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 4, 2017 Rubius Therapeutics, Inc., a Flagship Pioneering company, has reported the hiring of two key company leaders, David Epstein and Torben Straight Nissen, to accelerate development of new medicines from the company’s potentially revolutionary new product platform: Red-Cell Therapeutics (RCTs). Specifically, Epstein is joining as Chairman of the Board and Straight Nissen as President of the company. Flagship Pioneering developed Rubius in its innovation foundry, Flagship VentureLabs, throughout 2014 and launched the company in 2015 with an initial capital commitment of $25 million.

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Through the use of patented, advanced engineering techniques and know-how the company has successfully produced red blood cells that express therapeutic proteins that enable their use for the treatment of serious diseases. Rubius is now demonstrating that these newly equipped high performing, "off the shelf" Red-Cell Therapeutics have pre-clinical activity across a spectrum of medical applications. For example, in cancer a red blood cell can be transformed to express multiple synergistic proteins which can both inhibit cancer cell growth as well as activate the patient’s immune system. Alternatively, red blood cells have been engineered to replace missing enzymes for patients living with a variety of rare diseases, or even to remove unwanted metabolic products from the blood stream. Rubius has generated more than 200 prototypes to date. RCTs have demonstrated potential advantages compared to other cellular approaches to treating disease, such as greater durability, easier manufacturing scale-up and safety advantages due to the unique features of red blood cells.

"David and Torben bring a unique combination of scientific and business leadership experience which will accelerate Rubius’ development. As founders and primary investors, we are delighted to have the duo take the helm of this transformative company from the leadership provided by the Flagship VentureLabs team," stated Dr. Noubar Afeyan, Chairman of the Board of Rubius and CEO of Flagship Pioneering.

David Epstein, former CEO of Novartis Pharmaceuticals, has joined to serve as a Chairman of the Board. He will also will be serving in the newly created role of Executive Partner for Flagship Pioneering. At Novartis, Epstein was responsible for leading the development and commercialization of over 30 new medicines including breakthroughs such as Glivec, Gilenya, Cosentyx and Entresto.

As President of Rubius, Torben Straight Nissen, Ph.D, brings 20 years of deep scientific knowledge and business experience to expand the company’s platform and clinical programs. Torben joins Rubius from Pfizer, where he held multiple scientific and business leadership roles to advance the company’s therapeutic innovation, research and development.

"Flagship is breaking boundaries and exploring new frontiers that, I believe, could genuinely result in breakthroughs that directly improve survival and quality of life. I am tremendously excited to be part of the Rubius board and Flagship team," said David Epstein.

"Genetically-modified red blood cells hold incredible potential to provide superior treatment for many diseases, from rare to common conditions. Rubius is working on an exciting platform that could bring forward multiple therapies and modalities that improve and save lives," said Dr. Straight Nissen. "I am looking forward to growing the company and helping Rubius harness its platform to the fullest."

Commenting on the hires, Rubius Founding CEO and Flagship Partner Avak Kahvejian said, "The past two years of development at Rubius have shown the vast scope and applicability of Red-Cell Therapeutics. I look forward to continuing with this exciting venture in a new capacity as Chief Innovation Officer as Torben and David lead the transformation of Rubius into a development stage company in the near future."

About Rubius Therapeutics
Rubius Therapeutics is developing Red-Cell Therapeutics TM (RCTs) as a new treatment modality to address a wide array of indications including cancer, autoimmune disease, rare disease and metabolic disease. RCTs are enucleated cell-based therapies that can be engineered to have diverse activities. The company has established a platform for the rapid design, generation, testing and development of RCT products. The company was founded and launched by Flagship VentureLabs, the innovation foundry of Flagship Pioneering.

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).

On January 4, 2017 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported guidance for the current estimated timing of interim and final overall survival analysis from the PROSPECT study – a placebo controlled Phase 3 study designed to investigate the efficacy of PROSTVAC to prolong the survival of men with metastatic castration-resistant prostate cancer (mCRPC) (Press release, Bavarian Nordic, JAN 4, 2017, View Source [SID1234517268]).

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The company maintains its previous guidance that full data is expected within this year, albeit in the second half of 2017, with the third interim analysis likely to occur around mid-2017. This estimate is based on a decline in the number of average monthly events currently seen in the PROSPECT study.

"As there has been speculation that the third interim could occur during first quarter of 2017, we believe it is important to update the market on the current estimated timelines for readout of the Phase 3 study" said Paul Chaplin, President and CEO of Bavarian Nordic.

While the company remains blinded to all patient specific data, the latest estimates have been provided by the independent Data Monitoring Committee (DMC) following a routine analysis of the current survival data.

"While we will have to await the final read out of the PROSPECT study to establish the efficacy of PROSTVAC, we are encouraged that the current monthly event rate has declined. This is great news for the patients. Not only is this consistent with an improvement in the standard of care for patients with mCRPC, which has been observed in recent years, but could also be indicative of a therapeutic effect of PROSTVAC as well" said Paul Chaplin.

