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Bristol-Myers Squibb Announces Plans for Third Quarter Submission of a Biologics License Application for Opdivo® (nivolumab), an Investigational PD-1 Immune Checkpoint Inhibitor, for Previously Treated Advanced Melanoma

On July 10, 2014 Bristol-Myers Squibb reported that it, following discussions with the U.S. Food and Drug Administration (FDA), the company is planning a third quarter submission of a Biologics Licensing Application (BLA) for Opdivo (nivolumab) for previously treated advanced melanoma (Press release Bristol-Myers Squibb, JUL 10, 2014, View Source [SID:1234500639]). This will mark the second tumor type for which Bristol-Myers Squibb has a regulatory submission underway for Opdivo in the U.S.

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"We continue to collaborate closely with the FDA on Opdivo and the planned submission in advanced melanoma represents an important step forward in our company’s commitment to deliver innovative treatment options for patients with cancer," said Michael Giordano, MD, Head of Oncology Development, Bristol-Myers Squibb.

The advanced melanoma BLA is based on data from Checkmate -037, a multinational, multicenter, randomized open-label Phase 3 trial evaluating Opdivo compared to dacarbazine (DTIC) or carboplatin/paclitaxel in patients with unresectable or metastatic melanoma who have been previously treated with Yervoy (ipilimumab) and, if BRAF-mutation positive, a BRAF inhibitor regimen.

Bristol-Myers Squibb has proposed the name Opdivo (pronounced op-dee-voh), which, if approved by health authorities, will serve as the trade name for nivolumab.

Regeneus secures exclusive worldwide rights for new therapeutic human cancer vaccine

On July 8, 2014 Regeneus (ASX: RGS) reported that it has signed today an agreement with Northern Sydney Local Health District (NSLHD) for the exclusive worldwide rights to develop and commercialise a new personalised therapeutic human cancer vaccine. The technology was developed at the Bill Walsh Translational Cancer Research Laboratory which is part of the Kolling Institute of Medical Research at Royal North Shore Hospital in Sydney.

"We have secured the rights for human applications of the cancer vaccine technology following preclinical efficacy data and promising safety data generated from the treatment of a variety of dogs with a wide range of cancer types," said Professor Graham Vesey, CEO of Regeneus.* Regeneus holds the exclusive worldwide commercialisation rights of the vaccine technology for veterinary applications.

The production of the cancer vaccine for an individual patient requires a patient tumour sample obtained either by complete surgical removal or by small biopsy. This approach is a truly personalised therapeutic cancer immunotherapy.

Regeneus will fund a first-in-man trial (safety study) scheduled to commence in the first quarter of 2015 and further research at the Bill Walsh Cancer Research Lab to support the trial. Leading oncologists Professor Stephen Clarke and Associate Professor Nick Pavlakis, from the University of Sydney’s Northern Clinical School at the Kolling Institute, will be the investigators on the trial. "Following the positive results we have seen in canines, this has been an encouraging prelude to undertaking a human clinical trial. It’s exciting to see world-class innovative cancer research done at the Kolling Institute translated into the clinic as a potential new therapeutic cancer vaccine," Professor Clarke said. The trial design and target tumour type will be finalised prior to seeking ethics approval.

"The therapeutic vaccine has the potential to target a wide range of hard-to-treat cancers with a single product. As the vaccine uses the patient’s own tumour cells and can be prepared under the supervision of the treating clinician, the local regulatory environment for biological therapies in Australia may allow for an accelerated clinical pathway for the autologous cancer vaccine removing the need for expensive and time consuming phase III trials" said Professor Vesey.

Under the Licence Agreement, Regeneus is responsible for the clinical and commercial development of the cancer vaccine for human applications and will pay royalties to NSLHD on the commercial use of the product.

Over the last few years there has been an increased focus on therapeutic vaccines with the US Food and Drug Administration approving the first therapeutic vaccine for cancer in 2010. There is a growing pipeline of therapeutic vaccines for an array of chronic conditions including cancer. The market for therapeutic vaccines is projected to grow at 55% per year reaching $13billion in revenues by 2018.**

*Cancer Immunology Research, a peer-reviewed journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), published this trial data in February 2014.

**Oliver Wynan’s MedTRACK analysis, 2012.

Incyte Achieves $25 Million Milestone for Approval of Jakavi® (ruxolitinib) in Japan

On July 8, 2014 Incyte reported that it has earned a $25 million milestone payment from Novartis in connection with the approval of Jakavi (ruxolitinib) in Japan for the treatment of patients with myelofibrosis (Press release Incyte, JUL 8, 2014, View Source [SID:1234500622]). Incyte will record this amount as contract revenue in the third quarter. Under the Incyte-Novartis Collaboration and License Agreement, Novartis received exclusive development and commercialization rights to ruxolitinib outside of the United States for all hematologic and oncologic indications and sells ruxolitinib under the name Jakavi. Ruxolitinib is marketed by Incyte in the United States as Jakafi (ruxolitinib).

