APRE Aprea Therapeutics Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
|
APR-246 (eprenetapopt) and azacitidine
TP53 mutant Myelodysplastic syndromes (MDS)
|
Phase 2/3
Phase 2/3
|
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|
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
APR-548
TP53 mutant myelodysplastic syndromes (MDS)
|
Phase 1
Phase 1
|
Phase 1 trial to be initiated.
|
|
APR-246
Solid tumors
|
Phase 1/2
Phase 1/2
|
Phase 1/2 enrollment commenced August 2020.
|
|
APR-246 and venetoclax and rituximab
Chronic lymphoid leukemia (CLL) and Mantle cell lymphoma (MCL)
|
Phase 1
Phase 1
|
Phase 1 enrolment to commence 2H 2020.
|
|
APR-246 and azacitidine
TP53 mutated myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) - post transplant
|
Phase 2
Phase 2
|
Phase 2 enrollment to be completed 3Q 2020.
|
|
APR-246 / venetoclax and azacitidine
TP53 mutant AML
|
Phase 1
Phase 1
|
Phase 1 trial initiated 1Q 2020.
|
Latest News
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BOSTON, Oct. 14, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics to reactivate mutant tumor suppressor protein, p53, today announced the launch of p53reactivation.com. The new website contributes to Aprea's disease awareness initiative to educate healthcare professionals on the importance of p53 mutations in cancer and reactivation of mutant p53 as a potential therapeutic option for the treatment of cancer.
"Mutations in p53 are present in approximately half of all cancers and are often associated with poor treatment outcomes and resistance to traditional anti-cancer therapies," said Eyal Attar, M.D., Senior Vice President and Chief Medical Officer of Aprea Therapeutics. "Knowledge of the poor prognoses that accompany p53 mutations, the availability of diagnostic tests for their identification, and awareness of mutant p53 reactivation as a potential targeted therapeutic option, may collectively advance detection and treatment for cancer patients with this important and significant unmet medical need."
Corporate Contacts:
Scott M. Coiante
Sr. Vice President and Chief Financial Officer
617-463-9385Gregory A. Korbel
Vice President of Business Development
617-463-9385Source: Aprea Therapeutics, Inc.
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BOSTON, Oct. 07, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics Inc., (NASDAQ:APRE), a clinical-stage biotechnology company focused on developing and commercializing novel cancer therapeutics that reactivate mutant p53 tumor suppressor protein, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's Investigational New Drug (IND) application for APR-548 to treat TP53 mutant myelodysplastic syndromes (MDS). APR-548 is a next-generation small molecule reactivator of mutant p53 that is being developed for oral administration.
"The IND acceptance by FDA is an important milestone for APR-548 and Aprea's development of next-generation reactivators of mutant p53," said Christian S. Schade, Chairman and Chief Executive Officer of Aprea Therapeutics. "We look forward to initiating the Phase 1 clinical trial of APR-548 in MDS and to expanding our leadership in the development of needed therapeutic options for patients with p53 mutated cancers."
About Aprea Therapeutics
Aprea Therapeutics, Inc., (NASDAQ:APRE) is a biopharmaceutical company headquartered in Boston, Massachusetts with research facilities in Stockholm, Sweden, focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein p53. The Company's lead product candidate is eprenetapopt (APR-246), a small molecule in clinical development for hematologic malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). Eprenetapopt has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, and Orphan Drug designation from the European Commission for MDS, AML and ovarian cancer. APR-548, a next-generation small molecule reactivator of mutant p53, is being developed for oral administration. 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.
