On November 5, 2019 Montefiore Medicine’s Board of Trustees reported that Dr. Philip O. Ozuah has been named the next Chief Executive Officer of Montefiore Medicine, the umbrella organization for Montefiore Health System (MHS) and Albert Einstein College of Medicine (Press release, Montefiore Medical Center, NOV 5, 2019, View Source [SID1234550495]). As CEO, Dr. Ozuah will lead Montefiore Medicine’s next phase of growth and evolution as a global healthcare leader, renowned for its leading medical school, groundbreaking research and technology, and highly specialized, coordinated care of diverse populations in the New York region, across the country and globally. Dr. Ozuah will begin as Chief Executive Officer on November 15, 2019.

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"We are thrilled Dr. Philip Ozuah, a proven senior executive and strong strategic thinker, will lead Montefiore into the next decade," said Dan Tishman, Chair of the Board of Trustees of Montefiore Medicine. "What stood out was his impressive record of success at MHS, his intellect and warmth as a physician, his strength as a leader and manager and his deep commitment to Montefiore’s mission. I’d also like to thank our outgoing CEO, Dr. Steven Safyer, for his 40 years of service that put our organization on a path of excellence."

"It will be a privilege to lead Montefiore Medicine, an organization with a clear purpose – to heal, to teach, to discover and to advance the health of the communities we serve," said Dr. Ozuah. "Ever since first joining Montefiore in 1989, I’ve been inspired by our institution’s commitment to excellence. We are an organization of exceptionally talented and compassionate people. Working closely with the Board, I look forward to continuing to expand inclusive access to state-of-the-art care and to furthering Montefiore’s role as a global leader in healthcare and biomedical research."

Outgoing CEO Dr. Steven Safyer commented: "It has been a privilege to serve the Montefiore community over the past four decades and, having worked alongside Dr. Ozuah for the past 25 years, I know I am leaving our institution in the best possible hands. I have consistently been impressed by Dr. Ozuah’s strategic vision for the Montefiore Health System. His appointment as CEO will guarantee a smooth transition, and I know he’ll continue to uphold the standard of excellence on which Montefiore has built its reputation."

Dr. Ozuah currently serves as President of Montefiore Health System and previously served as Physician-in-Chief of the Children’s Hospital at Montefiore (CHAM), where he worked to deliver best-in-class clinical care with a commitment to healthcare access for the underserved. Under his leadership, U.S. News and World Report has ranked Montefiore Health System’s medical specialties in the top 1% of the nation’s hospitals and Children’s Hospital at Montefiore (CHAM) as one of "America’s Best Children’s Hospitals." Dr. Ozuah also has a strong commitment to medical education as well as deep academic medical research expertise, including as an NIH-funded investigator and as Professor and University Chairman of Pediatrics at the Albert Einstein College of Medicine.

In these roles, Dr. Ozuah expanded access for underserved communities, recruited and cultivated outstanding talent, advanced programs of excellence, fostered innovations in medical education, and improved financial and operational performance by integrating care across a rapidly growing and evolving Montefiore system that sees over six million patient interactions a year. He’s been recognized regionally and nationally for excellence in teaching and patient care, including as an inductee into the Alpha Omega Alpha Honor Medical Society and a two-time recipient of the Academic Pediatric Association’s prestigious Helfer Award for Innovation in Medical Education. Along with his various awards for teaching and clinical excellence, Dr. Ozuah has also been recognized by Modern Healthcare as one of the "Top 25 COOs in Healthcare."

Dr. Ozuah earned his medical degree from the University of Ibadan, Nigeria, a Master’s Degree in Education from the University of Southern California, Los Angeles, and a PhD in Educational Leadership and Administration from the University of Nebraska, Lincoln. He completed his Pediatric Internship and Residency at the Albert Einstein College of Medicine and Montefiore, and his Post-Doctoral Fellowship in Medical Education at the University of Southern California School of Medicine, Los Angeles.

Dr. Ozuah’s appointment follows a succession planning process conducted by the Board, who were advised by leadership consulting firm Spencer Stuart.

On November 5, 2019 Sandoz, a Novartis division and a global leader in biosimilars, reported that the US Food and Drug Administration (FDA) approved its biosimilar ZiextenzoTM (pegfilgrastim-bmez) (Press release, Sandoz, NOV 5, 2019, View Source [SID1234550446]). Sandoz biosimilar pegfilgrastim has been approved and marketed in Europe as Ziextenzo (pegfilgrastim) since 2018. Sandoz now intends to launch Ziextenzo in the US as soon as possible this year.

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Ziextenzo is indicated to decrease the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever), in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

"When a cancer patient with febrile neutropenia gets an infection, it can have serious consequences such as delays or dose reductions of chemotherapy," said Carol Lynch, President of Sandoz Inc. "The approval of Ziextenzo expands our oncology portfolio, providing physicians with a long-acting supportive oncology biosimilar option. It builds on the foundation of trust and experience we developed with our short-acting filgrastim Zarxio – the leading filgrastim by market share in the US – including consistent product supply and reliable patient services."

A study has shown that each year in the US, more than 60,000 cancer patients are hospitalized with evidence of neutropenia, including fever or infection, with more than 4,000 deaths as a result.1 Sandoz is now the first and only company to offer physicians in the US the choice between a long- and short-acting biosimilar filgrastim treatment to best suit the individual needs of tens of thousands of patients undergoing chemotherapy.

