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Share Skyrockets on news of positive early-stage results from GEN-009 Clinical Trials

12 Jun Share Skyrockets on news of positive early-stage results from GEN-009 Clinical Trials

Genocea Biosciences, Inc. (NASDAQ: GNCA) skyrocketed today based on news of promising data from its early stage clinical trials of GEN-009, its neoantigen vaccine candidate. There has been a stream of positive news from the company’s stables off late, including news of Journal of Clinical Oncology® selecting the company’s GEN-009 clinical results presentation, at the 2019 ASCO Annual Meeting, as a top 10 featured abstract in immuno-oncology.

It also received a shot in the arm with positive news coming from its best-in-class clinical results from its ongoing Phase 1/2a trial for GEN-009, its lead neoantigen vaccine candidate. Post-vaccination T cell responses were determined at an impressive 91% of vaccine neoantigens. It has also shown to be well tolerated, with no dose-limiting toxicities.

This news comes as a reprieve to the company, which has seen its share prices drop by a whopping 97% in the past five years and by 40% in the last year alone.

Genocea Biosciences (NASDAQ: GNCA)Chart
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Addressing the unmet needs in Cancer Vaccine Market

Cancer is the second leading cause of death in the U.S, next only to heart diseases. An estimated 1.7 million new cancer cases are likely to be diagnosed in 2019 in the U.S alone, with 606,880 Americans eventually succumbing to the disease, according to the American Cancer Society. The Agency for Healthcare Research and Quality estimates, that the direct medical costs for cancer in the US in 2015 were $80.2 billion. Therefore, it is imperative that there are treatments and therapeutics that can prevent the occurrence of this malady.

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Human papilloma virus (HPV) infections, one of the causes of cancer, contributed to over 42,700 new cases of cancer from 2011 to 2015 in the U.S alone. Cervical cancer is the most common HPV-associated cancer among women, followed by oropharyngeal cancers in men. Therefore HPV vaccinations are now recommended for girls and boys in the age group of 11 to 12 years old. In case of those who were not administered a vaccination, it is recommended for females through age 26 and males through age 21.

The Global Cancer Vaccine market which was valued at over $4 billion in 2016 is expected to grow at a CAGR of 17.7% from 2017 to 2023, to reach an estimated 12.81 billion according to a report by Allied Market Research. Scientific and Technological advancements will propel the growth in the market, with development of vaccines with antigenic components that can boost the body’s natural immunity. Furthermore, the rise in incidences of human papilloma virus (HPV) infections increased spending on research and development efforts and launch of novel therapeutics will help the market grow at a steady pace in the coming years.

Over 70% of cervical cancers are caused due to HPV infections. There is also a growing demand for prostate cancer and breast cancer vaccination especially of the recombinant variety. Currently there are various vaccines being developed using this technology such as Cervarix, Gardasil, and Recombivax HB.  Also there is a gradual shift being witnessed from prophylactic cancer vaccines to therapeutic cancer vaccines.

However, development of a vaccine takes an inordinate amount of time and effort and monetary resources.

Limitations of Current Treatment Options

At present, there are only two cancer prevention vaccines approved by the U.S. Food and Drug Administration (FDA). HPV Vaccines and Hepatitis B Vaccine can cause mild to moderate side-effects such as swelling or pain at the injection site, fever, headache, nausea, diarrhea, abdominal pain and muscle pain. In severe cases, it can lead to fertility issues. Also HPV vaccines do not offer a comprehensive protection against all forms of cancers; they are useful in prevention of only a few types of cancers. In addition, they cannot treat existing HPV-related illnesses.

The flipside of these vaccines is that they suppress the immune system, which may allow the cancer cells to grow further. They seldom work on their own and have to be administered in combination with other cancer treatment options. These vaccines are designed to harness the body’s natural immune system as a defense against cancer, however in case of a severely ill person; the immune system may already be compromised, which will render the vaccine ineffective.

T cell based therapies are revolutionizing cancer treatment, with development of novel therapeutic approaches that use immune checkpoint inhibitors (ICI) and adoptive cell therapies like chimeric antigen receptors (CAR-Ts). They are engineered to target a specific protein in the tumor that presents as peptide on the surface. There are numerous antigen candidates per person which elicit varied responses from their interaction with T Cells, making it a daunting task to precisely work out which antigen is the best fit for a patient.

Genocea Treatment Approach and Pipeline

Genocea’s proprietary ATLAS technology platform uses a patient’s own T cell immune response machinery, to identify optimal antigens, thereby eliminating the guesswork as to which antigen can have an optimal impact on T-Cells. It can create a per-patient tumor-specific immune response profile to narrow down the most pertinent antigens.

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Atlas works by delivering polypeptides that relate to a specific mutation from a patient’s tumor, to their antigen presenting cells (APCs), which then process and present the cell peptides on the cell’s surface, to be recognized by T Cells. The cytokine reaction, resulting from the T Cells binding to the peptide are then measured and monitored to determine the most appropriate antigen. GEN-009 is essentially a customized vaccine that delivers synthetic long peptides paired with the adjuvant Poly-ICLC to an individual’s immune system.

ATLAS was developed based on the work of the company’s scientific founder, Dr. Darren Higgins from Harvard University. Scientists at Genocea have been relentlessly working to develop a pipeline of targeted cancer immunotherapy candidates such as GEN-009, a neoantigen cancer vaccine and its lead candidate, which is currently undergoing phase 1 / 2 clinical trials.

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Additionally, it is developing GEN-011, a neoantigen T cell therapy for which the company plans to file for an IND in the first half of 2020. It has also discovered certain unique antigens for Epstein-Barr virus.

Key Takeaways

We believe that the positive data from its clinical trials will put to rest the questions about the company’s profitability and sustenance. The share has reached a high of $8.16 on 2018-06-13, a feat surpassed by today’s rally, where the stock ended at an all time high of $ 8.78.

The stocks poor performance since its inception was leading to concerns about the company’s survival, but with the reaffirmation provided by the data from its clinical trials, the company has put the naysayers at rest for the time being. A lot is riding on the successful outcome of its GEN-009 clinical trials and while it may be too early to say but if its trials progress as planned, then it may well be on the road to profitability.

About Genocea Biosciences

Genocea Biosciences, a clinical-stage biotechnology company develops personalized cancer immunotherapies, using its proprietary ATLAS™ technology platform, which identifies the right antigen-specific T cell responses based on an individual’s own cells.

The company’s lead immuno-oncology program is GEN-009, a neoantigen vaccine that is currently undergoing a Phase 1/2a clinical trial across a variety of solid tumor types. It is also developing GEN-011, a neoantigen-specific adoptive T cell therapy for which it intends to file for an IND in 2020. It was founded in 2006 and is headquartered in Cambridge, Massachusetts.

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Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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