About p53, eprenetapopt and APR-548
The p53 tumor suppressor gene is the most frequently mutated gene in human cancer, occurring in approximately 50% of all human tumors. These mutations are often associated with resistance to anti-cancer drugs and poor overall survival, representing a major unmet medical need in the treatment of cancer.Eprenetapopt is a small molecule that has demonstrated reactivation of mutant and inactivated p53 protein – by restoring wild-type p53 conformation and function – and thereby induce programmed cell death in human cancer cells. Pre-clinical anti-tumor activity has been observed with eprenetapopt in a wide variety of solid and hematological cancers, including MDS, AML, and ovarian cancer, among others. Additionally, strong synergy has been seen with both traditional anti-cancer agents, such as chemotherapy, as well as newer mechanism-based anti-cancer drugs and immuno-oncology checkpoint inhibitors. In addition to pre-clinical testing, a Phase 1/2 clinical program with eprenetapopt has been completed, demonstrating a favorable safety profile and both biological and confirmed clinical responses in hematological malignancies and solid tumors with mutations in the TP53 gene.
A pivotal Phase 3 clinical trial of eprenetapopt and azacitidine for frontline treatment of TP53 mutant MDS is ongoing. Eprenetapopt has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration for MDS, and Orphan Drug designation from the European Medicines Agency for MDS, AML and ovarian cancer.
APR-548 is a next-generation small molecule p53 reactivator. APR-548 has demonstrated high oral bioavailability, enhanced potency relative to eprenetapopt in TP53 mutant cancer cell lines and has demonstrated in vivo tumor growth inhibition following oral dosing of tumor-bearing mice. A Phase 1 clinical trial of APR-548 in TP53 mutant MDS is planned.
Forward-Looking Statements
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 clinical trials and regulatory submissions. We may, in some cases use terms such as "predicts," "believes," "potential," "continue," "anticipates," "estimates," "expects," "plans," "intends," "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 that involve risks, potential changes in circumstances, assumptions, and uncertainties. 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 risks related to the success and timing of our clinical trials or other studies and the other risks set forth in our filings with the U.S. Securities and Exchange Commission, including in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020. 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 publicly update such forward-looking statements to reflect subsequent events or circumstances.
Corporate Contacts:
Scott M. Coiante
Sr. Vice President and Chief Financial Officer
617-463-9385Gregory A. Korbel
Vice President of Business Development
617-463-9385Source: Aprea Therapeutics, Inc.
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BOSTON, Sept. 29, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics Inc., (NASDAQ:APRE), a clinical-stage biotechnology company focused on developing and commercializing novel cancer therapeutics that reactivate mutant p53 tumor suppressor protein, today announced the appointment of Michael A. Kelly to its Board of Directors. Mr. Kelly will serve as a member of the audit committee and nominating and corporate governance committee.
Mr. Kelly brings more than 20 years of executive leadership in the life sciences industry, including 14 years in senior leadership roles with Amgen Inc., and is the Founder and President of Sentry Hill Partners, LLC, a global life sciences management consulting business. Prior to founding Sentry Hill Partners, Mr. Kelly held multiple finance and operations positions at Amgen, most recently serving as Senior Vice President of Global Business Services and, in 2010 and 2014, was acting CFO. Prior to Amgen, he held senior and executive leadership positions at Tanox, Inc. Biogen, Inc., and Monsanto Life Sciences. Mr. Kelly holds a Bachelor of Science degree in business administration from Florida A&M University.
"Michael Kelly is a distinguished industry executive with considerable experience in the management and growth of innovative life sciences companies," said Christian S. Schade, Chairman and Chief Executive Officer of Aprea Therapeutics. "His deep operational and financial expertise will be invaluable as Aprea continues with its progress to advance our mutant p53 reactivator oncology programs toward commercialization. It is a great pleasure to welcome Michael to the Aprea team and our Board of Directors."
About Aprea Therapeutics
Aprea Therapeutics, Inc., (NASDAQ:APRE) is a biopharmaceutical company headquartered in Boston, Massachusetts with research facilities in Stockholm, Sweden, focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein p53. The Company's lead product candidate is APR-246 (eprenetapopt), a small molecule in clinical development for hematologic malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). APR-246 has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, and Orphan Drug designation from the European Commission for MDS, AML and ovarian cancer. 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.
