Senti Bio Announces First Patient Dosed in Clinical Trial of SN301A in Hepatocellular Carcinoma in Collaboration with Celest Therapeutics
Senti Biosciences (SNTI) announced the first patient dosing in a clinical trial of SN301A for hepatocellular carcinoma (HCC) in mainland China, in collaboration with Celest Therapeutics. The trial aims to evaluate safety, pharmacokinetics, and preliminary anti-tumor activity of SN301A, a CAR-NK cell therapy utilizing Senti's Gene Circuit platform, in patients with advanced GPC3-expressing HCC across multiple dose cohorts.
Celest is leading the clinical development, operations, and manufacturing in China, with Senti Bio providing technical and strategic input. The study will assess adverse events, dose-limiting toxicities, and efficacy using standard liver cancer response criteria. The collaboration may expand to Hong Kong, Macau, and Taiwan, while Senti Bio retains rights outside these regions.
Senti Biosciences (SNTI) ha annunciato la somministrazione al primo paziente in una sperimentazione clinica di SN301A per il carcinoma epatocellulare (HCC) nella Cina continentale, in collaborazione con Celest Therapeutics. Lo studio ha l'obiettivo di valutare la sicurezza, la farmacocinetica e l'attività antitumorale preliminare di SN301A, una terapia cellulare CAR-NK che utilizza la piattaforma Gene Circuit di Senti, in pazienti con HCC avanzato che esprimono GPC3 in diversi gruppi di dose.
Celest guida lo sviluppo clinico, le operazioni e la produzione in Cina, mentre Senti Bio fornisce input tecnici e strategici. Lo studio valuterà eventi avversi, tossicità limitanti delle dosi e l'efficacia utilizzando i criteri standard di risposta al cancro del fegato. La collaborazione potrebbe espandersi a Hong Kong, Macao e Taiwan, mentre Senti Bio mantiene i diritti al di fuori di queste aree.
Senti Biosciences (SNTI) anunció la primera dosificación en un paciente en un ensayo clínico de SN301A para el carcinoma hepatocelular (HCC) en la China continental, en colaboración con Celest Therapeutics. El ensayo tiene como objetivo evaluar la seguridad, la farmacocinética y la actividad antitumoral preliminar de SN301A, una terapia celular CAR-NK que utiliza la plataforma Gene Circuit de Senti, en pacientes con HCC avanzado que expresan GPC3 en varios grupos de dosis.
Celest lidera el desarrollo clínico, las operaciones y la fabricación en China, mientras que Senti Bio proporciona información técnica y estratégica. El estudio evaluará eventos adversos, toxicidades limitantes de dosis y eficacia utilizando criterios estándar de respuesta al cáncer de hígado. La colaboración podría expandirse a Hong Kong, Macao y Taiwán, mientras que Senti Bio retiene los derechos fuera de estas regiones.
센티 바이오사이언스(SNTI)는 셀레스트 테라퓨틱스와 협력하여 중국 본토에서 간세포암(HCC) 치료를 위한 SN301A의 첫 환자 투약을 발표했습니다. 이 임상 시험은 GPC3를 발현하는 진행성 HCC 환자에서 Senti의 Gene Circuit 플랫폼을 활용한 CAR-NK 세포 치료제인 SN301A의 안전성, 약동학 및 초기 항종양 활성을 평가하는 것을 목표로 하고 있습니다.
셀레스트는 중국에서 임상 개발, 운영 및 제조를 주도하며, 센티 바이오에서는 기술적이고 전략적인 지원을 제공합니다. 이 연구는 부작용, 용량 제한 독성과 효능을 간암 표준 반응 기준을 사용하여 평가할 것입니다. 이 협력은 홍콩, 마카오 및 대만으로 확대될 수 있으며, 센티 바이오는 이 지역 외의 권리를 유지합니다.
Senti Biosciences (SNTI) a annoncé le premier dosage d'un patient dans un essai clinique de SN301A pour le carcinome hépatocellulaire (HCC) en Chine continentale, en collaboration avec Celest Therapeutics. L'essai vise à évaluer la sécurité, la pharmacocinétique et l'activité antitumorale préliminaire de SN301A, une thérapie cellulaire CAR-NK utilisant la plateforme Gene Circuit de Senti, chez des patients atteints de HCC avancé exprimant GPC3 à travers plusieurs groupes de dose.
Celest dirige le développement clinique, les opérations et la fabrication en Chine, tandis que Senti Bio fournit des contributions techniques et stratégiques. L'étude évaluera les événements indésirables, les toxicités limitantes de dose et l'efficacité en utilisant des critères standard de réponse au cancer du foie. La collaboration pourrait s'étendre à Hong Kong, Macao et Taïwan, tandis que Senti Bio conserve ses droits en dehors de ces régions.
Senti Biosciences (SNTI) hat die erste Dosierung bei einem Patienten in einer klinischen Studie zu SN301A für das hepatozelluläre Karzinom (HCC) im Festlandchina in Zusammenarbeit mit Celest Therapeutics bekannt gegeben. Die Studie zielt darauf ab, die Sicherheit, Pharmakokinetik und vorläufige anti-tumorale Aktivität von SN301A, einer CAR-NK-Zelltherapie, die die Gene Circuit-Plattform von Senti nutzt, bei Patienten mit fortgeschrittenem, GPC3-exprimierenden HCC in mehreren Dosisgruppen zu bewerten.
