Sutro Biopharma Highlights Next-Generation ADC Innovation at Virtual R&D Day
Sutro Biopharma (NASDAQ: STRO) hosted a virtual R&D Day on Nov 12, 2025 to detail its next‑generation ADC platform and pipeline.
Key updates: STRO‑004, a Tissue Factor ADC, has entered Phase 1 after FDA IND clearance and showed preclinical activity plus a highest non‑severely toxic dose of 50 mg/kg in non‑human primates. Sutro named PTK7 as the target for its first dual‑payload candidate STRO‑227, with an IND submission targeted for 2026/2027. STRO‑006 (ITGB6) showed superior PK versus a Phase 3 comparator and is expected to enter the clinic in 2026. Astellas collaboration and a planned iADC clinical entry are also highlighted. Initial STRO‑004 clinical data are expected mid‑2026.
Sutro Biopharma (NASDAQ: STRO) ha organizzato un R&D Day virtuale il 12 novembre 2025 per dettagliare la sua piattaforma di prossima generazione ADC e il suo pipeline.
Aggiornamenti chiave: STRO‑004, un ADC di Tissue Factor, è entrato in Fase 1 dopo l'approvazione IND della FDA e ha mostrato attività preclinica oltre a una dose massima non tossica grave di 50 mg/kg nei primati non umani. Sutro ha indicato PTK7 come bersaglio per il suo primo candidato a dual payload STRO‑227, con una presentazione IND mirata per 2026/2027. STRO‑006 (ITGB6) ha mostrato una farmacocinetica superiore rispetto a un comparatore di Fase 3 e prevede di entrare in clinica nel 2026. Una collaborazione con Astellas e l'ingresso clinico previsto per i-ADC (iADC) sono anch'essi evidenziati. I dati clinici iniziali di STRO‑004 sono attesi a metà 2026.
Sutro Biopharma (NASDAQ: STRO) organizó un Día de I+D virtual el 12 de noviembre de 2025 para detallar su plataforma de ADC de próxima generación y su cartera.
Actualizaciones clave: STRO‑004, un ADC de Tissue Factor, ha entrado en Fase 1 tras la aprobación IND de la FDA y mostró actividad preclínica además de una dosis máxima no severamente tóxica de 50 mg/kg en primates no humanos. Sutro nombró PTK7 como diana para su primer candidato de doble payload STRO‑227, con una presentación IND prevista para 2026/2027. STRO‑006 (ITGB6) mostró una farmacocinética superior frente a un comparador de Fase 3 y se espera que entre en la clínica en 2026. La colaboración con Astellas y la entrada clínica planificada de iADC también se destacan. Se esperan los datos clínicos iniciales de STRO‑004 para mediados de 2026.
Sutro Biopharma (NASDAQ: STRO)는 2025년 11월 12일 차세대 ADC 플랫폼과 파이프라인을 자세히 설명하기 위한 가상 R&D 데이를 개최했습니다.
주요 업데이트: STRO‑004, 조직인자(Tissue Factor) ADC는 FDA IND 승인을 받아 1상에 진입했으며 비임상 활성과 비인간 영장류에서의 최고 용량 비독성량인 50 mg/kg를 보였습니다. Sutro는 PTK7를 첫 듀얼 페이로드 후보 STRO‑227의 표적으로 지목했고, 2026/2027을 목표로 IND 제출을 예정하고 있습니다. STRO‑006 (ITGB6)는 3상 비교대비 PK가 우수했고 2026년에 임상에 진입할 것으로 예상됩니다. Astellas와의 협력 및 계획된 iADC 임상 진입도 하이라이트로 소개되었습니다. 초기 STRO‑004 임상 데이터는 2026년 중반에 예상됩니다.
Sutro Biopharma (NASDAQ: STRO) a organisé une Journée R&D virtuelle le 12 novembre 2025 pour détailler sa plateforme ADC de prochaine génération et son pipeline.
Principales mises à jour : STRO‑004, un ADC à facteur tissulaire, est entré en phase 1 après l'approbation IND de la FDA et a montré une activité préclinique ainsi qu'une dose maximale non toxique sévère de 50 mg/kg chez les primates non humains. Sutro a nommé PTK7 comme cible pour son premier candidat à double payload STRO‑227, avec une soumission IND visée pour 2026/2027. STRO‑006 (ITGB6) a montré une pharmacocinétique supérieure par rapport à un comparateur de phase 3 et devrait entrer en clinique en 2026. Une collaboration avec Astellas et une entrée clinique iADC prévue sont également mises en évidence. Les données cliniques initiales de STRO‑004 sont attendues vers mi‑2026.
Sutro Biopharma (NASDAQ: STRO) veranstaltete am 12. November 2025 einen virtuellen R&D-Tag, um seine Plattform der nächsten Generation von ADCs und Pipeline im Detail vorzustellen.
