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, CA, USA I September 25, 2024 I 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.
“This new data gives us additional confidence that ORKA-001 can achieve our base-case expectation of dosing once every six months and further reason to believe that we could reach once-yearly dosing with the potential for higher efficacy,” said Lawrence Klein, Oruka’s Chief Executive Officer. “Our goal is to offer people with psoriasis the most possible freedom from their condition, and we think ORKA-001 is showing tremendous potential to achieve that.”
About ORKA-001
ORKA-001 is a novel, subcutaneously (SQ) administered, half-life extended monoclonal antibody targeting IL-23p19. Inhibitors of IL-23p19 have become the preferred first-line therapy for patients with moderate-to-severe PsO given their strong efficacy and safety profile. Currently approved therapies are dosed four to six times per year and deliver PASI 100, or fully clear skin, for less than half of patients after four months. ORKA-001 has the potential to be dosed just once or twice a year and is designed to achieve higher exposures than currently marketed IL-23p19 antibodies, which could lead to higher rates of disease clearance. Data from studies in non-human primates and other preclinical assays show that ORKA-001 binds to a similar epitope with similar affinity as risankizumab and has a significantly extended half-life over three times longer than risankizumab.
About Oruka Therapeutics
Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice a year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com and follow Oruka on LinkedIn.
SOURCE: Oruka Therapeutics
Post Views: 4,548
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, CA, USA I September 25, 2024 I 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.
“This new data gives us additional confidence that ORKA-001 can achieve our base-case expectation of dosing once every six months and further reason to believe that we could reach once-yearly dosing with the potential for higher efficacy,” said Lawrence Klein, Oruka’s Chief Executive Officer. “Our goal is to offer people with psoriasis the most possible freedom from their condition, and we think ORKA-001 is showing tremendous potential to achieve that.”
About ORKA-001
ORKA-001 is a novel, subcutaneously (SQ) administered, half-life extended monoclonal antibody targeting IL-23p19. Inhibitors of IL-23p19 have become the preferred first-line therapy for patients with moderate-to-severe PsO given their strong efficacy and safety profile. Currently approved therapies are dosed four to six times per year and deliver PASI 100, or fully clear skin, for less than half of patients after four months. ORKA-001 has the potential to be dosed just once or twice a year and is designed to achieve higher exposures than currently marketed IL-23p19 antibodies, which could lead to higher rates of disease clearance. Data from studies in non-human primates and other preclinical assays show that ORKA-001 binds to a similar epitope with similar affinity as risankizumab and has a significantly extended half-life over three times longer than risankizumab.
About Oruka Therapeutics
Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice a year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com and follow Oruka on LinkedIn.
SOURCE: Oruka Therapeutics
Post Views: 4,548
