On May 10, 2021 Flow Eighteen38 and FairJourney Biologics S.A. (FJB), leaders in the discovery and optimization of antibodies, have reported an agreement with the Hubrecht Institute to harness the potential of FJB’s proprietary llama naïve libraries to develop antibodies to be used as research tools for the group of Hans Clevers (Press release, FairJourney Biologics, MAY 10, 2021, View Source [SID1234580202]).

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The Clevers group dedicates its activity to the study of the molecular mechanisms of tissue development and cancer of various organs using organoids made from adult Lgr5 stem cells. Under the agreement, Flow Eighteen38/FJB will provide the Clevers group at the Hubrecht Institute with research tools, arising from an accelerated antibody research campaign, that will support the group’s future scientific developments.

The reagent antibodies generated by Flow Eighteen38/FJB for the Hubrecht Institute comply with the recent EU recommendations on Non-Animal-derived antibodies and will be derived from FJB’s proprietary llama naïve libraries through its phage display technology platform. The Clevers group will benefit from the combination of this technology and the increased speed of delivery from this innovative approach, thought and optimized by the experienced scientists at Flow Eighteen38/FJB.

António Parada, CEO of FairJourney Biologics commented: "Our experience in antibody development has been continuously reinforced throughout the years and our reagent antibodies platform is proving to be essential for the swift generation of unparalleled research tools. We look forward to supply the Clevers group at the Hubrecht Institute with robust reagents that can contribute to further scientific developments in their cancer organoids studies."

Hans Clevers, Principal Investigator at the Hubrecht Institute commented: "The development of novel and more suitable antibodies presents itself as an advantageous approach for the next generation of research tools. FairJourney Biologics’ experience in antibody discovery, combined with the speed of Flow Eighteen38’s reagent antibodies program, makes them ideal partners as we focus on finding novel research tools that can leverage our stem cell-based organoids platform."

On May 10, 2021 Race Oncology Limited ("Race") reported a team of researchers, led by Professor Borje Andersson and Associate Professor Ben Valdez of the MD Anderson Cancer Center (Texas, USA), have identified a number of clinically translatable drug combinations that showed synergy with Bisantrene when tested in Acute Myeloid Leukaemia (AML) cells (Press release, Race Oncology, MAY 10, 2021, View Source [SID1234580138]).

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This study1, sponsored by Race, has been published in the Journal of Clinical & Experimental Oncology and is entitled "Synergism of the Anthracene-Derivative Anti-Cancer Agent Bisantrene with Nucleoside Analogs and A Bcl-2 Inhibitor in Acute Myeloid Leukemia Cells".

The MD Anderson team identified that Bisantrene, when used in combination with the standard-of-care AML drugs cytarabine, cladribine, fludarabine, clofarabine and/or ABT199 (Venetoclax) showed enhanced activation of apoptosis (cell killing) in AML cells. Combinations of three or more of these drugs with Bisantrene showed additional synergism and effective cell killing at drug concentrations far below that observed when the drugs were used on their own.

This work provides the preclinical data to support our upcoming Phase II relapsed / refractory AML trial at the Chaim Sheba Medical Center, where patients will be treated with Bisantrene in combination with the nucleoside analogs, clofarabine and fludarabine. This trial is scheduled to begin in Q2 CY2021. We are extremely excited about being able to quickly translate this work from the lab into the clinic, where it has the potential to help AML patients in need.

On May 10, 2021 Gennao Bio, a privately held genetic medicines company developing first-in-class, targeted nucleic acid therapeutics, reported the closing of a $40 million Series A financing (Press release, Gennao Bio, MAY 10, 2021, View Source [SID1234580067]). The financing was co-led by OrbiMed and Logos Capital, with participation by Surveyor Capital (a Citadel company). Proceeds from the financing will be used to support the advancement of its proprietary, first-in-class gene monoclonal antibody platform (GMAB), exclusively licensed from Yale University, and the development of targeted nucleic acid therapeutic product candidates for the treatment of oncology and rare monogenic skeletal muscle diseases. Gennao Bio was co-founded in 2020 by Peter Glazer, M.D., Ph.D., Elias Quijano, M. Phil., Stephen Squinto, Ph.D. and Bruce Turner, M.D., Ph.D.

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Dr. Squinto will serve as the Company’s newly appointed chief executive officer and chair of the board, effective immediately. Dr. Squinto is a life sciences industry veteran with more than 25 years of experience and a proven track record of building value at companies, including Passage Bio, SpringWorks Therapeutics, Alexion and Regeneron.

