CRANBURY, N.J.–(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 AC0676 for the treatment of patients with relapsed/refractory B-cell malignancies. AC0676 is an orally bioavailable, chimeric degrader molecule designed to target and degrade Bruton’s Tyrosine Kinase (BTK) with high potency, selectivity, and broad mutant coverage. BTK plays a crucial role in the B-cell receptor (BCR) signaling pathway, and its constitutive activation is essential to the pathophysiology of many B-cell malignancies. Accutar expects to begin enrollment of a Phase 1 clinical trial for AC0676 in the beginning of the second quarter of 2023.
“The IND clearance for AC0676 is another important validation that our protein crystallography and AI platforms can support and advance the discovery of potentially differentiated clinical candidates quickly, especially complex compounds such as chimeric degraders. It marks Accutar as the first company to successfully bring oral chimeric degraders against three different targets into clinics,” said Jie Fan, Ph.D., Chief Executive Officer, Accutar Biotechnology, Inc. “The IND clearance for AC0676 is also critical towards offering a potential new treatment option for B-cell malignancies based on a differentiated mechanism of action from covalent and non-covalent BTK inhibitors by removing both kinase and scaffolding functions of BTK. We look forward to the clinical benefit that AC0676 treatment can potentially provide to patients.”
The Phase 1 study will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0676 treatment in patients with relapsed/refractory B-cell malignancies.
About AC0676
AC0676 is an investigational orally bioavailable, chimeric degrader of Bruton’s Tyrosine Kinase (BTK) for the potential treatment of relapsed/refractory B-cell malignancies. In preclinical studies, AC0676 has demonstrated potent and selective BTK protein degradation with broad coverage of BTK wildtype and mutants (including C481S, L528W, and others), 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.
Design and develop drug discovery software and applications. Research and design novel
computer models to improve drug discovery pipeline. Implement, analyze, and optimize
the algorithms. Design and develop tools and platforms to improve productivity of the
team.
Send resume to HR, Accutar Biotechnology, Inc., 800 West El Camino Real, Suite 180,
Mountain View, CA 94040
美国新泽西 & 中国上海–(BUSINESS WIRE)–冰洲石生物（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，今天宣布完成了AC0682在中国的1期临床研究第一例病人首次给药。这例病人在北京大学肿瘤医院入组并给药。
AC0682是由冰洲石生物自主研发并拥有全球专利的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。
“这个临床一期标志着我们公司嵌合降解剂管线第一次进入中国临床试验。这是AC0682在去年底获得美国IND批准并启动美国1期临床研究和今年在中国IND获批之后的又一个里程碑。” 冰洲石生物首席执行官范捷博士说，“乳腺癌是中国女性中最常见的癌症。我们期待中国I期临床研究极大地加速AC0682的研发，并进一步履行我们为全球癌症患者带来创新药物的承诺。” AC0682中国项目的组长单位北京大学肿瘤医院乳腺肿瘤内科的李惠平主任评价说:“能作为牵头人承接第一个在中国开展的作用于ER受体全新机制的蛋白降解药物，并完成了首例入组，标志着中国在药物临床研究进展方面已经与国际并行，势必推动新型药物的开发速度，使中国患者也能更早的用到被称为“蛋白降解先锋药物”的先进治疗方法。”
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。关于这个研究更多的信息列在www.clinicaltrials.gov网站 (NCT05489679).
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。
CRANBURY, N.J. & SHANGHAI–(BUSINESS WIRE)–Accutar Biotechnology, Inc., a clinical stage biotechnology company focusing on artificial intelligence (AI)-empowered drug discovery, announces the dosing of the first patient in China in a Phase 1 study of AC0682, an orally bioavailable chimeric degrader molecule designed to target ERα protein with high potency and selectivity.
“The initiation of this study marks the first program from our chimeric degrader portfolio to enter the clinic in China, after the initiation of AC0682 Phase 1 study in the US late last year and the IND clearance by the China National Medical Products Administration (NMPA) earlier this year,” said Jie Fan, Ph.D., Chief Executive Officer of Accutar Biotechnology, Inc. “Breast cancer is the most common cancer type among Chinese women. We look forward to accelerating the development of AC0682 globally with the goal of bringing transformative 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. Additional information on this clinical trial can be found on www.clinicaltrials.gov (NCT05489679).
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.
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.
Responsibilities
Conduct qualitative and quantitative chemical analyses of lab data for our drug discovery
pipelines with the assistance of developed artificial intelligence (AI) empowered
platform. Write technical papers and reports. Prepare standards and specifications for
operational protocols of drug discovery platform. Coordinate operations of company’s
medchem lab. Coordinate the drug discovery projects within with outsourcing researchers
and in house researchers. Collaborate with computation department to improve the
efficiency, scalability and precision of our drug-discovery platform.
Qualifications
Master’s degree in Chemistry or Chemical Engineering required, and 1 year of
experience in a position involving AI drug discovery management or research required.
Send resume to HR, Accutar Biotechnology, Inc., 800 West El Camino Real, Suite 180,
Mountain View, CA 94040
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.
Location: Accutar Biotechnology, Cranbury, New Jersey.
Accutar Biotechnology is a clinical stage biotech company focused on AI-enabled drug discovery, and its application to the discovery and development of clinically differentiated medicines. We are seeking a talented and self-motivated research associate to join our exciting drug discovery effort.
Responsibilities
Qualifications:
Position will be hired based on level of experience.
Accutar Biotech offers a competitive compensation in industry, friendly and rewarding working and training environment, and excellent growth potential.
To apply for this position, please send your CV to biocareer@accutarbio.com
Location: Accutar Biotechnology, Cranbury, New Jersey.
Accutar Biotechnology is a clinical stage biotech company focused on AI-enabled drug discovery, and its application to the discovery and development of clinically differentiated medicines. We are seeking a highly diligent, energetic, and self-motivated scientist with a proven track record of accomplishment in the field of cancer biology to join our exciting drug discovery effort.
Responsibilities:
The position offers a unique opportunity for a talented scientist to develop his/her career involving a broad scope of drug discovery in a fast-paced research environment.
Qualifications:
Position will be hired based on level of experience.
Accutar Biotech offers a competitive compensation in industry, friendly and rewarding working and training environment, and excellent growth potential.
To apply for this position, please send your CV to biocareer@accutarbio.com
Location: Accutar Biotechnology, Cranbury, New Jersey.
Accutar Biotechnology is a clinical stage biotech company focused on AI-enabled drug discovery, and its application to the discovery and development of clinically differentiated medicines. We are seeking a highly diligent, energetic, and self-motivated scientist with a proven track record of accomplishment in the field of immune-oncology or immunology to join our exciting drug discovery effort.
Responsibilities:
The position offers a unique opportunity for a talented scientist to develop his/her career involving a broad scope of drug discovery in a fast-pace research environment.
Qualifications:
Accutar Biotech offers a competitive compensation in industry, friendly and rewarding working and training environment, and excellent growth potential.
To apply for this position, please send your CV to biocareer@accutarbio.com