Equillium Maintains Rights to Itolizumab Following Ono Partnership
Equillium announced that Ono Pharmaceutical has allowed its option to acquire rights to itolizumab to expire, with Equillium maintaining all commercial rights. The decision was strategic and unrelated to clinical data. Equillium is evaluating accelerating completion of the Phase 3 EQUATOR study in aGVHD to Q1 2025. The company has enrolled over 150 patients and is temporarily pausing enrollment to review clinical options. A Phase 2 ulcerative colitis study was recently completed with topline data expected in Q1 2025. The company believes it has sufficient cash to achieve these milestones and extend operations into Q4 2025.
Equillium ha annunciato che Ono Pharmaceutical ha lasciato scadere l'opzione di acquisire i diritti su itolizumab, con Equillium che mantiene tutti i diritti commerciali. La decisione è stata strategica e non correlata ai dati clinici. Equillium sta valutando di accelerare il completamento dello studio di Fase 3 studio EQUATOR in aGVHD per il primo trimestre del 2025. L'azienda ha arruolato oltre 150 pazienti e sta temporaneamente sospendendo l'arruolamento per rivedere le opzioni cliniche. Un studio di Fase 2 sulla colite ulcerosa è stato recentemente completato e i dati preliminari sono attesi per il primo trimestre del 2025. L'azienda crede di avere sufficiente liquidità per raggiungere questi traguardi e prolungare le operazioni fino al quarto trimestre del 2025.
Equillium anunció que Ono Pharmaceutical ha dejado expirar su opción de adquirir los derechos sobre itolizumab, manteniendo Equillium todos los derechos comerciales. La decisión fue estratégica y no estaba relacionada con datos clínicos. Equillium está evaluando acelerar la finalización del estudio de Fase 3 estudio EQUATOR en aGVHD para el primer trimestre de 2025. La compañía ha inscrito a más de 150 pacientes y está pausando temporalmente la inscripción para revisar las opciones clínicas. Un estudio de Fase 2 sobre colitis ulcerosa se completó recientemente, y se esperan datos preliminares en el primer trimestre de 2025. La compañía cree que tiene suficiente efectivo para alcanzar estos hitos y extender operaciones hasta el cuarto trimestre de 2025.
Equillium은 Ono Pharmaceutical이 itolizumab에 대한 권리 인수 옵션이 만료되었음을 발표했으며, Equillium은 모든 상업적 권리를 유지합니다. 이 결정은 전략적이며 임상 데이터와는 관련이 없습니다. Equillium은 aGVHD에 대한 3상 EQUATOR 연구 완료를 2025년 1분기로 앞당기는 것을 검토하고 있습니다. 이 회사는 150명 이상의 환자를 등록했으며, 임상 옵션을 검토하기 위해 등록을 일시 중단하고 있습니다. 최근 2상 궤양성 대장염 연구가 완료되었으며, 주요 데이터는 2025년 1분기에 예상됩니다. 이 회사는 이 주요 목표를 달성하고 2025년 4분기까지 운영을 연장할 만큼 충분한 현금이 있다고 믿고 있습니다.
Equillium a annoncé qu'Ono Pharmaceutical a laissé expirer son option d'acquérir les droits sur itolizumab, Equillium conservant tous les droits commerciaux. La décision était stratégique et sans lien avec les données cliniques. Equillium envisage d'accélérer l'achèvement de l'étude de Phase 3 étude EQUATOR dans l'aGVHD pour le premier trimestre 2025. L'entreprise a recruté plus de 150 patients et suspend temporairement le recrutement pour examiner les options cliniques. Une étude de Phase 2 sur la colite ulcéreuse a été récemment achevée, avec des données préliminaires attendues pour le premier trimestre 2025. L'entreprise estime avoir suffisamment de liquidités pour atteindre ces étapes et prolonger ses activités jusqu'au quatrième trimestre 2025.
