OC-001 / Ocellaris Pharma - LARVOL DELTA

BLOSSOM: Biweekly Long-term Occidiofungin Study for Suppression of Mycotic Recurrence (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Sano Chemicals Inc

New P2 trial • Candidiasis • Vaginitis

A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers (clinicaltrials.gov) - P1/2 | N=73 | Terminated | Sponsor: Ocellaris Pharma, Inc. | Trial completion date: Sep 2026 ➔ Nov 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Mar 2026 ➔ Nov 2025; Business Decision

Monotherapy • Trial completion date • Trial primary completion date • Trial termination • B Cell Lymphoma • Bladder Cancer • Breast Cancer • Cervical Cancer • Gastric Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Merkel Cell Carcinoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Sarcoma • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • ALK • ER • HER-2 • PGR • ROS1

A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers (clinicaltrials.gov) - P1/2 | N=73 | Active, not recruiting | Sponsor: Ocellaris Pharma, Inc. | Recruiting ➔ Active, not recruiting | N=116 ➔ 73

Enrollment change • Enrollment closed • Monotherapy • Bladder Cancer • Breast Cancer • Cervical Cancer • Gastric Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Merkel Cell Carcinoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Sarcoma • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • ALK • ER • HER-2 • PGR • ROS1

Combination Therapy for Platinum-Resistant Ovarian Cancer: A Novel At-Home Regimen with Envafolimab, Lenvatinib, and Etoposide. (PubMed, Oncologist) - P2 | "Envafolimab combined with lenvatinib and etoposide showed promising efficacy and tolerable safety for patients with platinum-resistant recurrent ovarian cancer."

Journal • Platinum resistant • CNS Disorders • Depression • Hematological Disorders • Leukopenia • Mood Disorders • Oncology • Ovarian Cancer • Psychiatry • Solid Tumor • Thrombocytopenia

A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers (clinicaltrials.gov) - P1/2 | N=116 | Recruiting | Sponsor: Ocellaris Pharma, Inc. | N=80 ➔ 116

Combination therapy • Enrollment change • Metastases • Monotherapy • Bladder Cancer • Breast Cancer • Cervical Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Merkel Cell Carcinoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Sarcoma • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • ALK • ER • HER-2 • PGR • ROS1

Efficacy and safety of envafolimab plus lenvatinib combined with etoposide in recurrent ovarian, peritoneal, and fallopian tube cancer: An open-label, single-arm study—The ENLEN-OC-001 study. (ASCO 2024) - P2 | "Oral etoposide is administered for six to ten cycles... The combination of envafolimab plus lenvatinib combined with etoposide shows promising efficacy and manageable toxicities in patients with platinum-resistant ovarian cancer. Clinical trial information: NCT05422183."

Clinical • Fallopian Tube Cancer • Hematological Disorders • Leukopenia • Oncology • Ovarian Cancer • Thrombocytopenia

A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers (clinicaltrials.gov) - P1/2 | N=80 | Recruiting | Sponsor: Ocellaris Pharma, Inc. | Phase classification: P1b/2a ➔ P1/2 | Trial completion date: Nov 2022 ➔ Sep 2026

Phase classification • Trial completion date • Bladder Cancer • Breast Cancer • Cervical Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Merkel Cell Carcinoma • Non Small Cell Lung Cancer • Non-melanoma Skin Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Sarcoma • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • ALK • ER • HER-2 • PGR • ROS1

Intravaginal Gel for Sustained Delivery of Occidiofungin and Long-Lasting Antifungal Effects. (PubMed, Gels) - "A gel formulation containing occidiofungin (OCF001) is being developed for use to treat vulvovaginal candidiasis...In this study, the gel formulation was shown to reduce the drug substance rate of diffusion across a skin memetic membrane. The study showed that the formulation extends exposure time to inhibitory concentrations of occidiofungin over a 24-h period and supports a single daily application for the treatment of RVVC."

Journal • Candidiasis • Infectious Disease • Vaginitis

A phase Ib dose escalation study of CD137 mAb agonist OC-001 as monotherapy in patients with advanced or metastatic cancer (ESMO 2022) - P1b/2a | "The mAb has predicable PK characteristics. OC-001 is a potential candidate for combination therapy with immune-oncology agents."

Clinical • IO biomarker • Monotherapy • P1 data • Oncology • TNFRSF9

A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers (clinicaltrials.gov) - P1b/2a; N=80; Recruiting; Sponsor: Ocellaris Pharma, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Monotherapy • Bladder Cancer • Breast Cancer • Cervical Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Merkel Cell Carcinoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • ALK • ER • HER-2 • PGR • ROS1

A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers (clinicaltrials.gov) - P1b/2a; N=80; Not yet recruiting; Sponsor: Ocellaris Pharma, Inc.; Initiation date: Apr 2020 ➔ Aug 2020

Clinical • Combination therapy • Monotherapy • Trial initiation date • Bladder Cancer • Breast Cancer • Cervical Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hepatocellular Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Merkel Cell Carcinoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer • Triple Negative Breast Cancer • Urothelial Cancer • ALK • ER • HER-2 • PGR • ROS1