Indications

Acute myeloid leukemia (AML) is the most common affecting adults, and its incidence increases with age.

The disease is characterized by the rapid growth of abnormal white blood cells that build up in the bone marrow and interfere with the production of normal blood cells. Its symptoms include fatigue, shortness of breath, bruising and bleeding, and increased risk of infection. The cause of AML is unknown and the disease is typically fatal within weeks or months if untreated. Treatments include chemotherapy, and some people may receive a hematopoietic stem cell transplant (HSCT). The goal of upfront therapy for AML is to achieve a state of "complete response" (or CR), whereby the hematologic and clinical features of the disease are controlled. Nonetheless, essentially all patients in CR still harbor evidence of minimal residual disease (MRD). To date, other than an allogeneic HSCT (which is in principle an immunotherapy), no therapies have been proven to accord any meaningful benefit after patients achieve a CR status. Once the disease relapses, then 'second-line' therapies can be given, but even these have very limited positive clinical impact.

Multiple myeloma is a cancer formed by malignant plasma cells, and its cause is unknown.

The overgrowth of plasma cells in the bone marrow crowds out normal blood-forming cells, causing low blood counts and anemia (a shortage of red blood cells). Multiple myeloma can also cause a shortage of platelets and lead to increased bleeding and bruising, along with problems fighting infections. The cancer causes a host of organ problems and symptoms, including fatigue, bone pain, fractures and kidney failure. Treatment includes drugs that modulate the immune system, chemotherapy, , radiation and stem cell transplants (SCT's). Median survival is about three years though some patients have a life expectancy of 10 years. Despite significant therapeutic advances in the management of MM, the prognosis of patients with high risk cytogenetics at the time of diagnosis remains quite poor, even when they successfully complete an ASCT, especially if they continue to have evidence of MRD.

Malignant mesothelioma is an asbestos-related cancer that forms on the protective tissues that cover many of the internal organs.

The most common area affected is the lining of the lungs and abdomen though it can also form around the lining of the abdomen or heart. Most cases are traced to job-related exposures to asbestos and it can take around 40 years between exposure and cancer formation. Symptoms may include shortness of breath, a swollen abdomen, chest wall pain, cough, feeling tired, and weight loss. Mesothelioma is generally resistant to radiation and chemotherapy, while long term survival is rare, even in cases where aggressive upfront debulking multimodality therapy (extirpative surgery, chemotherapy and in some cases radiotherapy) are used. Typical survival is between 12 and 16 months, although select patients who complete a full course of indicated chemotherapy can survive up to 21 months.

Ovarian Cancer is a solid tumor that forms in the ovaries.

Due to the lack of specific symptoms, the majority of ovarian cancer patients are diagnosed at later stages of the disease, with an estimated 75% of women presenting with advanced-stage (III or IV) disease. New cases of ovarian cancer occur at an annual rate of 11.9 per 100,000 women in the U.S., with an estimated 22,280 new cases and 14,240 deaths in 2016. Approximately 46.2% of ovarian cancer patients are expected to survive five years after diagnosis.

Approximately 1.3% of women will be diagnosed with ovarian cancer at some point during their lifetime (2011 – 2013 data). The prevalence data from 2013 showed an estimated 195,767 women living with ovarian cancer in the United States.

Source: National Cancer Institute Surveillance, Epidemiology, and End Results Program

Hematology & Solid Tumors

The Phase 1/2 trial with galinpepimut-S plus KEYTRUDA® (pembrolizumab) in patients with WT1-positive relapsed or refractory tumors will explore the following cancer indications: colorectal (arm enriched in but not exclusive to patients with microsatellite instability-low [MSI-L]), ovarian, small cell lung, triple-negative breast, and AML.

Breast Cancer can take multiple forms and SELLAS is currently investigating three types.

New cases of breast cancer occur at an annual rate of 125 per 100,000 women in the U.S., with an estimated 246,660 new cases and 40,450 deaths in 2016. Approximately 89.7% of breast cancer patients are expected to survive five years after diagnosis. Approximately 12.4% of women will be diagnosed with breast cancer at some point during their lifetime (2011 – 2013 data). The prevalence data from 2013 showed an estimated 3,053,450 women living with breast cancer in the United States.

Source: National Cancer Institute Surveillance, Epidemiology, and End Results Program

Essential Thrombocythemia is a chronic myeloproliferative neoplasm (MPN) characterized by the overproduction of platelets by megakaryocytes in the bone marrow.

As with other MPNs, ET is a progressive blood cancer that can strike at any age, and for which there is no known cure; and, there is no single treatment option that is appropriate or effective for all ET sufferers. The U.S. prevalence of ET is between 120,000 and 185,000 with approximately seventy-five percent of patients receiving treatment.1 Common symptoms include headache, vision disturbances or migraines, dizziness or lightheadedness, coldness or blueness of fingers or toes, burning, redness, and pain in the hands and feet. Complications for patients with ET include blood clotting or bleeding or may be thrombotic in nature such as stroke, heart attack, or transient ischemic attack.

Sources: Mehta et al, (2014) Epidemiology of myeloproliferative neoplasms in the United States, Leukemia & Lymphoma, 55:3, 595-600, DOI: 10.3109/10428194.2013.813500; United States Census Bureau.

Patients

For more information about our clinical studies, please contact us at:

info@sellaslife.com