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Our Business
Summary
Vicus Therapeutics is a privately-held clinical- stage biopharmaceutical company located in Morristown, NJ, developing novel strategic approaches to the treatment of cancer supportive care indications.
Vicus's lead program, VT-122, is in Phase 2 clinical trials for the treatment of cancer cachexia in patients with advanced lung cancer. Additionally, Vicus has two preclinical programs for the treatment of oral mucositis and cancer fatigue.
Vicus leverages its proprietary science to design and screen two-drug combinations that work together to reverse the body's maladaptive responses to cancer and its treatment. Vicus' development programs are powered by a network of leading clinical investigators in the United States, India and Japan. This global network drives the high quality, rapid and cost effective clinical development of Vicus' product candidates.
Approach
We approach the development of cancer supportive care therapies through our insights into the linkages between cancer, therapy, inflammation and supportive care indications such as cachexia, oral mucositis and fatigue. In many cases, these severe cancer-related disorders are caused by chemotherapeutic agents and radiation therapy and often become key treatment-limiting factors and impair the effectiveness of curative therapy.
Because most supportive care indication have complex etiologies, we design and screen synergistic combinations of FDA, EMEA or PMDA- approved drugs that simultaneously target multiple disease causing pathways. In addition, based on the extensive information available on approved drugs, we design and screen the drug combinations to have excellent safety profiles and to be complementary to chemotherapy, radiation therapy and surgical procedures.
Our goal is to advance a product candidate through clinical Phase 2 clinical trials by generating powerful and compelling clinical data, and then to out-license the candidate to a partner to fund Phase 3 development and market the approved product.
Our overall discovery and development process allows for the ultra-efficient use of both capital and time. We develop the combination product candidates using the 312.2(b)(1) and 505(b)(2) regulatory pathways. This approach eliminates the need to undertake extensive, time consuming and expensive animal and human studies to establish the safety and preliminary efficacy of the product candidates.
To rapidly assess proof-of-concept, we sponsor Investigator-led pilot trials in the US, Europe and Japan. To further accelerate development and reduce costs, we conduct Phase 2 and Phase 3 trials in both the US and India under a commercial US IND.
The schematic below outlines our overall approach to discovering and developing novel, high-impact drugs for critical unmet clinical needs in the cancer supportive care arena:
 
 
 
VICUS   Product Engine
Therapeutics  
 
  Vicus Framework Published Research & Clinical Data Disease Model for Compelling Indication
         
         
Central Functional Process Imbalances Targets & Biomarkers Screen & Select Combinations for "State Switchers" Product Candidate, Trial Design and IP
         
         
Investigator-led "Learning Trials" via 312.2(b)(1) US & Indian Phase 2 "Proof of Concept" via 505(b)(2) Product Validation and Phase 3 plan
         
         
 
  • High value validated Phase 2 combination product candidates


  • Under two years and for less than $5 million
 
 
Markets
The overall worldwide revenue for cancer supportive care products exceeds $10 billion dollars, led by hematopoietic growth factors, anti-emetics, bisphosphonates and opioids. Our lead product, VT-122, is for the treatment of cancer cachexia, a catastrophic wasting disorder associated with a 40% reduction in the life expectancy and severely impaired quality of life. No FDA-approved therapies are available for cancer cachexia.
Based on an indication for the treatment of cachexia in patients with advanced lung cancer, we expect VT-122 to treat 50,000 U.S. lung cancer patients and generate annual revenue of more than $150 million. By expanding into other cancer indications, we expect U.S. revenues for VT-122 to exceed $250 million and worldwide revenue to exceed $350 million.
The worldwide market for oral mucositis is projected to exceed $1 billion dollars and worldwide market for cancer fatigue currently exceeds $5 billion based on the current revenue of erythropoiesis-stimulating agents.
 
 
 
     
                     
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