CRANBURY, N.J.–(BUSINESS WIRE)–Accutar Biotechnology, Inc., a biotechnology company focusing on artificial intelligence (AI)-enabled drug discovery, announced today that the US Food and Drug Administration (FDA) has granted the investigation of AC699 a Fast Track designation for the treatment of patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression on or after at least 1 line of endocrine-based therapy. AC699 is an investigational orally bioavailable, chimeric degrader of estrogen receptor (ER) α currently in a Phase 1 trial.

ER-positive/HER2-negative subtype is the most common subtype of breast cancer (~70%), and mutations in the estrogen receptor 1 (ESR1) gene are common (20-40%) among ER-positive/HER2-negative patients who received endocrine therapy in the metastatic setting. AC699 has demonstrated objective response rate (ORR) of 50% in patients with an ESR1 mutation, in an ongoing Phase 1 trial, presented at ASCO 2024.

“Receiving Fast Track designation for AC699 from the FDA highlights their recognition of the serious and life-threatening nature of this malignancy, the critical unmet medical needs not fully addressed by existing therapies, and the potential of AC699 to fill in the gap,” said Jie Fan, Ph.D., Chief Executive Officer of Accutar Biotechnology, Inc. “We look forward to working closely with the FDA to optimize and expedite the development program.”

The FDA’s Fast Track process is designed to facilitate the development and expedite the review of novel drugs intended to treat serious conditions and address significant unmet medical needs. Companies that receive Fast Track designation are eligible for more frequent meetings and communications with the FDA during clinical development and potentially accelerated approval and priority review, if relevant criteria are met. For more information on Fast Track Designation, please visit the FDA’s website at https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.

About AC699 and the Phase 1 Study (AC699-001)

AC699 is an investigational orally bioavailable, chimeric degrader of estrogen receptor (ER) α. In preclinical studies, AC699 has demonstrated potent and selective protein degradation of ERα wildtype and mutants with favorable pharmacological properties, as well as promising anti-tumor activities in ER-positive animal tumor models.

The purpose of the Phase 1 multi-center, open-label study is to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC699 treatment in patients with ER-positive / HER2-negative locally advanced or metastatic breast cancer (NCT05654532). Additional information on this clinical trial can be found on www.clinicaltrials.gov.

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.

– Differentiated Mechanism of Action of a Chimeric Degrader as Compared to Fulvestrant and Novel SERDs –

– Treatment with AC699 Monotherapy Resulted in 21% ORR for All Evaluable Patients, and 50% for Those Who Had an ESR1 Mutation –

– Favorable Safety and Tolerability Profile at All Doses with No DLTs or ≥ Grade 3 Adverse Events Related to AC699 –

CRANBURY, N.J.–(BUSINESS WIRE)–Accutar Biotechnology, Inc., a biotechnology company focusing on artificial intelligence (AI)-enabled drug discovery, announced data from an ongoing Phase 1 study of AC699 monotherapy in patients with ER-positive / HER2-negative locally advanced or metastatic breast cancer. The data will be presented in a poster discussion session at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL on June 1, 2024.

AC699 is a potent and selective orally bioavailable, chimeric degrader of estrogen receptor (ER) α, and offers a potential new breast cancer treatment option based on a differentiated mechanism of action as compared to fulvestrant and novel SERDs with deeper ERα degradation as demonstrated in preclinical studies. AC699 is currently being evaluated in an ongoing Phase 1 clinical study as a single agent for the treatment of ER-positive / HER2-negative locally advanced or metastatic breast cancer (NCT05654532). The primary objectives are to evaluate the safety and tolerability of AC699. Secondary and exploratory objectives include pharmacokinetics, preliminary efficacy and pharmacodynamic evaluation. The study uses a 3+3 dose-escalation design, with once-daily oral dosing of AC699 at 100, 200, 300, 400, and 600 mg.

