Polaris Pharmaceuticals
Multinational biotechnology company focused on developing oncology therapeutics and providing biologics CDMO services. The organization conducts structure-based drug design, operates cGMP biologics production facilities in the U.S. and China, and runs multi-center clinical development programs for a pegylated arginine-degrading biologic being evaluated across multiple cancer indications.
Industries
Nr. of Employees
small (1-50)
Patents
Products
Pegylated arginine-degrading biologic (lead therapeutic candidate)
A PEGylated enzyme designed to deplete plasma arginine to exploit arginine auxotrophy in certain cancers; evaluated in combination with standard chemotherapies and immuno-oncology agents.
Pegylated arginine-degrading biologic (lead therapeutic candidate)
A PEGylated enzyme designed to deplete plasma arginine to exploit arginine auxotrophy in certain cancers; evaluated in combination with standard chemotherapies and immuno-oncology agents.
Services
End-to-end CDMO services including process development, scale-up, formulation development, API production and sterile manufacturing under cGMP.
Analytical testing, assay development and QC services to support clinical supply release and product characterization.
Clinical protocol design, GCP-compliant trial management, safety monitoring and multi-center trial coordination.
Manufacturing process design, equipment engineering and construction/expansion of production lines.
End-to-end CDMO services including process development, scale-up, formulation development, API production and sterile manufacturing under cGMP.
Analytical testing, assay development and QC services to support clinical supply release and product characterization.
Clinical protocol design, GCP-compliant trial management, safety monitoring and multi-center trial coordination.
Manufacturing process design, equipment engineering and construction/expansion of production lines.
Expertise Areas
- Clinical trial management
- Biologics manufacturing and CDMO services
- Peptide drug development
- Process development and scale-up
Key Technologies
- Structure-based drug design
- PEGylated enzyme-based arginine-deprivation therapy
- Peptide synthesis and purification
- Cell culture and fermentation processes
News & Updates
Company reported that its Biologic License Application for the pegylated arginine-degrading biologic entered FDA substantive review; final portion of rolling submission completed June 9, 2025.
Company announced completion of a rolling Biologic License Application submission to the U.S. FDA for treatment of malignant pleural mesothelioma.
Announcements of exclusive licensing and distribution agreements to introduce the lead biologic in Argentina/LATAM and multiple EMEA markets.
Reported groundbreaking for a new plant expansion (six production lines) and stated multi-year investment plan to expand production capacity.
The lead pegylated arginine-degrading biologic has received orphan drug designations and expedited-pathway interactions (Fast Track / Protocol Assistance / Special Protocol Assessment) from regulatory authorities in the U.S. and Europe.
Company reported that its Biologic License Application for the pegylated arginine-degrading biologic entered FDA substantive review; final portion of rolling submission completed June 9, 2025.
Company announced completion of a rolling Biologic License Application submission to the U.S. FDA for treatment of malignant pleural mesothelioma.
Announcements of exclusive licensing and distribution agreements to introduce the lead biologic in Argentina/LATAM and multiple EMEA markets.
Reported groundbreaking for a new plant expansion (six production lines) and stated multi-year investment plan to expand production capacity.
The lead pegylated arginine-degrading biologic has received orphan drug designations and expedited-pathway interactions (Fast Track / Protocol Assistance / Special Protocol Assessment) from regulatory authorities in the U.S. and Europe.