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Sutro Biopharma to Highlight its Next-Generation Exatecan and Dual-Payload ADC Programs in Presentations at AACR 2025

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Sutro Biopharma announced two key presentations at the 2025 AACR Annual Meeting in Chicago, showcasing their advances in antibody drug conjugates (ADCs). The company will present data on two significant developments:

  • STRO-004: A novel exatecan Tissue Factor ADC showing strong anti-tumor activity and favorable safety in preclinical studies. Single-dose treatments demonstrated promising response rates in Tissue Factor-positive patient models across multiple cancers. The company plans to begin human trials later this year.
  • XpressCF+® Platform: Their proprietary cell-free platform enables creation of dual-payload ADCs with higher drug-to-antibody ratios and site-selective conjugation of two linker payloads.

CEO Jane Chung highlighted that STRO-004 achieved notable disease control rates in preclinical studies. The presentations will take place on April 28, with Dr. Alice Yam presenting on STRO-004 and Dr. Gang Yin discussing dual-payload ADC development. The research demonstrates Sutro's leadership in developing next-generation cancer treatments.

Sutro Biopharma ha annunciato due presentazioni chiave al 2025 AACR Annual Meeting di Chicago, mostrando i loro progressi negli anticorpi coniugati a farmaci (ADC). L'azienda presenterà dati su due sviluppi importanti:

  • STRO-004: un nuovo ADC exatecan contro il Tissue Factor che ha mostrato una forte attività antitumorale e un profilo di sicurezza favorevole negli studi preclinici. Trattamenti a dose singola hanno evidenziato tassi di risposta promettenti in modelli di pazienti positivi al Tissue Factor in diversi tipi di tumore. L'azienda prevede di iniziare le sperimentazioni sull'uomo entro la fine dell'anno.
  • Piattaforma XpressCF+®: la loro piattaforma proprietaria senza cellule consente la creazione di ADC a doppio payload con rapporti farmaco-anticorpo più elevati e coniugazione selettiva in siti specifici di due linker payload.

La CEO Jane Chung ha sottolineato che STRO-004 ha raggiunto tassi significativi di controllo della malattia negli studi preclinici. Le presentazioni si terranno il 28 aprile, con la Dott.ssa Alice Yam che presenterà STRO-004 e il Dott. Gang Yin che discuterà lo sviluppo degli ADC a doppio payload. La ricerca dimostra la leadership di Sutro nello sviluppo di terapie oncologiche di nuova generazione.

Sutro Biopharma anunció dos presentaciones clave en la Reunión Anual AACR 2025 en Chicago, mostrando sus avances en conjugados de anticuerpos y fármacos (ADC). La compañía presentará datos sobre dos desarrollos importantes:

  • STRO-004: un nuevo ADC exatecan dirigido al Tissue Factor que mostró una fuerte actividad antitumoral y un perfil de seguridad favorable en estudios preclínicos. Los tratamientos de dosis única demostraron tasas de respuesta prometedoras en modelos de pacientes positivos para Tissue Factor en múltiples tipos de cáncer. La empresa planea iniciar ensayos en humanos a finales de este año.
  • Plataforma XpressCF+®: su plataforma propietaria libre de células permite la creación de ADCs con doble carga útil, con mayores ratios droga-anticuerpo y conjugación selectiva en sitios específicos de dos cargas de enlace.

La CEO Jane Chung destacó que STRO-004 logró tasas notables de control de la enfermedad en estudios preclínicos. Las presentaciones se realizarán el 28 de abril, con la Dra. Alice Yam presentando STRO-004 y el Dr. Gang Yin discutiendo el desarrollo de ADCs con doble carga útil. La investigación demuestra el liderazgo de Sutro en el desarrollo de tratamientos oncológicos de próxima generación.

Sutro Biopharma는 시카고에서 열리는 2025 AACR 연례 회의에서 항체 약물 접합체(ADC) 분야의 진전을 선보이는 두 가지 주요 발표를 발표했습니다. 회사는 두 가지 중요한 개발에 대한 데이터를 공개할 예정입니다:

  • STRO-004: 전임상 연구에서 강력한 항종양 활성과 우수한 안전성을 보인 새로운 엑사테칸 기반 Tissue Factor ADC입니다. 단일 투여 치료는 여러 암종에서 Tissue Factor 양성 환자 모델에서 유망한 반응률을 보여주었습니다. 회사는 올해 말 인간 임상시험을 시작할 계획입니다.
  • XpressCF+® 플랫폼: 독자적인 세포 없는 플랫폼으로, 더 높은 약물-항체 비율과 두 개의 링커 페이로드를 부위 선택적으로 접합하는 이중 페이로드 ADC를 생성할 수 있습니다.

CEO 제인 청은 STRO-004가 전임상 연구에서 주목할 만한 질병 조절률을 달성했다고 강조했습니다. 발표는 4월 28일에 진행되며, 앨리스 얌 박사가 STRO-004를, 강 인 박사가 이중 페이로드 ADC 개발을 발표할 예정입니다. 이 연구는 차세대 암 치료제 개발에 있어 Sutro의 리더십을 보여줍니다.

