On March 19, 2018 Oncoceutics, Inc. reported that multiple abstracts from the company and its commercial and academic collaborators will be presented at the 2018 annual meeting of the American Association of Cancer Research (AACR) (Free AACR Whitepaper) in Chicago, Illinois, on April 14th to April 18th (Press release, Oncoceutics, MAR 19, 2018, View Source [SID1234558371]).

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These abstracts highlight the unique way that ONC201 engages the dopamine receptor, leading to downstream direct anti-tumor and immune oncology effects, which are especially pronounced in tumors with dopamine pathway dysregulation. These tumors include H3 K27M mutant high grade gliomas and other cancers, where ONC201 is now in advanced clinical trials.

Additionally, the abstracts showcase the continued preclinical advancement of other members of the imipridone family. ONC212 will be featured in an oral presentation highlighting its ability to treat aggressive leukemias as a single agent, and effectively synergize with other anti-leukemic agents, specifically BCL-2 inhibitors, due to its unique GPCR target. ONC206 demonstrates parallel characteristics with ONC201, while also being differentiated by a unique binding profile.

The abstracts are listed below and categorized by topic: ONC201 clinical translation; ONC201 preclinical single agent and combinatorial activity; and analogs (ONC206 and ONC212). All poster presentations will be in McCormick Place South, Exhibit Hall A, and the oral presentation of ONC212 will take place in Room S102 – McCormick Place South (Level 1) at the times described below.

ONC201 Clinical Translation:

Selective targeting of dopamine receptor dysregulation in high grade gliomas with imipridone ONC201
April 17, 2018, 8:00 AM

ONC201 induction of apoptosis in hPheo1 cell line supports use of this oral agent in ongoing phase 2 clinical trial against neuroendocrine tumors
April 17, 2018, 1:00 PM

Clinical immunostimulatory activity of imipridone ONC201, a selective DRD2 antagonist, in advanced solid tumor patients
April 18, 2018, 8:00 AM

ONC201 Preclinical Single Agent and Combinatorial Activity

Treatment and signaling contexts for the application of the imipridone ONC201 to prostate cancer cells
April 15, 2018, 1:00 PM

LB-082. ONC201 sensitizes resistant breast cancer cells to TRAIL through death receptor 5 upregulation

April 16, 2018, 8:00 AM – 12:00 PM

Synergistic antitumor effect of ONC201 in combination with radiation therapy
April 16, 2018, 1:00 PM

Combination ONC201 and radiation therapy in the treatment of breast cancer
April 16, 2018, 1:00 PM

Analogs (ONC206 and ONC212):

Receptor pharmacology and anti-cancer activity of selective DRD2/3 antagonist imipridone ONC206
April 17, 2018, 1:00 PM

The novel imipridone ONC212 highly synergizes with the BCL-2 inhibitor ABT-199 in AML and activates orphan receptor GPR132
April 17, 2018, 3:35 PM – Oral Presentation

Champions Oncology has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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Apellis Pharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Apellis Pharmaceuticals, 2018, MAR 19, 2018, View Source [SID1234527578]).

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Oncolytics Biotech has filed a 20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 20-F, Oncolytics Biotech, 2018, MAR 19, 2018, View Source [SID1234524879]).

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On March 19, 2018 SELLAS Life Sciences Group, Inc. (NASDAQ:SLS) ("SELLAS" or "the Company") reported the presentation of open label Phase 2 clinical and immunological data for its lead cancer immunotherapeutic candidate, galinpepimut-S (GPS), in the treatment of high-risk multiple myeloma at the 44th Annual European Society for Blood and Marrow Transplantation (EBMT) Meeting (Press release, Sellas Life Sciences, MAR 19, 2018, View Source [SID1234525471]). Safety results from the study were also presented. The EBMT presentation is being delivered by Guenther Koehne, M.D., Ph.D., Chief of Bone Marrow Transplantation and Hematologic Oncology at Miami Cancer Institute, Baptist Health South Florida.

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Median progression-free survival (PFS) of 23.6 months was reported in the 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. The open-label Phase 2 study consisted of 19 patients with multiple myeloma who had high-risk cytogenetics at diagnosis and remained at least minimal residual disease (MRD)-positive after a successful autologous stem cell transplant ("ASCT").

"These results are encouraging particularly given the patients’ poor prognosis due to their high-risk cytogenetic profile at disease presentation and their still harboring minimal residual disease prior to GPS treatment", said Angelos M. Stergiou, M.D., Sc.D. h.c., President and CEO of Sellas. "The improved PFS at 23.6 months in this setting instills further confidence in our advancing GPS development as an important immuno-therapeutic treatment option for aggressive multiple myeloma."

GPS was administered to patients in the study who achieved a stable disease or better status following ASCT, but still exhibited at least measurable minimal residual disease. GPS, a novel WT1-targeting direct immunizer, was evaluated as consolidation therapy to potentially stimulate a highly-specific immune response against WT1 to prevent or delay myeloma progression.

In the study, key data findings were:

Clinical activity was linked to antigen-specific immune responses.

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.

The GPS data suggest a distinctive link between clinical and immune responses, which has not been previously described for a peptide vaccine in multiple myeloma. The results offer mechanistic underpinnings for immune activation against WT1 in patients with aggressive multiple myeloma and are supportive of further testing of the putative anti-myeloma activity of GPS in more extensive clinical studies.
Dr. Koehne’s complete EBMT presentation covering the GPS results can be accessed at: www.sellaslifesciences.com/publications/galinpepimut-s-gps/default.aspx.

"High-risk multiple myeloma is a disease subset with high potential of short-term disease progression following autologous stem cell transplants, providing opportunities to improve on this limited clinical outcome. We are seeing an encouraging signal from GPS in our Phase 2 study with progression-free survival (PFS) exceeding historical outcomes with standard therapies," stated Guenther Koehne, M.D., Ph.D. Dr. Koehne added that "Currently, post-transplant maintenance therapies for these difficult-to-treat patients are seemingly limited, with PFS rarely exceeding 12-14 months". Dr. Koehne was the Principal Investigator for this study while at MSKCC.

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.