On December 18, 2019 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer, autoimmune diseases, asthma and allergic diseases, reported the appointment of Allen Yang, M.D., Ph.D., as senior vice president and chief medical officer (Press release, Xencor, DEC 18, 2019, View Source [SID1234552481]). He will be responsible for leading clinical development strategy and overseeing clinical operations for Xencor’s portfolio of XmAb antibody drug candidates, including bispecific antibodies and cytokines. Dr. Yang joins Xencor from Jazz Pharmaceuticals, where he served as senior vice president, head of clinical development and acting chief medical officer.

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"We are delighted to welcome Allen to Xencor. He joins our team with a strong record of successful drug development in oncology, including T-cell engaging bispecific antibodies, and a wealth of experience in translational research and as a practicing oncologist. As our bispecific oncology pipeline matures and as we continue to explore novel target combinations in the clinic, Xencor will benefit immensely from Allen’s leadership and expertise," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor.

"Xencor’s bispecific platform has generated a diverse set of product candidates that explore novel biological mechanisms, which hold the potential to address unmet needs for the treatment of patients with cancer," said Dr. Yang. "I look forward to contributing to the advancement of the Company’s growing portfolio of novel bispecific antibodies and cytokines."

Before assuming his most recent role at Jazz, Dr. Yang was the therapeutic area head for hematology and oncology, assembling its clinical development team and overseeing several oncology products, including Erwinaze, Defitelio and Vyxeos. Prior to Jazz, Dr. Yang led clinical development and clinical operations groups at Spectrum Pharmaceuticals, where he was vice president of clinical research. Previously, he held several roles of increasing responsibility at Amgen, including those of global development leader for Aranesp in oncology and clinical research medical director for Blincyto, the first bispecific antibody approved by the FDA. Before transitioning to the biopharmaceutical industry, Dr. Yang practiced medicine for several years as an academic oncologist at the University of Southern California, where he led a translational cancer research laboratory. Dr. Yang earned a B.A. in molecular biology from the University of California, Berkeley, and a Ph.D. in biochemistry and an M.D. from the University of Southern California. He completed his medical oncology fellowship at the MD Anderson Cancer Center.

Erwinaze is a registered trademark of Porton Biopharma Limited. Defitelio and Vyxeos are registered trademarks of Jazz Pharmaceuticals plc or its subsidiaries. Aranesp and Blincyto are registered trademarks of Amgen Inc.

On December 18, 2019 Zentalis Pharmaceuticals (the "Company" or "Zentalis"), a clinical-stage biopharmaceutical company focused on developing clinically differentiated, novel small molecule therapeutics that target fundamental pathways in cancer, reported that the U.S. Food and Drug Administration (FDA) has previously cleared its Investigational New Drug (IND) application for its third oncology drug candidate, ZN-c3, and that it has dosed the first patient in a Phase 1/2 clinical trial evaluating ZN-c3 in patients with advanced solid tumors (Press release, Zentalis Pharmaceuticals, DEC 18, 2019, View Source [SID1234552480]).

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The Company is developing ZN-c3, an oral small molecule DNA Damage Response (DDR) drug candidate targeting WEE1 in cancer settings. WEE1 is a protein tyrosine kinase that regulates the cell cycle by serving as a checkpoint preventing DNA replication in the presence of DNA damage. The inhibition of WEE1 aims to generate sufficient DNA damage in cancer cells to cause them to undergo a programmed cell death called apoptosis, thereby preventing tumor growth. The Company has applied its medicinal chemistry expertise to design and synthesize its oral, small molecule compound, ZN-c3, with a potentially best-in-class product profile, including good solubility, selectivity and pharmacokinetic properties. We believe these characteristics will provide for a differentiated drug product to help fight cancer, if ZN-c3 is approved.

There is currently no FDA-approved WEE1 inhibitor. The Company is evaluating the potential of ZN-c3 in a Phase 1/2 clinical trial as monotherapy and in combination with an FDA-approved PARP inhibitor. As of December 16, 2019, the Company has enrolled two patients in this clinical trial. The Company expects to report preliminary data from this clinical trial in 2021.

"We are excited about targeting WEE1 because of its potential for potent anti-tumor activity across multiple cancer types," said Dr. Kevin Bunker, Chief Operating Officer at Zentalis Pharmaceuticals. "ZN-c3 is an internally developed drug candidate that was designed to be a best-in-class molecule with optimized selectivity, great oral bioavailability, and tolerability. We believe these characteristics will provide significant clinical benefit for cancer patients."

On December 18, 2019 Paige, the leader in computational pathology transforming the diagnosis and treatment of cancer, reported it has closed its Series B funding round of $45 million, bringing the Company’s total capital raised to over $70 million (Press release, Paige AI, DEC 18, 2019, View Source [SID1234552479]). Healthcare Venture Partners brought the largest contribution to the round, with Breyer Capital, Kenan Turnacioglu, and other funds participating. Paige will use this new capital to drive FDA clearance of its products and expand its portfolio, delving deeper into cancer pathology, novel biomarkers and prognostic capabilities. Additionally, the Company will accelerate commercial efforts in the U.S. and expansion in Europe, Brazil, and Canada.

