also assess exploratory endpoints including pharmacokinetics, acute inflammatory biomarkers, hospitalisation events, imaging, and patient-reported outcomes. The topline results from the study are expected in mid-2021.

PRTC.L closed Friday's trading at £255.50, up 0.79%.

7. Orpheris To Initiate Phase 2 Study of OP-101 in Severe COVID-19 Patients

Orpheris, a subsidiary of Ashvattha Therapeutics, has been given the go-ahead by the FDA to initiate a phase II clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of OP-101 in patients with severe COVID-19.

In a phase I study, a single IV dose of OP-101 (20 or 40 mg/kg) in normal healthy volunteers was found to be generally well-tolerated, with no deaths or serious adverse events. A single subcutaneous dose of OP-101 (4 or 8 mg/kg) in healthy volunteers in the phase I study was found to be well tolerated with only mild transient injection site reactions and no other adverse events.

Ashvattha Therapeutics is a spinoff from Johns Hopkins Medicine.

8. Roche, Gilead Come Together For REMDACTA Trial

Roche (RHHBY.OB) is collaborating with Gilead Sciences Inc. (GILD) to initiate a phase III clinical trial of Actemra/RoActemra plus Remdesivir in hospitalized patients with severe COVID-19 pneumonia, dubbed REMDACTA.

Actemra/RoActemra is Roche's drug which is approved for rheumatoid arthritis, juvenile idiopathic arthritis, and giant cell arteritis. Remdesivir is Gilead's investigational antiviral.

The REMDACTA study is expected to begin enrolling in June with a target of approximately 450 patients globally.

A phase III clinical trial evaluating Actemra/RoActemra plus standard of care (SOC)in hospitalized adult patients with severe COVID-19 pneumonia, dubbed COVACTA, is already underway. Data from this study is expected to be available this summer.

RHHBY.OB closed Friday's trading at $43.35, down 1.37%.

9. I-Mab's Phase I Study Of COVID-19 Therapy Completes Part I, Moves To Part 2

I-Mab (IMAB), on Thursday, said that its phase I study of TJM2 in patients with cytokine release syndrome associated with severe coronavirus disease 2019 (COVID-19) has yielded positive results.

Part 1 of the phase I study evaluated the safety and tolerability of TJM2 in a total of 24 patients who were randomized at a ratio of 1:1:1 to receive either a single dose of 3 mg/kg TJM2, a single dose of 6 mg/kg TJM2 or placebo (standard care), administered by intravenous (IV) infusion.

The Data monitoring committee, which reviewed the part 1 clinical data has unanimously recommended that the study proceeds to part 2, indicating that TJM2 is safe and well-tolerated in the severe COVID-19 patients in the study. The part 2 of the study, which will evaluate the efficacy, safety and cytokine levels following a single dose of 6mg/kg TJM2or placebo in 120 patients with severe COVID-19, is expected to be initiated shortly.

IMAB closed Friday's trading at $24.93, up 2.38%.

10. Anivive Finds Purpose For Veterinary Drug In COVID-19

Anivive Lifesciences, a next-generation pet health drug discovery and commercialization company, is repurposing its veterinary drug GC376 for COVID-19, and has filed a pre-Investigational New Drug (pIND) request with the FDA.

GC376 has been evaluated since 2018 to treat the leading cause of death in kittens and young cats, Feline Infectious Peritonitis (FIP), a disease caused by a coronavirus.

The Company expects to get FDA guidance on the proposed clinical study protocol, after which it will submit an IND application for GC376 to be evaluated as a potential addition to the current standard of care treatment for COVID-19.

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