Immunotherapy Targets the Surgical Cycle: RRP’s Blockbuster Moment?
Inovio and Precigen race to commercialize first-ever FDA-approved therapies for a debilitating HPV-driven disease with persistent global need.
In this newsletter, we examine two companies—Inovio and Precigen—developing therapeutic candidates for Recurrent Respiratory Papillomatosis (RRP), a rare, chronic HPV-driven disease characterized by recurring benign airway tumors that can cause serious breathing and voice complications. Each company is pursuing a distinct mechanism of action, potentially targeting different segments of the RRP patient population.
While the eventual market dynamics remain uncertain, and investors may debate the relative advantages of each program, we believe there is a reasonable case for exposure to both. Given the differentiated biology and preliminary clinical data, it's possible that the therapies could prove complementary, with limited overlap and potential for sequential use—particularly in a setting where surgical intervention remains the norm and unmet need is high.
We believe that holding shares in both companies as they enter the RRP market in 2026–2027 may offer long-term investors a balanced exposure to this emerging therapeutic space.
Recurrent Respiratory Papillomatosis (RRP) is a rare, chronic disease caused by HPV types 6 and 11, marked by recurring benign tumors in the airway. These growths necessitate frequent surgeries, sometimes dozens annually, imposing immense physical, emotional, and financial burdens on patients. With no FDA-approved therapies, the standard of care has remained surgical for decades.
Distinct Therapies, Shared Opportunity
Recent years, however, have ushered in a new wave of therapeutic innovation. Two companies—Inovio and Precigen—are leading the charge to disrupt the RRP treatment paradigm through immunotherapy. Both target the underlying HPV viral proteins responsible for disease persistence using distinct platforms: Inovio’s DNA-based INO-3107 and Precigen’s gorilla adenovirus-based PRGN-2012.
Clinical data have been encouraging. In Phase 2 trials, both therapies have demonstrated reductions in surgery frequency and, in a subset of patients, complete elimination of surgical need for over 12 months. Both companies have received Breakthrough Therapy designation and are advancing toward accelerated FDA approval, with commercial launches expected in late 2025.
The market potential, while niche, is significant. Over 150,000 patients globally are affected, most lacking effective long-term treatment. Furthermore, HPV vaccination—while effective at reducing incidence in children—will not reduce the adult surgical burden for decades.
Financial models suggest blockbuster potential if either therapy captures meaningful share. Precigen forecasts over $400M in annual sales by 2028; Inovio anticipates turning profitable by 2029, almost entirely on the back of INO-3107. Institutional investors appear cautiously optimistic but are watching for execution on manufacturing and regulatory timelines.
In short, RRP is emerging as a new proving ground for immunologic precision medicine. The coming 12–18 months may redefine how this rare disease is managed—and unlock durable returns for first movers.
Risks
Despite promising data, both Inovio and Precigen face meaningful execution risks. Regulatory timelines, device-related manufacturing challenges (Inovio), or scale-up hurdles (Precigen) could delay launches. Competitive pressure may also intensify, with both programs racing toward FDA approval in a similar timeframe. Lastly, given the narrow commercial focus, failure to secure favorable reimbursement or clinician uptake could limit market penetration—even with strong efficacy.
Roosevelt Island, New York. Hartaj Singh. Summer, 2022.
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About the Author
Hartaj Singh brings over 30 years of experience in drug development, corporate strategy, hedge fund management, and biotech analysis. With a career spanning top investment banks, Hartaj has been a highly ranked analyst, known for providing astute guidance on biotech investments for over a decade. His deep sector knowledge, honed through years of navigating the biotech landscape, is now being put to use to help investors capitalize on biotech opportunities.