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Sanofi Discontinues Clinical Development of Investigational JAK2 Agent Fedratinib (SAR302503)

On November 18, 2013 Sanofi reported that the decision to halt all clinical trials and cancel plans for regulatory filings with its investigational JAK2 inhibitor, fedratinib (SAR302503).
Following a thorough risk-benefit analysis, including consultation with the U.S. Food and Drug Administration (FDA), study investigators, independent expert neurologists and neuro-radiologists, Sanofi determined that the risk to patient safety outweighed the benefit that fedratinib would bring to patients (Press release Sanofi, NOV 18, 2013, View Source [SID:1234500448]).
This decision follows recent reports of cases consistent with Wernicke’s encephalopathy in patients participating in fedratinib clinical trials. The FDA directed Sanofi to put all fedratinib trials on clinical hold while the company thoroughly investigated these cases to ensure the safety of fedratinib for patients. Sanofi took immediate action requesting that study investigators discontinue fedratinib treatment for patients in the trials.
Sanofi has notified investigators of all ongoing fedratinib trials, as well as health authorities, of its decision to halt the trials. Patients currently in fedratinib trials should consult with their treating physician to determine the best alternative course of therapy for their myelofibrosis.

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Baxter and Cell Therapeutics Announce Worldwide Strategic Collaboration to Develop and Commercialize Pacritinib

On November 15, 2013 Baxter International and Cell Therapeutics jointly reported that they have entered into an exclusive worldwide licensing agreement to develop and commercialize pacritinib (Press release CTI BioPharma, NOV 15, 2013, View Source;p=RssLanding&cat=news&id=1877358 [SID:1234500578]). Pacritinib is a novel investigational JAK2/FLT3 inhibitor with activity against genetic mutations linked to myelofibrosis, leukemia and certain solid tumors. Pacritinib is currently in Phase III development for patients with myelofibrosis, a chronic malignant bone marrow disorder.

Under the terms of the agreement, Baxter gains exclusive commercialization rights for all indications for pacritinib outside the United States and Baxter and CTI will jointly commercialize pacritinib in the United States. Baxter will make an upfront payment of $60 million, which includes an equity investment in CTI of $30 million. In addition, CTI is eligible to receive clinical, regulatory, and commercial launch milestone payments of up to $112 million, $40 million of which relates to clinical milestones that may be achieved in 2014. Assuming regulatory approval and commercial launch, CTI may receive additional sales milestone payments. CTI will receive royalties on net sales of pacritinib in ex-US markets, and the companies will share U.S. profits equally. Baxter will record a special pre-tax in-process research and development charge in the fourth quarter of 2013 of approximately $30 million.

”The collaboration will complement Baxter’s existing oncology business and growing oncology pipeline, and will leverage our global commercialization capacity to extend the availability of pacritinib, which we believe has the potential to address a significant unmet medical need,” said Ludwig Hantson, Ph.D., President of Baxter BioScience. ”As an established leader in hematology and rare diseases, we are committed to advancing novel therapies in an effort to broaden patient access to care.”

”We believe Baxter represents the ideal strategic partner to achieve the full potential of pacritinib,” said James A. Bianco, M.D., President and CEO of CTI. ”Our two companies share a dedication to oncology and a vision for bringing this unique oral JAK2/FLT3 inhibitor to patients with certain blood cancers and solid tumors. This collaboration will provide additional financial resources and commercial expertise to position us to pursue the development, commercialization and market potential of pacritinib.”

Pacritinib is an oral tyrosine kinase inhibitor (TKI) with dual activity against JAK2 and FLT3. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have been shown to be directly related to the development of certain blood related cancers including myeloproliferative neoplasms, leukemia and lymphoma.

Caliber and ImmunGene Launch Valor Biotherapeutics, a Joint Venture to Develop Antibody-Interferon Fusion Therapeutics to Treat Cancers

On November 13, 2012 ImmunGene, Inc. (ImmunGene) and Caliber Biotherapeutics, LLC (Caliber) reported the launch of Valor Biotherapeutics, LLC (Valor), a joint venture focused on the clinical development and commercialization of monoclonal antibody-interferon (mAb-IFN) fusion protein therapeutics targeting certain cancers (Press release, Valor Biotherapeutics, NOV 13, 2013, Caliber and ImmunGene Launch Valor Biotherapeutics, a Joint Venture to Develop Antibody-Interferon Fusion Therapeutics to Treat Cancers [SID:1234513256]). The mAb-IFN fusion protein technology was invented in Professor Sherie Morrison’s laboratory at the University of California, Los Angeles and licensed exclusively to ImmunGene. This technology is being used to enable the precise targeting of tumor cells with monoclonal antibodies and their destruction by interferon.

