In July a major initiative of the International Federation of Pharmaceutical Manufacturers and Associations, designed to combat the rising tide of antimicrobial resistance (AMR) and accelerate the pace at which new antibiotics are discovered and brought to market, was announced. The $1 billion AMR Action Fund, supported by 23 pharma companies, was created “because there was a clear realization that we have no time to spare to address the lack of innovation in this area,” said Martin Bott, interim general manager of the fund, who described the progress being made with the fund in a fireside chat at this week’s virtual BIO Investor Forum (BIF).
Bott was speaking with Gregory Frank, senior director of Infectious Disease Policy at the Biotechnology Innovation Organization (BIO), who leads several infectious diseases policy issues, including antimicrobial resistance and vaccine policy. In his opening remarks, Frank painted a dire picture of the current situation, where several innovative biotechnology companies working on antibiotics have had to close their doors unable to get sufficient return on their investments to remain viable. In parallel, there has been limited investment in the field because the rewards are simply not there.
Bott agreed, “The dearth of innovation is the direct result of the lack of valuation and rewards for companies working in this space.”
Using the existing drugs more efficiently and minimizing inappropriate use of antibiotics is not the answer either. “You cannot steward your way out of the problem,” Frank said, “you need to have a steady product pipeline as AMR will always be with us.”
In reality, the AMF is “buying time,” Bott explained, it will only serve as a temporary solution, since we also need to involve other stakeholders, such as governments, that will need to implement market-based changes, including reimbursement reforms and new pull incentives, to drive sustainable investments in antibiotic R&D. The fund seeks to bridge the gap and help bring at least two to four new antibiotics to market by 2030.
Bott explained that since the fund was first announced, there has been a lot of interest expressed and by the time the AMF closes, he said, additional investors will likely join the original pharmaceutical company group.
Bott said he hopes the fund will become operational by the end of 2020 with the establishment of a management team and an independent scientific advisory board (SAB). The fundamental focus of the fund will be on the science and the projects that will be funded will probably be phase II-ready. It is at this point smaller biotech companies usually lack the resources to fund large-scale, later-stage trials and this is where the fund can strengthen and accelerate antibiotic development, providing much-needed financial resources and technical support to help take promising candidates forward.
The SAB will be looking for scientific excellence and new antibiotics targeting the WHO/CDC priority lists of pathogens, that address the highest priority public health needs, Bott explained.
With the clock ticking on the urgent need to develop new antibiotics, the ongoing COVID-19 pandemic has given policy makers a sharp reminder that the focus should not be lost on antibiotic resistance as well, which has the potential to dwarf COVID-19 in terms of deaths and economic costs.
The current situation has also renewed investors’ interest in companies that not only have therapeutics in their pipelines to combat the spread of the coronavirus infection but also in the infectious diseases space.
The massive upward trend of the BioWorld Infectious Diseases index reflects this renewed enthusiasm for companies in the group. At market close today, it was recording a year-to-date increase in value of 161%. (See BioWorld Infectious Diseases index, below.)
There is no doubt that this jump has been in large part fueled by companies developing COVID-19 therapies. Gaithersburg, Md.-based Novavax Inc. (NASDAQ:NVAX) is case in point, with an incredible 2,590% gain in its share price year to date (YTD). Late last month, the company reported it had initiated its first phase III study to evaluate its COVID-19 vaccine candidate NVX-CoV2373. The trial, being conducted in the U.K. in partnership with the U.K. government’s Vaccines Taskforce, is expected to enroll and immunize up to 10,000 individuals between 18-84 (inclusive) years of age, with and without relevant comorbidities, over the next four to six weeks.
Novavax says it is also continuing to scale up its manufacturing capacity, currently at up to 2 billion annualized doses, once all capacity has been brought online next year.
South San Francisco-based Vaxart Inc., which is developing oral recombinant protein vaccines administered using a room temperature-stable tablet, rather than an injection, began the year as a “penny stock” but its stock price (NASDAQ:VXRT) has been on the rise ever since. At one point they had increased over 3,000% in value. However, they have since slipped and closed up 1,637%.
This month it reported that the first subject had been dosed in its phase I study of VXA-CoV2-1, an oral tablet COVID-19 vaccine candidate. The trial is designed to examine the safety and immunogenicity of two doses of VXA-CoV2-1 in up to 48 healthy adult volunteers aged 18 to 54 years old. Enrollment is expected to be completed next month, with participants receiving the low or high dose of the VXA-CoV2-1 oral tablet at days 1 and 29. Safety, reactogenicity and immunogenicity assessments will be performed at set times during the active phase.
The increasing share value of Seres Therapeutics Inc. (NASDAQ:MCRB) has also boosted the index with an initial surge in August following its positive top-line results from a pivotal phase III ECOSPOR III study evaluating its investigational oral microbiome therapeutic SER-109 for recurrent C. difficile infection (CDI). The study showed that SER-109 administration resulted in a highly statistically significant absolute decrease of 30.2% in the proportion of patients who experienced a recurrence in CDI within eight weeks of administration versus placebo, the study’s primary endpoint.
This week the company announced it will present this data at next week’s virtual American College of Gastroenterology scientific meeting along with new data that show SER-109 led to a sustained highly statistically significant absolute reduction in CDI recurrence at 12 weeks post-treatment when compared to placebo. Additionally, new findings demonstrate that SER-109 administration resulted in similar efficacy when stratified by age groups (i.e., > or <65 years) or prior antibiotic received (i.e., vancomycin or fidaxomicin). The company’s shares are trading up 887% year-to-date.
Cowen & Co. analyst Joseph Thome wrote in a note that, “We are encouraged that SER-109 continues to show a similar magnitude of benefit for patients out to 12-weeks post-treatment, and we believe the data in the study will be supportive of approval.”
Cowen is modeling for an approval and launch of the product late next year with peak U.S. revenues of $500 million in 2033.