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"This influx in funding reflects the acknowledgment and recognition that Paige’s technology is ready for prime time," said Leo Grady, CEO at Paige. "We believe that AI will have a transformative impact on pathology and cancer care by improving pathology quality, throughput, costs and by enabling new biomarkers and diagnostics. We are committed to offering these powerful technologies to hospitals around the world, and helping biopharma more effectively treat their patients and bring new therapies to market faster."

"The funding comes on the heels of a milestone year: Paige achieved the first FDA breakthrough designation for AI technology in Pathology and Oncology and later received the first CE mark in the space," added Thomas Fuchs, Founder of Paige and a researcher at Memorial Sloan Kettering (MSK). The Company also grew its digital slide archive to more than 1.2M images and is developing systems to combine digital slides with genomic, drug response and outcome information to create powerful new diagnostic solutions.

Paige continues its mission to create and deliver advanced computational diagnostics for pathologists and oncologists, which have been shown to work effectively across different slide preparation methodologies and the scanners used to digitize the images. The Company plans to deliver the powerful technology via partnerships, such as the recently announced Philips deal and Paige’s own AI-native platform, which is designed to help doctors maximize the benefits of these solutions while addressing the infrastructure and interoperability hurdles encountered by many of the early adopters of digital pathology.

"Paige exemplifies the benefits of digital pathology and represents the bright future of AI-driven medical diagnosis," said Jeff Lightcap of Healthcare Venture Partners. "As hospitals embark on digital transformations, they will face challenges associated with these transitions. We believe Paige addresses many of these issues by enhancing the ability of clinical teams and pathologists to collaborate. We’re confident in Paige’s future and believe they will continue to develop cutting-edge technologies that enable pathology departments to transform their practices, which have changed little in the last century."

"We applaud Paige’s commitment to building clinical AI products that will improve the diagnostic process and patient care," added Jim Breyer of Breyer Capital. "This is a critical time for Pathology, as pathologists are carrying a heavier workload than ever before. Paige understands their needs and the team has built cutting-edge technologies to address them. Paige represents the future of computational pathology and we look forward to their continued growth and success."

On December 18, 2019 Immunitas Therapeutics ("Immunitas"), an innovative single cell genomics discovery platform company focused on developing breakthrough immuno-oncology therapies, reported it has appointed Jeffrey M. Goldberg as Chief Executive Officer and Director (Press release, Immunitas Therapeutics, DEC 18, 2019, View Source [SID1234552478]). He succeeds founding CEO, Christoph Westphal, M.D, Ph.D., who assumes the role of Chairman of the Board of Directors.

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"One of the central challenges of drug development has been bridging the gap between laboratory research in model organisms to meaningful clinical advances in humans," said Jeff Goldberg. "Immunitas and our scientific co-founders use single cell genomic sequencing and sophisticated computational biology techniques to look at human biology directly. I believe this innovative approach can help to accelerate the development of new therapies for patients. I am excited to be joining the Immunitas team as we discover and develop these highly targeted new immuno-oncology therapies."

Immunitas identifies novel, promising oncology targets with potential applicability across both solid and liquid tumors. Additionally, as part of the discovery process, Immunitas develops key biomarkers to guide the selection of patients who may benefit from its new drugs. The company leverages its expertise in antibody discovery and engineering to create therapies that modulate these targets. Immunitas is currently advancing a number of programs toward early human studies, including a lead program with fully-human monoclonal antibodies that will be developed as single agents using a clinical biomarker strategy to guide early efficacy studies.

"Jeff Goldberg has over 20 years of industry experience driving programs from discovery through all phases of drug development to commercialization in multiple therapeutic areas, including oncology, neurology, renal, and rare diseases," said Lea Hachigian, President and Director, Immunitas Therapeutics. "We are fortunate to have his demonstrated ability leading and building teams as we create an oncology company powered by our human biology-focused approach to immunology."

Mr. Goldberg joins the Immunitas Board of Directors, which includes Dr. Laura Brass, Managing Director at Novartis Venture Fund, Dr. Jürgen Eckhardt, Head of Leaps by Bayer, Bayer’s strategic venture capital unit, Dr. Lea Hachigian, Principal, Longwood Fund, Dr. Lucio Iannone, Director of Venture Investments of Leaps by Bayer, Dr. Christoph Westphal, co-founder and General Partner of Longwood Fund, and Dr. Vincent Xiang, Managing Director at Hillhouse Capital.

