Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company
focused on the discovery and development of novel cancer
immunotherapies and predictive biomarkers, today announced an
update on its strategic collaboration with Celgene Corporation
(NASDAQ: CELG), originally established in July 2016. Under the
terms of a new license agreement, Celgene has licensed worldwide
rights to JTX-8064, a highly-selective, potential first-in-class
antibody that targets the LILRB2 receptor on macrophages. Jounce
retains full worldwide rights to its pipeline beyond JTX-8064,
including vopratelimab, JTX-4014 and all discovery programs, as
Jounce and Celgene have also entered into a mutual agreement to
terminate their original strategic collaboration agreement.
Under the terms of the new license agreement for JTX-8064,
Jounce receives a $50.0 million non-refundable license fee and is
eligible to receive from Celgene up to $480 million in development,
regulatory and commercial milestone payments, as well as royalties
on potential worldwide sales. Celgene will be responsible for all
development and commercialization of JTX-8064.
“We are grateful for Celgene’s investment and support of Jounce
over the past three years as it has helped us grow our diversified
pipeline and further enhance our translational science platform. We
are proud of the many accomplishments we have achieved under the
original agreement with Celgene and remain committed to developing
innovative immunotherapies for patients with cancer,” said Richard
Murray, Ph.D., chief executive officer and president of Jounce
Therapeutics. “The discovery and development of JTX-8064 showcases
the strength of our translational science platform, validating our
approach to discovering novel immunotherapies for patients in need.
We look forward to the advancement of JTX-8064 by Celgene. Most
importantly, we retain full global rights to all of our other
programs, including vopratelimab, giving Jounce greater flexibility
to create value for patients and shareholders moving forward. In
addition to our ongoing clinical development programs, we are also
poised to expand our broader pipeline and advance additional novel
immunotherapy programs based on our translational science
platform.”
“We are pleased to have collaborated with Jounce for the last
three years, and to continue our relationship with the licensing of
worldwide rights to JTX-8064, a novel macrophage program coming
from Jounce’s innovative, translational science platform,” said
Robert Hershberg, executive vice president and head of business
development of Celgene. “We look forward to advancing its
development toward an IND filing.”
Clinical Program Guidance:Jounce is currently
enrolling patients in the Phase 2 EMERGE clinical trial of
vopratelimab in combination with ipilimumab in patients with
non-small cell lung cancer or urothelial cancer who have progressed
on or after PD-1/PD-L1 inhibitor therapies. Jounce expects to
report preliminary efficacy data and biomarker relationships to
clinical outcomes from EMERGE in 2020.
Jounce is also currently conducting a Phase 1 clinical trial of
JTX-4014, its PD-1 inhibitor. This Phase 1 clinical trial is
nearing completion, and Jounce remains on track to identify the
recommended Phase 2 dose of JTX-4014 in 2019.
Revised Financial Guidance:As a result of the
changes to the Celgene strategic collaboration, Jounce now expects
to record approximately $50.0 million in cash revenue in 2019
related to the license of JTX-8064 and approximately $98.0 million
in non-cash revenue in 2019 representing the remaining recognition
of the upfront payment received in July 2016.
Based on its operating and development plans Jounce continues to
expect gross cash burn on operating expenses and capital
expenditures for the full year 2019 to be approximately $80.0
million to $95.0 million.
Conference Call and Webcast Information:Jounce
Therapeutics will host a live conference call and webcast today at
5:00 p.m. ET. To access the conference call, please dial (866)
916-3380 (domestic) or (210) 874-7772 (international) and refer to
conference ID 6684846. The live webcast can be accessed under
"Events & Presentations" in the Investors and Media section of
the company's website at www.jouncetx.com. The webcast will be
archived and made available for replay on the company’s website
approximately two hours after the call and will be available for 30
days.
