Oncternal Announces Enrollment Completed and Dosing Initiated for Sixth Dose Cohort of Phase 1/2 Study of ONCT-534 for the Treatment of R/R Metastatic Castration-Resistant Prostate Cancer
Oncternal Therapeutics (Nasdaq: ONCT) has announced significant progress in its Phase 1/2 study of ONCT-534, a dual-action androgen receptor inhibitor (DAARI) for treating metastatic castration-resistant prostate cancer. The company has completed enrollment and initiated dosing for the sixth dose cohort, with patients receiving 1200 mg of ONCT-534 orally once daily. This decision followed a review of data from the fifth dose cohort (600 mg daily) by the study's Safety Review Committee.
Key points:
- No dose-limiting toxicities observed to date
- Strong patient demand continues
- Initial update on safety and efficacy expected in Q3 2024
- Update will include data from the 1200 mg dose cohort
- Enrollment completed and dosing initiated for sixth dose cohort in Phase 1/2 study
- No dose-limiting toxicities observed to date
- Strong patient demand for the study
- Safety Review Committee approved progression to higher dose level
- None.
Insights
The completion of enrollment and initiation of dosing for the sixth dose cohort of ONCT-534 in a Phase 1/2 study marks a important milestone in the development of this drug. This study focuses on patients with metastatic castration-resistant prostate cancer (mCRPC) who have relapsed or are refractory to existing androgen receptor pathway inhibitors (ARPI). The progression to a 1200 mg dose suggests that the drug has been tolerated up to this point, an encouraging sign for its safety profile.
Given that the patients are in advanced stages of prostate cancer, the absence of dose-limiting toxicities is significant. It indicates a potentially favorable balance between efficacy and safety, which is critical for patients who have limited treatment options. The upcoming update on safety and efficacy based on prostate-specific antigen (PSA) levels will be pivotal. PSA levels are a well-established biomarker in prostate cancer management, often used to gauge the effectiveness of treatment. A positive result in this biomarker can provide early evidence of clinical benefit, which would be a promising development for both patients and investors.
As prostate cancer remains a leading cause of cancer-related death among men, a novel and effective treatment like ONCT-534 could have substantial implications for the oncology landscape. However, it is important to approach these early findings with cautious optimism, as Phase 1/2 trials are primarily designed to assess safety and preliminary efficacy. The true clinical benefit will need to be confirmed in later-stage trials.
From a financial perspective, the progression of Oncternal Therapeutics' clinical trial for ONCT-534 is an optimistic signal for investors. The swift enrollment and lack of dose-limiting toxicities suggest a potential for the drug to advance smoothly through clinical phases, which can expedite the path to market. This could lead to significant revenue streams if the drug proves effective, especially given the high unmet need in mCRPC treatment.
However, investors should be aware of the risks. Early-stage clinical trials often face challenges and initial positive signals do not always translate into successful outcomes in later stages. It's important to monitor the upcoming safety and efficacy updates closely, as these will provide more concrete data on the drug's potential market viability.
Oncternal Therapeutics' stock may experience volatility as new data is released, so it’s important for investors to stay informed and be prepared for fluctuations. Long-term investors should focus on the broader development pipeline and strategic direction of the company, while short-term investors might look for trading opportunities based on trial results and announcements.
The advancement of ONCT-534 into higher dosing for mCRPC patients represents a strategic move in a competitive oncology market. The lack of dose-limiting toxicities and strong patient demand noted so far are positive indicators of the drug’s potential acceptance in the market. If ONCT-534 continues to show favorable results, it could position Oncternal Therapeutics as a key player in the prostate cancer treatment space.
The mCRPC market is substantial, given the high incidence and recurrence rates of prostate cancer. The introduction of a novel dual-action androgen receptor inhibitor could address a significant unmet need, potentially capturing a sizable market share if the drug is approved. It’s essential for investors to consider the competitive landscape, including existing treatments and other drugs in development, as this can influence the commercial potential of ONCT-534.
Moreover, strategic partnerships or acquisitions could be on the horizon if ONCT-534 demonstrates strong enough data, which might further enhance Oncternal’s market position and financial standing. Investors should keep an eye on these developments as they could affect the company’s valuation and market dynamics.
SAN DIEGO, July 15, 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 sixth 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 sixth cohort are receiving ONCT-534, the company’s dual-action androgen receptor inhibitor (DAARI), at a dose of 1200 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 fifth dose level of 600 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 1200 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. 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 earlier 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 and dosing in six dose cohorts for the treatment of patients 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
FAQ
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