Novavax News: Progress Towards Phase 3 Trials of Coronavirus Vaccine

Maryland-based biotechnology company Novavax, Inc. (NASDAQ: NVAX) is developing and testing a genetically-engineered nanoparticle vaccine for the SARS-CoV-2 coronavirus which causes COVID-19, with plans to initate a phase 1 trial in mid-May, and phase 2 and phase 3 trials following positive top-line results. Here is a timeline of events and the latest news.

  • Novavax Vaccine Derived from Coronavirus Spike Protein and Evaluated in Animal Models
  • Novavax Receives $4 Million from CEPI for Coronavirus Vaccine Development, Partners with Emergent BioSolutions, Inc.
  • Novavax Identifies Vaccine Candidate NVX-CoV2373 for Human Clinical Trials, Phase 1 Trial to Start in Mid-May 2020
  • CEPI Provides Up To $384 Million in Funding to Support Clinical Advancement of NVX-CoV2373 with Progress Towards Phase 2 and Phase 3 Human Trials
  • Novavax Announces Initiation of Phase 1/2 Human Clinical Trial of COVID-19 Vaccine Candidate NVX-CoV2373
  • Novavax Purchases Praha Vaccines to Expand Vaccine Production Capability

Novavax Vaccine Derived from Coronavirus Spike Protein and Evaluated in Animal Models

On February 26th, 2020, Novavax announced the advancement of its nanoparticle-based coronavirus vaccine to testing in animal models, with plans to initiate human trials “by the end of spring 2020.” After evaluating the safety and immunogenicity of multiple vaccine candidates in animal models, the company intends to identify an optimal candidate for progression to testing in humans.

The vaccine targets the spike (S) protein of the coronavirus and was created using the company’s recombinant protein nanoparticle technology platform, which involves the genetic programming of the insect cell line Sf9 to efficiently produce desired recombinant proteins “that are correctly folded and biologically active” and self-assemble into immune-stimulating nanoparticles.

In the context of a respiratory syncytial virus (RSV) vaccine, Novavax scientists introduced modifications to a naturally-occurring viral protein to increase its stability and encourage the self-assembly of synthesized recombinant proteins into nanoparticles that “approximate the size” of the virus. This is likely also the case for the recombinant proteins included in Novavax’s vaccine for COVID-19.

https://www.youtube.com/watch?v=_bxAKrBJvTk

Novavax anticipates that the coronavirus vaccine will include its proprietary Matrix-M™ adjuvant, a saponin-based formula that is intended to stimulate the movement and activity of antigen-presenting cells (APCs) at the site of vaccine administration.

APCs are critically important to the early stages of the immune response, uptaking vaccine antigen and migrating from the site of injection to immune cell-rich lymph nodes to further propagate and amplify the immune response to the vaccine.

President and CEO of Novavax Mr. Stanley C. Erck stated, “Our previous experience working with other coronaviruses, including both MERS and SARS, allowed us to mobilize quickly against COVID-19 and successfully complete the critical preliminary steps to engineer viable vaccine candidates.”

“Now that the protein has been expressed stably in our baculovirus system, we aim to identify the optimal candidate and scale up production of sufficient vaccine for preliminary clinical trials. We are now well-positioned to advance the COVID-19 vaccine candidate to Phase 1 clinical testing in May or June,” Mr. Erck continued. Novavax has not announced the expected start date of phase 2 or phase 3 trials.

Novavax has previously developed vaccine candidates against the human coronaviruses Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV-1), which demonstrated “strong immunogenicity” and “100% protection against virus challenge in preclinical testing.” The company has also developed an Ebola vaccine candidate that proved safe and effective in non-human primates.

Novavax Receives $4 Million from CEPI for Coronavirus Vaccine Development, Partners with Emergent BioSolutions, Inc.

On March 10th, 2020 Novavax announced that the Coalition for Epidemic Preparedness Innovations (CEPI) had provided $4 million in funding to support the development of Novavax’s COVID-19 vaccine, with the potential for additional subsequent funding from CEPI for phase 1 human trials which are expected to start in the “late spring of 2020.”

Mr. Erck stated, “This first stage of funding from CEPI is critical to enable ongoing development of our COVID-19 vaccine candidates. We commend CEPI for its role as a vital partner to bridge the funding gap for innovative biotech companies like Novavax, which have robust vaccine technology platforms. Novavax is working tirelessly to create a vaccine against this growing epidemic.”

CEPI CEO Dr. Richard Hatchett stated, “The current crisis shows that we cannot prevent all infectious diseases from emerging. But we can and must double down on developing vaccines. CEPI has moved quickly and urgently to coordinate with global health authorities and vaccine-development partners. CEPI is pleased to be partnering with Novavax to rapidly develop a potential vaccine candidate against the global threat posed by COVID-19.”

In addition, Novavax announced its partnership with Emergent BioSolutions, Inc. (Emergent), which will manufacture vaccine for use in preclinical testing and phase 1 human trials and could eventually scale vaccine production for stockpiling.

Novavax Identifies Vaccine Candidate NVX-CoV2373 for Human Clinical Trials, Phase 1 Trial to Start in Mid-May 2020

On April 8th, 2020, Novavax announced that it had identified a coronavirus vaccine candidate, NVX-CoV2373, from those evaluated in preclinical studies, and would initiate phase 1 human trials of the vaccine in mid-May, with phase 2 and phase 3 trials to follow.

NVX-CoV2373 was found to induce a potent humoral immune response in animal models, leading to the production of “high levels” of virus-neutralizing antibodies after a single dose of the vaccine that increased eight-fold after the administration of a second dose. According to Novavax, “High titer microneutralizing antibodies are generally accepted evidence that a vaccine is likely to be protective in humans.”

