Cancer remains one of the world’s leading causes of death, putting significant strain on health care systems, in terms of costs and resources. However, as the number of cancer diagnoses rises, so too does the development of innovative and efficient therapies that demonstrate higher chances of success with minimum side effects. Among the many types of cancer treatments, a growing number of patients receiving immuno-oncology therapies are reporting impressive results. In this landscape, leading biotech companies such as TapImmune, Inc. (NASDAQ: TPIV) (TPIV Profile), OncoSec Medical, Inc. (NASDAQ: ONCS), Agenus, Inc. (NASDAQ: AGEN), Immune Design Corp. (NASDAQ: IMDZ) and Kite Pharma, Inc. (NASDAQ: KITE) are giving patients hope by introducing new, effective classes of immunotherapy drugs for a wide range of cancers.
According to World Health Organization (WHO), cancer is the second-leading cause of death worldwide, responsible for about 8.8 million deaths in 2015. Statistically, one in six deaths is caused by cancer. Most of these deaths were caused by lung cancer, followed by liver, colorectal, stomach and breast cancer. In addition, the WHO expects a 70-percent rise in the number of new cases over the next two decades. In 2016 alone, there were an estimated 1.7 million new cases of cancer in the United States, with approximately 595,000 deaths. Subsequently, annual cancer drug spending is also on the rise, expected to exceed $150 billion by 2020, according to a report by IMS Health Holdings, Inc. (NYSE: IMS). The 10.5 percent increase is largely driven by the emergence of new immunotherapies that are designed to help cancer patients’ immune systems learn how to attack tumors.
An innovative immunotherapy approach comes from TapImmune, Inc. (NASDAQ: TPIV) (TPIV Profile), whose next-generation technology can overcome the deficiencies of earlier vaccines and become a powerful therapy on its own or in combination with other types of immunotherapies. The company is developing two vaccines that target both helper T-cells (CD4) and killer T-cells (CD8) and are directed against specific proteins that are present on the surface of most target tumor cells. Being comprised of naturally processed antigens deriving from immune responses recognized by over 85 percent of the population, these off-the-shelf vaccines have the potential to successfully target and trigger a durable anti-immune response in a very large field of patients.
TapImmune is currently running several phase II clinical trials that study the vaccines’ safety and patient response, in particular for cases of ovarian and breast cancer. With plans to attain Food Drug Administration Orphan Disease and Fast Track designation for both vaccines, the company is working closely with industry leaders such as Mayo Clinic, AstraZeneca PLC (NYSE: AZN) or Memorial Sloan Kettering Cancer Center.
In addition to its T-cell vaccine candidates, TapImmune is developing a proprietary and groundbreaking peptide expression system meant to make DNA-based immunotherapy more effective. PolyStart™ is significantly more efficient than existing antigen expression technologies, as it can enhance the recognition of target cells by the immune system, making them easier to be identified and eliminated. The proprietary technology is still in preclinical development, and it has the potential to increase the efficiency of any DNA vaccine, including the company’s own T-cell vaccines, as well as other inoculation types that target cancer or infectious diseases, whether in development or already on the market.
Another company focusing on innovative DNA-based cancer therapy is OncoSec Medical (ONCS). The company’s lead product candidate, which recently received FDA Fast Track designation, is ImmunoPulse® IL-12, an intratumoral anti-cancer gene therapy currently in phase II clinical trials for various cancer types such as triple negative breast cancer or metastatic melanoma. The ImmunoPulse® IL-12 program’s focus is now on the unmet medical needs of patients with melanoma who are non-responsive to traditional therapies. In addition to ImmunoPulse® IL-12, OncoSec is developing other immune-targeting agents with the help of the ImunoPulse® technology, which is designed to enhance the delivery and uptake of DNA-based immune-targeting agents.
A wide range of immunotherapies, including but not limited to cancer vaccines and checkpoint antibodies, comes from Agenus (AGEN). The company also focuses on various combination therapy approaches, with the end goal of making cancer immunotherapy available to a broader patient population. Its lead product candidates include Prophage – a heat shock protein-based vaccine targeting glioblastoma; PhosphoSynVax – a vaccine targeting a new class of tumor specific neoepitopes; AutoSynVax – a neo-antigen based vaccine that targets neo-epitopes in cancer patients; and several checkpoint modulator product candidates. What sets Agenus apart is its suite of antibody discovery platforms, such as the Retrocyte Display™ which screens and generates antibody therapies by incorporating human antibodies expressed in mammalian B-lymphocyte cases.
Immune Design (IMDZ) is a clinical-stage immuno-oncology company with a pipeline of first-in-class immunotherapy candidates. Its two primary product candidates, CMB305 and G100, are currently in multiple phase I and phase II clinical trials. These candidates utilize two separate approaches (specific antigen and intratumoral immunization) designed to generate strong, tumor-specific cytotoxic T lymphocytes (CTLs) and overcome limitations of existing therapies. The specific antigen approach uses selected antigens found in the patient’s tumor, which enables the immune system to recognize the tumor antigen and kill tumor cells expressing the antigen. In contrast, the intratumoral immunization approach uses treatments such as chemotherapy or local radiation to lyse tumors and release endogenous antigens, which are then captured by neighboring G100-activated dendritic cells – this approach is intended to generate a broad and varied immune response.
Another innovative approach in the development of cancer immunotherapy products comes from Kite Pharma (KITE). Focusing on creating chimeric antigen receptor and T-cell receptor cell therapies with the declared goal of offering rapid and durable immunotherapeutic solutions to cancer patients, this clinical-stage biotech company has developed several autologous cell therapy-based products targeting solid and hematological malignancies. Its flagship product is KTE-C19, a chimeric antigen receptor undergoing several clinical trials. A recent study targeting relapsed/refractory non-Hodgkin lymphoma yielded very promising results, with 73 percent of patients responding to the treatment and 55 percent going into complete remission.
For more information on TapImmune Inc. please visit: TapImmune, Inc. (TPIV) or www.Tapimmune.com
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