About Sellas
Our leadership team is committed to addressing compelling medical needs
Our Board is comprised of experienced directors who provide relationships and oversight to the company.
Our team of scientific experts and specialists ensure we stay at the forefront of innovation
Galinpepimut-S (GPS) Therapy
GPS Cancer Immunotherapy
GPS Immunotherapy Development
Sellas Pipeline
Our unique mechanism of action is complimentary to existing therapies and applicable to many cancer indications
Galinpepimut-S (GPS) Clinical Trials
We are progressing on several trials aimed at treating various cancer types
NeuVax Clinical Trials
NeuVax is currently in several ongoing Phase 2 investigator sponsored trials.
Galinpepimut-S (GPS)
NeuVax (nelipepimut-S)
Cancer types our therapy targets
Information on how to enroll in our clinical trials
We partner with pre-eminent cancer centers and organizations to help realize our vision
Wt1 Cancer Immunotherapy
Wt1 Immunotherapy Development
NeuVax Clincal Trials
Anagrelide CR Clinical Trials
NeuVaxTM (nelipepimut-S)
SELLAS is partnering with Memorial Sloan Kettering Cancer Center to develop novel immunotherapies for a broad range of cancer indications
GALINPEPIMUT-S
THE GPS IMMUNOTHERAPY ENGINEERED FOR A BROAD SPECTRUM OF CANCER INDICATIONS
SELLAS' lead product candidate, galinpepimut-S, targets malignancies and tumors characterized by an overexpression of the WT1 antigen. The WT1 antigen is one of the most widely expressed cancer antigens in multiple malignancies. It has been ranked by the NCI as the top priority among cancer antigens for immunotherapy. SELLAS' WT1 immunotherapy is comprised of four peptide chains, two of which are modified chains that induce a strong innate immune response (CD4+/CD8+) against the WT1 antigen and access a broad range of HLA types. When administered to a patient, the induced immune response has the potential to recognize and destroy cancer cells and provide ongoing support and memory to the immune system so that it can continue to target and destroy recurring tumors and residual cancer cells.
The Company's lead product candidate, galinpepimut-S, targets malignancies characterized by an overexpression of the WT1 (Wilms Tumor Protein) antigen. The WT1 antigen is one of the most widely expressed cancer antigens in multiple malignancies. It has been ranked by the National Cancer Institute (NCI) as the Number 1 target for cancer immunotherapy. SELLAS' WT1 immunotherapy is comprised of four peptide chains, two of which are modified chains that induce a strong innate immune response (CD4+/CD8+) against the WT1 antigen and access a broad range of HLA types. When administered to a patient, the induced immune response has the potential to recognize and destroy cancer cells. This efficacy along with a well-tolerated safety profile gives galinpepimut-S the potential to be a highly effective approach to prolonging survival by delaying or preventing relapse/recurrence in patients in complete remission or with minimal residual disease.
WT1: Top Priority Cancer Antigen by the National Cancer Institute
Source: Cheever CCR 2009
Patients with AML, MPM, high-risk MM, relapsed ovarian Ca and other types of cancers who undergo debulking standard therapy have shown relapse rates in excess of 80% or more, as this therapy rarely leads to complete eradication of the disease. Although most patients enter into complete remission with currently available treatments, the majority of those patients, unfortunately, relapse thereafter. Thus, SELLAS' WT1 immunotherapy can target over 20 cancers that over-express WT1 and, due to its strong T-cell immune response, it is designed to prevent/delay relapses (by prolonging the progression-free interval) and eventually potentially prolong survival in these patients, which is evidenced by the positive results in Phase 1 & 2 clinical trials performed to date in AML (after 1st and 2nd line), MPM (after 1st line), high-risk MM (after upfront therapy including autotransplant, and relapsed ovarian Ca (after 1st or 2nd line).
Tumor types pursued by SELLAS' clinical program Other tumor types
AML: acute myelogenous leukemia MPM: malignant pleural mesothelioma
Source: Memorial Sloan Kettering Cancer Center data (based on review of literature and multiple studies)
GPS POISED TO BECOME AN EFFECTIVE immunotherapy
SELLAS' WT1 immunotherapy is comprised of four peptide chains, two of which are modified chains that induce a strong innate immune response (CD4+/CD8+) against the WT1 antigen and access a broad range of HLA types. When administered to a patient, the induced immune response has the potential to recognize and destroy cancer cells. This efficacy along with a well-tolerated safety profile gives galinpepimut-S the potential to be a highly effective approach to prolonging survival by delaying or preventing relapse/recurrence in patients in complete remission or with minimal residual disease.
The WT1 immunotherapy, originally developed by MSKCC and licensed to SELLAS, incorporates a set of immunogenic peptides that have been shown to stimulate both CD4 and CD8 T-cells. In addition, key amino acids from some of these peptides have been modified to improve their immunogenicity. SELLAS is further optimizing the manufacturing process towards a lyophilized formulation with high stability features. The general principles of the mechanism of action of galinpepimut-S is schematically represented in the graphic below.
