Patients and Treatment

Focus Disease Areas

Evive Biotech believes that it can deliver the most substantial impact for patients by focusing on inflammatory disorders and oncology, including oncology supportive care. Large molecules have been demonstrated to be effective at modulating the immune system, hematopoietic system and other functions that impact inflammatory disorders and oncology-related diseases. Evive Biotech’s technology platforms are particularly capable of developing novel assets that capitalize on this trend, enabling us to direct focus towards these disease areas.

Inflammatory Disorders

Inflammatory disorders happen when the immune system attacks the body’s own cells or tissues, and without proper treatment, this can sometimes result in life-threatening symptoms. Many drug makers have dedicated their efforts to developing biologic therapies in the hopes of solving the inadequate response associated with standard treatments such as corticosteroids. F-652, our novel recombinant human interleukin-22 dimer, has applications across a range of these disorders and received orphan drug designation for aGvHD.

Alcoholic Hepatitis

Alcoholic Hepatitis (AH) is an inflammatory condition of the liver caused by heavy alcohol consumption over an extended period. As an acute condition, >50% of patients with AH have established cirrhosis at the time of clinical presentation, and a one-year mortality rate after hospitalization is as high as 40%. The annual incidence of AH ranges from 0.15% to 0.2%, resulting in around 445,000 cases every year in US alone.

Among all AH patients, 60% tend to have a Maddrey’s Discriminant Function score over 32, which means they require drug treatment. However, only 40% of them have a response to standard treatment with steroids, highlighting significant unmet need for those that do not respond.

 

See study sponsored by our collaborators at the Mayo Clinic regarding the use of F-652 in Patients With Alcoholic Hepatitis

Graft Versus Host Disease (GvHD)

GvHD is a medical complication following transplant surgery from a genetically different donor. Acute GvHD (aGvHD) is commonly associated with stem cells such as bone marrow transplants, accounting for circa 60% of all GvHD cases. The annual incidence of aGvHD is around 8,000 patients in the US and 18,000 patients in Europe. Patients who develop aGvHD are treated with increased immunosuppression in the form of corticosteroids. However, response to corticosteroids is limited, with only 50% responding to treatment, and those who fail initial therapy have mortality rates as high as 95%.

 

See our sponsored study of IL-22 IgG2-Fc (F-652) for Subjects With Grade II-IV Lower GI aGVHD, in collaboration with Memorial Sloan Kettering Cancer Center

Oncology Support

The International Agency for Research on Cancer at the WHO reports global cancer incidence at over 11 million cases per year with the American Cancer Society estimating almost 2 million new cases diagnosed per year in the US alone. While modern medicine is producing newer, more effective, and better therapies to fight cancer, many therapies still present medical complications for patients due to the severity of their disease. Addressing the complications and side effects of these therapies, by providing oncology supportive care treatments, improves patients’ overall treatment experience, enables them to benefit from therapies their health conditions might otherwise prohibit and has the potential to decrease mortality rates. Evive Biotech strives to develop oncology supportive care therapies to address these unmet medical needs and improve patients’ experience and clinical outcomes.

 

See the World Health Organization’s estimate of cancer incident cases worldwide
See the American Cancer Society’s estimates of the numbers of new cancer cases and deaths that will occur in the United States

Chemotherapy Induced Neutropenia (CIN)

Chemotherapy Induced Neutropenia (CIN) commonly occurs during current cancer treatments involving cytotoxic chemotherapy. If left untreated, the reduction of these critical immune cells means that patients suffering from CIN are much more vulnerable to other infections. Mortality rates from opportunistic infections due to CIN mean that almost as many patients treated, with chemotherapy succumb to CIN as to the cancer being treated.

 

Furthermore, concerns around the risk and prognosis of CIN mean that some patients with poor prognosis forgo chemotherapy treatment altogether. Market research indicates that CIN affects more than 8 million people every year with around 1 million people affected in the US alone.

 

CIN is primarily treated with Granulocyte-Colony Stimulating Factor (G-CSF) and antibiotics. These long-acting G-CSFs also present unmet medical needs as highly heterogeneous populations that respond inconsistently to currently available options, and some sub-populations of patients are unresponsive to current therapies or do not tolerate pegylated products. F-627’s novel dimeric fusion protein structure addresses these unmet medical needs by providing a safe and efficacious alternative to current long-acting G-CSFs that avoids pegylation.

 

See the results of our Phase III China trials comparing the efficacy and safety of F-627 and GRAN® 

See our Phase III Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy