Engineering Clinically Benchmarked ex vivo Breast Tumors in Human Breast Tissue
For investigational new drugs (IND) that are in (or about to enter) Phase 1 or 2 human clinical trials, we offer ExoPlex, a powerful option to quantify the IND’s efficacy while providing 85% or greater cost savings.
The Problem
Low FDA Approval Rates
Despite an average $281M preclinical spend per Investigational New Drug (IND) 95% of cancer INDs fail FDA clinical trials
Low Efficacy
By law, new drug pricing to be based on efficacy vs. existing treatments
Our ex vivo tumors map 1:1 to human cancer
Clinical management
- TNM staging
- Tumor microenvironment (TME)
- Neoadjuvant vs. adjuvant setting
- Obesity status
- Race, diet, exercise, .....
Our Tumors
Our tumors are grown in their native TME:
- “Breast cancer in human breast tissue”
- T1, T2, T3, T4 tumors
- Neoadjuvant vs. adjuvant tumors
- Patient-specific factors are preserved:
menopausal status, obesity, race, age,
How it Works
Drug developer sends assets to test.
Despite an average $281M preclinical spend per Investigational New Drug (IND) 95% of cancer INDs fail FDA clinical trials
(small molecules, antibodies, cellular therapies)
They select donor demographics – same as a standard FDA trial.
By law, new drug pricing to be based on efficacy vs. existing treatments
We analyze the tumors and return biospecimens / data.
- Proteomics
- Transcriptomics
- Lipidomics
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 ExoPlex 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. ExoPlex 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. ExoPlex 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, ExoPlex can be completed in weeks vs. years for standard clinical trials. This dramatically de-risks and accelerates new therapeutic development.