WT1 immunotherapy is administered in combination with an adjuvant and an immune modulator (GM-CSF) to improve the immune response to the target. Initial pilot clinical studies have been conducted in patients with AML and thoracic cancers, such as lung cancer and MPM. Based on encouraging results in these initial studies, additional Phase 2 trials were launched in hematopoietic cancers and solid tumors. Results of these initial studies have shown that SELLAS' WT1 immunotherapy is well-tolerated and capable of inducing a robust immune response to the antigen. Patients enrolled in the AML and MPM trials have shown prolonged survival following active immunization with galinpepimut-S.
In patients with advanced cancers over-expressing WT1, SELLAS' immunotherapy is designed to prevent relapses and potentially improve survival rates of patients, while maintaining their quality of life. Clinical studies conducted at MSKCC have shown strong proof of concept, including compelling survival findings, and a well-tolerated safety profile.
Acute Myeloid Leukemia (AML)
Initial clinical studies of galinpepimut-S were conducted in AML due to the high levels of WT1 expression observed in this tumor type and the deep institutional experience of MSKCC with AML.
Phase 1 and Phase 2 studies were conducted with 9 and 22 patients, respectively. These patients were treated with galinpepimut-S in the maintenance setting, i.e. after having successfully achieved their first morphological complete remission (CR1) post-upfront standard antileukemic chemotherapy. Of these total 31 patients 16 (52%) remain alive with a median OS of the Phase 2 study patients of 67.6 months.
Galinpepimut-S was further independently validated at the Moffitt Cancer Center (MCC) in a more severe AML population in patients who had reached their second complete remission (CR2, post 2nd line chemotherapy), where it showed statistically significant clinical benefit when compared with a cohort at the same institution contemporaneously treated with best standard therapy, leading to a median survival of 16.5 months vs. 5.5 months. Disease free survival was 10.6 months vs 4.4 months with standard treatment.
A Phase 3 clinical trial for AML in the CR2 setting is currently being scheduled, pending funding availability.
Malignant Pleural Mesothelioma (MPM)
MPM was chosen as a clinical trial setting due to the high levels of expression of WT1 in patients with this tumor type.
A 41-patient Phase 2, double-blind, randomized study performed at MSKCC and MD Anderson Cancer Center and co-sponsored by the Department of Defense (DOD), demonstrated a well-tolerated safety profile.
The most recent analysis shows median OS was 22.8 months in the GPS arm vs. 18.3 months in the control arm, (HR: 0.79), with a median follow-up of 17.2 months.
A Phase 3 clinical trial for MPM is currently being scheduled, pending funding availability.
Multiple Myeloma (MM)
Phase 2 Study in high-risk patients after successful front-line therapy
20 patients enrolled; 18 evaluable.
88% actuarial OS at 18 months and median OS not reached.
Median PFS of 23.6 months.
All evaluable patients had evidence of minimal residual disease (MRD) after autologous stem cell transplantation (ASCT) and 15/18 patients also had high-risk cytogenetics as well as additional unfavorable clinical characteristics at diagnosis.
Typically, patients with the above features exhibit PFS rates that do not exceed 12 months following ASCT, even while on maintenance therapy with immunomodulatory drugs (IMIDs) or proteasom inhibitors.
Galinpepimut-S data source: Koehne G, et al. 44th Ann. Meeting of the European Society for Blood and Marrow Transplantation (EBMT), 2018; Abstr. # O132.
Phase 1/2 study in the maintenance setting in combination with nivolumab (OPDIVO®), an inhibitor of Programmed cell Death protein 1 (PD1) 11 patients (10 evaluable) with recurrent ovarian cancer who are in second or greater clinical remission
Combination therapy over 14-weeks with galinpepimut-S every 2 wks x 6 inoculations in combination with 7 infusions of nivolumab every 2 weeks
No additional toxicity burden above and beyond what would be expected with nivolumab alone
PFS rate at 1 year since initiation of salvage chemotherapy was 70% for patients who received >2 doses of the combination (n=10), which compared favorably with historical 1-yr PFS rates of 43-50% in this setting
Galinpepimut-S data source: O'Cearbhaill RE, et al. J Clin Oncol. 2018;36[15; Suppl], 5553).
Various Advanced Malignancies
Phase 1/2 study (5-arm 'basket' trial) in the metastatic/blastic disease setting in combination with pembrolizumab (KEYTRUDA®), a PD1 inhibitor.
Currently enrolling patients in five cancer indications, including AML (on hypomethylating agents having achieved only morphological partial response in front-line), and advanced, recurrent solid tumors (ovarian Ca, colorectal Ca -cohort enriched in but not exclusive to patients with microsatellite instability-low [MSI-L], small cell lung Ca, and triple-negative breast Ca). The study is planned to enroll up to 90 patients in various centers in the United States.
This study will assess the efficacy and safety of the combination, comparing overall response rates (ORRs – by RECIST criteria) and immune response markers achieved with the combination versus prespecified rates based on those seen with pembrolizumab alone in comparable patient populations.
(ClinicalTrials.gov Identifier: NCT03761914).
For more information on the WT1 program, please see "Galinpepimut-S: Publications and Presentations" on this website.
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