Celest leitet die klinische Entwicklung, die Operationen und die Herstellung in China, während Senti Bio technische und strategische Unterstützung bietet. Die Studie wird unerwünschte Ereignisse, dosislimitierende Toxizitäten und die Wirksamkeit anhand der standardisierten Kriterien für die Reaktion auf Leberkrebs bewerten. Die Zusammenarbeit könnte sich auf Hongkong, Macau und Taiwan ausdehnen, während Senti Bio die Rechte außerhalb dieser Regionen behält.
- First patient dosed in HCC clinical trial, marking pipeline advancement
- Strategic partnership with Celest enables market access in China, where 40% of global HCC cases occur
- Recent positive initial clinical data from SENTI-202 in blood cancer demonstrates platform potential
- Early-stage clinical trial with no efficacy data yet
- to Chinese market, with development rights restricted to specific regions
Insights
The initiation of clinical trials for SN301A in hepatocellular carcinoma represents a significant milestone in Senti Bio's pipeline development. The Gene Circuit platform's application in solid tumors, particularly targeting GPC3-expressing HCC, addresses a critical medical need, especially in China where HCC burden is substantial. The trial's design to evaluate both safety and preliminary anti-tumor activity through multiple dose cohorts follows standard clinical development protocols. The recent positive data from SENTI-202 in blood cancers provides encouraging validation for the platform technology. However, given SNTI's micro-cap status and early clinical stage, substantial risks remain before potential commercialization.
This development carries strategic importance for SNTI's market position and potential revenue streams. The collaboration with Celest Therapeutics provides a cost-effective route to market in China, which represents over
– Dose-finding clinical trial in China designed to evaluate safety and preliminary anti-tumor activity of SN301A (SENTI-301A manufactured in China) in hepatocellular carcinoma (“HCC”) –
SOUTH SAN FRANCISCO, Calif., Dec. 16, 2024 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today announced that the first patient has been dosed in the pilot trial of SN301A in HCC in mainland China in collaboration with Celest Therapeutics (Shanghai) Co. Ltd (“Celest”). SN301A utilizes the anti-GPC3 + crIL-15 (each as defined below) SENTI-301A Gene Circuit developed by Senti Bio and refers to the chimeric antigen receptor natural killer (“CAR-NK”) product candidate manufactured by Celest in China.
Through this collaboration, Celest is leading clinical development, operations and manufacturing of SN301A with technical, strategic and clinical input from Senti Bio. The clinical trial is designed to evaluate safety, pharmacokinetics and preliminary anti-tumor activity of SN301A and will include patients with advanced glypican 3 (“GPC3”)-expressing HCC across multiple dose cohorts. The study endpoints include safety assessments for adverse events and dose limiting toxicities, as well as efficacy analyses using standard response criteria for liver cancer.
“Today’s announcement is a significant demonstration of the progress in our strategic partnership with Celest to advance the clinical development of SENTI-301A, our solid tumor pipeline product candidate in China,” said Timothy Lu, MD, PhD, Chief Executive Officer and Co-Founder of Senti Bio. “We are proud of the rapid development to date, and value how our partnership with the Celest team is playing an important role in bringing Senti Bio’s Gene Circuit technology to patients who have limited or no therapeutic options today. We are excited by the recent positive initial clinical data from our first Gene Circuit enabled cell therapy SENTI-202 in blood cancer, and the potential to expand our platform to treat solid tumors with high unmet clinical needs.”
“We are thrilled to share this progress in the clinical development of SN301A. In successfully initiating this trial, we are now seeing the potential of integrating Senti’s novel Gene Circuit technology to our proprietary NK cell manufacturing and clinical operations expertise,” said Erdong Hua, Chairman of Celest and Managing Partner of 6 Dimensions Capital. “Importantly, as the second leading cause of cancer-related death in Asia, liver cancer remains a large health threat in China. Statistically, over 40 percent of global HCC cases are reported in China, underscoring the significant unmet need that we hope SN301A may help address.”
Additionally, Celest and Senti Bio have the option to expand clinical development of SN301A to Hong Kong, Macau and Taiwan. Senti Bio will retain all development and commercialization rights outside of mainland China, Hong Kong, Macau and Taiwan for SENTI-301A.
About the SN301A Clinical Trial
The safety and efficacy of SN301A is being evaluated in an investigator-initiated open-label, single-center study (NCT06652243) in adult patients with advanced GPC3-expressing HCC. Three dose levels of SN301A will be administered in cycles, each comprising of 3 weekly doses (Days 0, 7, 14) during a 28-day treatment cycle following a standard lymphodepletion conditioning regimen of fludarabine and cytarabine. Patients may continue to receive multiple cycles of treatment based on their safety and efficacy results.
