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
San Diego, California, United States, North America
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
CMC and process development support
Oversight and design of upstream process development, process characterization, scale-down/scale-up experiments, and definition of process control strategies for biologic vaccine manufacturing.
Clinical development and trial management
Design and conduct of multicenter, randomized, double-blind, placebo-controlled adaptive clinical trials, including protocol development, stratification, enrollment, and safety monitoring.
Regulatory strategy and agency engagement
Engagement with regulatory authorities to obtain formal protocol agreements and expedited development designations, and to align pivotal trial designs with regulatory expectations.
Immunogenicity and biomarker analysis support
Measurement and correlation of immune responses (T-cell and antibody) and circulating tumor/serum biomarkers with clinical outcomes.
CMC and process development support
Oversight and design of upstream process development, process characterization, scale-down/scale-up experiments, and definition of process control strategies for biologic vaccine manufacturing.
Clinical development and trial management
Design and conduct of multicenter, randomized, double-blind, placebo-controlled adaptive clinical trials, including protocol development, stratification, enrollment, and safety monitoring.
Regulatory strategy and agency engagement
Engagement with regulatory authorities to obtain formal protocol agreements and expedited development designations, and to align pivotal trial designs with regulatory expectations.
Immunogenicity and biomarker analysis support
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