Oncternal Announces Enrollment Completed and Dosing Initiated for Fifth Dose Cohort of Phase 1/2 Study of ONCT-534 for the Treatment of R/R Metastatic Castration-Resistant Prostate Cancer
Oncternal Therapeutics announced the completion of enrollment and initiation of dosing for the fifth dose cohort in its Phase 1/2 study of ONCT-534. This study targets patients with metastatic castration-resistant prostate cancer who have relapsed or are refractory to current androgen receptor pathway inhibitors (ARPI). The fifth cohort patients will receive a 600 mg daily dose of ONCT-534, following a safety review of the 300 mg dose cohort which showed no dose-limiting toxicities. Initial safety and efficacy results, focusing on prostate-specific antigen (PSA) levels, will be available in Q3 2024.
The company reports strong patient demand and continued site expansion for the study. The Chief Medical Officer, Salim Yazji, M.D., expressed optimism about the drug's tolerability and the forthcoming detailed clinical data.
- Enrollment completed and dosing initiated for fifth dose cohort in Phase 1/2 study of ONCT-534.
- No dose-limiting toxicities observed in the 300 mg dose cohort.
- Strong patient demand and continued site expansion for the study.
- Initial update on safety and efficacy expected in Q3 2024.
- Clinical data from the 600 mg dose cohort will not be available until Q3 2024, potentially delaying investor decisions.
- Study is still in early phases (Phase 1/2), indicating that ONCT-534 is years away from potential market approval.
Insights
Oncternal Therapeutics' announcement about the completion of enrollment and initiation of dosing for the fifth dose cohort in their Phase 1/2 study of ONCT-534 is a noteworthy milestone in their drug development pipeline for metastatic castration-resistant prostate cancer (mCRPC). ONCT-534 targets patients who have not responded to existing androgen receptor pathway inhibitors, a significant challenge in oncology. By reaching the 600 mg dose level without dose limiting toxicities, the drug shows promise in its safety profile, which is a important factor in early-stage clinical trials. Investors should be attentive to the upcoming safety and efficacy data in Q3 2024, as positive results could significantly enhance the drug's potential market value. The rapid enrollment and patient demand also suggest a strong interest in this treatment, reflecting a gap in effective therapies for this patient population.
Rating: 1
The initiation of the fifth dose cohort of ONCT-534 is an important step in addressing the unmet needs of mCRPC patients who have become refractory to standard treatments. Metastatic castration-resistant prostate cancer is a difficult-to-treat condition with limited options once resistance to androgen receptor inhibitors develops. The progression to a 600 mg dose suggests a careful and positive safety evaluation by the Safety Review Committee, highlighting the potential for this drug to offer a new line of defense. Investors should monitor not just the efficacy data related to PSA levels but also long-term outcomes in terms of patient survival and quality of life. Any significant improvements in these areas could translate into high demand and adoption in clinical settings, which would be important for the drug's success and profitability.
Rating: 1
SAN DIEGO, May 30, 2024 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that enrollment has been completed and dosing initiated for the fifth dose cohort of its Phase 1/2 study of ONCT-534 for the treatment of patients with metastatic castration-resistant prostate cancer who are relapsed or refractory to approved androgen receptor pathway inhibitors (ARPI). Patients in the fifth cohort are receiving ONCT-534, the company’s dual-action androgen receptor inhibitor (DAARI), at a dose of 600 mg taken orally once each day. The decision to proceed to this higher dose level was made by the study’s Safety Review Committee (SRC) after reviewing data from the fourth dose level of 300 mg ONCT-534 daily. An initial update on ONCT-534 safety and efficacy based on prostate-specific antigen (PSA) levels from this study is expected in the third quarter of 2024 and will include data from this 600 mg dose cohort.
“We are encouraged by the rapid enrollment in the dose escalation portion of our Phase 1/2 study with ONCT-534. The drug has been well tolerated, with no dose limiting toxicities observed to date. We continue to open new sites and patient demand continues to be strong,” said Salim Yazji M.D., Chief Medical Officer at Oncternal Therapeutics. “We are looking forward to sharing initial safety and efficacy data soon, which will include a larger, more robust set of clinical and biomarker results, as well as longer follow-up from the initial dosing cohorts.”
About Study ONCT-534-101
Study ONCT-534-101 is a Phase 1/2, single-arm, open-label, multi-center study to evaluate the safety and tolerability, pharmacokinetics, and preliminary anti-tumor activity of ONCT-534 in patients with mCRPC who have relapsed or are refractory to approved ARPIs including enzalutamide, abiraterone, apalutamide, and darolutamide. After the safety and tolerability and preliminary antitumor activity of ONCT-534 have been assessed in Phase 1, Phase 2 will commence to further evaluate the safety and antitumor activity of ONCT-534 to support selecting an optimal dose.
About Oncternal Therapeutics
Oncternal Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies for the treatment of patients with cancers that have critical unmet medical need. Oncternal pursues drug development targeting promising, yet untapped biological pathways implicated in cancer generation or progression, focusing on hematological malignancies and prostate cancer. ONCT-534 is an investigational dual-action androgen receptor inhibitor (DAARI) with demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR aberration. It is a potential treatment for patients with mCRPC with unmet medical need because of resistance to androgen receptor pathway inhibitors, including those with AR amplification, mutations in the AR ligand binding domain (LBD), or splice variants with loss of the AR LBD. Study ONCT-534-101 (NCT05917470) has completed enrollment in four dose cohorts and continues to enroll and dose patients for treatment with mCRPC. ONCT-808 is an investigational autologous chimeric antigen receptor T (CAR T) cell therapy that targets Receptor Tyrosine Kinase-Like Orphan Receptor 1 (ROR1) using the binding domain from zilovertamab. ONCT-808 has demonstrated activity in preclinical models against multiple hematological malignancies and solid tumors and has been shown to be specific for cancer cells expressing ROR1. Oncternal has developed a robust and reproducible manufacturing process that has the potential to reduce the time patients must wait for their individual CAR T therapy to be produced, compared with currently approved CAR T products. Oncternal has dosed patients under Study ONCT-808-101 (NCT05588440) with relapsed or refractory aggressive B-cell lymphoma, including patients who have failed previous CD19 CAR T treatment. Zilovertamab is an investigational monoclonal antibody designed to inhibit the function of ROR1. Zilovertamab has been evaluated in a Phase 1/2 Study CIRM-0001 (NCT03088878) in combination with ibrutinib for the treatment of patients with mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL) and marginal zone lymphoma (MZL), which resulted in
Forward-Looking Information
Oncternal cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on Oncternal’s current beliefs and expectations. Forward-looking statements include statements regarding anticipated timing for study enrollment and announcing clinical data. Forward-looking statements are subject to risks and uncertainties inherent in Oncternal’s business, including risks associated with the clinical development and process for obtaining regulatory approval of Oncternal’s product candidates, such as potential delays in the commencement, enrollment and completion of clinical trials; the risk that interim results of a clinical trial do not predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues, and as more patient data become available; and other risks described in Oncternal’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Oncternal undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contact Information:
Investors
Richard Vincent
858-434-1113
rvincent@oncternal.com
Media
Corey Davis, Ph.D.
LifeSci Advisors
212-915-2577
cdavis@lifesciadvisors.com
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