About p53 and APR-246
The p53 tumor suppressor gene is the most frequently mutated gene in human cancer, occurring in approximately 50% of all human tumors. These mutations are often associated with resistance to anti-cancer drugs and poor overall survival, representing a major unmet medical need in the treatment of cancer.
APR-246 is a small molecule that has demonstrated reactivation of mutant and inactivated p53 protein – by restoring wild-type p53 conformation and function – and thereby induce programmed cell death in human cancer cells. Pre-clinical anti-tumor activity has been observed with APR-246 in a wide variety of solid and hematological cancers, including MDS, AML, and ovarian cancer, among others. Additionally, strong synergy has been seen with both traditional anti-cancer agents, such as chemotherapy, as well as newer mechanism-based anti-cancer drugs and immuno-oncology checkpoint inhibitors. In addition to pre-clinical testing, a Phase 1/2 clinical program with APR-246 has been completed, demonstrating a favorable safety profile and both biological and confirmed clinical responses in hematological malignancies and solid tumors with mutations in the TP53 gene.
A pivotal Phase 3 clinical trial of APR-246 and azacitidine for frontline treatment of TP53 mutant MDS is ongoing. APR-246 has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration for MDS, and Orphan Drug designation from the European Medicines Agency for MDS, AML and ovarian cancer.
Forward-Looking Statements
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 clinical trials and regulatory submissions. We may, in some cases use terms such as "predicts," "believes," "potential," "continue," "anticipates," "estimates," "expects," "plans," "intends," "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 that involve risks, potential changes in circumstances, assumptions, and uncertainties. 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 risks related to the success and timing of our clinical trials or other studies and the other risks set forth in our filings with the U.S. Securities and Exchange Commission, including in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020. 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 publicly update such forward-looking statements to reflect subsequent events or circumstances.
Corporate Contacts:
Scott M. Coiante
Sr. Vice President and Chief Financial Officer
617-463-9385Gregory A. Korbel
Vice President of Business Development
617-463-9385Source: Aprea Therapeutics, Inc.
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BOSTON, Sept. 18, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics Inc., (NASDAQ:APRE), a clinical-stage biotechnology company focused on developing and commercializing novel cancer therapeutics that reactivate mutant p53 tumor suppressor protein, today announced the promotion of Gregory S. Wessels to the newly created position of Chief Commercial Officer.
"We are excited to have Greg assume the role of Chief Commercial Officer as we approach key milestones in our frontline MDS program and continue to execute on our plans for the future development of eprenetapopt," said Christian S. Schade, President and Chief Executive Officer of Aprea Therapeutics. "Greg's leadership and oncology market experience will be essential as we build out our commercial capabilities."
Mr. Wessels joined Aprea in February 2020 from Bristol-Myers Squibb where he most recently served as Executive Director – US Marketing for Lymphoma and Acute Myeloid Leukemia. Prior to joining Aprea from BMS, Mr. Wessels held global and regional oncology marketing positions of increasing responsibility over more than 11 years at Celgene Corporation.
The Company also announced today that two of its independent directors, Scott Rocklage, Ph.D. and Jonathan Hepple, Ph.D. have decided to step down after nearly a decade of collective service on the Board. In connection with the departure from the Board of Drs. Rocklage and Hepple, Christian S. Schade was appointed Chairman of the Board of Directors, John B. Henneman was named Lead Independent Director, Richard Peters, M.D., Ph.D, became Chairman of the Company's Compensation Committee and Fouad Namouni, M.D. became a member of the Company's Nominating and Corporate Governance Committee.
"On behalf of the Board of Directors and all Aprea employees, we are grateful to both Scott Rocklage and Jonathan Hepple for their contributions and years of invaluable service to the Company," added Christian S. Schade.
"Aprea has made tremendous progress in advancing therapeutics to target TP53 mutations in oncology," said Scott Rocklage. "With the addition to the Board of Drs. Namouni and Peters in June, I believe that the Company has the right team in place to transition to the next phase of its development leading with its Phase 3 program in frontline MDS. It has been a pleasure to be a part of the Aprea team."
