CAMBRIDGE, Mass., March 15, 2018 /PRNewswire/ -- Infinity
Pharmaceuticals, Inc. (NASDAQ: INFI) today announced its fourth
quarter 2017 financial results and provided an update on the
company, including its progress with IPI-549, a first-in-class oral
immuno-oncology product candidate that selectively inhibits
phosphoinositide-3-kinase-gamma (PI3K-gamma) and targets
immune-suppressive tumor microphages. Infinity is evaluating
IPI-549 as a monotherapy and in combination with Opdivo®
(nivolumab), a PD-1 immune checkpoint inhibitor, in a Phase
1/1b study in approximately 200
patients with advanced solid tumors.
"We made significant progress with IPI-549 over the past year,
and 2018 will be an important year for us as we report data from
the monotherapy expansion and combination dose escalation
components of our study and from seven combination expansion
cohorts, which will help define our development and regulatory
strategy for this first-in-class product candidate. Based on our
initial clinical data, IPI-549 has a favorable tolerability profile
and has demonstrated clinical and biological activity, both as a
monotherapy and in combination with nivolumab. We believe that
IPI-549 has the potential to increase the number of patients who
respond to immunotherapies as well as to increase the duration of
those responses," said Adelene
Perkins, Chief Executive Officer and Chair of Infinity
Pharmaceuticals. "In addition, we've continued to position Infinity
for success by expanding our board and clinical leadership team and
establishing a scientific advisory board with thought leaders in
the field of immuno-oncology."
Recent developments include the following:
IPI-549
- Advanced and expanded clinical development of IPI-549:
The Phase 1/1b monotherapy and
combination dose escalation components of the study have been
completed, and the monotherapy expansion component has been fully
enrolled. In addition, six disease-specific combination expansion
cohorts are enrolling at the recommended Phase 2 dose of 40 mg once
daily of IPI-549 plus Opdivo® (nivolumab) at 240 mg every two weeks
in patients with non-small cell lung cancer, melanoma, head and
neck cancer, triple-negative breast cancer, mesothelioma, and
adrenocortical carcinoma. An additional combination expansion
cohort of patients pre-selected for having high baseline blood
levels of myeloid derived suppressor cells (MDSCs) is expected to
open for enrollment in the next few weeks. Studies have shown that
poor response to checkpoint inhibitor therapy is correlated with
the presence of high baseline blood levels of MDSCs in cancer
patients.1,2,3 Preliminary translational data from the
study demonstrated an association between high baseline blood
levels of MDSCs and clinical responses. Preselecting patients with
high blood MDSCs could lead to improved clinical activity for
patients treated with the combination of IPI-549 and anti-PD1.
- Presented Phase 1/1b clinical
and translational data at SITC: In November, Infinity announced
updated data from the monotherapy dose-escalation component of the
Phase 1/1b study of IPI-549 in a
late-breaking presentation at the SITC Annual Meeting 2017. These
data demonstrated that IPI-549 dosed once daily was well tolerated
and clinically active. Among 18 patients evaluable for activity,
there was a 44 percent clinical benefit rate, defined as patients
who had remained on treatment for at least 16 weeks, including one
partial response in a patient with advanced peritoneal
mesothelioma. Initial translational data from patient blood samples
demonstrated that IPI-549 treatment results in a reduction in
immune suppression and increased immune stimulation, with
upregulation of interferon-gamma responsive factors and
reinvigoration/proliferation of exhausted T cells across multiple
tumor types and dose levels. Additionally, those patients who
showed a clinical benefit had increased numbers of activated
monocytes, suggesting a biologic correlate can be identified in
patients who remain on treatment longer.
Corporate
- David Beier appointed to
Board of Directors: David Beier,
J.D., is a Managing Director of Bay City Capital and brings a
wealth of experience to the Infinity Board. David serves as an
advisor to the Parker Institute for Cancer Immunotherapy, as a
Senior Fellow at the USC Schaeffer
Center for Health Policy & Economics and as a member of the
Board of Directors of Arcus Biosciences, UCSF Benioff Children's
Hospitals and the California Life Sciences Association. He also
serves as an appointee of Governor Brown on the California State
Government Organization and the Economy Commission. Having spent
two decades as part of the senior management teams for Amgen and
Genentech, he brings invaluable perspective regarding strategy for
entrepreneurial biotechnology firms and the industry in general as
a globally recognized leader in health care policy, regulatory
affairs, healthcare economics, and pricing. Mr. Beier also
previously served in the White House during the Clinton
Administration as a Chief Domestic Policy Advisor to the Vice
President.
