Polynoma LLC
Polynoma is an immuno-oncology company developing seviprotimut-L, a novel vaccine for the adjuvant treatment of melanoma. The company focuses on innovative vaccine technology, clinical trials, and advancing melanoma treatment options. It is headquartered in San Diego, California, and is a wholly-owned subsidiary of CK Life Sciences International, Inc.
Industries
Nr. of Employees
small (1-50)
Polynoma LLC
11230 Sorrento Valley Road, Suite 215, San Diego, CA 92121, USA
Products
Polyvalent shed-antigen melanoma vaccine (allogeneic, alum-adjuvanted)
An off-the-shelf, allogeneic vaccine composed of partially purified antigens shed from multiple human melanoma cell lines, formulated with an alum adjuvant and intended for intradermal administration as adjuvant therapy to reduce melanoma recurrence after surgical resection.
Polyvalent shed-antigen melanoma vaccine (allogeneic, alum-adjuvanted)
An off-the-shelf, allogeneic vaccine composed of partially purified antigens shed from multiple human melanoma cell lines, formulated with an alum adjuvant and intended for intradermal administration as adjuvant therapy to reduce melanoma recurrence after surgical resection.
Services
Oversight and design of upstream process development, process characterization, scale-down/scale-up experiments, and definition of process control strategies for biologic vaccine manufacturing.
Design and conduct of multicenter, randomized, double-blind, placebo-controlled adaptive clinical trials, including protocol development, stratification, enrollment, and safety monitoring.
Engagement with regulatory authorities to obtain formal protocol agreements and expedited development designations, and to align pivotal trial designs with regulatory expectations.
Measurement and correlation of immune responses (T-cell and antibody) and circulating tumor/serum biomarkers with clinical outcomes.
Oversight and design of upstream process development, process characterization, scale-down/scale-up experiments, and definition of process control strategies for biologic vaccine manufacturing.
Design and conduct of multicenter, randomized, double-blind, placebo-controlled adaptive clinical trials, including protocol development, stratification, enrollment, and safety monitoring.
Engagement with regulatory authorities to obtain formal protocol agreements and expedited development designations, and to align pivotal trial designs with regulatory expectations.
Measurement and correlation of immune responses (T-cell and antibody) and circulating tumor/serum biomarkers with clinical outcomes.
Expertise Areas
- Cancer vaccine development
- Immuno-oncology
- Clinical trial management (Phase II/III)
- Bioprocess development and CMC
Key Technologies
- Polyvalent shed-antigen vaccine platform
- Allogeneic tumor cell line-derived antigen production
- Mammalian cell culture in bioreactors
- Partial purification/downstream processing of secreted proteins
News & Updates
Polynoma announced it received a Special Protocol Assessment (SPA) agreement from the U.S. FDA for a pivotal Phase 3 clinical study of Seviprotimut-L, a melanoma vaccine.
Polynoma announced it received FDA Fast Track designation for its melanoma vaccine, Seviprotimut-L.
Polynoma presented the final analysis of its MAVIS Phase III trial data for Seviprotimut-L at the ASCO20 virtual scientific program.
Polynoma presented interim Phase III data for Seviprotimut-L at the 2019 Society for Immunotherapy of Cancer (SITC) Annual Meeting.
A publication in the Journal for ImmunoTherapy of Cancer detailing a multicenter, double-blind, placebo-controlled trial of seviprotimut-L in high-risk melanoma patients.
A 2020 ASCO poster presentation on the final analysis of relapse-free survival in a trial of seviprotimut-L.
Polynoma announced it received a Special Protocol Assessment (SPA) agreement from the U.S. FDA for a pivotal Phase 3 clinical study of Seviprotimut-L, a melanoma vaccine.
Polynoma announced it received FDA Fast Track designation for its melanoma vaccine, Seviprotimut-L.
Polynoma presented the final analysis of its MAVIS Phase III trial data for Seviprotimut-L at the ASCO20 virtual scientific program.
Polynoma presented interim Phase III data for Seviprotimut-L at the 2019 Society for Immunotherapy of Cancer (SITC) Annual Meeting.
A publication in the Journal for ImmunoTherapy of Cancer detailing a multicenter, double-blind, placebo-controlled trial of seviprotimut-L in high-risk melanoma patients.
A 2020 ASCO poster presentation on the final analysis of relapse-free survival in a trial of seviprotimut-L.