- PEN-866 positioned to begin clinical trials in
2017 –
Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) and Tarveda
Therapeutics, Inc. today announced an exclusive worldwide license
agreement providing for the discovery, development and
commercialization by Tarveda of products based on Madrigal’s HSP90
Drug Conjugate program, including the lead clinical candidate,
PEN-866. Madrigal is a clinical-stage biopharmaceutical company
focused on the development and commercialization of innovative
therapeutic candidates for the treatment of cardiovascular,
metabolic and liver diseases, and Tarveda Therapeutics, Inc., is a
biopharmaceutical company discovering and developing Pentarins™ as
a new class of targeted anti-cancer medicines to advance the
treatment of patients with solid tumors.
HSP90 drug conjugates are designed to increase cancer cell
killing while reducing collateral damage to normal cells and
overcome the challenges of current chemotherapies and other
payloads, which are commonly limited by insufficient drug exposure
in the tumor and/or systemic toxicities. HSP90 drug conjugates are
small-molecule conjugates consisting of an HSP90 targeting molecule
joined to an anti-cancer payload via a linker that is optimized for
controlled release of the payload inside cancer cells. The
conjugate’s sustained anti-tumor effect comes from selectively
accumulating and retaining the conjugate and, importantly, its
potent payload in tumors. HSP90 drug conjugates contrast with
previous HSP90 inhibitors that were designed to only inhibit HSP90.
Madrigal acquired the drug conjugate platform via its recent merger
with Synta Pharmaceuticals, Inc.
The lead HSP90 drug conjugate, PEN-866, is a small-molecule drug
conjugate that comprises an HSP90 ligand conjugated to SN-38, the
highly-potent, active metabolite of the chemotherapeutic agent
irinotecan. PEN-866 binds with high affinity to the intracellular
HSP90 target. Once bound to its target, PEN-866 delivers the
tumor-killing SN-38 payload. PEN-866 has shown an impressive degree
of efficacy and durability of response in multiple preclinical
tumor models, including patient-derived xenograft models. Studies
demonstrate that SN-38 released from PEN-866 accumulated at high
levels within the tumors and was associated with increased and
widespread cancer cell death when compared with irinotecan
alone.
Under the terms of the agreement, Madrigal will receive an
upfront payment and is eligible to receive up to an aggregate of
$163 million of contingent payments based upon the achievement of
specified development, regulatory and sales milestones related to
the first HSP90 drug conjugate product developed under the
agreement. Madrigal is also eligible to receive a tiered,
single-digit royalty based on future worldwide sales of HSP90 drug
conjugate products. Potential development, regulatory and
sales milestone payments related to a second HSP90 drug conjugate
product would be lower. Tarveda will be responsible for all of the
development costs for the HSP90 drug conjugate program.
“We are pleased to have completed this important and potentially
valuable agreement with Tarveda,” said Paul A. Friedman, M.D.,
Chairman and CEO of Madrigal. “This transaction is a key
element of Madrigal’s strategy to out-license our novel oncology
assets to organizations with the oncology focus and resources to
fully exploit the opportunity for product development and
commercial success.”
The Tarveda team is comprised of seasoned oncology leaders,
scientists and drug developers who are taking a novel approach to
cancer treatment by creating Pentarins™, which are miniaturized
drug conjugates uniquely designed to target, penetrate and
eradicate solid tumors. Creating Pentarin drug conjugates that
drive efficacy in solid tumors is the core expertise and focus of
the team at Tarveda.
“Tarveda is developing therapeutics to overcome the limitations
of current cancer treatments through our Pentarin platform.
Pentarins leverage their miniature size and improved
pharmacokinetics to penetrate into solid tumors and cause cancer
cell death with highly selective cell surface and intracellular
targeting, tuned linkers and potent payloads,” said Drew Fromkin,
President and CEO of Tarveda. “The HSP90 drug conjugate
platform with its lead drug candidate PEN-866, which is scheduled
to be in the clinic during the first half of 2017, is an ideal fit
for our growing Pentarin pipeline of novel oncology therapeutics.
The Tarveda pipeline also includes PEN-221, our Pentarin conjugate
that binds to the somatostatin cell surface receptor, after which
the conjugate’s potent payload is internalized into the cancer
cell. PEN-221 is scheduled to enter Phase I trials this year to
treat patients with neuroendocrine and small-cell lung cancer
tumors. We look forward to advancing both of these novel Pentarin
drug candidates into clinical studies in the near term and
expanding the Pentarin platform pipeline by developing new
conjugates linked to other potent payloads, including challenged
but promising payloads being developed by potential pharmaceutical
partners.”
About Madrigal Pharmaceuticals, Inc.
Madrigal Pharmaceuticals, Inc. is a company focused on the
development of novel compounds for the treatment of
cardiovascular-metabolic diseases and nonalcoholic steatohepatitis
(NASH). The Company’s lead candidate, MGL-3196, is an orally
administered, small-molecule liver-directed ß-selective THR agonist
with high liver uptake for the treatment of NASH and
dyslipidemia/hypercholesterolemia including in heterozygous and
homozygous familial hypercholesterolemia (HeFH, HoFH). For more
information, visit: http://www.madrigalpharma.com.
About Tarveda Therapeutics, Inc.
Tarveda Therapeutics, Inc., is a biopharmaceutical company
discovering and developing Pentarins™ as a new class of targeted
anti-cancer medicines to advance the treatment of patients with
solid tumor cancers. Tarveda’s lead Pentarin drug candidate,
PEN-221, is a miniaturized biologic drug conjugate that targets the
somatostatin receptor for treatment of patients with neuroendocrine
cancers including small-cell lung cancer. Tarveda is also advancing
its HSP90 drug conjugate platform with lead PEN-866, which is a
drug conjugate that comprises an HSP90 ligand conjugated to SN-38,
the highly-potent, active metabolite of irinotecan. Tarveda’s
strategy includes developing its own proprietary Pentarins as well
as applying the Pentarin platform to enhance the effectiveness of
the targeting moieties and novel payloads of pharmaceutical
collaborators. Tarveda has attracted top-tier investors including
Novo A/S, New Enterprise Associates, Flagship Ventures,
NanoDimension, and Eminent Venture Capital.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995 that involve substantial risks and
uncertainties. All statements, other than statements of
historical facts, included in this press release regarding our
strategy, future operations, and plans may be deemed
forward-looking statements. Forward-looking statements
reflect management's current knowledge, assumptions, judgment and
expectations regarding future performance or events. Although
management believes that the expectations reflected in such
statements are reasonable, they give no assurance that such
expectations will prove to be correct and you should be aware that
actual results could differ materially from those contained in the
forward-looking statements. Actual results or events could
differ materially from the plans, intentions, expectations and
projections disclosed in the forward-looking statements.
Various risks and uncertainties could cause actual results or
events to differ materially from the forward-looking statements
that we make, including, but not limited to, our ability to
successfully progress, partner or complete further development of
our programs, the timing, cost and uncertainty of obtaining
regulatory approvals, our ability to protect our intellectual
property, changes in the regulatory landscape, and other factors
listed under “Risk Factors” in our filings with the Securities and
Exchange Commission. We do not plan to update any such
forward-looking statements and expressly disclaim any duty to
update the information contained in this press release except as
required by law.
Contacts:
Investors & Media:
Madrigal Pharmaceuticals, Inc.
Marc Schneebaum
IR@madrigalpharma.com
Tarveda Therapeutics, Inc.
Blair McCarthy Atkinson
MacDougall Biomedical Communications
+1 781 235 3060
batkinson@macbiocom.com
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