On June 22, 2016 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD), a leading immuno-oncology company, reported initial safety data from the first cohort of patients in its Phase IIb AIPAC chemo-immunotherapy clinical study of Prima’s lead compound, IMP321 (Filing, 6-K, Prima Biomed, JUN 22, 2016, View Source [SID:1234513508]).

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AIPAC (Active Immunotherapy PAClitaxel) is a multi-national, randomised, double-blind, placebo-controlled study of IMP321-plus-paclitaxel in hormone receptor-positive metastatic breast cancer. The trial is currently being conducted out of Belgium, The Netherlands and now also Hungary, with further European sites to be initiated in the future.

The first six patients have received 6 mg doses of IMP321 in combination with paclitaxel. This dose has proved to be safe and well tolerated with no drug related serious adverse events. The data also demonstrated activation of blood monocytes/dendritic cells and CD8 T cells.

Prima’s Chief Medical Officer, Dr Frederic Triebel, said: "The data from this initial open-label run-in cohort of six patients confirms the safety, pharmacokinetics and pharmacodynamics of IMP321 and we are encouraged to have met our anticipated timelines for recruitment. We will now start enrolling nine additional patients in the second cohort with 30 mg of IMP321, with the results of both cohorts to be presented and compared in the fourth quarter of 2016. Then the randomisation phase with the recommended phase IIb dose will begin enrolling approximately 196 patients."

Prima’s CEO, Marc Voigt, commented: "We are pleased to have confirmed previous results at the 6 mg dose in metastatic breast cancer. We believe that the interim results obtained at 6 mg significantly de-risk the remainder of the trial as the previous phase I/IIa trials provided very encouraging results with that dose level."

The primary purpose of the AIPAC trial is to determine the clinical benefit of IMP321 in terms of Progression-Free Survival as the primary clinical endpoint. Details of the AIPAC study are available at NCT 02614833.

About IMP321
IMP321, a first-in-class Antigen Presenting Cell (APC) activator based on the immune checkpoint LAG-3, represents one of the first proposed active immunotherapy drugs in which the patient’s own immune system is harnessed to respond to tumour antigenic debris created by chemotherapy. As an APC activator IMP321 boosts the network of dendritic cells in the body that can respond to tumour antigens for a better anti-tumour CD8 T cell response.

IMP321 has been shown in an open-label Phase I study1, to be able to double the expected six-month response rate in HER-2 negative metastatic breast cancer patients receiving standard-of-care paclitaxel; from a 25% historic response rate2 (RECIST criteria), to 50% when combined with IMP321.

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]).

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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.”

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.”

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.”

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."