About SENTI-301A/SN301A
SENTI-301A is a multi-armed off-the-shelf healthy donor derived CAR-NK cell therapy designed for the treatment of GPC3 expressing tumors. The engineered NK cells target the GPC3 antigen, which is highly expressed in
About Senti Bio
Senti Bio is a clinical-stage biotechnology company developing a new generation of cell and gene therapies for patients living with incurable diseases. To achieve this, Senti Bio is leveraging a synthetic biology platform called Gene Circuits to create therapies with enhanced precision and control. These Gene Circuits are designed to precisely kill cancer cells, spare healthy cells, increase specificity to target cells and control the expression of drugs even after administration. Senti Bio’s wholly-owned pipeline includes off-the-shelf CAR-NK cells, outfitted with Gene Circuits, to target challenging liquid and solid tumor indications. Senti Bio’s lead program SENTI-202, a Logic Gated CD33 and/or FLT3-targeting hematologic cancer therapeutic candidate, demonstrated complete remissions in 2 of 3 patients in initial clinical data as of September 19, 2024. Senti Bio has also preclinically demonstrated that its Gene Circuits can function in T cells. Additionally, Senti Bio has preclinically demonstrated the potential breadth of Gene Circuits in other cell and gene therapy modalities, diseases outside of oncology, and continues to advance these capabilities through partnerships with Roche/Spark Therapeutics and Bayer/BlueRock Therapeutics.
About Celest
Celest was founded to develop intelligent CAR-immune cell therapy for effective treatment of challenging solid tumors. Celest technology platforms employ a suite of in-house developed immunological technologies, including platforms to screen for tumor microenvironment (“TME”) induced immune cell enrichment, trafficking and persistence. In parallel, the platforms also identify and optimize CAR-NK cell signaling domains using high-throughput methods including pooled library screenings. Incubated by 6 Dimensions Capital and 120 Capital with operations in Shanghai, China, Celest is building next-generation innovative cell therapy products with full-fledged capabilities from early R&D, cell manufacturing to clinical development and commercialization.
Forward-Looking Statements
This press release and document contain certain statements that are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally are identified by the words “believe,” “could,” “predict,” “continue,” “ongoing,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” “forecast,” “seek,” “target” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements are predictions, projections, and other statements about future events that are based on current expectations of Senti Bio’s management and assumptions, whether or not identified in this document, and, as a result, are subject to risks and uncertainties. Forward-looking statements include, but are not limited to, expectations regarding Senti Bio’s growth, strategy, progress and timing of its clinical trials and the timing of availability of data from the ongoing clinical trials; the ability of any product candidate to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data; the growth, strategy, progress and timing of clinical trials for SENTI-301A through Celest in China; expectations regarding the anticipated dosing of patients and availability of data from clinical trials, and the timing thereof; the ability to initiate new clinical programs; as well as statements about the potential attributes and benefits of Senti Bio’s platform technology and the progress and continuation of its collaborations with Celest and other collaboration and strategic partners. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by any investor as, a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Senti Bio. Many factors could cause actual future results to differ materially from the forward-looking statements in this document, including but not limited to: (i) changes in domestic and foreign business, market, financial, political and legal conditions, (ii) changes in the competitive and highly regulated industries in which Senti Bio operates, variations in operating performance across competitors, changes in laws and regulations affecting Senti Bio’s business, (iii) the ability to implement business plans, forecasts and other expectations, (iv) the risk of downturns and a changing regulatory landscape in Senti Bio’s highly competitive industry, (v) risks relating to the uncertainty of any projected financial information with respect to Senti Bio, (vi) risks related to uncertainty in the timing or results of Celest’s and Senti Bio’s clinical trial start up, clinical studies, patient enrollment, and GMP manufacturing startup activities, (vii) Senti Bio’s dependence on third parties in connection with clinical trial startup, clinical studies, and GMP manufacturing activities, (viii) risks related to delays and other impacts from macroeconomic and geopolitical events, increasing rates of inflation and rising interest rates on business operations, and (ix) the success of any future research and development efforts by Senti Bio. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of Senti Bio’s most recent periodic report filed with the U.S. Securities and Exchange Commission (“SEC”), and other documents filed by Senti Bio from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements in this document. There may be additional risks that Senti Bio does not presently know, or that Senti Bio currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements in this document. Forward-looking statements speak only as of the date they are made. Senti Bio anticipates that subsequent events and developments may cause Senti Bio’s assessments to change. Except as required by law, Senti Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise.
Availability of Other Information About Senti Biosciences, Inc.
For more information, please visit the Senti Bio website at https://www.sentibio.com or follow Senti Bio on X (formerly Twitter) (@SentiBio) and LinkedIn (Senti Biosciences). Investors and others should note that we communicate with our investors and the public using our company website (www.sentibio.com), including, but not limited to, company disclosures, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference call transcripts and webcast transcripts, as well as on Twitter and LinkedIn. The information that we post on our website or on Twitter or LinkedIn could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.
FAQ
What is the purpose of Senti Bio's SN301A clinical trial in China?
What are the key endpoints for SNTI's SN301A clinical trial?
Which regions are covered in the Senti Bio and Celest Therapeutics collaboration for SN301A?
Why is SNTI's focus on liver cancer in China significant?
