Dr. Mallik Sundaram, co-founder, president and chief-executive officer of Bengaluru-based Mitra Biotech Pvt. Ltd. (Mitra), says, “In the field of cancer drug development, the success rate of taking a drug from phase one to the market approval stage is abysmally low.” It is less than 10 per cent, not taking into account the years spent and the failures encountered at the pre-phase one stage. The fundamental reason for this is the mismatch between the patients and the drugs, shares Sundaram.

“Cancer drug development and cancer treatment need to be made far more efficient and this is within our reach through the use of Oncoprint technology.”

This is the gap that Mitra is trying to fill. Founded in 2008, Mitra is a translational biology company focused on personalised cancer therapy. The company matches drugs to cancer patients and vice-versa using its proprietary experiment driven Oncoprint® model. Mitra has developed this model for various solid cancers (that form discrete tumour mass) including breast cancer, colorectal cancer, pancreatic cancer, head and neck cancer, gastric cancer, cervical cancer, oesophagus cancer, glioblastoma, medulloblastoma and astrocytoma.

The founders have the experience of successfully taking multiple drugs from preclinical development stage to market. The founding team comprises former faculty from Massachusetts Institute of Technology and Harvard University, Dr. Pradip Majumder, Dr. Shiladitya Sengupta and Sundaram, with domain experience in the area of complex analytics and cancer biology. Enoxaparin, a low molecular weight heparin that is currently the only FDA approved generic drug for Sanofi-Aventis’ best seller Lovenox®, was developed by Sundaram at Momenta Inc., an organisation co-founded by him. Majumder developed and led two novel anti-cancer drugs from laboratory to Phase 2b clinical trial in the U.S. “While we applied a variety of complex analytics to hugely complex drug molecules at Momenta, we now use a variety of analytical technology (as applicable to cancer tissues) to cancer biology,” shares Sundaram. Mitra’s strength is the experience of the founders in the area of complex analytics and cancer biology from their previous jobs.

The Mitra model

The company’s personalised treatment strategy is based on the Oncoprint platform technology. “Cancer drug development and cancer treatment needs to be made far more efficient and this is within our reach through the use of Oncoprint technology,” says Sundaram. This technology is built using multiple experimental constraints which include clinical information, explant technology, sophisticated patient tumour derived in vivo models, detailed genomic and proteomic characterisation of patient tumours and bioinformatics analysis. “Just as an elephant cannot be described by its eyes, or ears, and tail alone, but has to be described by a composite picture of the individual details, we build our experimental model using multiple, orthogonal experimental inputs,” explains Sundaram. Different aspects of this model are used for the diagnostics and the drug development application. Since cancer is not a static disease but is dynamic, it is very important that the patient’s treatment option is selected in a short span of time. The company also aims to make this treatment affordable to all. “If it is cost effective to a patient is India, it will be cost effective for anyone in the world.” says Sundaram.

Mitra’s proprietary platform technology enables it to predict how the patient would respond to a given drug. This has two important applications: diagnostics and drug development. In diagnostics, Mitra’s Oncoprint technology is similar to antibiotic treatment. When one has a bacterial infection, the physician does not immediately prescribe an antibiotic but finds the causative bacteria and then prescribes an antibiotic accordingly. However, in the case of cancer, there are 50 different FDA-approved drug treatments for breast cancer alone. Depending on which physician one goes to, the patient will be prescribed a different (FDA approved) drug or drug cocktail. Mitra’s Oncoprint analysis takes this guess work out of the equation as the technology gets constantly validated. Currently, Mitra offers this Oncoprint through the HealthCare Global (HCG) group of hospitals in Bengaluru and will add more centres (Mysore, Ahmedabad and New Delhi among others) in 2012 and beyond.

In the case of drug development, clinical trials are the most expensive part of novel drug development. It takes multiple years and more than 80 per cent of total development cost to take a successful drug through Phase I, II and III clinical trials. However, the way it is currently being done has created a mismatch between the drug and the patients. Mitra solves this problem by selecting the optimal cancer, optimal drug combination and optimal patient profile for the given drug under development. This translates to lower trial cost, higher probability of success and ultimately, a lower cost of drug.

In pursuing this drug development model, Mitra is not involved in the chemistry aspect of the research. That is, the company does not design a molecule from scratch and take it all the way to the market. It works with others – both academia and global biotechnology and pharmaceutical companies – in developing their molecules. “We get remunerated on a transactional basis (fee for service) or as in most cases, we adopt the co-developmental models,” explains Sundaram. In addition to its proprietary technology, the company aims to develop and offer its products in a clinically relevant context so that there is a high amount of translation and benefit to the patients.

Success factors

A good relationship with the ecosystem like cancer hospitals, pharmaceutical industry, funding agencies, and other auxiliary players, defines the company’s success in this space. Mitra has partnered with HCG, Mazumdar Shaw Cancer Center, The Chaim Sheba Medical Center, Norwich Clinical Services, Kidwai Memorial Institute of Oncology, Sri Ramachandra University and Tata Memorial Hospital to name a few. “We have built a successful ecosystem for building and using our core patient segregation tools, and these hospitals and others are an important component of this ecosystem,” says Sundaram. It has different arrangements with the players in its ecosystem – some are monetary based and while others are not. Mitra plans to add other mutually beneficial strategic partnerships and collaborations with national and international players in the field in the near future.

Future plans

Mitra was funded by global VC fund Accel Partners, and Indian VC funds KITVEN (Karnataka Information Technology Venture Capital Fund) and India Innovation Fund in early 2010. The funds are being used to enhance its research and development platform. The company plans to open up three to four additional R&D centres in 2012 and 10 additional ones by 2016. It is also constantly validating its Oncoprint platform and broadening it to cover different categories of cancer such as solid cancers and haematological cancers (AML, CLL).

Mitra’s vision is to become one of the top three biotechnology companies in India by 2015 and be amongst the top five in the world by 2020. To get there, the company has adopted diagnostic and co-developmental models. “If we have at least two to three drugs in the Phase II stage through the co-developmental models and have a successful diagnostic business, we will be among the top three biotechnology companies in India in five years time,” signs off Sundaram.

Concept in brief

The Problem: In the field of cancer treatment as well as in cancer drug development, there is an enormous mismatch between the patients and drugs – not all drugs work for all patients. In fact, in secondary cancers, the success rate for any approved drug in less than 20 per cent. Further, the success rate of taking a drug from Phase I clinical trial stage to the market approval stage is less than 10 per cent.

The solution: Mitra matches drugs to cancer patients and patients to the drugs using its proprietary experiment driven Oncoprint® model. Different aspects of the Oncoprint platform technology are used for the diagnostics and the drug development application. In diagnostics, Mitra’s Oncoprint technology is analogous to bacterial sensitivity test and resulting selection of best course of antibiotic treatment. In case of drug development, Oncoprint enables the selection of the best cancer type, best combination strategy and optimal patient profile – all of which ensures high success rate of new drugs in clinical trials and would consequently result in lower drug costs.

Mitra and CSR

Mitra takes its corporate social responsibility (CSR) seriously. The company’s founders Dr. Mallik Sundaram and Dr. Pradip Majumder, and several employees of Mitra are avid marathon runners and participate in several runs for raising cancer awareness and other causes. They also support a non-profit organisation called ‘One Billion Literates’ (OBL) that is run by Majumder’s wife, Anamika Majumder. OBL is focused on providing education to children and providing employability to the women in rural outskirts of Bangalore.