Enabling Targeted Cancer Therapy

Enabling Targeted Cancer Therapy

Sequoia Capital and Artiman Ventures-backed OncoStem Diagnostics predicts cancer recurrence in a patient through its flagship product, CanAssist. While its current focus is on breast cancer, it aims to develop effective tests for oral, brain and colon cancer as well.

Manjiri Bakre, Founder and CEO, OncoStem Diagnostics

Most entrepreneurial ventures have a personal trigger and Manjiri Bakre’s story is no different. When she was doing her PhD in the late 90s, her friend was diagnosed with breast cancer and she lost her within two years of diagnosis, despite her taking Chemotherapy and bearing its side effects. This set her thinking and researching about how a person’s disease spreads and it led her to identify a couple of tests available in the West –in the U.S. and Netherlands – in early 2000. However, they were very expensive for Indian patients. “This was the trigger to develop our own test which is more cost effective and, more importantly, developed and validated on Indian patients,” recalls she.

What helped her was the fact that her PhD research was on tumor induced blood vessel formation.  After completing her doctorate, she was in the U.S. till 2003, after which she joined the Genome Institute of Singapore and worked there for 4 years.  Throughout her career, her work has been focussed on cell signalling–how a cell perceives signals and responds to it, how cancer builds its blood vessels and feeds itself, the cell signalling mechanisms used by embryonic stem cells to differentiate multitude cell types and more.  

She believed that she could put to use all that she has learnt into practice and clinicians were also positively inclined towards her idea. “There are times when the clinicians/patients do not know/want to give chemotherapy to a patient because they are at a very early stage. They also want to have such tools to assess and find out whether a patient can be treated with or without chemotherapy,” she explains.  

Some time later, in 2011, she decided to pursue this research more seriously, and founded OncoStem.

Early Days

OncoStem was set up with a mission of developing affordable and innovative tests which will help patients assess the aggressiveness of the tumor and thereby help plan an optimum chemotherapy treatment and get targeted therapy. In most patients, the tumor is first removed surgically and further recurrence is prevented using local radiation therapy or chemotherapy. “However, risk of recurrence is dependent on tumor type, stage and, most importantly, biology of that individual patient’s tumor. It needs to be assessed thoroughly before treatment is planned,” she notes.

There are measures to assess risk of cancer recurrence for different cancer types. In breast cancer, there are 4 bio-markers. Even though they are useful, they are not sufficient to assess the aggressiveness of the disease, because they primarily only look at ‘proliferation’ of tumor cells. Bakre believes that one needs to go beyond the bio-markers and into the biology of the tumour to assess it.  According to her,tumours are classified based on good biology (low potential for recurrence) and bad biology (high chance of recurrence). The team believes that patients who face a high risk of recurrence need something beyond chemotherapy. “They need targeted drugs as well,” opines the founder.

Our addressable market is high. In India, it can be as high as 75,000 breast cancer patients in a year and we need to achieve a substantial portion of that in the next 3 years

Launching CanAssist

The company decided to address this with the launch of CanAssist-Breast which predicts risk of cancer recurrence based on the molecular fingerprint of a tumor, using a Proteomics- based platform.

It has been developed and validated on 1,200+ patients in India and the U.S. The company has signed up 10 hospitals in India and a couple of hospitals in the US and Europe as well, for validating this test which is ISO 13485 accredited and CE-IVD marked. The test has been launched in India, Sri Lanka and Bangladesh and it recently closed the second round of funding which will help the company take the test to the Asian markets. “We also want to automate the test entirely (currently, 50 per cent is automated) and package it as a kit,” she shares.

OncoStem aims to remain a pure play diagnostics company with no direct involvement in targeted drug development. “We will partner with a pharmaceutical company to develop targeted drugs and our tests will become a companion diagnostics,” says Bakre, adding that they are already in talks with a few pharma companies.

It has done close to 1,200 sample studies on humans. “The presence and amount of certain type of bio-markers is enough to tell how the disease will progress. We have been doing preliminary work in our lab to show the importance of biomarkers for drugs,” adds she.

Talking about facilities, Bakre says that the company has a central NABL/ISO15189 accredited laboratory in Bengaluru and the test is offered as a service from that central lab. The laboratory has a capacity to run up to 80 to 100 tests a day. 

Awareness, the key

With a 17-member team, the company decided to go with distributors who would bring the tumor sample to them. The tests are run at their labs and reports are sent via email to the patients. 

The company has a good distributor network, with access to doctors across India, who can potentially recommend this test. The company also makes the doctors aware of its products via multiple seminars. “Once this happens, we need to visit them often to exercise the need,” says Bakre. This will be the company’s key go-to marketing strategy in Asia.

Overcoming Challenges

“Entrepreneurship is new to me. I am a researcher with no background in business matters,” says Bakre candidly. She learnt everything on the job, including the process of convincing hospitals to sign up. “There are people who told me that we cannot compete with Western tests while others told me that it is the worst time to raise funds,” she recalls. Her belief, grit, perseverance and patience saw her through this tough phase.

Working with hospitals has been a challenge. “It takes a really long time for the hospitals to sign up with you and it takes multiple visits to a hospital to get through a study,” she admits.   

Finding good statisticians was not easy either, as they don’t have prior experience in developing something which will go under the FDA scanner tomorrow.

Where to from here? 

“Our addressable market is high. In India, it can be as high as 75,000 breast cancer patients a year and we need to tap a substantial portion of that in the next three years,” she says.To do this, the company needs to have more sales people, lab trained people and a bigger network of distributors to reach out to every clinician and make them aware of its products.

OncoStem recently raised US $6 million in a funding round led by Sequoia Capital along with Artiman Ventures, which it plans to use towards deepening its R&D efforts, developing effective tests for oral, colon and brain cancer, and automating these tests. The company also plans to expand its presence in India, and introduce the tests in new markets in Asia and Europe.

OncoStem is taking long strides towards improving the quality of life of cancer patients and positively impacting disease outcome by delivering innovative tests.

Snapshot : OncoStem Diagnostics

Founder: Manjiri Bakre

City: Bengaluru             

Year: 2011

Funding: Totally raised US $9 million in a funding from Sequoia Capital and Artiman Ventures.

Profile: The company was set up with a mission of developing affordable and innovative tests which will assess the risk of cancer recurrence and thereby help patients in planning their treatment and in getting targeted therapy. It has developed, validated and launched flagship product ‘CanAssist-Breast’ which predicts risk of cancer recurrence for early stage breast cancer patients based on the molecular fingerprint of a tumor using Proteomics- based platform.

Poornima Kavlekar has been associated with The Smart CEO since the time of launch and is the Consulting Editor of the magazine. She has been writing for almost 20 years on a cross section of topics including stocks and personal finance and now, on entrepreneurship and growth enterprises. She is a trained Yoga Teacher, an avid endurance Cyclist and a Veena player.

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