On January 9, 2015 Chipscreen Biosciences reported regulatory approval of Chidamide (Epidaza), the world first orally administrated and subtype-selective histone deacetylase (HDAC) inhibitor for relapsed or refractory peripheral T-cell lymphoma (PTCL) patients, in China on Dec. 23, 2014 by the Chinese Food and Drug Administration (CFDA) (Press release, Shenzhen Chipscreen Biosciences, JAN 9, 2015, View Source [SID1234551991]).

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Peripheral T-cell lymphomas (PTCL) is a set of rare and heterogeneous group of mature T- and natural killer (NK)-cell neoplasms associated with poor outcome. PTCL makes up 25 percent to 30 percent of all Non-Hodgkin’s lymphoma (NHL) cases in China, much higher than that seen in Western countries of 10 percent to 15 percent. The subtype distribution of PTCL is also significantly different between China and Western countries, in which extranodal NK/T-cell lymphoma, nasal type (ENKL), a subtype highly aggressive with very poor prognosis, to be the leading subtype in Chinese population.

"Chidamide is the first new molecular entity discovered and developed by Chipscreen scientists in China. The CFDA’s decision to approval the world first orally administrated selective HDACi for PTCLs is an important validation of the drug’s therapeutic potential for this urgent medical need for Chinese PTCLs patients. The orally administrated Chidamide not just will provide affordable innovative treatment for the Chinese patients whom otherwise have no option to obtain most up-to-dated new treatment beyond conventional chemotherapies, but also have great potential, based on its unique epigenetic mechanism of actions and existing knowledge from the field, to be easily combined with other treatment modalities in comprehensive control and management of cancer patients in fight against drug resistance and tumor recurrence," said Xian-Ping LU, Ph.D., Chief Executive Officer and Chief Scientific Officer of Chipscreen Biosciences Ltd.

About Chidamide (Epidaza)

Chidamide is an orally bioavailable, low-nanomolar inhibitor of cancer-associated histone deacetylase (HDAC) enzymes with favorable pharmacology and tolerability profiles relative to existing benzamide and non-benzamide HDAC inhibitors. It targets specifically the subtype 1, 2, 3 of Class I and subtype 10 of Class IIb HDAC and is being studied in multiple clinical trials as a single agent or in combination with chemotherapeutic agents for the treatment of various hematological and solid cancers. In clinically administrated concentrations, it demonstrated a unique epigenetic mechanism of actions against tumor cell development, involving preferential induction of growth arrest and apoptosis in blood and lymphoid-derived tumor cells, activation of NK-mediated and CD8-mediated antigen-specific cellular anti-tumor immunity, differentiation of tumor stem cells, reversal of drug-resisting tumor cells and epithelia to mesenchymal transition, which are hallmarks of treatment resistance, tumor cell metastasis and recurrence.

Information about Chidamide: www.epidaza.com

On January 8, 2015 AVEO Oncology reported that it has received written confirmation from the European Medicine Agency (EMA) that tivozanib is eligible for submission of an application for a European Union Marketing Authorization under the Agency’s centralized procedure (Press release AVEO, JAN 8, 2015, View Source;p=RssLanding&cat=news&id=2004942 [SID:1234501284]). Confirmation of eligibility was given in response to the submission of a letter of intent enabling the Company to evaluate the opportunity for submitting a Marketing Authorization Application (MAA) for tivozanib with the EMA for the treatment of renal cell carcinoma (RCC). Tivozanib is an oral, potent, selective inhibitor of vascular endothelial growth factor tyrosine kinase inhibitor (VEGF TKI) with a long half-life and activity against all three VEGF receptors. Tivozanib has previously been granted orphan drug designation in Europe for the treatment of RCC.

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The letter of intent, which must be filed at least seven months prior to submission of a MAA, initiates the process to address a number of pre-submission requirements, including the assignment of a Rapporteur and Co-Rapporteur, who are two appointed members of the Committee for Human Medicinal Products (CHMP). The CHMP is the committee responsible for preparing opinions on questions concerning human medicines. Confirmation of eligibility for submission is not predictive of the EMA’s approval of a MAA.

"Our letter of intent and the subsequent confirmation of eligibility by the EMA are first steps in evaluating the potential for submission of a tivozanib MAA in Europe for the treatment of RCC," said Michael Bailey, president and chief executive officer of AVEO. "AVEO and its global RCC clinical advisors continue to believe that tivozanib has the potential to offer RCC patients an alternative to existing therapies. With the European rights to tivozanib recently regained, we now have the opportunity to work with the EMA to fully evaluate the potential for a MAA submission."

AVEO remains encouraged by the clinical outcomes from its Phase 2 and Phase 3 studies in RCC and the efficacy and tolerability profile that tivozanib may offer to patients suffering from this challenging disease. AVEO recently entered into an option agreement with Ophthotech to investigate tivozanib for the potential treatment of non-oncologic diseases of the eye, and the Company is actively pursuing partnerships to advance the development of tivozanib in solid tumors.

On January 7, 2015 Intellia Therapeutics, a leader in the development of therapeutic products using CRISPR/Cas9 technology for gene editing and repair, reported a five-year research and development collaboration with Novartis to accelerate the ex vivo development of new CRISPR/Cas9-based therapies using chimeric antigen receptor T cells (CARTs) and hematopoetic stem cells (HSCs) (Press release, Intellia Therapeutics, JAN 7, 2015, View Source [SID1234533042]). This collaboration comes only three months after Intellia was launched by Atlas Venture and Caribou Biosciences, providing an important validation of Intellia’s team and capabilities.

