For Patients

Patients who choose to enroll in our clinical trials are contributing to our understanding of the safety and efficacy of our investigational product candidate(s). We are grateful for the patients and families who help us advance our mission to deliver transformative outcomes for patients.

OBX-115, our lead product candidate, is an investigational TIL cell therapy that is genetically modified to produce a cytokine (IL15) that is membrane-bound (not secreted). Membrane-bound IL15 is designed to eliminate the need to co-administer high-dose IL2 as is required for conventional unengineered TIL cell therapies. The use of IL2 adds to the toxicity of unengineered TIL cell therapy and limits who can receive it. We expect membrane-bound IL15 to improve patient eligibility for OBX-115 TIL cell therapy and eliminate from the treatment regimen the potential toxicities associated with high-dose IL2.

We are investigating OBX-115 and enrolling patients in two ongoing clinical trials in advanced or metastatic melanoma.

Multi-Center Advanced Solid Tumors Clinical Trial: NCT06060613

US study sites are currently enrolling patients with advanced or metastatic solid tumors in a Phase 1/2 clinical trial of OBX-115.

The primary objectives of the trial are to assess the safety, tolerability, and preliminary efficacy of the OBX-115 TIL cell therapy regimen in adult patients with advanced or metastatic melanoma resistant to immune checkpoint inhibitors or relapsed or refractory metastatic non-small cell lung cancer (NSCLC).

Please contact obx115-2301trial@obsidiantx.com for more information.

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Single-Center Melanoma Clinical Trial: NCT05470283

The University of Texas MD Anderson Cancer Center is currently enrolling patients with advanced or metastatic melanoma in a Phase 1 clinical trial of OBX-115.

The primary objectives of the trial are to assess the safety, tolerability, and preliminary efficacy of the OBX-115 TIL cell therapy regimen in patients with advanced or metastatic melanoma who have previously received checkpoint inhibitor therapy and, where indicated, also received BRAF±MEK inhibitor therapy.

Please contact clinical@obsidiantx.com for more information.

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ABOUT OBX-115

OBX-115 is a novel engineered tumor-infiltrating lymphocyte (TIL) therapy armed with regulated membrane-bound IL15 that is designed to remove the need for concomitant IL2 therapy, a toxic and costly requirement for conventional TILs.

Preclinical data have demonstrated enhanced TIL persistence, potency and improved tumor control compared to unengineered TILs, which is anticipated to improve clinical outcomes in patients suffering from different types of solid tumors.

Benefits of TIL-endogenous mbIL15 vs. systemic IL2:

Drive antigen-independent
TIL expansion & persistence

Drive adjacent NK cell
expansion & activity

Drive phenotype towards
CD8+ and memory T-cells

Unlike IL2, suppresses activation-induced cell death, doesn’t expand immunosuppressive Tregs or cause capillary leak syndrome-associated toxicity

OBX-115 is developed without using IL2 in the rapid expansion phase
(REP) process, and designed to be used without concomitant IL2

Elimination of IL2 from the TIL treatment regimen is a significant advantage, driving the opportunity to displace un-engineered TIL therapy requiring systemic IL2. Systemic IL2 therapy is associated with serious side effects and is expensive and complicated to administer. Eliminating IL2 is projected to expand patient eligibility by enabling treatment of patients who cannot tolerate or access IL2 administration.

Our preclinical data across numerous in vitro and in vivo assays demonstrate enhanced potency, persistence, and anti-tumor efficacy of cytoTIL15™ (without IL2) compared to un-engineered TIL + IL2.

Our proprietary, differentiated manufacturing process drives a desired TIL phenotype (memory T-cells, CD8+ T cells) and generates less exhausted cells, which is anticipated to improve clinical outcomes in patients.

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