K36 Therapeutics Advances Phase 1 Clinical Trial of KTX-2001
KTX-2001 is currently being evaluated as both a standalone treatment and in combination with another drug for patients with metastatic castration-resistant prostate cancer (mCRPC).
K36 Therapeutics, a clinical-stage biotechnology company focused on innovative cancer therapies, recently announced the completion of dosing in the first patient cohort of its Phase 1 clinical trial evaluating KTX-2001. This drug is a groundbreaking, orally administered, selective NSD2 inhibitor targeting metastatic castration-resistant prostate cancer.
The initiated trial is known as STRIKE-001 and is structured to analyze KTX-2001's effectiveness as a monotherapy and in conjunction with darolutamide, which is a well-regarded oral androgen receptor inhibitor.
According to Terry Connolly, Ph.D., President and CEO of K36 Therapeutics, “KTX-2001 is a first-in-class NSD2 inhibitor targeting a well-known epigenetic factor affecting prostate cancer progression. Despite the availability of new therapies, many patients run out of successful treatment options. This clinical trial represents a shift in treatment paradigm with a promising epigenetic approach for men facing advanced prostate cancer.”
K36 Therapeutics is also pleased to announce the addition of Shinta Cheng, M.D., Ph.D., as their new Chief Medical Officer. Dr. Cheng has extensive experience in oncology and hematology, having held significant roles at various leading pharmaceutical companies. Her background in prostate cancer includes developing notable therapies.
Dr. Cheng expressed her enthusiasm for joining the team at K36 Therapeutics, stating, “The advancement of KTX-2001 emphasizes the pressing need for innovative therapies for advanced prostate cancer. I am excited to be part of K36 at such a transformative time for our second NSD2 inhibitor prospect.”
The company has also reported that site activation for the trial is proceeding ahead of schedule, with over 75% of sites forecasted to be activated shortly. Recruitment for further patient cohorts is already underway, indicating a robust interest in novel epigenetic therapies targeting advanced prostate cancer. This positions K36 Therapeutics at the forefront of developing effective options for patients with critical health needs.
About the KTX-2001 Phase 1 Clinical Trial (STRIKE-001)
STRIKE-001 is a comprehensive clinical trial that includes both monotherapy and combination treatment investigations. The trial aims to establish the safety profile and efficacy of KTX-2001, including determining the maximum tolerated dose and identifying effective combination dosages with darolutamide.
Approximately 140 patients suffering from metastatic castration-resistant prostate cancer who have previously used androgen receptor inhibitors or chemotherapeutic agents will be enrolled in this important study.
KTX-2001 is a small molecule that selectively inhibits NSD2, disrupting its oncogenic pathways by preventing methylation of histone H3 at lysine 36. This inhibition can potentially alter the course of cancer progression significantly.
About K36 Therapeutics, Inc.
K36 Therapeutics is committed to innovating therapies that modulate epigenetic pathways for cancer treatment. Founded in early 2021, K36 is supported by prominent investors focused on advancing cancer therapeutics. Their mission prioritizes the research and development of small molecule therapies that can significantly improve outcomes for cancer patients globally.
Contacts:
K36 Therapeutics
Soo Bang
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Media
Sarah Sutton
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Frequently Asked Questions
What is KTX-2001?
KTX-2001 is a selective NSD2 inhibitor under evaluation for the treatment of metastatic castration-resistant prostate cancer.
What is the STRIKE-001 trial?
STRIKE-001 is a Phase 1 clinical trial assessing the safety and effectiveness of KTX-2001 as a standalone treatment and in combination with darolutamide.
Who is Shinta Cheng?
Shinta Cheng, M.D., Ph.D., is the newly appointed Chief Medical Officer at K36 Therapeutics, bringing significant expertise in oncology.
Why is KTX-2001 important?
KTX-2001 represents a novel therapeutic approach for men with advanced prostate cancer, addressing a substantial unmet medical need.
How many patients will be involved in the trial?
The trial is expected to enroll approximately 140 patients who have prior experience with androgen receptor inhibitors and chemotherapy.
