Innovate Oncology's Product Portfolio
One in three Americans will be diagnosed with cancer, and two out of three
diagnosed with the disease will die from it, according to Reuters Business
Insight. Our objective is to provide cancer patients with effective and safe
therapeutics that save or prolong their lives. We are developing a diversified
product portfolio targeting multiple forms of cancer, including three of the
most prevalent: breast, prostate and colon cancer. Our pipeline of seven drugs
consists of five drug candidates in or beginning clinical trials and two in
pre-clinical stages of development. The clinical candidates can be divided into
the following categories: New Chemical Entities ("NCE"), therapeutic switches of
existing drug in the market that are not indicated currently to treat cancer,
and reformulations of drugs in the market indicated to treat cancer.
The portfolio of clinical candidates includes two NCEs, which may have the
greatest commercial potential, but also carry the highest risk precisely because
of their novelty. The portfolio's therapeutic switch offers the advantages of
being a proven drug that we believe may have medical and market value that isn't
realized fully by its current use. Like a therapeutic switch, reformulating an
existing, FDA-approved compound offers lower risk to the Company because it's a
validated therapy and potentially less expensive to develop. We believe this
diversified approach balances the risks and rewards inherent in each drug
candidate and its particular development program.
Our portfolio is characterized by compounds that have multiple mechanisms of
action, which, we believe might substantially increase a compound's clinical
efficacy. Also, several of these products are lead compounds derived from novel
technologies with the potential for follow-on compounds to be developed into
separate products for related indications.
Phase of Development
Product -------------------------------------------------------
Candidate Indication Pre-Clinical Phase I Phase II Phase III
INOC-001 Chemo-Resistance Inhibitor X X X
INOC-002 Chemotherapy Potentiator X X X
INOC-005 Capridine Beta X X
INOC-009 Oral Paclitaxal Formulation X X
INOC-010 Polymer-Formulated Camptothecin X X
INOC-016 HER2 Oncogene Inhibitor X
INOC-019 Prostate Tumor Suppressor X
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"Pre-Clinical" refers to the series of tests in the laboratory and those
performed on animals after a lead molecule has been identified. Basic
pharmacology is completed in this phase as well as the toxicology required for
human testing, which may be ongoing. Primary and secondary manufacturing of the
active compound and the method of drug delivery (intravenous or tablet, for
example) will be established during this time. Testing in humans is expected to
begin within 18 and 24 months. Pre-clinical tests must be completed before an
Investigational New Drug application ("IND") can be submitted to the FDA.
"IND" refers to the preparation of an Investigational New Drug application, the
process by which a drug is submitted to the FDA to receive approval for human
testing.
"Phase I" refers to the stage in which compounds are tested for safety, maximal
tolerated dose and pharmacokinetics in volunteers without the disease.
"Phase II" refers to the initial stages of compound testing in patients with the
disease (a particular indication) or symptoms of interest for ultimate New Drug
Application ("NDA") approval and labeling. This stage first demonstrates the
compound's efficacy and dosing range, and expands the safety profile.
"Phase III" refers to the rigorously controlled test of a new drug in a large
population of patients with the disease. After the successful conclusion of
Phase III clinical trials, an NDA is filed with the FDA for approval to market
the drug.
INNOVATE PRODUCTS IN DEVELOPMENT: CLINICAL CANDIDATES
INOC-001 Chemo-resistance Inhibitor
Description. INOC-001 is the lead drug candidate in our portfolio. Our
management believes that the compound offers a novel approach to overcoming
resistance to chemotherapy that many patients develop over the course of
treatment. The compound, which is marketed as an anti-viral drug in Germany and
other European countries, is being tested to treat metastatic pancreatic cancer.
In pre-clinical studies, INOC-001 demonstrated an ability to reduce toxic side
effects, slow disease progression and increase survival rates when used in
conjunction with some chemotherapeutic drugs. Pre-clinical experiments have
shown evidence of INOC-00l inhibiting several genes responsible for
chemo-resistance as well as using multiple mechanisms of action. We have
completed a Phase I trial with various types of solid tumors and chemotherapy
regimens and have documented early efficacy in patients with pancreatic cancer.
Market Opportunity. The American Cancer Society estimates that in 2005, 32,180
people in the U.S. will be diagnosed with pancreatic cancer and 31,800 patients
will die from the disease. The five-year survival rate is only 4.4%, making it
one of the most lethal forms of cancer. Fewer than 10% of patients respond to
treatment.
Partnerships. Cynat Oncology a wholly owned subsidiary of Bioaccelerate, is a
joint venture partner in Resistys, Inc. with Avantogen formerly known as
Australian Cancer Technology ("ACT"). As part of Bioaccelerate's obligation to
provide six clinical products to Innovate, Bioaccelerate transferred 100% of the
capital stock of Cynat Oncology to Innovate on March 16, 2005 following an
announcement on February 14, 2005, that Bioaccelerate would assign its rights to
develop and commercialize INOC-001 to Innovate. The Company is sharing the
development costs equally with its partner as well as an exclusive license to
market the product in the U.S. and Canada.