Phase 1 Study Results:

– As of April 8, 2024, 29 participants were enrolled and treated with AC699 at doses ranging from 100-400 mg. The participants had a median of 5 (range 2-10) prior lines of therapy, including 3 (range 1-8) prior lines in the metastatic setting
– The objective response rate was 21% (4/19) and increased to 50% (4/8) for those who had an ESR1 mutation
– There were no > Grade 3 drug-related adverse events (AEs), no dose limiting toxicities, no discontinuations and no dose reductions due to AEs
– AEs related to AC699 occurred in 38% of participants and included nausea (14%), hot flush (14%), and fatigue (10%)
– The maximum tolerated dose had not been reached yet

Details of the poster presentation at ASCO 2024 are as follows:

– Date/Time: June 1, 2024, 9:00 AM – 12:00 PM CDT
– Abstract Number: 3074
– Title: Preliminary results from a phase 1 study of AC699, an orally bioavailable chimeric estrogen receptor degrader, in patients with advanced or metastatic breast cancer.
– Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
– Abstracts and full session details can be accessed through the ASCO meeting planner: Link

“We are extremely pleased with the groundbreaking safety and efficacy that AC699 has demonstrated thus far in Phase 1, with early evidence of its best-in-class potential, especially for patients with ESR1 mutations,” said Jie Fan, Ph.D., Chief Executive Officer of Accutar Biotechnology, Inc. “We look forward to completing the dose escalation portion of the study and starting the Phase 2 study soon. We believe that the oral dosing of AC699 and its differentiated mechanism of action, as compared to fulvestrant and novel SERDs, can potentially provide a new safe and effective treatment option for this patient population.”

About AC699 and the Phase 1 Study (AC699-001)

AC699 is an investigational orally bioavailable, chimeric degrader of estrogen receptor (ER) α. In preclinical studies, AC699 has demonstrated potent and selective protein degradation of ERα wildtype and mutants with favorable pharmacological properties, as well as promising anti-tumor activities in ER-positive animal tumor models.

The purpose of the Phase 1 multi-center, open-label study is to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC699 treatment in patients with ER-positive / HER2-negative locally advanced or metastatic breast cancer (NCT05654532). Additional information on this clinical trial can be found on www.clinicaltrials.gov.

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.

Coordinate and lead medical drug discovery clinical trial projects. Design and develop plans and process for specific drug during clinical trial process. Manage investigational product supplies and participate internal audits. Develop and review specific research-related documents. Develop and coordinate research project budget, management project progress and review project performance. Collect feedbacks and data from clinical trials and prepare reports for improvement of drug performance. Manage outsourced Central Lab activities.  Serve as the contacts with partners and government agency in drug approving processing.  

Requirements:

Master in Medicine or MD degree required.  One years of experience in clinical trial project management related duties required.

Send resume to HR, Accutar Biotechnology Inc. 8 Clarke Dr. Ste. 4, Cranbury, NJ 08512

Design and develop drug discovery software. Design state of the art algorithms to solve challenging problems in drug discovery. Implement, analyze, and optimize algorithms with collaboration with the product team to productize the algorithms. Use tools include Google Cloud, PyTorch, Linux, Python, Deep Learning, Advanced linear algebra, C++, and Fast algorithm design. Salary: $200,000 / year

Requirements:

Master’s degree in Computer Science or Computer Engineering required.  Two years of experience as Research Assistant, Researcher or Engineer or a similar position involving research in algorithms related duties required (accept either academic or industry experience).

Work Location: Bellevue, WA

Send resume to HR, Accutar Biotechnology, Inc., 11100 NE 8th St, Suite #800, Bellevue, WA 98004

Prostate cancer (PCa) is primarily driven by aberrant Androgen Receptor (AR) signaling. Although there has been substantial advancement in antiandrogen therapies, resistance to these treatments remains a significant obstacle, often marked by continuous or enhanced AR signaling in resistant tumors. While the dysregulation of the ubiquitination-based protein degradation process is instrumental in the accumulation of oncogenic proteins, including AR, the molecular mechanism of ubiquitination-driven AR degradation remains largely undefined. We identified UBE2J1 as the critical E2 ubiquitin-conjugating enzyme responsible for guiding AR ubiquitination and eventual degradation. The absence of UBE2J1, found in 5–15% of PCa patients, results in disrupted AR ubiquitination and degradation. This disruption leads to an accumulation of AR proteins, promoting resistance to antiandrogen treatments. By employing a ubiquitination-based AR degrader to adeptly restore AR ubiquitination, we reestablished AR degradation and inhibited the proliferation of antiandrogen-resistant PCa tumors. These findings underscore the fundamental role of UBE2J1 in AR degradation and illuminate an uncharted mechanism through which PCa maintains heightened AR protein levels, fostering resistance to antiandrogen therapies.

