AC699 / Accutar Biotech - LARVOL DELTA

AC699-001: Study of AC699 in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P1 | N=100 | Active, not recruiting | Sponsor: Accutar Biotechnology Inc | Recruiting ➔ Active, not recruiting | N=60 ➔ 100 | Trial completion date: Dec 2024 ➔ May 2026 | Trial primary completion date: Jul 2024 ➔ Mar 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

AC699, a novel chimeric estrogen receptor degrader, in a phase I study in breast cancer (ESMO 2024) - P1 | "Selective ER degraders (SERD) such as elacestrant and fulvestrant result in objective response rates (ORR) of approximately 7% and 2% in the EMERALD trial. Preliminary data from this ongoing phase 1 trial evaluating AC699 indicate promising safety, tolerability, and anti-tumor activity, with linear PK up to 400 mg orally once daily. Phase 1b and phase 2 studies are planned."

P1 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Accutar Biotechnology Receives FDA Fast Track Designation for AC699 in ER+ / HER2- Breast Cancer (Businesswire) - "Accutar Biotechnology, Inc...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."

Fast track • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor

Sixteen Researchers from Florida Cancer Specialists & Research Institute Share Cancer Care Discoveries at 2024 ASCO Annual Meeting (PRNewswire) - "Florida Cancer Specialists & Research Institute, LLC (FCS) physicians will present findings from multiple clinical studies that are contributing to global advancements in cancer care at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Clinical research originating from trials conducted at the three FCS Phase 1 Drug Development Units and late-phase studies at FCS clinics throughout Florida are among those being published or presented during the five-day international gathering of oncology physicians and professionals."

Clinical data • P1 data • P1/2 data • Breast Cancer • Liver Cancer • Non Small Cell Lung Cancer • Solid Tumor

Preliminary results from a phase 1 study of AC699, an orally bioavailable chimeric estrogen receptor degrader, in patients with advanced or metastatic breast cancer. (ASCO 2024) - P1 | "Prior treatments included CDK4/6 inhibitor (100%), aromatase inhibitor (91%), fulvestrant (82%), novel oral SERD or covalent antagonist (SERCA) (23%), and ER chimeric degrader (14%). Preliminary data from the ongoing phase 1 trial evaluating AC699 indicate promising safety, tolerability, and anti-tumor activity, at doses up to 300 mg orally once daily. A phase 2 study will begin enrolling in early 2024."

Clinical • Metastases • P1 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Fatigue • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Targeted Protein Degradation • ER • HER-2

Accutar Biotechnology Presents Phase 1 Data of AC699 Monotherapy in Patients with ER+ / HER2- Breast Cancer at ASCO 2024 (Businesswire) - P1 | N=60 | NCT05654532 | Sponsor: Accutar Biotechnology Inc | "Accutar Biotechnology, Inc...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 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."

P1 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor

A Phase 1 trial evaluating AC699, an orally bioavailable chimeric estrogen receptor degrader, in patients with advanced or metastatic breast cancer (AACR 2024) - P1 | "Aromatase inhibitors, selective estrogen receptor modulators, and selective ER degraders (SERDs) such as fulvestrant, and more recently elacestrant, are integral components of the therapeutic strategy for patients with ER-positive breast cancer. Secondary objectives include assessment of preliminary anti-tumor activity and characterization of the pharmacokinetic profile of single and multiple doses of AC699. Enrollment began in December 2022 and a total of 5 sites have been activated in the United States."

Clinical • Metastases • P1 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

AC699-001, a first in human Phase 1 trial utilizing a novel estrogen receptor chimeric degrader in patients with advanced or metastatic breast cancer (SABCS 2023) - P1 | "Modulation of estrogen activity with therapeutics such as tamoxifen and aromatase inhibitors have been the mainstay therapeutic strategy for ER-positive breast cancer. Several ER-directed therapies have been developed to antagonize the oncogenic ER function, including Selective ER Degraders (SERDs) such as fulvestrant which is approved to treat patients with advanced or metastatic breast cancer...Enrollment began in December 2022 with five sites in the United States planned. NCT05654532."

Clinical • Metastases • P1 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Study of AC699 in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Accutar Biotechnology Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Study of AC699 in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Accutar Biotechnology Inc

Metastases • New P1 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2