New York, NY (Press Release) – SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) (“SELLAS” or the “Company”), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the devel­op­ment of novel cancer immuno­therapies for a broad range of cancer indi­ca­tions, today announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has approved orphan medicinal prod­uct desig­na­tion (OMPD) for galinpepimut‑S (GPS), the Company’s lead prod­uct can­di­date, for the treat­ment of multiple myeloma (MM). GPS is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms Tumor 1 (WT1) protein, which is present in an array of tumor types. GPS has also been granted orphan drug desig­na­tion and fast track desig­na­tion by the U.S. Food and Drug Admin­istra­tion (FDA) for the treat­ment of MM.

“This OMPD endorsement by the COMP of the EMA for GPS in MM complements the orphan desig­na­tion awarded by the US FDA for this prod­uct in the same indi­ca­tion,” said Angelos Stergiou, MD, ScD h.c., Pres­i­dent and Chief Executive Officer of SELLAS. “The results from our open-label Phase 2 study reinforce the poten­tial of GPS to serve as a ther­apy for high-risk MM patients in the post-autotransplant main­te­nance setting. The inno­va­tive nature and unique mech­a­nism of action for GPS provide a promising poten­tial addi­tion to the current arsenal of ther­a­pies in this indi­ca­tion. We con­tinue to work closely with the FDA and EMA, as well as multiple myeloma KOLs to further ad­vance the clin­i­cal devel­op­ment of GPS in this malig­nan­cy and look forward to gaining further insights on the poten­tial thera­peutic role of GPS in high-risk MM patients.”

The EMA orphan medicinal prod­uct desig­na­tion is granted to medicines being developed for the diag­nosis, prevention or treat­ment of a life-threatening or chronically debilitating con­di­tion with a prev­a­lence of not more than five in 10,000 people in the European Union. Orphan desig­na­tions are granted by de­ci­sions of the European Com­mis­sion based on opinions from the Committee for Orphan Medicinal Products within EMA. EMA orphan drug desig­na­tion benefits in­clude protocol assistance, access to the EU centralized authori­za­tion procedure, reduced EU regu­la­tory filing fees and 10 years of market exclusivity across the EU.

About the Phase 2 Trial of GPS in Multiple Myeloma

The open-label Phase 2 study consisted of 19 patients with multiple myeloma who had high-risk cytogenetics at initial diag­nosis and remained at least minimal residual disease (MRD)-positive after a successful au­tol­o­gous stem cell trans­plant (“ASCT”). GPS was admin­istered to patients in the study who achieved a stable disease or better status (per Inter­na­tional Myeloma Work­ing Group criteria) fol­low­ing ASCT. GPS was eval­u­ated as consolidation ther­apy (on top of lena­lido­mide or bor­tez­o­mib) to poten­tially stimulate a highly-specific immune response against WT1 in order to prevent or delay myeloma pro­gres­sion. Median pro­gres­sion-free survival (PFS) of 23.6 months was reported in this high-risk disease setting, compared to historically inferior out­comes while on an immuno­modu­la­tory drug (IMID) or pro­te­a­some inhibitor post-ASCT main­te­nance. Median over­all survival has not been reached to date. GPS stimulated time-dependent and robust CD4+ T cell or CD8+ T cell immune responses (IRs) specific for all four WT1 peptides within GPS, two of which are heteroclitic (mutated, by design). In addi­tion, GPS stimulated similar IRs against the two counterpart native peptides. The IRs were con­firmed in up to 91% of patients across HLA allele types, with multivalent IRs emerging in up to 64% of patients. Multifunctional cross-epitope T cell reactivity was observed in 75% of patients to an­ti­genic epitopes against which hosts were not specifically immunized, in a pattern akin to epitope spreading. A link of clin­i­cal activity to an­ti­gen-specific immune responses was suggested.