“We are very pleased with the progress that Novartis is making in the global roll-out of Jakavi,” stated Hervé Hoppenot, President and Chief Executive Officer of Incyte. “The recent approval of Jakavi in Japan is further evidence of that progress.”

Novartis also continues to make progress in obtaining formal pricing and reimbursement approval for a third major European country and expects this to occur in the second half of 2014. Once achieved, Incyte will earn an additional $60 million milestone payment.

Austrian Biotech Company “APEIRON” Announces Start of its First Clinical Trial for Neuroblastoma Patients in Japan

On July 7, 2014 APEIRON Biologics reported that a phase I clinical trial with its neuroblastoma immunotherapy APN311 has received all necessary approvals to start recruiting patients. The trial will be locally conducted by Nagoya University Hospital and is part of a long-term collaboration to make this therapy available to patients suffering from this severe type of children’s cancer (Press release, Apeiron Biologics, JUL 7, 2014, View Source [SID:1234502247])r. In Japan, it won a grant by the Japanese government as an Investigator-initiated clinical trial that utilizes collaboration between the Department of Pediatrics and the Center for Advanced Medicine and Clinical Research (CAMCR) at Nagoya University Hospital. "This is a great achievement for us as we have supported this joint effort from the very beginning. Two years ago the ground was prepared when the Austrian Embassy – Commercial Section in Tokyo hosted a scientific meeting for Japanese pediatric oncologists to learn about this innovative therapy of pediatric neuroblastoma developed by Apeiron ", says Dr. Martin Glatz, Commercial Counsellor of the Austrian Embassy. "The meeting two years ago was part of a focus program aiming to bring more Austrian medical research and biotech companies to the Japanese market. The market has seen tremendous changes recently with companies exploring new opportunities and the government addressing regulatory issues," he added. Hans Loibner, PhD, CEO of Apeiron, commented, "We are very happy and proud to be rewarded with this milestone achievement after all the effort that was invested. I would like to particularly thank the physicians from Nagoya University, Dr. Seiji Kojima and Dr. Yoshiyuki Takahashi, as well as Dr. Masaaki Mizuno, Dr. Katsuyoshi Kato and Dr. Shinobu Shimizu at CAMCR, as we owe it to their dedication and tireless work that this trial can now start. We are confident that Japanese patients will benefit from the introduction of APN311 to Japan and look forward to making the next steps towards approval of this promising antibody therapy of neuroblastoma by the Japanese regulatory authorities."

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

On July 7, 2014 Compugen reported that it has achieved the initial milestone in the cancer immunotherapy collaboration it entered last year with Bayer HealthCare (Bayer) (Filing 6-K , Compugen, JUL 7, 2014, View Source [SID:1234500619]). The collaboration provides for the development and commercialization of therapeutic antibodies against two checkpoint protein candidates discovered by Compugen. The milestone being announced today relates to the first preclinical milestone for one of two checkpoint protein candidates for which Compugen will receive a $1.2 million payment out of the $30 million potential milestone payments associated with joint preclinical research for the two programs.

Dr. Anat Cohen Dayag, Compugen’s President and CEO, stated, “We are very pleased by the achievement of this initial drug development milestone for one of the two programs in our collaboration with Bayer. After investing more than a decade of extensive multidisciplinary research in establishing our broadly applicable predictive discovery infrastructure, we selected the area of checkpoint-based cancer immunotherapy as our first focused discovery effort. Therefore, it is extremely satisfying to see our growing competitive position, in terms of both advancement of our therapeutic programs in immuno-oncology and continuing discoveries of novel targets in this exciting area, which is increasingly being viewed as a potential major breakthrough in cancer treatment.”

About the Bayer HealthCare/Compugen Collaboration and License Agreement
The collaboration and license agreement provides the framework for the research, development, and commercialization of antibody-based therapeutics for cancer immunotherapy against two novel Compugen-discovered immune checkpoint regulators. Under the terms of the agreement, Bayer and Compugen are jointly pursuing a preclinical research program for each of the two candidates. Subsequently, Bayer will have full control over further development and have worldwide commercialization rights for potential cancer therapeutics.

Under the terms of the agreement, Compugen has received an upfront payment of $10 million and is eligible to receive over $500 million in potential milestone payments for both checkpoint programs, plus an additional $30 million of potential milestone payments associated with joint preclinical research for the two programs. Compugen is also eligible to receive royalties on global net sales from any resulting products under the collaboration.