1771P - Blessed: Expanded yccess for DeltaRex-G in vivo gene therapy for sarcoma, pancreas and breast cancer (NCT04091295) and other solid malignancies (IND# 19130)

Background

Overexpression of CCNG1 was previously reported in 100% of cancer types tested at the Cancer Center of Southern California, indicating that CCNG1 is a molecular target for DeltaRex-G CCNG1 inhibitor therapy.

Methods

Expanded access for DeltaRex-G was available for eligible patients ≥ 12 years of age for sarcoma and ≥ 18 years of age for pancreas and breast cancer and other solid tumors. Endpoints: Primary: overall survival. Secondary: disease control rate, incidence of treatment related adverse events; Correlative: correlation between CCNG1 RNA expression level and survival. Treatment Schedule: DeltaRex-G 1-4 x 10e11 cfu intravenously 1-3x a week with or without an FDA approved drug. Statistical analysis: descriptive statistics was used.

Results

This expanded access program enrolled 23 patients for treatment with either DeltaRex-G monotherapy or in combination with FDA approved drugs (DeltaRex-G+). Histological types included sarcoma (n=13), pancreatic adenocarcinoma (n=3), non-small cell lung cancer (n=1), breast carcinoma (n=3), prostate cancer (n=1), cholangiocarcinoma (n=1) and basal cell carcinoma (n=1). Median number of chemo/immuno/targeted therapy regimens = 4 (range 1-10). Of 23 patients enrolled, 18 patients were treated with DeltaRex-G monotherapy or DeltaRex-G+. With DeltaRex-G alone (n=9), the response was 2 SD, 7PD, and 28% DCR and all patients had metastatic disease. With DeltaRex-G+ (n=9): 2 had no recurrence, 2PR, 4SD, 1PD, 28.5% ORR and 86% DCR. (Table). In one patient, steroid-resistant immune-related pneumonitis resolved with DeltaRex-G+. No DeltaRex-G-related adverse events were reported.

Conclusions

Taken together, these data suggest that (1) CCNG1 is a molecular target for DeltaRex-G, a CCNG1 inhibitor, (2) DeltaRex-G+ may prevent recurrence in high-risk patients with Stage 1 breast cancer, (3) DeltaRex-G+ may evoke tumor growth stabilization in patients who had previously failed chemotherapy, (4) DeltaRex-G+ may prime tumors to better respond to chemotherapy, targeted therapy, immunotherapy, ((5) DeltaRex-G+ may be an effective treatment for steroid resistant immune-related pneumonitis.

Clinical trial identification

NCT04091295 February 6, 2020.

Editorial acknowledgement

Legal entity responsible for the study

Sarcoma Oncology Research Center.

Funding

Aveni Foundation.

Disclosure

R. Carter: Financial Interests, Personal, Full or part-time Employment: BostonGene, Inc. W. Swaney: Financial Interests, Personal, Full or part-time Employment: Expression Therapeutics, Incc. F.L. Hall: Financial Interests, Personal, Member: Delta Next-Gene, LLC. P. Chang, P. Song: Financial Interests, Personal, Full or part-time Employment: NKGen Biotech, Inc. E.M. Gordon: Financial Interests, Personal, Member: Delta Next-Gene, LLC. All other authors have declared no conflicts of interest.