Read More

Evommune will leverage Accutar’s AI-empowered drug discovery platform for therapies targeting chronic inflammatory diseases

PALO ALTO, Calif. and CRANBURY, N.J., Nov. 28, 2023 /PRNewswire/ — Evommune, Inc., a biotechnology company discovering and developing new ways to treat immune-mediated inflammatory diseases, and Accutar Biotechnology Inc., a company focusing on artificial intelligence (AI)-empowered drug discovery, today announced a new strategic partnership focused on the discovery of novel small molecule drug candidates in chronic inflammatory diseases. The collaboration will leverage Accutar’s proprietary AI platform as well as Evommune’s expertise in the design and development of novel oral small molecule treatments against targets that are the root cause of chronic immune-mediated inflammatory diseases. Terms of the agreement will not be disclosed.

“We are excited to partner with Accutar, a leader in accelerating drug discovery, as we work to identify and validate novel targets that could have a profound impact on chronic inflammatory diseases,” said Jeegar Patel, Ph.D., Chief Scientific Officer of Evommune. “Accutar has a highly sophisticated hybrid approach of computational drug design and wet lab validation, and we plan to leverage this to overcome the limitations of traditional drug discovery methods on our targets of interest – allowing us to more efficiently design safe and efficacious therapies for complex chronic inflammatory diseases. Accutar is a team we know well, having collaborated with them on our current program targeting PKCθ, and we are thrilled to be expanding our partnership in a broader capacity.”

“Chronic inflammatory diseases represent the greatest threat to human health today, with nearly 60 percent of people in the U.S. alone suffering from at least one chronic condition,” said Jie Fan, Ph.D., Chief Executive Officer of Accutar. “We look forward to partnering with Evommune, a company with in-depth understanding in inflammatory diseases and extensive expertise in clinical development. By combining Evommune’s deep biological insights with our AI-empowered medicinal chemistry engine, and its application to the discovery and development of clinically differentiated medicine, we have great confidence we’ll be able to develop the next generation of therapies for chronic inflammatory diseases.”

About Evommune, Inc.
Evommune, Inc., a Palo Alto based biotech company, is creating game-changing science to treat immune-mediated inflammatory diseases by discovering, developing, and delivering therapies that address symptoms and halt progressive disease. For more information, please visit Evommune.com.

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

Contact:
Paul Laland
415.519.6610
Paul.laland@evommune.com

Jiaqi Ren
media@accutarbio.com

SOURCE Evommune, Inc.

Accutar Biotech Inc., a biotechnology company specializing in artificial intelligence (AI) – empowered drug discovery, today announced that Dr. Erika Hamilton, director of breast cancer research at Sarah Cannon Research Institute (SCRI), has joined the Scientific Advisory Board (“SAB”) of the company to advise on clinical trials of the company’s phase 1 breast cancer programs that are orally bioavailable, chimeric degrader molecules designed to target and degrade ERα protein with high potency and selectivity.

Dr. Hamilton is a leader in the field of both breast and gynecologic cancers.  She had led numerous clinical trials, ranging from first-in-human phase I developmental trials to Phase III registrational trials.  Her expertise led to her appointment as the chairperson of the ASCO Scientific Committee for Metastatic Breast Cancer, which is just one of her many recognitions and accomplishments.  “We are honored to have Dr. Hamilton join our SAB at this critical inflection point for our company”, said Jie Fan, PhD, founder and CEO of Accutar.  “Her innovative contributions to drug development, focus on advancing new therapies, and compassion for patients makes her the ideal person to help forge the next steps to bring our revolutionary medicine to patients.”

