Oncology Ventures Thesis: Precision Medicine via Biomarkers
The State of Oncology Biomarkers Today
Every year, 2M individuals are diagnosed with cancer in the U.S. They (and their families) face a whirlwind of uncertainty, treatments, surgeries and scans. The complexity of cancer, with its hundreds of types and subtypes, is colossal. The genetic profile of each tumor can vary greatly, even amongst patients diagnosed with the same type of cancer.
Personalized, precision cancer treatment is a targeted approach to better prevent, diagnose and manage cancer based on an individual’s specific profile. Precision medicine can help to drastically improve outcomes and reduce costs for cancer patients.
One of the leading ways precision medicine can be accomplished is through better use of cancer biomarkers.
Cancer biomarkers (biological markers) are a broad class of molecules produced by the body or cancer cells that can be measured in bodily fluids or tissues. Biomarkers provide information about the presence, progression or response to a disease, such as cancer. Biomarkers therefore can determine the condition (e.g. use for screening / early detection), optimal treatment for that condition (e.g. treatment selection / clinical trial support) and can be used to analyze response to that treatment (e.g. monitoring treatment response / recurrence).
These biomarkers can be genetic mutations, proteins, immune complexes and more. There is an opportunity to better leverage biomarkers to bring precision medicine to oncology care:
Cancer biomarkers can identify people who have cancer or who are at risk of developing cancer.
For example, the BRCA1 and BRCA2 mutation biomarkers confer a high likelihood of breast and ovarian cancers.
Cancer biomarkers can also help select or predict those people who are likely to derive therapeutic benefit from specific drugs.
Some examples include genetic mutations that can cause or promote cancer, such as BCR-ABL on chromosome 22 in leukemia, as well as proteins on cancer cells, such as estrogen receptors in breast cancer.
By promoting this precision oncology, biomarkers can improve the efficacy, efficiency and safety of anti-cancer drugs.
Biomarkers are also useful for preclinical development.
Currently, 97% of all oncology clinical trials fail, meaning there is a lot of wasted time, effort and potential. One of the significant reasons for this is the lack of precision in the trials, aggregating different end points and cohorts.
Accordingly, biomarkers can help solve this problem by indicating exactly what the drugs should be targeting and who should be in the clinical trials. Consequently, research has shown that biomarker use increases the success of clinical trials by 12x.
And, biomarkers can be used to monitor remission, through routine blood tests and imaging.
Biomarkers can help ensure that a person gets the right treatment at the right time.
Despite this potential, the adoption of biomarkers in clinical practice and preclinical development is still embryonic. Less than half of all anti-cancer drugs target specific biomarkers and 44% of cancer drugs target only 3 single gene biomarkers.
So, why haven’t biomarkers taken off? Biomarker testing is widely available for many types of cancer (breast, colorectal, lymphoma, lung, melanoma and more). However, their authorized use, reimbursement and implementation is lacking.
To use biomarkers efficiently, and discover new ones, requires a massive amount of information and data. The process to act on that data is complex, long and expensive as there are inherent difficulties integrating molecular, clinical and genomic data, which is scattered across different data sources.
Biomarkers need to undergo rigorous validation and standardization processes to ensure their accuracy, reliability and clinical utility. This requires large-scale clinical trials and collaboration among researchers, clinicians and regulatory bodies. And, the regulatory approval process for biomarker-based tests is difficult to navigate.
Once you are approved, there are reimbursement challenges that come into play. Further, the integration of biomarkers into clinical practice relies on the continued development of evidence-based guidelines and recommendations.
These issues make it difficult to choose and support the next FDA-approved biomarker. Yet, there is a massive opportunity for innovation in this space, as biomarkers are one critical target to revolutionize cancer care.
How Big is this Market?
The market for AI-assisted biomarker research should continue to scale as costs are rapidly increasing, outcomes are poor and the opportunity to reduce spend and improve outcomes is clear through the better use and understanding of biomarkers.
On the preclinical level, the cost of developing a new drug is $2.6B, according to the Centre for the Study of Drug Development. The same study estimated that about 32% of these costs are attributed to preclinical development, which is approximately $800M per medication.
If we could leverage data to make the process of developing biomarkers more efficient, we can reduce preclinical costs by narrowing the therapeutic target, identifying drug synergies and generating relevant cohorts for trials. By reducing preclinical costs even by a modest percentage (say, 10%), we could save around $80 million per drug, generating a multibillion dollar total addressable market (“TAM”).
Notably, the TAM for AI-assisted drug discovery is currently $600M and predicted to rise to $4B by 2027.
On the clinical level, globally, there are 20M new cancer diagnoses annually. This commands high expenditures for diagnosis and treatment, mainly through anti-cancer drugs and diagnosis, showing the potential market for the downstream outputs of technologies in this space.
Overall, the total health expenditure for cancer is $210B, growing at 12%+ per year, And, the cancer biomarker testing service globally is predicted to be $200B by 2030. We continue to see an increasing willingness to pay for and explore cancer biomarkers.
How is Concr Enhancing Biomarker Research?
Oncology Ventures is excited to partner with Concr, which is taking a pick-and-shovel approach to enhancing biomarker research and development.
Identifying and effectively utilizing biomarkers requires extensive datasets and resources. And, while there is a growing abundance of data available on this, that data is siloed and unlinked to patient outcomes.
Concr integrates that discordant and incomplete data to find multi-modal biomarkers for every oncology patient. Their platform helps to predict which patients will respond to which cancer treatments.
Concr’s technology platform, FarrSight®, integrates pre-clinical and clinical data into a single composite model leveraging cosmology principles. Essentially, they turn ‘small data' into 'big data' and use it to make biomarker (and other) predictions to enable precision oncology. This is particularly valuable at early stages of drug development and in cases where data is limited.
Concr’s machine learning methods integrate diverse oncology data, enabling better prediction of treatment responses and aiding in drug development. Their platform requires 300x less pre-clinical data and 7x less clinical data than rival, “best-in-class” models.
Their proprietary data platform and algorithm (called Lens) is being used for early-stage drug development through clinical cohort enrichment and treatment outcome predictions. It enables identification of biomarkers for novel pharmacological agents, synergistic drug combinations for a target, as well as identification of primary site for cancers of unknown primary. Note that Concr does not provide biological testing itself.
Concr aligns well with Oncology Ventures’ thesis on precision medicine through better use of data - by creating a platform that integrates disparate biomedical data, Concr is making strides toward improving data accessibility and scalability.
Oncology Ventures is thrilled to partner with Matt Foster, Irina Babina and the Concr team as they seek to bring precision medicine to a population in desperate need of tailored care and support. For more information on what they are building, check out this link or reach out to us for an introduction.