CRANBURY, N.J. & SHANGHAI–(BUSINESS WIRE)–Accutar Biotechnology, Inc., a clinical stage biotechnology company focusing on artificial intelligence (AI)-empowered drug discovery, announces that the China National Medical Products Administration (NMPA) has cleared the company’s investigational new drug application (IND) for AC0176 for the treatment of patients with metastatic Castration Resistant Prostate Cancer (mCRPC). AC0176 is an orally bioavailable chimeric degrader molecule designed to target Androgen Receptor (AR) protein with high potency and selectivity.

“Prostate cancer is one of the most common cancers among men in China, and the speed of increase in its incidence and death rates ranks highest in China. We are excited about the IND clearance of AC0176 in China, after its IND clearance and initiation of the first-in-human Phase 1 study in the US early this year,” said Jie Fan, Ph.D., Chief Executive Officer, Accutar Biotechnology, Inc. “We look forward to accelerating the development of AC0176 and furthering our commitment to bringing innovative medicines to patients worldwide.”

The Phase 1 study in China will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0176 treatment in Chinese patients with mCRPC. Accutar expects to begin enrollment of this study in the second half of this year.

About AC0176

AC0176 is an investigational orally bioavailable, chimeric degrader of androgen receptor (AR) for the potential treatment of prostate cancers. AR is a hormonal transcription factor, and plays important roles during prostate cancer onset and progression. In preclinical studies, AC0176 has demonstrated potent and selective AR protein degradation with broad coverage of AR mutants, favorable pharmacological properties, as well as promising anti-tumor activities in animal models.

About Accutar Biotechnology, Inc.

Accutar is a clinical stage biotech company focused on AI-empowered drug discovery, and its application to the discovery and development of clinically differentiated medicines.

Be transformative. For patients.

To learn more about Accutar, please visit us at www.accutarbio.com.

BROOKLYN, N.Y.–(BUSINESS WIRE)–Accutar Biotechnology, Inc., a clinical stage biotechnology company focusing on artificial intelligence (AI)-enabled drug discovery, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AC0176 for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC) with disease progression on or after treatment with androgen receptor signaling inhibitors. AC0176 is an orally bioavailable, chimeric degrader molecule targeting the androgen receptor (AR). AC0176 is currently being evaluated in a Phase 1 clinical trial to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity in patients with mCRPC.

“mCRPC is a devastating cancer for men marked by high recurrence rate and poor survival. Receiving Fast Track designation from the FDA highlights the high unmet medical need for mCRPC and acknowledges the potential of AC0176 as a novel treatment for this patient population,” said Jie Fan, Ph.D., Chief Executive Officer of Accutar Biotechnology, Inc. “AC0176 was designed to potently degrade both AR wildtype and prevalent AR mutations which confer drug resistance to current AR signaling inhibitors. We look forward to continued interaction with FDA as we quickly advance the development of this potentially promising treatment option for patients in need.”

About Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Prostate cancer (PC) is the second most commonly diagnosed cancer among men worldwide, and the first among men in the United States. mCRPC is a lethal diagnosis, and more effective therapeutic approaches are urgently needed for patients, particularly those who progressed on AR signaling inhibitors. AR-reactivating mechanisms conferring resistance to AR signaling inhibitors include, AR amplification and overexpression, AR point mutations, AR splicing variants, intra-tumoral androgen synthesis, promiscuous AR activation by other factors, etc.

About AC0176

AC0176 is an investigational orally bioavailable, chimeric degrader of AR for the potential treatment of prostate cancers. In preclinical studies, AC0176 demonstrated potent and selective AR protein degradation, favorable pharmacological properties, as well as promising anti-tumor activity in animal models. AC0176 was designed to have broad coverage of AR wildtype and prevalent AR mutations, including but not limited to L702H, T878A, H875Y, W742C. AC0176 is being evaluated in a Phase 1 clinical trial, and information on the study can be found on www.clinicaltrials.gov (NCT05241613).

About Accutar Biotechnology, Inc.

Accutar is a clinical stage biotech company focused on AI-enabled drug discovery, and its application to the discovery and development of clinically differentiated medicines.

Be transformative. For patients.

To learn more about Accutar, please visit us at www.accutarbio.com.

BROOKLYN, N.Y. & SHANGHAI–(BUSINESS WIRE)–Accutar Biotechnology, Inc., a clinical stage biotechnology company focusing on artificial intelligence (AI)-empowered drug discovery, announces that the China National Medical Products Administration (NMPA) has cleared the company’s investigational new drug application (IND) for AC0682 for the treatment of patients with estrogen receptor (ER)-positive breast cancers. AC0682 is an orally bioavailable chimeric degrader molecule designed to target ERα protein with high potency and selectivity.

