OPKO Biologics
Clinical-stage biologics drug development company focused on creating long-acting, bio-better versions of therapeutic proteins and peptides using fusion-peptide, reversible PEGylation, and stabilizer-protein approaches. Operates integrated R&D and laboratory facilities in Israel, including GLP bioanalytical units, CMC development labs and a cGMP-certified QC lab. Since 2013 the company has operated as a wholly-owned subsidiary of a larger healthcare group.
Industries
Nr. of Employees
medium (51-250)
OPKO Biologics
Kiryat Gat, South District, Israel
Patents
Products
NGENLA (somatrogon)
Once-weekly recombinant human growth hormone molecule created by fusing native growth hormone sequence with a carboxyl-terminal peptide to extend half-life; developed for children and adolescents with growth hormone deficiency.
Long-acting recombinant Factor VIIa (MOD-5014)
Recombinant Factor VIIa engineered with a peptide fusion to extend circulatory half-life for treatment and prevention of bleeding episodes in hemophilia A or B.
OPK-8801002 (long-acting IGF-1)
Extended-release IGF-1 repletion therapy using a stabilizer-based approach for treatment of severe primary IGF-1 deficiency (SPIGFD).
OPK-8801001 (long-acting hGH antagonist)
Long-acting human growth hormone antagonist developed using a stabilizer-based approach for treatment of acromegaly with the aim of reduced dosing frequency.
OPK-8801004 (long-acting PTH)
Long-acting parathyroid hormone candidate using stabilizer-based technology for treatment of hypoparathyroidism with reduced dosing frequency.
OPK-8801002
Severe primary insulin-like growth factor 1 (IGF-1) deficiency (SPIGFD) results in short stature and increased insulin sensitivity. OPKO Biologics is developing OPK-8801002 as an extended release IGF-1 repletion therapy.
NGENLA (somatrogon)
Once-weekly recombinant human growth hormone molecule created by fusing native growth hormone sequence with a carboxyl-terminal peptide to extend half-life; developed for children and adolescents with growth hormone deficiency.
Long-acting recombinant Factor VIIa (MOD-5014)
Recombinant Factor VIIa engineered with a peptide fusion to extend circulatory half-life for treatment and prevention of bleeding episodes in hemophilia A or B.
OPK-8801002 (long-acting IGF-1)
Extended-release IGF-1 repletion therapy using a stabilizer-based approach for treatment of severe primary IGF-1 deficiency (SPIGFD).
OPK-8801001 (long-acting hGH antagonist)
Long-acting human growth hormone antagonist developed using a stabilizer-based approach for treatment of acromegaly with the aim of reduced dosing frequency.
OPK-8801004 (long-acting PTH)
Long-acting parathyroid hormone candidate using stabilizer-based technology for treatment of hypoparathyroidism with reduced dosing frequency.
OPK-8801002
Severe primary insulin-like growth factor 1 (IGF-1) deficiency (SPIGFD) results in short stature and increased insulin sensitivity. OPKO Biologics is developing OPK-8801002 as an extended release IGF-1 repletion therapy.
Services
End-to-end CMC services including expression and cell line development, upstream and downstream process development, pilot-scale production, formulation development, and tech transfer to CMOs.
Design and conduct of in vitro and in vivo studies for proof-of-concept, potency, pharmacology and toxicology to support IND-enabling work.
GLP-compliant bioanalytical method development, validation and sample analysis for PK and immunogenicity, including sample receipt and archiving.
Operational management of clinical programs including trial setup, site identification and qualification, KOL engagement, CRO/vendor management, and eTMF maintenance.
Quality management system operation, electronic document management, internal audit programs, training, and support for regulatory inspections and CSV/equipment validation.
End-to-end CMC services including expression and cell line development, upstream and downstream process development, pilot-scale production, formulation development, and tech transfer to CMOs.
Design and conduct of in vitro and in vivo studies for proof-of-concept, potency, pharmacology and toxicology to support IND-enabling work.
GLP-compliant bioanalytical method development, validation and sample analysis for PK and immunogenicity, including sample receipt and archiving.
Operational management of clinical programs including trial setup, site identification and qualification, KOL engagement, CRO/vendor management, and eTMF maintenance.
Quality management system operation, electronic document management, internal audit programs, training, and support for regulatory inspections and CSV/equipment validation.
Expertise Areas
- Biologics drug development
- Half-life extension technologies for proteins and peptides
- CMC development and tech transfer
- Preclinical pharmacology and toxicology
Key Technologies
- CTP fusion-based half-life extension
- Reversible PEGylation with hydrolysable linkers
- Stabilizer protein reversible binding
- Recombinant protein expression (bacterial and mammalian)
News & Updates
Received marketing authorization for pediatric growth hormone deficiency in multiple jurisdictions including the U.S., EU, UK, Canada, Australia, South Korea, Japan, Taiwan, India and Brazil.
Factor VIIa program incorporating half-life extension received orphan drug designation in the U.S. and Europe.
A long-acting oxyntomodulin program progressed through a Phase 1 clinical trial (historical pipeline entry).
Received marketing authorization for pediatric growth hormone deficiency in multiple jurisdictions including the U.S., EU, UK, Canada, Australia, South Korea, Japan, Taiwan, India and Brazil.
Factor VIIa program incorporating half-life extension received orphan drug designation in the U.S. and Europe.
A long-acting oxyntomodulin program progressed through a Phase 1 clinical trial (historical pipeline entry).