Immunotherapy is changing the way we perceive and treat cancer. Advances in science and technology have brought about a new wave of promising cancer immunotherapies, which harness the power of the immune system to fight disease. We are witnessing the emergence of a new vision within the cancer treatment landscape – one that is having an immediate and powerful impact on cancer patients everywhere.
During this year’s State of the Union address, President Barack Obama announced Cancer Moonshot 2020: a new initiative aimed at eliminating cancer as we know it. Cancer Moonshot 2020 plans to break down barriers and enable progress by enhancing data access, facilitating collaborations, and investing in the development of new technologies and treatments. We applaud this initiative not only for its emphasis on eliminating the burden of cancer, but also for its practical approaches and acknowledgement of the complexities of this mission.
We were thrilled to participate in the Nasdaq Opening Bell Ceremony to celebrate our recent listing to The Nasdaq Capital Market. This marks an exciting and significant milestone for our company as we continue to build on our success and advance our technologies to one day benefit patients everywhere.
SAN DIEGO – January 7, 2014 — OncoSec Medical Inc. (OTCQB: ONCS), a biotechnology company developing its advanced-stage ImmunoPulse DNA-based immunotherapy to treat solid tumors, today announced that Punit Dhillon, President and CEO, will provide a corporate update at Biotech Showcase 2014; one of the world’s largest life sciences conferences held annually in San Francisco.
The presentation is scheduled to take place on Tuesday, January 14 at 2:30 p.m. PST at the Parc 55 Wyndham San Francisco–Union Square, located at 55 Cyril Magnin Street. A live webcast will be available by visiting the following link: http://www.media-server.com/m/p/byw47js4.
About Biotech Showcase 2014
Biotech Showcase™ is an investor and partnering conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and pharmaceutical executives in one place during the course of one of the industry’s largest annual healthcare investor conferences. Investors and biopharmaceutical executives from around the world gather in San Francisco during this critical week, which is widely viewed as setting the tone for the coming year.
Now in its sixth year, Biotech Showcase is expected to attract upwards of 1,700 attendees. The program includes lunch plenary sessions featuring top industry leaders and innovators speaking on industry and time-relevant topics, as well as presentations from both private and public companies.
SAN DIEGO – January 11, 2014 — OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy to treat solid tumors, today announced that Punit Dhillon, President and CEO, will present at “TEN”; Noble Financial Capital Markets’ Tenth Annual Equity Conference, at Club Med in Sandpiper Bay, Florida, on Tuesday, January 21 at 1:30 p.m. (EST) in Room 1.
At the time of the presentation, a live audio and high-definition video webcast of OncoSec’s presentation will be available at the following link:
OncoSec recommends registering at least 10 minutes prior to the start of the presentation to ensure timely access. Participants will require a Microsoft Silverlight viewer (a free download from the presentation link) in order to participate.
About Noble Financial Capital Markets
Noble Financial Capital Markets was established in 1984; 2014 marks its 30th Anniversary. Noble Financial is an equity research driven, full-service, investment banking boutique focused on life sciences, technology and media, emerging growth, companies. The company has offices in Boston, Los Angeles, and Boca Raton, FL. In addition to non-deal road shows and sector-specific conferences throughout the year, Noble Financial hosts its large format annual equity conference in January in South Florida featuring 120 – 150 presenting companies from across North America and total attendance of close to 600. For more information: www.noblefcm.com
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.”
Favorable Safety Profile, Robust Response Rates Reinforce Potential of Novel Immunotherapy
SAN DIEGO – December 16, 2013 — OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy to treat solid tumors, today announced positive interim data from its ongoing Phase 2 trial of OMS-I100 in the treatment of metastatic melanoma. The results were presented by principal investigator Adil Daud, MD, at the Advances in Cancer Immunotherapy meeting at the University of California San Francisco.
Data from the multicenter, open-label, single-arm study confirm the safety of OncoSec’s lead product candidate, ImmunoPulse, which leverages the company’s OMS electroporation technology to deliver the anti-tumor agent pIL-12 directly into the tumor. In Phase 1 and Phase 2 studies, a total of 47 melanoma patients have been treated to date without a single drug-related, serious adverse event.
Patients treated in OMS-I100 also demonstrated positive response rates based on RECIST criteria, the gold standard measure of solid-tumor response to treatment. Interim efficacy analysis of 21 evaluable patients on Day 180 indicated that 38.1% (8/21) achieved an objective overall response, defined as >30% reduction in summed size of lesions. At the time of this interim analysis, six patients (28.6%) had demonstrated a partial response, and two patients (9.5%) had achieved a complete response, lasting at least 6 months. An additional 9.5% (2/21) of patients exhibited clinically beneficial disease stabilization for at least 3 months.
These data strengthen and expand upon previously reported Phase 1 results, which indicated a complete response in 16% of patients (3/19) and disease stabilization in 38% (7/19). These data were published in Journal of Clinical Oncology in 2008.
Importantly, 61.1% of patients (11/18) with evaluable lesions exhibited systemic antitumor immune responses, as evidenced by objective regression (>30% reduction in size) in at least one untreated lesion.
