AC-699

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 Pro 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 . 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 . View source version on businesswire.com: Contacts Jiaqi Ren Media@accutarbio.com Source: Accutar Biotechnology, Inc. View this news release online at:

NASHVILLE, Tenn.--(BUSINESS WIRE)-- Sarah Cannon Research Institute (SCRI), one of the world’s leading oncology research organizations conducting community-based clinical trials, announced today that it will highlight its latest research insights through more than 145 presentations at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting from Friday, May 31 – Tuesday, June 4 in Chicago, Ill. Over 100 investigators from across SCRI’s network are co-authors on clinical trial updates that will be showcased at the Annual Meeting, including data from more than 65 early-phase clinical trials. “We look forward to connecting with colleagues from around the world at ASCO’s Annual Meeting to discuss the latest developments in advancing therapies for cancer patients,” says Howard A. “Skip” Burris, III, MD, President, SCRI. “The depth and breadth of clinical research being presented by SCRI experts signifies our commitment to accelerating drug development and providing greater access to cutting-edge therapies closer to home.” For a comprehensive list of abstracts and presentations, visit SCRI’s ASCO Site. To learn more about our research experts, visit our Leadership Page. Noteworthy Presentations Breast Cancer Erika Hamilton, MD, SCRI, will present “H3B-6545 in Women with Locally Advanced/Metastatic Estrogen Receptor-Positive, HER2 Negative Breast Cancer” in an oral presentation during the Breast Cancer – Metastatic Rapid Oral Abstract Session on Monday, June 3 from 11:30 a.m. - 1:00 p.m. CDT in Hall D1. Joyce O'Shaughnessy, MD, SCRI at Texas Oncology I The US Oncology Network, will deliver “Association of MammaPrint Index and 3-Year Outcome of Patients with HR+HER2- Early-Stage Breast Cancer Treated with Chemotherapy with or without Anthracycline” in an oral presentation during the Breast Cancer—Local/Regional/Adjuvant Rapid Oral Abstract Session on Friday, May 31 from 2:45 p.m. - 4:15 p.m. CDT in E451. Denise Yardley, MD, SCRI, will give the oral presentation, “Baseline Characteristics and Efficacy Endpoints for Patients with Node-Negative HR+/HER2− Early Breast Cancer: NATALEE Trial” during the Breast Cancer—Local/Regional/Adjuvant Rapid Oral Abstract Session on Friday, May 31 from 2:45 p.m. - 4:15 p.m. CDT in E451. Lung Cancer David Spigel, MD, SCRI, will discuss “ADRIATIC: Durvalumab as Consolidation Treatment for Patients with Limited-Stage Small-Cell Lung Cancer” in an oral presentation during the Plenary Session on Sunday, June 2 from 1:00 p.m. - 4:00 p.m. CDT in Hall B1. Clinical Trial Access Ishwaria Subbiah, MD, MS, SCRI, will present “5-Year Multicenter Analysis of Clinical Trial Participation and Total Cost of Care for Older Adults with Cancer” in an oral presentation during the Quality Care/Health Services Research Rapid Oral Abstract Session on Monday, June 3 from 1:15 p.m. - 2:45 p.m. CDT in S102. In addition to scientific presentations, SCRI leadership will participate in and lead ASCO sessions, including: Meredith McKean, MD, MPH, SCRI, is a discussant in the Oral Abstract Session, Melanoma/Skin Cancers, on Friday, May 31 from 2:45 p.m. - 5:45 p.m. CDT in Hall D1, where she will present “PD-1–Refractory Advanced Melanoma: How Do We Get to the Finish Line?” Dr. Burris will deliver the “Presentation and Recognition of Conquer Cancer Top Donors” in the Opening Session on Saturday, June 1 from 9:30 a.m. - 12:00 p.m. CDT in Hall B1. Dr. Hamilton will chair the Clinical Science Symposium, Next-Generation Antibody-Drug Conjugates: The Revolution Continues, and present “The ABCs of ADCs: What Does the Future Hold?” on Sunday, June 2 from 9:45 a.m. - 11:15 a.m. CDT in Hall D1. Abdul Naqash, MD, SCRI at OU Health - Stephenson Cancer Center, will chair the Oral Abstract Session, Developmental Therapeutics—Immunotherapy, on Monday, June 3 from 11:30 a.m. - 2:30 p.m. CDT in Hall D2. Andrew McKenzie, PhD, SCRI & Genospace, and Vivek Subbiah, MD, SCRI, will serve as panelists in the Case-Based Panel, Beyond Tumor Types: Advancing Tumor-Agnostic Drug Development and the Role of the Tumor Microenvironment, on Monday, June 3 from 3:00 p.m. - 4:00 p.m. CDT in Hall D2. Cesar Perez, MD, SCRI at Florida Cancer Specialists & Research Institute, will present “Emerging Data for Antibody Drug Conjugates in Head and Neck Squamous Cell Carcinoma,” during the Breaking