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Vical Phase 3 Trial of Allovectin Fails to Meet Efficacy Endpoints

On August 12, 2013 Vical reported top-line results from a Phase 3 trial of Allovectin (velimogene aliplasmid), an investigational intratumoral cancer immunotherapy, in patients with metastatic melanoma (Press release Vical, AUG 12, 2013, View Source [SID:1234501043]). The 390-subject trial failed to demonstrate a statistically significant improvement vs. first-line chemotherapy for either the primary endpoint of objective response rate at 24 weeks or more after randomization or the secondary endpoint of overall survival. Trial data will be further analyzed and detailed results will be submitted for publication.

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"We are disappointed that the trial did not meet either the primary or secondary efficacy endpoints, even though we believe it was well-designed and well-executed," said Vijay B. Samant, President and Chief Executive Officer of Vical. "Based on this outcome, we are terminating the Allovectin program and focusing our resources on our infectious disease vaccine programs." Mr. Samant added, "We would like to recognize all of the patients and their families, trial investigators and employees who participated in the conduct of this trial and thank them for their efforts."

Teva Receives European Marketing Authorization for Lonquex (XM22 lipegfilgrastim)

On August 8, 2013 Teva reported that the European Commission has granted marketing authorization for Lonquex (lipegfilgrastim) (Press release Teva, AUG 8, 2013, View Source;p=irol-newsArticle&ID=1846232 [SID:1234500815]). This approval provides the regulatory framework for the commercialization of Lonquex in all twenty eight countries of the European Union plus Norway, Iceland and Liechtenstein.

Lonquex is a long-acting recombinant granulocyte colony-stimulating factor (G-CSF) with the active ingredient lipegfilgrastim – a novel glycoPEGylated (PEG; polyethylene glycol) filgrastim molecule. Lonquex (lipegfilgrastim) is indicated for the reduction of the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes). Lonquex is intended as a once-per-cycle fixed dose, subcutaneous injection for neutrophil support in cancer patients receiving myelosuppresive chemotherapy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes).

"This is an important milestone for Teva Specialty Medicines in Europe and demonstrates our commitment to making a difference to the lives of those with cancer" said Dr. Rob Koremans, President and CEO of Teva Specialty Medicines. "Lonquex is an alternative G-CSF treatment for helping manage neutropenia during myelosuppressive chemotherapy. The European approval comes earlier than expected, just 8 weeks after the positive CHMP opinion. We look forward to providing this oncology supportive care treatment option in all European Union member states."

Lonquex has undergone a full clinical development program, including pre-clinical to clinical in vivo studies, as part of the efficacy and tolerability assessment for use with chemotherapy patients.

Dr. Michael Hayden, Teva’s President of Global R&D and Chief Scientific Officer, commented: "Effective prevention and treatment of febrile neutropenia is an important consideration for clinicians managing cancer patients who are undergoing cytotoxic chemotherapy. As well as targeting cancer cells, chemotherapy affects rapidly-dividing bone marrow cells, thereby dramatically reducing a patient’s ability to fight off infection, with potentially serious consequences. This approval is testament to Teva’s commitment to bringing new and alternative treatments to market to support clinicians in caring for patients."

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]).

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.

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])