Valor will combine the assets and resources of Caliber with ImmunGene’s technologies, know-how, and intellectual property (IP). ImmunGene will grant Valor exclusive licenses to its IP for three mAb-IFN fusion product candidates currently in various stages of preclinical development. Caliber will commit sufficient funds to enable Valor to reach certain development milestones for these compounds in the treatment of non-Hodgkin’s lymphoma, multiple myeloma, and breast cancer.

Valor will be led by Rahul Singhvi, Sc.D., Managing Director of Caliber Biotherapeutics, LLC and former President and CEO of Novavax, Inc. Dr. Singhvi will be joined on the Valor board of directors by David Shanahan, a serial entrepreneur, philanthropist and a Caliber founder. Mr. Shanahan is also the founder and President of Gradalis, Inc., a cancer immunotherapy company, and President of the Mary Crowley Cancer Research Center. Dr. Sanjay Khare, CEO of ImmunGene, and Dr. Michael Gresser, Chair of ImmunGene’s scientific advisory board, will also join the Valor board.

Dr. Singhvi commented, "The creation of Valor Biotherapeutics further marks the evolution of Caliber from a technology company into a drug development company with a highly promising pipeline. We intend to leverage our complementary resources to develop these product candidates and welcome the opportunity to work with the highly accomplished ImmunGene team to accomplish our goals."

"We are impressed with the promise of ImmunGene’s mAb-IFN fusion technology in addressing many unmet needs in cancer," said Mr. Shanahan. "We are thrilled to support the development of this technology through our joint venture and demonstrate the potential benefits this technology can bring to cancer patients."

"This joint venture will allow us to accelerate the development of ImmunGene’s antibody interferon fusion drug candidates into human proof-of-concept studies in cancer patients." said Sanjay D. Khare, Ph.D., CEO of ImmunGene. "We believe our technology has the potential to improve the treatment of certain cancers and that Caliber’s unique experience in cancer research will help us realize the clinical and commercial potential of our pipeline through this promising joint venture."

About Monoclonal Antibody – Interferon (mAb-IFN) Fusion Proteins

mAb-IFN fusion proteins are a new class of biotherapeutics that are produced by fusing antibodies to tumor cell-killing cytokines (e.g. IFN). These fusion proteins offer potential advantages because several important properties can be built into a single, genetically engineered molecule. They are thought to kill tumor cells mainly by stimulating apoptosis, in an ADCC (antibody-dependent cell-mediated cytotoxicity)-independent manner. Consequently, these molecules have the potential to be efficacious in patients with defective ADCC mechanisms. In addition, they have the potential to be cytotoxic to tumor cells with low density of targeted surface antigens. The fusion proteins retain the properties of conventional, non-fused antibody therapeutics in stimulating ADCC and complement-dependent cytotoxicity (CDC) functions. Such mAb-IFN fusion proteins have demonstrated superior efficacy and safety in preclinical studies, validating the therapeutic potential of this technology.

Merck Enters into Further Global Co-Development and Commercialization Agreement for PARP Inhibitor with Chinese R&D Company BeiGene

On November 13, 2013 Merck Serono (Merck KGaA) reported that a global licensing, co-development, and commercialization agreement for BeiGene-290 has been signed with BeiGene (Press release BeiGene, NOV 13, 2013, View Source [SID:1234500416]).
The compound, which is a potent poly (ADP-ribose) polymerase (PARP) inhibitor for the treatment of cancer, is currently in preclinical development and is expected to enter clinical development next year. This is the second collaboration agreement between the two companies this year.
PARP inhibitors are thought to target an enzyme family, poly (ADP-ribose) polymerase, which is involved in a number of cellular processes, including DNA repair and programmed cell death.
Under the terms of the collaboration, BeiGene will be responsible for the development and commercialization of BeiGene-290 in China, and Merck will be responsible for the development and commercialization of BeiGene-290 for the rest of the world. BeiGene will receive an undisclosed upfront payment and is eligible to receive further payments of up to € 170 million (US$ 232 million) for the achievement of clinical developmentand potential commercial milestones in both the People’s Republic of China and rest of the world, as well as royalties on net sales.

Lundbeck Canada launches a new treatment for a rare form of acute leukemia: acute promyelocytic leukemia

On November 13, 2013 it was reported that Health Canada had recently approved Trisenox (arsenic trioxide) for relapsed or refractory acute promyelocytic leukemia (APL) ((Press release Lundbeck, NOV 13, 2013, View Source(ENGLISH)%20-%20November%2013%202013.pdf [SID:1234500348])). This was made possible by a decision from Health Canada’s Therapeutic Products Directorate to remove a prior regulatory prohibition on arsenic containing drug therapies for use in humans and by granting priority review.