SystImmune to Receive Milestone Payment from Bristol Myers Squibb Under Iza-Bren Collaboration
SystImmune (collaborating with BMY) announced the first patient treated in the IZABRIGHT-Breast01 Phase 2/3 registrational study of izalontamab brengitecan (iza-bren) in previously untreated triple negative breast cancer ineligible for anti-PD(L)1 drugs.
That event triggered a $250 million one-time milestone payment from Bristol Myers Squibb (BMY) under the 2023 collaboration and exclusive license agreement. SystImmune is eligible for up to an additional $250 million near-term and up to $7.1 billion in further contingent development, regulatory and sales milestones. Iza-bren has received Breakthrough Therapy Designation from the FDA for previously treated advanced EGFR-mutated NSCLC and is being evaluated in multiple ongoing global trials.
SystImmune (in collaborazione con BMY) ha annunciato che è stato trattato il primo paziente nello studio IZABRIGHT-Breast01 di fase 2/3 registrazionale di izalontamab brengitecan (iza-bren) in cancer del seno triplo negativo non precedentemente trattato e non eleggibile ai farmaci anti-PD(L)1.
Questo evento ha innescato un pagamento una tantum di 250 milioni di dollari da Bristol Myers Squibb (BMY) ai sensi dell'accordo di collaborazione e licenza esclusiva del 2023. SystImmune ha diritto a ulteriori fino a 250 milioni di dollari a breve termine e fino a 7,1 miliardi di dollari in ulteriori milestone contingenti di sviluppo, regolatorie e vendite. Iza-bren ha ricevuto la Breakthrough Therapy Designation dalla FDA per NSCLC avanzato mutato EGFR precedentemente trattato ed è valutato in molteplici studi globali in corso.
SystImmune (en colaboración con BMY) anunció que se trató al primer paciente en el estudio IZABRIGHT-Breast01 de fase 2/3 registracional de izalontamab brengitecan (iza-bren) en cáncer de mama triple negativo no tratado previamente e inelegible para fármacos anti-PD(L)1.
Ese evento activó un pago inicial de 250 millones de dólares de Bristol Myers Squibb (BMY) conforme al acuerdo de colaboración y licencia exclusiva de 2023. SystImmune es elegible para hasta 250 millones de dólares adicionales a corto plazo y hasta 7,1 mil millones de dólares en hitos contingentes de desarrollo, regulatorios y ventas. Iza-bren ha recibido la Designación de Terapia Innovadora (Breakthrough Therapy Designation) de la FDA para NSCLC avanzado con mutación de EGFR previamente tratado y se está evaluando en múltiples ensayos globales en curso.
SystImmune( BMY와 협력) 은 izalontamab brengitecan(iza-bren) 이니셜 IZABRIGHT-Breast01 2/3상 등록 연구에서 이전에 치료받지 않은 삼중 음성 유방암으로 anti-PD(L)1 약물에 대한 자격이 없는 환자에게 치료를 받은 첫 번째 환자를 발표했습니다.
그 사건은 2023년 협력 및 독점 라이선스 계약에 따라 Bristol Myers Squibb(BMY)로부터 2억 5천만 달러의 일회성 마일스톤 지급을 촉발했습니다. SystImmune은 단기적으로 추가로 2억 5천만 달러를 받을 자격이 있으며, 개발, 규제 및 판매 마일스톤에서 최대 71억 달러까지 받을 수 있습니다. Iza-bren은 이전에 치료받은 EGFR 변이 NSCLC에 대해 FDA의 Breakthrough Therapy Designation을 받았고 전 세계에서 진행 중인 다수의 임상시험에서 평가되고 있습니다.
SystImmune (en collaboration avec BMY) a annoncé le premier patient traité dans l'étude IZABRIGHT-Breast01 de phase 2/3 enregistrant izalontamab brengitecan (iza-bren) pour un cancer du sein triple négatif chez des patients préalablement non traités et inéligibles aux médicaments anti-PD(L)1.
Cet événement a déclenché un paiement unique de 250 millions de dollars de Bristol Myers Squibb (BMY) dans le cadre de l'accord de collaboration et de licence exclusive de 2023. SystImmune est éligible à jusqu'à 250 millions de dollars supplémentaires à court terme et à jusqu'à 7,1 milliards de dollars de jalons supplémentaires liés au développement, à la réglementation et aux ventes. Iza-bren a reçu la Breakthrough Therapy Designation de la FDA pour un NSCLC avancé muté EGFR précédemment traité et est évalué dans plusieurs essais mondiaux en cours.
SystImmune (in Zusammenarbeit mit BMY) gab bekannt, dass der erste Patient in der IZABRIGHT-Breast01-Phase-2/3-Registrierungsstudie von izalontamab brengitecan (iza-bren) bei zuvor unbehandeltem dreifach negativem Brustkrebs, der für Anti-PD(L)1-Medikamente nicht in Frage kommt, behandelt wurde.
Dieses Ereignis löste eine Einmalzahlung in Höhe von 250 Millionen US-Dollar von Bristol Myers Squibb (BMY) gemäß der Kooperations- und Exklusivlizenzvereinbarung von 2023 aus. SystImmune hat Anspruch auf weitere bis zu 250 Millionen US-Dollar kurzfristig und bis zu 7,1 Milliarden US-Dollar an weiteren bedingten Entwicklungs-, Zulassungs- und Verkaufsmeilensteinen. Iza-bren hat die Breakthrough Therapy Designation der FDA für zuvor behandeltes fortgeschrittenes EGFR-mutiertes NSCLC erhalten und wird in mehreren laufenden globalen Studien bewertet.
