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Lead Product ApoVax104-HPV™
ApoImmune's first product will be ApoVax104-HPV™, a proprietary therapeutic vaccine for cervical cancer in which ApoVax104™ is combined with the tumor antigen E7, a protein from the human papillomavirus (HPV) that causes cervical cancer in women. In preclinical studies, the vaccine has proven to be much more effective and less toxic than other vaccine components currently being tested in late stage clinical trials by large pharmaceutical companies.
HPV is the most common sexually transmitted virus and an estimated 20 million people are infected with HPV in the United States alone. Cervical cancer is the second most common cause of cancer death in women worldwide, resulting in nearly a half-million diagnoses and 240,000 deaths each year. Although Merck & Co. recently marketed a vaccine against HPV, Gardasil®, this vaccine only prevents HPV infection from occurring and does not protect women already infected with HPV from developing cancer, consequently, a therapeutic approach is still necessary to combat HPV infection and cervical cancer.
Primary treatment for cervical cancer consists of surgical removal of the tumor for the early stages of the disease, and radiotherapy and chemotherapy for the more advanced stages. However, recurrent disease presents a therapeutic challenge and has an extremely poor prognosis. Thirty-five percent of patients with invasive cervical cancer have persistent or recurrent disease after treatment and only 10% of those patients will be treated and alive at 5 years representing an important unmet therapeutic need.
In answer to this, ApoVax™ 104-HPV is expected to function as an important therapeutic vaccine, unlike Gardasil® which is only a preventive vaccine. In recent studies, vaccination with ApoVax104-HPV™ not only prevented cancer development in mice but inhibited growing tumors in animals with none of the surviving animals developing tumors upon rechallenge with live cancer cells. This suggests the generation of immune memory responses which are critical for long-term survival. Moreover, in a more clinically relevant setting, vaccination of mice with ApoVax104-HPV™ following surgical removal of the tumors prevented regrowth of tumors.
The Company envisions ApoVax104-HPV™ being used as a therapeutic vaccine for patients infected with HPV to clear the virus and prevent the onset of cancer, and also for patients with cervical cancer to eradicate the tumors in the early stages and prevent regrowth following surgery in the later stages. This is the first lead vaccine for the Company's ApoVax104™-based vaccines. Derivatives are currently being investigated for other indications which may lead to the development of an entire line of ApoVax104™-based vaccines. Use of these vaccines will lower the death rate and improve the quality of life for millions of patients. The long-term success of this project will lead to more effective treatment of cancer in a way that preserves the patient's overall health.
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