SVP™ for Immune Tolerance
Selecta Biosciences, Inc. is advancing therapies based on its proprietary Synthetic Vaccine Particle (SVP™) platform to induce antigen-specific immune tolerance to mitigate the formation of anti-drug antibodies (ADAs) that may severely compromise the efficacy and safety of life-sustaining drugs.
Many rare and life-threatening diseases are treated with biologic therapies that are foreign to the patient’s immune system and elicit an undesired immune response, such as ADA formation. The induction of ADAs can lead to neutralization of efficacy, modification of pharmacokinetics and pharmacodynamics, as well as allergic responses. Drug immunogenicity is a significant hurdle for the development of safe and effective biologic treatments and has become a key concern for regulators, as evidenced by over 100 approved biologics that describe immune responses on their labels. Drug immunogenicity may be a cause of treatment failure for patients and product development failure for biopharmaceutical companies.
Selecta’s Immune Tolerance SVP platform is designed to program the immune system to elicit tolerance to a specific antigen without impacting the rest of the immune system. Selecta’s primary development efforts include:
- An enzyme therapy for chronic severe gout,
- An immunotoxin for pancreatic cancer and mesothelioma,
- Gene therapies for rare inborn errors of metabolism, and
- Partnerships and license agreements for a range of other applications.
Selecta’s antigen‑specific SVP tolerance programs utilize SVP‑Rapamycin, the company’s biodegradable nanoparticle encapsulating the immunomodulator rapamycin. SVP‑Rapamycin is co‑administered at the beginning of therapy with a biologic drug to mitigate the formation of ADAs without altering the drug or its dose regimen.
Each pairing of SVP‑Rapamycin with a biologic drug offers the potential for a new proprietary product candidate that can be separately patented, approved and marketed.
The image above depicts a model of how SVP-Rapamycin would enter a lymph node and be taken up by a dendritic cell. Both the biologic drug and SVP-Rapamycin are designed to be taken up and processed by dendritic cells in a manner that induces regulatory T cells, which can block the activation of helper T cells, mitigating the formation of ADAs.