- Clinical leadership team expanded: Marie-Louise
Fjällskog M.D., Ph.D., has been appointed as Vice President of
Clinical Development and will play an integral role in the expanded
clinical development of IPI-549. Dr. Fjällskog is an Associate
Professor of Oncology at Uppsala
University, Sweden, and has
over twenty-five years of experience in clinical oncology,
translational research, and drug development. She joins Infinity
from the Novartis Institute for Biomedical Research, where she
served as a Clinical Program Leader, Translational Clinical
Oncology, and as the global lead for several immuno-oncology
programs, including those targeting CSF-1 and PD-1.
In addition, Suresh Mahabhashyam,
M.D., M.P.H., was promoted to Vice President of Safety and Risk
Management. Dr. Mahabhashyam has over 20 years of experience in
medical practice and epidemiology with the last decade focused on
drug development at Infinity, Alexion and Allergan.
- Scientific Advisory Board established with four thought
leaders in immuno-oncology:
-
- Dmitry Gabrilovich, M.D., PhD.,
a leader in myeloid cell biology and the Christopher M. Davis
Professor in Cancer Research and Program Leader, Immunology,
Microenvironment, and Metastasis at the Wistar Institute in
Philadelphia and Wistar Professor
at the Department of Pathology and Laboratory Medicine, Perelman
School of Medicine, University of
Pennsylvania;
- Roy Herbst, M.D., Ph.D., a
leader in lung cancer treatment and research and the Ensign
Professor of Medicine (Medical Oncology) and Professor of
Pharmacology; Chief of Medical Oncology, Yale Cancer Center and
Smilow Cancer Hospital;
- Stephen Hodi, M.D., a leader in
developing immune therapy and melanoma therapeutics and the
Director of the Melanoma Center and the Center for Immuno-Oncology
at Dana-Farber/Brigham and Women's Cancer Center, the Sharon
Crowley Martin Chair in Melanoma at Dana-Farber Cancer Institute
and Professor of Medicine at Harvard Medical
School; and
- David H. Munn, M.D., a pioneer
in T cell activation and indoleamine 2,3-dioxygenase (IDO) research
and a Professor of Pediatric Hematology-Oncology at the
Medical College of Georgia, Augusta
University.
2018 Program Goals for IPI-549
- 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 six disease-specific combination
expansion cohorts in the second quarter of 2018
- Report more mature clinical and translational data (including
insights from paired tumor biopsies) from the six disease-specific
cohorts and initial data from the cohort of patients pre-selected
for having high baseline blood levels of myeloid derived suppressor
cells (MDSCs) in the combination expansion component of the study
in the second half of 2018
Full Year 2017 Financial Results
- At December 31, 2017, Infinity
had total cash, cash equivalents and available-for-sale securities
of $57.6 million, compared to
$92.1 million at December 31, 2016.
- Revenue during 2017 was $6.0
million, all of which related to the amount received from
Verastem for the DUO study meeting the pre-specified criteria at
completion. Revenue during 2016 was $18.7
million related to Infinity's previous collaboration
agreement with AbbVie Inc.
- R&D expense for 2017 was $20.8
million, compared to $119.6
million for 2016. The decrease in R&D expense was
primarily related to the company's 2016 restructuring activities
and out-licensing of duvelisib to Verastem.
- General and administrative expense was $21.6 million for 2017, compared to $42.2 million for 2016. The decrease in G&A
expense was primarily due to the company's 2016 restructuring
activities.
- Net loss for 2017 was $41.8
million, or a basic and diluted loss per common share of
$0.83, compared to a net loss of
$30.1 million, or a basic and diluted
loss per common share of $0.61 for
2016.
Financial Outlook
Infinity's updated 2018 financial
guidance is as follows:
- Net Loss: Infinity expects net loss for 2018 to range
from $35 million to $45 million.
- Cash and Investments: Infinity expects to end 2018 with
a year-end cash, cash equivalents and available-for-sale securities
balance ranging from $15 million to
$25 million.
- Cash Runway: Based on its current operational plans,
Infinity expects that its existing cash, cash equivalents and
available-for-sale securities will be adequate to satisfy the
company's capital needs into the third 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, or a potential
$2 million milestone payment from
PellePharm, a private company, upon initiation of a Phase 3 study
for the hedgehog inhibitor program, which Infinity licensed to
PellePharm in 2013. Verastem announced that it submitted a New Drug
Application for duvelisib to the U.S. Food and Drug Administration
on February 7, 2018. With the
potential Verastem milestone payment, Infinity expects to extend
its cash runway into 2020.