About Aprea Therapeutics, Inc.
Aprea Therapeutics, Inc., (NASDAQ:APRE) is a biopharmaceutical company headquartered in Boston, Massachusetts with research facilities in Stockholm, Sweden, focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein p53. The Company's lead product candidate is APR-246 (eprenetapopt), a small molecule in clinical development for hematologic malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). APR-246 has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, and Orphan Drug designation from the European Commission for MDS, AML and ovarian cancer. 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.
About p53 and APR-246 (eprenetapopt)
The p53 tumor suppressor gene is the most frequently mutated gene in human cancer, occurring in approximately 50% of all human tumors. These mutations are often associated with resistance to anti-cancer drugs and poor overall survival, representing a major unmet medical need in the treatment of cancer.
Eprenetapopt (APR-246) is a small molecule that has demonstrated reactivation of mutant and inactivated p53 protein – by restoring wild-type p53 conformation and function – and thereby inducing programmed cell death in human cancer cells. Pre-clinical anti-tumor activity has been observed with eprenetapopt in a wide variety of solid and hematological cancers, including MDS, AML, and ovarian cancer, among others. Additionally, strong synergy has been seen with both traditional anti-cancer agents, such as chemotherapy, as well as newer mechanism-based anti-cancer drugs and immuno-oncology checkpoint inhibitors. In addition to pre-clinical testing, a Phase 1/2 clinical program with eprenetapopt has been completed, demonstrating a favorable safety profile and both biological and confirmed clinical responses in hematological malignancies and solid tumors with mutations in the TP53 gene.
A pivotal Phase 3 clinical trial of eprenetapopt and azacitidine for frontline treatment of TP53 mutant MDS is ongoing. Eprenetapopt has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration for MDS, and Orphan Drug designation from the European Medicines Agency for MDS, AML and ovarian cancer.
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 clinical trials and regulatory submissions. We may, in some cases use terms such as "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 that involve risks, potential changes in circumstances, assumptions, and uncertainties. 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 risks related to the success and timing of our clinical trials or other studies, risks associated with the coronavirus pandemic and the other risks set forth in our filings 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 publicly update such forward-looking statements to reflect subsequent events or circumstances.
Source: Aprea Therapeutics, Inc.
Corporate Contacts:
Scott M. Coiante
Sr. Vice President and Chief Financial Officer
617-463-9385
Gregory A. Korbel
Vice President of Business Development
617-463-9385
-
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BOSTON, Sept. 03, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced that the Company is scheduled to present at two upcoming healthcare investor conferences:
- Baird 2020 Global Healthcare Conference
Date: Thursday, September 10, 2020
Presentation Time: 11:25 a.m. ET - Morgan Stanley 18th Annual Global Healthcare Conference
Date: Monday, September 14, 2020
Presentation Time: 2:15 p.m. ET
Webcasts of the presentations can be accessed from the "Events Calendar" in the News and Events section of the Aprea website at Link.
About Aprea Therapeutics, Inc.
Aprea Therapeutics, Inc. is a biopharmaceutical company headquartered in Boston, Massachusetts with research facilities in Stockholm, Sweden, focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53. The Company's lead product candidate is APR-246 (eprenetapopt), a small molecule in clinical development for hematologic malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). APR-246 has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, and Orphan Drug designation from the European Commission for MDS, AML and ovarian cancer. 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 clinical trials, regulatory submissions and projected cash position. We may, in some cases use terms such as "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 that involve risks, potential changes in circumstances, assumptions, and uncertainties. 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 risks related to the success and timing of our clinical trials or other studies, risks associated with the coronavirus pandemic and the other risks set forth in our filings 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 publicly update such forward-looking statements to reflect subsequent events or circumstances.Source: Aprea Therapeutics, Inc.
Corporate Contacts:
Scott M. Coiante
Sr. Vice President and Chief Financial Officer
617-463-9385Gregory A. Korbel
Vice President of Business Development
617-463-9385 - Baird 2020 Global Healthcare Conference