On January 5, 2017 Kite Pharma, Inc. (Nasdaq:KITE) reported that Ian T. Clark, former Chief Executive Officer, Head of Commercial Operations and member of the Board of Directors for Genentech Inc., a member of the Roche Group, has been appointed to its Board of Directors (Press release, Kite Pharma, JAN 5, 2017, View Source [SID1234517275]). Clark brings extensive commercialization experience to the Board as Kite plans for key milestones in 2017, including potential approval and launch in the United States of its engineered chimeric antigen receptor (CAR) T cell therapy, axicabtagene ciloleucel, as a treatment for patients with refractory aggressive B-cell non-Hodgkin lymphoma (NHL).

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In addition to Clark’s appointment as an independent director to Kite’s Board, he was also appointed to serve as the Chairman of Kite’s newly established Commercialization Committee and will join Kite’s Audit Committee.

"We are very pleased to have Ian join our Board of Directors as we embark on potential approval and commercialization of axicabtagene ciloleucel by the U.S. FDA," said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer of Kite. "Ian, with his tenure at the helm of Genentech and road-tested experience launching 15 new drugs, including the immunotherapy Tecentriq, strengthens our board’s breadth of talent and background. His expertise will bolster our already impeccable commercial team led by Shawn Tomasello. We look forward to drawing on his significant experience and strong track record developing and executing commercial strategies in oncology."

"I have watched history begin to unfold as Kite has emerged as one of the leaders in cell therapy," said Ian Clark. "I look forward to lending my expertise to the teams at Kite, the management and my fellow Board members as Kite solidifies its position in immunotherapy."

Clark joined Genentech in 2003 as Senior Vice President and General Manager, BioOncology. In August 2005 he was named Senior Vice President, Commercial Operations and in January 2006, Clark was named Executive Vice President, Commercial Operations and became a member of the Executive Committee. Clark was named Head of Global Product Strategy and Chief Marketing Officer of Roche in April 2009.

Prior to joining Genentech, Clark served as General Manager of Novartis Canada, overseeing all of the company’s country operations. Before assuming his post in Canada, Clark served as Chief Operating Officer for Novartis United Kingdom. Clark worked in executive positions in sales and marketing for Sanofi and Ivax in the United Kingdom, France and Eastern Europe. Clark began his career at Searle, where he held management positions in both sales and marketing. He has served on the Board of Directors of the Biotechnology Industry Organization (BIO) since 2009 as well as on the boards of TerraVia, the Gladstone Foundation and as a member of the Federal Reserve Bank of San Francisco’s Economic Advisory Council. Clark received a Bachelor of Science degree and honorary doctorate in Biological Sciences from Southampton University in the United Kingdom.

About axicabtagene ciloleucel

Kite Pharma’s lead product candidate, axicabtagene ciloleucel, is an investigational therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells. Axicabtagene ciloleucel has been granted Breakthrough Therapy Designation status for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) regulatory support for DLBCL in the EU.

On January 5, 2017 ARTSaVIT LTD reported that it has completed a $6.3 million Series A round of financing led by Arkin Bio Ventures and Pontifax, with participation of M Ventures, Carmel Innovation and Carmel – Haifa University Economic Corporation Ltd (Press release, ARTSaVIT, JAN 5, 2017, View Source [SID1234561841]).

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ARTSaVIT was co-founded by Carmel, the economic corporation of the University of Haifa, Carmel Innovations Fund and Professor Sarit Larisch from the University of Haifa, Israel. Prof. Larisch has identified and characterized ARTS, a protein which regulates the levels of several important anti-apoptotic proteins by promoting their degradation. Apoptosis is a highly regulated process of natural cell death. Faulty regulation of apoptosis is implicated in many human diseases, including cancer. Moreover, resistance to apoptosis is a hallmark of most human cancers.

The insights gathered by Prof. Larisch and the unique function of ARTS led to the establishment of the company, which is developing small molecule ARTS mimetics designed to selectively induce apoptosis in cancer cells. The company received seed investment from the Carmel Innovations Fund, which supported the research and development of the company to its current stage.

