OncoSec Medical (ONCS) is a clinical-stage biotechnology company focused on developing cytokine-based intratumoral immunotherapies with new technologies to stimulate the body’s immune systems to target and attack cancer. In an exclusive interview with The Fly, CEO Daniel O’Connor and CFO Sara Bonstein talked about the company, its pipeline, recent investments in OncoSec, upcoming events, its collaboration with Merck (MRK) and much more. Here are some of the highlights:
KEYNOTE-695 STUDY, TAVO + KEYTRUDA COMBO: OncoSec has recently initiated a Phase II study of Tavo, or tavokinogene telseplasmid, plus Merk’s Keytruda in triple negative breast cancer patients who have received one prior chemo or immunotherapy, with preliminary data expected in 2019. CEO Daniel O’Connor highlighted the importance of taking patients who are “non-responders to prior checkpoint therapy” and “very carefully and definitively” define that checkpoint non-responder. “We are trying to articulate what Tavo’s contribution can be in the patient that failed PD-1 checkpoint therapy, then comes on to our study gets our drug and gets Keytruda again. Obviously, you have to make sure that the patient actually did not get a benefit and unequivocally failed the prior check point. […] The reason for doing so is that we hope to be able to go to the FDA with the data from this study and seek a conditional approval,” the executive explains.
‘VERY COMFORTABLE’ CASH POSITION: OncoSec has recently secured a $15M investment from Alpha Holdings, a Korean technology company, with the biotech closing the first $8M tranche of investment last month. The additional $7M are expected by the end of the year. “We feel very comfortable with our cash position. As a biotech, you always want to continue to augment your balance sheet and have a strong balance sheet. Since Dan [O’Connor] joined the company, we’ve been able to do some great financing – Alpha is one of them,” CFO Sara Bonstein added.
FOCUS ON KEYNOTE-695, KEYNOTE-890: Looking out over the remainder of the year and into next year, O’Connor sees OncoSec focusing on two KEYNOTE studies, namely KEYNOTE-695 and KEYNOTE-890. Regarding KEYNOTE-695, the executive pointed out that the goal is “making sure that we stay very focused on enrolling that study fully, gathering the data and then analyzing the data, publishing it and going to the regulators looking for a conditional approval should the data support doing so.” “KEYNOTE-890 study is [OncoSec’s] second keynote study with Merck. It’s again taking Tavo/Keytruda combination in patients in late stage triple negative breast cancer. We just announced that we started that study with the first site opening. We’re now opening more sites, enrolling patients and looking to have data with respect to that study next year,” O’Connor noted.
DRUG PRICING: President Trump has been very vocal on drug pricing and the healthcare industry. The CEO acknowledged that the company is “following the dialogue,” but pointed out that its “focus is on our clinical trials and demonstrating the potential of our Tavo and our platform.”
‘EXTREMELY DIFFICULT’ PATIENT POPULATION: Discussing potential misconceptions and overlooked aspects of the company by the market, O’Connor pointed out that OncoSec is “targeting [an] extremely difficult patient population” that failed treatment available for them, such as anti-PD1 checkpoint therapy. “Given the way that we are defining that failure, very precisely, we will be able to go to the FDA and request conditional approval. That’s where the focus should be when people look at us, look at our technology,” he contended. Additionally, the executive noted the importance of its technology safety profile. “We see a very consistent safety profile with grade 1 transient discomfort or pain. Most technologies that are being pursued to date have a great percentage of serious adverse events, which obviously impacts patients experience.”
