Our high-throughput functional genomics helps Biopharma from drug development to commercialization.
We are currently collaborating with top biotech and pharmaceutical companies, as well as numerous leading academic medical centers. From elucidating the MOA of a candidate, through charting the specific mutations and secondary mutations on specific genes that best respond to a candidate, all the way to identifying patient subpopulations in off-label indications, NovellusDx is helping bringing new targeted therapies to market.
Genomics is good, functional genomics is better.
Information about genomic alterations has propelled drug development forward allowing to take specific genomic profile into account, but the functional significance of most mutations is uncertain (VUS).
This causes drug developers to ignore most of the NGS information, introducing possible resistance mechanisms to their candidates, or unnecessarily limiting the patient population.
Leap forward by looking backwards
NovellusDx’s advanced synthetic biology capabilities uniquely position it to make in-vitro live-cell analyses starting only with NGS data. This allows our partners to explore the functional significance of mutations and their response to drug candidates even in retrospective settings.
NovellusDx Offers Several Solutions To Biopharma Companies
Better patient selection leading to smaller and faster clinical trials with improved results. This can also be done retrospectively to salvage failed assets.
Identification of new subgroups of patients and the corresponding biomarkers with the potential to respond to existing drugs. Thereby, growing market size and extending IP.
Revealing new target mechanisms by observing the results of previously unknown driver mutations. Using in-vitro screening on heterogonous populations instead of specific cell-lines.
Becoming a true Companion Diagnostics (CDx) by in-vitro testing the full mutational landscape of specific patients and their response to the drugs.
Medium Size Drug Company (MSDC) is developing two compounds to inhibit a specific gene, GENE1. About 50% of mutations occurring in GENE1 are in three very well-known locations. But the rest of the mutations found in databases occur in about 700 different locations. Most advanced patients in the relevant indication have more than one mutation in GENE1.
(MSDC) studied the compound in several relevant cell-lines and xenograft models, but for obvious reasons had to concentrate on the high frequency mutations. This lead to a dilemma: how to move forward into clinical trials? Losing about 50% of patients in advance or risking failure?
NovellusDx generated GENE1 with all relevant mutations, subsequently testing the functional significance of each mutation and its response to the two candidates. Identifying additional driver mutations responding to the candidates. Thus, allowing (MSDC) to move forward into clinical trials with a target population larger by 30% and no adverse effect on trial likelihood.
Large Size Drug Company (LSDC) has an approved inhibitor known to inhibit a specific gene, GENE2. The drug is approved for an indication with relatively low mutational burden, and failed trials in a larger indication with higher mutational burden. This may be attributed to background mutations, but genomic data was too limited to stratify the patients.
(LSDC) sent NovellusDx the NGS data and the drug in the hopes to functionally characterize a subpopulation of patients and their response to the drug.
For each of the patients, NovellusDx synthetically generated all the relevant mutated genes with the mutations found in them. When integrating the observed responses of the mutated genes to the drug, NovellusDx predicted correctly the clinical responses. Subsequently, NovellusDx identified two resistance mechanisms and their genomic markers, allowing a new subpopulation of responders in the larger indication.
WHAT ARE VARIANTS OF UNCERTAIN SIGNIFICANCE?
A tumor may contain driver mutations, which are known to cause an oncogenic effect, and passenger mutations, which are known not to exert such effect. Alterations which have not been designated as driver or passenger mutations, are called Variants of Uncertain Significance (VUS) and may contribute not only to the development of a tumor, but also to drug resistance.
DO YOU ANALYZE ALL TUMOR TYPES?
Our platform can analyze all types of solid tumors.