About the PROSPECT study
PROSPECT is a global, randomized, double-blind, placebo-controlled phase 3 study being conducted under a Special Protocol Assessment (SPA) from the FDA. The objective of the study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival. The study has been fully enrolled with 1,297 asymptomatic or minimally symptomatic mCRPC patients as of January 2015. Patients were enrolled at more than 200 sites in 15 countries. Both the first and second interim analyses confirmed that the study would continue as planned. Final study data requires 534 events in both comparisons of treatment arms versus placebo, and the third interim analysis will occur at 427 events.

About PROSTVAC
PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec, or "rilimogene") is a prostate specific antigen (PSA)-targeted immunotherapy candidate designed to enhance or stimulate the body’s immune response, specifically T cells that will home to and kill prostate cancer cells, altering the course of the disease and improving overall survival (OS) of patients with prostate cancer. A robust data package has been established that includes 18 ongoing or completed clinical studies, comprising more than 2,000 patients of which more than 1,100 patients have been actively treated with PROSTVAC, which has been generally well-tolerated. A randomized, placebo-controlled Phase 2 trial demonstrated the potential of PROSTVAC to extend the median overall survival by 8.5 months in patients with advanced prostate cancer. These results led to the initiation of the PROSPECT pivotal Phase 3 study.

PROSTVAC is being developed in collaboration with the National Cancer Institute under a Cooperative Research and Development Agreement.

On January 4, 2017 Tarveda Therapeutics a biopharmaceutical company discovering and developing Pentarins as a new class of potent and selective anti-cancer medicines, reported that a Phase 1/2a clinical trial evaluating PEN-221 in patients with advanced neuroendocrine tumors and small cell lung cancer expressing the somatostatin receptor 2 (SSTR2) is underway, with patients enrolled and treated (Press release, Tarveda Therapeutics, JAN 4, 2017, View Source [SID1234517269]). The somatostatin receptor is highly expressed in neuroendocrine cancers. PEN-221 is a novel, miniaturized drug conjugate designed to selectively target SSTR2 and then internalize and release its potent DM1 payload in the tumor cell.

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"Pentarins are engineered to rapidly penetrate and kill solid tumors that have proven challenging for treatment modalities such as antibody drug conjugates and chemotherapeutics," said Gordon B. Mills, M.D., Ph.D., Professor and Chair, Department of Systems Biology, at The University of Texas MD Anderson Cancer Center, Houston, TX. "The miniaturized size, unique design and potent payloads of Pentarins allow for sustained payload release in solid tumors to drive potential efficacy while sparing normal tissue.

"PEN-221 has high affinity for the SSTR2 on the surface of neuroendocrine and small cell lung cancer cells, which facilitates internalization followed by release of its potent cell-killing payload, DM1. Pentarins offer a new treatment approach to address the deficits of current treatments, and PEN-221 has the potential to address the urgent and significant medical need of patients with neuroendocrine and small cell lung cancers. Having an imaging approach to identify neuroendocrine and small cell lung cancers expressing the somatostatin receptor 2 makes the PEN-221 trial an exciting proof-of-concept as well as an opportunity for patients with these challenging tumors," concluded Mills.

The Phase 1/2a first-in-human study is an open-label, multicenter trial to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of PEN-221 in patients with SSTR2-expressing advanced neuroendocrine cancers, including a range of neuroendocrine tumors and small cell lung cancer. Utilizing FDA-approved imaging diagnostics, the study employs a seamless, Phase 1/2a design that identifies and selects advanced cancer patients with SSTR2 expressing tumors. These patients are believed to be the most likely to benefit from treatment with PEN-221. For additional information on this clinical trial, please visit clinicaltrials.gov, identifier number NCT02936323.

"The initiation of this Phase 1/2a clinical trial of PEN-221 in patients with neuroendocrine tumors and small cell lung cancer marks an important milestone in the development of this product candidate and our Pentarin drug conjugates," said Leila Alland, M.D., Chief Medical Officer of Tarveda. "PEN-221 consistently demonstrated complete and durable regressions in hard-to-treat xenograft cancer models. We and our industry leading clinical investigators are excited to advance this therapy into the clinic."

About Pentarins
Tarveda is developing Pentarins, potent and selective miniaturized drug conjugates with high affinity for specific cell surface and intracellular targets. Pentarins are engineered to bind to their tumor cell targets and provide sustained release of their potent therapeutic payloads deep into solid tumor tissue. Comprised of a targeting ligand conjugated to a potent cell-killing agent through a chemical linker, Pentarins are designed to overcome the deficits of both larger antibody drug conjugates and small molecules that limit their therapeutic effectiveness against solid tumors. Together, the components of Tarveda’s Pentarins have distinct, yet synergistic, anticancer attributes: the small size of Pentarins allows for effective penetration and distribution into the tumor tissue, the ligand’s targeting ability allows for specific binding and retention in tumor cells, and the chemical linker is tuned to optimize the release of the potent, cell-killing payload inside the cancer cells for efficacy.