Aprea Therapeutics Announces FDA Clearance of IND for APR-1051, its Next Generation WEE1 Kinase Inhibitor for Cyclin E Overexpressing Cancers
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Insights
The advancement of APR-1051 into a Phase 1 clinical trial represents a significant milestone in the treatment of Cyclin E overexpressing cancers, such as breast and ovarian cancers. Cyclin E is a protein involved in cell cycle regulation and its overexpression can lead to uncontrolled cell proliferation, a hallmark of cancer. The selectivity of APR-1051 for the WEE1 kinase, which plays a crucial role in DNA damage response, suggests a targeted approach that may limit damage to healthy cells. This specificity could be particularly beneficial for patients who have not responded to conventional therapies.
From a medical perspective, the potential absence of QT prolongation—a common side effect that can lead to cardiac arrhythmias—is notable. QT prolongation is a significant concern with many cancer treatments and a drug that offers significant efficacy without this side effect would be a considerable advancement. Furthermore, the promising preclinical pharmacokinetic properties suggest that APR-1051 could maintain adequate drug levels in the body with potentially fewer doses, which could improve patient compliance and quality of life.
The FDA's clearance of the IND for APR-1051 is a pivotal regulatory step that allows Aprea Therapeutics to proceed with human trials, which is essential for determining the drug's safety and efficacy in a clinical setting. The focus on synthetic lethality, a concept where two gene deficiencies can lead to cell death but one alone does not, could position APR-1051 as a novel therapeutic option in precision oncology. The differentiation from other WEE1 inhibitors in terms of molecular structure and selectivity indicates a potentially improved therapeutic index and a reduced risk of side effects associated with off-target activity.
Investors and stakeholders should monitor the progress of the ACESOT-1051 trial closely, as positive preliminary results could lead to significant stock valuation changes for Aprea. However, it is crucial to consider that drug development is inherently risky and the transition from preclinical to clinical efficacy is uncertain. Additionally, the competitive landscape of oncology treatments is rapidly evolving and the emergence of new treatments could impact the potential market share of APR-1051.
The initiation of the Phase 1 trial for APR-1051 has implications for Aprea Therapeutics' financial outlook. Clinical trials are costly and the progression into human testing will likely increase the company's R&D expenditures in the short term. However, the market for breast and ovarian cancer treatments is substantial and a successful WEE1 inhibitor could capture a significant portion of this market, leading to long-term revenue growth.
Investors should be aware that the timeline for drug development can be protracted, with an update from the trial not expected until Q4 2024. The investment in APR-1051 will require patience and the stock may experience volatility as the market reacts to interim updates and data releases. It is also important to consider the company's cash runway and its ability to fund operations through the trial period without diluting current shareholders' equity. Strategic partnerships or licensing deals may become necessary and could alter the financial landscape for Aprea.
Company plans to initiate Phase 1 ACESOT-1051 (A Multi-Center Evaluation of WEE1 Inhibitor in Patients with Advanced Solid Tumors, APR-1051) clinical trial evaluating, highly selective, oral WEE1 inhibitor, for monotherapy treatment of Cyclin E overexpressing cancers including breast and ovarian cancers
Update from the ACESOT-1051 clinical trial expected in Q4 2024
DOYLESTOWN, Pa., March 11, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application (IND 169359) for APR-1051.
“APR-1051 is a next-generation inhibitor of WEE1 kinase and, based on its unique characteristics, we believe it will be best in class,” said Dr. Oren Gilad, President and CEO of Aprea. “The FDA's clearance of our IND is a critical step in the APR-1051 development program. We look forward to evaluating therapeutic activity in patients, focusing on Cyclin E overexpressing cancers, including ovarian and breast cancers.”
Based on preclinical studies, APR-1051 is differentiated from other WEE1 inhibitors in its:
- Molecular structure;
- Selectivity for WEE1 versus off-target inhibition of the polo-like kinase, or PLK, family of kinases;
- Potentially superior pharmacokinetic (PK) properties;
- Potential absence of QT prolongation at doses that significantly inhibit WEE1*
APR-1051 was discovered and preclinically evaluated by Aprea’s team of chemists and scientists. Aprea has conducted extensive pre-clinical studies with APR-1051, which have demonstrated that the molecule has potent anti-tumor activity, along with a favorable pharmacokinetic (PK) profile. Additionally, pre-clinical data show that APR-1051 may demonstrate less toxicity than other WEE1 inhibitors.*
Clearance of the IND application will allow Aprea to initiate the Phase 1 ACESOT-1051 dose escalation trial to evaluate the safety, tolerability, and preliminary efficacy of APR-1051. Enrollment of the first patient in this study is expected in the first half of 2024 with an update expected in the fourth quarter of the year.
* No head-to-head studies have been conducted with APR-1051
About Aprea
Aprea Therapeutics, Inc. is a clinical-stage biopharmaceutical company headquartered in Doylestown, Pennsylvania, focused on precision oncology through synthetic lethality. The Company’s lead program is ATRN-119, a clinical-stage small molecule ATR inhibitor in development for solid tumor indications. Aprea has received FDA clearance on an IND to begin clinical studies of APR-1051, its oral, small molecule WEE1 inhibitor. For more information, please visit the company website at www.aprea.com.
The Company may use, and intends to use, its investor relations website at https://ir.aprea.com/ as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.
Forward-Looking Statement
Certain information contained in this press release includes “forward-looking statements”, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended related to our study analyses, clinical trials, regulatory submissions, and projected cash position. We may, in some cases use terms such as “future,” “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “targeting,” “confidence,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team and on information currently available to management that involve risks, potential changes in circumstances, assumptions, and uncertainties. All statements contained in this press release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize, and achieve market acceptance of our current and planned products and services, our research and development efforts, including timing considerations and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. Any or all of the forward-looking statements may turn out to be wrong or be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. These forward-looking statements are subject to risks and uncertainties including, without limitation, risks related to the success, timing, and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of our ongoing clinical trials, our ability to continue as a going concern, our understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs, and the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release. We undertake no obligation to update such forward-looking statements for any reason, except as required by law.
Investor Contact:
Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com
FAQ
What is the purpose of the Phase 1 ACESOT-1051 clinical trial for APR-1051?
What are the unique characteristics of APR-1051 compared to other WEE1 inhibitors?
When is the enrollment of the first patient in the Phase 1 trial expected?
Who discovered and preclinically evaluated APR-1051?
What has preclinical studies shown about APR-1051?
