Sellas Pipeline

GALINPEPIMUT-S (GPS) – DEVELOPMENT PROGRAMS

Program Preclinical Phase 1 Phase 2 Phase 3
Acute Myeloid Leukemia   Init. Phase 3 – Q2/3 17
Multiple Myeloma   Phase 2 Study Ongoing
Multiple Myeloma - P2b   Phase 2 Study 2H17
Mesothelioma   Ph 2 complete. Ph 3 TBA
Ovarian Cancer (comb. w/OPDIVO)   Phase 1/2 Study Ongoing
         
Chronic Myelogenous Leukemia   Phase 2 Study Pending
         
WT1-Lm Product (ADXS)   Pre-clinical work has commenced. Phase 1 FPI 1H:18

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 II trial in (AML) patients, galinpepimut-S improved overall and progression-free survival in patients with AML in first complete remission in comparison to historical data.

According to the Phase II trial results, administration of galinpepimut-S resulted in a median overall survival of 67.6 months in AML patients, 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. There was 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 III program for AML patients is due to begin in H2:17.

Malignant Pleural Mesothelioma (MPM):

SELLAS’s randomized, double-blind, placebo-controlled Phase II study in MPM patients enrolled a total of 40 patients at Memorial Sloan Kettering Cancer Center and M.D. Anderson Cancer Center.

According to Phase II 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, median overall survival of 24.8 months was recorded for galinpepimut-S-treated MPM patients, compared to a median 16.6 month overall survival for patients in the control arm. Patients with a complete tumor resection and subsequent treatment with galinpepimut-S showed a significant survival benefit, with galinpepimut-S inducing 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 III program for MPM patients is poised to commence by EOY:17/H1:18.

Multiple Myeloma (MM):

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

Such patients typically relapse within 12 months after frontline induction therapy, followed by successful autologous stem cell transplantation (ASCT), even when they receive maintenance therapy with immunomodulatory drugs (IMIDs). Updated data from the clinical study show an 88% actuarial overall survival at the 18-month landmark in 18 evaluable patients. All patients had evidence of minimal residual disease after ASCT and 15 had high-risk cytogenetics at diagnosis. Combined, these characteristics typically result in low progression-free survival rates that do not exceed 12 months following ASCT, even while on maintenance therapy with immunomodulatory drugs 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). The Company’s 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 minimal residual disease status post-ASCT and on continuous thalidomide maintenance. SELLAS’ Phase II 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:

The Company has an open-label, non-randomized phase 1/2 trial clinical trial underway to evaluate the safety and efficacy of galinpepimut-S in combination with Nivolumab (Opdivo®), Bristol- Myers Squibb’s 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 Memorial Sloan Kettering Cancer Center. Patients enrolled in the study will receive the combination therapy during the trial’s 14-week treatment period. Individuals who have not progressed by the end of this period will also receive a maintenance course of the WT1 immunotherapy. Pending the successful progress of the trial a larger, follow-on, randomized study may be planned. Initial data are due in 2H:17, with a primary endpoint being to assess the safety of repeated vaccination with concomitant GPS with GM-CSF and Montanide for a total of 6 vaccinations in combination with 7 infusions of Nivolumab to patients.