ARTSaVIT will move from its facilities at Carmel, University of Haifa, to the state-of-the-art facilities at the M Ventures Israel BioIncubator, which will support the development of the start-up with its infrastructure and a wide range of incubation facilities and services.

Dr. Rom Eliaz, Head of the M Ventures Israel BioIncubator commented: "We are excited to join forces with Arkin Bio Ventures, Pontifax and Carmel and would like to welcome ARTSaVit to our BioIncubator. Following the completion of this fundraising, the company is now well positioned to reach its next value inflection point".

Elka Nir, CEO of Carmel Ltd, the economic corporation of the Haifa University and CEO of Carmel Innovations Fund, noted: "We are proud and excited that M Ventures together with Arkin Bio Ventures and Pontifax invested in ARTSaVIT. It demonstrates the excellent quality and potential of the research and researchers at the University of Haifa. It is another great success for the Carmel Innovation Fund and its business model, which is funding seed companies, supporting them to a stage of significant value "

On January 5, 2017 Neon Therapeutics, an immuno-oncology company developing neoantigen-based therapeutic vaccines and T cell therapies to treat cancer, reported the successful completion of a $70 million Series B financing (Press release, Neon Therapeutics, JAN 5, 2017, View Source [SID1234517277]). Proceeds from the financing will be used to advance Neon Therapeutics’ lead program NEO-PV-01, a fully personalized neoantigen vaccine, through an ongoing Phase 1b clinical trial. In addition, this investment will support preclinical development of NEOPTC-01, a personalized adoptive T cell program, and the Shared Neoantigen Program.

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The Series B financing was led by Partner Fund Management. Joined by existing investors Third Rock Ventures and Access Industries, additional new investors included Fidelity Management & Research Company, Wellington Management Company, Inbio Ventures and Nextech Invest.

"The investor quality in this financing reflects the promise of the neoantigen biology platform, as well as our leading position," said Hugh O’Dowd, chief executive officer of Neon Therapeutics. "This capital is a testament to our strong team and our approach to neoantigen-based therapeutics, and will provide important resources to bring potentially life-changing medicines to cancer patients in need."

On January 5, 2017 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform, and Servier, an independent international pharmaceutical company, reported a broad collaboration in immuno-oncology (IO) (Press release, Pieris Pharmaceuticals, JAN 5, 2017, View Source [SID1234517279]). Despite the impressive clinical efficacy of checkpoint inhibitors to date, a majority of patients fail to respond to approved therapies. The collaboration seeks to address this significant unmet clinical need by advancing a series of novel molecules, including multiple dual immune checkpoint blockade approaches.

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Under the collaboration, Pieris and Servier will initially pursue five bispecific therapeutic programs, led by Pieris’ PRS-332 program, a potentially best-in-class PD-1-targeting bispecific checkpoint inhibitor. Pieris and Servier will jointly develop PRS-332 and split commercial rights geographically, with Pieris retaining all commercial rights in the United States and Servier having commercial rights in the rest of the world. The four additional committed programs have been defined, which may combine antibodies from the Servier portfolio with one or more Anticalin proteins based on Pieris’ proprietary platform to generate innovative immuno-oncology bispecific drug candidates. The collaboration may be expanded by up to three additional therapeutic programs. Pieris has the option, at a predefined time point, to co-develop and retain commercial rights in the United States for up to three programs beyond PRS-332, while Servier will be responsible for development and commercialization of the 4 other programs worldwide.

The financial terms of the collaboration include an upfront payment to Pieris of EUR30 million (approximately $31.3 million USD). Pieris may also receive FTE funding for specific projects, an option fee upon potential expansion of the collaboration as well as development-dependent and commercial milestone payments for PRS-332 and each additional program. The total development, regulatory and sales-based milestone payments to Pieris could reach EUR324 million (approximately $338 million USD) for PRS-332, and up to EUR193 million (approximately $201 million USD) for each of the other programs.Pieris and Servier will share preclinical and clinical development costs for each co-developed program. In addition, Pieris will be entitled to receive tiered royalties up to low double digits on the sales of commercialized products in the Servier territories.

