Tuesday, January 08, 2019 5:42:39 PM
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Target Price: $5.00
TAVO to Move into Second Registration-Enabled Study; Cervical Cancer
maximgrp.com
Summary:
OncoSec announced the company, in collaboration with the Gynecologic Oncology Group (GOG) Foundation, plans to conduct a registration-enabled study evaluating the combination of TAVO (DNA-based IL-12) + Keytruda in recurrent/persistent cervical cancer (study OMS-150).
Recall that the P2b registration-enabled study (KEYNOTE-695) of the combination in late stage melanoma patients that have failed checkpoint therapy is ongoing with more data expected in 2019. The cervical cancer study is expected to initiate in 1H19.
In both indications, the expected response to continued checkpoint therapy is <15%. TAVO has demonstrated in solid tumors an ability to turn 'cold' tumors 'hot' to increase the response rate to checkpoints.
The study in cervical cancer plans to enroll 80-100 patients. KEYNOTE-695 enrollment is targeting ~80 patients. The trial sizes are in-line with trial sizes for single arm studies aiming for potential registration. Keytruda in this stage of cervical cancer received accelerate approval from an N=98 patient study with a 14% response rate.
Conclusion. The potential to leverage TAVO as an immune stimulator to be combined with checkpoints continues to grow indication by indication. Melanoma P2b is ongoing, a P2 in breast cancer and the cervical cancer study are next. Updates expected in 2019.
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