On November 21, 2013 Covagen and Tanabe Research Laboratories U.S.A, Inc. (TRL), a fully owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), reported that they expanded their strategic research collaboration. MTPC and TRL have nominated a first bispecific FynomAb for formal preclinical development which triggered an undisclosed milestone payment (Press release Mitsubishi Tanabe Pharma, NOV 21, 2013, View Source [SID:1234501611]). MTPC and TRL also exercised an option for a second bispecific FynomAb program based on the parties’ research and licensing agreement signed in October 2012. Under the agreement, Covagen will use its proprietary Fynomer-antibody platform to generate bispecific antibodies (FynomAbs) against a second target pair selected by TRL and MTPC.

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"We believe Covagen’s FynomAb platform is a source of innovative bispecific antibodies with excellent biophysical properties that will allow more effective treatment of inflammatory and oncologic diseases," said Roland Newman, Ph.D., chief scientific officer of TRL. "We look forward to continuing our cooperative work with the Covagen team as we advance the first FynomAb into preclinical development and look towards discovery of the second FynomAb as part of this expanded collaboration.".

Through payment of an undisclosed option fee, MTPC secured global, exclusive rights to bispecific FynomAbs against a second target pair in oncology. Under the agreement, MTPC will fund all research activities and be solely responsible for the development, manufacturing and global commercialization activities. Upon achievement of certain research, development and regulatory milestones, Covagen is entitled to receive payments of up to €108.25 million for the second program as well as tiered royalties on worldwide net sales of products resulting from the collaboration.

"The expansion of our collaboration with MTPC and TRL provides substantial validation of Covagen’s bispecific FynomAb technology as we advance several therapeutic programs toward the clinic in 2014 and 2015," said Julian Bertschinger, Ph.D., chief executive officer of Covagen.

Dragan Grabulovski, Ph.D., chief scientific officer of Covagen, added, "The expansion to a second bispecific FynomAb program is the result of the successful discovery and early preclinical development of the FynomAb from the original collaboration. This FynomAb was generated less than one year after initiating the joint research collaboration and showed excellent activity in pre-defined in vitro and in vivo studies. Our work with the MTPC and TRL team has been extremely productive, and we are eager to continue development of both projects."

On November 18, 2013 Patrys reported that it has been granted a second Australian patent for clinical anti-cancer product PAT-SM6 (Press release Patrys, NOV 18, 2013, View Source [SID:1234500548]).
The Australian Patent Office has issued the official "Notice of Grant" on a key patent in the PAT-SM6 family; application number 2007355108 entitled "Novel glycosylated peptide target in neoplastic cells". It offers patent protection through to November 2027.
This is the second patent to be granted in Australia.
This patent is one of a series of patent applications that have been submitted to cover the PAT-SM6 product, target and mechanism of action. The claims in this patent cover the PAT-SM6 antibody and binding fragments and methods of use of the antibody and binding fragments for treatment of various cancers including multiple myeloma. In February 2012, Patrys was granted a patent by the US Patent Office that contains claims that cover the PAT-SM6 antibody which binds to apolipoprotein B containing low-density lipoprotein (LDL) and apolipoprotein B containing oxidised LDL which are part of the complex, multistep mechanism of action for the product. To date, seven patents in the PAT-SM6 family have been granted in various jurisdictions including Europe, Japan, the US and Australia.

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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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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.

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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.

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.

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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.