CRX100 / BioEclipse - LARVOL DELTA

CRX100 Delivers Responses and Tolerability in Platinum-Resistant Ovarian Cancer (Targeted Oncology) - P1 | N=60 | NCT04282044 | Sponsor: BioEclipse Therapeutics | "The combination of the novel adoptive natural killer-like T (NK-T) cell therapy CRX100 with oncolytic vaccinia virus demonstrated tolerability and conferred responses in a small cohort of patients with recurrent platinum-resistant ovarian cancer, according to findings from a phase 1 trial (NCT04282044) presented as a poster at the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Investigators reported stable disease in 1 patient who received an initial dose of 1E8 plaque-forming units (PFUs) of vaccinia plus 2-5E9 NK-T cells. Additionally, the patient had reduced tumor burden following a second dose of CRX100. This patient received subsequent treatment with an experimental antibody-drug conjugate plus pembrolizumab (Keytruda), which reduced CA125 serum marker levels to 296 U/mL."

P1 data • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Safety and tolerability of CRX100, an NKT cell therapy combined with tumor-specific oncolytic vaccinia virus, among patients with recurrent, platinum-resistant ovarian cancer (SGO 2024) - P1 | "Eleven months following the second CRX100 treatment, the CA125 serum marker level decreased significantly from 20,435 iU/ml to 11,538 iU/ml with regression of several tumor sites by CT imaging, The patients’ follow-up treatment using an experimental antibody drug conjugate targeting CD25 on Treg cells combined with pembrolizumab induced a further decrease of CA125 to 296 U/ml. This is the first in human trial using adoptive NK-T cell infusion combined with an oncolytic vaccinia virus. The treatment with CRX100 was well tolerated and induced both clinical and immunological responses in patients with recurrent, platinum resistant ovarian cancer. Based on our clinical observations and translational data, we have developed an expansion clinical protocol that will include lymphodepletion prior to CRX100 treatment, and immune checkpoint inhibition to amplify anti-tumor cellular immune responses in the tumor microenvironment."

Clinical • IO biomarker • Oncolytic virus • Breast Cancer • Colorectal Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • IFNG • IL2 • IL2RA • MUC16 • NCAM1

Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: BioEclipse Therapeutics | N=24 ➔ 60 | Trial completion date: Mar 2025 ➔ Oct 2026 | Trial primary completion date: Oct 2024 ➔ Aug 2025

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Osteosarcoma • Ovarian Cancer • Sarcoma • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

Study of CRX100 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: BioEclipse Therapeutics | Trial completion date: May 2022 ➔ Mar 2025 | Trial primary completion date: May 2022 ➔ Oct 2024

Trial completion date • Trial primary completion date • Breast Cancer • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Osteosarcoma • Ovarian Cancer • Sarcoma • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

BioEclipse Therapeutics Awarded Almost $8 Million Grant by California Institute for Regenerative Medicine (CIRM) to Fund Ongoing Phase 1 CRX100 Cancer Immunotherapy Clinical Trial (PRNewswire) - "BioEclipse Therapeutics...announced...it has been awarded a $7,999,689.00 grant by the California Institute for Regenerative Medicine (CIRM) to support its ongoing clinical study: A Phase 1, open-label, dose-escalation study of CRX100 in patients with advanced solid tumors."

Financing • Oncology • Solid Tumor

A phase 1 open label, first in human trial to study safety and tolerability of NK-T cells combined with vvDD: An accelerated dose escalation in multiple tumor types (AACR 2022) - "Introduction: BioEclipse Therapeutics has developed CRX100 an adoptive NK-T Cells therapy combined with vaccinia vvDD, an oncolytic virus... Thus far in escalation, all doses of the therapy have been safe and well-tolerated. Two patients with ovarian cancer treated with the adoptive NKT cell therapy combined with an oncolytic virus demonstrated changes in CA-125 potentially consistent with immune inflammation. Peripheral blood obtained at 3 and 6 month will be analyzed to assess specific immune responses."

