Immunitor started Phase II clinical trials of tableted vaccines against endometriosis, myoma (uterine fibroids), cervical, ovarian and breast cancers
VANCOUVER, BC – BRITISH COLUMBIA, CANADA, July 8, 2018 /EINPresswire.com/ — Immunitor Inc, recognized as leading company in oral vaccines industry, announces addition to its pipeline new tableted immunotherapeutic candidates intended to address the unmet need in female health area. The enrollment into open label Phase II clinical trials in women with most common gynecological problems, including breast cancer, started this month as posted at clinicaltrials.gov.
Dr. Allen Bain, director of Vancouver-based Immunitor Inc., commented: “We are proud of achieving such a feat – in less than a year we have, in collaboration with a major academic institution, developed, manufactured, and evaluated the safety of five new orally-delivered vaccines. Three of these are intended to treat most prevalent malignancies in women: V3-OVA for ovarian cancer; V3-CERVIX for cervical cancer; and V3-MOMMO for breast cancer. In addition, we have made first in the world vaccine, V-Endo, for endometriosis – main cause of infertility, afflicting 10-15% of women worldwide and major risk factor for ovarian cancer. V3-Myoma is our brand-new daily pill to treat myomas or fibroids – benign tumors in the uterine wall that strike up to 80% of women by age of 50. Immunitor strives to help women who often have no treatment options and our preliminary investigations have shown very promising results.”
Immunitor has been involved in cancer immunotherapy since 2001, but only recently has made it as a business priority. In 2017 results of Phase II trial in 75 patients with inoperable liver cancer or advanced hepatocellular carcinoma (HCC) were published showing that over 90% of patients survived over 12 months and complete response rate was 16%. The response to immunotherapy as judged by decrease of tumor burden and liver cancer marker AFP was significant; 2 out of 3 patients benefited from simple once-per-day pill regimen. Vaccine was extremely safe – it has not caused any adverse effects. This vaccine, hepcortespenlisimut-L or Hepko-V5, has received orphan drug status from the US FDA in 2015. Vaccine, formulated as a pill, is derived from pooled blood of patients with HCC and comprises widest possible repertoire of hydrolyzed tumor antigens, neoantigens and circulating in the blood cancer cells. Unlike injectable cancer vaccine that delivers hydrolyzed tumor antigens via dendritic cells, serving as antigen presenting cells (APC), the role of APC in orally delivered Immunitor vaccines is played by enterocytes, constituting the mucosal surface of the gastrointestinal tract. The intestine is an organ that processes and delivers to the body non-self antigens on daily basis, mostly those found in food, has an area of about 400 square meters – representing largest, but often ignored APC in the body. Such an off-shell vaccine, has obvious advantages, and is stable at room temperature for years – obliterating the need in cold chain storage – the inconvenient feature that plagues all injectable vaccines. The same principle, targeting uniquely the mucosal immunity, was applied toward making vaccines against pancreatic cancer (V3-P) and cholangiocarcinoma or bile duct cancer (V3-X), both in Phase II trial. “After meeting the need for liver-related cancers, our next frontier was women’s diseases, for which we have successfully built decent size pipeline,” concluded Mr. Vichai Jirathitikal – pharmacist and co-founder of Immunitor.
“We are currently negotiating licensing and partnership agreements with various companies. Available immune therapies for female cancers have mediocre efficacy rates and unpredictable side-effects; hence there is a heightened interest in finding safer and better treatment options,” said Dr. Aldar Bourinbaiar, CEO of Immunitor. We welcome additional corporate partners and investors who might be interested in these candidates or any other immunotherapy against cancer of their choice. We can make and deliver them quickly due to advantages we have with this unique technology patented by us,” added Dr. Bourinbaiar.
The treatment market for women’s diseases in Immunitor portfolio is US $54.5 billion, with largest share, i.e., $28 bln, attributable to breast cancer – most common malignancy affecting 1.7 mln women per year. Cervical cancer is second by frequency with 560,000 new cases and largest 2nd global market worth $19 bln. While ovarian cancer is less common with about 240,000 new cases per year, it is ranked as deadliest, fetching $5.2 bln. Markets for myoma and endometriosis, despite afflicting exceedingly higher number of women than those with cancer, are not large, only $2.3 bln, but certainly with enormous growth potential, since no meaningful therapeutic interventions exist, except painkillers, hormones and surgery.
Privately held, commercial stage biopharmaceutical company based in Vancouver, Canada with affiliated Immunitor companies in Beijing, Hong Kong, Johannesburg, Moscow, Ulaanbaatar and clinical sites in Ukraine, Mongolia and soon in China. Immunitor’s strength resides in its proprietary oral vaccine platform validated by numerous clinical trials conducted over the past 17 years. Immunitor makes several immunotherapy products addressing major health problems, in infectious diseases area; i.e., HIV, HBV, HCV, influenza, malaria, fungal and microbial infections including tuberculosis and drug-resistant TB (MDR-TB); in autoimmune and metabolic diseases area: i.e., renal failure, thyroiditis, Alzheimer disease, hypertension, atherosclerosis, obesity and diabetes; and recently in oncology space, with several candidates currently being investigated.
Allen Bain, PhD
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Source: EIN Presswire