“The response rate of untreated tumors suggests an induction of systemic antitumor response, without systemic toxicity,” commented Dr. Daud. “We will continue to assess the responses of our remaining patients and look forward to sharing our findings.”
Robert H. Pierce, MD, OncoSec’s chief medical officer, added, “Systemic response is significant for two main reasons. First, it suggests that unlike most locally administered melanoma treatments, ImmunoPulse may induce antitumor response throughout the entire body, which would have clear benefits in the treatment of metastatic disease. Secondly, the favorable safety profile of ImmunoPulse indicates its potential to deliver systemic benefit, without the toxicities associated with many other systemic treatments. We are therefore highly encouraged by this finding, combined with the safety and primary efficacy data, and look forward to continuing our investigation of OMS-I100 in the treatment of metastatic melanoma.”
Melanoma is the most serious form of skin cancer. If it is recognized and treated early, it is almost always curable. If it is not, the cancer can advance and spread to other parts of the body, where it becomes hard to treat and can be fatal. While it is not the most common of the skin cancers, it causes the most deaths. The American Cancer Society estimates that at present, about 123,000 new cases of melanoma in the U.S. are diagnosed in a year, resulting in approximately 10,000 deaths. Melanoma originates in melanocytes, the cells that produce the pigment melanin that colors our skin, hair, and eyes. The majority of melanomas are black or brown, but often they can also be skin-colored, pink, red, purple, blue or white. Currently, few treatment options remain for patients with late-stage metastatic disease that can extend survival for the broad population.
Former Merck Research Labs Executive Director/Member of Global Anti-PD-1 Development Team to Oversee OncoSec’s Clinical Development Studies
SAN DIEGO – December 12, 2013 — OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy to treat solid tumors, announced today that Dr. Robert H. Pierce has joined the company as Chief Medical Officer.
A graduate of Yale College and the Brown University School of Medicine, Dr. Pierce is well regarded for his career-long research into mechanisms of immune tolerance as well as recent drug development experience, most notably being a key member of the global development team behind Merck’s FDA-designated “breakthrough” anti-PD-1 program (MK-3475). Dr. Robert H. Pierce joins OncoSec Medical from Merck Research Labs – Palo Alto (formerly DNAX Research Institute/Schering-Plough Biopharma) where he spent almost seven years leading a 20–person team, dedicated to developing disease-oriented and tissue-based translational medicine platforms. As Executive Director, Dr. Pierce was responsible for contributions to multiple successful IND applications, including critical biomarker development programs such as the anti-PD-L1 immunohistochemistry assay supporting Merck’s MK-3475 trials. In addition, Dr. Pierce was instrumental in designing two Phase 2 anti-PD-1 (MK-3475) oncology studies. Prior to focusing on immunomodulatory receptor (IMR) programs, Dr. Pierce had served as a discovery project team leader for two novel drug candidates.
From 2001 to 2007, before leaving academics to join industry, Dr. Pierce held several leadership positions at the University of Rochester School of Medicine, including Director of the Autopsy Service at Strong Memorial Hospital. From practicing as a staff pathologist to developing the graduate curriculum in pathomechamism of disease, to acting as the principal investigator of a RO1-funded research lab, Dr. Pierce played an important role in the university’s clinical and academic research programs. He continues to act as an adjunct professor at the university to this day.
He is the co-author of over fifty peer-reviewed journal articles and book chapters, and has been a reviewer for numerous scientific journals as well as National Institute of Health grants.
Dr. Pierce received his post-doctoral training at the University of Washington, Seattle, WA, his graduate education and training at Brown University School of Medicine in Providence, RI, and received his undergraduate education at Yale University in New Haven, CT. As a Fulbright Award recipient, Dr. Pierce studied Philosophy at the Albert-Ludwigs-University in Freiburg, Germany.
Dr. Pierce comments, “We stand at a transformational moment in oncology. I’m convinced that intralesional therapy with IL12 drives systemic anti-tumor immune responses and has the potential to augment immunomodulatory therapies such as anti-PD-1.”
Punit Dhillon, President and CEO of OncoSec, said, “Robert’s expertise in immunotherapy and drug development will be invaluable to OncoSec as we advance our immunotherapy products through human trials, and he will help us move forward in our efforts to develop and innovate new therapies to target solid tumors. Also, his background represents a unique mix of medical and scientific expertise that is highly relevant to OncoSec’s proprietary DNA-based immunotherapy and delivery technology, and complementary to our existing management team and advisors.”
SAN DIEGO – November 26, 2013 — OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors, has announced it will be presenting at the Sixth Annual LD Micro Conference.
Punit Dhillon, President and CEO of OncoSec Medical, will provide a company overview and will be available to participate in one-on-one meetings with investors who are registered to attend the conference.
The presentation will take place on Wednesday, December 4 at 12 p.m. at the Luxe Sunset Bel Air Hotel in Los Angeles, California.
About the LD Micro Conference
The LD Micro conference hosts over 230 companies in the small cap and micro cap space. The three-day event brings innovative companies together with a tight-knit and loyal investor base. To find out more about the conference, visit the website.