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Dr. James Koropatnick, Chief Scientific Officer (James.Koropatnick@sarissa.ca) Sarissa, Inc. is an
emerging Canadian biotechnology company partnered with Isis Pharmaceuticals
of Carlsbad, California. Sarissa is a cancer-focused company with
an optimised lead compound, SARI-083, being prepared for an
IND. Sarissa is seeking funds ($10 million) to support this process and
to conduct several phase I studies in major cancer markets. SARI-083 is a
second-generation antisense oligonucleotide directed against one of the most
validated targets in oncology -- thymidylate synthase (TS). TS is also the
target of important chemotherapies such as 5-fluorouracil (5FU), and Eli
Lilly's Alimta (pemetrexed). When cancer cells are exposed to these
chemotherapies they upregulate TS, making it more difficult for the
chemotherapy to work. SARI-083 crushes the TS level down again, restoring
sensitivity to the chemotherapy. Elevated TS is well-described as a
major mechanism of drug resistance in cancer. Therefore, SARI-083 is a novel
method to overcome that form of drug resistance, commonly encountered in
treatment of a range of human cancers including colorectal cancer and lung
cancer. Some cancer cells have elevated TS, not only in response to
treatment, but prior to any chemotherapy exposure -- these cancers are known
to be inherently more aggressive and dangerous. Indeed, there is evidence
that TS by itself can act as an oncogene, with the power to transform if
overexpressed. It is envisaged
that SARI-083 will be employed alongside standard chemotherapy protocols
(using 5FU or Alimta) to prevent the emergence of drug resistant clonal
tumor cell populations or to deal with them if they exist already.
Second-generation oligonucleotides, exemplified by SARI-083 (which uses Isis'
proprietary 2MOE gapmer technology) can be given in the same fashion as
current intravenous chemotherapy, with a short infusion every week or
two. As a consequence it would be relatively simple to add SARI-083 on to
existing regimens for colorectal cancer and nonsmall cell lung
cancer. In the former disease, 5FU is a deeply-entrenched standard;
in the latter (lung cancer) Alimta is a major choice in second line treatment
and stands an excellent chance of becoming a first line drug of choice,
especially in the largest lung cancer subgroup (adenocarcinoma). Other
cancer sites of interest, where TS is an important therapeutic target,
include breast cancer, stomach cancer, head and neck cancer and
mesothelioma. Isis' mipomersen,a
noncancer product, and which has a similar second-generation backbone,
was recently out-licenced in a widely-publicised landmark deal. Sarissa co-developed
this technology with Isis and has a worldwide exclusive licence in respect of
this target, together with issued patents in the USA and Europe (Japan
and Canada pending). Sarissa also has a siRNA version filed with
the US PTO. Supporting peer-reviewed publications
are available, as well as due diligence binders. Sarissa is privileged
to have Dr Mace Rothenberg, a well known US oncologist, on its Medical
Advisory Board. Sarissa was founded
in 2000 by Mark D Vincent, MD FRCPC (an academic medical oncologist) and Jim
Koropatnick PhD (a cancer research scientist). Funding to date has been
provided by the founders ($400,000). Sarissa also has
access to other small molecules and biological of great interest, which might
be in-licenced to expand the portfolio. |
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Commercialization
Strategy & Financing Plans Sarissa intends to
raise $10 million immediately, to support two species safety/pharmacology
work preparatory to filing for a Canadian-IND equivalent; and up to four
phase I clinical trials. Isis is entitled to a portion of Sarissa's stock on
successful completion of this round of capital formation, and back-ended
milestones and royalties, and which are reasonable by industry standards. Sarissa's intention
is to take SARI-083 through to the completion of phase II trials in advanced
colorectal cancer and nonsmall cell lung cancer, and then to seek an
out-licencing partner in the form of a major western pharmaceutical
company. Sarissa will also seek a partner in the far east as soon as
possible, to pursue development in that geographical area with a focus
on stomach cancer (prevalent in that region). Sarissa is
interested in in-licencing small molecules and other biologicals of interest,
to which Dr. Vincent has access because of his network of consulting and
advisory relationships. Some of these have already been in human trials and
therefore might reasonably represent near-term opportunities. Funds permitting,
Sarissa might pursue a fast track strategy in conditions of high unmet need,
such as mesothelioma, since Sarissa has shown that in vitro mesothelioma cell lines are exquisitely sensitive to
SARI-083. Sarissa will also
pursue other, novel targets, which have been identified as likely
to be suitable for an antisense approach. Mindful of the fact
that technologies continue to evolve, Sarissa has an open mind about
optimising delivery strategies and is prepared to enter into appropriate
licencing arrangements as necessary. |
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Goals for
BioPartnering North America Sarissa would like
to discuss capital formation opportunities with interested parties including
venture capital firms and merchant banks. Sarissa is also open
to discussing partnership arrangements with pharmaceutical companies.
Sarissa will also consider in-licencing other cancer compounds of
interest. |