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.

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.

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.

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.

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.

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.