How is OncoSec’s TAVO™ helping the patient population that is seeing no positive result from using Keytruda and Opdivo?

Checkpoint therapies, like KEYTRUDA® (pembrolizumab) and OPDIVO® (nivolumab), have been highly successful for some patients, but not the majority. In fact, about 70% of patients who receive checkpoint therapy do not see their tumors go away. Those tumors lack essential immune elements that enable checkpoint therapies to be effective. They are metaphorically referred to as ‘cold’ tumors – while ‘hot’ tumors are likely to receive a benefit from anti-PD-1 checkpoint therapies.

OncoSec’s lead product candidate, TAVO™ (tavokinogene telseplasmid), is administered using our proprietary electroporation gene delivery system (EP) and designed to help turn ‘cold’ tumors ‘hot’. TAVO has demonstrated anti-tumor activity with whole body (abscopal) effect in metastatic melanoma and four other cancer types both as a monotherapy and in combination with anti-PD-1 checkpoint inhibitors.

TAVO is DNA-based interleukin-12 (IL-12), a hormone-like messenger, which facilitates communication between cells of the immune system to signal immune activation and inflammation.  TAVO is administered directly into the tumor using EP, which employs a series of momentary energy pulses. Those pulses increase the permeability of the cell membrane and facilitate uptake of IL-12 coded DNA into cells. This non-invasive, non-physical method is easy to perform and avoids systemic toxicity issues historically associated with the use of intravenous cancer immunotherapies. 

OncoSec is currently running two KEYNOTE clinical programs in partnership with Merck – a pivotal study in late-stage checkpoint resistant metastatic melanoma (KEYNOTE-695) and a phase 2 study in metastatic triple negative breast cancer (KEYNOTE-890).

The pivotal KEYNOTE-695 study is a multicenter, open-label, single-arm, non-comparative trial evaluating TAVO plus EP and KEYTRUDA combination therapy in approximately 100 patients with unresectable or metastatic melanoma who are progressing or have progressed on KEYTRUDA or OPDIVO. To date, the response rates from this study have far exceeded the single digit response rates expected with KEYTRUDA monotherapy in this late-stage checkpoint refractory ‘salvage’ setting. The KEYNOTE-695 study has been granted Fast Track and Orphan Drug designations by the FDA. OncoSec expects to complete enrollment in KEYNOTE-695in 2020 and submit a biologics license application (BLA) filing as soon as possible thereafter.

The KEYNOTE-890 study is a phase 2, multicenter, open-label, single-arm, non-comparative study evaluating TAVO plus EP and KEYTRUDA combination therapy in approximately 25 patients with inoperable locally advanced or metastatic triple negative breast cancer (mTNBC). In December 2019, OncoSec presented interim data of 28.5% objective response rate (ORR) at the San Antonio Breast Cancer Symposium (SABCS). This study is now fully enrolled, and OncoSec expects to expand its TNBC clinical program with Merck in 2020. 

What are some of the key partnerships that OncoSec has and how will they help spur growth?

OncoSec has established several world class strategic partnerships that we are leveraging to enhance our pipeline opportunities. Our relationship with Merck and the two ongoing KEYNOTE clinical programs is a prime example of that.

Beyond Merck, we recently entered into a strategic partnership with China Grand Pharmaceutical and Healthcare Holdings (CGP), and its U.S. affiliate, Sirtex Medical US Holdings (Sirtex).

How do you view the effectiveness of business incentive programs in New Jersey?

I have been a very vocal supporter of the New Jersey Technology Business Tax (NOL) program. It allows for your operating losses and your research and development tax credits to be sold to a profitable company. That means we can receive revenue without selling stock or licensing our technology. OncoSec received approximately US$885,000 in non-dilutive capital through the NOL program for the 2019 year.

What objectives is OncoSec seeking to accomplish over the next year?

2020 is a break-out year for OncoSec. With the US$30 million investment from CGP and Sirtex, we now have the resources we need to drive both our TAVO KEYNOTE clinical programs to the finish line. We expect to complete enrollment in the pivotal KEYNOTE-695 study this year and will then submit our BLA filing for FDA review. The KEYNOTE-890 study in metastatic triple negative breast cancer (TNBC) is already fully enrolled and we’re looking forward to expanding our relationship with Merck in TNBC this year. We’re also continuing to advance our novel visceral lesion applicator (VLA) program designed to reach and target deep internal tumors with our EP technology. This is truly a groundbreaking program that has the potential to revolutionize cancer immunotherapy.