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Aprea Therapeutics, Inc. (NASDAQ: APRE) is a clinical-stage biopharmaceutical company headquartered in Doylestown, Pennsylvania, focused on precision oncology through synthetic lethality. The company’s pioneering research aims to develop and commercialize cancer therapeutics that target the DNA damage response (DDR) pathways. Aprea's lead product candidate, ATRN-119, is a macrocyclic ATR inhibitor designed for treating solid tumors with DDR-related gene mutations. This inhibitor is currently in a Phase 1/2a clinical trial and has shown promising preliminary data, being well tolerated with no dose-limiting toxicities.
Another key candidate, APR-1051, is a highly selective WEE1 kinase inhibitor. The company recently received FDA clearance for an Investigational New Drug (IND) application for APR-1051, enabling the initiation of a Phase 1 clinical trial aimed at treating cancers that overexpress Cyclin E, including ovarian and breast cancers. Preclinical studies have demonstrated APR-1051's potential low toxicity and high selectivity, making it a candidate for best-in-class treatment.
Aprea’s commitment to advancing precision oncology is underscored by recent financial results and corporate developments. For instance, as of March 31, 2024, the company reported $32.4 million in cash and cash equivalents. Notably, Aprea has secured a private placement financing of up to $34 million to support its ongoing and upcoming clinical trials. Furthermore, Aprea’s strong leadership team, including newly appointed Chief Medical Officer Dr. Nadeem Q. Mirza, continues to drive the company’s strategic initiatives.
Recent achievements include the presentation of promising preclinical and clinical data at major conferences such as the AACR Annual Meeting. These presentations highlighted the potential of ATRN-119 and APR-1051 in treating cancers with specific genetic mutations, reinforcing Aprea’s potential to fill significant unmet medical needs in oncology.
For more detailed information about Aprea Therapeutics and its innovative approaches to cancer treatment, please visit their website at www.aprea.com.
Aprea Therapeutics (Nasdaq: APRE) reported Q2 2024 financial results and provided a business update. Key highlights include:
1. Enrollment began in the ACESOT-1051 Phase 1 trial for APR-1051, a WEE1 kinase inhibitor, with no myelosuppression observed in the first cohort.
2. Cash position of $28.7 million as of June 30, 2024, with runway extended into Q4 2025.
3. Q2 2024 operating loss of $3.8 million, compared to $3.7 million in Q2 2023.
4. Net loss of $3.5 million ($0.58 per basic share) for Q2 2024.
5. Ongoing progress in ABOYA-119 trial for ATRN-119, an ATR inhibitor.
6. Appointment of Nadeem Q. Mirza as Chief Medical Officer.
Aprea Therapeutics will host a virtual Key Opinion Leader (KOL) event on Monday, June 24, 2024, at 9:00 AM ET to discuss APR-1051, a highly selective, potentially best-in-class oral WEE1 inhibitor. The event will feature experts Joseph Vacca, PhD, and Eric J. Brown, PhD, who will delve into the drug's medicinal chemistry history, selective design, and preclinical findings.
APR-1051 targets WEE1, an enzyme important to the DNA damage response pathway, making it a validated oncology target. The drug is designed to minimize off-target toxicity and is currently being evaluated in the Phase 1 ACESOT-1051 trial for patients with significant unmet medical needs, including those with Cyclin E overexpression. The event will also include a live Q&A session.
Joseph Vacca, a seasoned medicinal chemist with significant contributions to several approved drugs, and Eric J. Brown, an expert on replication stress response, will lead the discussions. This event aims to provide a comprehensive overview of APR-1051 in the context of emerging WEE1 inhibitors while highlighting its potential benefits and ongoing research.
Aprea Therapeutics has announced the dosing of the first patient in the ACESOT-1051 Phase 1 trial for their oral WEE1 inhibitor, APR-1051. This study is evaluating APR-1051 as a monotherapy for patients with advanced solid tumors who have unmet medical needs. APR-1051, developed by Aprea, targets the WEE1 kinase, an enzyme involved in the DNA damage response pathway. The trial will assess safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy over 28-day cycles. The first part involves dose escalation, while the second part focuses on dose optimization. The trial aims to confirm APR-1051's safety and determine the recommended Phase 2 dose. Updates are expected by year-end 2024 with preliminary efficacy data in 2025.
Aprea Therapeutics announced that the Safety Review Committee (SRC) has approved dosing patients with ATRN-119 at 800 mg once daily in the ongoing ABOYA-119 clinical trial. ATRN-119, the first macrocyclic ATR inhibitor in clinic trials, has demonstrated a favorable safety profile through five dosage levels (up to 550 mg) with no dose-limiting toxicities. This advancement allows for Cohort 6 enrollment and positions Aprea to complete dose escalation and potentially release initial efficacy data by the second half of 2024. Clinical data show increasing systemic drug exposure with higher doses, and preliminary benefits observed in the trial include stable disease in two patients. The Phase 1 dose escalation is expected to conclude by the fourth quarter of 2024, with a recommended Phase 2 dosage to be identified by early 2025. Further Phase 2a cohort studies will begin in early 2025, aiming to evaluate ATRN-119's efficacy in advanced solid tumors with specific DDR pathway mutations.
Aprea Therapeutics (NASDAQ: APRE) announced FDA clearance for their new oral WEE1 inhibitor, APR-1051, and plans to initiate Phase 1 clinical trials in June 2024. Their ATR inhibitor, ATRN-119, is progressing in the ABOYA-119 trial, with initial efficacy data expected in 2H 2024. The company presented four posters at the AACR Annual Meeting, including updates on these key programs. Aprea has $32.4 million in cash as of March 31, 2024, and recently raised up to $34 million through a private placement. First-quarter 2024 results showed an operating loss of $3.1 million, down from $4.6 million in the same period of 2023, and net loss narrowed to $2.8 million. R&D expenses increased to $1.6 million, while G&A expenses decreased to $1.9 million. They also appointed Nadeem Q. Mirza, M.D., as Chief Medical Officer, effective May 1, 2024.
Aprea Therapeutics (Nasdaq: APRE), a clinical stage biopharmaceutical company specializing in precision oncology, announced its participation in the 2024 RBC Capital Markets Global Healthcare Conference. The event is scheduled for May 14-15, 2024, in New York, NY. Management will be available for one-on-one meetings during the conference. Interested parties can arrange meetings through their conference representative.
Aprea Therapeutics, Inc. announces the appointment of Dr. Nadeem Q. Mirza as Chief Medical Officer, strengthening its leadership team. Dr. Mirza brings extensive experience in oncology and drug development, enhancing Aprea's clinical pipeline. The company also grants Dr. Mirza stock options and restricted stock units as inducement for his appointment.
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