On April 21, 2020 OncoSec Medical Incorporated ("OncoSec") (Nasdaq: ONCS), a company developing late-stage intratumoral cancer immunotherapies, reported pre-clinical data from a feasibility study of its visceral lesion applicator (VLA) electroporation device and APOLLO generator which were presented online at the Annual Meeting of the Society of Interventional Radiology (SIR) (Press release, OncoSec Medical, APR 21, 2020, View Source [SID1234556479]). The feasibility study demonstrated the capability of a rigid, trocar-like VLA applicator to safely deliver and electroporate DNA-based immunotherapy directly into target organs in a large animal model using a CT-guided approach and OncoSec’s new, lower voltage APOLLO generator.
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In a study titled, "Can an Intratumoral DNA-Encoded Immunotherapeutic Device Platform Currently Used in the Management of Cutaneous Lesions Be Scaled in Size to Function in the Treatment of Visceral Tumors Through Image-Guided Techniques?", investigators built upon data presented at the Annual Meeting of the Society of Interventional Oncology (SIO) demonstrating the VLA’s ability to reach deep visceral organs using laparoscopic/ultrasound and bronchoscope/steerable catheter methods in live large animal models.
In the study presented online at the Annual Meeting of the SIR, OncoSec demonstrated the ability to guide and deploy the VLA under a different guidance method and electroporate with the APOLLO generator. Using CT-guidance, investigators were able to reach high value targets including liver, lung, bone, and pancreas in a live large animal model. Additionally, TAVO was safely delivered and electroporated directly into the liver. Importantly, data also showed that it had no significant effects on hemodynamics, as indicated by consistent heart rate and arterial blood pressure. Animals were survived for at least 24 hours and no adverse events were observed.
"The potential opportunities that this technology represents are very promising. Interventional radiologists are eager to find treatment solutions that extend beyond standard of care. The possibility of delivering potent immunotherapy directly to visceral tumors in radiology suites could shift the paradigm of how we treat certain tumors, particularly in the liver, lung and bone," said Dr. Daniel Simon, Board Certified Interventional Radiologist at Vascular Management Associates of New Jersey and Maryland Cardiology Associates, and scientific advisor to OncoSec, who performed these large animal studies presented at SIR.
OncoSec has developed a short mechanism of action video that illustrates the way the VLA system is designed to target and treat tumors in humans. The video can be accessed on the Company’s website via View Source
In the previous feasibility study originally reported at SIO, large live healthy animal subjects were placed under general anesthesia while investigators safely and successfully accessed and deployed the VLA in the lungs with a flexible, catheter-based applicator using a bronchoscope and a steerable catheter, and liver using ultrasound-guided laparoscopy with a rigid-trocar-based applicator. Following deployment of the VLA, electroporation was performed in the liver using the company’s proprietary APOLLO generator. No adverse effects were recorded during or after electroporation. Additionally, initial data from the APOLLO generator’s built-in feedback system embedded within the platform detected and recorded trends in impedance values between different tissue types, as well as between the presence and absence of DNA. The APOLLO generator was also able to indicate when the applicator tip was not effectively placed within the tissue. These data highlight the safety mechanisms as well as the future possibility of differentiating between healthy tissue and a local tumor. Data from both SIR and SIO can be accessed via the two respective posters at View Source
"This study of our VLA device demonstrates the feasibility of reaching critical tissue targets, delivering a drug — in this case our lead product, TAVO, and electroporating in a large-animal model," said John Rodriguez, Vice President, Product Engineering at OncoSec. "We are very encouraged by these data, as they support our belief that electroporation combined with delivering drug intratumorally may be possible in tumors located within internal organs. These results allow us to move forward with a preclinical safety study in the near term, followed by the potential filing of an Investigational New Drug application and initiation of a phase 1 human clinical trial using the VLA platform in combination with TAVO."