Drug name
Last update: Nov 2025ORKA-001 (mAb)
Developer(s)
Drug information
Not provided
Long-acting IL-23p19 antibody
ORKA-001; PR035
Biotherapeutic
Not provided
ORKA-001 is a humanized IgG1 monoclonal antibody targeting IL-23p19, a key cytokine in psoriasis. It binds IL-23 with high affinity (<5–20 pM), potently inhibits STAT3 signaling and IL-17 secretion, and shares a validated epitope with risankizumab. Engineered for extended half-life, it showed ~30–34 days in NHP and ~100 days in humans, enabling dosing every 6–12 months or annually. Phase 1 data confirmed sustained PK exposure, complete IL-23 pathway inhibition for 24 weeks, and a favorable safety profile—no severe adverse events, only mild headaches, URTI, and transient injection-site erythema. ORKA-001 aims to deliver higher efficacy, greater PASI 100 clearance, and extended off-treatment remission compared to current IL-23 inhibitors, reducing treatment burden and improving adherence.
Not approved yet (under clinical investigation)
Not approved yet (under clinical investigation)
Therapeutic area(s)
- psoriasis
- Treatment
Administration route
Subcutaneous
Associated long-acting platforms
Sterile Solution
Use of drug
- Administered by a community health worker
- Administered by a nurse
- Administered by a specialty health worker
- Every 6 months
- Yearly
Not provided
Dosage
Adult Doses: 300 mg, 600 mg and 1200 mg (under clinical investigation)
1200 mg
ORKA-001, at doses of 300 mg, 600 mg, or 1200 mg, is administered subcutaneously in patients under 18 years of age as part of an ongoing Phase 1 clinical investigation.
NA
Not provided
Associated technologies
Not provided
Comment & Information
Developer(s)
Oruka Therapeutics, Inc.
Oruka Therapeutics, founded in 2023 in Menlo Park, CA, develops monoclonal antibody therapies for chronic skin diseases and inflammatory conditions. Its pipeline targets IL-23 and IL-17 pathways for psoriasis and psoriatic arthritis, aiming for near-complete clearance with minimal annual doses. The name reflects its mission: restoring healthy skin and advancing global dermatology innovation.
Paragon Therapeutics, Inc.
Paragon Therapeutics, founded in 2021 in Waltham, MA, is a private biotech company focused on engineering best-in-class biologics for immunology and inflammatory diseases. It uses advanced protein design and screening technologies to accelerate antibody discovery. Paragon has launched spin-offs like Apogee (immunology), Spyre (IBD), and Oruka (dermatology).
Drug structure
Scale-up and manufacturing prospects
Not provided
CO₂ incubators, shaking incubators, biosafety cabinet (Class II), Nucleofector/electroporators, ClonePix™ 2, FACS sorters, automated colony pickers, Wave bioreactors, 50–2000 L single-use stirred-tank bioreactors, & ion-exchange chromatography
The process encompasses gene design and expression construct selection, including Fc variants such as wild-type IgG1/IgG2/IgG4 or modified Fc with half-life extending substitutions (e.g., YTE: M252Y/S254T/T256E; LS: M428L/N434S). It proceeds through host cell selection and stable cell line development, upstream production (seed train to bioreactor), primary recovery and clarification, downstream purification using a validated platform adapted to ORKA-001, formulation development, sterile fill-finish, and establishment of analytical methods and specifications.
LC-MS/MS (Thermo Orbitrap, SCIEX TripleTOF), UHPLC-QTOF MS, HILIC-UPLC + fluorescence/MS (Waters H-Class, Thermo Vanquish) and HCP ELISA.
Excipients
Not provided
Not provided
Not provided
Delivery device(s)
Not provided
Il-23 antibody compositions and methods of use
The present application claims benefit of and priority to U.S. Provisional Patent Application Nos. 63/550,224 (filed February 6, 2024), 63/550,173 (filed February 6, 2024), 63/550,178 (filed February 6, 2024), and 63/698,552 (filed September 24, 2024), the entire contents of each of which are hereby incorporated by reference for all purposes.
WO2025170982A2
Not provided
Paragon Therapeutics Inc
Not provided
August 6, 2026
Pending
Publications
There are no publication
Additional documents
Useful links
There are no additional links
Collaborate for development
Consider on a case by case basis, collaborating on developing long acting products with potential significant public health impact, especially for low- and middle-income countries (LMICs), utilising the referred to long-acting technology
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Provide necessary technical information to a potential partner, under confidentiality agreement, to enable preliminary assessment of whether specific medicines of public health importance in LMICs might be compatible with the referred to long-acting technology to achieve a public health benefit
Work with MPP to expand access in LMICs
In the event that a product using the referred to long-acting technology is successfully developed, the technology IP holder(s) will work with the Medicines Patent Pool towards putting in place the most appropriate strategy for timely and affordable access in low and middle-income countries, including through licensing