About Vopratelimab Jounce’s lead product
candidate, vopratelimab (formerly JTX-2011), is a clinical-stage
monoclonal antibody that binds to and activates ICOS,
the Inducible T
cell COStimulator, a
protein on the surface of certain T cells commonly found in many
solid tumors. Vopratelimab was assessed in a Phase 1/2 clinical
trial that we refer to as ICONIC. In the initial Phase 1/2 portion
of ICONIC, vopratelimab was found to be safe and well-tolerated,
both alone and in combination with nivolumab, an anti-PD-1
antibody. At the June 2018 annual meeting of the American Society
of Clinical Oncology, we reported Response Evaluation Criteria in
Solid Tumors, or RECIST, responses and other tumor reductions as
determined by investigator assessment that were associated with an
ICOS pharmacodynamic biomarker. We subsequently reported that these
responses were durable, lasting six or more months and that all
responders, as determined by investigator assessments, remained on
study for more than one year. ICONIC also included dose-escalation
Phase 1 portions to assess vopratelimab in combination with
pembrolizumab, an anti-PD-1 antibody, and in combination with
ipilimumab, an antibody that binds to CTLA-4 on certain T cells.
This Phase 1 portion established the safety of vopratelimab in
combination with each of ipilimumab and pembrolizumab.
About JTX-4014 JTX-4014 is a well-characterized
fully human IgG4 monoclonal antibody designed to block binding to
PD-L1 and PD-L2. Jounce is developing JTX-4014 for potential use in
combination with its pipeline of future product candidates.
JTX-4014 is currently in Phase 1 clinical development, which is
nearing completion.
About JTX-8064 JTX-8064 is an anti-Leukocyte
Immunoglobulin Like Receptor B2 (LILRB2) antibody and is the first
candidate to emerge from Jounce’s Translational Science Platform
efforts that focuses on tumor-associated macrophages. Preclinical
data presented at the 2019 American Association for Cancer Research
Annual Meeting supports the development of JTX-8064 as a novel
immunotherapy to reprogram immune-suppressive macrophages and
enhance anti-tumor immunity.
About Jounce TherapeuticsJounce Therapeutics,
Inc. is a clinical-stage immunotherapy company dedicated to
transforming the treatment of cancer by developing therapies that
enable the immune system to attack tumors and provide long lasting
benefits to patients. Through the use of its Translational Science
Platform, Jounce first focuses on specific cell types within the
human tumor microenvironment to prioritize targets, and then
identifies related biomarkers designed to match the right
immunotherapy to the right patient. Jounce has two clinical product
candidates, vopratelimab, a monoclonal antibody that binds to and
activates ICOS and JTX-4014, a monoclonal antibody that binds
to PD-1 and for potential use in combination with Jounce’s pipeline
of future product candidates. In addition, Jounce is progressing
numerous novel discovery stage programs. For more information,
please visit www.jouncetx.com.
Forward-Looking StatementsStatements in this
release concerning Jounce’s future expectations and plans,
including without limitation, Jounce’s clinical development
strategy may constitute forward looking statements for the purposes
of the safe harbor provisions under The Private Securities
Litigation Reform Act of 1995 and other federal securities laws and
are subject to substantial risks, uncertainties and assumptions.
You should not place reliance on these forward-looking statements,
which include words such as “believe,” “expect,” “aims,”
“anticipates,” “intend,” “may,” “potential” or similar terms,
variations of such terms or the negative of those terms. Although
the Company believes that the expectations reflected in the
forward-looking statements are reasonable, the Company cannot
guarantee such outcomes. Actual results may differ materially from
those indicated by these forward-looking statements as a result of
various important factors, as well as those risks more fully
discussed in the section entitled “Risk Factors” in Jounce’s most
recent annual report on Form 10-K or quarterly report on Form 10-Q,
as well as discussions of potential risks, uncertainties, and other
important factors in Jounce’s subsequent filings with the U.S.
Securities and Exchange Commission. All such statements speak only
as of the date made, and the Company undertakes no obligation to
update or revise publicly any forward-looking statements, whether
as a result of new information, future events or otherwise.
Investor Contact:Komal JoshiJounce
Therapeutics, Inc.(857) 320-2523kjoshi@jouncetx.com
Media Contact:Gina NugentThe Yates Network(617)
460-3579gina@theyatesnetwork.com
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