Status. On December 15, 2004, Bioaccelerate announced it had initiated a Phase
I/II clinical trial for the treatment of metastatic pancreatic cancer with its
co-development partner ACT. The eight-month study will include 22 patients with
metastatic pancreatic cancer and will be conducted at three leading centers in
Germany: Chemnitz Clinics in collaboration with the Technical University
Dresden; Munich University of Technology's Kilinikum rects der Isar; and
University of Munich Hospital's Klilnikum Gro(beta)hadern. The trial is being
managed by Swiss CRO Hesperion. INOC-001 tablets are administered in conjunction
with conventional chemotherapy agents and will be evaluated in this study with
Gemcitabine. Eighteen patients have been enrolled and dosed.
Patents. A U.S. patent, number US 6,589,941 was granted for the compound in 2003
and another U.S. patent is pending. A patent was issued under the terms of the
Patent Cooperative Treaty ("PCT"), which is adhered to by more than 100
countries.
INOC-002 Chemotherapy Potentiator
Description. INOC-002 is an enhancement and a new dosing regimen of an
intravenous drug approved to treat colon cancer. The Company intends to test a
novel dosing regimen, administering the drug simultaneously with capecitabine, a
commonly used chemotherapeutic agent. Administering the drugs simultaneously
could make capecitabine more effective, and therefore may permit a lower dose,
which in turn would reduce toxic side effects. The Company believes that current
dosing regimens based on its labeled use as an anti-worming agent have not
optimized the potential synergistic effect of INOC-002 that could be achieved by
combined dosing. The lead indication of INOC-002 is a post-operative adjuvant
therapeutic agent.
Market Opportunity. Colorectal cancer is the third most prevalent form of cancer
globally, according to Reuters Business Insight. Its annual mortality rate is
almost as high as the mortality rates for breast and prostate cancer patients
combined even though the patient population for those two types of cancer is
more than four times the size of the colorectal patient population. In 2003,
approximately 889,000 patients were being treated for the disease and 428,000
new patients were diagnosed.
Partnerships. On August 6, 2004, Bioaccelerate entered into an agreement with
Targent, Inc. to acquire eight patents and certain confidential information
related to INOC-002. Bioaccelerate assigned this agreement to Innovate on March
16, 2005 subject to consent by Targent. The agreement between Bioaccelerate and
Targent requires consent by the other party to any assignment which consent may
not be unreasonably withheld or delayed. Bioaccelerate has sought consent from
Targent to the assignment and is awaiting confirmation by Targent. The Company
is responsible for the drug development costs as well any maintenance fees on
patents and patent applications.
Status. Pre-clinical trials confirmed the additive effect of INOC-002. The
Company plans to initiate its clinical program within a year. .
Patents. Eight patent applications were filed between December 1, 2000 and March
15, 2005 for patents in the U.S., Canada, Europe, Australia, Japan, Hong Kong
and an international patent.
INOC-005 Capridine Beta
Description. INOC-005 is an NCE to treat prostate cancer. The compound renders
aggressive hormone-independent prostate cells hormone-sensitive and therefore
may be effective in treating both hormone-sensitive and hormone-insensitive
tumors in combination with anti-androgen therapy. In pre-clinical development,
INOC-005 also showed activity against leukemia, melanoma, lung, colon, ovarian,
renal and bladder cancer. Toxicology studies indicate that this compound may
have lower bone marrow toxicity.
Market Opportunity. In 2003, approximately 300,000 men in the seven major market
countries (U.S., France, Germany, Italy, Spain, Japan and the UK) were diagnosed
with prostate cancer; the total patient population was 1,774,000, according to
Reuters Business Insight. Those patients had a 99.7% one-year survival rate and
a 96.8% five-year survival rate. Treatment for prostate cancer is one of the
success stories in oncology research. Nonetheless there's room for improvement
given the prevalence of the disease.
Partnerships. On March 31, 2005, the Company entered into an agreement with
Prostagenics, LLC pursuant to which, Innovate obtained the global patent rights
to develop and commercialize INOC-005.
Status. Pre-clinical development has been completed. The Company expects to file
an IND application by mid 2006 to conduct Phase I clinical trials for advanced
prostate cancer.
Patents. A U.S. patent, number US 6,589,961 was granted to this product
candidate in 2003. Seven other patent applications have been filed for this
compound in the U.S., Canada, Mexico, Europe and Israel.
