Oruka Therapeutics Announces Preclinical Data for ORKA-001 at the European Academy of Dermatology and Venereology Congress
Oruka Therapeutics (Nasdaq: ORKA) announced preclinical data for ORKA-001, a novel extended half-life monoclonal antibody targeting IL-23p19, at the European Academy of Dermatology and Venereology Congress. Key findings include:
1. Non-human primate (NHP) half-life of 30.3 days (subcutaneous) and 33.8 days (intravenous), over three times longer than risankizumab.
2. Projected human half-life of ~50 days could enable dosing every six months; ~75 days could allow yearly dosing.
3. Binds to a similar epitope with comparable affinity to risankizumab (below 5 picomolar).
4. Equivalent potency across various in vitro assays.
The extended half-life could result in higher antibody exposures, potentially leading to greater efficacy in treating chronic skin diseases like plaque psoriasis.
Oruka Therapeutics (Nasdaq: ORKA) ha annunciato dati preclinici per ORKA-001, un nuovo anticorpo monoclonale con emivita prolungata che targetizza l'IL-23p19, durante il Congresso dell'Accademia Europea di Dermatologia e Venereologia. Le principali scoperte includono:
1. Emivita nei primati non umani (NHP) di 30,3 giorni (sottocutanea) e 33,8 giorni (intravenosa), oltre tre volte superiore rispetto al risankizumab.
2. L'emivita umana stimata di ~50 giorni potrebbe consentire dosaggi ogni sei mesi; ~75 giorni potrebbe permettere dosaggi annuali.
3. Si lega a un epitopo simile con affinità comparabile al risankizumab (sotto 5 picomolari).
4. Potenza equivalente in vari saggi in vitro.
L'emivita prolungata potrebbe portare a maggiori esposizioni agli anticorpi, potenzialmente conducendo a una maggiore efficacia nel trattamento di malattie cutanee croniche come la psoriasi a placche.
Oruka Therapeutics (Nasdaq: ORKA) anunció datos preclínicos para ORKA-001, un nuevo anticuerpo monoclonal de vida media extendida que dirige el IL-23p19, en el Congreso de la Academia Europea de Dermatología y Venereología. Los hallazgos clave incluyen:
1. Vida media en primates no humanos (NHP) de 30,3 días (subcutáneo) y 33,8 días (intravenoso), más de tres veces más larga que la del risankizumab.
2. La vida media proyectada en humanos de ~50 días podría permitir una dosificación cada seis meses; ~75 días podría permitir una dosificación anual.
3. Se une a un epítopo similar con afinidad comparable a risankizumab (por debajo de 5 picomolares).
4. Potencia equivalente en varios ensayos in vitro.
La vida media extendida podría resultar en mayores exposiciones a anticuerpos, lo que potencialmente conduciría a una mayor eficacia en el tratamiento de enfermedades dérmicas crónicas como la psoriasis en placas.
오루카 테라퓨틱스(Nasdaq: ORKA)는 유럽 피부과 및 성병 학회에서 IL-23p19를 표적으로 하는 새로운 반감기 연장 단일클론 항체 ORKA-001의 전임상 데이터를 발표했습니다. 주요 발견 사항은 다음과 같습니다:
1. 비인간 영장류(NHP)의 반감기는 피하 주사에서 30.3일, 정맥 주사에서 33.8일로 리산키주맙의 반 이상 길다.
2. 예상되는 인간 반감기가 약 50일로 6개월마다 투여할 수 있으며, 약 75일이면 연간 투여가 가능할 수 있다.
3. 리산키주맙과 유사한 에피토프에 결합하며 비교 가능한 친화성을 보인다(5 피코몰 이하).
4. 다양한 인 비트로 시험에서 동등한 효능.
연장된 반감기는 더 높은 항체 노출을 일으킬 수 있으며, 이는 플라크 건선과 같은 만성 피부 질환 치료에서 더 큰 효능으로 이어질 수 있습니다.
Oruka Therapeutics (Nasdaq: ORKA) a annoncé des données précliniques pour ORKA-001, un nouvel anticorps monoclonal à demi-vie prolongée ciblant l'IL-23p19, lors du Congrès de l'Académie Européenne de Dermatologie et de Vénérologie. Les principales conclusions incluent :
1. Demi-vie chez les primates non humains (NHP) de 30,3 jours (sous-cutanée) et 33,8 jours (intraveineuse), plus de trois fois plus longue que celle du risankizumab.
2. La demi-vie humaine projetée d'environ 50 jours pourrait permettre des doses tous les six mois ; environ 75 jours pourrait permettre des doses annuelles.
3. Se lie à un épitope similaire avec une affinité comparable à celle du risankizumab (en dessous de 5 picomolaire).
4. Puissance équivalente dans divers tests in vitro.
La demi-vie prolongée pourrait entraîner une exposition plus importante aux anticorps, ce qui pourrait potentiellement conduire à une plus grande efficacité dans le traitement de maladies cutanées chroniques telles que le psoriasis en plaques.
Oruka Therapeutics (Nasdaq: ORKA) hat präklinische Daten zu ORKA-001, einem neuartigen monoklonalen Antikörper mit verlängerter Halbwertszeit, der IL-23p19 anvisiert, auf dem Kongress der Europäischen Akademie für Dermatologie und Venerologie vorgestellt. Wichtige Ergebnisse umfassen:
1. Halbwertszeit bei nicht-menschlichen Primaten (NHP) von 30,3 Tagen (subkutan) und 33,8 Tagen (intravenös), über drei Mal länger als bei Risankizumab.
2. Die projizierte menschliche Halbwertszeit von ~50 Tagen könnte Dosierungen alle sechs Monate ermöglichen; ~75 Tage könnten jährliche Dosierungen erlauben.
3. Bindet an ein ähnliches Epitop mit vergleichbarer Affinität zu Risankizumab (unter 5 Pikomolar).
4. Entsprechende Potenz in verschiedenen in-vitro-Tests.
Die verlängerte Halbwertszeit könnte zu höheren Antikörperexpositionen führen, was potenziell eine größere Wirksamkeit bei der Behandlung von chronischen Hautkrankheiten wie plaque Psoriasis zur Folge haben könnte.
- ORKA-001 demonstrates a significantly longer half-life compared to risankizumab, potentially enabling less frequent dosing
- Projected human half-life supports the possibility of six-monthly or yearly dosing
- ORKA-001 shows equivalent potency and binding affinity to risankizumab in preclinical assays
- Extended half-life could lead to higher antibody exposures, potentially resulting in greater efficacy
- None.
Insights
The preclinical data for ORKA-001 presented at EADV is highly encouraging for Oruka Therapeutics. The extended half-life of 30.3 days (SQ) and 33.8 days (IV) in non-human primates is a significant achievement, potentially enabling dosing intervals of 6 months to 1 year in humans. This could be a game-changer in psoriasis treatment, offering patients significantly reduced dosing frequency compared to existing therapies.
The comparable binding affinity and potency to risankizumab, a proven IL-23 inhibitor, suggests ORKA-001 has a validated mechanism of action. This reduces development risk and increases the likelihood of clinical success. The potential for higher antibody exposures due to the extended half-life could lead to improved efficacy, giving ORKA-001 a competitive edge in the crowded psoriasis market.
While these results are promising, investors should note that preclinical data doesn't always translate directly to human outcomes. The true value of ORKA-001 will be determined in upcoming clinical trials. If successful, this could significantly boost Oruka's market position and long-term revenue potential in the lucrative psoriasis treatment market.
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
FAQ
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