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CRISPR/Cas9-based gene editing holds promise across a range of gene therapy applications, including blood disorders, cancer and other genetic based diseases. It has been shown to be an efficient and precise method for gene editing across multiple cell and tissue types, making it an ideal platform for ex vivo applications, such as CART- and HSC-based therapies, as well as in vivo applications.

Under the terms of the agreement, Novartis receives exclusive rights to develop all collaboration programs focused on engineered CARTs. Within HSCs, Novartis and Intellia will jointly advance multiple programs, and have agreed to a process for assigning development and ownership rights, which will enable Intellia to develop its own proprietary internal HSC pipeline.

In addition to increasing its equity holding in Intellia, Novartis is making an upfront payment, and providing technology access fees and funding for R&D programs during the five-year term of the collaboration. Intellia is also eligible to receive downstream success-based milestones and royalties. Intellia will gain access to certain Novartis intellectual property and technology for the development of its own product pipeline. Intellia also reserves the right to pursue additional enabling partnerships in other areas of therapeutic interest.

"Our collaboration with Novartis is an important building block for Intellia that will greatly accelerate our effort to translate the promise of CRISPR/Cas9 into meaningful advances for 2 patients," said Nessan Bermingham, Ph.D., Chief Executive Officer and co-founder of Intellia. "CARTs and HSCs represent two of the most immediate opportunities for CRISPR therapeutic development, and Novartis, as a leader in this space, is the ideal partner with which to develop strong product pipelines in these areas."

On January 7, 2015 Nuvilex, Inc. (OTCQB:NVLX) reported that the Company has changed its name to PharmaCyte Biotech, Inc. Shares in PharmaCyte Biotech will trade under the new ticker symbol "PHCB" on the OTCQB electronic platform (Press release, PharmaCyte Biotech, JAN 7, 2015, View Source [SID:1234510563]). The new symbol is expected to become effective at the open of the market on January 8, 2014. The name change is part of the Company’s transformation process to operate solely as a pure biotechnology firm leveraging its Cell-in-a-Box technology, a proprietary cell encapsulation platform being utilized to develop "targeted" treatments for solid cancerous tumors and insulin dependent diabetes.

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"Over the past year, we’ve implemented an aggressive strategy to facilitate the advancement of the treatments we are developing for cancer and diabetes, with our Cell-in-a-Box technology at the core of these treatments. Our new name reflects the tremendous progress we’ve accomplished in terms of clinical development and signifies the structural completion of our transition to becoming a fully dedicated biotechnology company," said Kenneth L. Waggoner, Chief Executive Officer of PharmaCyte Biotech.

Some of the highlights in 2014 that have marked this transition include:

Receiving "orphan drug" designation from the U.S. Food and Drug Administration (FDA) for the Company’s pancreatic cancer treatment, with applications filed with the EMA and the TGA for the same status in Europe and Australia.

Development of a clinical protocol for a planned Phase 2b clinical trial with the goal of initiating the clinical trial in 2015.

A preclinical study being completed evaluating the effectiveness of the Company’s pancreatic cancer treatment on the accumulation of malignant ascites fluid often associated with the growth of abdominal cancers with positive results that have led to a follow-up study about to be launched.

The establishment of a world-wide Diabetes Consortium with a number of research agreements now in place with major universities and institutions that will permit the development of a break-through treatment for insulin dependent diabetes that combines Cell-in-a-Box with insulin-producing cells.

Progression at the University of Northern Colorado in the pursuit of treatments for brain and other forms of difficult to treat cancers that will combine cannabinoid or cannabinoid-like compounds with the Cell-in-a-Box technology.
"With exciting developments on the horizon for 2015, our work to develop treatments for both cancer and diabetes will move forward under our new name because it speaks to what we actually do here at PharmaCyte Biotech," concluded Mr. Waggoner.

On January 6, 2015 Argos Therapeutics reported a collaboration with Saint-Gobain’s Performance Plastics division, a leader in high-performance components and solutions using engineered polymers (Filing 8-K , Argos Therapeutics, JAN 7, 2015, View Source [SID:1234501282]). Under the terms of the agreement, Saint-Gobain will partner with Argos to design, integrate and scale production of a range of disposables for use in the automated manufacturing of Argos’ lead product candidate, AGS-003, currently being tested in a Phase III clinical trial for the treatment of metastatic renal cell carcinoma (mRCC).

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"We believe Saint-Gobain is the ideal partner to provide us with disposables that meet the technical specifications we need in the manufacturing of our personalized immunotherapies," says Jeff Abbey, president and CEO of Argos. "Their commitment to this development program and to Argos is a critical step in our effort to bring together all of the high quality resources and expertise we need to support the potential future commercialization of AGS-003. The utilization of their disposables with our automated production technology positions us to maximize throughput while processing biomaterials from multiple patients simultaneously in the same automated manufacturing suite."

"Argos’ Arcelis technology platform shows clear potential to support development of a range of autologous cell therapies that could change the future of patient care in cancer and infectious diseases. We are excited about the opportunity to partner with the Argos team to develop and supply the essential range of disposables that will be required to advance AGS-003 through late stage development and on to commercialization," says Steve Maddox, General Manager of Saint-Gobain Performance Plastics’ Life Sciences business unit.