The Vancouver-based biopharmaceutical company Immunitor announced that it has developed five new orally delivered vaccines designed to target several gynecological conditions, including endometriosis and benign uterine fibroids, and breast cancer.
“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,” Allen Bain, PhD, director of Immunitor, said in a press release. “In addition, we have made [the] first in the world vaccine, V-Endo, for endometriosis.”
The vaccine, derived from pooled blood from women with endometriosis, is meant to be taken orally, leading to immune tolerance and anti-inflammatory effects.
V-Endo is being evaluated in a Phase 1/2 clinical trial (NCT03340324), expected to be completed in September. The trial, enrolling by invitation, aims to assess the effect of the vaccine on patients’ pelvic pain, as assessed by the visual analogue scale (VAS).
“Immunitor strives to help women who often have no treatment options and our preliminary investigations have shown very promising results,” Bain added.
The company is also recruiting participants for its Phase 2 trial (NCT03550703) to evaluate the safety of the tablet-formulated V3-Myoma vaccine for women with uterine fibroids, also known as myoma, which are benign tumors that grow in the uterus.
V3-Myom is based on dehydrated proteins collected from inactivated blood and tumor tissues of patients with uterine myoma. The vaccine is expected to trigger a specific anti-cancer immune response and anti-inflammatory effect.
The study plans to enroll 30 adult women with confirmed diagnoses of myoma, who will receive oral V3-Myoma daily for three months. During this period, researchers will evaluate the vaccine’s effect on tumor size, bleeding patterns, pain, urinary difficulties, and constipation.
“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 Aldar Bourinbaiar, PhD, CEO of Immunitor.
Three of the vaccines were developed to treat the most prevalent cancers in women: V3-OVA for ovarian cancer, V3-CERVIX for cervical cancer, and V3-MOMMO for breast cancer. The company has initiated three Phase 2 clinical studies (NCT03556566, NCT03550755, and NCT03572361) to evaluate the safety and efficacy of these vaccines, respectively. All are currently recruiting participants.
Unlike injectable cancer vaccines, which rely on the activation of the immune system through dendritic cells by the delivery of small cancer proteins, oral vaccines use cells from the gastrointestinal tract to undertake that role.
This innovative strategy uses the large area of the intestine, which has an area of about 400 square meters, to enhance the vaccine’s delivery. The new vaccine formulation also is stable at room temperature for years, which considerably improves its use and delivery.
“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,” Bourinbaiar added.