Sutro Biopharma a annoncé deux présentations clés lors de la réunion annuelle AACR 2025 à Chicago, mettant en avant leurs avancées dans les conjugués anticorps-médicaments (ADC). La société présentera des données sur deux développements majeurs :

  • STRO-004 : un nouvel ADC exatecan ciblant le Tissue Factor, démontrant une forte activité antitumorale et une sécurité favorable dans des études précliniques. Des traitements en dose unique ont montré des taux de réponse prometteurs dans des modèles de patients positifs au Tissue Factor pour plusieurs cancers. La société prévoit de débuter des essais cliniques chez l'humain d'ici la fin de l'année.
  • Plateforme XpressCF+® : leur plateforme propriétaire sans cellule permet la création d'ADCs à double charge utile avec des ratios médicament-anticorps plus élevés et une conjugaison sélective sur site de deux charges utiles liées.

La PDG Jane Chung a souligné que STRO-004 a atteint des taux notables de contrôle de la maladie lors des études précliniques. Les présentations auront lieu le 28 avril, avec le Dr Alice Yam présentant STRO-004 et le Dr Gang Yin discutant du développement des ADC à double charge utile. Cette recherche démontre le leadership de Sutro dans le développement de traitements anticancéreux de nouvelle génération.

Sutro Biopharma kündigte zwei wichtige Präsentationen auf der 2025 AACR Jahrestagung in Chicago an, bei denen ihre Fortschritte bei Antikörper-Wirkstoff-Konjugaten (ADCs) vorgestellt werden. Das Unternehmen wird Daten zu zwei bedeutenden Entwicklungen präsentieren:

  • STRO-004: Ein neuartiges Exatecan-Tissue-Factor-ADC, das in präklinischen Studien eine starke antitumorale Aktivität und ein günstiges Sicherheitsprofil zeigte. Einzeldosisbehandlungen zeigten vielversprechende Ansprechraten in Tissue-Factor-positiven Patientenmodellen bei verschiedenen Krebsarten. Das Unternehmen plant, noch in diesem Jahr mit klinischen Studien am Menschen zu beginnen.
  • XpressCF+® Plattform: Ihre proprietäre zellfreie Plattform ermöglicht die Herstellung von Dual-Payload-ADCs mit höheren Wirkstoff-zu-Antikörper-Verhältnissen und ortsspezifischer Konjugation von zwei Linker-Payloads.

CEO Jane Chung hob hervor, dass STRO-004 in präklinischen Studien bemerkenswerte Krankheitskontrollraten erzielte. Die Präsentationen finden am 28. April statt, wobei Dr. Alice Yam STRO-004 vorstellt und Dr. Gang Yin die Entwicklung von Dual-Payload-ADCs erläutert. Die Forschung zeigt Sutros Führungsrolle bei der Entwicklung von Krebsbehandlungen der nächsten Generation.

Positive
  • STRO-004 demonstrated potent anti-tumor activity in preclinical studies across all tested doses
  • Single dose of STRO-004 achieved promising response rates in Tissue Factor-positive patient-derived xenograft models
  • Company's XpressCF+® platform enables creation of advanced dual-payload ADCs with higher drug-to-antibody ratios
  • IND-enabling studies progressing with first-in-human trial planned for later this year
  • Platform demonstrates validated cell-free ADC manufacturing process
Negative
  • STRO-004 data is only preclinical - no human trial results yet
  • Success in preclinical studies does not guarantee effectiveness in human trials

Insights

Sutro's STRO-004 shows promising preclinical results with planned clinical trial initiation in 2025, advancing their ADC pipeline in oncology.

Sutro Biopharma's upcoming AACR presentations highlight meaningful progress for their antibody-drug conjugate (ADC) pipeline, particularly STRO-004, their novel Tissue Factor-targeting ADC with exatecan payload. The preclinical data package demonstrates three critical elements sought in advancing ADC candidates: potent dose-dependent anti-tumor activity, favorable safety profile across tested doses, and promising response rates in patient-derived xenograft models spanning multiple cancer types.

The advancement of STRO-004 to IND-enabling studies marks a significant development milestone, with first-in-human trials planned for later in 2025. This progression establishes a clear near-term clinical translation timeline for this pipeline asset.

Beyond STRO-004, Sutro is showcasing their XpressCF+® platform's capabilities in creating dual-payload ADCs with higher drug-to-antibody ratios and site-selective conjugation of two different payloads - technical attributes that could potentially enhance therapeutic index and efficacy. This platform differentiation comes amid substantial industry focus on ADC technologies.

While these preclinical findings represent important progress, the true clinical profile will only be established once human studies begin. The planned initiation of first-in-human trials provides a concrete milestone to monitor for continued pipeline advancement in Sutro's oncology-focused ADC portfolio.

