Theranosis Life Sciences: Pioneering Precision Medicine in Oncology by Developing Innovative Liquid Biopsy Platform for Theranostics (Therapy + Diagnostics)

Personalized Medicine is being adopted widely in India as we enter a new era of medicine and is one of the rapidly advancing fields of healthcare. Every patient is unique in the way they respond to treatments due to the differences in their genetic makeup, inherited germline mutations and acquired somatic mutations influenced by lifestyle and environmental factors. Instead of the “one size fits all approach” personalized medicine seeks to address this inherent biological variability among people. The goal is to custom tailor the treatment based on their pharmacogenomic profiles.

One such approach is the Precision Medicine in Oncology initiative by Theranosis Life Sciences Pvt Ltd, a biotech startup incubated at CCMB, Hyderabad. Theranosis is creating a new paradigm shift in the way we treat cancer patients. Cancer is a multifactorial complex disease where genomic integrity gets compromised leading to an uncontrolled growth of certain cell types. Recent advances in pharma has led to novel immunotherapies and targeted therapies for cancer. Now the treatment is not just personalized but also targets only specific cancer cells without affecting the normal cells. Despite these advances we still do not have an effective means to monitor treatment success or failure. Radiological assessment (CT, MRI and PET CT scans) has several limitations and by the time we see some changes in the PET CT scan it is already too late for the patient with advanced metastatic disease. That is where liquid biopsy comes to the rescue by identifying metastasis or disease progression at a very early stage so that the oncologists can start the treatment at the right time to prevent the spread of the disease. Theranosis Life Sciences is literally talking about improving cancer patient’s quality of life and extending survival from six months to six years.

The global personalized medicine market is growing profoundly and is estimated to increase to a whopping $2.8 billion by 2022. Theranosis Life Sciences was founded in 2016 by Dr. Shibichakravarthy Kannan, a physician scientist with more than a decade of cancer research experience. Being one of the ET Power of Ideas competition winners they received the first seed investment from CIIE, IIM Ahmedabad. The team has since participated in multiple accelerator programs from T-Hub, Forge Accelerator, IKP Accelerator, Philips Healthworks and NASSCOM. The biggest achievement was getting the Biotech Ignition Grant from BIRAC, DBT which helped them to start lab operations with full-fledged cell culture facility at IKP Knowledge Park, Genome Valley, Hyderabad. Their rapid prototyping microfluidics lab is now fully operational at CCMB Hub.

Driven by a mission to “improve cancer treatment outcomes” while at the same time to “reduce the unwanted toxicity of chemotherapy” by personalized medicine approach, the core values of Theranosis team are a long-term commitment to cancer research and addressing the unmet needs in the cancer treatment landscape. Their secret sauce – direct access to Asia’s largest tumor tissue biobank from Apollo Hospitals which enables accelerated in-house R&D and rapid product development. Their flagship product is the Thera-CTC device which detects the circulating tumor cells (CTCs) in a cancer patient’s blood sample. Downstream tests like tumor mutational profiling (companion diagnostics for targeted therapies) and chemosensitivity assays are made possible by enriching the viable CTCs by patent pending Thera-CTC lab-on-a-chip.

Thera-CTC liquid biopsy platform will soon be ready for clinical trials and real-world testing. The best part about Thera-CTC chip is that it is immensely affordable for developing countries like India at a cost of $33 (INR 2145) per test for a patient which is about 20 to 60 times less pricing than most competitors. All the major and minor cancer types (solid tumors only, not applicable for lymphoma or leukaemia) can be tested with more indications coming soon that are specific for Indian patients like oral cancer and gastrointestinal tumors.

