RION Launches INTENT Biologics to Advance Late-Stage Clinical Exosome Therapies in Inflammation & Immunology; Appoints Industry Leader Suneet Varma as CEO
RION, a clinical-stage regenerative medicine company recognized globally for its pioneering work in exosome-based therapeutics, has announced the formation of INTENT Biologics, an independent biotechnology company dedicated exclusively to developing first-in-class exosome therapies for Inflammation and Immunology (I&I). This strategic spinout represents a major milestone in the evolution of exosome-based therapeutics and marks an important step forward in accelerating late-stage clinical programs that aim to transform patient care in immune-mediated and tissue-regenerative conditions.
With this launch, INTENT Biologics assumes exclusive, perpetual worldwide rights to RION’s innovative Purified Exosome Product (PEP™) biologic platform in I&I. The new company will spearhead development of PEP Biologic™, advancing it into Phase 3 clinical development with an initial focus on advanced tissue regeneration and immune-mediated dermatologic diseases—areas where conventional therapies have left significant gaps in efficacy and patient outcomes.
Leadership Appointment: Suneet Varma Takes the Helm
In conjunction with the formation of INTENT Biologics, RION announced the appointment of Suneet Varma as Chief Executive Officer. Varma brings to the role over 30 years of international biopharma leadership, including highly influential positions as Global President of Pfizer Oncology and Rare Diseases and most recently as a member of the Board of Directors at Cerevel Therapeutics, a neuroscience-focused biopharma company.
Varma’s experience spans diverse therapeutic areas, global commercialization, and late-stage clinical strategy, making him a strategic fit for INTENT Biologics’ mission to move rapidly into pivotal trials. His leadership style—balancing scientific rigor with commercial execution—will be central to guiding the company through the demanding late-stage development process, eventual regulatory submissions, and future market entry.
Reflecting on the opportunity, Varma said:
“INTENT Biologics is uniquely positioned to redefine therapeutic approaches in Inflammation & Immunology with a novel mechanism of action that harnesses regenerative exosomes to restore immune balance and reduce inflammation. This not only promotes optimal healing but also opens doors to addressing diseases across multiple patient subpopulations. With a $30B+ market opportunity and a highly de-risked clinical path, we are poised to advance PEP Biologic™ into late-stage pivotal trials with speed and conviction.”
Strategic Rationale Behind the Spinout
The creation of INTENT Biologics reflects RION’s commitment to maximizing the clinical and commercial potential of exosome therapeutics. According to Atta Behfar, M.D., Ph.D., Co-Founder of RION, the separation allows both organizations to sharpen their focus:
“The creation of INTENT Biologics marks a pivotal milestone in our mission to revolutionize standards of care through regenerative exosome science. By building a company with a dedicated focus on I&I, we can accelerate the clinical and commercial path for PEP Biologic and unlock its full potential across multiple high-impact indications.”
This structural move offers several advantages:
- Dedicated Focus – INTENT Biologics will concentrate exclusively on Inflammation & Immunology, avoiding the dilution of resources across multiple therapeutic areas.
- Acceleration of Clinical Development – A smaller, independent entity with targeted leadership can move more quickly through late-stage clinical and regulatory milestones.
- Attraction of Specialized Capital – Investors interested specifically in I&I innovation may find INTENT Biologics more aligned with their focus, thereby diversifying funding pathways.
- Risk Mitigation for RION – Spinning out an independent entity allows RION to continue developing its broader regenerative exosome pipeline in other therapeutic areas while de-risking the financial and operational burden of late-stage I&I trials.
Scientific Platform: RION’s Purified Exosome Product (PEP™)
At the core of INTENT Biologics’ pipeline is PEP Biologic™ (Purified Exosome Product), a first-in-class exosome therapeutic discovered through the Mayo Clinic Van Cleve Cardiac Regenerative Medicine Program. Built upon over two decades of foundational stem cell and exosome research, PEP Biologic is now emerging as one of the most clinically advanced exosome-based biologics globally.
Unique Features of PEP Biologic™
- Exosome-Based Mechanism: Exosomes are nanosized vesicles secreted by cells that carry proteins, lipids, and RNA, acting as natural messengers in cell-to-cell communication. PEP Biologic leverages platelet-derived regenerative exosomes specifically engineered for therapeutic benefit.
- Polyvalent Biologic Signals: Unlike single-target biologics, each dose of PEP Biologic delivers a broad spectrum of regenerative cues, simultaneously reducing inflammation, regulating immune responses, and promoting tissue regeneration.
- Shelf-Stable Lyophilized Powder: Packaged in a freeze-dried formulation, PEP Biologic overcomes one of the biggest challenges in advanced biologics—stability and scalability—ensuring that the product can be manufactured, stored, and distributed at commercial scale.
