CAMBRIDGE, Mass., Jan. 8, 2018 /PRNewswire/ -- Infinity
Pharmaceuticals, Inc. (NASDAQ: INFI) today announced the
achievement of four development milestones for IPI-549, a
first-in-class, oral, immuno-oncology product candidate targeting
tumor-associated myeloid cells through selective
phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition, thereby
reducing pro-tumor macrophage function and increasing anti-tumor
macrophage function. First, the Phase1/1b monotherapy expansion component of the
study has been fully enrolled. Second, the combination dose
escalation component of the study has been completed. Third,
six disease-specific combination expansion cohorts are open to
enrollment at the recommended phase 2 dose of 40mg daily of IPI-549
plus Opdivo® (nivolumab) at 240 mg every two weeks in patients with
non-small cell lung cancer, melanoma, triple negative breast
cancer, head and neck cancer, mesothelioma, and adrenocortical
carcinoma. Fourth, the company announced today the expansion of its
Phase 1/1b clinical trial of IPI-549
to include a combination cohort of IPI-549 plus Opdivo that will
enroll patients with high baseline levels of myeloid derived
suppressor cells (MDSCs). Studies have shown that poor response to
checkpoint inhibitor therapy is correlated with the presence of
high baseline levels of MDSCs in cancer patients.1
2 3 In addition, preliminary translational data from
Infinity's Phase 1/1b study
demonstrated an association between high baseline levels of MDSCs
and clinical responses. Enriching for patients with high MDSCs
could lead to improved clinical activity for patients treated with
the combination of IPI-549 and anti-PD1. Infinity expects to begin
enrolling this combination expansion cohort in patients with high
baseline levels of MDSCs in the first quarter of 2018.
Infinity also provided financial guidance for 2018 and outlined
anticipated 2018 milestones for the development of IPI-549. During
the year, the company expects to make substantial progress with the
Phase 1/1b clinical study of IPI-549,
which is designed to evaluate IPI-549 both as a monotherapy and in
combination with Opdivo. Infinity plans to report data from the
monotherapy expansion and combination dose escalation components
and initial data from the combination expansion component of the
Phase 1/1b study of IPI-549 with
Opdivo in the second quarter of 2018. In the second half of 2018,
Infinity expects to report more mature clinical data from the
combination expansion component of the study including
translational insights from paired tumor biopsies across multiple
diseases.
"2018 will be a decisive year for both Infinity and IPI-549, as
we look forward to reporting maturing data from the Phase
1/1b trial both in monotherapy and in
combination with Opdivo at several medical meetings throughout the
year, which will help to define our development and regulatory
strategy for this first-in-class product candidate," stated
Adelene Perkins, Infinity's chair
and chief executive officer. "IPI-549 represents a unique approach
to targeting tumors through its effects on myeloid cells within the
tumor microenvironment, and we are very pleased with the data to
date. There is a significant need for better treatment options for
patients, especially for patients who do not respond to, or develop
resistance to, existing immunotherapies, as well as for types of
cancer where there is limited benefit from treatment with
checkpoint inhibitors. We look forward to presenting updates
throughout 2018 from our Phase 1/1b
clinical trial."
"As the majority of patients treated with IPI-549 monotherapy
have advanced forms of cancer and received several therapies prior
to enrollment in this study, it's very encouraging to see
single-agent activity, including a patient with a partial response
who has remained on treatment for over a year and continues on
study today," said Dr. David Hong
from MD Anderson Cancer Center, Deputy Chair of the Department of
Investigational Cancer Therapeutic. "IPI-549 has also been well
tolerated with a favorable safety profile."
Infinity's chair and chief executive officer, Adelene Perkins, will discuss the company's
continued execution on its corporate strategy and 2018 priorities
as part of a podium presentation at the 36th Annual J.P. Morgan
Healthcare Conference on Thursday, January
11, at 9:30 a.m. PST
(12:30 p.m. EST). The presentation
will be webcast on Infinity's website, www.infi.com.
Anticipated Milestones in 2018
During 2018, Infinity
expects to achieve the following IPI-549 data milestones:
- Report data from the monotherapy expansion component of the
study in the second quarter of 2018
- Report data from the combination dose-escalation component of
the study in the second quarter of 2018
- Report initial data from the combination expansion component of
the study in the second quarter of 2018
- Report additional data from the combination expansion
component, with more mature clinical and translational data,
including insights from paired tumor biopsies, in the second half
of 2018
2018 Financial Guidance
Infinity ended 2017 with
approximately $57.6 million in cash
and investments (unaudited) and plans to report its fourth quarter
and full-year 2017 financial results in March. The company is
providing the following financial guidance today:
- Net Loss: Infinity expects net loss for 2018 to range
from $40 million to $50 million.