Empowering Cancer Patients

Cancer treatment is currently driven by rigid protocols and there is no room for an experimental approach. Chemotherapy is given by trial and error approach to see if the patient responds to it or not. Conventional imaging techniques like CT or PET CT scans have several limitations. In a typical PET CT scan the limit of detection is about 10 million cancer cells (size of a pea). Anything smaller than that will go unnoticed. It takes at least two to three months’ time to see some visible changes in the scans between treatments. Whereas liquid biopsy can give results within the same day and it can be repeated as many time as needed. Surgical biopsies are impossible in certain scenarios for example in lung cancer. Liquid biopsy is an emerging trend globally and is soon becoming mainstream. But all these developments are happening in the western hemisphere and India is left behind. There are no such clinical trials or reliable liquid biopsy service providers in India and those who do are prohibitively priced so that market penetration is very poor. Lack of awareness and scepticism from oncologists regarding the clinical utility of liquid biopsy is preventing the widespread adoption of this technology that can save patient lives and improve clinical outcomes. Theranosis team is working towards partnering with Regional Cancer Centers in Telangana, Andhra Pradesh, Tamilnadu, Kerala and Karnataka (Pan South India) to conduct a large scale multicentric study to prove the value of liquid biopsy in breast and ovarian cancers. This data will be used to get regulatory approvals from DCGI/CDCSO India and later for CE IVD followed by US FDA.

Product Pipeline

Theranosis Life Sciences is working on cutting-edge technologies such as Lab-on-chip – Using microfluidics technology the development of in vitro diagnostics assay on a glass slide (chip) can save time and ability to detect biological parameters even at nanoscales; Organ-on-a-chip – Using 3D Bioprinting technology the creation of artificial tissue slices (mimicking the actual organs) in vitro will simulate the tumor microenvironment and aids in the study of the effect of drugs on patient derived primary cancer cells and Cancer Genomics – By using Next Generation Sequencing the team can study the mutational profile of tumor tissues and circulating tumor cells. Their main focus is to establish clonality of the CTCs and find clinically actionable mutations such as EGFR, KRAS, BRAF and more.

Clinical Diagnostics R&D Services

The company is offering industry leading R&D services to its research partners. Liquid Biopsy – Three main types of liquid biopsy based on the cellular fraction being tested: Circulating Tumor Cells (CTCs), Circulating Tumor DNA (ctDNA) and Exosomes (ctRNA) – extracellular vesicles containing miRNA and protein biomarkers. The team can detect these molecules from various biological fluids such as blood, urine, cerebrospinal fluid and more. Immunohistochemistry (IHC) – Visualize tumor markers such as oncogenes, tumor-specific antigens, tumor suppressor genes and tumor proliferation markers, pathologists can efficiently predict oncogenesis and diagnose cancer as benign or malignant, determine the stage and the grade of cancer. This can be done on FFPE (paraffin embedded) blocks or fresh frozen surgical biopsy tissue. Flowcytometry – In this sophisticated technique, the team is proficient in detecting cell surface biomarkers from a sample of blood. The blood cells are stained with fluorescently labelled antibodies and using various gating strategies they can find rare tumor cell populations. This technique is commonly used for blood cancers such as lymphoma and leukaemia. Mutational Profiling – Using Next Generation Sequencing techniques they can identify the driver mutations that are causally implicated in oncogenesis (cancer causing genes). Their strong bioinformatics team has built pipelines to analyze the data on the cloud and give clinically interpretable actionable reports.

Creating an Engaging Workplace Driven by Science

Theranosis Life Sciences has a mutually challenging and scientifically engaging workplace. The company follows innovative HR policies to create perfect work-life balance. Minimum 7.5 hours physical presence in the workspace, flexible hours with 30 minutes for lunch break, all national & state holidays are observed with additional 12 days sick leave with 90 days of work from home. Employee benefits such as life insurance and health insurance policy promoted a healthy atmosphere with reduction in number of sick days. Daily stand-up meetings on Slack App and once a week team meeting keeps the employees up to date and connected with each other. This makes a positive difference in enhancing employee productivity and work satisfaction. The company also offers various training and development initiatives that include Online Learning – MOOC, Datacamp subscription, on-site training, hands-on training and Research Internship Program for the period of 3-6 months for the students to get industrial training in Biomedical Engineering, Cell Culture, Bioinformatics and Molecular Biology. The company culture is driven by a passion for science and an eye for innovation.

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