Aprea Therapeutics Announces Strategic IP Portfolio Evolution in DNA Damage Response (DDR) Cancer Therapeutics

Rhea-AI Summary

Aprea Therapeutics (NASDAQ: APRE) provided an update on its patent portfolio for DNA Damage Response (DDR) cancer therapeutics. The company's ATR inhibitor program is protected by four granted U.S. patents, one pending U.S. application, and one provisional application, along with 19 granted non-U.S. patents and 16 pending non-U.S. applications. These patents expire between 2035-2037, with pending applications potentially extending exclusivity to 2044.

The company's lead ATR inhibitor, ATRN-119, is being evaluated in the ABOYA-119 clinical trial for advanced solid tumors. Additionally, Aprea's WEE1 kinase inhibitor program includes one pending U.S. patent application and 12 pending non-U.S. applications, set to expire in 2043 if granted. The lead WEE1 inhibitor, APR-1051, is currently in Phase 1 clinical trials (ACESOT-1051) for advanced/metastatic solid tumors.

Positive

• Strong patent protection with 23 granted patents globally
• Patent protection extends until 2037, with potential extension to 2044
• Two clinical-stage programs: ATRN-119 and APR-1051
• Additional regulatory exclusivity potential of up to 5 years

Negative

• WEE1 inhibitor patents still pending, not yet granted
• Some patent applications may not be granted, risking future market exclusivity

DOYLESTOWN, Pa., Feb. 05, 2025 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, today provided an update on its existing patent portfolio.

“Our strong patent portfolio reflects our commitment to innovation and leadership in the field of DNA Damage Response therapeutics,” said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. “Intellectual property is an essential component of Aprea’s strategy, enabling us to advance first in class and best in class oncology treatments while protecting the value of our assets. Our commitment to securing global intellectual property rights underscores our long-term vision to develop and commercialize breakthrough therapies for difficult to treat cancers.”

Aprea’s ATR inhibitor program is protected by a strong patent estate, including four granted U.S. patents, one pending U.S. application, and one pending provisional application. There are 19 granted non-U.S. patents and 16 pending non-U.S. patent applications. The granted patents will expire 2035-2037 and the pending applications, if granted, could extend exclusivity into 2044. Additional regulatory exclusivities up to five years may also be available. This portfolio comprehensively covers the program’s proprietary compounds, pharmaceutical compositions, and methods of use. The Company’s lead ATR inhibitor, ATRN-119, is currently being evaluated in the ABOYA-119 clinical trial as monotherapy in patients with advanced solid tumors having at least one mutation in a defined panel of DNA damage response (DDR)-related genes.

The intellectual property covering Aprea’s WEE1 kinase inhibitor program includes one pending U.S. patent application and 12 pending non-U.S. patent applications. The WEE1 family of applications, if granted, will expire in 2043, not including any regulatory exclusivities that may be awarded. The WEE1-portfolio covers key aspects of the program, including proprietary compounds, pharmaceutical compositions, and methods of use. The Company’s lead WEE1 inhibitor, APR-1051, is currently being evaluated in the ACESOT-1051 Phase 1 clinical trial in advanced/metastatic solid tumors harboring certain cancer-associated gene alterations.

About Aprea

Aprea is pioneering a new approach to treat cancer by exploiting vulnerabilities associated with cancer cell mutations. This approach was developed to kill tumors but to minimize the effect on normal, healthy cells, decreasing the risk of toxicity that is frequently associated with chemotherapy and other treatments. Aprea’s technology has potential applications across multiple cancer types, enabling it to target a range of tumors, including ovarian, colorectal, prostate, and breast cancers. The company’s lead programs are APR-1051, an oral, small-molecule inhibitor of WEE1 kinase, and ATRN-119, a small molecule ATR inhibitor, both in clinical development for solid tumor indications. 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 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 and Media Contact:

Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com

FAQ

When do Aprea Therapeutics' (APRE) ATR inhibitor patents expire?

Aprea's granted ATR inhibitor patents expire between 2035-2037, with pending applications potentially extending exclusivity to 2044 if granted.

How many patents does Aprea Therapeutics (APRE) have for its ATR inhibitor program?

Aprea has 4 granted U.S. patents, 19 granted non-U.S. patents, 1 pending U.S. application, and 16 pending non-U.S. patent applications for its ATR inhibitor program.

What clinical trials is Aprea Therapeutics (APRE) currently conducting?

Aprea is conducting the ABOYA-119 trial for ATRN-119 in advanced solid tumors and the ACESOT-1051 Phase 1 trial for APR-1051 in advanced/metastatic solid tumors.

When will Aprea Therapeutics' (APRE) WEE1 inhibitor patents expire?

If granted, Aprea's WEE1 inhibitor patent applications will expire in 2043, not including potential regulatory exclusivities.