Wichtige Updates: STRO‑004, ein Tissue Factor ADC, ist nach FDA-IND-Genehmigung in die Phase 1 eingetreten und zeigte präklinische Aktivität sowie eine höchste nicht toxische Dosis von 50 mg/kg bei Nichtmenschlichen Primaten. Sutro nannte PTK7 als Ziel für seinen ersten Dual-Payload-Kandidaten STRO‑227, mit einer IND-Einreichung angestrebt für 2026/2027. STRO‑006 (ITGB6) zeigte eine bessere PK gegenüber einem Phase-3-Vergleichsmedikament und wird voraussichtlich im 2026 in die Klinik gehen. Die Zusammenarbeit mit Astellas und der geplante iADC-Klinikeintritt werden ebenfalls hervorgehoben. Erste klinische STRO‑004-Daten werden voraussichtlich Mitte 2026 erwartet.
Sutro Biopharma (NASDAQ: STRO) عقدت يوم بحث وتطوير افتراضي في 12 نوفمبر 2025 لشرح منصة ADC من الجيل التالي وخط الإنتاج.
التحديثات الرئيسية: STRO‑004، وهو ADC لعامل النسيج، دخل مرحـلة 1 بعد موافقة IND من FDA وأظهر نشاطًا قبل سريريًا بالإضافة إلى أقصى جرعة غير سامة بشدة تبلغ 50 mg/kg في الرئيسيات غير البشرية. سمت Sutro PTK7 كهدف لأول مرشح مزدوج الحمولة STRO‑227، مع هدف تقديم IND في 2026/2027. أظهر STRO‑006 (ITGB6) فصر PK متفوق مقابل مُقارَن من المرحلة 3 ومن المتوقع دخوله إلى العيادة في 2026. كما تُبرز التعاون مع أستيلياس والدخول السريري المخطط لـ iADC. من المتوقع الحصول على بيانات أولية للعيادة لـ STRO‑004 بحلول منتصف 2026.
- STRO‑004 entered Phase 1 after FDA IND clearance
- Preclinical HN, NSCLC, colorectal, pancreatic activity for STRO‑004
- 50 mg/kg highest non‑severely toxic dose in non‑human primates for STRO‑004
- STRO‑006 showed superior pharmacokinetics vs a Phase 3 ITGB6 ADC
- Astellas collaboration advancing dual‑payload iADC; first iADC clinic entry early 2026
- No clinical efficacy data reported yet; STRO‑004 is in Phase 1
- STRO‑227 IND only targeted for 2026/2027, indicating multi‑year development timeline
- STRO‑006 clinical start not expected until 2026, delaying near‑term readouts
Insights
STRO-004 has entered first-in-human testing and initial Phase 1 data is expected mid-
As a clinical development readout, the initiation of a Phase 1 study for Sutro’s STRO-004 and the FDA IND clearance cited form a clear near-term milestone. The announcement notes preclinical anti-tumor activity across several tumor types and a highest non-severely toxic dose of 50 mg/kg in non-human primates, which supports a widened therapeutic window hypothesis.
The program depends on tolerability and early signs of efficacy in the Phase 1 cohort; safety, dose-escalation rate, and objective responses will determine next steps. Watch for initial clinical safety, pharmacokinetics, and any objective responses expected by mid-
Pipeline expansion includes a single-payload TF ADC in clinic and an advancing dual-payload PTK7 program with IND plans in
The company highlights its cell-free platform enabling site-specific ADCs and dual-payload constructs, naming STRO-006 with a superior PK profile and STRO-227 (PTK7) as its first dual-payload candidate. The collaboration with Astellas and an iADC aimed for clinic entry in early
Key risks include whether clinical PK/safety replicate preclinical advantages and the timing of INDs; monitor the Phase 1 safety/pharmacokinetic data for STRO-004 by mid-
- Company has initiated Phase 1 study with STRO-004, its potential best-in-class Tissue Factor ADC -
- Sutro has selected PTK7 as the target for its initial dual-payload candidate, STRO-227 -
- Investor webcast today at 7:00AM PT / 10:00AM ET -
SOUTH SAN FRANCISCO, Calif., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), is hosting a virtual R&D Day today highlighting the details of its platform innovation and next-generation ADC pipeline. The presentation will include an overview of Sutro’s near- and long-term priorities, beginning with STRO-004, its potential best-in-class Tissue Factor ADC, which has now entered clinical development. The Company will also provide details on its dual-payload ADC programs, uniquely enabled by its proprietary cell-free platform, and reveal STRO-227, its first dual-payload candidate designed to target PTK7.
“The programs we are advancing showcase our platform’s unique potential to meaningfully expand the therapeutic window and address some of the most persistent challenges with conventional ADCs,” said Jane Chung, Sutro’s Chief Executive Officer. “With STRO-004 entering the clinic and our dual-payload programs accelerating, we are positioned to deliver ADCs that combine optimized target engagement, differentiated design, and industry-leading pharmacokinetics to enable deeper and more durable responses to redefine what is possible for cancer care.”
Ms. Chung continued: “The selection of PTK7 for our initial dual-payload program underscores our strategy to address difficult-to-treat solid tumors where standard approaches have been insufficient. Additionally, through strategic collaborations including our partnership with Astellas, we continue to broaden the impact of our ADC technology and advance novel payload combinations to deliver therapies with the potential to transform the standard of care to patients.”