“Breast cancer is the most common cancer among women in China. We are excited about the IND clearance of AC0682 in China, after its IND clearance and initiation of a Phase 1 study in the US late last year,” said Jie Fan, Ph.D., Chief Executive Officer, Accutar Biotechnology, Inc. “We look forward to accelerating the development of AC0682 and furthering our commitment to bringing innovative medicines to patients worldwide.”

The Phase 1 study in China will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0682 treatment in Chinese patients with ER-positive breast cancer. Accutar expects to begin enrollment of this study in the second half of this year.

About AC0682

AC0682 is an investigational orally bioavailable, chimeric degrader of ERα for the potential treatment of ER-positive breast cancers. ERα is a hormone-regulated transcription factor that plays a critical role in breast cancer initiation and proliferation, and nearly 80% of breast cancers express ERα. In preclinical studies, AC0682 demonstrated potent and selective ERα protein degradation with favorable pharmacological properties, as well as promising anti-tumor activity in ER-positive animal tumor models.

About Accutar Biotechnology, Inc.

Accutar is a clinical stage biotech company focused on AI-empowered drug discovery, and its application to the discovery and development of clinically differentiated medicines.

Be transformative. For patients.

To learn more about Accutar, please visit us at www.accutarbio.com.

– Chimeric Degrader With a Differentiated Mechanism of Action vs. Androgen Receptor Inhibitors –

– Broad AR Mutant Coverage Designed to Overcome Resistance to Current AR-Targeted Therapies –

BROOKLYN, N.Y.–(BUSINESS WIRE)–Accutar Biotechnology, Inc., a clinical stage biotechnology company focusing on artificial intelligence (AI)-enabled drug discovery, today announced the dosing of the first patient in a Phase 1 study of AC0176, an orally bioavailable, chimeric degrader molecule designed to target the androgen receptor (AR) with high potency and selectivity.

“The initiation of this study marks the second program from our AI-enabled drug discovery platform and our chimeric degrader portfolio to enter the clinic,” said Jie Fan, Ph.D., Chief Executive Officer of Accutar Biotechnology, Inc. “AC0176 was designed to potently degrade both AR wildtype and prevalent AR mutants which confer drug resistance to current AR-targeted therapies, including but not limited to L702H, T878A, H875Y, W742C. We are excited about the differentiated therapeutic profile of AC0176 and its broad potential to treat prostate cancer patients.”

The purpose of the Phase 1 multi-center, open-label study is to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0176 treatment in patients with mCRPC. Additional information on this clinical trial can be found on www.clinicaltrials.gov (NCT05241613).

About AC0176

AC0176 is an investigational orally bioavailable, chimeric degrader of AR for the potential treatment of prostate cancers. In preclinical studies, AC0176 demonstrated potent and selective AR protein degradation with broad coverage of AR mutants, favorable pharmacological properties, as well as promising anti-tumor activity in animal models.

About Accutar Biotechnology, Inc.

Accutar is a clinical stage biotech company focused on AI-enabled drug discovery, and its application to the discovery and development of clinically differentiated medicines.

Be transformative. For patients.

To learn more about Accutar, please visit us at www.accutarbio.com.

Accutar Biotech Inc., a biotechnology company specializing in artificial intelligence (AI)-empowered drug discovery, today announced that Dr. Alexander Varshavsky, a world leader in the ubiquitination system, has joined the Scientific Advisory Board (SAB) of the company to advise on novel E3 ligase discovery programs.

“It is our great honor and privilege to have Dr. Varshavsky join our SAB”, said Jie Fan, PhD, founder and CEO of Accutar. “Dr. Varshavsky’s pioneering work in ubiquitination and the N-degron pathway of protein degradation has opened up a whole new field for basic science and for the pharmaceutical industry with tremendous potential. Dr. Varshavsky’s unique insights and vision has further improved our confidence to move forward on our first-in-class E3 ligase inhibitor programs with the hope of bringing brighter futures to patients.”

BROOKLYN, N.Y.–(BUSINESS WIRE)–Accutar Biotechnology, Inc., a biotechnology company focusing on artificial intelligence (AI)-empowered drug discovery, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug application (IND) for AC0176 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). AC0176 is an orally bioavailable, chimeric degrader molecule designed to target and degrade androgen receptor (AR) with high potency, selectivity, and broad mutant coverage. AR is a hormone-regulated transcription factor, and its activation plays a critical role in prostate cancer initiation and progression. Accutar expects to begin enrollment of a Phase 1 clinical trial for AC0176 in the first quarter of 2022.

