#USA #Cambridge #K36 Therapeutics #Prostate Cancer #KTX-2001

K36 Therapeutics Makes Progress with KTX-2001 in Prostate Cancer

K36 Therapeutics, a clinical-stage biotechnology firm, has recently made significant strides in prostate cancer treatment with their investigational drug, KTX-2001. This innovative therapy is now being evaluated as part of a Phase 1 clinical trial, known as STRIKE-001. The trial aims to determine the safety and tolerability of KTX-2001 in patients suffering from metastatic castration-resistant prostate cancer (mCRPC).

On February 5, 2026, K36 Therapeutics announced that the first cohort of patients has completed dosing, marking an important milestone in the evaluation of this first-in-class oral medication. KTX-2001 functions as a selective inhibitor of NSD2, a protein well-acknowledged for its role in the progression of prostate cancer.

The STRIKE-001 trial comprises two parts: Part A involves the assessment of KTX-2001 as a monotherapy, while Part B evaluates its effectiveness when combined with darolutamide, a recognized nonsteroidal androgen receptor inhibitor. According to Terry Connolly, President and CEO of K36 Therapeutics, this trial aims to offer a much-needed alternative for patients who have run out of efficient treatment options.

New Leadership

In a related announcement, K36 welcomed Dr. Shinta Cheng as the new Chief Medical Officer. Dr. Cheng comes with over 20 years of experience in drug development across oncology and hematology. Her prior roles include significant positions at reputable organizations like Johnson & Johnson and Bristol Myers Squibb, where she gained extensive knowledge in prostate cancer therapies.

Dr. Cheng expressed her enthusiasm regarding KTX-2001, emphasizing the urgent need for innovative therapies targeting advanced prostate cancer and paving the way for novel treatment approaches.

Clinical Trial Details

The Phase 1 trial (NCT07103018) is structured to include approximately 140 patients with mCRPC who have previously undergone treatment with androgen receptor inhibitors and chemotherapy. The primary objectives involve examining the safety and tolerability of KTX-2001, determining the maximum tolerated dose, and recommending Phase 2 doses for both the monotherapy and combination therapy with darolutamide. Secondary objectives will evaluate pharmacokinetics, pharmacodynamics, and preliminary clinical activity metrics.

KTX-2001 works by inhibiting NSD2's role in the methylation of histone H3, a fundamental process that influences gene expression and cancer progression. This mechanism disrupts numerous oncogenic pathways linked to prostate cancer, offering promising potential as a treatment option.

Looking Ahead

With site activations progressing ahead of schedule and strong clinical interest in oral epigenetic therapies, K36 Therapeutics is making headway towards enrolling more patients for subsequent cohorts of the trial. As Jason Redman, Medical Director of the Prostate Program at K36, noted, the early momentum signifies a pressing demand for fresh therapeutic options for men dealing with advanced cases of prostate cancer.

K36 Therapeutics was founded in February 2021 and is backed by prominent investors such as Atlas Venture and Bristol Myers Squibb, focusing on developing novel small molecule therapeutics targeting cancer care. The successful trial of KTX-2001 could mark a pivotal moment in the ongoing battle against prostate cancer. For those interested in learning more, the company's website provides additional information about their innovative research and potential treatment options for patients worldwide.

For further updates on the clinical trial, new therapeutic insights, and company developments, keep an eye out for future announcements from K36 Therapeutics.