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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])

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

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.

CRT, The Institute of Cancer Research and Merck Serono sign WNT licensing deal

On July 31, 2013 CANCER RESEARCH TECHNOLOGY (CRT), the commercial arm of Cancer Research UK, The Institute of Cancer Research, London, and , Merck Serono, a division of Merck KGaA, Darmstadt, Germany, reported to have signed a licensing deal extending a successful initial alliance to discover and develop anticancer drugs that block the WNT signalling pathway (Press release, Cancer Research Technology, 31 31, 2013, View Source [SID1234523252]).

Today’s deal grants Merck Serono the rights to develop molecules discovered through a recently-completed four-year research collaboration between Merck Serono, CRT, The Institute of Cancer Research (ICR) and Cardiff University.

At the same time the ICR, CRT and Merck Serono are signing a new two-year major collaboration to progress the existing compounds towards candidates for clinical trials and design further molecules to target the WNT signalling pathway. The work will also involve identifying biomarkers for target inhibition and patient selection. The new drug discovery work will be carried out by scientists at the ICR in London and at Merck Serono’s headquarters in Darmstadt with some financial support from Cancer Research UK.

The WNT pathway is key to tissue development and maintenance. Faults in the WNT pathway can leave it permanently switched on – and this is linked to the development of colorectal, breast and other cancers. An aberrantly activated WNT pathway could also play a role in establishing and maintaining cancer stem cells within tumours.

Professor Julian Blagg, the project’s lead scientist at The Institute of Cancer Research, London, said: "Signalling through the WNT pathway is critical to uncontrolled cell proliferation in a number of tumour types, particularly colorectal cancer. In some cases the WNT pathway is permanently switched on by mutations in components of this signalling cascade – leading to uncontrolled growth. In a fast-moving and successful collaboration, we have discovered small molecule modulators of cancer cell signalling and we are excited by the opportunity to further progress this work in collaboration with Merck Serono. The announcement today helps to bring us a step closer to new treatments for cancer patients."

Through today’s agreements Merck Serono has licensed the rights to all future intellectual property resulting from the new two-year alliance as well as to all existing intellectual property already generated through the completed four-year alliance.

Merck Serono will pay an upfront license fee to CRT and make further payments to CRT upon reaching development milestones. Merck Serono will also pay royalties from potential future drugs. CRT will share revenue with the ICR and Cardiff University.

Dr Phil L’Huillier, CRT’s director of business development, said: "This important agreement consolidates a previous fertile collaboration to discover and develop new cancer drugs. The WNT pathway is an exciting area of research with untapped potential to treat a range of cancer types. We’re bringing together partners from industry and academia with specialist expertise and experience to accelerate the development of exciting new treatments – which, we hope, will one day increase cancer survival."