On September 4, 2018 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that effective February 1, 2019, David Schenkein, M.D., will transition to the role of executive chairman of the board of directors and serve as a member of the board’s Science & Technology Committee, after a successful decade-long tenure as chief executive officer (Press release, Agios Pharmaceuticals, SEP 4, 2018, View Source [SID1234529308]). Jacqualyn ("Jackie") Fouse, Ph.D., a member of the company’s board, has been named as Agios’ next chief executive officer.

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Prior to joining Agios’ board in December 2017, Dr. Fouse served as president and chief operating officer of Celgene Corporation, a global biopharmaceutical company, until April 2017, and as a member of its board through June 2017. Dr. Fouse joined Celgene in 2010 as chief financial officer and was named president of the company’s global hematology and oncology franchise in 2014. Prior to joining Celgene, Dr. Fouse served as chief financial officer of Bunge Limited, a leading agribusiness and food company. Earlier in her career, she held senior roles at Alcon Laboratories and various international companies.

Dr. Schenkein has served as Agios’ chief executive officer since 2009. During this time, he has overseen the evolution of Agios from a pure research organization to a fully integrated biopharmaceutical company with two approved medicines from its discovery engine, three additional molecules in clinical development and a robust research pipeline.

"With the recent approval and launch of our second internally discovered medicine, Agios has demonstrated that it is capable of discovering, developing and commercializing precision medicines. After leading the company for nearly 10 years, the board and I believe now is the right time to begin this transition. Having worked closely with Jackie for several years and as a member of our board, I am confident that she is the right person to build on the strong foundation we’ve established," said Dr. Schenkein. "It has been a privilege to lead Agios from a blank piece of paper to a thriving biopharmaceutical company with a science-focused culture that puts patients at the center of everything we do. I look forward to continuing my engagement with the company as executive chair and working with Jackie and the leadership team over the next several months to ensure a smooth transition."

John Maraganore, Ph.D., chairman of the Agios board of directors, said, "Jackie’s appointment as CEO is the result of a thoughtful succession planning process jointly undertaken by David and the board. Jackie brings extensive global leadership experience, a proven track record and tremendous knowledge of our industry. Throughout her career, Jackie has demonstrated the ability to effectively plan for and successfully execute on clinical and commercialization strategies, which will be essential as the company works to further its transition to a sustainable multi-product company. On behalf of the entire board of directors, I want to thank David for his extraordinary leadership and his unwavering commitment to patients during his tenure. Under David’s leadership, Agios has become a recognized leader in cellular metabolism with demonstrated ability to rapidly translate novel biology into precision medicines in areas of high unmet need. Agios will continue to benefit from David’s scientific and clinical expertise as part of his new role as executive chairman of the board."

"Agios is well positioned to become one of the next great science-focused companies in our industry, and I am honored to succeed David as the company’s next CEO," said Dr. Fouse. "I greatly admire David’s leadership in addition to the high-performance track record and enviable culture that he and the Agios team have built. Together with the leadership team and all of Agios’ employees, I look forward to building on this strong foundation and continuing our pace of innovation and execution. Importantly, I bring a shared commitment to culture, science and patients."

With Dr. Schenkein transitioning to the role of executive chairman effective February 1, 2019, Dr. Maraganore will transition to a director of the Agios board at that time, and Dr. Fouse will remain a member of the board.

On September 4, 2018 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a Fortress Biotech (NASDAQ: FBIO) Company focused on the development of novel immunotherapies based on proprietary chimeric antigen receptor engineered T cell (CAR T) technology and gene therapies for rare diseases, reported oral and poster presentations related to its CAR T therapies at the 4th Annual CAR-TCR Summit 2018, to be held September 4-7,2018, at the Seaport Hotel & World Trade Center in Boston (Press release, Mustang Bio, SEP 4, 2018, View Source [SID1234529307]).

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Details on the oral presentations are as follows:
Title: Confronting Analytical Challenges of Chimeric Antigen Receptor T Cell
Presenter: Junxia Wang, M.D., Ph.D., Director of Analytical Development, Mustang Bio
Track: Manufacturing
Date and Time: Tuesday, September 4, 2018, 3 p.m. EDT

Title: CAR T Cell Therapy for Glioblastoma: Progress, Promises and Challenges
Presenter: Behnam Badie, M.D., Professor and Chief, Division of Neurosurgery & Director, Brain Tumor Program,
City of Hope Medical Center
Track: Focus Day: Overcoming CAR T Toxicity in Solid Tumors
Date and Time: Friday, September 7, 2018, 12 p.m. EDT

