SAN DIEGO, CA, January 14, 2014 — OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy to treat solid tumors, today announced a strategic update and reported on progress made in 2013. Progress included advancing metastatic melanoma, Merkel cell clinical programs and preclinical combination studies with anti-PD-1, anti-PDL-1, and anti-CTLA4, which highlight a commercial path forward.
“2013 was a landmark year for OncoSec in which we earned recognition in both the scientific and investment communities as a fast-emerging leader in cancer immunotherapy,” said Punit Dhillon, OncoSec’s president and CEO. “Culminating a year of aggressive clinical development activity, the interim results of our Phase 2 melanoma study underscore the potential of ImmunoPulse to shift the treatment paradigm for patients with metastatic melanoma and generate significant value for stakeholders.”
“Having welcomed our CMO, Robert Pierce, M.D., former Merck Research Labs Executive Director/Member of Global anti-PD-1 Development Team to oversee OncoSec’s clinical development studies, we look forward to further advancing our melanoma program this year as we continue to progress and expand our other clinical and preclinical programs. With a solid balance sheet, a promising pipeline and enhanced R&D and manufacturing capabilities, we are entering 2014 well positioned to continue building on the meaningful progress we have made over the last year.”
The following is an overview of key strategic goals for OncoSec’s ImmunoPulse program in 2014:
- Metastatic melanoma Phase 2 study (OMS-I100)
- Complete enrollment in study being led by the University of California San Francisco (UCSF), University of Washington and other U.S. cancer centers
- Evaluate dose-intensified treatment schedules
- Report interim and final analysis of clinical data
- Initiate Phase 2b metastatic melanoma study
- Merkel cell carcinoma Phase 2 study (OMS-I110)
- Complete enrollment in study being led by the University of Washington and UCSF
- Report clinical data
- Expand Phase 2 cutaneous T-cell lymphoma study to a multi-institution trial to enhance enrollment and leverage additional expertise in CTCL
- Initiate additional Phase 1 study in new solid tumor indication
The following is a summary of milestones achieved in 2013 and additional detail on the company’s vision for 2014:
Metastatic melanoma Phase 2 study (OMS-I100)
Last December, interim data from OncoSec’s ongoing Phase 2 trial in metastatic melanoma confirmed the safety of ImmunoPulse; to date, a total of 47 melanoma patients have been treated without a single serious adverse event. In addition, patients demonstrated positive response rates, reinforcing the encouraging clinical results from the Phase 1 study.
Importantly, the data also indicated a systemic antitumor immune response in 61.1% of evaluable patients (11/18), as evidenced by objective regression (>30% reduction in size) in at least one untreated lesion. This finding, coupled with the favorable safety data, indicates the potential of ImmunoPulse to deliver systemic benefit, without the toxicities associated with many other systemic treatments.
Having completed enrollment of 25 patients, OncoSec expects to reach its expanded enrollment target of 30 patients in the near future and report additional data from the trial in mid 2014. As OncoSec prepares to initiate a potential Phase 2b study, the company is also planning to evaluate additional dose-intensified treatment schedules in the current trial and report interim and final analysis later this year.
Merkel cell carcinoma Phase 2 study (OMS-I110)
In partnership with leading clinical centers, OncoSec is continuing enrollment in a Phase 2, open-label, single-arm study in Merkel cell carcinoma. OncoSec expects to complete enrollment in this trial in the first quarter and report additional data from the trial in mid 2014.
Expansion of ImmunoPulse development programs
Last June, OncoSec entered into a sponsored research agreement with Old Dominion University to evaluate ImmunoPulse in combination with various therapeutic agents, including anti-CTLA4, anti-PD-1, anti-PD-L1 and other immune modulators. As OncoSec continues to investigate ImmunoPulse as monotherapy, this collaboration will enable the company to identify combination approaches that may enhance the efficacy of ImmunoPulse.
In 2014, OncoSec also expects to expand ImmunoPulse into at least one new solid tumor indication to increase its development pipeline.
Strategic growth opportunities
In 2013, OncoSec relocated to a new 6,000 sq. ft. facility where all research and development and general and administrative activities are managed, as well as in-house capabilities to build, maintain and develop its own devices. In 2014, the company expects to enhance manufacturing capabilities for ongoing and future clinical trials, through additional efficiencies and the ability to scale up production as needed to support potential partners.
Other key areas of growth this year will focus on technical operations, including:
- Launching new applicator probes for clinical trials
- Completing working prototype of new OMS Electroporation device
- Renewing ISO13485 qualification and certification
- Renewing CE Mark of OncoSec Medical System
- Completing additional in-licensing opportunities
- Expanding R&D footprint by acquiring or outsourcing additional lab facilities
OncoSec plans to hire additional scientists and engineers to support these goals. Next-generation devices and new DNA-based constructs resulting from these efforts are expected to build product value by generating additional intellectual property, both organically and through other in-licensing opportunities.
With a strong balance sheet of $15.2 million as of Q4 2013, OncoSec plans to continue focusing on advancing an aggressive clinical development strategy while maintaining its relatively lean burn rate.
The company continues to focus on clinical development opportunities, which includes potentially initiating proprietary programs funded by third parties. The company is actively seeking additional grant funding and strategic partnerships to further develop its novel immunotherapy products.
Dhillon stated, “OncoSec has made great progress in 2013 that has served to validate our clinical efforts and expand our visibility in the scientific community. We look forward to an excellent year ahead and will continue building on our strong fundamentals with the goal of increasing shareholder value, while delivering a meaningful benefit to patients and families impacted by cancer.”