- Novel Mechanism of Action: The therapy modulates T-cells and polarizes resident embryonic macrophages to promote regeneration at the site of tissue damage, offering a biologically comprehensive approach beyond symptom suppression.
Clinical Development Path
PEP Biologic has already established a de-risked clinical foundation through encouraging results in earlier-stage studies. With Phase 3 development on the horizon, INTENT Biologics is prioritizing indications in:
- Advanced Tissue Regeneration – Addressing severe wounds and damage where conventional healing approaches are insufficient.
- Immune-Mediated Dermatologic Diseases – Offering a novel therapeutic mechanism for conditions that resist biologics targeting single cytokines or receptors.
These indications represent significant unmet medical needs and collectively comprise a multi-billion-dollar market opportunity.
Market Context: The $30 Billion+ I&I Opportunity
The field of Inflammation & Immunology represents one of the largest and most dynamic segments in global biopharma. Diseases such as rheumatoid arthritis, psoriasis, inflammatory bowel disease, and systemic lupus erythematosus affect millions of patients worldwide. Current treatments, including TNF inhibitors, IL-17 blockers, and JAK inhibitors, have transformed care but remain limited by safety issues, loss of efficacy over time, and lack of regenerative effects.
Exosome-based therapies like PEP Biologic aim to shift the paradigm by addressing the underlying biology of immune dysregulation and tissue damage rather than just controlling symptoms. This potential positions INTENT Biologics to compete not only against traditional biologics but also to create an entirely new therapeutic class within I&I.
If successful in Phase 3 and subsequent regulatory approvals, PEP Biologic could redefine how physicians approach immune-mediated diseases, especially those where regeneration of damaged tissue is as critical as suppressing inflammation.
About INTENT Biologics
Headquartered in Minnesota, INTENT Biologics is structured as a clinical-stage biotechnology company focused solely on I&I. Building on Mayo Clinic’s two decades of exosome research, the company’s mission is to “revolutionize and replace” existing standards of care by advancing regenerative exosome science into mainstream medicine.
- Core Asset: PEP Biologic™ (Purified Exosome Product)
- Therapeutic Focus: Inflammation & Immunology, advanced tissue regeneration, immune-mediated dermatology
- Development Stage: Preparing for late-stage pivotal clinical trials
- Leadership: CEO Suneet Varma, supported by an experienced executive and scientific team
- Vision: Establish exosome-based therapeutics as the new gold standard in I&I treatment
For more information, visit www.intent.bio.
About RION
RION remains the global leader in regenerative exosome science, with a broader clinical and preclinical pipeline spanning multiple therapeutic areas. Founded at the Mayo Clinic after over 20 years of rigorous research, RION specializes in isolating and mass-producing platelet-derived regenerative exosomes. Its flagship platform, Purified Exosome Product (PEP), is designed as a shelf-stable biologic capable of activating the body’s natural healing processes.
RION continues to advance a wide array of programs, including:
- Diabetic Foot Ulcers
- Knee Osteoarthritis
- Musculoskeletal Injury
- Dermatologic Conditions
- Pulmonary Disease
- Cardiovascular Health
- Women’s Health
The company’s vision extends beyond a single therapeutic category, aiming to lead the therapeutic exosome revolution globally. More information is available at www.riontx.com.
The Bigger Picture: Exosomes as the Future of Biologics
The launch of INTENT Biologics comes at a pivotal time for the broader biopharma industry. Exosome therapeutics are rapidly gaining recognition as the next frontier in biologics, much like monoclonal antibodies were in the 1990s and cell/gene therapies in the 2010s.
Key advantages include:
- Natural Biocompatibility: Exosomes are endogenous messengers, reducing risks of immunogenicity.
- Scalable Manufacturing: RION’s platform overcomes historic production challenges.
- Broad Mechanism: Polyvalent biological signaling allows for multi-pathway modulation, addressing complex diseases better than single-target drugs.
- Potential Across Indications: From wound healing to autoimmunity, the scope is vast.
By placing I&I at the center of INTENT Biologics’ focus, RION is betting on exosomes as the next multi-billion-dollar therapeutic class.
The formation of INTENT Biologics represents far more than a corporate restructuring—it signals the emergence of a new player with the potential to redefine immunology and regenerative medicine. With exclusive rights to RION’s PEP Biologic platform in I&I, a world-class CEO in Suneet Varma, and a late-stage clinical program ready for acceleration, INTENT Biologics enters the biotech landscape as one of the most closely watched companies in the regenerative medicine field.
As the company advances toward pivotal trials, the stakes are high: success could establish exosome therapeutics as a transformative new class of medicines for immune-mediated and tissue-regenerative diseases. In an industry where innovation often takes decades to materialize, INTENT Biologics is poised to compress timelines, harnessing over 20 years of foundational research into therapies that may soon change how medicine treats some of the most challenging diseases of our time.