- Cash and Investments: Infinity expects to end 2018 with
a year-end cash and investments balance ranging from $10 million to $20
million.
- Based on its current operational plans, Infinity expects that
its existing cash, cash equivalents and available-for-sale
securities at December 31, 2017, will
be adequate to satisfy the company's capital needs into the first
quarter of 2019.
Infinity's financial guidance excludes additional funding or
business development activities and does not include the potential
$22 million payment from Verastem
upon the first regulatory approval of duvelisib. Verastem has
provided its expectation that it plans to submit a New Drug
Application to the U.S. Food and Drug Administration for duvelisib
in the first quarter of 2018.
About IPI-549
IPI-549 is an investigational
first-in-class, oral, immuno-oncology product candidate targeting
tumor-associated myeloid cells through selective
phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition, thereby
reducing pro-tumor macrophage function and increasing anti-tumor
macrophage function. In preclinical studies, IPI-549 reprograms
macrophages from a pro-tumor (M2), immune suppressive function, to
an anti-tumor (M1) immune activating function and can enhance the
activity of, and overcome resistance to, checkpoint
inhibitors.4 5 As such, IPI-549 may have the
potential to treat a broad range of solid tumors and represents a
potentially additive or synergistic approach to restoring
anti-tumor immunity in combination with other immunotherapies such
as checkpoint inhibitors.
The ongoing Phase 1/1b study being
conducted by Infinity is designed to evaluate the safety,
tolerability, activity, pharmacokinetics and pharmacodynamics of
IPI-549 as a monotherapy and in combination with Opdivo in
approximately 200 patients with advanced solid tumors.6
The four-component study includes monotherapy and combination
dose-escalation components, in addition to monotherapy expansion
and combination expansion components. The monotherapy
dose-escalation component is complete and the monotherapy expansion
component has been fully enrolled. The combination
dose-escalation component is also complete, and combination
expansion cohorts are open to enrollment.
The combination expansion component of the study includes
multiple cohorts designed to evaluate IPI-549 in patients with
specific types of cancer, including patients with non-small cell
lung cancer (NSCLC), melanoma, and head and neck squamous cell
carcinoma (HNSCC) whose tumors show initial resistance or initially
respond to but subsequently develop resistance to immune checkpoint
blockade therapy. The combination expansion component also includes
a cohort of patients with triple negative breast cancer (TNBC) who
have not been previously treated with immune checkpoint blockade
therapy, a cohort of patients with mesothelioma, a cohort of
patients with adrenocortical carcinoma and a cohort of patients
with high baseline levels of MDSCs.
IPI-549 is an investigational compound, and its safety and
efficacy have 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 1/1b study in
approximately 200 patients with advanced solid tumors is ongoing.
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; plans to
report preclinical, clinical and translational data of IPI-549;
unaudited year-end 2017 cash and investments balance, 2018
financial guidance; 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 clinical development phases or
that Infinity will receive any of the benefits of the agreement
with Verastem including the receipt of milestone and royalty
payments. Further, there can be no guarantee that any positive
developments in Infinity's product portfolio or any 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 the following: Infinity's results of clinical
trials and preclinical studies, including subsequent analysis of
existing data and new data received from ongoing and future
studies; the content and timing of decisions made by the U.S. FDA
and other regulatory authorities; Infinity's ability to obtain and
maintain requisite regulatory approvals and to enroll patients in
its clinical trials; unplanned cash requirements and expenditures;
development of agents by Infinity's competitors for diseases in
which Infinity is currently developing or intends to develop
IPI-549; and Infinity's ability to obtain, maintain and enforce
patent and other intellectual property protection for IPI-549.
These and other risks which may impact management's expectations
are 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 November 7, 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:
Stephanie
Ascher, Stern Investor Relations, Inc.
212-362-1200 or Stephanie@sternir.com
1 Kitano et al. Myeloid Derived Suppressor Cell
Quantity Prior to Treatment with Ipilimumab at 10mg/kg Predicts for
Improved Overall Survival in Patients with Metastatic Melanoma.
ASCO annual meeting #2518, 2013
2 Postow et al. Immunologic Correlates of the
Abscopal Effect in a Patient with Melanoma. NEJM 2012, 366;10.
3 Kitano et al. Computational Algorithm-Driven
Evaluation of Monocytic Myeloid-Derived Suppressor Cell Frequency
For Prediction of Clinical Outcomes. Cancer Immunol Res. 2014,
2(8): 812
4 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.
5 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.
6 www.clinicaltrials.gov, NCT02637531.
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SOURCE Infinity Pharmaceuticals, Inc.