DOYLESTOWN, Pa. - Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company, has announced progression in its ABOYA-119 clinical trial involving the cancer drug ATRN-119, which is now proceeding to a higher dosage phase. After the Safety Review Committee reviewed safety and pharmacokinetic data from the 550 mg once daily cohort, dosing at 800 mg has been approved to begin.
ATRN-119 is a macrocyclic ATR inhibitor, a drug designed for precision oncology treatments, specifically targeting cancers with mutations in DNA damage response (DDR) pathways. These mutations are associated with a high unmet medical need and poor patient prognosis. ATRN-119 has shown a favorable safety and tolerability profile in the initial phases of the trial, with no dose limiting toxicities identified.
The ongoing Phase 1/2a trial aims to determine the drug's tolerability, pharmacokinetics, and recommended Phase 2 dose, along with an analysis of patient biomarkers. Aprea anticipates completing the dose escalation part of the study by the fourth quarter of 2024 and announcing initial human efficacy data in the second half of the same year.
To date, 17 patients have been enrolled in the trial's dose escalation stage, with preliminary signs of clinical benefit observed in two patients who achieved stable disease. The company has submitted an amendment to the FDA to include additional cohorts with higher dosages, aiming to dose patients in up to eight cohorts in total.
The trial has been featured at the AACR Annual Meeting, where new pharmacokinetic data indicated that plasma concentrations of ATRN-119 are reaching the expected therapeutic range at dose levels of 550 mg and above. The full data from the AACR presentation can be found on the Aprea corporate website.
Aprea Therapeutics is focused on developing treatments for solid tumor indications through synthetic lethality, an approach that targets specific vulnerabilities in cancer cells. The company's lead program is ATRN-119, and it has also completed IND enabling studies for its WEE1 inhibitor, APR-1051, which recently received FDA IND clearance.
This update on Aprea's clinical trial is based on a press release statement and reflects the company's ongoing efforts to develop new therapies for cancer patients with limited treatment options. The completion of the Phase 1 dose escalation and the expected determination of the recommended Phase 2 dose are significant milestones in the development of ATRN-119.
InvestingPro Insights
Aprea Therapeutics, Inc. (NASDAQ:APRE) continues to make strides in its clinical trials, but what do the numbers say about the company's financial health and market performance? With a market capitalization of 28.77 million USD, the company remains a smaller player in the biopharmaceutical industry. Analysts who follow Aprea have highlighted a few key points that potential investors should consider.
One of the InvestingPro Tips is that Aprea holds more cash than debt on its balance sheet, which can be a positive sign of financial stability. This could provide the company with the necessary resources to fund ongoing research and development activities without the immediate pressure of debt repayments. Moreover, analysts anticipate sales growth in the current year, suggesting that there may be optimism around Aprea's revenue prospects.
Still, it is not all smooth sailing. The company is quickly burning through cash, and suffers from weak gross profit margins, as indicated by a gross profit margin of -691.4% for the last twelve months as of Q1 2024. Moreover, Aprea has not been profitable over the last twelve months, with an adjusted P/E ratio of -2.26, which reflects the challenges it faces in achieving profitability.
Investors looking for capital gains might find Aprea's recent market performance of interest. The company has experienced a large price uptick over the last six months, with a 41.31% total return, and a one-year price total return of 55.85%. However, it's vital to note that Aprea does not pay a dividend to shareholders, which means that investment returns would solely depend on stock price appreciation.
For those considering an investment in Aprea Therapeutics, the InvestingPro Tips and real-time metrics provided here can offer a snapshot of the company's financial situation and market performance. To delve deeper into these insights and access additional tips, check out InvestingPro at https://www.investing.com/pro/APRE. Remember, you can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription. There are 10 additional tips listed in InvestingPro that could further inform your investment decisions.
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