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OncoSec Seeks Accelerated Approval to Treat Melanoma

- By Joshua Rodriguez

The fight against cancer has always been at the forefront of the biotech industry. As the methods of attacking and healing cancer can vary greatly between different companies, researchers are always searching for newer and more effective ways to combat the disease. Likewise, experienced biotech investors are always on the lookout for emerging opportunities that show promise in bringing a new treatment to the table.

OncoSec Medical Inc. (ONCS) is maturing as one of those niche companies that has earned significant interest from investors and sector partners alike, thanks to its robust and differentiated approach to cancer treatment.

OncoSec advances with novel platform

OncoSec, a San Diego-based biotechnology company, is combining over two decades of research and development processes that may very well define a new chapter in how disease gets treated. The company's mission is laser focused on developing new and effective ways of treating various types of cancer, specifically through its innovative and proprietary immunotherapy treatments. OncoSec's focus is intent on developing immunotherapy benefits designed to address an unmet medical need in the market by providing a proven safe and clinically effective treatment for anti-PD-1 relapse/refractory patients, alongside other cancer indications.

Immunotherapy, as biotech investors know, has become an industry buzzword and in its simplest form works by using the body's immune system to engage its war against cancer. The therapy attempts to increase the uptake and absorption of DNA-based treatments directly into the tumor. OncoSec is well on its way to demonstrating best-in-class potential built out by compelling proof-of-concept clinical trials. Data published by OncoSec is impressive, showing a 48% BORR (best overall response rate) in patients diagnosed with immunologically "cold" tumors. "Cold" tumors are those designated as difficult for the body's immune system to treat on its own and carries a high likelihood of relapse.

Recognizing its value, immunotherapy is now considered a primary option for tumor treatment, and scientists are looking toward innovative and combination therapies to treat these diseases. To address that need, OncoSec has established its use of electroporation technology to deliver a safe and targeted method of gene transmission. Additionally, OncoSec is working to broaden its deliverables by building upon multigene plasmid constructs to meet next generation treatment strategies. OncoSec has secured Fast Track Designation from the Food and Drug Administration (FDA), and alongside an Orphan Drug Status for additional pipeline candidates, the company sits on the verge of earning an FDA review for accelerated approval for its lead program in 2019.

Furthermore, OncoSec has in place a drug supply and clinical collaboration agreement with Merck (MRK), a globally recognized player in the pharmaceutical industry. Overall, the convincing clinical capability built out by OncoSec may indeed provide a sizable advantage among competitors in securing a valuable and competitive place in the market.

OncoSec's approach makes a difference

Although OncoSec may be a relatively small company at the moment, the company's targeted strategy has allowed it to not only keep pace with its competitors but in several clinical aspects surpass them, supported by published and compelling clinical data. While most competitors' programs are still in Phase 1 or 2 studies, OncoSec is now advancing its Phase 2 registration-enabling clinical trials in an expedited manner.

Additionally, the company's projected milestone for treatment approval in early 2019 suggests that OncoSec may further distance itself from market competitors and emerge as a market leader in targeted cancer treatment, enjoying licensing and partnership opportunities intended to exploit the multibillion-dollar market potential.

Being a disruptor may be an advantage, and the innovative technology within OncoSec's pipeline is a key factor that sets the company apart from its competitors, potentially leading to OncoSec 's ability to alter the course of cancer treatment. OncoSec's flagship treatment, ImmunoPulse(R) IL-12, is an innovative, nonviral gene delivery platform designed to utilize the power of the human immune system to target and attack tumors in the body. The nonviral treatment works by introducing a controlled amount of IL-12 in the tumor's microenvironment, which allows the immune system to recognize the tumor and assemble an army of killer T cells to eliminate the diseased target.

In clinical trials, the ImmunoPulse(R) IL-12 system was shown to deliver equal gene transmission rates while maintaining a higher safety profile than other currently available viral and nonviral therapies. ImmunoPulse(R) IL-12 benefits are proven and validated through multiple human clinical trials across multiple disease types, and as there is no limit on size or number of genes delivered to the patient, the therapy can be specifically targeted to address multiple disease indications. With this advantage, the device carries the opportunity to be the first of its kind on the market, putting OncoSec in a potentially lucrative and enviable position by cementing a landscape for both a strategic and partnership opportunity.

