TetraLogic Agrees to Acquire Shape Pharmaceuticals, Inc.
April 07 2014 - 4:05PM
- SHAPE, a novel, tissue-targeted topical HDAC inhibitor, is
expected to enter Phase 2 trials for early-stage CTCL
- Encouraging responses seen in a randomized Phase 1 trial after
only 28 days of use, with no significant safety events
- SHAPE is designed to avoid systemic absorption and related
HDACi toxicities
- Adds second clinical-stage oncology compound to the TetraLogic
portfolio
- Conference call at 8:00 a.m., tomorrow, April 8, 2014
TetraLogic Pharmaceuticals Corporation (Nasdaq:TLOG) announced
today that it has executed a definitive agreement to acquire by
merger 100% of Shape Pharmaceuticals, a
privately-held biotechnology company developing
suberohydroxamic acid phenyl ester (SHAPE), a novel,
tissue-targeted HDAC inhibitor in a topical gel formulation to
treat stage IA-IIA Cutaneous T-Cell Lymphoma (CTCL), adding a
second clinical-stage oncology compound to the TetraLogic
portfolio.
SHAPE is designed to be rapidly degraded in plasma, thus
avoiding systemic exposure. In a randomized Phase 1 trial,
promising early activity with SHAPE was observed, with responses
seen after only 28 days of administration. SHAPE was
generally well tolerated in this study with no dose limiting
toxicities observed.
The Company believes that the gel formulation provides
concentrated local effect and the molecule itself is designed to
avoid systemic absorption and related toxicities. The Company
expects to commence a Phase 2 trial of SHAPE for early-stage CTCL
in the fourth quarter of 2014.
SHAPE's composition of matter patent extends until at least
2028; in addition, SHAPE has been granted US orphan drug
designation for CTCL. TetraLogic has acquired worldwide
development and commercialization rights to SHAPE for all
indications.
Under the terms of the agreement, TetraLogic will acquire Shape
for an upfront cash payment of $13 million. TetraLogic is also
responsible for future development and commercialization
milestones, as well as tiered royalties on product sales.
"We are pleased to have augmented our oncology pipeline with
this acquisition," said J. Kevin Buchi, TetraLogic's President and
CEO. "We are encouraged with SHAPE's clinical data to date,
specifically the response rate and early onset of action, and we
expect to advance it into Phase 2 trials later this year with a
goal of evaluating the 6 month efficacy of SHAPE in Stage IA-IIA
CTCL patients."
SHAPE Clinical Development Program
In a Phase 1 randomized, double-blind, placebo-controlled,
dose-escalating clinical trial, 15 patients were administered
SHAPE, BID for 28 days, while 3 patients were administered
placebo. 4 of the 15 patients demonstrated PRs (clinical
improvement of lesions) by Composite Assessment of Index Lesion
Severity or CAILS score, while the patients on placebo demonstrated
no significant improvements. PK data indicated minimal
systemic exposure, and PD data demonstrated local dermal
acetylation. No significant safety events were observed.
About Cutaneous T-Cell Lymphoma
Cutaneous T-Cell Lymphoma (CTCL) is a rare, life-altering, and
life-threatening form of Non-Hodgkin's lymphoma (NHL) which
initially presents in the skin. CTCL is a heterogeneous group of
malignant lymphomas that are more common in men, occur most often
in people older than 55, and affect twice as many African-Americans
as Caucasians. CTCL patients typically present with skin symptoms
and lesions, including follicular papules, erythematous patches,
elevated plaques, alopecia, pendulous slack skin, pustular lesions
and subcutaneous nodules. Lesions of this lymphoma may remain as
patches or plaques confined to the skin for many years prior to the
development of cutaneous tumors or visceral disease. US CTCL
prevalence is approximately 30,000 patients. Stage IA, IB, and
IIA, the stages of the disease restricted to the skin, comprise 75%
of the CTCL patient population.
Conference Call Information
At 8:00 a.m. Eastern Time tomorrow, April 8, 2014, TetraLogic's
management team will host a conference call and live audio webcast
to review the transaction and related matters. The live webcast and
a replay may be accessed by visiting TetraLogic's website at
http://ir.tetralogicpharma.com. Please connect to the Company's
website at least 15 minutes prior to the live webcast to ensure
adequate time for any software download that may be needed to
access the webcast. Alternatively, please call 888-734-0328 (U.S.)
or 678-894-3054 (international) to listen to the conference call.
The conference ID number for the live call is 24892387. To access
the replay, please call (855)-859-2056 (U.S.) or (404) 537-3406
(international). The conference ID number for the replay is
24892387. The telephone replay will be available until April 15,
2014.
About TetraLogic
TetraLogic is a clinical-stage biopharmaceutical company focused
on discovering and developing novel small molecule therapeutics in
oncology and infectious diseases. Birinapant is currently
being tested in Phase 1 and Phase 2 clinical trials for
hematological malignancies and solid tumors. SHAPE is entering
Phase 2 trials for early-stage CTCL.
Forward Looking Statements
Some of the statements in this release are forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, Section 21E of the Securities Exchange Act of 1934 and the
Private Securities Litigation Reform Act of 1995, which involve
risks and uncertainties. These statements relate to future
events or TetraLogic's pre-clinical and clinical development of
birinapant, SHAPE and other clinical programs, future expectations,
plans and prospects. Although TetraLogic believes that the
expectations reflected in such forward-looking statements are
reasonable as of the date made, expectations may prove to have been
materially different from the results expressed or implied by such
forward-looking statements. TetraLogic has attempted to
identify forward-looking statements by terminology including
''believes,'' ''estimates,'' ''anticipates,'' ''expects,''
''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,''
''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or
other words that convey uncertainty of future events or outcomes to
identify these forward-looking statements. These statements
are only predictions and involve known and unknown risks,
uncertainties, and other factors, including those discussed under
the heading "Risk Factors" in our Annual Report on Form 10-K filed
with the Securities and Exchange Commission on March 19,2014.
Any forward-looking statements contained in this release speak only
as of its date. We undertake no obligation to update any
forward-looking statements contained in this release to reflect
events or circumstances occurring after its date or to reflect the
occurrence of unanticipated events.
CONTACT: Company Contact:
Pete A. Meyers
Chief Financial Officer and Treasurer
TetraLogic Pharmaceuticals Corporation
(610) 889-9900, x103
pete.meyers@tlog.com
Investor Relations Contact:
Ami Bavishi
Burns McClellan, Inc.
(212) 213-0006
abavishi@burnsmc.com
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