CAMBRIDGE, Mass., July 27, 2017 /PRNewswire/ -- Infinity
Pharmaceuticals, Inc. (NASDAQ: INFI), today announced that it has
amended its license agreement with Takeda Oncology for IPI-549,
Infinity's potentially first-in-class immuno-oncology product
candidate that selectively inhibits phosphoinositide-3-kinase gamma
(PI3K-gamma). Under the amended agreement, Infinity will no longer
have an obligation to pay Takeda future royalties on worldwide net
sales of selective inhibitors of PI3K-gamma, including IPI-549.
In exchange for eliminating the royalty obligation, Infinity
issued to Takeda an unsecured $6.0
million convertible note that matures on July 27, 2018, and accrues interest at an annual
rate of eight percent. The company is obligated to pay the
principal amount together with any accrued interest on or before
the maturity date in cash or in shares of Infinity common stock, at
the election of Takeda. The share payment price would equal the
average closing price of Infinity's common stock for the 20 days
prior to the payment date.
"Our decision to enter this amendment underscores Infinity's
belief in the potential of IPI-549 to be an oral, selective
first-in-class inhibitor of PI3K-gamma for the treatment of a broad
range of solid tumors, and we are continuing to advance our Phase 1
study evaluating IPI-549 both as a monotherapy and in combination
with Opdivo, a PD-1 immune checkpoint inhibitor," stated
Adelene Perkins, Infinity's chief
executive officer. "This amendment reduces the total royalty burden
on any future net sales of IPI-549 to four percent due to
Mundipharma and Purdue from a previous
agreement."
Infinity remains obligated to pay development, regulatory and
commercial milestones to Takeda for IPI-549. The remaining
milestones comprise up to a total of $5
million in development milestones, up to $50 million in success-based regulatory
milestones, and up to $115 million in
commercial milestones, which are due once certain sales thresholds
have been met.
Under a previous agreement, Infinity is obligated to pay
Mundipharma International Corporation Limited and Purdue
Pharmaceutical Products L.P. a four percent royalty in the
aggregate on worldwide net sales of IPI-549, which steps down to
one percent in the U.S. after a certain sales threshold is met.
About IPI-549 and the Ongoing Phase 1 Study
IPI-549 is an investigational, orally administered
immuno-oncology development candidate that selectively inhibits
PI3K-gamma. In preclinical studies, IPI-549 reprograms macrophages
from a pro-tumor to an anti-tumor phenotype and is able to overcome
resistance to checkpoint inhibition.1,2 As such, IPI-549
may have the potential to treat a broad range of solid tumors and
represents a potentially complementary approach to restoring
anti-tumor immunity in combination with other immunotherapies such
as checkpoint inhibitors.
A Phase 1 study of IPI-549 in patients with advanced solid
tumors is ongoing to explore the activity, safety, tolerability,
pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy
and in combination with Opdivo® (nivolumab), a PD-1
immune checkpoint inhibitor, in patients with advanced solid
tumors.3 The study includes monotherapy and combination
dose-escalation phases, in addition to a monotherapy expansion
cohort and combination expansion cohorts. The expansion cohorts
evaluating IPI-549 plus Opdivo will include patients with non-small
cell lung cancer (NSCLC), melanoma and squamous cell carcinoma of
the head and neck (SCCHN). Patients enrolled in these combination
expansion cohorts represent a difficult-to-treat population, as
they must have demonstrated initial resistance or subsequently
develop resistance to a PD-1 or PD-L1 therapy immediately prior to
enrolling in the study. Overall, the study is expected to enroll
approximately 175 patients.
IPI-549 is an investigational compound and its safety and
efficacy has not been evaluated by the U.S. Food and Drug
Administration or any other health authority.
About Infinity
Infinity is an innovative biopharmaceutical company dedicated to
advancing novel medicines for people with cancer. Infinity is
advancing IPI-549, an oral immuno-oncology development candidate
that selectively inhibits PI3K-gamma. A Phase 1 study in patients
with advanced solid tumors is ongoing.3 For more
information on Infinity, please refer to Infinity's website at
www.infi.com.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. Such forward-looking statements include those regarding: the
therapeutic potential of PI3K-gamma selective inhibition and
IPI-549, alone and in combination with checkpoint inhibitors,
including Opdivo; clinical trial plans regarding IPI-549; the
potential benefits of entering into the amendment to the license
agreement with Takeda, and the company's ability to execute on its
strategic plans. Such statements are subject to numerous important
factors, risks and uncertainties that may cause actual events or
results to differ materially from the company's current
expectations. For example, there can be no guarantee that IPI-549
will successfully complete necessary preclinical and clinical
development phases. Further, there can be no guarantee that any
positive developments in Infinity's product portfolio or other
strategic options Infinity may pursue will result in stock price
appreciation. Management's expectations and, therefore, any
forward-looking statements in this press release could also be
affected by risks and uncertainties relating to a number of other
factors, including those described in greater detail under the
caption "Risk Factors" included in Infinity's quarterly report on
Form 10-Q filed with the Securities and Exchange Commission
(SEC) on May 9, 2017, and other filings filed by Infinity with
the SEC. Any forward-looking statements contained in this
press release speak only as of the date hereof, and Infinity
expressly disclaims any obligation to update any forward-looking
statements, whether as a result of new information, future events
or otherwise.
OPDIVO® is a registered trademark of Bristol-Myers
Squibb.
Contact:
Jaren Irene
Madden, Senior Director,
Investor Relations and Corporate Communications
Jaren.Madden@infi.com
1 Kaneda, M., Messer, K., Ralainirina, N., Li, H., et
al. PI3Kγ is a molecular switch that controls immune suppression.
Nature, 2016 Nov;539:437–442.
2 De Henau, O., Rausch, M., Winkler, D., Campesato, L.,
et al. Overcoming resistance to checkpoint blockade therapy by
targeting PI3Kγ in myeloid cells. Nature, 2016
Nov;539:443-447.
3 www.clinicaltrials.gov, NCT02637531.
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SOURCE Infinity Pharmaceuticals, Inc.