VAXinia (CF33-hNIS)

P1, N=100, Active, not recruiting, Imugene Limited | Recruiting --> Active, not recruiting

P1, N=50, Active, not recruiting, Imugene Limited | Recruiting --> Active, not recruiting

P1, N=100, Recruiting, Imugene Limited | Trial completion date: Jan 2025 --> Nov 2026 | Trial primary completion date: Dec 2024 --> Jun 2026

P1, N=50, Recruiting, Imugene Limited | N=33 --> 50

P1, N=33, Recruiting, Imugene Limited | N=52 --> 33 | Trial completion date: Sep 2025 --> May 2029 | Trial primary completion date: Sep 2024 --> Jun 2027

P1, N=100, Recruiting, Imugene Limited

CF33-hNIS can replicate within cholangiocarcinoma lesions, as shown by SPECT imaging, and drive immunological changes known to promote antitumor immunity. CF33-hNIS monotherapy may be an effective and safe treatment option for GI malignancies, including cholangiocarcinoma, a rare disease with an unmet medical need. Treatment with CF33-hNIS monotherapy was well tolerated and the study has advanced to examine combination therapy with pembrolizumab.

P1, N=52, Recruiting, Imugene Limited | Not yet recruiting --> Recruiting

Finally, PET scanning was performed following injection of the radioisotope I-124, for imaging of tumors, and a single dose of virus as low as 1E03 pfu, administered intra-tumorally or intravenously, allowed for PET imaging of tumors. In conclusion, CF33-hNIS is safe and effective in controlling human tumor xenografts in nude mice, and it also facilitates noninvasive imaging of tumors.

Lastly, PET scanning was performed following injection of the radioisotope I-124, for imaging of tumors, and a single dose of virus as low as 1E03 pfu, administered intratumorally (I.T.) or intravenously (I.V.), allowed for PET imaging of tumors. In conclusion, CF33-hNIS is safe and effective in controlling human tumor xenografts in nude mice, and it also facilitates non-invasive imaging of tumors.

Currently, there are six systemic therapies available for patients with advanced disease including atezolizumab in combination with bevacizumab, lenvatinib, regorafenib, cabozantinib and ramucirumab while curative treatments include ablation, surgical resection, and liver transplantation...We have harnessed this capability of OV and developed a chimeric vaccinia-based OV called CF33-CD19t (onCARlytics) that delivers a non-signaling, truncated CD19 (CD19t) antigen to solid tumors allowing CD19-specific T cells to target them...In addition, this combination approach demonstrated impressive in vivo anti-tumor responses in a human xenograft HepG2 tumor model. By using this combination OV and CAR T cell strategy, we have now broadened the utility of CD19 ARTEMIS® T cells to otherwise target-less tumors such as HCC, which we anticipate can be applied to a wide array of solid cancers as an effective immunotherapy approach.

This combination approach demonstrated impressive in vivo anti-tumor response in human tumor xenograft models. Conclusions In summary, our results have demonstrated that further development of this combination immunotherapy for the potential treatment of a wide array of solid tumors is warranted.