Bench to Bedside, Simplified.

For investigational new drugs (IND) that are in (or about to enter) Phase 1 or 2 human clinical trials, we offer OncoTrials, a powerful option to quantify the IND’s efficacy while providing 85% or greater cost savings.

In OncoTrials, discard, healthy adipose tissue (breast, prostate, peri-colonic, peritoneal, and subcutaneous) is procured and processed into hundreds of cancer microenvironments. Within each microenvironment, the desired cancer model(s) can be seeded. These include cancer cell lines, patient-derived organoids, tumoroids, and patient-derived xenograft tumors. Importantly, clients can also select adipose tissue donor characteristics including race/ethnicity, medical comorbidities, age, and gender. This unlocks rare cancer types, such as male breast cancer and pediatric breast cancer.
 
Further value comes from our ability to distinguish – for the first time – the relative contributions of cancer subtypes vs. patient-specific factors on therapeutic efficacy. Previously, if an IND was effective in one patient but not another, it was unclear if the difference was due to differences in the patient (genetics, epigenetics, medical comorbidities) or the tumor.  In OncoTrials, the same tumors can be grown in hundreds of patient tissues, providing clear insight into the patient vs. tumor factors driving treatment efficacy.

Standard Clinical Trials (6-8 years)

OncoTrials (2-3 weeks)

No Risks to Humans

In the current framework, there is no option to generate human-specific data without testing in humans. This is because there are no experimental models that recapitulate human physiology. In general, libraries of candidate therapeutics are screened in cell lines and 3D systems, promising candidates move on to animal models, and the best of those move into humans. As the only company in the world that can stably culture human tissues AND tumors in vitro, Keliomics adds the ability to perform human testing without human subjects.

Target Population Identification

 In cancer, targeted therapies tend to be most clinically efficacious and cost effective. Identifying the correct patient populations can save drug developers tens to hundreds of millions of dollars in clinical trial costs. This is because higher efficacy rates requires smaller clinical trials. Unfortunately, most INDs fail to identify their target patient populations until late in the clinical trial process. Because OncoTrials produces dozens of cancer subtypes in each healthy subject, developers can identify the correct patient populations before starting clinical trials.

Solving the Clinical Trials Bottleneck

Although cancer is distressingly common, fewer than 5% of adult cancer patients enroll in cancer clinical trials.  In 2021, nearly 1,500 oncology clinical trials were enrolling subjects, generating fierce competition for each subject and driving up costs. OncoTrials solves this bottleneck by using healthy discard tissues to generate cancer models. In breast cancer, for example, only 12,000 patients enroll in clinical trials each year. In contrast, 100,000 breast reductions are performed annually in the U.S.  Moreover, each discard breast specimen can generate dozens of breast cancer subtypes, thereby solving the clinical trials bottleneck.

Inversion of the Clinical Trial Paradigm

Currently, INDs proceed through the clinical trials paradigm first to demonstrate safety (Phase 1), then effectiveness (Phase 2), and finally a comparison with gold standard therapy (Phase 3). However, if an IND is not more efficacious than existing therapies, it is unlikely to gain market traction. The current paradigm therefore forces developers to spend USD 24.5-117 million before learning if their IND is better than the gold standard.  OncoTrials provides data on efficacy and an apples-to-apples comparison against the gold standard before entering Phase 1 trials, and at a 95-99% cost reduction. Moreover, OncoTrials can be completed in weeks vs. years for standard clinical trials. This dramatically de-risks and accelerates new therapeutic development.

Get in touch.

Keliomics, Inc.
4640 S. Macadam Ave, Suite 270
Portland, OR 97239

info@keliomics.com