INOC-009 Oral Paclitaxal
Description. INOC-009 is a reformulation of a commonly used intravenous
chemotherapeutic agent that treats several types of cancer, including breast,
ovarian and AIDS-related Kaposi's sarcoma. This new, oral formulation improves
the drug's solubility and therefore facilitates absorption into the bloodstream.
The formulation also prevents efflux of the drug from the intestine.
Market Opportunity. Breast cancer is the second most common form of cancer
worldwide, according to the World Health Organization's World Cancer Report. An
existing intravenous paclitaxal product (Taxol(R)) was one of the top 10 selling
cancer drugs in 2004 with sales of more than $1.2 billion.
Partnerships. On July 15, 2004, Bioaccelerate entered into a license and
co-marketing agreement with Supratek, Pharma, Inc. to develop INOC 009 to treat
cancer in humans. Innovate is already a licensee under the terms of the
agreement but Bioaccelerate has also assigned its rights under this agreement to
Innovate on March 16, 2005, subject to receipt of Supratek's written consent,
which can not be unreasonably witheld. Bioaccelerate has sought that consent and
is awaiting confirmation by Supratek.
Status. Pre-clinical testing has been completed. The Company expects to file an
IND application with the FDAmid 2006.
Patents. Supratek owns a total of four "composition of matter" patents numbers
US 5,817,321, 6,060,518, 6,277,410 and 6,387,406 in the U.S. related to its
proprietary technology and is responsible for maintenance and upkeep of its
patents
INOC-010 Polymer-Formulated Camptothecin
Description. INOC-010 is a reformulation that uses an innovative, proprietary
carrier technology to treat drug-resistant tumors. This technology has
demonstrated improved efficacy compared with the previous formulation because it
increases the amount of the drug taken up by tumor cells and inhibits drug
efflux associated with tumor resistance. This intravenous reformulation of
topotecan showed no apparent change in toxicity during pre-clinical tests to
treat melanoma, breast and lung cancer.
Market Opportunity. Topotecan is currently indicated to treat ovarian cancer and
small cell lung cancer.
Partnerships. On November 10, 2004, Bioaccelerate entered into a licensing and
co-marketing agreement with Supratek Pharma, Inc. to develop, seek regulatory
approval and, in major markets, commercialize INOC-010. Supratek granted
Bioaccelerate an exclusive global license to its intellectual property related
to INOC-010. Innovate is also a licensee under the terms of the agreement but
Bioaccelerate has also assigned its rights under this agreement to Innovate on
March 16, 2005, subject to receipt of Supratek's written consent, which consent
can not be unreasonably withheld. Bioaccelerate has sought that consent and is
awaiting confirmation from Supratek.
Status. Pre-clinical testing is complete. The Company expects to file an IND
application with the FDA in 2006.
Patents. Supratek owns a total four "composition of matter" patents in the U.S.
related to its proprietary technology and is responsible for maintenance and
upkeep of its patents.
PRE-CLINICAL PROJECTS
INOC-016 HER2 Oncogene Inhibitor
Description. INOC-016 is a small molecule that has been shown to inhibit
expression of the HER2 gene that is over expressed in 30% of all breast cancer
tumors and is associated with a poor outcome. Herceptin(R) is a monoclonal
antibody that binds to HER2 on tumor cells. It is currently marketed and
approved for use with chemotherapy to treat advanced breast cancer.
The Company believes that INOC-016, by preventing the expression of the gene,
may lead to a more complete eradication of the HER2 protein and therefore be
more efficacious in the management of breast cancer.
Status. In pre-clinical testing of this drug, INCO-016 has been shown to stop
the growth of breast cancer tumors in animal models.
Partnerships. On January 4, 2005, Bioaccelerate entered into an exclusive
license agreement with Baylor College of Medicine granting Bioaccelerate
worldwide exclusive rights to patents and other intellectual property rights
associated with INOC-016 to develop and commercialize the compound.
Bioaccelerate conditionally assigned this agreement to Innovate on March 16,
2005.
Patents. A U.S. patent application was filed in 2003 and a joint PCT/U.S. patent
application was filed in 2003. Baylor is responsible for filing, prosecuting and
maintaining all patents. The Company will pay all legal costs associated with
these patents.
INOC-019 Prostate Tumor Suppressor
Description. A peptide derived from a novel, proprietary tumor suppressor
protein designed to induce the death of prostate cancer cells in vitro and in
animal models.
Partnerships. On March 15, 2005, Bioaccelerate entered into a license agreement
with Northwestern University. The agreement granted Bioaccelerate an exclusive
global license to the patent rights to develop and commercialize INOC-019.
Bioaccelerate assigned this agreement to Innovate on March 16, 2005.
Patents. A U.S. patent, number US 6,780,984 was granted for this compound in
2004.
http://www.innovateoncology.com
Innovate Oncology, Inc.
Sujay R. Kango, 646-723-8944
sujay.kango@innovateoncology.com
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