Pieris’ multispecific technology allows simultaneous checkpoint inhibition on the same cell, which could have a clear advantage over monoclonal antibody cocktails against different checkpoint targets. PRS-332 is a novel PD-1-based bispecific, comprising an anti-PD-1 antibody genetically linked to an Anticalin protein targeting an undisclosed checkpoint target. Pieris has developed PRS-332, which is currently in preclinical development, with the intent to simultaneously block two immune checkpoints co-expressed on exhausted T cells to further improve on existing PD-1 therapies.

"Servier is a highly complementary partner for Pieris, with a very clear commitment to oncology and outstanding development capabilities," stated Dr. Louis Matis, Senior Vice President and Chief Development Officer of Pieris. "The synergies of building unique bispecifics from Servier’s antibodies and Pieris’ Anticalin proteins are multifold, as the versatility of our platform allows for extensive combinatorial target opportunities with the numerous IO ‘building blocks’ our team has discovered to date."

"This alliance will significantly enhance Servier’s portfolio in immuno-oncology, which already comprises 5 products in late preclinical or early development. Servier’s recognized expertise in drug development will efficiently complement Pieris’ innovative technology, allowing both companies to bring innovative solutions to cancer patients," stated Jean-Pierre Abastado, PhD, Director of Oncology R&D at Servier.

"Servier has built a diversified and innovative portfolio in oncology that includes small molecules, engineered antibodies, and cell therapies for the treatment of both hematological malignancies and solid tumors. Today’s alliance with Pieris adds another dimension to our strategy of becoming a key player in oncology, providing several next-generation bispecific IO drugs to our pipeline," added Emmanuel Canet, M.D., Ph.D., President of Servier R&D.

"Our alliance with Servier is clearly a transformative one for Pieris and is the type of partnership we deliberately set out to achieve to create significant long-term value. This collaboration provides not only an opportunity to advance multiple programs with retained rights in the number one oncology market, but also provides significant funding and flexibility for Pieris to balance financial and operational resources as we enter the next stage of corporate development," stated Stephen Yoder, President and Chief Executive Officer of Pieris. "The Servier alliance will act as a significant building block of our pipeline expansion in immuno-oncology and demonstrates the value of our proprietary Anticalin drug class."

On January 4, 2017 Asana BioSciences, LLC, an oncology focused, clinical stage biopharmaceutical company, reported that the first patient has been dosed in a Phase 1 trial for ASN003, a novel and highly selective B-RAF/phosphoinositide 3-kinase (PI3K) inhibitor (Press release, Asana BioSciences, JAN 4, 2017, View Source [SID1234533384]). Activation of these two major signaling pathways has been implicated in abnormal cell growth in various human cancers including melanoma, colorectal, breast and lung.

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"We are delighted to initiate the clinical development of ASN003, which is a first-in-class highly selective B-RAF/PI3K inhibitor designed to delay or treat acquired resistance observed in patients treated with current therapies targeting these individual pathways. The dosing of the first cohort in the trial has been completed, and the drug was well tolerated," said Sandeep Gupta, PhD, Founder, President and Chief Executive Officer at Asana BioSciences. "ASN003 is our 3rd clinical stage program in less than 2 years, affirming Asana’s efficiency and dedication to provide new and better treatment options to cancer patients."

ASN003 has shown broader anti-proliferative activity in tumor cell lines as compared to the B-RAF selective inhibitors, vemurafenib and dabrafenib, and shows robust antiproliferative activity in B-RAF and MEK inhibitor-resistant cell lines. It potently inhibits tumor growth in multiple B-RAF mutant and B-RAF/PI3K double mutant mouse xenograft tumor models. ASN003 also showed greater efficacy in tumor models when administered in combination with immune checkpoint and IDO inhibitors.

The Phase 1, multicenter, dose-finding, cohort expansion study will enroll patients with advanced solid tumors with B-RAF V600 mutation or PI3K pathway alterations, including patients with metastatic colorectal cancer (CRC) or advanced non-small cell lung cancer (NSCLC). The trial is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of ASN003 (NCT02961283).