Title: CAR T cells and Combination Therapies: The Next Chapter of the Immuno-Oncology Revolution
Panelist: Ekta Patel, Ph.D., Associate Director of Translational Sciences, Mustang Bio
Track: Focus Day: Alternative CAR Strategies
Date and Time: Friday, September 7, 2018, 1 p.m. EDT
Details on the poster presentation are as follows:

Title: Considerations for the Industrialization of a Phase 1 Academic CD20 CAR-T Manufacturing Process
Presenter: Suchit Sahai, Ph.D., Staff Scientist, Process Development, Fred Hutchinson Cancer Research Center
Track: Scientific Poster Session
Date and Time: Thursday, September 6, 2018, 8 a.m. EDT

Dr. Sadik Kassim, Chief Scientific Officer of Mustang Bio, will also present a plenary talk titled "From Academia to
Industry: Lessons Learned in the Development of CAR-T Therapies" during the opening ceremony on Wednesday,
September 5, 2018, at 8:45 a.m. EDT.

On September 4, 2018 Aduro Biotech, Inc. (NASDAQ:ADRO) reported that preclinical data for its first-in-class anti-APRIL antibody BION-1301 was presented at the 5TH European Congress of Immunology in Amsterdam, The Netherlands. Data from the preclinical studies demonstrated that BION-1301 was well-tolerated (Press release, Aduro Biotech, SEP 4, 2018, View Source;p=RssLanding&cat=news&id=2365988 [SID1234529284]). In addition, pharmacological activity of BION-1301 binding to APRIL (A Proliferation-Inducing Ligand), a ligand for the receptors BCMA (B cell maturation antigen) and TACI (transmembrane activator and cyclophilin ligand interactor), was established in a dose-dependent fashion. The pharmacokinetics (PK) and target engagement biomarkers were used to predict the first-in-human dose. APRIL mediates important B-cell functions including activation, survival and maturation. Serum levels of APRIL are enhanced in patients diagnosed with multiple myeloma (MM) and correlate with a poor prognosis. APRIL in the bone marrow triggers a cascade of events to support human MM to proliferate, survive, induce resistance to standard-of-care drugs in MM cells and provide an immune protective environment.

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"The pioneering work on the mechanism of action, PK and pharmacodynamics presented today has paved the way for the first clinical evaluation of BION-1301, an ongoing Phase 1/2 trial in patients with multiple myeloma," commented Hans van Eenennaam, Ph.D., executive vice president antibody research and site head, Aduro Biotech Europe.

Aduro is conducting a Phase 1/2 multi-center, open-label study (see www.clinicaltrials.gov, identifier NCT03340883) designed to evaluate the safety and activity of BION-1301 in patients with relapsed or refractory MM whose disease has progressed after at least 3 prior systemic therapies, including immunomodulatory drugs, proteasome inhibitors, chemotherapies, or monoclonal antibodies.

About BION-1301
Aduro is currently evaluating BION-1301, its most advanced proprietary B-select monoclonal antibody, as a novel therapy for MM. Despite new treatments recently approved in MM, this disease remains incurable as patients relapse, or become resistant to, currently-available therapies. In preclinical studies, Aduro has established that APRIL plays a crucial part in the protective bone marrow tumor microenvironment. In these studies, APRIL, through BCMA, was shown to be critically involved in the survival, proliferation and chemoresistance of MM, and upregulates mechanisms of immunoresistance, including PD-L1 upregulation. BION-1301, a humanized antibody that blocks APRIL from binding to its receptors, has been shown in preclinical studies to halt tumor growth and overcome drug resistance. In addition, BION-1301 also demonstrated the ability to inhibit immune suppressive effects of regulatory T cells via TACI but not BCMA in MM blood and bone marrow. BION-1301 is currently being evaluated in a Phase 1/2 clinical study in patients with relapsed or refractory MM.

On September 4, 2018 Aduro Biotech, Inc. (NASDAQ: ADRO) reported the publication of a peer reviewed paper in Leukemia authored by scientists from the Dana Farber Cancer Institute and Aduro as part of their ongoing collaboration to study the role of APRIL (A PRoliferation Inducing Ligand) in multiple myeloma (MM) (Press release, Aduro Biotech, SEP 4, 2018, View Source;p=RssLanding&cat=news&id=2366001 [SID1234529283]). The authors profile the impact that APRIL, acting through its receptor TACI (transmembrane activator and cyclophilin ligand interactor), has on immune regulatory T cells (Tregs) in MM. The paper further reports that APRIL binding to TACI contributes to the immunosuppressive and treatment resistant MM bone marrow microenvironment, an effect that could potentially be mitigated by anti-APRIL antibody, BION-1301. Aduro is currently advancing BION-1301 in a Phase 1/2 dose escalation trial for the treatment of MM.

