The devastating societal and economic effects caused by the ongoing COVID-19 pandemic should sound a warning bell on how ill-prepared we are in our ability to fight lethal infectious diseases for which no effective therapies or vaccines currently exist.
Indirectly, the intense public attention on companies that are engaged in developing COVID-19 cures is also spilling over to companies researching to uncover new anti-infectives that will be needed to replace the diminishing arsenal of effective therapies to combat drug-resistant bacteria and fungi. This is certainly evident among public companies in the space, with the BioWorld Infectious Diseases index showing an increasing upward trend since the beginning of the year. At market close on May 11, the index had, in fact, grown in value by a whopping 47%. (See BioWorld Infectious Diseases index, below.)
Not surprisingly, the index value has been catalyzed by those companies developing COVID-19 therapies. South San Francisco-based Vaxart Inc., for example, reports it is developing oral recombinant protein vaccines administered using a room temperature-stable tablet, rather than an injection. Late January, it announced that it had initiated a program to develop a COVID-19 vaccine candidate based on its vaccine platform.
In April, it reported that it had obtained positive preclinical results for its COVID-19 vaccine candidates, with several of them generating immune responses in all tested animals after a single dose. Antibody responses in all vaccinated groups were statistically significant compared to the untreated controls. That latest dataset, the company said, will help it to select the lead candidate for manufacturing, and it is looking to start a first phase I study in the second half of the year. The company’s shares (NASDAQ:VXRT) have jumped a massive 672% since the beginning of the year.
Shares of Gaithersburg, Md.-based Novavax Inc. popped 62% May 12 (355% year-to-date) on news that the Coalition for Epidemic Preparedness Innovations (CEPI) is planning to invest up to $384 million of additional funding in the company, on top of $4 million it invested in March, to further clinical development of NVX-CoV2373, the company’s coronavirus vaccine candidate against SARS-CoV-2. The funds will also enable the rapid scale-up of the NVX-CoV2373 vaccine antigen, as well as Novavax’s Matrix-M adjuvant, which is expected to enhance immune responses by stimulating high levels of neutralizing antibodies. It will also allow Novavax to significantly increase its large-scale manufacturing capability.
With the funds in hand, the company is looking to start a phase I/II trial testing NVX-CoV2373, with the phase I portion starting this month in Australia and the phase II component to be conducted in multiple countries following successful phase I top-line results expected in July.
In a research note on the development, H.C. Wainwright analyst Vernon Bernardino commented that CEPI was impressed with Novavax’s extensive history working with emerging infectious diseases, including CoV. “We believe prior experience can help Novavax close the gap with its competitors. In terms of timeline, we believe Novavax can close the gap that companies, such as J&J, Moderna Therapeutics and Pfizer with its partner, Biontech, may have in lead time with clinical development of their own CoV vaccine candidates. We give the odds of success as between 70% to 80%.”
Novavax is also a member of an expert group brought together by the World Health Organization (WHO) to work on the development of COVID-19 vaccines. They have signed a pledge to strengthen collaboration and sharing of data.
In a declaration on WHO’s website, companies including Sanofi SA, Moderna Inc., Inovio Inc., Clover Biopharmaceuticals Inc., Cansino Biologics Inc., Curevac AG and Novavax, which have some of the most advanced vaccine candidates, say they will continue efforts to strengthen the “unprecedented” cooperation, “to help reduce inefficiencies and duplication of effort.”
Vir Biotechnology Inc. (NASDAQ:VIR) has also received a great deal of investor enthusiasm of late for its investigational RNAi therapeutic candidates targeting the SARS-CoV-2 genome. As a result, the company’s shares have shot up by 143% year-to-date.
Last week, it announced that, together with Alnylam Pharmaceuticals Inc., it had selected VIR-2703, an inhalational formulation for the potential treatment and/or prevention of COVID-19, as a development candidate to move into clinical trials. The companies said they are planning to meet with regulatory authorities to discuss a potential accelerated path for an investigational new drug (IND) or IND-equivalent filing by the end of the year.
San Francisco-based Vir is also working on securing manufacturing capabilities. In April, it entered a manufacturing agreement with Samsung Biologics Co. Ltd., of Songdo, South Korea, under which Samsung Biologics will perform large-scale manufacturing services for Vir’s SARS-CoV-2 monoclonal antibody program. Under terms of the deal, valued at about $362 million, Samsung Biologics is expected to start manufacturing as early as October, with potential commercial batches to be manufactured starting next year.