“The IND clearance for AC0176 is another important validation, after our AC0682 entered the clinic recently, that our AI platform can support and advance the discovery of potentially differentiated clinical candidates quickly, especially complex compounds such as chimeric degraders,” said Jie Fan, Ph.D., Chief Executive Officer of Accutar Biotechnology, Inc. “The IND clearance for AC0176 is also critical towards offering a potential new treatment for prostate cancer based on a differentiated mechanism of action from second generation nonsteroidal AR antagonists, which are the current standard of care for this patient population. We look forward to the clinical benefit that AC0176 treatment can potentially provide to prostate cancer patients.”

The Phase 1 study will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0176 treatment in mCRPC patients.

About AC0176

AC0176 is an investigational orally bioavailable, chimeric degrader of androgen receptor (AR) for the potential treatment of prostate cancers. In preclinical studies, AC0176 has demonstrated potent and selective AR protein degradation with broad coverage of AR mutants, favorable pharmacological properties, as well as promising anti-tumor activities in animal models.

About Accutar Biotechnology, Inc.

Accutar is a clinical stage biotech company focused on AI-empowered drug discovery, and its application to the discovery and development of clinically differentiated medicines.

Be transformative. For patients.

To learn more about Accutar, please visit us at www.accutarbio.com.

For More Information:
media@accutarbio.com

– Differentiated Mechanism of Action by Chimeric Degrader vs. Fulvestrant and Novel SERDs –

– ERα Wildtype & Mutant Coverage to Overcome Resistance –

– Blood-Brain Barrier Penetration to Address Brain Metastases –

BROOKLYN, N.Y.–(BUSINESS WIRE)–Accutar Biotechnology, Inc., a biotechnology company focusing on artificial intelligence (AI)-enabled drug discovery, today announced the dose administration for the first patient in a Phase 1 study of AC0682, an orally bioavailable, chimeric degrader molecule designed to target and degrade ERα protein with high potency and selectivity.

“The initiation of this study represents a significant milestone for Accutar, as it marks the first program from our AI-enabled drug discovery platform and our chimeric degrader portfolio to enter the clinic,” said Jie Fan, Ph.D., Chief Executive Officer of Accutar Biotechnology, Inc. “We look forward to the clinical benefit that AC0682 treatment can potentially provide to ER-positive breast cancer patients.”

The purpose of the Phase 1 multi-center, open-label study is to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0682 treatment in patients with ER-positive / HER2-negative locally advanced or metastatic breast cancer. Additional information on this clinical trial can be found on www.clinicaltrials.gov.

About AC0682

AC0682 is an investigational orally bioavailable, chimeric degrader of estrogen receptor (ER) α for the potential treatment of ER-positive / human epidermal growth factor receptor 2 (HER2)-negative breast cancers. In preclinical studies, AC0682 has demonstrated potent and selective protein degradation of ERα wildtype and mutants with favorable pharmacological properties and brain penetration, as well as promising anti-tumor activities in ER-positive animal tumor models. AC0682 offers a potential new breast cancer treatment based on a differentiated mechanism of action from fulvestrant and novel SERDs.

About Accutar Biotechnology, Inc.

Accutar is a clinical stage biotech company focused on AI-enabled drug discovery, and its application to the discovery and development of clinically differentiated medicines.

Be transformative. For patients.

To learn more about Accutar, please visit us at www.accutarbio.com.

BROOKLYN, N.Y.–(BUSINESS WIRE)–Accutar Biotechnology, Inc., a biotechnology company focusing on artificial intelligence (AI)-enabled drug discovery, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug application (IND) for AC0682 for the treatment of patients with estrogen receptor (ER)-positive breast cancers. AC0682 is an orally bioavailable, chimeric degrader molecule designed to target and degrade ERα protein with high potency and selectivity. ERα is a hormone-regulated transcription factor that plays a critical role in breast cancer initiation and proliferation, and nearly 80% of breast cancers express ERα. Accutar expects to begin enrollment of a Phase 1 clinical trial for AC0682 in the last quarter of this year.

“The IND clearance for AC0682 is a key milestone for Accutar and AI-enabled drug discovery. This is an important validation that our AI platform can support and advance the discovery of potentially differentiated clinical candidates quickly, especially complex compounds such as chimeric degraders. To bring one of the world’s first wave of AI-enabled molecules into clinics with our own platform is a great achievement. ” said Jie Fan, Ph.D., Chief Executive Officer, Accutar Biotechnology, Inc. “The IND clearance for AC0682 is also critical towards offering a potential new breast cancer treatment based on a differentiated mechanism of action from fulvestrant, which is the current standard of care for this patient population. We look forward to the clinical benefit that AC0682 treatment can potentially provide to the ER-positive breast cancer patients.”

