What was the reason behind the establishment of RAPT Therapeutics and what is your vision for the company?
RAPT is an emerging clinical stage biotherapeutics company focused on the discovery, development, and eventual commercialization of oral drugs that target the immunologic causes of inflammation and cancer. The company's mission and vision are to develop game-changing new medicines in these therapeutic areas.
We’ve used our novel drug discovery platform to advance a diverse pipeline of drug candidates that address large market opportunities in areas of unmet medical need. Our development progress is derived from our platform’s ability to interrogate large datasets, using advances in computational sciences and our own immunology insights, to find and target the underlying drivers of these diseases.
Can you speak to RAPT’s pipeline and the progress the company has made to date?
Our two lead programs, RPT193 and FLX475, are novel approaches to targeting the immune system.
RPT193, our lead asset in inflammation, is a once-daily oral drug that targets a specific immune cell that has been linked to a variety of allergic disorders such as atopic dermatitis and asthma.
We presented findings from a placebo-controlled trial that showed encouraging efficacy, safety and tolerability in patients with atopic dermatitis. As an oral drug, we believe RPT193 may be preferable to other options that must be injected or infused. We are currently in a Phase 2 clinical trial that, if successful, will allow us to begin a Phase 3 clinical trial in 2024 that could serve as the basis for approval in both the United States and around the world.
FLX475 is our novel lead oncology asset that is designed to improve the body's natural ability to detect and eliminate cancer cells. It is currently being evaluated in a Phase 2 clinical trial and has shown encouraging results in lung cancer and certain lymphomas.
Capital markets have been difficult for life science biotechs in recent years; what is RAPT's financing strategy?
Investors are still active in the sector, but they are very selective in their support. This has been observed in both private company finances, new issuances and IPOs, as well as secondary public financings. With that said, we are pleased to have successfully raised US$125 million in 2022 from high-quality investors in response to encouraging data from both of our lead programs, and we now have the cash to support our operations into 2025, including to key data readouts and the start of our planned Phase 3 clinical trials. We attribute our successful fundraising in a difficult market to the promising data we have generated with our novel drug candidates and because we are focused on two therapeutic areas that are very attractive, and we are developing novel oral agents that could be much more appealing to patients.
Some of your colleagues have mentioned that it has been difficult to recruit patients for clinical trials. What has your experience been in this regard?
Enrolling and recruiting patients remains a challenge across the industry and therapeutic areas. In this new environment, we continue to monitor our enrollment rate and spend significant time selecting the right investigators and clinical trial sites that are experienced with enrolling patients in the type of trials we are running. Our initial trials enrolled during the COVID period, which presented significant challenges, but we were able to overcome these obstacles thanks to appropriate trial designs and logistics.
How has the global pandemic impacted the life science sector in your view?
COVID-19 is an incredible example of how, in the right circumstances, the biotech industry can truly move mountains to protect public health. This was a modern-day Manhattan Project in which decades of investment in basic research, a thriving biotechnology sector, and collaboration with the FDA resulted in highly effective vaccines and therapeutics in record time.
One major takeaway is that it is critical for the United States and other countries to continue funding and supporting basic research in order to provide a nurturing environment for innovative biotechnology companies, as well as to foster collaboration with regulatory agencies and the industry, to continue tackling these big problems in healthcare. I hope that this will continue to permeate the industry and improve people's quality of life around the world.
What are RAPT’s main objectives for the next three to five years?
We began our RPT193 program in the United States, but we intend to expand into Europe, Australia, and other countries. Our Phase 3 trials will be heavily focused in the United States and Europe in order to obtain marketing authorization in those regions. Our FLX475 program is focused on the United States as well as Asia because many of the cancer types we are targeting are endemic in Asian populations, but we intend to develop this compound globally.
For our cancer program, we are collaborating with the global pharmaceutical company Merck, in a clinical collaboration evaluating FLX 475 in combination with their immunotherapy drug Keytruda. We have also formed a partnership with Hanmi Pharmaceutical, a South Korean company with expertise not only in South Korea but also in China, Taiwan, and Hong Kong. Partnering is an excellent way to gain expertise and knowledge of regulatory environments in various countries in order to rapidly develop our drugs.
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