SystImmune (بتعاون مع BMY) أعلنت عن معالجة أول مريض في دراسة IZABRIGHT-Breast01 من المرحلة 2/3 تسجيلية لـ izalontamab brengitecan (iza-bren) في سرطان الثدي ثلاثي السلبي غير المعالج سابقاً وغير المؤهل للأدوية المضاد PD(L)1.
هذا الحدث أدى إلى دفعة سُداسية تبلغ 250 مليون دولار أمريكي كمبلغ واحد من Bristol Myers Squibb (BMY) بموجب اتفاقية التعاون والترخيص الحصري لعام 2023. وأتاحت SystImmune أن تصبح مؤهلة للحصول على ما يصل إلى 250 مليون دولار إضافية في المدى القريب وإلى ما يصل إلى 7.1 مليار دولار إضافية في معالم تطوير وتنظيم ومبيعات مستقبلية. لقد حصل iza-bren على توصيف FDA بـ Breakthrough Therapy Designation لعلاج NSCLC المتقدم المصاب بتبدل EGFR وتم تقييمه في العديد من التجارب العالمية الجارية.
SystImmune（与 BMY 合作）宣布，在 IZABRIGHT-Breast01 第2/3阶段注册性研究中，izalontamab brengitecan（iza-bren）用于先前未治疗且不符合抗 PD(L)1 药物的三阴性乳腺癌患者，已治疗的首例患者。
这一事件触发了 Bristol Myers Squibb（BMY）按2023年的合作与独家许可协议提供的一次性 2.5亿美元 里程碑付款。SystImmune 有资格在短期内再获得最多 2.5亿美元，并在未来的开发、监管和销售里程碑中最多获得 71亿美元。Iza-bren 已获 FDA 对先前治疗的 EGFR 突变性 NSCLC 的突破性治疗认定（Breakthrough Therapy Designation），并在全球多项正在进行的试验中进行评估。
- $250M one-time milestone payment received
- Eligible for up to $250M in additional near-term payments
- Program eligible for up to $7.1B in contingent milestones
- FDA Breakthrough Therapy designation for EGFR-mutated NSCLC
- First patient enrolled in global Phase 2/3 IZABRIGHT-Breast01
- Remaining milestone payments up to $7.1B are contingent and not guaranteed
- Commercial rights exclude China (developed by Biokin in China)
Insights
SystImmune earned a
The payment follows first-patient treatment in the IZABRIGHT-Breast01 registrational Ph2/3 study (NCT06926868) of izalontamab brengitecan (iza-bren). The collaboration agreement ties this clinical event to a one-time
The program's value to SystImmune depends on successful progression of multiple trials and regulatory milestones described, including the IZABRIGHT series and China trials, and an existing Breakthrough Therapy Designation in a separate lung-cancer indication noted in the release. Key risks remain the usual clinical and regulatory outcomes; the announcement states milestone receipt but does not disclose trial efficacy or safety data. Watch for enrollment and primary endpoint readouts from the IZABRIGHT-Breast01 study and any regulatory filings or approvals over the next clinical readout windows, as those events will determine near- and long-term contingent payments and materially affect program valuation.
Iza-bren is a potential first-in-class bispecific topoisomerase 1 inhibitor-based antibody-drug conjugate (ADC) that targets both epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3). It is being developed by SystImmune's parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin) in
"This milestone marks a significant step forward in the global clinical development of iza-bren," said Dr. Yi Zhu, Chairman, SystImmune. "The robust data generated from our
"Together with Bristol Myers Squibb, we have made significant progress in developing iza-bren globally. We remain deeply committed to delivering this potentially transformative therapy to patients with triple negative breast cancer and other solid tumors," said Dr. Jie D'Elia, CEO, SystImmune. "This
Iza-bren is currently being evaluated in multiple ongoing clinical trials, including BL-B01D1-LUNG-101 (NCT05983432), IZABRIGHT-Lung01 (NCT07100080), IZABRIGHT-Bladder01 (NCT07106762), and studies in
About iza-bren
SystImmune, in collaboration with BMS outside of
About SystImmune
SystImmune is a clinical-stage biopharmaceutical company located in
Forward-Looking Statements
Any research and development information provided by SystImmune is intended for general information purposes only. Such information is not intended to provide complete medical information. We do not offer patient-specific treatment advice and if you have medical conditions, please see your medical doctor or healthcare provider.
This press release may contain forward-looking statements with the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995, which reflects the expectations regarding the company's goals, strategies, results of operations, performance, business prospects, and opportunities, including but not limited to the ability to gain Investigational New Drug status for the resulting new product and the ability to develop a successful formulation. Terms such as "anticipates," "believes," "expects," "estimates," "could," "intends," "may," "plans," "potential," "projects," "will," "would" and other similar expressions, or the negative of these terms, are generally indicative of forward-looking statements.
While SystImmune, Inc. believes that expectations expressed in the forward-looking statements are based on the company's reasonable assumptions and beliefs in light of the information available to the company at the time such statements are made, it cannot give assurance that such forward-looking statements will prove to have been correct. Such forward-looking statements are not fact and are subject to uncertainties and other factors that could cause actual results to differ materially from such statements. We undertake no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
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FAQ
What milestone triggered SystImmune's $250 million payment from BMY on October 13, 2025?
How much total contingent milestone funding can SystImmune receive under the BMY collaboration?
What regulatory recognition has iza-bren received that could affect BMY (NYSE: BMY) collaboration value?
Which trial start is linked to the recent milestone payment to SystImmune?
How does the collaboration allocate development rights between SystImmune and Biokin?
