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Oruka Therapeutics Announces Preclinical Data for ORKA-001 at the European Academy of Dermatology and Venereology Congress
Half-life in non-human primates (NHP) of 30.3 days after subcutaneous (SQ) administration and 33.8 days after intravenous (IV) administration
Equivalent potency to risankizumab with similar binding affinity and epitope demonstrated in several preclinical assays
MENLO PARK, Calif., Sept. 25, 2024 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. ("Oruka") (NASDAQ:ORKA), a biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis (PsO), today announced new preclinical data on ORKA-001, a novel extended half-life monoclonal antibody targeting IL-23p19, from its presentation at the European Academy of Dermatology and Venereology Congress (EADV).
• ORKA-001 has an NHP half-life of 30.3 days following SQ administration and 33.8 days following IV administration, over three times longer than risankizumab and one of the longest NHP half-lives observed for an extended half-life antibody. Projections of ORKA-001 pharmacokinetics (PK) in humans indicate that a human half-life of approximately 50 days could enable dosing once every six months, while a human half-life of approximately 75 days could enable once-yearly dosing. The NHP half-life observed for ORKA-001 supports the potential to achieve these extended dosing intervals given that other YTE-modified antibodies have had an approximately two to four times longer half-life in humans than in NHPs. In addition, the extended half-life of ORKA-001 could result in higher antibody exposures than risankizumab, which could lead to greater efficacy.
• ORKA-001 binds to a similar epitope with similar affinity to risankizumab and shows equivalent potency across a variety of in vitro assays. ORKA-001 binds IL-23p19 with an affinity below five picomolar. Based on cryo-EM structural analysis, ORKA-001 binds to a nearly identical epitope to risankizumab. When assessed across four different assays in cell lines and primary cells, ORKA-001 also had comparable functional potency for IL-23 antagonism. These findings support that ORKA-001 has a validated mechanism of action and further derisk its development path.
Half-life in non-human primates (NHP) of 30.3 days after subcutaneous (SQ) administration and 33.8 days after intravenous (IV) administration
Equivalent potency to risankizumab with similar binding affinity and epitope demonstrated in several preclinical assays
MENLO PARK, Calif., Sept. 25, 2024 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. ("Oruka") (NASDAQ:ORKA), a biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis (PsO), today announced new preclinical data on ORKA-001, a novel extended half-life monoclonal antibody targeting IL-23p19, from its presentation at the European Academy of Dermatology and Venereology Congress (EADV).
• ORKA-001 has an NHP half-life of 30.3 days following SQ administration and 33.8 days following IV administration, over three times longer than risankizumab and one of the longest NHP half-lives observed for an extended half-life antibody. Projections of ORKA-001 pharmacokinetics (PK) in humans indicate that a human half-life of approximately 50 days could enable dosing once every six months, while a human half-life of approximately 75 days could enable once-yearly dosing. The NHP half-life observed for ORKA-001 supports the potential to achieve these extended dosing intervals given that other YTE-modified antibodies have had an approximately two to four times longer half-life in humans than in NHPs. In addition, the extended half-life of ORKA-001 could result in higher antibody exposures than risankizumab, which could lead to greater efficacy.
• ORKA-001 binds to a similar epitope with similar affinity to risankizumab and shows equivalent potency across a variety of in vitro assays. ORKA-001 binds IL-23p19 with an affinity below five picomolar. Based on cryo-EM structural analysis, ORKA-001 binds to a nearly identical epitope to risankizumab. When assessed across four different assays in cell lines and primary cells, ORKA-001 also had comparable functional potency for IL-23 antagonism. These findings support that ORKA-001 has a validated mechanism of action and further derisk its development path.
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