纽约布鲁克林 & 中国上海–(BUSINESS WIRE)–（Accutar Biotechnology, Inc.），一家专注于人工智能药物研发的临床阶段生物技术公司，今天宣布国家药品监督管理局（NMPA）已批准该公司在研药物AC0682用于治疗雌激素受体阳性乳腺癌患者的试验用新药申请（IND）。AC0682是一种口服嵌合降解剂分子，可高效选择性地靶向降解雌激素受体蛋白。AC0682也成为全球范围内第一个获得FDA以及NMPA许可，进入临床试验的口服雌激素受体嵌合降解剂。
“乳腺癌是中国女性中最常见的癌症。我们很高兴AC0682 在中国IND获批，这是该药在去年底获得美国IND批准并启动美国1期临床研究之后的又一个里程碑。” 冰洲石生物首席执行官范捷博士说，“我们期待加速AC0682的临床研发，并进一步履行我们为全球癌症患者带来创新药物的承诺。”
中国1期临床研究将评估AC0682治疗中国雌激素受体阳性乳腺癌患者的安全性、耐受性、药代动力学和初步抗肿瘤活性。冰洲石生物预计将于今年下半年在中国启动1期临床试验。
关于 AC0682
AC0682是一种在研口服雌激素受体嵌合降解剂，用于治疗雌激素受体阳性乳腺癌。雌激素受体是一种雌激素调节的转录因子，在乳腺癌的发生和增殖中起关键作用，近 80% 的乳腺癌表达雌激素受体。在临床前研究中，AC0682证明了有效和选择性的雌激素受体蛋白降解，具有良好的药理特性，以及在动物肿瘤模型中具有良好的抗肿瘤活性。
关于冰洲石生物（Accutar Biotechnology, Inc.）
Accutar 是一家临床阶段的生物技术公司，专注于人工智能支持的药物设计，尤其是临床差异化药物的研发。
变革治疗。心系患者。
欲了解有关Accutar的更多信息，请访问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.
We have developed an end-to-end, retrosynthesis system, named ChemiRise, that can propose complete retrosynthesis routes for organic compounds rapidly and reliably. The system was trained on a processed patent database of over 3 million organic reactions. Experimental reactions were atom-mapped, clustered, and extracted into reaction templates. We then trained a graph convolutional neural network-based one-step reaction proposer using template embeddings and developed a guiding algorithm on the directed acyclic graph (DAG) of chemical compounds to find the best candidate to explore. The atom-mapping algorithm and the one-step reaction proposer were benchmarked against previous studies and showed better results. The final product was demonstrated by retrosynthesis routes reviewed and rated by human experts, showing satisfying functionality and a potential productivity boost in real-life use cases.
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
We propose a method based on neural networks to accurately predict hydration sites in proteins. In our approach, high-quality data of protein structures are used to parametrize our neural network model, which is a differentiable score function that can evaluate an arbitrary position in 3D structures on proteins and predict the nearest water molecule that is not present. The score function is further integrated into our water placement algorithm to generate explicit hydration sites. In experiments on the OppA protein dataset used in previous studies and our selection of protein structures, our method achieves the highest model quality in terms of F1 score, compared to several previous studies.
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.