"I am thrilled to take-on the role of CEO and for the future of Gennao, which is poised to become a leader in genetic medicine," said Dr. Squinto. "GMAB is the only platform technology that can deliver multiple classes of nucleic acids, allowing us to develop targeted, cell penetrating therapeutics for a wide-range of genetic diseases. We are pleased to have the support and trust of established biotech investors OrbiMed, Logos and Surveyor. The capital raised in this Series A round will enable us to accelerate our research and development efforts and expand our team."

As part of the financing, Chau Q. Khuong, a partner on the private equity team at OrbiMed, has been appointed to Gennao Bio’s board of directors. Mr. Khuong brings significant experience in private and public company operations as well as business development. Mr. Khuong will serve alongside Dr. Turner, who joined the Company’s board in 2020.

Dr. Squinto will remain an executive partner at OrbiMed in addition to his role at Gennao Bio. Most recently, Dr. Squinto served as interim chief executive officer at Passage Bio, Inc., a genetic medicines company focused on developing therapies for rare, monogenic central nervous system disorders. Prior to that, he co-founded Alexion Pharmaceuticals, Inc. and served as its executive vice president and chief global operations officer. Prior to this role, he was Alexion’s global head of research and development. Earlier in his career, Dr. Squinto held various positions at Regeneron Pharmaceuticals, Inc. and held a joint academic position at both the Tulane University and LSU Medical Schools. He is a recipient of numerous honors and awards from academic and professional organizations for his scientific work. Dr. Squinto received his B.A. in Chemistry and Ph.D. in Biochemistry and Biophysics from Loyola University of Chicago.

On May 10, 2021 Allergan Aesthetics, an AbbVie company (NYSE: ABBV) and Soliton (NASDAQ: SOLY) reported a definitive agreement under which Allergan Aesthetics will acquire Soliton and RESONICTM, its Rapid Acoustic Pulse device which recently received U.S. Food and Drug Administration (FDA) 510(k) clearance and is a non-invasive treatment for the short-term improvement in the appearance of cellulite (Press release, AbbVie, MAY 10, 2021, View Source [SID1234580065]). The acquisition of Soliton expands and complements Allergan Aesthetics’ Body Contouring treatment portfolio which includes CoolSculpting Elite.

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The novel platform technology uses non-invasive rapid, high-frequency sound waves to disrupt targeted cellular structures and connective tissue, physically impacting the fibrous septae beneath the skin that contribute to the dimpled appearance of cellulite. In clinical trial data submitted to the FDA, after a single treatment session RESONICTM demonstrated significant improvement and strong patient satisfaction with 92.9 percent of subjects agreeing or strongly agreeing their cellulite appeared improved.

"There is a huge unmet need to address cellulite and effective treatments have been elusive and frustrating for consumers," said Carrie Strom, President, Global Allergan Aesthetics and Senior Vice President, AbbVie. "Soliton’s technology offers a new, completely non-invasive approach with clinically-proven results to reduce the appearance of cellulite with no patient downtime. The addition of this technology complements Allergan Aesthetics’ portfolio of body contouring treatments. Health care providers will now have another option to address consumers’ aesthetic concerns."

"Allergan Aesthetics’ brand recognition, global footprint, track record and commitment to developing best-in-class aesthetic treatments makes the Company ideally suited to maximize the commercial potential of the RESONICTM rapid acoustic pulse technology," said Walter Klemp, Executive Chairman, Soliton. "I am proud of the passion and accomplishments of the Soliton team and thankful for the ongoing support of our investors which have culminated in this transaction. We look forward to working with Allergan Aesthetics to ensure a successful completion of this transaction."

Under the terms of the transaction, Allergan Aesthetics will pay $22.60 per share in cash for each outstanding share of Soliton. Soliton’s enterprise value for the transaction is approximately $550 million and was approved by the Boards of Directors of both companies. The transaction is subject to customary closing conditions, including clearance by the U.S. antitrust authorities under the Hart-Scott-Rodino Act and approval of Soliton’s shareholders. Guggenheim Securities served as financial advisor to Soliton and Hogan Lovells served as legal counsel to Soliton.

RESONICTM has also received FDA 510(k) clearance for use in conjunction with laser for tattoo removal and has demonstrated clinical results in fibrotic scars.

