I could not help but notice that ImmunoCellular Therapeutics' (IMUC) ICT-107, for the treatment of glioblastoma multiforme (GBM) -- the most common and most aggressive malignant primary brain tumor in humans- has been highlighted in a special report from Fierce Biotech as one of 10 therapeutic vaccines now being tested in humans and generating buzz.
Back in I August, I wrote about ICT-107, a candidate which shares some stark contrasts to the known toxicities of conventional chemotherapies.
In that report, I highlighted the fact that while some therapeutic vaccines show a promising a future with highly potent and powerful therapeutic agents designed to work in harmony with patients’ own immune systems to wipe out cancer and other diseases. I also warned that some publicly traded companies in biotech have simply been over-hyping their treatment’s market potential, and not being pro-active against some of the same technology traps that have snagged Dendreon's (DNDN) investors.
I contacted Dr. Manish Singh, who has been the president and CEO of ImmunoCellular Therapeutics since February of 2008. I was able to ask him some pointed questions about this topic and others.
Q: Some have argued that DNDN's stock was over-valued because the drug has marginal benefits. Can you tell us how your immunotherapy differs from theirs and others?
Dr. Manish Singh, CEO of IMUC: While Dendreon increases survival by 20% in prostate cancer patients (22 months to 26 months), we have seen survival improvement by more than 150% (from 14.6 months for historical standard of care to 38.4 months based on Phase I). In glioblastoma, where the current standard of care drug, Temodar, increases survival by only 2 months, increasing this survival by 2 years, is quite remarkable. If this were validated in a pivotal clinical trial, this would be seismic shift in how you care for glioblatsoma patients. What makes IMUC different is our strategy to target cancer stem cells, widely acknowledged as the roots of cancer. Every tumor mass has a small number of these cells which are responsible for progression of disease even after most of the tumor has been removed by surgery and knocked down by chemotherapy and radiation therapy. We are the first company that has characterized the tumor antigens that are highly expressed on brain tumor cancer stem cells and have designed vaccine specifically to target those cells.
Q: How have you been able to be so careful with investor dollars versus some of your competitors during the usually expensive development process?
Dr. Manish Singh, CEO of IMUC: Current business model of spending 100-200 million dollars to get to a true inflexion point (Phase II data or Phase III trial) is just not sustainable as it doesn't give investors much upside. Our mantra is one should raise no more than 35-40 million dollars and primarily focus on innovative end of drug development and get to Phase II clinical data. If Phase II data is positive, one can create a situation with 5-10x return for investors as we have only raised $21 since inception four years ago. Our burn is very low as we have smaller salaries combined with higher equity packages which aligns economic interests of shareholders and management. In addition, we outsource everything to the best of breed providers although we try to negotiate them to a reasonable costs. This allows us flexibility, access to technologies and systems developed by others, and makes us nimble in accelerating product development.
Q: What are your biggest pending milestones?
Dr. Manish Singh, CEO of IMUC: Enrollment should be completed by Q2, 2012 followed by an interim analysis in Q4,2012/Q1,2013 which can give us great insights in how well the trial is working. In addition, we plan to launch two more INDs in the next nine months.
Q: What are your biggest challenges?
Dr. Manish Singh, CEO of IMUC: Our biggest challenge is to do these developments with limited resources as that is only way to create larger returns. We have a team of only seven people, but have experience with over 25 clinical compounds in the last 20 years. We have developed a culture of innovation, collaboration, consensus, respect and frugality, and it is difficult to maintain that as you grow in size. By keeping the team small, we all are bursting at seams with things we are doing. However, there is passion and persistence in all of us to do this better than other companies with larger resources.
Q: Are there some things investors should be aware of regarding ImmunoCellular Therapeutics, that perhaps they are not?
Dr. Manish Singh, CEO of IMUC: Our Phase I data is often looked as a single center and small cohort data without any control, but we do have data comparing ICT-107 to a tumor lysate vaccine in the same patient setting, and have demonstrated significant survival improvement of 18 months over the tumor lysate trial. All patients in these two trials went through similar surgeries with same surgeons and had similar age and health thus minimizing biases of single center trial. We see a lot of physicians who treat glioblastoma patients very excited about our trial results and Phase II trials. The value of this company will sky rocket if we see even half good as results in this Phase II study.
In wrapping up, I'd like readers to know that II have reached out to other CEOs and companies whose vaccines appear (as well as others' whose vaccines were mysteriously absent) from the Special Report in Fierce Biotech. You may expect some follow up as I gather more information and wait for responses from my inquiries.