Sellas Pipeline

GALINPEPIMUT-S (GPS) – DEVELOPMENT PROGRAMS

Program Preclinical Phase 1 Phase 2 Phase 3
Acute Myeloid Leukemia   Ph3 Ready
Mesothelioma   Ph3 Ready
Immune Combination Trial  
Chronic Myelogenous Leukemia (CML)  
 
AML (with Hypomethylating Agent)    
Multiple Myeloma –Randomized    
Multiple Myeloma – Single arm    
Ovarian Cancer (comb. with nivolumab)    
         

In-Licensed WT1 Delivery Technology

         
WT1-Lm Product (ADXS)   Planned

GALINPEPIMUT-S (GPS) – DEVELOPMENT PROGRAMS

I - Preclinical II - Phase 1 III - Phase 2 IV - Phase 3
Program: Acute Myeloid Leukemia
I II III IV
  Init. Phase 3 – Q2/3 17
Program: Multiple Myeloma
I II III IV
  Phase 2 Study Ongoing
Program: Multiple Myeloma - P2b
I II III IV
  Phase 2 Study 2H17
Program: Ovarian Cancer (comb. w/OPDIVO)
I II III IV
  Phase 1/2 Study Ongoing
Program: Mesothelioma
I II III IV
  Init. Phase 3 - Pending
Program: Chronic Myelogenous Leukemia
I II III IV
  Phase 2 Study Pending
Program: WT1-Lm Product (ADXS)
I II III IV
  Phase 1 FPI 1H:18

Clinical Trials

Two phase 3 ready indications - Acute Myeloid Leukemia and Malignant Pleural Mesothelioma

Acute Myeloid Leukemia (AML):

In a Phase 2 trial in AML patients, in first complete remission, galinpepimut-S was shown to improve OS and PFS in comparison to historical data.

According to the Phase 2 trial results, administration of galinpepimut-S resulted in a median OS of 67.6 months, which represents a substantial improvement compared to best standard therapies. Serial active immunization with galinpepimut-S showed a favorable safety and tolerability profile in this patient population, whose median age was 63 years old. In addition, galinpepimut-S elicited immune responses in patients, including CD4+ and CD8+ T cell responses. The results also evidenced a trend in improved clinical outcomes in patients who mounted an immune response with galinpepimut-S compared to those patients who did not. A Phase 3 program for AML patients is currently being scheduled.

Malignant Pleural Mesothelioma (MPM):

SELLAS randomized, double-blind, placebo-controlled Phase 2 study in MPM patients enrolled a total of 41 patients at MSKCC and M.D. Anderson Cancer Center.

According to an initial analysis of the Phase 2 MPM study data of galinpepimut-S presented at the 2016 International Mesothelioma Interest Group and the 2016 Annual Meeting of the American Society of Clinical Oncology, as of May 2016, and with a median follow-up of 16.3 months, median OS of 24.8 months was recorded for galinpepimut-S-treated MPM patients, compared to a median 16.6 months OS for patients in the control arm. In that analysis, patients with a complete tumor resection and subsequent treatment with galinpepimut-S showed a significant survival benefit. In a subsequent analysis, and with a median follow up of 17.2 months, median OS of 22.8 months was observed for galinpepimut-S-treated MPM patients, compared to a median 18.3 months OS for patients in the control arm (Zauderer M, et al, Clin Cancer Res, 2017). In the datasets from both these analyses, galinpepimut-S induced CD8+ and CD4+ T cell activation. Galinpepimut-S also demonstrated a favorable safety and tolerability profile in MPM patients and was well-tolerated by patients in the trial. A Phase 3 clinical study in MPM is currently being scheduled.

Multiple Myeloma (MM):

SELLAS has reported updated positive Phase 2 data from its WT1 immunotherapeutic anti-cancer treatment, galinpepimut-S, which indicate a meaningful clinical benefit among high-risk multiple myeloma (MM) patients.

High-risk MM patients typically relapse within 12 months after frontline induction therapy, followed by successful ASCT, even when they receive maintenance therapy with IMIDs. SELLAS reported updated positive Phase 2 data showing 88% actuarial OS at the 18-month landmark in 18 evaluable patients. All patients had evidence of MRD after ASCT and 15 had high-risk cytogenetics at diagnosis. Combined, these characteristics typically result in low PFS rates that do not exceed 12 months following ASCT, even while on maintenance therapy with IMIDs or proteasome inhibitors. Current median PFS is 23.6 months, while median OS has not been reached. SELLAS’ results compare favorably with an unmatched cohort of MM patients with high-risk cytogenetics published by the UK Medical Research Council (Myeloma IX trial). SELLAS’ galinpepimut-S therapy demonstrated a 2.5-fold increase in median PFS, as well as a 2.6-fold increase in the PFS rate at 18 months versus the aforementioned historical cohort, which included MM patients with high-risk cytogenetics and MRD post-ASCT and on continuous thalidomide maintenance. SELLAS’ Phase 2 study started in June 2014 and has enrolled a total of 20 patients, who are being monitored long-term. All non-progression events are confirmed and ongoing (median follow-up at 18 months for survivors).

Ovarian Cancer:

SELLAS has an open-label, non-randomized Phase 1/2 clinical study underway to evaluate the safety and efficacy of galinpepimut-S in combination with nivolumab (Opdivo®), a PD-1 immune checkpoint inhibitor, in patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who are in second or greater clinical remission.

This Phase 1/2 study is expected to enroll at least ten patients with recurrent ovarian cancer who are in second or greater clinical remission at MSKCC. Patients enrolled in the study will receive the combination therapy during the study’s 14-week treatment period. Individuals who have not progressed by the end of this period will also receive a maintenance course of the galinpepimut-S. Pending the successful progress of this study a larger, follow-on, randomized study may be planned. Initial data are due soon, with a primary endpoint being to assess the safety of repeated vaccination with galinpepimut-S for a total of 6 vaccinations in combination with 7 infusions of nivolumab.