– Chimeric Degrader With a Differentiated Mechanism of Action vs. BTK Inhibitors by Removing Both Kinase And Scaffolding Functions of BTK –

– Broad BTK Mutant Coverage Designed to Overcome Resistance to Covalent And Non-Covalent BTK Inhibitors 

– Improved Selectivity Profile Sparing Common Off-Targets Observed for BTK Inhibitors –

CRANBURY, N.J.–(BUSINESS WIRE)–Accutar Biotechnology, Inc., a biotechnology company focusing on artificial intelligence (AI)-empowered drug discovery, today announced the dosing of the first patient in a Phase 1 study of AC0676, an orally bioavailable, chimeric degrader molecule designed to target and degrade Bruton’s Tyrosine Kinase (BTK) with high potency, selectivity, and broad mutant coverage.

“The initiation of this study distinguishes Accutar as the first company to successfully bring oral chimeric degraders against three different targets into the clinic,” said Jie Fan, Ph.D., Chief Executive Officer of Accutar Biotechnology, Inc. “Leveraging our protein crystallography and AI-empowered PPI-TAC (Protein-Protein Interaction Targeting Chimera) platforms, AC0676 was designed to potently and selectively degrade both wildtype BTK and BTK mutations that confer drug resistance to both covalent and non-covalent BTK inhibitors, including but not limited to C481S and kinase dead mutations such as L528W. We are excited about the differentiated therapeutic profile of AC0676 and its broad potential to treat patients with B-cell malignancies.”

The purpose of the Phase 1 multi-center, open-label study is to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0676 treatment in patients with relapsed/refractory B-cell malignancies, including Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), non-GCB Diffuse Large B-cell Lymphoma (DLBCL), Mantle Cell Lymphoma (MCL), Follicular Lymphoma (FL), , Marginal Zone Lymphoma (MZL), or Waldenström Macroglobulinemia (WM). Additional information on this clinical trial can be found on www.clinicaltrials.gov (NCT05780034).

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 activity 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.

Our Motto: Be transformative. For patients.

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

美国新泽西 & 中国上海–(BUSINESS WIRE)–(美国商业资讯)–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AC0176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。

AC0176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雄激素受体蛋白。AC0176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雄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二次进入中国临床试验。这是AC0176在去年启动美国1期临床研究和去年在中国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,“前列腺癌是中国男性中最常见的癌症之一,在中国发病率及死亡率增速均位列恶性肿瘤第一。我们期待中国I期临床研究极大地加速AC0176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。” AC0176中国项目的主要研究者,来自北京大学肿瘤医院泌尿外科的杨勇主任及教授评价说:“本次临床试验的首例患者入组,也是国内首例作用于AR受体全新机制的蛋白降解药物的患者入组,标志着国内医学界在前列腺癌治疗领域迈出了重要一步,正在与国际接轨,对我们来说是一个振奋人心的里程碑,期待AC0176在临床中的表现,为中国患者家庭带来新的治疗希望。”

中国1期临床研究将评估AC0176治疗中国转移性去势抵抗性前列腺癌患者的安全性、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 (NCT05673109).

关于 AC0176

AC0176是一种在研口服雄激素受体嵌合降解剂,用于治疗前列腺癌。雄激素受体是一种雄激素调节的转录因子,在前列腺癌的发生和增殖中起关键作用。在临床前研究中,AC0176证明了有效和选择性的雄激素受体蛋白降解,具有对多种雄激素受体突变有效的广谱性,良好的药理特性,以及在动物肿瘤模型中良好的抗肿瘤活性。

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 AC0176, an orally bioavailable chimeric degrader molecule designed to target Androgen Receptor (AR) protein with high potency and selectivity.

“The initiation of this study marks the second program from our chimeric degrader portfolio to enter the clinic in China, after the initiation of AC0176 Phase 1 study in the US and the IND clearance by the China National Medical Products Administration (NMPA) last year,” said Jie Fan, Ph.D., Chief Executive Officer of Accutar Biotechnology, Inc. “Prostate cancer is one of the most common cancers among men in China, and the increase in its incidence and death ranks highest in China. We look forward to accelerating the development of AC0176 globally to bring transformative 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 metastatic Castration Resistant Prostate Cancer (mCRPC). Additional information on this clinical trial can be found on www.clinicaltrials.gov (NCT05673109).

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.