Oncternal Therapeutics Enrolls Patients into the Third Dosing Cohort of its Phase 1/2 Study of ONCT-534 for the Treatment of R/R Metastatic Castration-Resistant Prostate Cancer
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Insights
The enrollment of the fourth patient into Oncternal Therapeutics' Phase 1/2 study of ONCT-534 represents a critical step in the clinical development of this potential new treatment for advanced prostate cancer. The study's adaptive Bayesian Optimal Interval (BOIN) design is noteworthy, as it allows for a more flexible approach to determining the optimal dosing by using statistical probabilities to guide decisions. This design can potentially reduce the number of patients exposed to subtherapeutic or toxic doses, thereby increasing the efficiency of the dose-finding process.
From a medical research perspective, the progression to the third dosing cohort indicates a satisfactory safety profile at the lower doses, as determined by the Safety Review Committee (SRC). The incremental dosing strategy, starting at 40 mg and advancing to 160 mg, is a prudent approach to characterizing the drug's pharmacodynamics and pharmacokinetics. The enthusiasm of the ONCT-534-101 investigators suggests a positive outlook on the drug's potential efficacy and safety, although it is important to remain cautious until more comprehensive data is available.
For stakeholders, the advancement of ONCT-534 through clinical trials could signal a promising addition to the limited treatment options for patients with advanced prostate cancer, particularly those who are relapsed or refractory to current ARPIs. The success of this drug could have significant implications for Oncternal Therapeutics' valuation and future revenue streams.
ONCT-534's mechanism as a dual-action androgen receptor inhibitor is particularly significant in the context of advanced prostate cancer. Androgen receptor pathway inhibitors are a cornerstone of treatment for this disease and resistance to these therapies is a common and challenging issue. A dual-action inhibitor could potentially overcome some of the resistance mechanisms by simultaneously targeting different aspects of the androgen receptor signaling pathway.
For patients with advanced prostate cancer, especially those with relapsed or refractory disease, the development of new therapies like ONCT-534 is crucial. These patients have often exhausted other treatment options and a new effective therapy could improve survival rates and quality of life. However, it's essential to consider that the current phase of the study is still early and while the SRC's approval to proceed is a positive sign, efficacy and long-term safety are yet to be established.
The enrollment of the fourth patient into the Phase 1/2 study of ONCT-534 is a small but significant milestone for Oncternal Therapeutics, particularly in a competitive oncology market. The company's focus on a dual-action androgen receptor inhibitor could potentially capture a niche within the prostate cancer segment, especially given the limited treatment options for patients who are relapsed or refractory to current therapies.
Investors and stakeholders typically monitor such developments closely, as they can be early indicators of a drug's progress and potential market impact. While the current trial phase is primarily concerned with safety and dosage optimization, successful results could lead to larger, pivotal trials that, if positive, would pave the way for regulatory approval and commercialization.
It is important for investors to understand the inherent risks and long timelines associated with biopharmaceutical development. The implications for the stock market are often speculative at this stage, but positive trial results could lead to increased investor confidence and an uptick in Oncternal Therapeutics' stock price. Conversely, any setbacks could have an adverse effect. Thus, the progress of ONCT-534 should be monitored as an indicator of the company's future prospects.
SAN DIEGO, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that the fourth patient has now been enrolled into its Phase 1/2 study of ONCT-534, its dual-action androgen receptor inhibitor, for the treatment of patients with advanced prostate cancer who are relapsed or refractory to approved androgen receptor pathway inhibitors (ARPI). The last two patients were enrolled into the third dosing cohort, to receive ONCT-534 at a dose of 160 mg taken orally each day. The study utilizes an adaptive Bayesian Optimal Interval (BOIN) design, under which the first two dosing cohorts treated one patient each at 40 mg ONCT-534 per day and 80 mg ONCT-534 per day, respectively. The decision to proceed to dose level 3 was confirmed by the study’s Safety Review Committee (SRC).
“The ONCT-534-101 investigators are enthusiastic about this study, and we are excited about the enrollment and progress through the initial dosing levels. Reaching the third cohort represents an important milestone for the program, as we believe we are nearing potentially therapeutic doses that may benefit prostate cancer patients who have progressed after treatment with approved ARPI such as enzalutamide, abiraterone, apalutamide and darolutamide,” said Salim Yazji M.D., Chief Medical Officer at Oncternal Therapeutics. “We believe ONCT-534, with its novel mechanism of action involving both the ligand-binding domain and the N-terminal domain of the androgen receptor (AR), may address a significant unmet medical need for patients with advanced metastatic prostate cancer, especially those with splice variants of the AR, mutations in the ligand-binding domain of the AR, or AR amplification, common mechanisms of resistance that may develop to treatment with currently approved AR pathway inhibitors.”
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 the Phase 1 portion of this study, Phase 2 will commence to further evaluate the safety and preliminary 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 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 dosed patients and continues to enroll 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 about the potential of meeting the therapeutic dose in ONCT-534-101. 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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