SAN DIEGO - Oncternal Therapeutics, Inc. (NASDAQ: ONCT), a clinical-stage biopharmaceutical company, announced updated results from its Phase 1/2 study of ONCT-534 for treating metastatic Castration-Resistant Prostate Cancer (mCRPC). The study, which included two additional dosing cohorts with twice-daily oral administration of ONCT-534, showed the drug was well tolerated, with no related Grade 3 or higher toxicities reported as of September 30, 2024.
In the study, fifteen patients received ONCT-534 once daily in six dosing cohorts, and six patients received the drug twice daily in two dosing cohorts. Notably, one patient with a rising PSA level on a 160 mg twice-daily dose experienced a 50% reduction in PSA after four weeks on a 300 mg dose. Concurrently, a CAT Scan revealed a 16% reduction in target lesions compared to baseline.
Additionally, circulating tumor cell (CTC) analysis indicated promising effects on the expression of androgen receptor (AR)-regulated genes and AR nuclear translocation in six patients. Some patients who did not respond to ONCT-534 exhibited neuroendocrine features in their prostate cancer, which are linked to AR-independent disease.
Despite the decision to discontinue the ONCT-534-101 clinical trial due to the current biotechnology environment, these results highlight ONCT-534's potential in prostate cancer treatment. James Breitmeyer, M.D., Ph.D., President and CEO of Oncternal, expressed belief in the value of further exploring twice-daily dosing and the application of ONCT-534 in earlier treatment lines for advanced prostate cancer.
Oncternal is actively seeking strategic alternatives for its product candidates, including ONCT-534, to maximize shareholder value. The company focuses on developing novel oncology therapies for cancers with unmet medical needs, targeting hematological malignancies and prostate cancer.
ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) that has shown preclinical activity in prostate cancer models, including against unmutated AR and various AR mutations and aberrations. The drug is designed for mCRPC patients resistant to current AR pathway inhibitors.
This report is based on a press release statement from Oncternal Therapeutics.
In other recent news, Oncternal Therapeutics has disclosed a significant reduction in its workforce and the discontinuation of certain clinical trials. The company is aiming to decrease operating expenses while exploring business development opportunities for its clinical programs. The workforce reduction, which accounts for approximately 37% of its employees, was unanimously approved by the board of directors. The company estimates charges around $1.0 million due to severance and related costs, mostly expected to be recognized in the third quarter of 2024.
Oncternal has also announced the cessation of its clinical trials for ONCT-534 and ONCT-808, treatments for metastatic castration-resistant cancer and aggressive B-cell lymphoma respectively. The company is now investigating strategic alternatives to maximize shareholder value, which may include asset sales, licensing, mergers, or other business combinations. During this process, all product development activities will be halted and further cost reductions will be implemented.
The recent developments also include the departure of Chief Medical Officer Dr. Salim Yazji, effective October 1, 2024. Despite these changes, Oncternal's forward-looking statements caution that there is no guarantee of successful strategic transactions or continued operations.
InvestingPro Insights
Oncternal Therapeutics' recent clinical trial results for ONCT-534 come at a time when the company is facing significant financial challenges. According to InvestingPro data, Oncternal's market capitalization stands at a modest $6.19 million, reflecting the company's current struggles in the biotechnology sector.
Despite the promising clinical results, InvestingPro Tips highlight that Oncternal is not profitable over the last twelve months and analysts do not anticipate the company will be profitable this year. This aligns with the company's decision to discontinue the ONCT-534-101 clinical trial due to the challenging biotechnology environment.
However, it's not all negative for Oncternal. An InvestingPro Tip indicates that the company holds more cash than debt on its balance sheet, which could provide some financial flexibility as it seeks strategic alternatives for its product candidates. Additionally, the company has seen a significant return over the last week, with a 72.73% price total return, possibly reflecting market optimism about the latest clinical trial results.
For investors considering Oncternal's potential, it's worth noting that the stock generally trades with high price volatility. This is evident in the contrasting short-term and long-term performance metrics: while the 1-month price total return is 36.6%, the 6-month return shows a substantial decline of -75.56%.
These insights offer a more comprehensive view of Oncternal's financial position and market performance, complementing the clinical progress reported in the article. For those interested in a deeper analysis, InvestingPro offers 13 additional tips for Oncternal Therapeutics.
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