Benitec Biopharma licenses ddRNAi technology to Regen BioPharma Inc for the development of Cancer Vaccines

On August 6, 2013 Benitec Biopharma reported that it has entered into a licensing agreement with San Diego (US) based Regen BioPharma. Benitec’s exclusive licence allows Regen to develop cancer vaccines using Benitec’s ddRNAi gene silencing technology (Press release Benitec, AUG 6, 2013, View Source [SID:1234500858]).

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Benitec’s licence to Regen covers the application of ddRNAi to silence indoleamine 2,3-doxygenase (IDO) in Dendritic Cells. IDO is associated with immune-suppression and is over-expressed in cancer. Regen has produced pre–‐clinical evidence that modification of these cells using ddRNAi targeting the silencing of IDO should significantly enhance their efficacy as anti- cancer vaccine agents. A peer – reviewed publication describing this work was published in the February 2013 volume of the International Journal of Cancer (Zheng et al. Silencing IDO in dendritic cells: a novel approach to enhance cancer immunotherapy in a murine breast cancer model. Int J Cancer. 2013 Feb 15;132(4):967 – 77). Whilst the terms are commercial, in confidence, they are within the expected guidelines for small biotech companies in the early stage of therapeutic development, with fees based on the achievement of agreed milestones.

Chief Executive Officer of Benitec Biopharma Ltd, Dr Peter French, commented, "Benitec is very pleased to have executed this licensing deal with Regen BioPharma. Using ddRNAi to manipulate Dendritic Cells to stimulate the immune system to kill cancer cells is an innovative concept for the treatment of cancer in a non–‐toxic manner. Regen joins a growing list of biotechnology companies that have recognised the advantage of licensing Benitec’s transformational gene silencing technology, ddRNAi, to develop novel therapies for human disease. For Benitec this provides the opportunity to generate additional evidence that validates and reinforces the potential of our platform technology."

Chairman & Chief Executive Officer of Regen BioPharma, Dr. David Koos, commented, "Benitec is the leader in clinical development of ddRNAi, which allows for "gene–‐specific surgery". By combining our existing data with the issued patents and experience of Benitec, we look forward to developing an immune–‐based, non–‐toxic, cancer treatment initially targeting breast cancer."

Compugen Announces Collaboration and License Agreement with Bayer for Antibody-Based Cancer Immunotherapies

On August 5, 2013 Compugen Ltd. (NASDAQ: CGEN) reported the signing of a collaboration and license agreement for the research, development, and commercialization of antibody-based therapeutics for cancer immunotherapy against two novel Compugen discovered immune checkpoint regulators (Press release, Compugen, AUG 5, 2013, View Source [SID1234527715]). Under the terms of the agreement, Bayer HealthCare (Bayer) and Compugen will jointly pursue a preclinical research program. Subsequently, Bayer will have full control over further development and have worldwide commercialization rights for potential cancer therapeutics.

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Under the agreement Compugen will receive an upfront payment of USD 10 million, and is eligible to receive over USD 500 million in potential milestone payments for both programs, not including milestone payments of up to USD 30 million associated with preclinical activities. Additionally, Compugen is also eligible to receive mid to high single digit royalties on global net sales of any resulting products under the collaboration.

"Bayer is committed to translating the science of cancer research into effective therapies helping people affected by cancer live longer and improve their quality of life," said Prof. Andreas Busch, Member of the Bayer HealthCare Executive Committee and Head of Global Drug Discovery. "Antibody-based immunotherapies are promising approaches in oncology which can stimulate the body’s own immune cells to fight cancer cells. Immunotherapy is one of our focus areas in oncology research. We are looking forward to expanding our portfolio in this area through partnering with Compugen."

Anat Cohen-Dayag, Ph.D., President and CEO of Compugen, added "We are very excited to initiate this collaboration with Bayer, a leading global life science company with a broadening oncology franchise, for the development of antibody-based cancer immunotherapies against these two promising novel immune checkpoint targets. In addition, we believe that the prediction and validation of these two targets, through the use of our broadly applicable predictive discovery infrastructure, provides additional validation for our long-term commitment to establishing this unique capability".

The immunotherapy approach aims at combatting cancer by stimulating the body´s own immune cells. The tumor and its environment suppress the ability of cancer patients to develop an effective anti-tumor immune response and in this way protect both tumor growth and survival. Compugen has discovered two novel immune checkpoint regulators that potentially play a key role in immunosuppression. Researchers at Compugen are developing specific therapeutic antibodies that are geared to block the immunosuppressive function of these targets and to reactivate the patient`s anti-tumor immune response in order to fight cancer.

About Cancer Immunotherapy

Latest cancer immunotherapies have demonstrated impressive clinical benefit, even for end-stage patients with difficult-to-treat tumors such as metastatic melanoma and non-small cell lung cancer. Unlike conventional cancer therapies, which act by directly targeting the cancer cells, resulting often in only transient clinical responses as cancer cells become resistant, clinical responses to cancer immunotherapy tend to be durable, sometimes resulting in dramatic long term survival and absence of resistance or recurrences.

(Press release, Apeiron Biologics, AUG 1, 2013, View Source [SID:1234505893])

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(Press release, Arisaph Pharmaceuticals, JUL 31, 2013, View Source [SID:1234505084])

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Announcement of identification of the highly potent small molecule drug candidates targeting a novel kinase and decision of pursuing clinical development

On July 31, 2013 OncoTherapy Science reported that OncoTherapy has identified novel highly potent small molecule drug candidates for a novel kinase target and has decided to pursue clinical development (Press release OncoTherapy Science, JUL 31, 2013, View Source [SID:1234500750]). OncoTherapy has been developing small molecule inhibitors for several novel targets that had been discovered with the genome-wide expression profile analysis. Recently, OncoTherapy has identified novel small molecule compounds including OTS964 that specifically inhibit a novel kinase target and decided to pursue clinical development of them. This novel kinase is totally different from MELK (maternal embryonic leucine zipper kinase) for which US Food and Drug Administration (FDA) has already accepted Phase I clinical trial with the MELK inhibitor OTS167. This novel kinase is not expressed in the important vital organs at all, but highly up-regulated in various types of cancers such as the lung cancer, and plays an important role in tumor growth. These highly potent small molecule drug candidates including OTS964 which specifically inhibit the novel kinase showed striking anti-tumor effects against human lung and bladder cancers in animal studies, and are therefore expected to show potent anti-tumor effects in human. This drug candidate is our second small molecule drug candidate, following OTS167. OncoTherapy does make every effort to develop this candidate, based on our mission "To develop anti-cancer medicine and cancer therapy with high efficacy and minimum risk of adverse events, and to win the war against cancer". The impact of this identification on our consolidated business performance is immaterial.

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