The FDA approval of Ziextenzo was based on analytical, preclinical and clinical research, including data from a pivotal three-way pharmacokinetics (PK) and pharmacodynamics (PD) study (LA-EP06-104).2 This study compared Sandoz pegfilgrastim with US-sourced reference pegfilgrastim, Sandoz pegfilgrastim with EU-sourced reference pegfilgrastim, and US-sourced with EU-sourced reference pegfilgrastim. PK and PD similarity were demonstrated in all three comparisons, and no clinically meaningful differences were observed regarding safety and immunogenicity among the treatment groups.

Sandoz has proven biosimilars create early and expanded patient access to life-changing biologics while increasing healthcare savings. Its four approved biosimilars in the US are part of a leading global portfolio with eight marketed biosimilars. Building on this success, Ziextenzo can help increase positive treatment outcomes for patients undergoing chemotherapy and drive significant savings for the healthcare system.2,3

Sandoz is a global biosimilar leader and will continue to help millions of patients in oncology, immunology, endocrinology and other underserved therapy areas access biologic medicines sustainably and affordably.

About Ziextenzo (pegfilgrastim-bmez)
Pegfilgrastim is a long-acting form of filgrastim. Filgrastim is very similar to a natural protein (granulocyte-colony stimulating factor) – also known as G-CSF – produced by a person’s own body. Ziextenzo is indicated in the US to decrease the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever), in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.4 Febrile neutropenia is caused by cytotoxic chemotherapy (medicines that destroy rapidly growing cells); white blood cells are important as they help your body fight infection.5

On November 5, 2019 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) reported that it will release third quarter 2019 financial results after the market closes on Tuesday, November 12, 2019 (Press release, Cumberland Pharmaceuticals, NOV 5, 2019, View Source [SID1234550387]). A conference call and live Internet webcast will be held on Tuesday, November 12, at 4:30 p.m. Eastern Time to discuss the results.

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To participate in the call, please dial 877-303-1298 (for U.S. callers) or 253-237-1032 (for international callers). A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 855-859-2056 (for U.S. callers) or 404-537-3406 (for international callers). The Conference ID for the rebroadcast is 9865969. The live webcast and rebroadcast can be accessed via Cumberland’s website at View Source

On November 5, 2019 Ryvu Therapeutics (WSE: RVU) reported that Pawel Przewiezlikowski, Chief Executive Officer, will present a corporate overview at the following conference in Hamburg, Germany (Press release, Ryvu Therapeutics, NOV 5, 2019, View Source [SID1234550386]):

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Event: BIO-Europe 2019, Nov. 11-13, 2019
Location: Congress Center Hamburg
Date/Time: Tuesday, Nov. 12, at 4:15 p.m. CET

On November 5, 2019 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported preclinical results from its COM902 anti-TIGIT program supporting its potential clinical use in various combinations with PD-1 inhibitors and COM701, a first-in-class PVRIG inhibitor (Press release, Compugen, NOV 5, 2019, View Source [SID1234550385]). The findings will be presented in a poster titled "COM902, a Novel Therapeutic Antibody Targeting TIGIT Augments T Cell Function and the Activity of PVRIG Pathway Blockade In Vitro and In Vivo" at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2019) in National Harbor, Maryland, on Saturday, November 9, 2019.

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"These new preclinical data further substantiate our theory that TIGIT and PVRIG are part of a foundational immuno-oncology axis, the DNAM axis," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We believe that a combined treatment of COM902 with COM701, our first-in-class PVRIG antibody, has the potential to enhance the clinical impact of cancer immunotherapy in patients unresponsive to approved treatments. We look forward to advancing COM902 to the clinic early next year."

Key findings in the poster include:

Broad expression of TIGIT and PVRIG ligands, PVR and PVRL2 in solid tumors.
Superior binding affinity of COM902 to T cells with similar and or greater in vitro function compared to several clinical anti-TIGIT antibodies.
Increased T cell activation by COM902 on tumor infiltrating lymphocytes (TILs), which was further enhanced by combination with COM701.
Reduced mouse melanoma tumor growth in TIGIT and PVRIG knockout mice with further tumor growth reduction in TIGIT/PVRIG double knockouts.
COM902 inhibited tumor growth and increased survival when combined with anti-PVRIG or anti-PD-L1 antibodies in a mouse model of colon cancer.
The poster will be available on Compugen’s website following the poster presentation.

About COM902

COM902, a high affinity, fully human antibody targeting TIGIT, was developed for combination treatment with COM701. Preclinical data demonstrate that TIGIT inhibition, either alone or in combination with other checkpoint inhibitors, can enhance T cell activation and increase anti-tumor immune responses. Parallel inhibition of TIGIT and PVRIG, the two coinhibitory arms of the DNAM-1 axis, results in synergistic effects on effector T cell function and tumor growth inhibition in various model systems that can be further increased with the addition of PD-1 blockade. Based on preclinical data these combinations may be clinically important for enhancing anti-tumor immune response and expanding the patient population responsive to checkpoint inhibition. The Company plans to initiate Phase 1 studies in patients with advanced malignancies in early 2020 pursuant to the FDA’s clearance of an investigational new drug application in October 2019.

Compugen discovered TIGIT in 2009 leveraging its immune checkpoint computational discovery platform through which PVRIG was also discovered. The TIGT discovery was published by Compugen in October 2009 in the Proceedings of the National Academy of Sciences (PNAS).