Jeff Goldberg is an experienced biotech program and brand leader with over 20 years of industry experience. He has driven programs from discovery and pre-clinical through IND, clinical trials, NDA, and commercialization in multiple therapeutic areas, including oncology, neurology, renal, and other rare and orphan diseases. Mr. Goldberg joins Immunitas from Akcea Therapeutics, where he was Chief Operating Officer from the time of its formation in January 2015. Previously, Mr. Goldberg was VP of Business Operations, leading both program management and business development at Proteostasis Therapeutics, Inc., a biotech company focusing on neurology and rare diseases. He also spent more than 11 years in positions of increasing responsibility with Genzyme and Sanofi, providing brand management for two marketed products within Sanofi Oncology. Prior to joining Sanofi Oncology, Mr. Goldberg served as Global Program Lead for Genzyme’s stem cell mobilization agent Mozobil, leading the global launch team and overseeing the program management and marketing functions for the product. He began his career at Genzyme as Director, Program Management overseeing the development and launch of Renvela in patients undergoing dialysis. Mr. Goldberg has both an MBA and a Master’s degree in Chemical Engineering from the Massachusetts Institute of Technology, and a B.S. in Chemical Engineering from Cornell University.

On December 18, 2019 FerGene, a new gene therapy company launched by Ferring Pharmaceuticals and Blackstone Life Sciences in November, reported the appointment of David Meek as President and Chief Executive Officer, effective January 14, 2020 (Press release, FerGene, DEC 18, 2019, View Source [SID1234552477]).

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Mr. Meek has 30 years of industry experience. Most recently, he has served as CEO of Ipsen, a leading global biopharmaceutical company focused on innovation and specialty care and dedicated to improving lives through the discovery of new medicines in oncology, neuroscience and rare diseases.

"I’m honored to lead FerGene in this exciting role and spearhead the effort to develop and commercialize this critical and innovative therapy and advance its clinical development. We will build a committed, patient-centric team and with the support from Ferring and Blackstone Life Sciences, I am confident we can efficiently and effectively bring this life changing therapy to patients in need," said Mr. Meek.

Jean Duvall, Co-Chair of FerGene and Executive Committee member of Ferring Pharmaceuticals, said, "We are extremely confident in David and his ability to lead and build FerGene as it seeks to bring a promising therapy to market for bladder cancer patients and improve the standard of care. With an impressive track record of corporate leadership experience, David is poised to excel in this role."

Paris Panayiotopoulos, Co-Chair of FerGene and Blackstone Life Sciences Managing Director, said, "We are thrilled to welcome David as FerGene’s new CEO. David’s proven track record of growing businesses across both Biotech and Pharma, as well as his deep knowledge of the US Oncology market, make him the ideal fit to lead FerGene. David’s experience will be instrumental as we advance a breakthrough investigational gene therapy that offers the potential to meaningfully improve the standard of care for a patient population which has seen little innovation over the past twenty years."

FerGene was launched in November 2019 with a focus on US commercialization of nadofaragene firadenovec (rAd-IFN/Syn3), an investigational novel gene therapy in late stage development for patients with high-grade, Bacillus Calmette-Guérin (BCG) unresponsive, non-muscle invasive bladder cancer (NMIBC).

FerGene also recently announced Phase 3 study results of nadofaragene firadenovec, which FerGene reports met its primary endpoint with more than half of patients with high-grade, BCG unresponsive non-muscle invasive bladder cancer (cis ± ta/t1) achieving a complete response at three months.

While at Ipsen, Mr. Meek has led a growth strategy of financial results and pipeline advancement. He has also transformed Ipsen into a global biopharma growth leader with initiatives to transform external innovation, Ipsen’s R&D operations and build out the company’s footprint in countries like the U.S. and China. In addition to his time as CEO of Ipsen, Mr. Meek’s prior leadership roles have included serving as Executive Vice President & President of Oncology at Baxalta from 2014 – 2016, following its spin-off from Baxter. He was also Chief Commercial Officer of Endocyte from 2012 – 2014. Prior to that, Mr. Meek served in various executive leadership roles at Novartis Pharma and Novartis Oncology after beginning his career at Johnson & Johnson and Janssen from 1989 – 2004.

About nadofaragene firadenovec

Nadofaragene firadenovec (rAd-IFN/Syn3) is an investigational gene therapy being developed as a treatment for patients with high-grade, BCG unresponsive, NMIBC. It is an adenovirus vector-based gene therapy containing the gene interferon alfa-2b, administered by catheter into the bladder every three months. The vector enters the cells of the bladder wall, where, it breaks down, releasing the active gene to do its work. The internal gene/DNA machinery of the cells ‘picks up’ the gene and translates its DNA sequence, resulting in the cells secreting high quantities of interferon alfa-2b protein, a naturally occurring protein the body uses to fight cancer. This novel gene therapy approach thereby turns the patient’s own bladder wall cells into multiple interferon microfactories, enhancing the body’s natural defenses against the cancer.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

NMIBC is an early form of bladder cancer which is present in the superficial layer of the bladder and has not invaded deeper into the bladder or spread to other parts of the body.1 It is estimated that there will be 80,000 new cases of bladder cancer in the U.S. in 2019; more than 70% of these cases present as NMIBC.2,,3 In patients with high-grade NMIBC, intravesical BCG is the recommended treatment; however, between 30% and 50% cases with high-grade disease will recur.4 The outcome for BCG unresponsive patients is poor, with total cystectomy (complete removal of the bladder) often being the next treatment option.5