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Interview
conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published –
January 20, 2012
CEOCFO:
Dr. Lammers, what attracted you to Mirna?
Dr. Lammers:
What I liked about it was the promise of microRNA based therapeutics.
MicroRNAs are a relatively young discovery but show tremendous potential
based on in vitro and in vivo results for creating a new class of targeted
cancer therapies that intrigued me. Therefore, I was eager to join Mirna in
November of 2009 as president and CEO.
CEOCFO: How has Mirna changed and
developed under you leadership?
Dr. Lammers:
Apart from the growth, we have moved from being a purely high-science driven
company to one that is also now focused not just on science, but also on
development. However, that is a transition that takes time and understanding
of what it takes to build a therapeutics company. The history of Mirna was
that it was a spinout from Asuragen, another company in Austin, Texas. Dr.
Matthew Winkler founded Asuragen on the promise of the diagnostic and
therapeutic applications of microRNAs but management realized after about a
year that therapeutics and diagnostics were different businesses requiring
different core strengths and capabilities, and therefore the decision was
made to spin out the therapeutic know-how and IP into Mirna Therapeutics.
Building a therapeutics company requires a different mindset, capabilities,
and focus. After I joined in 2009, I realized that next to our fantastic
scientists, whose strong scientific work is being published in leading
scientific and cancer research journals, we needed to bring in more
development experienced people to add to the team. When I joined, I was
officially the seventh employee; now we are fifteen of which twelve are
full-time and three are consultants or temporary. We are aiming to complete
a large institutional equity financing in the next few months and should it
happen, then I would like to see those three join full time as well.
However, I want to keep the number of employees relatively small, as I
intent to keep our burn at a reasonable level, which should always a key
focus, especially when you are trying to attract VC firms to invest in your
company.
CEOCFO: What is the science? What is
Mirna is that is either not being done at all, or is being done differently?
Dr. Lammers:
Basically, going back to biology 101, in the past people realized that there
was DNA, RNA and protein. Proteins ultimately decided the function of cells
and RNA was a messenger between DNA and the production of proteins. Then
about fifteen to twenty years ago, several researchers realized there was an
abundance of small pieces of RNA in the cytoplasm of the cell. Initially,
they considered this ‘junk RNA’, until they realized that these small pieces
of RNA, microRNAs as they are called, truly determine and regulate gene
expression. So, the world of microRNA was founded and started to mushroom.
If you look at the number of publications over the last ten years, it has
grown exponentially, notably on the role and importance of microRNAs in
development of cellular function, and therefore, also their role in the
development of disease. What the group at Mirna has done is try to compare
initially the expression differences of certain microRNAs between healthy
tissue and diseased tissue, in our case tumor samples, and we found out that
there are certain microRNAs that are differently expressed. Subsequently,
through functional studies they discovered what the exact role was of these
microRNAs, what the processes are that they are involved in: is it
apoptosis, is it blood vessel formation, or is it cells aging. We truly
identified about 20 microRNAs that we think are key in the development,
outgrowth and dissemination of cancer. The company then decided to focus
specifically on so-called tumor suppressor microRNAs. These are microRNAs
that have a tumor suppressor function, and which are under-expressed in
samples of numerous leading human cancers. For example, miR-34, which is our
lead therapeutic candidate, is a tumor suppressor that works just downstream
of p53, a key tumor suppressor in almost all cancers. miR-34 is
under-expressed in many leading cancers, for example, in lung, prostate,
colon and liver cancer. As a therapeutic approach, we apply ‘miRNA
replacement therapy’, so we bring this microRNA back into the tissue and by
doing so are able to basically inhibit cancer growth, and re-establish a
normal balance within the cells. It is just like hormone replacement
therapy, a process whereby we are bringing something back that nature is
missing.
CEOCFO: What is your arrangement with
Marina Biotech, and how is that going to further the development progress?
Dr. Lammers:
We realized that if you want to bring a microRNA into a tumor, you need to
have a carrier to get it there. During the last five or six years there has
been a lot of focus on the delivery of these microRNAs and other, so-called,
oligonucleotides. Delivery has been a big issue in this field, whether for
anti-sense, siRNA and also for microRNA molecules, and a lot of research
done and progress made. We worked internally initially with an in-house
developed delivery carrier, which worked great and we showed animal proof of
concept, which was fantastic. However, we realized that this may not be the
optimal formulation to take into an IND, into the FDA and into patients.