“Treatment options are limited for patients with metastatic ER+ breast cancer after hormonal and CDK4/6 inhibitor treatment,” said Dr. Erika Hamilton, Director, Breast Cancer and Gynecologic Cancer Research Program, Sarah Cannon Research Institute at Tennessee Oncology, and the lead Principal Investigator for the study. “AC0682 potentially addresses an unmet clinical need for patients post endocrine therapy and CDK4/6 inhibitors who need additional treatment options. We look forward to exploring this novel drug to advance care for people facing ER+ metastatic breast cancer.”

The Phase 1 study will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0682 treatment in ER-positive breast cancer patients. Additional information on this clinical trial can be found on www.clinicaltrials.gov.

About AC0682

AC0682 is an investigational orally bioavailable, chimeric degrader of estrogen receptor (ER) α for the potential treatment of ER-positive breast cancers. In preclinical studies, AC0682 has demonstrated potent and selective ERα protein degradation with favorable pharmacological properties, as well as promising anti-tumor activities in ER-positive animal tumor models. 

About Accutar Biotechnology, Inc.

Accutar is a clinical stage biotech company focused on AI-enabled drug discovery, and its application to the discovery and development of clinically differentiated medicines. 

Be transformative. For patients. 

To learn more about Accutar, please visit us at www.accutarbio.com.

For More Information:

Contact media@accutarbio.com

Accutar Biotech Inc., a technology company specialized in AI guided drug discovery, announced Dr. Carlos Garcia-Echeverria serves as CEO advisor to support the company’s internal drug discovery pipeline.

“We are honored to have Dr. Garcia-Echeverria’s insights to develop best-in-class and first-in-class medicines for unmet medical needs,” said Jie Fan, PhD, founder and CEO of Accutar, “Carlos sets a high bar for our AI guided drug discovery efforts which is extremely instrumental to our company philosophy, because in this business, Science Prevails.”  


Dr. Carlos Garcia-Echeverria, Ph.D.

Dr. Carlos Garcia-Echeverria currently serves as Chief of Rx Creation at EQRx. He was the chief operating officer of research and global head of research platforms at Sanofi, where he was responsible for overseeing the establishment and execution of the Sanofi research strategy. Before joining Sanofi in 2010, Carlos held several positions of increasing responsibility at Novartis, including executive director, oncology drug discovery head, where he was responsible for managing multiple late-stage drug discovery cancer programs. Carlos is an inventor on 45 patents and has published more than 190 peer-reviewed articles, book chapters and review papers. He received his Ph.D. in organic chemistry from the University of Barcelona.

Accutar Biotech Inc., a technology company pioneering AI guided drug discovery to bring broader benefits for patients, announced Dr. Pasi A. Jänne joins scientific advisory board to support development of the company’s pipeline drugs in lung cancer.

“It is our honor to have world esteemed leaders like Dr. Pasi A. Jänne to advise us to develop precision medicines for unmet medical needs in the field,” said Jie Fan, PhD, founder and CEO of Accutar, “Dr. Jänne’s insights will strengthen our company’s Lung Cancer franchise.”


Dr. Pasi A. Jänne, M.D., Ph.D.

Dr. Jänne is the Director of the Lower Center for Thoracic Oncology at Dana-Farber Cancer Institute and a Professor of Medicine at Harvard Medical School. He is also the Director of the Belfer Center for Applied Cancer Science at the Dana-Farber Cancer Institute. After earning his MD and PhD from the School of Medicine at the University of Pennsylvania, Dr. Jänne completed his internship and residency in Medicine at Brigham and Women’s Hospital, Boston.  He subsequently completed fellowship training at Dana-Farber Cancer Institute/Massachusetts General Hospital combined program in medical oncology in 2001. In 2002 he earned a Master’s Degree in clinical investigation from Harvard University.

Dr. Jänne’s research combines laboratory-based studies, with translational research and clinical trials of novel therapeutic agents in patients with lung cancer. His main research interests center around understanding and translating the therapeutic importance of oncogenic alterations in lung cancer.  He has made seminal therapeutic discoveries, including being on one of the co-discoverers of EGFR mutations, and findings from his work has led to the development of several clinical trials. Dr. Jänne has received several awards for his work including from the American Association for Cancer Research, European Society for Medical Oncology and the American Society of Clinical Oncology.