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The Week That Was: COVID-19 Drug/Vaccine Development Landscape

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The deadly pathogen SARS-COV-2, which causes COVID-19, continues to spread unabated in most parts of the world while in some regions it has been brought under control. At last count, the total number of confirmed cases of infection across the globe is 5.31 million and the death toll is 342,147. The U.S. tops the list with 1.62 million confirmed cases and 97,087 fatalities, according to Johns Hopkins University.

As the companies race against time to develop antibiotics or vaccines against the novel coronavirus, here's what happened in the COVID-19 drug/vaccine development space in the week that went by.

1. Moderna's COVID-19 Vaccine Candidate On Track For Phase II Study

Moderna Inc.'s (MRNA) vaccine candidate against the novel coronavirus, mRNA-1273, has yielded positive results in a phase I study that was led by the National Institute of Allergy and Infectious Diseases.

In the phase I study, all eight participants evaluated to date across the 25 µg and 100 µg dose cohorts of mRNA-1273 developed detectable antibodies in the blood against the novel coronavirus at or above levels seen in convalescent sera. In addition, the vaccine candidate elicited neutralizing antibody titer levels in all the participants across the 25 µg and 100 µg dose cohorts, reaching or exceeding neutralizing antibody titers generally seen in convalescent sera. Neutralizing antibodies interferes with a virus/pathogen's ability to infect a cell.

The phase II study of mRNA-1273 vaccine will be conducted by Moderna. The Company was given FDA clearance to initiate a phase II study of the vaccine on May 6, and the study is expected to begin shortly.

Moderna is finalizing the protocol for a phase III study, which is scheduled to begin in July 2020.

MRNA closed Friday's trading at $69.00, up 2.91%.

2. IMV Selects COVID-19 Vaccine Candidate To Advance Into Phase I testing

IMV Inc. (IMV), which has been evaluating a number of peptide epitopes in an animal model, has selected a vaccine candidate for COVID-19 to advance into human testing.

The vaccine, dubbed DPX-COVID-19, is designed to utilize a multi-target approach, to optimize immune response against virus' weaknesses, enhance efficacy at preventing infection and reduce the potential for immune escape, according to the Company.

A phase I clinical study of DPX-COVID-19 in Canada is scheduled to be launched during summer 2020.

IMV closed Friday's trading at $3.53, down 2.75%.

3. NantKwest Gets Clearance To Move BM-Allo.MSC Into Clinical Study In COVID-19 Patients

NantKwest Inc. (NK) has been given the go-ahead by the FDA to advance BM-Allo.MSC, an allogeneic mesenchymal stem cell (MSC) product derived from human bone marrow, into human testing for the treatment of acute respiratory distress syndrome (ARDS) caused by COVID-19.

The clinical study of BM-Allo.MSC in severe COVID-19 disease patients receiving care in the critical care or ICU setting in Los Angeles area hospitals is expected to start this quarter (Q2).

NK closed Friday's trading at $5.58, down 2.45%.

4. Aldeyra To Advance Potential COVID-19 Meds Into Clinical Study In Q3, 2020

Aldeyra Therapeutics Inc. (ALDX) has plans to test two of its compounds - ADX-1612 and ADX-629 - as a treatment for COVID-19.

ADX-1612 is an inhibitor of chaperone protein HSP90, a target widely implicated in viral disease.

In lab studies, ADX-1612 has demonstrated nanomolar potency similar to or greater than that of Gilead's Remdesivir. Complementary to the nucleic acid inhibition mechanism of action of Remdesivir and related antiviral compounds, ADX-1612 potentially leads to the inhibition of proteins associated with viral replication and infection and thereby may enhance the activity of other antiviral drugs for the treatment of COVID-19, according to the Company.

The Company plans to submit an Investigational New Drug (IND) application, seeking clearance to initiate a clinical trial of ADX-1612, in the third quarter of 2020.

The second potential COVID-19 drug candidate ADX-629 has been granted a BARDA CoronaWatch meeting.

