OncoSec Medical has dosed the first patient in the OMS-104 phase 2 clinical trial, which is evaluating TAVO (tavokinogene telseplasmid) in combination with OPDIVO (nivolumab) as a neoadjuvant therapy for melanoma.
TAVO is OncoSec Medical’s intratumoral DNA plasmid-based interleukin-12 (IL-12) therapy, which is intended to be administered using its gene delivery platform (gene electrotransfer).
On the other hand, OPDIVO is an anti-PD-1 checkpoint inhibitor from Bristol-Myers Squibb, which has been approved for the treatment of certain types of cancer.
The OMS-104 clinical trial will investigate the TAVO/ OPDIVO combination as a neoadjuvant therapy before carrying out surgery in patients having operable, locally or regionally advanced melanoma.
The mid-stage clinical trial is designed to study if the addition of TAVO can enhance clinical outcomes observed already with nivolumab alone used as a neoadjuvant therapy.
The OMS-104 phase 2 clinical trial aims to have 33 patients on board and will have three phases – neoadjuvant phase, surgical phase, and adjuvant phase.
The primary endpoint of the OMS-104 melanoma clinical trial is pathological complete response, which will be estimated based on the proportion of participants without any viable tumor on histologic assessment at definitive surgery following the 12-week neoadjuvant period.
According to OncoSec Medical, anti-PD1 checkpoint inhibitors when used as a neoadjuvant therapy have delivered promising clinical results, however quick recurrence continues to be an issue for several patients.
The US biotech company said that TAVO in combination with OPDIVO can deliver deep anti-tumor immune responses and full elimination of tumors prior to surgery, thereby resulting in better long-term clinical outcomes for a considerable proportion of treated patients.
In a phase 2 clinical trial, TAVO when combined with Merck’s anti-PD-1 checkpoint inhibitor KEYTRUDA (pembrolizumab) delivered improved overall response rate and partial tumor responses in patients having anti-PD-1 checkpoint-refractory metastatic melanoma.
Daniel J. O’Connor – President and CEO of OncoSec Medical said: “TAVO delivers DNA plasmid-based IL-12 directly into the tumor using gene electrotransfer, which demonstrably enhances the immunogenicity of the treated tumors to yield productive ‘in situ’ vaccines. This principle has yielded striking results in post-PD-1 patients and is likely relevant in this earlier clinical setting.
“We look forward to exploring the utility of TAVO as a potential neoadjuvant therapy in a variety of solid tumor settings for patients in need of more effective treatment options.”