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.
  

“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.

Forward Looking Statements

Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Oruka’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, Oruka’s ability to achieve the expected benefits or opportunities with respect to ORKA-001, including the potency, binding affinity, efficacy and antibody exposures of ORKA-001 vis-à-vis risankizumab, the potential human half-life of ORKA-001 and its potential dosing interval. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Oruka will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Oruka's control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those uncertainties and factors described under the heading “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in Oruka’s most recent filings with the Securities and Exchange Commission (including its S-4 Registration Statement). Should one or more of these risks or uncertainties materialize, or should any of Oruka’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Oruka does not undertake or accept any duty to make any updates or revisions to any forward-looking statements.

Investor Contact: 
Alan Lada 
(650)-606-7911 
alan.lada@orukatx.com