A key advantage: the ImmunoPulse effect

As stated earlier, the ImmunoPulse(R) IL-12 system works by delivering a certain amount of IL-12 into the patient's tumor. IL-12, or Interleukin-12, is a powerful and pro-inflammatory cytokine, and tavokinogene teslaplasmid, or "Tavo," is a plasmid DNA encoding for IL-12. The process plays out by Tavo getting injected into the microenvironment of the tumor, then delivering the Tavo inside the cells, which in turn secretes the IL-12 inside the tumor. Subsequently, the body's T cells can better identify and determine how to fight against the cancerous cells, leading to a proficient anti-tumor response from the body.

The intratumoral delivery made possible by the ImmunoPulse(R) device carries a notably low toxicity level for any immunotherapeutic treatment, making it a safe yet powerful treatment unlike anything currently on the market. Another important feature of the ImmunoPulse(R) system is its flexibility. The platform allows for precisely measurable variability in the number of genes delivered to a targeted area, which allows physicians to adjust the treatment to bring out the best possible anti-tumor immune response in patients.

Finally, and intrinsically important, is that the device has proven effective in its ability to deliver multiple genes into the tumor simultaneously, which may significantly reduce the likelihood for the tumor to avoid the internal defenses of the body's immune system after treatment.

While industry limitations exist in overcoming the tumor's ability to challenge an immune response, the strategy in place by OncoSec, utilizing the ImmunoPulse(R) platform, aims to target and defeat that limitation. Currently, the majority of patients with solid tumors do not respond to anti-PD-1 therapy, regardless of the cancer type. This occurrence, of course, begs the question: what is causing these patients to not receive any benefit from this kind of therapy? Scientists have found that in general, patients who do respond to anti-PD-1 therapies have what is known as a "hot" or "inflamed" tumor, meaning that the tumor already has a high expression of PD-L1 in its cells, along with a higher density of tumor-infiltrating lymphocytes. A "hot" tumor is more easily detected by the body's immune system, thus more responsive to anti-PD-1 therapies, opening the door to OncoSec's novel technology. Complimented by the ImmunoPulse(R) platform, interim clinical studies have shown that the OncoSec treatment has the potential to convert "cold" tumors to "hot," actually increasing the patient's odds of responding positively to anti-PD-1 therapies. During these clinical trials, ImmunoPulse(R) IL-12 was shown to have a noticeable response in patients who were confirmed to have "cold" tumors. After the treatment regimen, results showed a 48% BORR in patients provided with ImmunoPulse(R) IL-12 combined with anti-PD-1, proving the value in patients who initially had a lower chance of benefiting from the anti-PD-1 treatment alone. The published data suggests that people who were unable to receive healing treatment are now able to significantly increase their chances of responding to the same therapy after using ImmunoPulse(R) IL-12. If these test results prove to be durable throughout the upcoming clinical trials, OncoSec could be well positioned to introduce a lucrative and game-changing cancer treatment technology to a receptive market.

All signs point to yes

Alongside the development of its ImmunoPulse(R) IL-12 treatment, OncoSec is strategizing on how to best take advantage of the company's expected developments and market opportunities. Primarily, OncoSec has set its target patient population to those with a pathological diagnosis of unresectable or metastatic melanomas (stage III/IV) that fail anti-PD1 therapy. Currently, there are over 10,200 of these patients in the U.S. who could potentially benefit from ImmunoPulse(R) IL-12 therapy in combination with anti-PD-1.

For example, there are an estimated 9,900 patients undergoing anti-PD-1 therapy in the U.S. Of these 9,900 people, around 6,400 have shown poor response rates to anti-PD-1 therapy alone, demonstrating that a significant subset of individuals could receive a tremendous benefit from treatment via the ImmunoPulse(R) IL-12 platform. And, with over 80,000 new cases of melanoma diagnosed in the U.S. per year, OncoSec's ImmunoPulse(R) device, utilizing combination therapies, could prove to be a revolutionary treatment for those who are unresponsive to current procedures.

