Sutro Biopharma and Boehringer Ingelheim BioXcellence™ collaboration: Established first-in-class cell-free capabilities at commercial scale
Sutro Biopharma (STRO) and Boehringer Ingelheim BioXcellence™ have successfully scaled up Sutro's proprietary cell-free expression technology to commercial scale manufacturing. The collaboration achieved production of luveltamab tazevibulin (luvelta), Sutro's antibody-drug conjugate (ADC) for ovarian cancer treatment, at 4,500L scale in Boehringer's Vienna facility.
The breakthrough represents an industry milestone, marking the first successful transition from small-scale to large-scale GMP production using Sutro's cell-free protein synthesis platform. All manufactured batches met the required quality criteria for clinical studies. The platform's unique advantage lies in its modular approach, utilizing non-natural amino acids for site-specific protein conjugation, potentially offering improved safety and efficacy profiles compared to traditional ADC production methods.
This achievement validates the commercial viability of Sutro's technology and can be applied to their pipeline of next-generation ADCs targeting various cancers. Sutro is actively seeking business development partners to advance their technology platform and product pipeline.
Sutro Biopharma (STRO) e Boehringer Ingelheim BioXcellence™ hanno scalato con successo la tecnologia proprietaria di espressione cellulare libera di Sutro per la produzione su scala commerciale. La collaborazione ha raggiunto la produzione di luveltamab tazevibulin (luvelta), il coniugato anticorpo-farmaco (ADC) di Sutro per il trattamento del cancro ovarico, su scala di 4.500L presso l'impianto di Vienna di Boehringer.
Questo traguardo rappresenta un momento decisivo per l'industria, segnando la prima transizione riuscita dalla produzione su piccola scala alla produzione GMP su larga scala utilizzando la piattaforma di sintesi proteica cellulare libera di Sutro. Tutti i lotti prodotti hanno soddisfatto i criteri di qualità richiesti per gli studi clinici. Il vantaggio unico della piattaforma risiede nel suo approccio modulare, che utilizza aminoacidi non naturali per la coniugazione proteica specifica, offrendo potenzialmente profili di sicurezza ed efficacia migliorati rispetto ai metodi di produzione tradizionali di ADC.
Questo risultato convalida la fattibilità commerciale della tecnologia di Sutro e può essere applicato alla loro pipeline di ADC di nuova generazione mirati a vari tumori. Sutro sta attivamente cercando partner per lo sviluppo commerciale per far progredire la propria piattaforma tecnologica e il portafoglio di prodotti.
Sutro Biopharma (STRO) y Boehringer Ingelheim BioXcellence™ han escalado con éxito la tecnología de expresión celular libre propietaria de Sutro para la fabricación a escala comercial. La colaboración logró la producción de luveltamab tazevibulin (luvelta), el conjugado anticuerpo-fármaco (ADC) de Sutro para el tratamiento del cáncer de ovario, a una escala de 4,500L en la instalación de Boehringer en Viena.
Este avance representa un hito en la industria, marcando la primera transición exitosa de la producción a pequeña escala a la producción GMP a gran escala utilizando la plataforma de síntesis de proteínas sin células de Sutro. Todos los lotes fabricados cumplieron con los criterios de calidad requeridos para los estudios clínicos. La ventaja única de la plataforma reside en su enfoque modular, utilizando aminoácidos no naturales para la conjugación específica de proteínas, lo que podría ofrecer perfiles de seguridad y eficacia mejorados en comparación con los métodos tradicionales de producción de ADC.
Este logro valida la viabilidad comercial de la tecnología de Sutro y puede aplicarse a su cartera de ADCs de próxima generación dirigidos a varios tipos de cáncer. Sutro está buscando activamente socios para el desarrollo comercial para avanzar su plataforma tecnológica y cartera de productos.
Sutro Biopharma (STRO)와 Boehringer Ingelheim BioXcellence™는 Sutro의 독점 세포 자유 발현 기술을 상업적 규모의 제조로 성공적으로 확대했습니다. 이 협력은 오varian cancer 치료를 위한 Sutro의 항체-약물 결합체(ADC)인 luveltamab tazevibulin (luvelta)을 Boehringer의 비엔나 시설에서 4,500L 규모로 생산하는 데 성공했습니다.
이 전환은 산업의 중요한 이정표를 나타내며, Sutro의 세포 자유 단백질 합성 플랫폼을 사용하여 소규모에서 대규모 GMP 생산으로의 첫 성공적인 전환을 뜻합니다. 제조된 모든 배치는 임상 연구에 필요한 품질 기준을 충족했습니다. 이 플랫폼의 독특한 장점은 특정 부위의 단백질 결합을 위해 비자연 아미노산을 활용하는 모듈식 접근 방식에 있으며, 전통적인 ADC 생산 방법에 비해 향상된 안전성 및 효능 프로필을 제공할 수 있습니다.
