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CG Oncology Completes…

Key Takeaway: CG Oncology has successfully completed patient enrollment for the BOND-003 Phase 3 study, which evaluates cretostimogene grenadenorepvec in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer. A total of 110 patients have been enrolled across North America and the Asia-Pacific regions. The study's primary endpoint is complete response, with several secondary endpoints aimed at assessing the treatment's effectiveness and safety.

Market Sentiment Analysis

POSITIVE FACTORS

  • Completion of patient enrollment is a significant milestone.
  • Cretostimogene grenadenorepvec offers hope for patients with limited options.
  • The study involves a substantial number of participants across multiple regions.
  • The company is focused on developing bladder-sparing therapeutics.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+139%
120-day peak, hindsight
Typical move
6.3%
average across 5 past catalysts
Cash runway
~66 mo
Minimal dilution risk
Lead asset
CG0070
Phase 2 · Non Muscle Invasive Bladder Cancer

Full Press Release Details

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CG Oncology Completes Patient Enrollment in BOND-003 Phase 3 Monotherapy Study with cretostimogene grenadenorepvec in BCG-Unresponsive High-Risk NMIBC
[/et_pb_text][/et_pb_column][/et_pb_row][et_pb_row _builder_version=”4.27.4″ _module_preset=”default” custom_margin=”-50px||||false|false” custom_margin_tablet=”-50px||||false|false” custom_margin_phone=”-50px||||false|false” custom_margin_last_edited=”on|desktop” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_code _builder_version=”4.27.4″ _module_preset=”default” width_tablet=”” width_phone=”326px” width_last_edited=”on|phone” height_tablet=”” height_phone=”157px” height_last_edited=”on|phone” custom_margin=”30px||||false|false” custom_margin_tablet=”” custom_margin_phone=”-50px||||false|false” custom_margin_last_edited=”on|phone” global_colors_info=”{}”]
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[/et_pb_code][/et_pb_column][/et_pb_row][et_pb_row _builder_version=”4.27.4″ _module_preset=”default” custom_margin=”-30px||||false|false” custom_margin_tablet=”-30px||||false|false” custom_margin_phone=”-30px||||false|false” custom_margin_last_edited=”on|desktop” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_font=”Montserrat||||||||” text_text_color=”#000000″ text_font_size=”18px” width_tablet=”” width_phone=”329px” width_last_edited=”on|phone” height_tablet=”” height_phone=”1590px” height_last_edited=”on|phone” custom_margin_tablet=”” custom_margin_phone=”10px||||false|false” custom_margin_last_edited=”on|phone” global_colors_info=”{}”]IRVINE, Calif.– (BUSINESS WIRE )– CG Oncology, Inc. , announced today completion of patient enrollment for BOND-003, a single arm, Phase 3, monotherapy study evaluating cretostimogene grenadenorepvec in patients with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG).
In the BOND-003 study there are 110 patients enrolled with BCG-Unresponsive High-Risk NMIBC across North America and the Asia-Pacific regions. The primary endpoint of the study is complete response (CR) at any time. Secondary endpoints include CR at 12 months, duration of response, progression-free survival, cystectomy-free survival, and safety. For more information about BOND-003, visit www.clinicaltrials.gov ( NCT04452591 ).
“As a patient advocacy organization, it is exciting to see new treatments get closer to being available to bladder cancer patients with BCG-unresponsive disease, who have so few options available. Many will only have the option of bladder removal, which is not always available due to other health concerns,” said Andrea-Maddox Smith, Chief Executive Officer, Bladder Cancer Advocacy Network (BCAN). “We have consistently advocated for increased funding for research and encouraged patients to seek out appropriate trials.”
“We would like to thank all those who partnered with us to complete this study especially patients, care givers, physicians and health care teams in the United States and globally who helped us reach this important milestone,” said Arthur Kuan, Chief Executive Officer, CG Oncology. “We are intensely focused on developing bladder-sparing therapeutics and are actively engaged in making cretostimogene available to patients as soon as possible.”[/et_pb_text][/et_pb_column][/et_pb_row][et_pb_row _builder_version=”4.27.4″ _module_preset=”default” custom_margin=”-30px||||false|false” custom_margin_tablet=”-30px||||false|false” custom_margin_phone=”10px||||false|false” custom_margin_last_edited=”on|phone” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_font=”Montserrat||||||||” text_text_color=”#000000″ text_font_size=”18px” width_tablet=”” width_phone=”326px” width_last_edited=”on|phone” custom_margin_tablet=”” custom_margin_phone=”-250px||||false|false” custom_margin_last_edited=”on|phone” global_colors_info=”{}”] About Cretostimogene Grenadenorepvec Cretostimogene grenadenorepvec is an intravesically delivered oncolytic immunotherapy agent in a Phase 3 trial for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. Cretostimogene grenadenorepvec is also in a Phase 2 study in combination with KEYTRUDA (pembrolizumab) in the same indication. Other types of bladder ® cancer are being evaluated with cretostimogene grenadenorepvec in combination with OPDIVO (nivolumab).
About Bladder Cancer More than 82,000 people are estimated to be diagnosed with bladder cancer this year. NMIBC is the most common form of bladder cancer, representing approximately 75% of cases. Four times more men are diagnosed with bladder cancer than women and is the fourth most common type of cancer in men in the United States.
About CG Oncology CG Oncology is an oncolytic immunotherapy company focused on developing bladder-saving therapeutics for patients with urologic cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative therapies to live and work with dignity and an enhanced quality of life. To learn more, please visit: www.cgoncology.com .
CONTACTS: Investor Relations Bing Kung Vice President, Corporate Development CG Oncology bd@cgoncology.com
Media Kimberly Ha KKH Advisors (917) 291-5744 kimberly.ha@kkhadvisors.com [/et_pb_text][/et_pb_column][/et_pb_row][et_pb_row module_class=”cta-wrapper-row” _builder_version=”4.27.4″ _module_preset=”default” custom_margin=”-30px||||false|false” custom_css_free_form=”.et_post_meta_wrapper{|| display: none;||}” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_divider color=”#ff5100″ module_class=”divider-container” _builder_version=”4.27.4″ _module_preset=”default” custom_margin=”50px||||false|false” custom_margin_tablet=”” custom_margin_phone=”||||false|false” custom_margin_last_edited=”on|phone” global_colors_info=”{}”][/et_pb_divider][et_pb_code module_class=”cta-wrapper” _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”]
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Frequently Asked Questions

What is the BOND-003 study?

The BOND-003 study is a Phase 3 trial evaluating cretostimogene grenadenorepvec in patients with high-risk NMIBC unresponsive to BCG.

How many patients were enrolled in the study?

A total of 110 patients were enrolled in the BOND-003 study across North America and the Asia-Pacific.

What are the primary endpoints of the study?

The primary endpoint is complete response at any time, with secondary endpoints including duration of response and safety.

Who is the CEO of CG Oncology?

Arthur Kuan is the Chief Executive Officer of CG Oncology.

What is cretostimogene grenadenorepvec?

Cretostimogene grenadenorepvec is an oncolytic immunotherapy agent being tested for NMIBC.

Last updated: Jul 24, 2023