On December 9, 2022 Imugene Limited (ASX:IMU), a clinical stage immuno-oncology company, reported new and first data from triple negative breast cancer (TNBC) patients in the Phase I CHECKVacc trial has been presented as a poster presentation at the 2022 San Antonio Breast Cancer Symposium (SABC 2022) on 9 December 2022 AEDT in San Antonio, Texas (Press release, Imugene, DEC 9, 2022, View Source [SID1234624966]). Information is also available on the company’s website.

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The presentation, titled "Phase I study of intratumoral administration of CF33-hNIS-antiPD-L1 (CHECKvacc) in patients with metastatic triple negative breast cancer", was presented by Dr Yuan Yuan M.D., PhD, Cedars Sinai Medicine, Los Angeles and Dr Jamie Rand M.D., City of Hope, Los Angeles.

Imugene MD & CEO Leslie Chong said: "Phase 1 trials are generally designed to look for safety, tolerability and early response signals to determine the optimal dose for further development. I am encouraged that we are seeing positive signals with correlative biomarker and imaging data at such an early stage of our CHECKVacc Phase I trial."

CF33-hNIS-antiPD-L1 administered by intratumoral injection in patients with metatstatic TNBC is safe and well tolerated at the dose levels tested.

Highlights and results include:

1. From October 2021 to June 2022, 6 patients were enrolled in this ongoing study and received at least 1 dose of CHECKvacc injection at dose level 1 (1 x 10^5 pfu) or dose level

2 (3 x 10^5 pfu). 2. No dose-limiting toxicities were observed. No treatment related adverse events were reported for 6 patients except 1 patient with injection site discoloration.

3. 99mTc SPECT imaging for virus tracking from virus induced replication of the human sodium iodide (hNIS) transgene shows enhancement in 4/6 (67%) patients in the first 2 dose levels. Enhancement was greater in patients with injection of nodal disease compared to dermal metastasis.

4. SPECT imaging of patient COH-004 (DL-2) on C1D8 showed significant enhancement of injected lymph node.

5. Baseline and on-treatment tumor biopsies of patient COH-004 using spatial immune profiling showed an increase in PD-L1 positive cells following treatment with CHECKVacc, demonstrating immune activation and tumor microenvironment changes in association with response to therapy. IMUGENE LIMITED ACN 009 179 551 2

Taken together, these data support further evaluation of CHECKVacc in TNBC. CF33-hNIS-antiPDL1 is an immune checkpoint inhibitor armed chimeric vaccinia poxvirus from the lab of CF33 inventor Professor Yuman Fong, Chair of Sangiacomo Family Chair in Surgical Oncology at City of Hope, one of the largest cancer research and treatment organizations in the United States, and a noted expert in the oncolytic virus field.

Oncolytic viruses (OVs) are designed to both selectively kill tumour cells and activate the immune system against cancer cells, with the potential to improve clinical response and survival.

Full study details can also be found on clinicaltrials.gov under study ID: NCT05081492