ORKA-001 (mAb)

Drug information

Delivery device(s)

Not provided

Scale-up prospects

Not provided

Tentative equipment list for manufacturing

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

Manufacturing

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.

Specific analytical instrument required for characterization of formulation

LC-MS/MS (Thermo Orbitrap, SCIEX TripleTOF), UHPLC-QTOF MS, HILIC-UPLC + fluorescence/MS (Waters H-Class, Thermo Vanquish) and HCP ELISA.

ORKA-001-111

Identifier

NCT06698939

Link

https://clinicaltrials.gov/study/NCT06698939

Phase

Phase I

Status

Not provided

Sponsor

Oruka Therapeutics, Inc.

More details

This is a Phase 1, First-in-human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ORKA-001 in Healthy Participants.

Purpose

ORKA-001 in Healthy Volunteers

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-12-19

Anticipated Date of Last Follow-up
2025-05-15

Estimated Primary Completion Date
2026-06-01

Estimated Completion Date
2026-06-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Key Inclusion Criteria: 1. Healthy male or female participants 2. 18 to 65 years (inclusive) with a body mass index (BMI) 18 to 32 kg/m2 3. Willing and able to remain at the study site unit for the duration of the confinement period and return for the outpatient visit/s defined in the protocol 4. Using a highly effective method of contraception from admission through the end of the study. 5. Willing to abstain from regular, continuous alcohol use or tobacco use as per protocol Key Exclusion Criteria: 1. Any clinically significant medical condition or finding that, in the Investigator's opinion, is likely to unfavorably alter the risk of study participation, confound study results, or interfere with the study conduct or compliance.

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

24

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

EVERLAST-A

Identifier

NCT07090330

Link

https://clinicaltrials.gov/study/NCT07090330

Phase

Phase II

Status

Recruiting

Sponsor

Oruka Therapeutics, Inc.

More details

This is a multicenter, randomized, double-blinded, placebo-controlled, proof-of-concept study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis.

Purpose

ORKA-001 Versus Placebo in Patients With Moderate-to-Severe Plaque Psoriasis

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2025-07-18

Anticipated Date of Last Follow-up
2025-10-30

Estimated Primary Completion Date
2026-09-01

Estimated Completion Date
2027-05-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: 1. Participants ≥ 18 years of age 2. Have a diagnosis of plaque psoriasis for \> 6 months 3. Have moderate-to-severe chronic plaque psoriasis defined as: 1. BSA ≥ 10%, and 2. PASI ≥ 12, and 3. IGA score of ≥ 3 on a 5-point scale 4. Candidate for systemic therapy or phototherapy 5. Women of childbearing potential must have a negative pregnancy test Exclusion Criteria: 1. Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis 2. Significant history or clinical manifestation of any metabolic, other dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, respiratory, endocrine, or psychiatric disorder, or any infectious disease 3. History of malignancy, except for non-

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

80

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

Proprietary excipients used

Not provided

Novel excipients or existing excipients at a concentration above Inactive Ingredients Database (IID) for the specified route of administration

Not provided

Residual solvents used

Not provided

Description

Il-23 antibody compositions and methods of use

Brief description

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.

Representative patent

WO2025170982A2

Category

Not provided

Patent holder

Paragon Therapeutics Inc

Exclusivity

Not provided

Expiration date

August 6, 2026

Status

Pending

Publications

There are no publication

Additional documents

• Characterization of ORKA-001, a Novel Extended Half-life Monoclonal Antibody Targeting IL-23 for the Treatment of Psoriasis

• Interim Phase 1 Results for ORKA-001

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 Not provided
	Share technical information for match-making assessment 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 Not provided
	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 Not provided

Not provided