Ground in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Novel Therapies Beyond PD-L1 Immunotherapy Education Session on Tuesday, June 4 from 8:00 a.m. - 9:15 a.m. CDT in S100a. Additional Poster Presentations with SCRI First Authors Saturday, June 1 “Validation of PD-L1 as a Predictive Biomarker of Response in Operable Gastroesophageal Adenocarcinoma: A Meta-Analysis and Meta-Regression of Neoadjuvant Chemoimmunotherapy Trials,” Antonella Cammarota, MD, SCRI at HCA Healthcare UK, 1:30 p.m. - 4:30 p.m. CDT, Hall A. “Phase 1 Trial Safety and Efficacy of Ragistomig, a Bispecific Antibody Targeting PD-L1 and 4-1BB, in Advanced Solid Tumors,” Gerald Falchook, MD, SCRI at HealthONE, 9:00 a.m. - 12:00 p.m. CDT, Hall A. “NALIRIFOX versus Nab-Paclitaxel and Gemcitabine in Treatment-Naïve Patients with Metastatic Pancreatic Ductal Adenocarcinoma: Updated Overall Survival Analysis with 29-Month Follow-Up of NAPOLI 3,” Maen Hussein, MD, SCRI at Florida Cancer Specialists & Research Institute, 1:30 p.m. - 4:30 p.m. CDT, Hall A. “Safety and Preliminary Efficacy of EIK1001 in Combination with Atezolizumab in Participants with Advanced Solid Tumors,” & “Preliminary Results from a Phase 1 Study of AC699, an Orally Bioavailable Chimeric Estrogen Receptor Degrader, in Patients with Advanced or Metastatic Breast Cancer,” Manish Patel, MD, SCRI at Florida Cancer Specialists & Research Institute, 9:00 a.m. - 12:00 p.m. CDT, Hall A. “Results from Phase 1a/1b Analyses of TTX-080, a First in Class HLA-G Antagonist, in Combination with Cetuximab in Patients with Metastatic Colorectal Cancer and Head and Neck Squamous Cell Carcinoma,” Susanna Ulahannan, MD, MMEd, SCRI at OU Health - Stephenson Cancer Center, 9:00 a.m. - 12:00 p.m. CDT, Hall A. “Phase 1/2 Study of NGM707, an ILT2/ILT4 Dual Antagonist Antibody, in Advanced Solid Tumors: Interim Results from Dose-Escalation,” Judy Wang, MD, SCRI at Florida Cancer Specialists & Research Institute, 9:00 a.m. - 12:00 p.m. CDT, Hall A Sunday, June 2 “Trastuzumab Deruxtecan vs Trastuzumab Emtansine in Patients with HER2+ Metastatic Breast Cancer: Updated Survival Results of DESTINY-Breast03,” Dr. Hamilton, 9:00 a.m. - 12:00 p.m. CDT, Hall A. Monday, June 3 “Subcutaneous Epcoritamab Administered Outpatient for Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma: Results from Phase 2 EPCORE NHL-6," David Andorsky, MD, SCRI at Rocky Mountain Cancer Centers I The US Oncology Network, 9 a.m. - 12 p.m. CDT, Hall A “MYTX-011 in Patients with Previously Treated Locally Advanced or Metastatic NSCLC: Initial Dose Escalation Results in The Phase 1 KisMET-01 Study,” Melissa Johnson, MD, SCRI, 1:30 p.m. - 4:30 p.m. CDT, Hall A. “Clinical Activity and Safety of Naptumomab Estafenatox and Docetaxel in Patients with Checkpoint Inhibitor –Pretreated Advanced/Metastatic Non-Small Cell Lung Cancer: Preliminary Results of a P2 Trial,” Tim Larson, MD, SCRI at Minnesota Oncology I The US Oncology Network, 1:30 p.m. - 4:30 p.m. CDT, Hall A. “Treatment of Acute Myeloid Leukemia with Orca-T,” Jeremy Pantin, MD, SCRI at TriStar Centennial, 9:00 a.m. - 12:00 p.m. CDT, Hall A. “Safety and Tolerability of Durvalumab + Carboplatin/Paclitaxel Followed by Durvalumab ± Olaparib in Patients with Newly Diagnosed Advanced or Recurrent Endometrial Cancer in the DUO-E/GOG-3041/ENGOT-EN10 Trial,” Jessica Thomes Pepin, MD, SCRI at Minnesota Oncology I The US Oncology Network, 9:00 a.m. - 12:00 p.m. CDT, Hall A. “OPTec: A Phase 2 Study to Evaluate Outpatient Step-Up Administration of Teclistamab, a BCMA-Targeting Bispecific Antibody, in Patients with Relapsed/Refractory Multiple Myeloma,” Robert Rifkin, MD, SCRI at Rocky Mountain Cancer Centers I The US Oncology Network, 9:00 a.m. - 12:00 p.m. CDT, Hall A. “Clinical Trial Participation and End-of-Life Care Among Older Adults: A Multi-Center Longitudinal Observational Cohort Analysis of 121,717 Patients with Cancer,” Dr. I. Subbiah, 9:00 a.m. - 12:00 p.m. CDT, Hall A. “Performance of Comprehensive Genomic Profiling versus Single Gene Testing in Guideline-Recommended Biomarker Selection in Non-Small Cell Lung Cancer,” Dr. V. Subbiah, 1:30 p.m. - 4:30 p.m. CDT, Hall A. About Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI joined with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 750 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today. SCRI’s research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 states across the U.S. Learn more about our research offerings. View source version on businesswire.com: Contacts Becca Gelman Becca.Gelman@scri.com Source: Sarah Cannon Research Institute View this news release online at: