6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On October 16, 2017 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported that new preclinical data and a patient case study for its CD47-blocking agent, TTI-621 (SIRPa-IgG1 Fc), were presented at the EORTC CLTF meeting “Cutaneous Lymphomas – Insights and Therapeutic Progress”, October 13-15, in London, England (Press release, Trillium Therapeutics, OCT 16, 2017, View Source [SID1234520947]).

Oral Presentation O-16: CD47 Blockade with TTI-621 (SIRPαFc) in Sézary Syndrome
Presenter: Dr. Oleg Akilov, University of Pittsburgh

This oral presentation highlighted that leukemic cells from patients with Sézary syndrome, a form of cutaneous T cell lymphoma (CTCL), express the CD47 “do not eat” signal at almost four times the level of normal lymphocytes and that over-expression of CD47 is associated with poor prognosis. In vitro experiments demonstrated that blockade of CD47, employing TTI-621, may constitute a promising therapeutic approach for patients with Sézary syndrome. Two clinical trials of TTI-621 that include patients with relapsed or refractory CTCL are ongoing at multiple North American sites (NCT02663518 and NCT02890368).

Poster Presentation P-10: Synergistic Effect of Successive Administration of TTI-621 (SIRPαFc) and PEGylated Interferon-α2a in a Patient with Sézary Syndrome
Presenter: Dr. Oleg Akilov, University of Pittsburgh

This case study reported local and systemic anti-tumor activity in a Sézary syndrome patient treated with a single intratumoral dose of TTI-621. Administration of PEGylated Interferon-α2a seven days after TTI-621 resulted in decreased leukemic burden and improvements in clinical symptoms. Trillium believes such a reduction is not observed regularly with standard regimens and would not be anticipated following PEGylated Interferon-α2a monotherapy, suggesting a synergistic effect of TTI-621 and PEGylated Interferon-α2a.

“CTCL patients are being treated in both our intratumoral and intravenous trials,” said Dr. Niclas Stiernholm, Trillium’s Chief Executive Officer. “Careful study of the effects of TTI-621 in CTCL patients potentially provides us with a unique opportunity to better understand the mechanism behind TTI-621’s anti-tumor activity and the role of CD47 in the overall immuno-oncology landscape, ultimately leading to targeted indications and combination therapies with sound scientific rationale.”

About Cutaneous T-Cell Lymphoma (CTCL)

CTCL is a rare type of non-Hodgkin’s lymphoma which is characterized by localization of malignant T lymphocytes to the skin. The two most common types of CTCL are mycosis fungoides and Sézary syndrome. The disease most often involves the skin, may progress to involve lymph nodes, blood, viscera and other organs, and in select cases may become leukemic.

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On June 22, 2016 Compugen Ltd. (NASDAQ: CGEN), a leading predictive therapeutic discovery company, reported at the JMP Securities Life Science Conference in NY, COM701 as the lead monoclonal antibody therapeutic candidate for the Company’s CGEN-15029 target program (Filing, 6-K, Compugen, JUN 22, 2016, View Source [SID:1234513507]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This antibody candidate is now undergoing preclinical development activities in preparation for advancement to clinical trials, with an anticipated IND filing next year. CGEN-15029 is one of multiple novel immune checkpoint targets discovered by the Company through the use of its unique in silico predictive discovery infrastructure.

COM701 was selected from among multiple candidate antibodies for CGEN-15029, which were generated through various antibody discovery technologies and screened at Compugen USA, Inc., the Company’s wholly-owned subsidiary in South San Francisco. This effort resulted in a collection of high affinity antibodies with the ability to block CGEN-15029 from binding to its ligand, and which demonstrated activation of T cells in functional studies. The selected hybridoma lead antibody demonstrated potent, reproducible enhancement of T cell activation, consistent with the desired mechanism of action of activating T cells in the tumor microenvironment to generate anti-tumor immune responses. COM701 was successfully humanized and has advanced into preclinical development. Cell line development has been initiated for this antibody candidate, and the Company has entered into agreements for the manufacturing and respective analytics of the therapeutic antibody.

The CGEN-15029 target was predicted in silico and experimentally confirmed to be a receptor-like checkpoint protein expressed on immune cells, with restricted expression on T and NK immune cells, similar to PD-1. Experimental validation systems established over the last two years have enabled Compugen to validate and advance multiple novel immuno-oncology targets, and have allowed Compugen’s scientists to show that this target is expressed in tumor-infiltrating T cells (TILs) in various solid and hematologic cancer types. Over expression of CGEN-15029 was shown to decrease T cell activation, whereas inhibition of CGEN-15029 by knocking down its gene resulted in increased T cell activation, indicating that this novel target is indeed an immune checkpoint protein. With its established infrastructure, the Company is pursuing a number of immuno-oncology target programs based on other Compugen-discovered targets in addition to CGEN-15029, and has two additional programs that are the subject of an ongoing pharma collaboration.

Dr. Anat Cohen-Dayag, President and CEO of Compugen, explained, "Selection of COM701 as our lead clinical candidate marks a new phase for Compugen, where we not only discover novel targets for immuno-oncology, but are now positioned to advance our discoveries into preclinical and clinical development on our own. The rapid progress of the CGEN-15029 program, with extremely aggressive timelines from target discovery and validation to therapeutic antibody development, was made possible in large part by the identification of CGEN-15029’s binding partner and the expansion of the Company’s immuno-oncology R&D infrastructure. In parallel to the CGEN-15029 program, Compugen is using this infrastructure to pursue additional novel immuno-oncology programs and is now positioned to advance them. In addition to the information disclosed today, the Company intends to share further data with respect to the CGEN-15029 program and the status of its Pipeline Program in the coming months."

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On June 22, 2016 Compugen Ltd. (NASDAQ: CGEN), a leading predictive therapeutic discovery company, reported at the JMP Securities Life Science Conference in NY, COM701 as the lead monoclonal antibody therapeutic candidate for the Company’s CGEN-15029 target program (Filing, 6-K, Compugen, JUN 22, 2016, View Source [SID:1234513507]). This antibody candidate is now undergoing preclinical development activities in preparation for advancement to clinical trials, with an anticipated IND filing next year. CGEN-15029 is one of multiple novel immune checkpoint targets discovered by the Company through the use of its unique in silico predictive discovery infrastructure.

COM701 was selected from among multiple candidate antibodies for CGEN-15029, which were generated through various antibody discovery technologies and screened at Compugen USA, Inc., the Company’s wholly-owned subsidiary in South San Francisco. This effort resulted in a collection of high affinity antibodies with the ability to block CGEN-15029 from binding to its ligand, and which demonstrated activation of T cells in functional studies. The selected hybridoma lead antibody demonstrated potent, reproducible enhancement of T cell activation, consistent with the desired mechanism of action of activating T cells in the tumor microenvironment to generate anti-tumor immune responses. COM701 was successfully humanized and has advanced into preclinical development. Cell line development has been initiated for this antibody candidate, and the Company has entered into agreements for the manufacturing and respective analytics of the therapeutic antibody.

The CGEN-15029 target was predicted in silico and experimentally confirmed to be a receptor-like checkpoint protein expressed on immune cells, with restricted expression on T and NK immune cells, similar to PD-1. Experimental validation systems established over the last two years have enabled Compugen to validate and advance multiple novel immuno-oncology targets, and have allowed Compugen’s scientists to show that this target is expressed in tumor-infiltrating T cells (TILs) in various solid and hematologic cancer types. Over expression of CGEN-15029 was shown to decrease T cell activation, whereas inhibition of CGEN-15029 by knocking down its gene resulted in increased T cell activation, indicating that this novel target is indeed an immune checkpoint protein. With its established infrastructure, the Company is pursuing a number of immuno-oncology target programs based on other Compugen-discovered targets in addition to CGEN-15029, and has two additional programs that are the subject of an ongoing pharma collaboration.

Dr. Anat Cohen-Dayag, President and CEO of Compugen, explained, “Selection of COM701 as our lead clinical candidate marks a new phase for Compugen, where we not only discover novel targets for immuno-oncology, but are now positioned to advance our discoveries into preclinical and clinical development on our own. The rapid progress of the CGEN-15029 program, with extremely aggressive timelines from target discovery and validation to therapeutic antibody development, was made possible in large part by the identification of CGEN-15029’s binding partner and the expansion of the Company’s immuno-oncology R&D infrastructure. In parallel to the CGEN-15029 program, Compugen is using this infrastructure to pursue additional novel immuno-oncology programs and is now positioned to advance them. In addition to the information disclosed today, the Company intends to share further data with respect to the CGEN-15029 program and the status of its Pipeline Program in the coming months.”