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Key findings from the study include the observation that TACI expression is significantly higher in Tregs than conventional T cells from the same patient. APRIL significantly stimulates proliferation and survival of these Tregs, whereas a neutralizing anti-APRIL antibody (BION-1301) may inhibit these effects. Furthermore, the paper explained how APRIL specifically augments Tregs to enhance MM cell survival.

"It is now well-known that APRIL acts through its two receptors TACI and BCMA (B cell maturation antigen), the most specific MM antigen expressed at high levels in malignant plasma cells/B cells of all MM patients. Our newest findings from this study indicate that an anti-APRIL antibody such as BION-1301 may have the potential to treat MM through a differentiated mechanism of action, not only by inhibiting APRIL binding to BCMA, but also stimulating immunity to cancer by blocking APRIL binding to TACI," commented Dr. Yu-Tzu Tai, lead author and Principal Scientist in Medical Oncology at the Dana-Farber Cancer Institute.

The paper entitled "APRIL signaling via TACI mediates immunosuppression by T regulatory cells in multiple myeloma: therapeutic implications," can be accessed at View Source

About APRIL
APRIL is a member of the tumor necrosis factor superfamily and is primarily secreted by bone marrow and/or myeloid cells. APRIL is overproduced in patients with multiple myeloma and binds to BCMA and TACI to stimulate a wide variety of responses that promote MM growth and survival and suppress the immune system so that the tumor cells are protected and sustained in the bone marrow.

About BION-1301
Aduro is currently evaluating BION-1301, its most advanced proprietary B-select monoclonal antibody, as a novel therapy for MM. Despite new treatments recently approved in MM, this disease remains incurable as patients relapse, or become resistant to, currently-available therapies. In preclinical studies, Aduro has established that APRIL plays a crucial part in the protective bone marrow tumor microenvironment. In these studies, APRIL, through BCMA, was shown to be critically involved in the survival, proliferation and chemoresistance of MM, and upregulates mechanisms of immunoresistance, including PD-L1 upregulation. BION-1301, a humanized antibody that blocks APRIL from binding to its receptors, has been shown in preclinical studies to halt tumor growth and overcome drug resistance. In addition, BION-1301 also demonstrated the ability to inhibit immune suppressive effects of regulatory T cells via TACI but not BCMA in MM blood and bone marrow. BION-1301 is currently being evaluated in a Phase 1/2 clinical study in patients with relapsed or refractory MM.

On September 4, 2018 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported the achievement of a development milestone in its collaboration with Eli Lilly and Company (Press release, Zymeworks, SEPT 4, 2018, View Source [SID1234529269]). In accordance with Zymeworks’ 2013 licensing and collaboration agreement with Lilly, Zymeworks will receive a milestone payment of US$2.0 million for Lilly’s submission of an IND application for a bispecific antibody enabled by Zymeworks’ proprietary Azymetric platform. Previously, Zymeworks announced Lilly’s nomination of two bispecific immuno-oncology drug candidates for late-stage preclinical development.

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"The team at Lilly has done an impressive job advancing a novel bispecific therapeutic built on our Azymetric platform to the IND stage in a relatively short period of time," said Ali Tehrani, Ph.D., President and Chief Executive Officer of Zymeworks. "Moving a compound into the clinic is an important step in drug development and we look forward to future progress with Lilly as well as our five other partners."

Under its two licensing and collaboration agreements with Lilly, Zymeworks has granted Lilly worldwide licenses to research, develop and commercialize multiple bispecific therapeutics directed towards Lilly’s targets. To date, Zymeworks has received an upfront licensing payment and multiple research milestone payments under these agreements, in addition to historical equity investments made by Lilly in Zymeworks. Zymeworks is also eligible to receive further development and commercial milestone payments and tiered royalties on global product sales.

About the Azymetric Platform

The Azymetric platform enables the transformation of monospecific antibodies into bispecific antibodies, giving the antibodies the ability to simultaneously bind two different targets. Azymetric bispecific technology enables the development of multifunctional biotherapeutics that can block multiple signaling pathways, recruit immune cells to tumors, enhance receptor clustering degradation, and increase tumor-specific targeting. These features are intended to enhance efficacy while reducing toxicities and the potential for drug-resistance. Azymetric bispecifics have been engineered to retain the desirable drug-like qualities of naturally occurring antibodies, including low immunogenicity, long half-life and high stability. In addition, they are compatible with standard manufacturing processes with high yields and purity, potentially significantly reducing drug development costs and timelines.