On May 10, 2021 Yale University, in partnership with Boehringer Ingelheim, reported the launch of a Biomedical Data Science Fellowship program designed to attract and support some of the brightest and most innovative minds in data science from around the world (Press release, Boehringer Ingelheim, MAY 10, 2021, View Source [SID1234579522]).

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Post-doctoral researchers awarded a three-year fellowship will have access to Yale’s robust computational resources, biomedical data repositories and faculty expertise. In addition, they will benefit from access to Boehringer Ingelheim’s corporate labs, scientists and executives. Applicants are invited to submit research proposals for consideration by June 15. If approved for a fellowship, they will be jointly mentored throughout the research process by industry experts and scientists from Boehringer Ingelheim — one of the world’s leading pharmaceutical companies — as well as Yale’s world-class researchers and scholars. Fellowship training begins Sept. 1.

"This collaboration with Boehringer Ingelheim creates a world-class data science fellowship program that will drive development of novel methods and tools to analyze and interpret the many large and complex biomedical datasets that have been created in recent years," said Yale School of Public Health Professor of Biostatistics, Genetics, Statistics, and Data Science Hongyu Zhao, PhD, principal investigator for the project.

The program will be based at the Yale Center for Biomedical Data Science (CBDS) in New Haven, Connecticut. The center is an essential part of a growing data science hub at Yale University, which has identified integrated data science as one of its primary investment areas over the next decade. CBDS is located within Yale School of Medicine and currently supports more than 100 faculty members and researchers representing such disciplines as bioinformatics, modeling, statistics, computer science, artificial intelligence, mathematics, biology, precision medicine and public health.

"In partnering with a top-tier academic and research institution like Yale, we aim to recruit and train a new generation of highly skilled data scientists to help us accelerate development of novel treatments and therapies for human disease and improve health outcomes for our patients," said Jan Nygaard Jensen, PhD, Global Head of Computational Biology and Digital Sciences at Boehringer Ingelheim.

The partnership reflects a mutual vision between Boehringer Ingelheim and Yale University. It is part of a comprehensive strategic program at Boehringer Ingelheim which will harness the power of data science to transform drug discovery and development. The aim is to catalyze the next breakthrough therapies that change lives by accelerating timelines, improving scientific and clinical success and further elevating patient centricity.

"Boehringer Ingelheim is pleased to build upon our successful relationships with Yale to foster the next generation of scientists and harness the power of data science to bring our vision of making new and better medicines for patients in need," said Clive R. Wood, PhD, Senior Corporate Senior Vice President, Global Head, Discovery Research, Boehringer Ingelheim. "We believe our shared ambition and outlook will build a world-class data science community to attract outstanding researchers and work to achieve breakthroughs that patients need."

Initially the program will award as many as three competitive fellowships per year, up to a total of nine over the first five years. In addition to receiving research funding and mentorship, program fellows will be invited to participate in campus and corporate visits, networking events and annual symposia.

A joint selection committee comprising representatives of Yale and Boehringer Ingelheim will set annual data-driven research themes for the program. These themes may include such topics as genomic analysis, biomarkers, data-driven therapeutic research, medical image informatics, precision medicine and translational medicine. The selection committee will consider proposed research projects’ alignment with prioritized themes in judging submissions and post-doctoral applicants.

Yale’s data science ecosystem is supported by a host of cutting-edge research institutions working collaboratively. In addition to CBDS, they include Yale’s Systems Biology Institute, Center for Mendelian Genomics, Center for RNA Science and Medicine, and Center for Medical Informatics. Yale’s biobanks and technology core include: the Yale BioBank GENERATIONS, VA Million Veteran Program, Center for Research Computing, Center for Genomic Health, and Center for Genomic Analysis, which houses the ninth largest genomic library in the world.

Xinxin (Katie) Zhu, MD, PhD, executive director of the Yale Center for Biomedical Data Science, said the fellowship program offers an exciting opportunity for the development of innovative data-driven approaches for different medical conditions that can be translated from the lab to the patient’s bedside. It is an especially opportune time, she said.

"The vast amount of biomedical data being generated today has created a tremendous need for highly skilled data scientists who can use this information to advance care," said Zhu.

Specialists in biomedical data science and health informatics can identify statistical associations and patterns of disease. They also can develop complex machine learning models and simulations of molecular, cellular and organismic systems to increase the probability of clinical success through precision medicine and other methods.

"This helps clinicians and pharmaceutical companies such as Boehringer Ingelheim identify potential new pathways for treatment and eradication of disease," Zhu said.