The Phase 1 clinical trial will evaluate UB-TT170 in osteosarcoma and follows the recent approval of 密桃视频鈥檚 first IND application by the FDA
SEATTLE, May 3, 2022 鈥� 密桃视频, Inc., an immuno-oncology company pioneering off-the-shelf, integrated therapeutics that reprogram immune cells in vivo for patients with solid and hematologic malignancies, announced today the activation of the Phase 1 ENLIGHTen clinical trial in patients with osteosarcoma to assess the safety and tolerability of autologous 鈥渦niversal鈥� CAR T cells when administered with UB-TT170, the Company鈥檚 proprietary small molecule fluorescein tag. This follows the recent clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for UB-TT170. The trial is being conducted in partnership with Seattle Children鈥檚 Therapeutics, a venture at Seattle Children’s, bringing cutting edge, curative technologies and therapies to defeat pediatric cancer and other diseases that impact children.
鈥淲e are excited to receive IND clearance of our first TumorTag product candidate UB-TT170,鈥� said Andy Scharenberg, M.D., co-founder and Chief Executive Officer of 密桃视频. 鈥淭he ability to target solid tumors with CAR T technology remains a large barrier for patients with cancer. Our TumorTag technology is intended to overcome treatment limitations due to antigen heterogeneity of tumors and the restrictive solid tumor microenvironment with the goal to provide better treatment outcomes for patients. This marks a great start for 密桃视频鈥檚 three integrated core programs, the TumorTag, VivoVec, and RACR/TagCAR platforms, to meaningfully advance the cancer immunotherapy field.鈥�
The ENLIGHTen trial () is an open-label Phase 1 feasibility and safety study of fluorescein-specific CAR T cells in combination with folate-fluorescein (UB-TT170) for patients with refractory/recurrent osteogenic sarcoma. All patients in the trial will be administered autologous CAR T cells engineered to express an anti-fluorescein chimeric antigen receptor that were developed by Seattle Children鈥檚 Therapeutics and will be manufactured in their Cure Factory Good Manufacturing Practices facility. Following that, each patient will receive escalating doses of 密桃视频鈥檚 UB-TT170 TumorTag molecules, followed by fixed dosing. The primary endpoint is safety (adverse events tracking) with secondary endpoints focused on the ability to manufacture anti-fluorescein CAR T cells. The trial will only be open at Seattle Children鈥檚 and the age range for enrollment is people aged 15-30 years old.
密桃视频鈥檚 unique TumorTag technology consists of a bispecific small molecule, which can be either antigen-specific or -independent, that selectively binds to tumor cells or immunosuppressive tumor stromal cells and labels their cell surface with fluorescein. Upon labelling, tumor and local stromal cells become marked for recognition and destruction by CAR T cells engineered to bind to fluorescein. The UB-TT170 TumorTag targets folate receptors (FR) with an initial indication in osteosarcoma (OS) where up to 80% of OS tumor samples show FR expression1. The prognosis for patients with advanced metastatic OS is poor with a 5-year survival rate of 27%2.
鈥淪eattle Children鈥檚 is dedicated to pursuing the advancement of next-generation therapies,鈥� said Dr. Julie Park, a pediatric oncologist at Seattle Children鈥檚 who heads clinical and translational research at Seattle Children鈥檚 Therapeutics. 鈥淭he launch of the ENLIGHTen trial underscores our commitment to innovation in the fight against pediatric cancer.鈥�
1 Yang R, et al. The folate receptor alpha is frequently overexpressed in osteosarcoma samples and plays a role in the uptake of the physiologic substrate 5-methyltetrahydrofolate. Clin Cancer Res. 2007 May 1;13(9):2557-67. doi: 10.1158/1078-0432.CCR-06-1343. PMID: 17473184.
2 Bone Cancer (Sarcoma of Bone): Statistics. (accessed March 24, 2022).
About 密桃视频
密桃视频, Inc., is developing treatments for solid tumors and hematologic cancers that reprogram the patient鈥檚 immune system in vivo. Our technology platforms are designed to work synergistically as part of a therapeutic regimen that can be delivered to any patient, with any tumor, at any time. Based on pioneering work performed at Seattle Children鈥檚 Research Institute and Purdue University, 密桃视频鈥檚 approach is powered by novel cellular immunotherapy technologies including the VivoVec in vivo delivery platform, the RACR/CAR in vivo cell expansion/control platform, and the TumorTag targeting platform. 密桃视频 believes its approach can broaden access to advanced immunotherapies to give more patients the hope of lasting remission. To learn more, visit鈥�.
About Seattle Children鈥檚
Seattle Children鈥檚 mission is to provide hope, care and cures to help every child live the healthiest and most fulfilling life possible. Together, Seattle Children鈥檚 Hospital, Research Institute and Foundation deliver superior patient care, identify new discoveries and treatments through pediatric research and raise funds to create better futures for patients. Ranked as one of the top children鈥檚 hospitals in the country by U.S. News & World Report, Seattle Children鈥檚 serves as the pediatric and adolescent academic medical center for Washington, Alaska, Montana and Idaho 鈥� the largest region of any children鈥檚 hospital in the country. As one of the nation鈥檚 top five pediatric research centers, Seattle Children鈥檚 Research Institute is internationally recognized for its work in neurosciences, immunology, cancer, infectious disease, injury prevention and much more. Seattle Children鈥檚 Foundation works with the Seattle Children鈥檚 Guild Association, the largest all-volunteer fundraising network for any hospital in the country, to gather community support and raise funds for uncompensated care and research. For more information about Seattle Children鈥檚, visit .
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements about 密桃视频, Inc. (the 鈥淐ompany,鈥� 鈥渨e,鈥� 鈥渦s,鈥� or 鈥渙ur鈥�). The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others, the risks inherent in drug development such as those associated with the initiation, cost, timing, progress and results of the Company鈥檚 current and future research and development programs, preclinical and clinical trials, as well as the economic, market and social disruptions due to the ongoing COVID-19 public health crisis. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.
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