Sutro Biopharma Announces Research Collaboration with the FDA to Advance Regulatory Standards for Antibody Drug Conjugates
Sutro Biopharma (NASDAQ: STRO) has announced a significant research collaboration with the FDA to advance regulatory standards for Antibody Drug Conjugates (ADCs). The partnership will utilize Sutro's proprietary XpressCF® technology to develop reference materials and enhance analytical methods for ADC drug development.
The collaboration involves Sutro working with the FDA's Office of Pharmaceutical Quality (OPQ) to jointly lead study design and selection of target antigens, payload-linkers, and drug conjugation sites. The initiative aims to improve quality assessments and regulatory standards for both approved ADCs and those in development, with results to be published upon completion.
Sutro Biopharma (NASDAQ: STRO) ha annunciato una collaborazione di ricerca significativa con la FDA per migliorare gli standard regolatori relativi agli Antibody Drug Conjugates (ADC). La partnership sfrutterà la tecnologia proprietaria di Sutro, la XpressCF® technology, per sviluppare materiali di riferimento e perfezionare i metodi analitici per lo sviluppo di farmaci ADC.
La collaborazione prevede che Sutro lavori insieme all'Office of Pharmaceutical Quality (OPQ) della FDA per guidare congiuntamente la progettazione degli studi e la selezione di antigeni target, payload-linkers e siti di coniugazione del farmaco. L’iniziativa mira a migliorare le valutazioni qualitative e gli standard regolatori sia per gli ADC già approvati sia per quelli in fase di sviluppo, con la pubblicazione dei risultati al termine del progetto.
Sutro Biopharma (NASDAQ: STRO) ha anunciado una colaboración de investigación significativa con la FDA para avanzar en los estándares regulatorios de los Antibody Drug Conjugates (ADCs). La asociación utilizará la tecnología propietaria de Sutro, la XpressCF® technology, para desarrollar materiales de referencia y mejorar los métodos analíticos para el desarrollo de medicamentos ADC.
La colaboración implica que Sutro trabaje junto con la Office of Pharmaceutical Quality (OPQ) de la FDA para liderar conjuntamente el diseño del estudio y la selección de antígenos objetivo, enlaces de carga útil y sitios de conjugación del fármaco. La iniciativa busca mejorar las evaluaciones de calidad y los estándares regulatorios tanto para los ADC aprobados como para los que están en desarrollo, con la publicación de los resultados al finalizar.
Sutro Biopharma (NASDAQ: STRO)는 항체-약물 접합체(ADCs)에 대한 규제 기준을 향상시키기 위해 FDA와 중요한 연구 협력을 발표했습니다. 이 파트너십은 Sutro의 독자적인 XpressCF® 기술을 활용하여 참조 물질을 개발하고 ADC 약물 개발을 위한 분석 방법을 개선할 예정입니다.
이번 협력은 Sutro가 FDA의 Office of Pharmaceutical Quality (OPQ)와 함께 연구 설계 및 표적 항원, 페이로드-링커, 약물 접합 부위 선정을 공동으로 주도하는 것을 포함합니다. 이 이니셔티브는 승인된 ADC와 개발 중인 ADC 모두의 품질 평가 및 규제 기준을 개선하는 것을 목표로 하며, 결과는 완료 후 공개될 예정입니다.
Sutro Biopharma (NASDAQ : STRO) a annoncé une collaboration de recherche majeure avec la FDA pour faire progresser les normes réglementaires des conjugués anticorps-médicaments (ADC). Ce partenariat utilisera la technologie propriétaire de Sutro, la XpressCF® technology, pour développer des matériaux de référence et améliorer les méthodes analytiques pour le développement des médicaments ADC.
La collaboration implique que Sutro travaille avec le Office of Pharmaceutical Quality (OPQ) de la FDA pour co-diriger la conception des études ainsi que la sélection des antigènes cibles, des linkers de charge utile et des sites de conjugaison du médicament. Cette initiative vise à améliorer les évaluations de qualité et les normes réglementaires tant pour les ADC approuvés que pour ceux en développement, avec la publication des résultats à la fin du projet.
