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ImmunoCellular Therapeutics Transcript with Manish Singh, President and CEO

Published: 08:33 11 Aug 2011 BST

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Harry Norman: Hello, this is Harry Norman for Proactive Investors and welcome to another Proactive audio interview. 

Today is the 27th of July 2011 and I'm talking with Manish Singh, President and CEO of ImmunoCellular Therapeutics, listed on the Over the Counter Bulletin Board in the United States, pharmaceutical sector. 

Stock ticker IMUC; share price 2.17 dollars; market cap 62.84 million dollars; web address imuc.com. Thank you very much for joining us for this interview.

 

Manish Singh: Well thank you for having me. 

 

Harry Norman: Please give the investment community a brief introduction to ImmunoCellular Therapeutics, its immune based products to treat and diagnose cancer, and the company’s business development strategy.

 

Manish Singh: The best way to think of ImmunoCellular Therapeutics is to think of this as cancer vaccine 2.0.. 

What we are trying to do is to leverage the developments in immunology – as well as tumour biology – that have happened over the last 20 years. 

Our products are specifically targeting cancer stem cells which are like the roots of these cancers. 

The best way to think of a cancer is to think of this as the weeds that grow in the garden. The gardener can cut it or he can throw some chemicals but as long as the roots are still there these cancers tend to come back. 

What we are trying to do is to go after the root itself. And this is really the only vaccine therapy today out there that is trying to go after the roots of these cancers. 

Our business strategy is to really develop this through the phase I and phase II and demonstrate in randomized clinical trials a clear proof of efficacy. 

And essentially partner at that stage with a large pharmaceutical or a large biotech company and really leverage their ability to commercialise and develop these products further. 

 

Harry Norman: ImmunoCellular has two cancer vaccine candidates in its product pipeline. ICT-107 is a vaccine for glioblastoma, GBM, which has completed phase I trials. What were the results of ICT-107’s phase I trials?

 

Manish Singh: Phase I trial results from the ICT-107 study were some of the most impressive results that have been seen in the last 30 years of clinical development in this field. 

If you think of a glioblastoma patient he typically lives about 14 or 15 months. And the best example is really the late Senator Kennedy who was diagnosed in May of 2008 and by August of 2009 he passed away in spite of the best medical care that the US could provide. 

What we are seeing is an increase in the median survival of these patients from 14 or 15 months to 36 months or longer. 

But what is much more impressive is about 40% of these patients continue to be completely free of disease and those roots of those cancers have been completely taken out and have no measurable disease after three or four years. 

At this time about 5% or less of the patients are expected to be completely disease free. So to have 6 out of the 16 patients that we have treated to be completely disease free is a remarkable story for this clinical trial.

 

Harry Norman: Phase II trials of ICT-107 for GBM started in January. Please would you talk us through the design of phase II, the timetable, and progress with these trials?

 

Manish Singh: The phase II trial is designed as a randomized double blinded placebo controlled clinical trial. 

We plan to enrol about 200 patients of which 102 patients will be treated. 

This is a 2:1 randomization and the primary endpoint in this trial is really overall survival. 

So far we have 9 clinical sites that are already enrolling patients and we expect to do this clinical trial in 20 or more clinical sites. 

Our timeline for this is to enrol all the patients by May or June of 2012, have the interim analysis between October and December of 2012, and have the final analysis in Q3 or Q4 of 2013. 

 

Harry Norman: ICT-107 targets particular antigens expressed by GBM cancer stem cells. What other types of cancer could be susceptible to ICT-107?

 

Manish Singh: A number of these antigens that are present on ICT-107 are also present on breast cancer, ovarian cancer, colon cancer, pancreatic cancer and a number of other indications. 

What we have here is really a platform of delivery of these cancer stem cell antigens for multiple different indications. 

So for example for ovarian cancer we could swap some of these non-ovarian cancer antigens out and insert ovarian cancer antigens in that composition and have a vaccine that is much more targeted towards ovarian cancer stem cells. 

So we really have the ability to go after multiple different indications with this technology platform by using some of the same antigens as what we have in ICT-107 and combining it with the additional antigens that are more specific to cancer stem cells in different diseases.

 

Harry Norman: ImmunoCellular has a stable of three clinical monoclonal antibodies. What applications do you see for these monoclonal antibodies Manish?

 

Manish Singh: These antibodies that we have are currently targeting pancreatic cancer, lung cancer, as well as a few other indications. 

From a business model point of view we are really focused on developing a cancer stem cell targeting vaccine and we are trying to leverage these antibody assets by partnering them with well established or well experienced players who can not only develop this but also have sufficient funding to actually develop this further downstream. 

We have done one deal recently where we partnered our antibody discovery platform with a company in a joint venture with BioWa  which is part of the Kyowa Hakko Kirin Group out of Japan. 

And we are continuing to talk with other partners about potentially partnering some of our other antibodies out. 

What we really want to do is to monetise these assets so that we can create a long-term shareholder value as our partners develop these in phase I/phase II clinical trials.

 

Harry Norman: How well protected is ImmunoCellular Therapy’s intellectual property and technology Manish?

 

Manish Singh: We have over 40 patents or patent applications that cover both monoclonal antibodies as well as the cancer vaccines. 

We think of intellectual property as a set of onion layers. The best way to think of, for example ICT-107 is there is a layer of intellectual property around certain antigens. There is a layer of antigens and antigens in combination vaccines. There’s a layer around the utility of this vaccine in combination with chemotherapy or other treatments. And there’s also a layer of the manufacturing processes. 

So by having all these layers we believe we can create a significant barrier to entry for any other player to come with the same disease or with the similar antigens to go after the targets that we are going after. 

 

Harry Norman: In February 2011 ImmunoCellular had 12.4 million dollars US in the bank. What is the company’s financial situation going forward?

 

Manish Singh: We are really [developed 0:06:57] and plan to do so in the future as well to be a very capital efficient company. 

We only borrowed about 4 million dollars last year and our borrowing rate for this year will between 6 to 7 million dollars. 

So far we only raised 21 million dollars since the inception of this company and out of which we still have about 11 million in [cash]. Only 10 million dollars has been invested in the company so far. 

And if you look at our market value it is between 50 to 60 million dollars. So we have created 5 or 6 dollars of value for every dollar that has been invested. 

We’ll raise more capital in the next 12 months or so but we expect to raise that at a higher price as well as raise just sufficient amount to take the completion of the ICT-107 trial as well as the initiation of one or two additional trials.

 

Harry Norman: What can the investment community expect of ImmunoCellular over the next 12 to 18 months?

 

Manish Singh: We have a number of catalysts that are lined up over the next 18 months. 

To start with the data that I talked about has been presented at the conferences but has not been actually published. And a peer reviewed publication does carry certain weight and we plan to do that sometime this year. 

We should complete the enrolment of this clinical trial by May or June of next year and by the 18 month time point we should have the interim analysis data. That can be a significant value creator. 

In addition to that we expect to initiate at least one or two additional clinical indications using our technology platform as well as on the business development side additional partnering on the antibodies side. 

So we think over the next 18 months we are going to see significant value added catalysts that should occur. 

And for a company whose market cap is only about 60 million dollars or so today we think we should expect a significant appreciation in that value as we demonstrate our ability to execute on these clinical trials.

 

Harry Norman: Remember Proactive Investors is not an investment advice service. Make sure you register at proactiveinvestors.com or proactiveinvestors.co.uk for our weekly newsletter which will keep you informed about our articles, interviews and events. Thank you for listening.

 

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