Pipeline
Our initial clinical development has focused on advancing our core platforms, with the goal of integrating these into therapeutic regimens that can treat any tumor at any stage. Our approach is to validate our core technologies in parallel clinical trials, with the goal of bringing them all together in an integrated product capable of being applied across multiple indications. Strategically we will build additional value through partnering our component technologies to enable our collaborators to build best-in-class products via Umoja platforms.
Therapeutic Programs
development
development
Target: Multiple TumorTags
UB-TT170
development
Target: CD19
development
Target: Multiple
TumorTag Portfolio
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development
development
development
development
development
for Solid Tumors
Building on the results we will obtain from ENLIGHTen, our lead clinical program is UB-VV200 + UB-TT170 for solid tumors.
UB-VV200 comprises VivoVec particles for in vivo delivery of a payload comprising our RACR synthetic cytokine receptor system and a TagCAR.
The UB-VV200 + UB-TT170 clinical program is currently at the IND-enabling data generation stage. We anticipate bringing this program forward as an off the shelf therapeutic approach for folate receptor expressing solid tumors: UB-VV200 will be injected directly into the patient in order to generate TagCAR T-cells in vivo, and the expansion of TagCAR T-cells will be supported by activation of the RACR synthetic cytokine receptor system. Patients will receive infusions of UB-TT170, based on dosing defined in ENLIGHTen, to direct the TagCAR T-cell population to attack and kill folate receptor-expressing tumor cells and stromal elements. These tumors include ovarian, cervical, endometrial cancers (ie, gyn onc) along with triple negative breast and non-small cell lung cancers.
Following in vivo proof of concept for tumor targeting with a single TumorTag, our development plan will move forward to evaluate including multiple TumorTags as a cocktail to increase therapeutic effectiveness. A cocktail of multiple TumorTag adapters (we currently have four adapters in development: UB-TT170/UB-TT430/UB-TT220/UB-TT500) is planned to target cancer and stromal cells found in a high percentage of solid tumors. This approach is designed to establish a path to target any solid tumor cancers including breast, colorectal, and gynecologic cancers, among others.
for Solid Tumors
Our initial clinical program following FDA approval of our first IND application is the Phase 1 ENLIGHTen trial (NCT05312411), an open-label Phase 1 feasibility and safety study of our first TumorTag in patients with refractory/recurrent osteogenic sarcoma (aka osteosarcoma).
UB-TT170 TumorTag molecules are bispecific folate-fluorescein molecules that target the folate receptors expressed in up to 80% of osteosarcoma tumors and label them with fluorescein, a molecule not normally expressed in human cells which serves as a synthetic tumor associated antigen for targeting of CAR T-cells to the tumor.
UB-TT170 TumorTag molecules will be administered to patients along with autologous CAR T cells engineered to express an anti-fluorescein (anti-Tag) chimeric antigen receptor (TagCAR). The trial is being conducted in partnership with Seattle Children’s Therapeutics, a venture at Seattle Children’s Hospital that uses innovative, curative therapies to defeat pediatric cancer and other diseases impacting children.
UB-VV100 comprises VivoVec particles for in vivo delivery of a payload comprising our RACR synthetic cytokine receptor system and a CD19 CAR. The UB-VV100 program is currently at the IND-enabling data generation stage and will be partnered.
We anticipate bringing this program forward as an off the shelf therapeutic approach for CD19-expressing hematologic malignancies. UB-VV100 particles will be injected directly into a patient to generate CD19 CAR T-cells in vivo, and the expansion of the CD19 CAR T-cells will be supported by activation of the RACR synthetic cytokine receptor system. The CD19 CAR has a fixed specificity and will direct CD19 CAR T-cell mediated killing of CD19-expressing tumor cells including, DLBCL, CLL, FL and MCL.
UB-iC200 comprises RACR-iCILs (RACR-induced cytotoxic innate lymphocytes) – iCILs are engineered tumor killing cells that can be generated in large scale for “off the shelf” delivery to patients. They incorporate Umoja’s RACR synthetic cytokine receptor technology to support expansion and engraftment. They have robust intrinsic tumor killing capabilities, and also incorporate a TagCAR system for combinatorial tumor targeting via TumorTag adapters (as above). The UB-iC200 program is currently at the IND-enabling data generation stage.
We anticipate bringing the UB-iC200 program forward as an off the shelf therapeutic for either hematologic malignancies or solid tumors. UB-iC200 iCIL’s unique intrinsic killing properties and TagCAR are anticipated to allow for broad and diverse clinical development opportunities.
