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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) has initiated twice daily (BID) dosing at 550mg in its ABOYA-119 Phase 1/2a clinical trial of ATRN-119, the first macrocyclic ATR inhibitor in clinical trials. The study, which previously tested once-daily doses from 50 to 800mg, now includes a protocol amendment for BID dosing starting at 550mg twice daily (1,100mg total daily dose).
The strategic shift to BID dosing aims to maintain optimal therapeutic levels over 24 hours, potentially enhancing efficacy and accelerating the path to regulatory approval. The trial continues to evaluate ATRN-119 as monotherapy in patients with advanced solid tumors having DNA damage response gene mutations. The Phase 1 readout is anticipated in the second half of 2025.
Aprea Therapeutics (NASDAQ: APRE) reported Q3 2024 financial results and provided updates on its clinical pipeline. The company reported preliminary results from Phase 1 ACESOT-1051 trial of WEE1 inhibitor APR-1051, showing good tolerability. Cash position stands at $26.2 million as of September 30, 2024, providing runway for at least 12 months. Q3 operating loss was $4.1 million with net loss of $3.8 million ($0.64 per share). Active enrollment continues in both ACESOT-1051 and ABOYA-119 trials, with preliminary efficacy data from ACESOT-1051 expected in H1 2025.
Aprea Therapeutics (APRE) presented preliminary safety results for its WEE1 inhibitor APR-1051 at the EORTC-NCI-AACR Symposium. The Phase 1 ACESOT-1051 trial is evaluating APR-1051 as monotherapy in advanced solid tumors. Data from two of three enrolled patients show the drug is safe and well-tolerated with no hematologic toxicity. All adverse events were Grade 1 and 2, with no QT prolongation observed. The trial is actively enrolling at three U.S. sites, with planned doses ranging from 10mg to 150mg daily. The study consists of two parts: dose escalation (up to 39 patients) and dose optimization (up to 40 patients).
Aprea Therapeutics (Nasdaq: APRE), a clinical-stage biopharmaceutical company specializing in precision oncology through synthetic lethality, has announced its participation in the Maxim 2024 Healthcare Virtual Summit. Dr. Oren Gilad, President and CEO of Aprea, will be presenting at two sessions during the event, which is scheduled from October 15 to 17, 2024.
The first presentation will be part of the Precision and Immune Oncology Panel on Wednesday, October 16, from 2:00 - 3:00 PM ET. This will be followed by a Fireside Chat on Thursday, October 17, from 3:30 - 4:00 PM ET. The conference will be hosted live on M-Vest, and interested parties can access the presentations by signing up for M-Vest membership.
Aprea Therapeutics (Nasdaq: APRE) announced that four abstracts have been accepted for poster presentation at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain, from October 23-25, 2024. The posters showcase progress in Aprea's oncology pipeline of DNA damage response (DDR) inhibitors, featuring updates on two clinical-stage candidates: APR-1051 and ATRN-119.
The presentations include two clinical posters on the safety and efficacy of APR-1051 (a WEE1 inhibitor) and ATRN-119 (a novel macrocyclic ATR inhibitor) in patients with advanced cancers. Additionally, two preclinical posters will be presented, focusing on APR-1051's favorable characteristics for treating CCNE1-overexpressing cancers and the development of macrocyclic ATR inhibitors for cancer treatment.
Aprea Therapeutics (Nasdaq: APRE) has engaged Philippe Pultar, MD as senior medical advisor to support the development of APR-1051, their potential best-in-class WEE1 inhibitor. Dr. Pultar brings extensive oncology experience, including the development of azenosertib, another WEE1 inhibitor. This aligns with Aprea's commitment to providing top resources for their WEE1 inhibitor program.
The Phase 1 ACESOT-1051 study is ongoing, evaluating APR-1051 in advanced solid tumors with specific gene alterations. Aprea plans to update on this study by year-end 2024. The WEE1 program is part of Aprea's DDR-targeted therapeutics portfolio, aiming to deliver precision medicine solutions.
Dr. Pultar expressed excitement about APR-1051's potential, citing its differentiated profile and compelling pre-clinical data. Aprea's CEO, Oren Gilad, Ph.D., highlighted Dr. Pultar's expertise as valuable for advancing their WEE1 program. Concurrently, Dr. Nadeem Mirza will step down as Chief Medical Officer, effective October 9, 2024.
Halda Therapeutics, a biotech company developing RIPTAC™ (Regulated Induced Proximity TArgeting Chimeras) therapeutics for cancer, has appointed Christian Schade as President, CEO, and Board member. Schade brings over 20 years of pharma and biotech industry experience, including leadership in clinical pipeline development and value-creating deals. Tim Shannon continues as Board Chairman.
Schade's appointment comes as Halda prepares to enter clinical trials, with the first RIPTAC therapeutic expected to begin trials in the first half of 2025. The company is focusing on developing therapies for prostate and breast cancer. Schade's previous roles include CEO of Aprea Therapeutics, Growth Partner at Flagship Pioneering, and executive positions at Novira, Omthera Pharmaceuticals, and Medarex.
Aprea Therapeutics (Nasdaq: APRE), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, has announced its participation in the Lytham Partners Fall 2024 Investor Conference on October 1, 2024. The event will be held virtually, featuring:
1. A webcasted presentation by Oren Gilad, Ph.D., President and CEO, at 12:30pm ET.
2. One-on-one meetings with investors throughout the event.
The webcast can be accessed via the conference home page or a direct link, and will be available for replay after the event. Investors interested in arranging meetings with management can contact Lytham Partners or register through the provided link.
Aprea Therapeutics (Nasdaq: APRE), a clinical stage biopharmaceutical company focusing on precision oncology through synthetic lethality, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for September 9-11, 2024 in New York, NY.
Dr. Oren Gilad, President and CEO of Aprea, will deliver a corporate update during the conference. The presentation will be available on-demand starting at 7:00 A.M. (ET) on September 9, 2024, and will remain accessible for 90 days. Interested parties can access the webcast through the provided link.
Additionally, Aprea's management team will be available for one-on-one meetings with institutional investors during the conference. Attendees interested in scheduling a meeting are advised to contact their conference representative.
Aprea Therapeutics (Nasdaq: APRE), a clinical stage biopharmaceutical company focusing on precision oncology through synthetic lethality, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for September 9-11, 2024 in New York, NY.
Dr. Oren Gilad, President and CEO of Aprea, will deliver a corporate update during the conference. The presentation will be available on-demand starting at 7:00 A.M. (ET) on September 9, 2024, and will remain accessible for 90 days. Interested parties can access the webcast through a provided link.
Additionally, Aprea's management team will be available for one-on-one meetings with institutional investors during the conference. Attendees interested in scheduling a meeting are advised to contact their conference representative.
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