Researchers within the company have expressed that their early proof of concept in melanoma patients indicates a potential for the ImmunoPulse(R) IL-12 platform to work on other ailments with similar characteristics. For instance, diseases such as triple negative breast cancer and head and neck cancers are known to have accessible tumors, and similar to melanoma also carry a high rate of nonresponse to anti-PD-1 therapy alone. The characteristics of both of these cancers point to a likely possibility of patients responding to the ImmunoPulse(R) IL-12 platform similarly to how it works in patients with melanoma, and OncoSec has established plans to investigate additional ways of broadening the device's reach.

From the inhibition of a tumor's immunosuppressive environment to cell signaling and trafficking, OncoSec researchers are already aware of many potential applications of Interleukin-12 delivered through the ImmunoPulse(R) device, and company management acknowledges that the application's power may be an extremely profitable opportunity.

Investors will be pleased to know that the market and medical community interest in melanoma and immunotherapy treatments are significant and that a gap in the market is waiting to get filled by a responsive company, like OncoSec , that is demonstrating the ability to provide a reliable, safe and curable treatment to cancer patients. In the past, companies have spent vast sums of money on earlier programs that dealt with the same issues on which OncoSec focused.

For example, Amgen's (AMGN) 2011 acquisition of BioVex demonstrated the proof of interest and need for an effective melanoma treatment. BioVex was a company that had been researching and developing a treatment against melanoma called Imlygic, also known as T-VEC. T-VEC was an oncolytic viral therapy that aimed to promote a similar anti-tumor response to OncoSec's ImmunoPulse(R). The company showed promise and in 2011 was purchased by Amgen for $1 billion in the hope that the treatment would prove revolutionary.

Unfortunately, as additional clinical data continued to become available, it was found that the treatment was not as effective as initially hoped, and as of 2016, there was little evidence the treatment was able to extend the lives of people with melanoma. Additionally, T-VEC was known to cause a myriad of undesirable side effects, including fever, nausea and other flulike symptoms in over 30% of those treated. Although the treatment proved unsuccessful, the BioVex deal was still one of the largest deals in the immunotherapy field at the time and signaled a voracious interest in bringing to market a more effective product. Keeping this goal in mind, OncoSec may hold the potential to provide the treatment that T-VEC was unable to deliver.

OncoSec on the fast track

OncoSec, in some respects, is in a similar position to BioVex before its acquisition by Amgen - the company has robust clinical data to date, and as its Phase 2 data continues to unfold, the company is sure to spark the interest of respected players within the biotech industry. Not only has the initial testing of its ImmunoPulse(R) IL-12 platform brought positive results, it is also doing so without causing many of the uncomfortable side effects caused by earlier and similar treatments.

Additionally, the FDA's granting of Orphan Drug Status and Fast Track Approval to the company will allow it to more quickly develop and undergo research trials for its products, removing many of the restrictions that may be faced by competitors. Finally, as stated earlier, OncoSec has indicated that its ImmunoPulse(R) system is likely able to work on multiple tumor types, allowing the company to expand its label across different kinds of diseases rather than simply melanoma.

As for what's in store for OncoSec, the company plans to initiate its enrollment for a phase 2 trial and collaboration with Merck, referred to as PISCES, by the end of 2017. The company also intends to hold an End of Phase 2 (EOP2) meeting with the FDA during the first half of 2018, which is anticipated to grant OncoSec with an accelerated approval path for anti-PD-1 nonresponders in melanoma, along with an approval of its plans for phase 3 trials. This phase 3 confirmatory study is expected to run throughout 2018 and carry on into late 2019, when the company has set milestone goals to obtain a marketing authorization to penetrate a market in need of a viable and responsive cancer treatment.

OncoSec may be considered by some to be a small company, but what can't get overlooked is that it has built an enviable foundation and scientific infrastructure. From a position of clinical strength, OncoSec may be ideally placed to reap enormous benefit from the development of its promising immunotherapy treatment system. If ImmunoPulse(R) IL-12, with combination therapy, continues to deliver positive results, OncoSec may very well be the company the market has been waiting to embrace, providing game-changing cancer treating technology that may alter the therapeutic landscape and fill a void to address unmet medical needs.

Disclosure: The author has no position in any stock mentioned herein or plans to open a position within the next 72 hours.

This article was originally featured on CNA Finance.

This article first appeared on GuruFocus.