​Inovio’s SynCon®: A Platform You Should Get to Know

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It’s an exciting time for cancer treatments, with innovative new drugs and therapies offering hope like never before to patients riddled with the disease that lack options. Consider just this week Puma Biotechnology (PBYI) getting FDA approval for its breast cancer drug and a FDA advisory panel recommending for approval Novartis’ (NVS) immunotherapy drug, tisagenlecleucel, for patients with the blood cancer known as B-cell acute lymphoblastic leukemia (ALL) who failed other therapies.

Novartis’ drug, if approved, will represent a watershed moment for the promising field of immunotherapy as a first-in-class gene therapy. The immunotherapy breakthrough validates the potential of other pioneers in the space with novel therapies deep in the clinical pipeline, including Inovio Pharmaceuticals, Inc. (INO), a company that prides itself on “taking immunotherapy to the next level in the fight against cancer and infectious diseases.”

Inovio is looking to set precedent itself, seeking to become the first company to earn an approval for a DNA-based immunotherapy.

The Inovio Approach

Simply speaking, immunotherapy is underpinned by eliciting an immune response to fight pathogens. However, there are different methodologies to achieve the goal. Inovio uses a novel synthetic vaccine design, branded as SynCon®, to help the immune system recognize cells expressing certain antigens as foreign matter, releasing a killer T-cell and antibody response.

First, Inovio selects antigens uniquely associated with a disease or virus. That’s followed by choosing multiple variants of the cancer or virus and analyzing the amino acid sequence in the DNA. Computer algorithms take it from there to select integral amino acids at each position of the antigen’s sequence to create a new arrangement called a synthetic consensus sequence. The new synthetic sequence is then made part of a DNA plasmid that is essentially the heart of Inovio’s SynCon® technology. By injecting the plasmid into a patient via the company’s Cellectra® 5PSP device, the immune system gets a helping hand in identifying pathogens that it may otherwise overlook and allow to multiply.

Source: Inovio Pharmaceuticals Corporate Presentation, June 2017

With a true platform technology, changing the target is a matter of repeating the process with a different antigen and its variants to create a new plasmid.

The Plymouth Meeting, Pennsylvania-based company is working with major pharma companies on developing new targeting therapies, including Regeneron (REGN), AstraZeneca’s (AZN) MedImmune and Roche’s (RHHBY) Genentech. Combination programs with Regeneron and Genentech for brain cancer and bladder cancer, respectively, are ready to enter human trials. A phase 1/2 study funded in part by MedImmune was initiated during the second quarter. The trial is combining Inovio’s immunotherapy MEDI0457 with MedImmune’s experimental PD-LI checkpoint inhibitor durvalumab for the treatment of metastatic HPV-associated squamous cell head & neck cancer following chemotherapy.

In June, Inovio began a phase 3 trial to evaluate its DNA-based immunotherapy, VGX-3100, for the treatment of cervical dysplasia resulting from the human papillomavirus (HPV). More specifically, the trial is looking to see the effect of VGX-3100 in destroying the HPV infection causing regressing high-grade squamous intraepithelial lesions (HSIL), which are known to be a precursor to cervical cancer.

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Market participants should already start looking ahead for results as the REVEAL (Randomized Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) trial is evaluating cervical tissue changes at only nine months after beginning a three-dose regimen of VGX-3100 administered at months 0, 1, and 3. There are currently no immunotherapies approved for the indication, putting Inovio in a leadership position in the space.

In a Phase 2b study, VGX-3100 was shown to deliver a statistically significant improvement in HPV clearance and HSIL regression. The trial enrolled 167 patients, with 40.2% of those treated with VGX-3100 demonstrating both cervical HISL regression to low or normal levels along with elimination of HPV compared to only 14.3% in the control group.

Replicating the results in a 198-patient phase 3 trial should captivate the industry and investment community.

Flush with Cash

In order to help fund the new studies, Inovio is tapping a shelf registration with the intentions to raise $75.0 million through a public offering of common stock. As of the end of March 31, 2017, Inovio had cash and cash equivalents and short-term investments of $89.7 million.

If Oncology Alone Wasn’t Enough

The company also has four externally funded infectious disease clinical studies ongoing for serious infections: HIV, Ebola, MERS and Zika. In fact, the company’s HIV vaccine PENNVAX®-GP, a cocktail of four HIV antigens, produced one of the highest overall levels of immune response rates ever in a human trial of an HIV vaccine.

Elsewhere, a phase 1 study in Puerto Rico is now fully enrolled, evaluating Inovio’s GLS-5700 Zika vaccine for safety in healthy patients. Lab research has supported further investigation of new vaccines across a range of infections. Recent research released this month showed a potent response in lethal Influenza A and B for Inovio’s DNA-based monoclonal antibody product. The data dovetails with prior research showing the potential for the dMAb® platform for infections, such as HIV, dengue and Chikungunya.

Add it up and there’s a complete package in a small biotech on the cusp of what would be a major breakthrough in immunotherapy. We’re seeing “firsts” again in biotech research and approvals. When it comes to DNA-based immunotherapy opportunities, Inovio is not only a leader in the cancer space, but is also demonstrating a viable bridge between oncology and infectious disease with its methodologies.

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