OncoSec Medical begins phase 2 trial for TAVO and OPDIVO combination in melanoma treatment

OncoSec Medical, a US-based biotechnology company, has officially dosed the first patient in its phase 2 clinical trial, OMS-104, aimed at evaluating the combination of TAVO (tavokinogene telseplasmid) and OPDIVO (nivolumab) as a neoadjuvant therapy for melanoma. This move represents a significant step forward in the quest for more effective treatment options for operable, locally or regionally advanced melanoma.

The OMS-104 trial will assess whether the addition of TAVO can enhance the already promising results seen with nivolumab, an anti-PD-1 checkpoint inhibitor developed by Bristol-Myers Squibb. By combining these two therapies, OncoSec Medical hopes to achieve deeper anti-tumor immune responses and potentially eliminate tumors before surgery, leading to better long-term clinical outcomes.

What is TAVO and how does it work in melanoma treatment?

TAVO is an innovative intratumoral DNA plasmid-based interleukin-12 (IL-12) therapy developed by OncoSec Medical. It is delivered directly into tumors using a process called gene electrotransfer, which enhances the immune response in the targeted area. This therapy has shown promising results in earlier clinical trials, particularly when combined with anti-PD-1 checkpoint inhibitors like Merck’s KEYTRUDA (pembrolizumab).

In earlier phase 2 trials, the TAVO-KEYTRUDA combination demonstrated improved overall response rates and partial tumor responses in patients with anti-PD-1 checkpoint-refractory metastatic melanoma. This success has bolstered OncoSec’s confidence in exploring TAVO’s potential in a neoadjuvant setting, where the goal is to shrink or eliminate tumors before surgery.

The role of OPDIVO in enhancing neoadjuvant therapy for melanoma

OPDIVO, a leading anti-PD-1 checkpoint inhibitor, plays a critical role in the OMS-104 trial. As an immune checkpoint inhibitor, OPDIVO works by blocking the PD-1 receptor on immune cells, which in turn prevents cancer cells from evading immune system detection. This approach has already shown significant success in treating a variety of cancers, including melanoma.

When used as a neoadjuvant therapy, OPDIVO aims to shrink tumors before surgery, making them more manageable for surgical resection. OncoSec’s hypothesis is that the addition of TAVO may bolster the immune system’s ability to target and eliminate melanoma cells more effectively than nivolumab alone.

Clinical trial design and primary endpoints for OMS-104

The OMS-104 phase 2 trial is designed to enroll 33 patients and will be conducted in three distinct phases: the neoadjuvant phase, the surgical phase, and the adjuvant phase. The primary endpoint for the trial is to assess the pathological complete response rate, which refers to the proportion of patients with no viable tumor cells found during histologic examination at the time of definitive surgery, following the 12-week neoadjuvant treatment period.

OncoSec Medical believes that the combination of TAVO and OPDIVO could provide a more robust immune response, potentially reducing the risk of quick recurrence, which remains a challenge with current treatments.

Expert analysis on the potential of TAVO as a neoadjuvant therapy

According to Daniel J. O’Connor, President and CEO of OncoSec Medical, TAVO’s unique mechanism of action allows it to enhance the immunogenicity of treated tumors, turning them into “in situ” vaccines. This approach has already yielded striking results in patients who are refractory to anti-PD-1 therapy, and OncoSec hopes to replicate these successes in earlier-stage patients. O’Connor expressed optimism about the potential of TAVO as a neoadjuvant therapy across various solid tumor types, suggesting that it could offer more effective treatment options for patients in need.

As the OMS-104 trial progresses, the medical community will be watching closely to see whether the combination of TAVO and OPDIVO can truly transform the treatment landscape for melanoma, potentially setting the stage for broader applications in oncology.