- Preclinical findings show STRO-004's promising anti-tumor activity and favorable safety profile -

SOUTH SAN FRANCISCO, Calif., April 28, 2025 (GLOBE NEWSWIRE) -- Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), an oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced poster presentations at the upcoming 2025 American Association for Cancer Research (AACR) Annual Meeting, taking place April 25-30 in Chicago, IL. The presentations will cover preclinical activity and safety data for STRO-004, the Company’s novel exatecan Tissue Factor ADC, as well as showcase the unique advantages of Sutro’s XpressCF+® platform in enabling precise and efficient development of dual-payload ADCs.

“We are excited to share our progress advancing our next-generation ADC pipeline at AACR,” said Jane Chung, Sutro’s Chief Executive Officer. “In preclinical studies, STRO-004 consistently demonstrated potent, dose-dependent anti-tumor activity and a favorable safety profile across all tested doses. Of note, STRO-004, after only a single dose, achieved promising overall response and disease control rates in Tissue Factor-positive patient-derived xenograft models spanning multiple cancer types. We look forward to continuing to investigate the full potential of STRO-004, as we complete IND-enabling studies and prepare to initiate a first-in-human trial later this year.”

Ms. Chung continued: “Also, as presented at AACR, our XpressCF+® cell-free platform is uniquely capable of creating revolutionary dual-payload ADCs—differentiated by higher drug-to-antibody ratios, fully site-selective conjugation of two linker payloads and a validated, cell-free ADC manufacturing process. We are excited to showcase these and other key features of our platform, which enable our ADC candidates to overcome limitations of conventional ADCs and the challenges of targeting complex disease biology. These presentations further reinforce our technology leadership and our highly differentiated ADC candidates.”

Poster Presentation Details:

Title: Preclinical activity and safety of STRO-004, a novel ADC targeting tissue factor for solid tumors
Abstract: #1572
Session: PO.ET02.01 - Antibody-Based Cancer Therapeutics 1
Date & Time: Monday, April 28, 2025, 9:00 a.m. - 12:00 p.m. CT
Presenter: Alice Yam, Ph.D., Vice President of Drug Discovery at Sutro Biopharma

Title: Enhancing Topo1i ADC efficacy: development of homogeneous dual-payload ADCs combining Topo1i with microtubule inhibitors or PARP inhibitors
Abstract: #2870
Session: PO.ET02.11 - Antibody-Based Cancer Therapeutics 2
Date & Time: Monday, April 28, 2025, 2:00 p.m. - 5:00 p.m. CT
Presenter: Gang Yin, Ph.D., Vice President of Platform Engineering & Process Research at Sutro Biopharma

The abstracts are currently available on AACR’s website and the poster presentations will be accessible through the News & Events page of the Investor Relations section of the Company’s website at www.sutrobio.com.

About Sutro Biopharma
Sutro Biopharma, Inc., is relentlessly focused on the discovery and development of precisely designed cancer therapeutics to transform what science can do for patients. Sutro’s fit-for-purpose technology, including cell-free XpressCF®, provides the opportunity for broader patient benefit and an improved patient experience. Sutro is advancing a robust early-stage pipeline of novel exatecan and dual-payload antibody drug conjugates (ADCs), coupled with high-value collaborations and industry partnerships, which validate its continuous product innovation. Sutro is headquartered in South San Francisco. 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, including enrollment and site activation; timing of announcements of clinical results, trial initiation, and 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; the timing and receipt of anticipated future milestone payments; the Company’s expected cash runway; and the expected costs and cost reductions associated with the restructuring. 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 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 are the key findings of STRO-004 presented at AACR 2025?

STRO-004, Sutro's Tissue Factor ADC, demonstrated potent anti-tumor activity and favorable safety across all tested doses in preclinical studies. After a single dose, it achieved promising response rates in Tissue Factor-positive patient-derived xenograft models across multiple cancer types.

When will Sutro Biopharma (STRO) begin human trials for STRO-004?

Sutro Biopharma plans to initiate first-in-human trials for STRO-004 later in 2025, following completion of their current IND-enabling studies.

What makes Sutro's XpressCF+ platform unique for ADC development?

Sutro's XpressCF+ platform uniquely creates dual-payload ADCs with higher drug-to-antibody ratios, fully site-selective conjugation of two linker payloads, and uses a validated cell-free ADC manufacturing process.

What presentations will Sutro Biopharma (STRO) give at AACR 2025?

Sutro will present two posters at AACR 2025: one on STRO-004's preclinical activity and safety on April 28 at 9:00 AM CT, and another on dual-payload ADCs combining Topo1i with other inhibitors at 2:00 PM CT.

How does STRO-004 differ from conventional ADCs?

STRO-004 is designed to overcome limitations of conventional ADCs through Sutro's XpressCF+ platform, specifically targeting Tissue Factor with improved drug-to-antibody ratios and site-selective conjugation for better efficacy.
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