이 성과는 Sutro의 기술 상업적 실행 가능성을 검증하며 여러 암을 목표로 하는 차세대 ADC 파이프라인에 적용할 수 있습니다. Sutro는 기술 플랫폼과 제품 파이프라인을 발전시키기 위해 actively 사업 개발 파트너를 찾고 있습니다.
Sutro Biopharma (STRO) et Boehringer Ingelheim BioXcellence™ ont réussi à élever la technologie d'expression sans cellules brevetée de Sutro à une fabrication à grande échelle commerciale. Cette collaboration a permis de produire du luveltamab tazevibulin (luvelta), le conjugué anticorps-médicament (ADC) de Sutro pour le traitement du cancer de l'ovaire, à l'échelle de 4 500 L dans l'usine de Vienne de Boehringer.
Cette avancée représente une étape clé pour l'industrie, marquant la première transition réussie d'une production à petite échelle à une production GMP à grande échelle utilisant la plateforme de synthèse de protéines sans cellules de Sutro. Tous les lots fabriqués ont satisfait aux critères de qualité requis pour les études cliniques. L'avantage unique de la plateforme réside dans son approche modulaire, utilisant des acides aminés non naturels pour la conjonction spécifique des protéines, offrant potentiellement des profils de sécurité et d'efficacité améliorés par rapport aux méthodes de production traditionnelles des ADC.
Cette réalisation valide la viabilité commerciale de la technologie de Sutro et peut être appliquée à leur portefeuille de nouveaux ADC ciblant divers cancers. Sutro recherche activement des partenaires pour le développement commercial afin d'avancer sa plateforme technologique et son portefeuille de produits.
Sutro Biopharma (STRO) und Boehringer Ingelheim BioXcellence™ haben erfolgreich die proprietäre zellfreie Expressions-Technologie von Sutro für die kommerzielle Herstellung skaliert. Die Zusammenarbeit erreichte die Produktion von luveltamab tazevibulin (luvelta), dem Antikörper-Wirkstoff-Konjugat (ADC) von Sutro zur Behandlung von Eierstockkrebs, im Maßstab von 4.500L in der Wiener Einrichtung von Boehringer.
Dieser Durchbruch stellt einen Meilenstein in der Branche dar und markiert den ersten erfolgreichen Übergang von der Klein- zur Großserien-GMP-Produktion mithilfe von Sutros zellfreier Protein-Synthese-Plattform. Alle hergestellten Chargen entsprachen den erforderlichen Qualitätskriterien für klinische Studien. Der einzigartige Vorteil der Plattform liegt in ihrem modularen Ansatz, der nicht-natürliche Aminosäuren für die standortspezifische Protein-Konjugation verwendet und potenziell verbesserte Sicherheits- und Wirksamkeitsprofile im Vergleich zu traditionellen ADC-Herstellungsmethoden bietet.
Dieser Erfolg validiert die kommerzielle Lebensfähigkeit von Sutros Technologie und kann auf ihre Pipeline der nächsten Generation von ADCs angewendet werden, die auf verschiedene Krebsarten abzielt. Sutro ist aktiv auf der Suche nach Geschäftspartnern für die Weiterentwicklung ihrer Technologieplattform und Produktpipeline.
- Successfully scaled up cell-free technology to commercial production level (4,500L)
- All manufactured batches met clinical study quality requirements
- Demonstrated third-party commercial manufacturing capability
- Validated technology's commercial viability for future pipeline development
- None.
Insights
The achievement of GMP-compliant production at Boehringer's facility proves the technology's transferability and commercial viability. For investors, this derisks the manufacturing aspect of Sutro's pipeline, particularly for luvelta, their lead ADC candidate for ovarian cancer. The platform's modular nature could also generate additional revenue through licensing opportunities.
For investors, this technology validation strengthens Sutro's position in the competitive ADC landscape, where manufacturing consistency and scalability are critical differentiators. The platform's demonstrated success with luvelta suggests similar potential for Sutro's broader pipeline of ADC candidates, enhancing the company's value proposition in potential partnering discussions. The explicit mention of seeking business development partners signals potential future licensing deals or collaborations.
The commercial-scale validation opens three key value drivers: 1) reduced manufacturing risk for their pipeline programs, 2) enhanced partnering opportunities for their technology platform and 3) potential licensing revenues. The explicit statement about seeking business development partners suggests near-term catalyst potential through new partnerships or licensing deals. This positions Sutro to potentially leverage their validated platform across multiple revenue streams, from internal drug development to technology licensing.
SOUTH SAN FRANCISCO, Calif., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Boehringer Ingelheim BioXcellence™ and Sutro Biopharma Inc. today announced that they successfully applied Sutro’s proprietary cell-free expression technology on a commercial scale to manufacture luveltamab tazevibulin (luvelta), Sutro’s Tubulin FRα-targeting antibody-drug conjugate (ADC) designed to treat a broad range of patients with ovarian cancer and other FRα expressing cancers.