The event will feature presentations by key members of Sutro’s senior management team and Anthony Tolcher, M.D., FRCPC, FACP, a medical oncologist and founder and head of NEXT Oncology. Sutro management will participate in a Q&A session at the end of the presentation.
Next-Generation ADC Innovation
Sutro’s platform is designed to optimize every component of an ADC—the antibody, linker, and payload—rather than focusing on one or two elements in isolation. This holistic control is enabled by the Company’s cell-free technology, which allows unparalleled flexibility in designing ADCs and the potential to dose higher due to optimized safety and efficacy, even in complex biological settings. In addition, the platform enables sophisticated dual-payload combinations, enabling therapies that could redefine the standard-of-care.
Program Highlights and Near-Term Pipeline Milestones
Single-payload ADC Programs
Single-payload programs will establish Sutro’s foundation by tackling hard-to-reach, complex targets.
- STRO-004: A potential best-in-class Tissue Factor (TF) targeting ADC, STRO-004, has entered clinical trials following recent IND clearance from the U.S. Food and Drug Administration (FDA). In preclinical TF-expressing models of head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and pancreatic cancer, STRO-004 showed promising anti-tumor activity. Combined with a highest non-severely toxic dose of 50 mg/kg in non-human primate studies, STRO-004 is anticipated to meaningfully widen the therapeutic window versus conventional ADCs to address a wide range of tumors of unmet need.
- STRO-006: A potential best-in-class, highly selective integrin β6 (ITGB6) targeting ADC, STRO-006, has demonstrated a superior pharmacokinetic profile compared to the current ITGB6-targeting ADC in Phase 3 development. Additionally, STRO-006 demonstrated encouraging anti-tumor activity and duration of response in preclinical models. STRO-006 is expected to enter clinical development in 2026 for the treatment of multiple solid tumors.
Dual-Payload ADC Program
Sutro’s dual-payload ADCs are designed to overcome resistance, delay progression, and potentially set a new standard-of-care by unlocking durable efficacy.
- STRO-227: Sutro has selected tyrosine-protein kinase-like 7 (PTK7) as the target for its initial dual-payload candidate. PTK7 is overexpressed in many different cancers, including breast, lung, ovarian and colorectal cancer. The Company is working to accelerate its dual-payload ADC program, with an IND submission now targeted for 2026/2027.
Summary of Pipeline Milestones
- STRO-004: Phase 1 study ongoing; initial data expected mid-2026
- STRO-006: IND submission targeted for 2026
- STRO-227: IND submission targeted for 2026/2027
Next-Generation ADC Collaborations
Research and development programs are progressing under Sutro’s collaboration, with Astellas focused on dual-payload immunostimulatory ADCs (iADCs). The first iADC program is expected to enter the clinic in early 2026.
Webcast Information:
To access the live audio webcast beginning at 7:00AM PT / 10:00AM ET, please go to https://ir.sutrobio.com/news-events/ir-calendar. An archived replay of the webcast will be available on the Company’s website following the event.
About Sutro Biopharma
Sutro Biopharma, Inc. is advancing a next-generation antibody-drug conjugate (ADC) platform designed to deliver single- and dual-payload ADCs that enable meaningful breakthroughs for patients with cancer. By fully optimizing the antibody, linker, and payload, Sutro’s cell-free platform produces ADCs that are engineered to improve drug exposure, reduce side effects, and expand the range of treatable tumor types. With unique capabilities in dual-payload ADCs, Sutro aims to overcome treatment resistance and redefine what’s possible in cancer therapy. The Company’s pipeline of single- and dual-payload ADCs targets large oncology markets with limited treatment options and significant need for improved therapies.
For more information, follow Sutro on social media @Sutrobio or visit www.sutrobio.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated preclinical and clinical development activities; timing of announcements of IND submissions, trial initiation, clinical results, and other regulatory filings; outcome of discussions with regulatory authorities; potential benefits of the Company’s product candidates and platform; potential business development and partnering transactions; potential market opportunities for the Company’s product candidates and the timing and receipt of anticipated future milestone payments. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, the Company cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause the Company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the Company’s ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, the market size for the Company’s product candidates to be smaller than anticipated, clinical trial sites, supply chain and manufacturing facilities, the Company’s ability to obtain, maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, the Company’s ability to fund development activities and achieve development goals, the Company’s ability to protect intellectual property, and the Company’s commercial collaborations with third parties and other risks and uncertainties described under the heading “Risk Factors” in documents the Company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
Investor Contact
Emily White
Sutro Biopharma
(650) 823-7681
ewhite@sutrobio.com
Media Contact
Amy Bonanno
Lyra Strategic Advisory
abonanno@lyraadvisory.com
FAQ
What clinical milestone did Sutro (STRO) announce on Nov 12, 2025?
When does Sutro (STRO) expect initial STRO‑004 clinical data?
What is STRO‑227 and when is its IND targeted for Sutro (STRO)?
What timeline did Sutro (STRO) give for STRO‑006 entering clinical trials?
How does Sutro (STRO) describe its ADC platform advantage?
What collaboration did Sutro (STRO) highlight at the R&D Day and what is its near‑term plan?