Equillium gab bekannt, dass Ono Pharmaceutical seine Option zur Übernahme der Rechte an itolizumab hat auslaufen lassen, wobei Equillium alle kommerziellen Rechte behält. Die Entscheidung war strategisch und stand nicht im Zusammenhang mit klinischen Daten. Equillium prüft, ob das Abschlussdatum der Phase-3-Studie EQUATOR-Studie zu aGVHD auf das erste Quartal 2025 vorgezogen werden kann. Das Unternehmen hat über 150 Patienten eingeschrieben und pausiert vorübergehend die Einschreibung, um klinische Optionen zu überprüfen. Eine Phase-2-Studie zu Colitis ulcerosa wurde kürzlich abgeschlossen, und die Topline-Daten werden im ersten Quartal 2025 erwartet. Das Unternehmen glaubt, dass es über ausreichende Mittel verfügt, um diese Meilensteine zu erreichen und die Tätigkeiten bis zum vierten Quartal 2025 auszudehnen.
- Maintains full commercial rights to itolizumab
- Over 150 patients enrolled in EQUATOR study
- Cash runway extended into Q4 2025
- Holds orphan drug and fast track designations for first-line aGVHD
- Temporary pause in EQUATOR study enrollment
- Loss of Ono Pharmaceutical partnership
- Pausing activities related to EQ101 and EQ302 programs
Insights
The expiration of Ono's option to acquire itolizumab rights represents a significant development for Equillium. While losing a strategic partner, retaining full commercial rights to itolizumab could be valuable given the drug's potential in multiple indications. The company has two important catalysts approaching in Q1 2025: topline data from both the Phase 3 EQUATOR study in aGVHD and Phase 2 ulcerative colitis trial.
The cash position appears sufficient to reach these milestones, with runway extended into Q4 2025 through operational adjustments including pausing EQ101 and EQ302 programs. The decision to accelerate the EQUATOR study completion while maintaining registrational integrity could provide earlier insights into itolizumab's potential in first-line aGVHD, where no approved drugs currently exist.
The 150+ patients enrolled in EQUATOR and positive interim review data suggest continued progress, though temporary enrollment pause warrants monitoring. The strategic nature of Ono's decision, rather than data-driven concerns, somewhat mitigates negative implications.
Ono Pharmaceutical makes strategic business decision to allow itolizumab option to expire
Equillium evaluating accelerating completion of Phase 3 EQUATOR study in aGVHD to Q1 2025
Phase 2 ulcerative colitis study recently completed; topline data expected Q1 2025
Management will host a conference call and webcast today at 8:30 am ET
“We are very grateful to our colleagues at Ono for the close partnership and support we have received, providing substantial non-dilutive financing that has fully funded itolizumab research and development since July 2022. This enabled us to advance the program through two important milestones – positive interim review from the EQUATOR study and positive topline data from the EQUALISE study in lupus nephritis. We are informed that Ono’s decision was strategic in nature, and that the data we have delivered from these studies met expectations,” said Bruce Steel, chief executive officer at Equillium.
“To date we have enrolled over 150 patients in EQUATOR. At this time, we are temporarily pausing enrollment to review clinical options for the program, including the potential to accelerate our timeline to topline data to early 2025 while preserving registrational integrity of the study. We maintain orphan drug and fast track designations for first-line acute graft-versus-host disease, where currently no drugs are approved. In addition, in collaboration with Equillium, our partner Biocon has recently completed a robust placebo-controlled Phase 2 study of itolizumab in biologic-naïve patients with moderate to severe ulcerative colitis, and we expect topline data from this study also early in the new year,” continued Mr. Steel. “We remain enthusiastic about the therapeutic potential and commercial opportunity for itolizumab, and we are very pleased to maintain our rights to the program as we approach the two most important data events in Equillium’s history.”