For the first time, the cross-functional teams were able to scale up Sutro’s cell-free protein synthesis platform from a small-scale Good Manufacturing Practice (GMP) production to a large-scale GMP production marking an industry milestone. All batches of luvelta manufactured in 4,500 L at Boehringer’s large-scale manufacturing facility in Vienna, Austria, met the product quality criteria required for the use in clinical studies.
Sutro’s cell free platform utilizes cellular components necessary for protein generation. The cell-free extract contains everything that is needed for synthesis, including energy production, transcription, and translation. By adding a specific DNA sequence, the desired protein can be synthesized. This technology has proven effective for a large range of molecule sizes, from small peptides to complex mammalian proteins such as monoclonal antibodies.
“We’re thrilled that our long-standing partnership with Sutro built the foundation to choose our site to demonstrate its technology on a commercial scale, which proves our reputation as manufacturing experts,” said Dr. Tilman Rock, site head Biopharma Austria at Boehringer Ingelheim. Ute Lehmann, Head of Business Development, Key Account Management & Marketing of Boehringer Ingelheim’s contract manufacturing arm, BioXcellence, added: “Our partnership with Sutro shows how we can achieve more together. It's through these synergies that we enhance our capabilities, complementing our partners' expertise. This is the essence of our partnership approach at Boehringer Ingelheim BioXcellence™.”
A unique advantage of the Sutro cell-free protein synthesis platform is its modular approach. It uses non-natural amino acids to achieve site-specific conjugation of proteins to chemicals in a way that isn’t possible with cell-bound approaches. This is a crucial aspect in creating, for instance, next-generation ADCs for oncology treatments that are designed to have certain benefits in the safety and efficacy profile compared to ADCs produced by traditional methods. Sutro's lead candidate was selected to demonstrate commercial viability. These insights can be applied to their robust pipeline of next-generation ADCs targeting a variety of cancers.
“In our partnership with Boehringer Ingelheim BioXcellence™, we have been working toward demonstrating that ADCs built with our cell-free platform can be manufactured by a third party at commercial scale under GMP conditions,” said Venkatesh Srinivasan, PhD, Sutro’s Chief Technical Operations Officer. “Today we are excited to share that we have achieved this goal together with our partner. We look forward to applying these learnings to our broader ADC pipeline. Sutro is actively seeking business development partners to continue to advance and accelerate our technology platform’s potential and our product pipeline.”
Boehringer Ingelheim
Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. More than 53,500 employees serve over 130 markets to build a healthier, more sustainable, and equitable tomorrow.
Learn more at www.boehringer-ingelheim.com.
Boehringer Ingelheim BioXcellence™
Building on this, Boehringer Ingelheim BioXcellence™ collaborates with partners to reliably supply biopharmaceutical therapies. The companies’ extensive experience in their contract development and manufacturing has resulted in supplying more than 45 commercial products to patients in need worldwide. It operates a global manufacturing network in key technologies such as mammalian and microbial, turning biologic innovations into commercial successes.
Learn more at www.bioxcellence.com.
Sutro Biopharma, Inc.
Sutro Biopharma, Inc., is a clinical-stage company 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 has multiple clinical stage candidates, including luveltamab tazevibulin, or luvelta, a registrational-stage folate receptor alpha (FolRα)-targeting ADC in clinical studies. A robust pipeline, coupled with high-value collaborations and industry partnerships, validates Sutro’s 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, Sutro’s potential commercial-scale manufacturing capabilities; anticipated preclinical and clinical development activities; timing of announcements of clinical results, trial initiation, and regulatory filings; potential benefits of luvelta and Sutro’s other product candidates and platform; potential business development and partnering transactions; and potential market opportunities for luvelta and Sutro’s other product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although Sutro believes that the expectations reflected in such forward-looking statements are reasonable, Sutro 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 Sutro’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Sutro’s ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates and Sutro’s ability to successfully leverage Fast Track designation, the market size for Sutro’s product candidates to be smaller than anticipated, clinical trial sites, supply chain and manufacturing facilities, Sutro’s ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, Sutro’s ability to fund development activities and achieve development goals, Sutro’s ability to protect intellectual property, and Sutro’s commercial collaborations with third parties and other risks and uncertainties described under the heading “Risk Factors” in documents Sutro 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 Sutro undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
Contacts:
Emily White
Sutro Biopharma
(650) 823-7681
ewhite@sutrobio.com
Rebekka Wuester
Communication Lead BioXcellence
bioxcellence@boehringer-ingelheim.com
FAQ
What milestone did Sutro Biopharma (STRO) achieve with Boehringer Ingelheim in January 2025?
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What are the advantages of STRO's cell-free protein synthesis platform?
Where is STRO's luveltamab tazevibulin being manufactured at commercial scale?
What are STRO's next steps following this manufacturing milestone?
