UroGen Advances Long-Term Growth Strategy by Acquiring a Next-Generation Investigational Oncolytic Virus (ICVB-1042) and Announces Multiple Strategic Research Collaborations
20 Febbraio 2025 - 2:00PM
Business Wire
- ICVB-1042 is an Oncolytic Virus Engineered to Selectively
Destroy Cancer Cells While Retaining Potency and Trigger a Robust
Immune Response
- Strategic Research Collaborations Focused on Exploring the
Potential of UroGen’s Innovative RTGel® Technology to Enhance the
Clinical Effectiveness of Multiple Immunotherapies
- Conference Call Webcast to be Held Today at 12:00 PM ET
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated
to developing and commercializing innovative solutions that treat
urothelial and specialty cancers, today announced expansion of its
oncology pipeline portfolio through the acquisition of assets
relating to a next-generation oncolytic virus ICVB-1042 from
IconOVir Bio, Inc. (IconOVir). In addition, UroGen also announced
that it has entered into multiple strategic research collaborations
to explore the potential of its proprietary RTGel technology to
enhance clinical effectiveness of multiple immunotherapies,
including optimizing dwell time to improve treatment outcomes.
“UroGen’s long-term growth strategy is built on advancing our
uro-oncology pipeline, expanding our portfolio, and driving
innovation in cancer treatment,” said Liz Barrett, President and
Chief Executive Officer of UroGen. “The acquisition of ICVB-1042, a
next-generation investigational oncolytic virus, marks a
significant milestone in our plan to develop novel, locally
administered therapies for bladder cancer and other specialty
cancers. This strategic investment underscores our commitment to
identifying and advancing high-impact therapies that address
critical unmet needs. Through targeted acquisitions and research
collaborations, we are strengthening UroGen’s leadership in
oncology and laying the foundation for sustained innovation and
growth.”
The use of biological agents to treat bladder cancer has its
roots in the development of Bacillus Calmette-Guérin (BCG) therapy.
Much like BCG therapy, ICVB-1042 is being developed to activate the
immune system within the tumor microenvironment, but unlike BCG
therapy, ICVB-1042 has the potential to selectively destroy cancer
cells while retaining potency and trigger a robust immune response.
A fusion of potency and cancer cell destruction would mark a
groundbreaking step forward, unlocking new possibilities in the
fight against cancer.
“The treatment of bladder cancer has long been shaped by
immunological approaches such as BCG therapy. UroGen now seeks to
advance bladder cancer treatment with highly targeted,
next-generation viral immunotherapies like ICVB-1042,” said Mark
Schoenberg, M.D., Chief Medical Officer of UroGen. “ICVB-1042 may
represent an exciting leap forward, with several attributes we
believe differentiate this asset from other oncolytic viruses.
Supported by a robust non-clinical data package, we are eager to
develop this investigational therapy as a potential new treatment
in localized cancer.”
Asset Purchase
On February 14, 2025, UroGen acquired certain assets of
IconOVir, including product candidate ICVB-1042, and assumed
certain liabilities and obligations of IconOVir arising under
certain acquired contracts. As consideration for the assets, UroGen
issued IconOVir 374,843 of its ordinary shares (representing a
value of approximately $4.0 million based on 30-day VWAP), agreed
to pay IconOVir a one-time payment of $15.0 million in cash upon
the achievement of a cumulative aggregate worldwide net sales
milestone for all products, including combination products, that
incorporate or comprise ICVB-1042 (ICVB Products), and agreed to
pay IconOVir a certain low, single-digit percentage royalty on a
ICVB Product-by-ICVB Product basis on annual worldwide net sales of
such ICVB Product.
Conference Call & Webcast Information
Members of UroGen’s management team will host a live conference
call and webcast today at 12:00 PM ET to discuss the Company’s
long-term growth strategy. The live webcast can be accessed by
visiting the Investors section of the Company’s website at
http://investors.UroGen.com. Please connect 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.
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and
commercializing innovative solutions that treat urothelial and
specialty cancers because patients deserve better options. UroGen
has developed RTGel® reverse-thermal hydrogel, a proprietary
sustained-release, hydrogel-based platform technology that has the
potential to improve the therapeutic profiles of existing drugs.
UroGen’s sustained release technology is designed to enable longer
exposure of the urinary tract tissue to medications, making local
therapy a potentially more effective treatment option. Our first
product to treat low-grade upper tract urothelial cancer and
investigational treatment UGN-102 (mitomycin) for intravesical
solution for patients with LG-IR-NMIBC are designed to ablate
tumors by non-surgical means. UroGen is headquartered in Princeton,
NJ with operations in Israel. To learn more, visit www.UroGen.com
to learn more or follow us on X (Twitter) @UroGenPharma.
Forward-Looking Statements
This press release contains forward-looking statements as that
term is defined in the Private Securities Litigation Reform Act of
1995, including, without limitation, statements regarding: UroGen’s
long-term growth strategy; UroGen’s targeted acquisitions and
research collaborations strengthening UroGen’s leadership in
oncology and laying the foundation for sustained innovation and
growth; the focus of UroGen’s strategic research collaborations;
the potential of ICBV-1042 to selectively target cancer cells while
retaining potency, triggering an immune response, and minimizing
systemic exposure; the belief that ICVB-1042 has several attributes
that differentiate it from other oncolytic viruses; the potential
of UroGen’s proprietary RTGel technology to improve therapeutic
profiles of existing drugs and UroGen’s sustained release
technology making local delivery potentially more effective as
compared to other treatment options. Words such as “believe,”
“plan,” “potential,” “will,” or other words that convey uncertainty
of future events or outcomes are used to identify these
forward-looking statements. These statements are subject to a
number of risks, uncertainties and assumptions, including, but not
limited to: prior results may not be indicative of results that may
be observed in the future; the ability to maintain regulatory
approval; complications associated with commercialization
activities; the labeling for any approved product; competition in
UroGen’s industry; the scope, progress and expansion of developing
and commercializing UroGen’s product candidates; the size and
growth of the market(s) therefor and the rate and degree of market
acceptance thereof vis-à-vis alternative therapies; UroGen’s
ability to attract or retain key management, members of the board
of directors and other personnel; UroGen’s RTGel technology may not
perform as expected; UroGen’s financial condition and need for
additional capital; and UroGen may not successfully develop and
receive regulatory approval of any other product that incorporates
RTGel technology. In light of these risks and uncertainties, and
other risks and uncertainties that are described in the Risk
Factors section of UroGen’s Quarterly Report on Form 10-Q for the
quarter ended September 30, 2024, filed with the SEC on November 6,
2024 (which is available at www.sec.gov), the events and
circumstances discussed in such forward-looking statements may not
occur, and UroGen’s actual results could differ materially and
adversely from those anticipated or implied thereby. Any
forward-looking statements speak only as of the date of this press
release and are based on information available to UroGen as of the
date of this release.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250220875021/en/
INVESTOR CONTACT: Vincent Perrone Senior Director,
Investor Relations vincent.perrone@UroGen.com 609-460-3588 ext.
1093
MEDIA CONTACT: Cindy Romano Director, Communications
cindy.romano@urogen.com 609-460-3583 ext. 1083
Grafico Azioni UroGen Pharma (NASDAQ:URGN)
Storico
Da Gen 2025 a Feb 2025
Grafico Azioni UroGen Pharma (NASDAQ:URGN)
Storico
Da Feb 2024 a Feb 2025