ADX-629 has completed pre-IND discussions with the Pulmonary Division of the FDA, and Aldeyra expects to submit an IND application, seeking clearance to initiate a human trial, in June 2020.

ALDX closed Friday's trading at $4.27, up 0.71%.

5. Appili To Test Favipiravir As Preventative Measure against COVID-19 Outbreaks

Appili Therapeutics Inc. (APLI.V) has received regulatory clearance from Health Canada to conduct a phase II study evaluating FUJIFILM Toyama Chemical's Favipiravir as a preventative measure against COVID-19 outbreaks.

The study, which will enroll approximately 760 subjects, both residents and staff, at 16 long-term care homes (LTCHs) in Ontario, is expected to begin immediately. This is the first clinical study to examine the use of Favipiravir for COVID-19 outbreak control.

Favipiravir, under the brand name Avigan, is approved in Japan as a treatment and stockpile countermeasure for the pandemic influenza outbreak.

APLI.V closed Friday's trading at C$1.69, up 0.60%.

6. Octapharma To Initiate Phase III of Trial Of Octagam 10% In COVID-19 Patients

Privately-held Octapharma USA has secured FDA clearance to initiate a phase III trial of Octagam 10% therapy in COVID-19 patients with severe disease progression.

Octagam 10% is an immune globulin intravenous (human) liquid preparation indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) in adults.

The trial to evaluate Octagam 10% therapy will enroll about 54 adult patients diagnosed with COVID-19 with a resting SpO2 of less than or equal to 93%, requiring oxygen supplementation. SpO2, also known as oxygen saturation, is a measure of the amount of oxygen-carrying hemoglobin in the blood relative to the amount of hemoglobin not carrying oxygen.

Octapharma hopes to report results from the phase III Octagam 10% therapy study in COVID-19 patients by the third quarter of 2020.

7. Inovio Expects Phase I Covid-19 Vaccine Trial Results In June

Inovio Pharmaceuticals Inc.'s (INO) vaccine candidate against the novel coronavirus SARS-CoV-2, which causes COVID-19, INO-4800, has demonstrated promising results in animal testing.

Mice and guinea pigs vaccinated with INO-4800 generated robust binding and neutralizing antibody as well as T cell responses, which could provide protection from SARS-CoV-2.

A phase I clinical trial evaluating the safety profile and immunogenicity of INO-4800 in humans is underway in the U.S. Preliminary safety and immune response data from the phase I trial are expected in June.

If all goes well as planned, the Company plans to start a phase II/III efficacy trial of INO-4800 in July/August.

INO closed Friday's trading at $14.08, down 1.12%.

8. Vaxart's COVID-19 Vaccine Candidate To Enter Phase I Study In Summer

After evaluating multiple vaccine candidates in preclinical models, Vaxart Inc. (VXRT) has selected its lead COVID-19 vaccine candidate and has contracted with KindredBio to manufacture bulk vaccine to complement the manufacturing capacity of partner Emergent BioSolutions.

Vaxart's vaccines are produced in tablet form and are not injectable vaccines.

The Company is planning to start its first phase I study of COVID-19 vaccine candidate in the second half of this year, possibly as early as the summer.

VXRT closed Friday's trading at $2.91, down 3.32%.

9. CanSino' Phase I Study Results of COVID-19 Vaccine Candidate Published In Lancet

CanSino Biologics Inc.'s recombinant novel coronavirus vaccine candidate Ad5-nCoV has demonstrated that it is tolerable and immunogenic at 28 days post-vaccination in a phase I study.

The phase I study was conducted in Wuhan, China, and it involved healthy adults aged between 18 and 60 years.

Ad5-nCoV as an intramuscular injection of vaccine was tested in three dose groups. Humoral response, i.e., the formation of antibodies against SARS-CoV-2, peaked at day 28 post-vaccination in healthy adults, and rapid specific T-cell responses were noted from day 14 post-vaccination, according to the study findings published in the Lancet.

A phase II trial of Ad5-nCoV, designed to enroll 500 healthy adults, is underway, with results expected to be available by January 2021.

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