Anticipated Upcoming Milestones:
- Itolizumab: Topline data from Phase 3 EQUATOR study in aGVHD – potential acceleration to Q1 2025
- Itolizumab: Topline data from Phase 2 study in ulcerative colitis – Q1 2025
Equillium believes it has cash sufficient to achieve the above milestones, assuming acceleration of EQUATOR study completion, and is taking operational steps expected to extend operating runway into Q4 2025. With the repositioning of itolizumab as the top priority in the pipeline, these measures include pausing further activities related to EQ101 and EQ302.
Webcast and Conference Call
Management will host a conference call accompanied by a slide presentation to provide a corporate update focused on Equillium’s retention of rights to itolizumab, for analysts and institutional investors, at 8:30 am ET today, October 31, 2024. To access the call, please dial (800) 715-9871 or (646) 307-1963 for international callers, and if needed provide conference ID number 2574379. A live webcast of the call will also be available on the company’s Investor Relations page. The webcast will be archived for 180 days.
About Equillium
Equillium is a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need. The company’s pipeline consists of the following novel first-in-class immunomodulatory assets and product platform targeting immuno-inflammatory pathways. Itolizumab: a monoclonal antibody that targets the CD6-ALCAM signaling pathway which plays a central role in the modulation of effector T cells that drive a number of immuno-inflammatory diseases; currently under evaluation in a Phase 3 clinical study of patients with acute graft-versus-host disease (aGVHD) and announced positive data from a Phase 1b clinical study of patients with lupus/lupus nephritis in April 2024. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited, who also provides commercial manufacturing for the product. EQ101: a selective tri-specific cytokine inhibitor targeting IL-2, IL-9, and IL-15; recently announced positive results from a Phase 2 proof-of-concept clinical study of patients with alopecia areata. EQ302: an orally delivered, selective bi-specific cytokine inhibitor targeting IL-15 and IL-21 at pre-clinical stage.
For more information, visit www.equilliumbio.com.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking Statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “could”, “continue”, “expect”, “estimate”, “may”, “plan”, “outlook”, “future,” “potential” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements include, but are not limited to, statements regarding Equillium’s plans and strategies with respect to developing itolizumab, including repositioning itolizumab as the top priority in the pipeline, the importance of anticipated upcoming milestones, timelines for topline data for itolizumab, the temporary pausing and potential acceleration of the EQUATOR study, the pausing of further activities related to EQ101 and EQ302, the extension of Equillium’s cash runway and related assumptions, and the potential benefits of Equillium’s product candidates. Because such statements are subject to risks and uncertainties, many of which are outside of Equillium’s control, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: Equillium’s ability to execute its plans and strategies; risks related to performing clinical and pre-clinical studies; whether the results from clinical and pre-clinical studies will validate and support the safety and efficacy of Equillium’s product candidates; changes in the competitive landscape; changes in Equillium’s strategic plans; uncertainties related to Equillium’s capital requirements and ability to obtain sufficient financing to fund Equillium’s strategic plans; the potential impact on the registrational integrity that would be caused by Equillium’s decision to accelerate the completion of EQUATOR; and having to use cash in ways or on timing other than expected and the impact of market volatility on cash reserves. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and elsewhere in Equillium's filings and reports, which may be accessed for free by visiting the Securities and Exchange Commission’s website and on Equillium’s website under the heading “Investors.” Investors should take such risks into account and should not rely on forward-looking statements when making investment decisions. All forward-looking statements contained in this press release speak only as of the date on which they were made. Equillium undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241031983949/en/
Investor Contact
Michael Moore
Vice President, Investor Relations & Corporate Communications
619-302-4431
ir@equilliumbio.com
Source: Equillium Inc.
FAQ
Why did Ono Pharmaceutical end its partnership with Equillium (EQ)?
When will Equillium (EQ) release topline data for its Phase 3 EQUATOR study?
What is the current enrollment status of Equillium's (EQ) EQUATOR study?
How long will Equillium's (EQ) current cash runway last?