Conference Call Information
Infinity will host a
conference call today, March 15,
2018, at 4:30pm EDT to discuss
these financial results and company updates. A live webcast of the
conference call can be accessed in the "Investors/Media" section of
Infinity's website at www.infi.com. To participate in the
conference call, please dial 1-877-316-5293 (domestic) and
1-631-291-4526 (international) five minutes prior to start time.
The conference ID number is 5558799. An archived version of the
webcast will be available on Infinity's website for 30 days.
About IPI-549 and the Ongoing Phase 1b Study
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 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 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 enrolling.
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 blood levels of MDSCs.
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 cancer
treatments. Infinity is advancing IPI-549, a potentially
transformative immuno-oncology approach that aims to reprogram
tumor-associated macrophages by selectively inhibiting 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 clinical and translational data of IPI-549; 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 preclinical and clinical development phases or
that Infinity will receive any of the benefits of its agreement
with Verastem, Inc., including the receipt of milestone
and royalty payments. Further, there can be no guarantee that any
positive developments in Infinity's product portfolio 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; a failure of
Infinity and/or Verastem to fully perform under the license
agreement; 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 annual report on Form 10-K
filed with the Securities and Exchange Commission (SEC)
on March 15, 2018, 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.
INFINITY
PHARMACEUTICALS, INC.
|
Condensed
Consolidated Balance Sheets
|
(in
thousands)
|
(unaudited)
|
|
|
December 31,
2017
|
|
December 31,
2016
|
Cash, cash
equivalents and available-for-sale securities
|
$
|
57,609
|
|
$
|
92,064
|
Other current
assets
|
777
|
|
9,596
|
Property and
equipment, net
|
219
|
|
23,424
|
Other long-term
assets
|
748
|
|
571
|
Total
assets
|
$
|
59,353
|
|
$
|
125,655
|
|
|
|
|
Note
payable
|
$
|
6,000
|
|
$
|
—
|
Other current
liabilities
|
5,595
|
|
23,863
|
Financing obligation,
less current portion
|
—
|
|
19,149
|
Other long-term
liabilities
|
28
|
|
189
|
Total stockholders'
equity
|
47,730
|
|
82,454
|
Total liabilities and
stockholders' equity
|
$
|
59,353
|
|
$
|
125,655
|
|
|
|
|
INFINITY
PHARMACEUTICALS, INC.
|
Condensed
Consolidated Statements of Operations
|
(in thousands,
except share and per share amounts)
|
(unaudited)
|
|
|
Three Months Ended
December 31,
|
|
Twelve Months
Ended
December 31,
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Collaboration
revenue
|
$
|
—
|
|
$
|
—
|
|
$
|
6,000
|
|
$
|
18,723
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
3,552
|
|
14,662
|
|
20,830
|
|
119,611
|
General and
administrative
|
4,468
|
|
8,571
|
|
21,615
|
|
42,219
|
Total operating
expenses
|
8,020
|
|
23,233
|
|
42,445
|
|
161,830
|
Gain on AbbVie
Opt-Out
|
—
|
|
—
|
|
—
|
|
112,216
|
Loss from
operations
|
(8,020)
|
|
(23,233)
|
|
(36,445)
|
|
(30,891)
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest expense
|
(121)
|
|
(304)
|
|
(1,010)
|
|
(1,225)
|
Other expense
|
—
|
|
—
|
|
(6,882)
|
|
—
|
Investment and other
income
|
124
|
|
607
|
|
1,787
|
|
2,015
|
Total other income
(expense)
|
3
|
|
303
|
|
(6,105)
|
|
790
|
Loss before income
taxes
|
(8,017)
|
|
(22,930)
|
|
(42,550)
|
|
(30,101)
|
Income taxes
benefit
|
720
|
|
—
|
|
720
|
|
—
|
Net loss
|
$
|
(7,297)
|
|
$
|
(22,930)
|
|
$
|
(41,830)
|
|
$
|
(30,101)
|
Basic and diluted
loss per common share:
|
$
|
(0.14)
|
|
$
|
(0.46)
|
|
$
|
(0.83)
|
|
$
|
(0.61)
|
Basic and diluted
weighted average
number of common shares outstanding:
|
50,721,658
|
|
50,099,153
|
|
50,560,195
|
|
49,608,234
|
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.
View original
content:http://www.prnewswire.com/news-releases/infinity-pharmaceuticals-provides-company-update-and-reports-fourth-quarter-and-full-year-2017-financial-results-300614821.html
SOURCE Infinity Pharmaceuticals, Inc.