Therefore, we reached out to several specialized delivery technology
companies that already had their delivery systems in the clinic, i.e.,
involved in clinical testing. We thought that if we would be successful and
we see efficient delivery to tumors, we would already have a carrier
reviewed by FDA, with an open IND, therefore, it would facilitate our path
forward into the clinic. Most of 2011 has been dedicated to this delivery
program and we have been working with several different ones. We observed
very efficient delivery with four of those technologies tested, and felt
that the data with Marina’s delivery system, the SMARTICLESÒ
technology as it is called, was very compelling and there was an interest
and opportunity to discuss a license. That basically led to the announcement
late December. We are very excited to work with this delivery technology to
bring it to the clinic and having this license agreement done now opens up
the door for our path towards the clinic. We hope to submit an IND by late
2012 and then go to our first Phase I trial cancer in early 2013.
CEOCFO: You mentioned a potential series
of financing; what do you need and where are you in the process of funding
to move Mirna and its technologies forward?
Dr. Lammers:
We have so far about $23 million in committed and received funding at the
company. Initially, Asuragen, the former parent company of which we were
spun out in 2007, funded the first two years of operations for about $5.5
million. Then in late 2009, we received from the State of Texas Emerging
Technology Fund (ETF) a $5 million award and last year we were the fortunate
recipients of a $10.3 million award from State of Texas through a new
program called CPRIT, which stands for Cancer Prevention and Research
Institute of Texas, which is a newly implemented program. Out of 89
companies, only three were funded and we were one of the three and we
received the highest award, which is truly fantastic. Both of those awards
have been a great way for us to support and fund our research. However, we
also realize that we need to supplement this kind of research money with
other funds. We are trying to raise $25 million in an institutional equity
round with a small group of well-funded and reputable VC firms. We are
talking to several of them and we hope to be able to complete that in the 1st
Quarter or so of 2012.
CEOCFO: What is it that Mirna
understands or is in the process of developing, that would cause people to
want to invest with you as opposed to another company that is doing similar
work?
Dr. Lammers:
Basically, if you listen to the pharmaceutical companies, the oncology R&D
folks and licensing folks, they say, “We need new therapeutic approaches,
new targets in cancer”. And that is exactly what we represent. Several
companies in the microRNA space are working on the idea of trying to
suppress an over-expressed microRNA. We take the other approach with the
replacement therapy approach where we bring something back that is missing
and by doing so control tumor growth, and that is truly a new approach
different from the rest. The data that we have is very compelling and pharma
is paying attention, so we are talking to several pharma companies, because
they are expressing an interest in our approach. More and more leading
cancer researchers and clinical investigators are looking at replacement
therapy with microRNA and think that it may very well be a great approach to
follow. So, there is support for our approach, an approach that we have
pioneered, and we expect to be the first in the clinic with a microRNA
replacement therapy treatment for cancer.
CEOCFO: Is the investment community
aware, or are they still a little behind the pharma community in
understanding the value of Mirna Therapeutics’ approach?
Dr. Lammers:
We feel that venture financing in the US is a challenge for all small
companies right now. We are part of this group of nucleic acid-based
therapeutics and are basically a later entry into the field. As I mentioned,
it all started with antisense molecules, followed by siRNAs, and now there
microRNAs, and for all three classes of molecules delivery became an issue.
Therefore, a lot of VCs have lost a bit of confidence in the field, which
was bolstered by the fact that Roche as a large pharmaceutical company,
decided to leave the RNAi space late 2010. However, it all comes down to
delivery, and we feel that we have now gone over this delivery hurdle with
the SMARTICLESÒ
technology and are
ready to go towards the clinic. That is why we are excited to meet with VCs
right now, because we have made significant progress this year. The other
important progress for us is that we received from the US-PTO therapeutic
use claims in cancer for fifteen of our key microRNAs, including all the
microRNA targets that we have in our pipeline as therapeutic candidates.
CEOCFO: In closing, what should
potential investors remember most when they read about Mirna Therapeutics?
Dr. Lammers:
Exciting technology, new approach to treating cancer, creating the potential
next class of targeted cancer therapies.
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