Clinical • IO biomarker • P1 data • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Osteosarcoma • Ovarian Cancer • Sarcoma • Solid Tumor • Triple Negative Breast Cancer • MUC16

BioEclipse Therapeutics Announces First Patient Dosed in Phase 1 Dose-Escalation Clinical Trial of CRX100 in Refractory Solid Tumors (PRNewswire) - "BioEclipse Therapeutics™...announced...the administration of the first dose of CRX100 to a volunteer in the ongoing Phase 1 clinical trial in patients with refractory solid tumors. The trial is a first-in-human study for CRX100...The study will enroll up to 24 participants ­18 years or older and specifically target six potential cancer indications, including: triple-negative breast cancer, colorectal cancer, hepatocellular carcinoma, osteosarcoma, epithelial ovarian cancer, and gastric cancer."

Trial status • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Hepatocellular Cancer • Oncology • Osteosarcoma • Ovarian Cancer • Sarcoma • Solid Tumor • Triple Negative Breast Cancer

BioEclipse Initiates Enrollment in Phase 1 Dose-Escalation Clinical Trial for CRX100 at HonorHealth Research Institute (PRNewswire) - "BioEclipse Therapeutics...announced...the initiation of patient enrollment at the HonorHealth Research Institute in Scottsdale, Ariz. for a Phase 1 dose-escalation trial to treat refractory solid tumors. The trial marks the first-in-human study of CRX100, an intravenously delivered agent designed to target and destroy multiple cancer types and address disease recurrence....The trial specifically targets six potential cancer indications, including: triple-negative breast cancer, colorectal cancer, hepatocellular carcinoma, osteosarcoma, epithelial ovarian cancer, and gastric cancer."

Enrollment open • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Hepatocellular Cancer • Oncology • Osteosarcoma • Ovarian Cancer • Sarcoma • Triple Negative Breast Cancer

BioEclipse Initiates Enrollment in Phase 1 Dose-Escalation Clinical Trial for CRX100 (PRNewswire) - "BioEclipse Therapeutics...announced today the initiation of patient enrollment in a Phase 1 dose-escalation trial to treat refractory solid tumors...Patient enrollment is underway at our first clinical trial site, Moores Cancer Center at UC San Diego Health in La Jolla, CA. Additional clinical trial sites are expected to follow....'The initiation of this clinical trial is welcome news given the urgent need for more effective approaches, especially for patients with cancer refractory to standard treatments,' said Sandip Patel, M.D..."

Media quote • Trial status • Oncology • Solid Tumor

Study of CRX100 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: BioEclipse Therapeutics; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Breast Cancer • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Osteosarcoma • Ovarian Cancer • Sarcoma • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2

Study of CRX100 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: BioEclipse Therapeutics; Initiation date: Jun 2020 ➔ Oct 2020

Clinical • Trial initiation date • Breast Cancer • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Osteosarcoma • Ovarian Cancer • Sarcoma • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2

BioEclipse receives FDA clearance of Investigational New Drug Application for CRX100 (PRNewswire) - “BioEclipse Therapeutics™…announced today that the U.S. Food and Drug Administration has cleared the Investigational New Drug (IND) application for the Company's lead drug candidate, CRX100…BioEclipse plans to initiate a Phase 1 clinical trial of its patented CRX100 in therapy-refractory solid tumors in 2020....'We have an urgent need for more effective treatments especially for patients with disease refractory to standard treatments,' said Oliver Dorigo...'CRX100 has the potential to be effective not only in women with ovarian cancer, but in many other tumor types with an otherwise poor prognosis. This new immunotherapy is based on meticulous scientific studies and brings new hope to our patients and their families.'"

IND • Media quote • Oncology • Solid Tumor

"#BioEclipse Receives #FDA Clearance of #InvestigationalNewDrugApplication for #CRX100 https://t.co/EnhxBy02a2" (@1stOncology)

IND

Study of CRX100 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: BioEclipse Therapeutics

Clinical • New P1 trial • ER • HER-2