Name:
Institution:
Type:
PI
Grant Award Details
PHASE 1, OPEN LABEL, DOSE-ESCALATION STUDY OF CRX100 IN PATIENTS WITH ADVANCED SOLID TUMORS
Grant Type:
Grant Number:
CLIN2-12823
Project Objective:
- The objective of this award is to complete a Phase 1 open label dose-escalation trial to test the safety and preliminary efficacy of CRX100 in patients with advanced solid tumors. CRX100 is comprised of autologous Cytokine-Induced Killer (CIK) immune cells that have been infected with a vaccinia virus that has been engineered for both safety and oncolytic activity.
Investigator:
Disease Focus:
Cancer
Solid Tumors
Human Stem Cell Use:
Adult Stem Cell
Award Value:
$7,999,689
Status:
Active
Grant Application Details
Application Title:
- PHASE 1, OPEN LABEL, DOSE-ESCALATION STUDY OF CRX100 IN PATIENTS WITH ADVANCED SOLID TUMORS
Public Abstract:
Therapeutic Candidate or Device
Immune cells loaded with a cancer-killing virus that targets cancer tissue, not healthy tissue.
Indication
Advanced, refractory solid tumors: CRC, HCC, Osteosarcoma, NNN Breast, Ovarian, Gastric
Therapeutic Mechanism
The proposed therapy pairs activated immune cells with an adapted oncolytic virus that selectively infects and kills malignant cells. The result of this combination is a multi-mechanistic, targeted treatment that we believe will not only eradicate cancer cells, but also protect the patient from relapse and recurrence, through a durable immune response that prevents the development of new cancers, even in the face of new challenges from disease.
Unmet Medical Need
We address the unmet need of resistant and recurring cancers by combining activated cytokine-induced killer cells (CIK) and an oncolytic virus that have been thoroughly tested in humans with excellent safety profiles but which if taken as individual therapies have limited efficacy.
Project Objective
Phase 1 trial completed
Major Proposed Activities
- Manufacture CRX100
- Assess Safety and Tolerability
- Determine Maximum Tolerated Dose
Statement of Benefit to California:
Our compound holds promise for metastatic disease treatment with limited toxicity. Because our therapy uses a patient’s own immune cells, expanded and activated outside the body, a patient does not have to undergo depletion of their circulating cells by a specific drug or receive highly toxic cytokines during treatment, which may increase safety. Thus, this research has the potential to greatly benefit the State of California and its citizens.
