Vicus Therapeutics is a privately-held biopharmaceutical company focused on developing
oncology supportive care drug products for serious unmet medical needs. These products
include: VT-122, in Phase 2 clinical trials for cancer cachexia; VT-211 and VT-212, in
investigator-led pilot trials for chemotherapy-induced oral mucositis and neutropenia; and
VT-310, in pre-clinical evaluation for cancer-related fatigue. Each product candidate is a
novel combination and dosing regimen of two generic drugs with known safety
profiles. The constituent drugs and dosing regimens are chosen based on the results of
Vicus’ predictive disease models and the company’s understanding of the body’s maladaptive
response to cancer and its treatment.
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 indications 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 provide safe and synergistic
therapy and to complement chemotherapy, radiation therapy and surgical procedures.
Our goal is to advance a product candidate
through 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:
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 for cancer cachexia addresses a $1 billion market where there is no
FDA approved treatment. In advanced cancer patients, the prevalence of cachexia increases
from 50% at diagnosis to more than 80% prior to death. Cachexia is a debilitating, progressive
muscle wasting condition manifested by unintentional weight loss, muscle weakness, anemia,
fatigue, and death. This widespread, serious and costly unmet medical need bodes well for
attractive reimbursement, broad Medicare Part-D drug plan coverage and rapid revenue
growth. In addition, there is growing recognition within the medical community that patients
with persistent weight loss have substantially worse prognoses than patients who are weight
stable. In a study of over 3,000 stage IV cancer patients, weight loss at time of diagnosis is
associated with a 20% to over 50% reduction in median life expectancy by type of cancer.
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.
