PHASE 1, OPEN LABEL, DOSE-ESCALATION STUDY OF CRX100 IN PATIENTS WITH ADVANCED SOLID TUMORS

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Grant Award Details

Grant Number:
CLIN2-12823
Investigator(s):
Disease Focus:
Human Stem Cell Use:
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.