Aneustat™ : Breakthrough Cancer-Regulating Multitarget Drug Candidate
The Problem: There are at least 3.1 million men with prostate cancer (PC) in the U.S.A. The American Cancer Society estimates that in 2020 there will be 191,000 new cases diagnosed and 33,330 deaths from PC. Surgery, chemotherapy and radiation therapy for PC all result in serious side effects and reduced quality of life.
Unmet Needs: Better therapy to control metastatic PC and reduce mortality, an effective therapy to block the progress of localized, early stage PC in 3 million men, and a drug that improves the benefits of current therapies by reducing toxicity and delaying drug resistance.
Photo Credit: Mediaphotos
Solution: Aneustat™ (OMN54) is a multi-targeted, multi-action drug to treat cancer. Tumors are complex, rapidly evolving, multicellular tissues that present complicated challenges to the host’s immune system and single target treatments. Single targeted therapy is partially effective with certain tumor types, but is not generally successful in controlling or eradicating the most common forms of solid tumors.
Furthermore, toxic side effects from treatments are often severe, and eventual drug resistance frequently leads to more aggressive and dangerous forms of cancer. The Company also has evidence of efficacy on other solid tumors.
Aneustat™ is a proprietary phytochemical-combination that addresses the heterogeneous complexities of cancer and limitations of single-target therapy.
Strategic Objective: Omnitura Therapeutics is seeking partners to support its upcoming FDA clinical trials and path towards commercialization. The total projected funding requirement through 2023, when the Company expects to receive accelerated FDA breakthrough drug designation approval, is $70 million.
Clinical Studies
Aneustat™ Phase I Clinical Trial Completed in 2016
Human trial conducted at BC Cancer Agency, Vancouver, BC, Canada
No toxicity or significant side effects attributed to
Good patient quality of life and compliance with therapy
Significant dose-dependent reduction of key biomarkers of immune suppression and cancer promoting activity Duration of treatment for these end-stage patients averaged 2.5 months with a maximum of 8 months
Key Highlights
Four Initial Prostate Cancer Indications – 2nd most common cancer in U.S.
Potent Anti-Cancer Activity – proven pre- clinical and in-vivo activity against numerous targets & pathways associated with cancer initiation and progression
Combination Drug Synergies – Enhances the efficacy of current standard-of-care drugs by lowering toxicity and drug resistance
Extensive testing data available – highly predictive PDX models verify modulation of key cancer biomarkers (TGF𝛽, EGF, etc.)
Phase I/IIa study verified human safety, lack of toxicity, minimal side effects.
Pivotal ADAPT 1 Phase IIb/III trial planned for late 2020 – will enroll 225-333 patients with late-stage mCRPC to demonstrate benefits of Aneustat + docetaxel. (Tisch Cancer Institute, Mount Sinai Medical Center)
Oral delivery in capsule form – no injections or intrusive delivery; healthcare delivery cost benefits.
Pre-Clinical Studies
In published and peer-reviewed preclinical studies on patient-derived xenograft tumors, Aneustat™ demonstrated high synergy when combined with all standard-of-care drugs for prostate cancer and reduced drug resistance for docetaxel, Casodex, Xtandi, Zytiga, Erleada and Nubega. Effects included:
reduced immunologic and metabolic factors that promote the initiation and growth of cancer
increases in immune cells that induce cancer cell death (apoptosis)
reduced immunosuppression in tumors, and
Aneustat™ pushed cancer cells out of the resting/latency phase into the active growth phase where chemotherapy works best
Patents
Aneustat™, both singly, and in combination with each key standard-of-care drug for prostate cancer, is protected by issued patents or patent applications in the USA, China, Japan and the European Union
Board, Management and Organization
Omnitura has assembled an experienced and complementary team of expert scientists, clinical trialists and pharma professionals, together with collaborating medical practitioners and institutions in prostate cancer treatment and research to maximize the output of its studies and to organize its upcoming clinical trials.