Sutro Biopharma (NASDAQ: STRO) hat eine bedeutende Forschungskooperation mit der FDA angekündigt, um regulatorische Standards für Antikörper-Wirkstoff-Konjugate (ADCs) voranzutreiben. Die Partnerschaft wird Sutros firmeneigene XpressCF®-Technologie nutzen, um Referenzmaterialien zu entwickeln und analytische Methoden für die ADC-Arzneimittelentwicklung zu verbessern.
Die Zusammenarbeit umfasst, dass Sutro gemeinsam mit dem Office of Pharmaceutical Quality (OPQ) der FDA die Studienplanung sowie die Auswahl von Zielantigenen, Payload-Linkern und Wirkstoffkonjugationsstellen leitet. Ziel der Initiative ist es, Qualitätsbewertungen und regulatorische Standards für zugelassene ADCs sowie solche in Entwicklung zu verbessern, wobei die Ergebnisse nach Abschluss veröffentlicht werden.
- Strategic collaboration with FDA validates Sutro's XpressCF® technology platform
- Opportunity to influence future regulatory standards for ADC development
- Enhanced visibility and recognition in the ADC development space
- Potential to accelerate future ADC approvals through improved regulatory standards
- None.
Insights
Sutro's FDA collaboration validates their technology platform and positions them as leaders in shaping emerging ADC regulatory standards.
This FDA collaboration represents a strategic regulatory positioning for Sutro Biopharma that extends beyond typical industry-regulator relationships. By partnering directly with the FDA's Office of Pharmaceutical Quality to develop reference materials for antibody-drug conjugates, Sutro gains unique insights into evolving regulatory standards while simultaneously validating their XpressCF® platform technology.
The collaboration highlights three significant advantages for Sutro:
- Regulatory intelligence: Direct involvement in shaping future ADC analytical standards provides Sutro privileged understanding of FDA's quality expectations
- Technical validation: Selection of Sutro's platform technology by FDA signals recognition of its precision and reliability for producing consistent ADCs
- Competitive differentiation: As ADCs become increasingly important therapeutic modalities, Sutro positions itself as a technological leader with regulatory credibility
From an industry perspective, ADCs represent one of biopharma's fastest-growing segments, with over 15 FDA-approved products and hundreds in clinical development. However, their complex nature—combining antibodies with cytotoxic payloads—presents unique manufacturing and analytical challenges. Regulatory standards are still evolving, and this collaboration directly addresses this gap.
While this partnership won't immediately impact Sutro's revenue or clinical programs, it establishes valuable regulatory relationships and enhances their platform credibility. This positions Sutro advantageously against competitors and potentially streamlines future regulatory interactions for their own therapeutic candidates.
SOUTH SAN FRANCISCO, Calif., July 22, 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 that it has entered into a collaboration with the U.S. Food and Drug Administration (FDA) to develop reference materials to improve regulatory standards and enhance analytical methods for ADC drug development. The collaboration will leverage Sutro’s cell-free XpressCF® technology to precisely engineer ADCs with predefined attributes, as well as FDA’s cutting-edge analytical capabilities to fully characterize these materials.
“ADCs represent one of the most promising and fast-growing modalities for new biopharmaceuticals. We’re honored to be among a select group collaborating with the FDA to help shape regulatory standards for ADC development and quality control,” said Hans-Peter Gerber, Ph.D., Sutro’s Chief Scientific Officer. “This collaboration underscores the precision and flexibility of our cell-free XpressCF® platform in advancing next-generation ADCs, and we look forward to the impact of this work across the industry, with regulators, and for the patient community. We thank the FDA for the opportunity to help define the future of ADC innovation.”
As part of the collaboration, Sutro and the Office of Pharmaceutical Quality (OPQ) within the FDA Center for Drug Evaluation and Research (CDER) will jointly lead the study design and selection of target antigens, payload-linkers, and drug conjugation sites representative of both approved ADCs and those in development. The results will be published upon completion, and the insights gained from this collaboration are expected to enhance OPQ’s ongoing research efforts aimed at bolstering the FDA’s capacity for the analytical characterization of ADCs to enhance ADC quality assessments.
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; and the potential benefits of the Company’s collaboration with the FDA. 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
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