About Galin­pepimut-S (GPS)

GPS is a heteroclitic multivalent, multi-peptide cancer immuno­therapeutic agent composed of four peptides, addressing over 20 epitopes, and derived from the WT1 protein, which has been ranked by the National Cancer Institute as a top priority among cancer an­ti­gens for immuno­therapy. Importantly, because the WT1 an­ti­gen is overexpressed in many malig­nan­cies, and is not found in most normal tissues, GPS has the poten­tial to be a broad immuno­therapy, effective across a multitude of diverse cancer types and patient pop­u­la­tions.

About SELLAS Life Sciences Group, Inc.

SELLAS is a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the devel­op­ment of novel cancer immuno­therapeutics for a broad range of cancer indi­ca­tions. SELLAS’ lead prod­uct can­di­date, galin­pepimut-S (GPS), is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms Tumor 1 (WT1) protein, which is present in an array of tumor types. GPS has poten­tial as a mono­therapy or in com­bi­na­tion to address a broad spectrum of hema­to­logic malig­nan­cies and solid tumor indi­ca­tions. SELLAS has Phase 3 clin­i­cal trials planned for GPS in two indi­ca­tions, acute myeloid leukemia (AML) and malignant pleural mesothelioma (MPM) and is also devel­op­ing GPS as a poten­tial treat­ment for multiple myeloma (MM) and ovarian cancer. SELLAS plans to study GPS in up to four addi­tional indi­ca­tions. SELLAS has received Orphan Drug (or Medicinal Product) desig­na­tions for GPS from both the U.S. Food & Drug Admin­istra­tion (FDA) and the European Medicines Agency (EMA) for AML, MPM, and MM. GPS also received Fast Track desig­na­tion for AML, MPM and MM from the FDA. SELLAS’ second prod­uct can­di­date, NeuVax™ (nelipepimut-S), is a HER2-directed cancer immuno­therapy being in­ves­ti­gated for the prevention of the recurrence of breast cancer after standard of care treat­ment in the adjuvant setting. NeuVax™ has received Fast Track status desig­na­tion by FDA for the treat­ment of patients with early stage breast cancer with low to intermediate HER2 ex­pres­sion, other­wise known as HER2 1+ or 2+, fol­low­ing standard of care.

For more in­­for­ma­tion on SELLAS, please visit www.sellaslifesciences.com.

Forward-Looking Statements

This press release con­tains forward-looking state­ments. All state­ments other than state­ments of historical facts are “forward-looking state­ments,” in­­clud­ing those relating to future events. In some cases, forward-looking state­ments can be identified by terminology such as “plan,” “expect,” “antic­i­pate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These state­ments, in­clude, without limitation, state­ments related to the timing and results of clin­i­cal studies and as to further devel­op­ment of GPS for a broad range of cancer indi­ca­tions. These forward-looking state­ments are based on current plans, objectives, esti­mates, ex­pec­ta­tions and intentions, and in­her­ently involve sig­nif­i­cant risks and un­cer­tain­ties. Actual results and the timing of events could differ materially from those antici­pated in such forward-looking state­ments as a result of these risks and un­cer­tain­ties, which risks in­clude, without limitation, risks and un­cer­tain­ties asso­ci­ated with immune-oncology prod­uct devel­op­ment and clin­i­cal success thereof, risks and un­cer­tain­ties related to the timing of clin­i­cal trials, the uncertainty of regu­la­tory approval, the uncertainty of partnering its clin­i­cal assets, and other risks and un­cer­tain­ties affecting SELLAS and its devel­op­ment pro­grams as set forth under the caption “Risk Factors” in Exhibit 99.1 in its Current Report on Form 8-K filed on July 18, 2018 and in its other SEC filings. Other risks and un­cer­tain­ties of which SELLAS is not cur­rently aware may also affect SELLAS’ forward-looking state­ments and may cause actual results and the timing of events to differ materially from those antic­i­pated. The forward-looking state­ments herein are made only as of the date hereof. SELLAS under­takes no obli­ga­tion to update or supple­ment any forward-looking state­ments to reflect actual results, new in­­for­ma­tion, future events, changes in its ex­pec­ta­tions or other cir­cum­stances that exist after the date as of which the forward-looking state­ments were made.

Source: SELLAS.