Novavax’s President of Research and Development Dr. Gregory Glenn, MD, stated, “Our scientists identified an ideal vaccine candidate selected from a number of constructs and, in partnership with Dr. Matthew Frieman, demonstrated that NVX-CoV2373 produces high levels of neutralizing antibodies against SARS-CoV-2 in animal studies.”

“In addition, we have worked closely with our colleagues at Emergent BioSolutions to transfer our production technology that allows the manufacture of GMP vaccine for clinical trials. With preliminary CEPI funding, these heroic efforts, combined with the candidate’s excellent early results, put us in position to have preliminary human data in July,” Dr. Glenn continued.

Associate Professor at the University of Maryland School of Medicine Dr. Matthew Frieman, PhD, stated, “We validated that NVX-CoV2373 generates high titer neutralizing antibodies against live SARS-CoV-2 virus. This is strong evidence that the vaccine created by Novavax has the potential to be highly immunogenic in humans which could lead to protection from COVID-19 and helping to control the spread of this disease.”

The NVX-CoV2373 clinical development plan combines a Phase 1/Phase 2 approach to allow rapid advancement during the current coronavirus pandemic. The Phase 1 clinical trial is a placebo-controlled observer blinded study of ~130 healthy adults and includes assessment of dosage amount and number of vaccinations. The trial is expected to begin in mid-May with preliminary immunogenicity and safety results in July.

A phase 1 placebo-controlled observer-blinded human clinical trial of the coronavirus vaccine is expected to start in mid-May and include approximately 130 healthy adults. The human trial will assess the “dosage amount and number of vaccinations” with preliminary data on the safety and immunogenicity of the vaccine available in July of 2020.

“Because of the tireless efforts and commitment of the Novavax team and our collaborators, we are preparing to initiate the NVX-CoV2373 Phase 1 trial in mid-May, weeks ahead of schedule. This progress demonstrates the ability of our recombinant nanoparticle technology to rapidly create vaccine candidates for emerging viruses like SARS-CoV-2. In addition, the performance of NVX-CoV2373 in multiple preclinical studies and testing gives us increased confidence in its potential to protect against COVID-19 disease,” said Mr. Stanley C. Erck, Novavax’s President and CEO.

CEPI Provides Up To $384 Million in Funding to Support Clinical Advancement of NVX-CoV2373 with Progress Towards Phase 2 and Phase 3 Human Trials

On May 11th, 2020, Novavax announced that the Coalition for Epidemic Preparedness Innovations (CEPI) would invest up to $384 million to support the clinical development of the coronavirus vaccine candidate NVX-CoV2373.

The funding will support the increased production of NVX-CoV2373 vaccine antigen and the proprietary Matrix-M™ adjuvant and will enable Novavax “to dramatically increase its large-scale manufacturing capacity for both antigen and adjuvant in multiple locations.” Novavax would require increased manufacturing capacity for phase 2 and phase 3 clinical trials and eventual clinical use of the vaccine, if these were to occur.

Mr. Erck stated, “CEPI plays a vital role in advancing innovative technologies against the COVID-19 pandemic. Their partnership and support allows Novavax to leverage its innovative vaccine platform and expertise in this global crisis. For the last few months, the entire Novavax team has been working nonstop in an ongoing effort to make our vaccine a reality, and we appreciate CEPI’s confidence in our technology platform and our progress.”

Novavax plans to use the funding to support its Australia-based phase 1 vaccine trial and, if successful top-line results are achieved, to fund phase 2 trials in multiple countries and amplified vaccine manufacturing that could allow for the production of 100 million doses of the vaccine by the end of the year and over one billion doses during 2021. Novavax will need to complete phase 3 clinical trials prior to widespread use of their vaccine.

CEPI CEO Dr. Richard Hatchett stated, “The expansion of our partnership with Novavax represents CEPI’s single biggest investment to date. Our vaccine R&D programmes are starting to show progress, so it is vital that we invest now to boost manufacturing capacity, so that our partners have the ability to produce vaccines at a global scale.”

“We still have a long way to go, but we’re making important steps forward to deliver a safe, effective, and globally accessible vaccine as quickly as possible,” Dr. Hatchett continued.

Novavax Announces Initiation of Phase 1/2 Human Clinical Trial of COVID-19 Vaccine Candidate NVX-CoV2373

On May 25th, 2020, Novavax announced the initiation of a phase 1/2 human trial of their vaccine candidate NVX-CoV2373. The trial will occur in two parts: a phase 1 study of the vaccine at two sites in Australia, and a phase 2 trial in multiple countries including the United States.

The vaccine candidate was selected for advancement to human trials based on immunogenicity and neutralizing antibody data in preclinical animal models.

Preliminary data on the safety and immunogenicity of the vaccine from the phase 1 portion of the trial is anticipated to be available in July of 2020. If the phase 1 study is successful, the phase 2 portion will begin promptly afterwards.

Novavax Purchases Praha Vaccines to Expand Vaccine Production Capability

On May 28th, 2020, Novavax announced its purchase of Praha Vaccines, a biologics manufacturer in the Czech Republic, with the intention of expanding its ability to mass produce its vaccine candidate should it be found safe and effective in a phase 3 human trial.

In addition to Novavax, a COVID-19 vaccine is under development by Moderna Pharmaceuticals and Inovio Pharmaceuticals, which have initiated human clinical trials. Ibio is also developing a COVID-19 vaccine but has not yet started human trials. Gilead Pharmaceuticals has completed a phase 3 clinical trial evaluating the use of the pharmacologic antiviral agent Remdesivir for the treatment of COVID-19.