Praha Vaccines’ assets include a 150,000-square foot vaccine and biologics manufacturing facility and other support buildings in Bohumil, Czech Republic. Novavax said the Bohumil facility is expected to deliver an annual capacity of over 1 billion doses of antigen starting in 2021 for NVX-CoV2373, the COVID-19 vaccine candidate being developed by Novavax.
The Bohumil facility is completing renovations that include the addition of Biosafety Level-3 (BSL-3) capabilities. The site’s approximately 150 employees with “significant experience” in vaccine manufacturing and support have joined Novavax, the company said.
NVX-CoV2373 consists of a stable, prefusion protein made using Novavax’ proprietary nanoparticle technology, and incorporates that company’s proprietary saponin-based Matrix-M™ adjuvant. NVX-CoV2373 is one of 19 “Front Runner” candidates among the 200+ COVID-19 therapeutics under study in GEN’s updated and just-launched “COVID-19 Drug & Vaccine Candidate Tracker.”
On Monday, Novavax enrolled its first participants in a Phase I/II clinical trial of NVX‑CoV2373 (NCT04368988). The trial is a two-part randomized, observer-blinded, placebo-controlled study designed to evaluate the immunogenicity and safety of the vaccine with or without Matrix-M adjuvant in healthy participants ≥ 18 to 59 years of age. Preliminary immunogenicity and safety results from the Phase I portion of the trial are expected in July 2020.
“Manufacturing capacity is a critical component of our strategy to deliver a vaccine for the COVID-19 pandemic,” Novavax CEO Stanley C. Erck, president and CEO, said in a statement. “This acquisition provides the vital assets required to produce more than 1 billion doses per year.”
In parallel with ramping up production at Bohumil, Erck added, Novavax will continue efforts to expand antigen capacity in the U.S. and Asia, and will increase production of Matrix-M to match antigen capacity at multiple sites globally.
Up to $388M from CEPI
Novavax said its acquisition of Praha is among uses to be funded by up to $388 million committed to the company by the Coalition for Epidemic Preparedness Innovations (CEPI). The funding consists of a $384 million grant announced May 11, and a $4 million investment CEPI made in March.
Also supported by CEPI funding is Novavax’s Phase I/II trial of NVX-CoV2373. The Phase I portion is a randomized, observer-blinded, placebo-controlled trial designed to evaluate the immunogenicity and safety of NVX-CoV2373, both adjuvanted with Matrix-M and unadjuvanted. The trial is enrolling approximately 130 healthy participants ages 18–59 at two sites in Australia. The protocol’s two-dose trial regimen assesses two dose sizes (5 and 25 micrograms) with Matrix-M and without.
The Phase II 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. Novavax said the Phase I/II approach will allow for rapid advancement of NVX-CoV2373 during the pandemic.
Based in Pune, India, the Cyrus Poonawalla Group owns companies that include its flagship, the Serum Institute of India (SII). SII says it is the world’s largest vaccine manufacturer based on numbers of doses produced and sold globally—more than 1.3 billion doses per year.
Novavax said it will work collaboratively with SII to increase production levels at the Bohumil facility by the end of this year. The partners in March agreed to use Novavax’s proprietary Matrix-M™ vaccine adjuvant with SII’s malaria vaccine candidate, now in a Phase IIb clinical trial.
“We believe Novavax and Praha reflect the ideal complement of capabilities and expertise to advance innovative vaccines that are vitally needed at this critical time,” said Cyrus Poonawalla, Chairman and Founder of his namesake group. “We are confident that the technologies and employees are in good hands and look forward to continuing our collaborations with Novavax.”
