Global Organoids and Spheroids Market Is Expected to Reach USD 2794.79 Million by 2027 : Fior Markets – GlobeNewswire

September 08, 2020 16:00 ET | Source: Fior Markets

Newark, NJ, Sept. 08, 2020 (GLOBE NEWSWIRE) -- As per the report published by Fior Markets, the global organoids and spheroids market is expected to grow from USD 502.92 million in 2019 and to reach USD 2794.79 million by 2027, growing at a CAGR of 23.91 % during the forecast period 2020-2027.

The growing prevalence of chronic disorders in recent times has increased the demand for effective drugs. The organoids and spheroids model is increasingly becoming popular as they provide a better perspective for human developmental biology research. The organoids model reveals the effects of covid-19 on several intestinal cells. Thus, these models are playing a significant role in the vaccine development process. The rise in demand for diagnostics and therapeutics solutions for these chronic diseases is fuelling market growth.

The organoids and spheroids are the three-dimensional structures that replicate the condition of different tissues present in the human body. The organoids model works as an in-vitro model for the study of biological development. The organoids can be established for organs such as kidney, retina, brain, liver, small and large intestine, lungs, etc. The organoids can be derived from a single adult stem cell or the embryonic stem cell. On the other hand, spheroids consist of a cluster of cells. These are derived from both the single-cell type and multi-cellular stems. The organoids and spheroids differ in the driving force required for the development. The organoids are formed by internal development processes and spheroids forms by adhesion of cells to each other. These also differ in the time duration for which the 3D culture can be maintained.

The human organoids have helped in the analysis of many tissues, which helps in a better understanding of the working of the organs. The 3D models of human organs have opened up opportunities for conducting various studies and experiments to analyze the effects of drugs on different organs. It also has provided potential ways of organ transplantation. Further, the growing technological advancements in the spheroid and organoid 3D models are fuelling the market growth. Apart from this, the major players operating in the market are also focusing on facilitating cell activities by taking control of the microenvironment of the culture.

DOWNLOAD FREE SAMPLE REPORT AThttps://www.fiormarkets.com/report-detail/418832/request-sample

Key players operating in the organoids and spheroids market are 3D Biotek LLC, 3D Biomatrix, ATCC, Cellesce Ltd., Hubrecht Organoid Technology (HUB), Merck KGaA, STEMCELL Technologies Inc., Corning Incorporated, AMS Biotechnology Limited, Perkin Elmer, Kuraray, Thermo Fisher Scientific, Inc., Greiner Bio-One, Prellis Biologics, Lonza and others. The major players in the organoids and spheroids market are focusing on expansionary strategies such as mergers & acquisitions, recent developments, joint ventures, collaborations, product innovations and partnerships. These strategies would extract higher market shares for the players and thus strengthen their position in the global market. Thermo Fisher Scientific and Corning Incorporated are some of the biggest manufacturers and suppliers of organoids and spheroids in the global market.

Spheroids segment dominated the market and held the largest market share of 54.92% in the year 2019

On the basis of type segment, the global organoids and spheroids market includes organoids and spheroids. The organoids are segmented into product type, techniques and source. The product type of organoids includes neural organoids, intestinal organoids, hepatic organoids and others. The techniques include crypt organoid culture techniques, general submerged technique, clonal organoid from Lgr5+ cells, air-liquid interface (ALI) method and brain and retina organoid formation protocol. The sources segment includes primary tissues and stem cells. The spheroids are also segmented into product type, techniques and source. The product type of spheroids includes mammospheres, neurospheres, embryoid bodies, multi-cellular tumor spheroids and hepatospheres. The techniques segment includes hanging drop method, micropatterned plates, low cell attachment plates and others. The source of spheroid includes primary cells, cell line and iPSCs derived cells. Spheroids dominated the market and held the largest market share of 54.92% in the year 2019. The spheroids are in high demand owing to its increased application in cancer research and drug discovery. The spheroids can be cultured to produce cells of consistent shape, which can be used for thorough analysis. Further, the organoids segment is projected to register an impressive growth rate as these are used as in-vitro models in the process of drug discovery. The segment is expected to be driven by the intestinal organoids type owing to the increased application is cell biology and disease modeling.

Developmental biology segment dominated the market and held the largest market share of 28.65% in the year 2019

On the basis of the application segment, the global organoids and spheroids market includes personalized medicine, developmental biology, drug toxicity and efficacy testing, disease pathology testing and regenerative medicine. Developmental biology dominated the market and held the largest market share of 28.65% in the year 2019. The organoids which are derived from induced pluripotent stem cells and embryonic stem cells are useful in human developmental biology. The spheroids and organoids have been increasingly used in the development biology study of the pancreas, kidney, stomach, liver, etc. for the purpose of embryonic development, tissue homeostasis and lineage specification.

Biotechnology and pharmaceutical companies segment dominated the market and held the largest market share of 39.82% in the year 2019

The end-user segment includes academic and research institutes, hospitals and diagnostic centers and biotechnology and pharmaceutical companies. Biotechnology and pharmaceutical companies segment dominated the market and held the largest market share of 39.82% in the year 2019. The organoids and spheroids are mainly used in clinical applications owing to the vast scope of the experiment. Thus, the biotechnology and pharmaceutical companies are using these increasingly in the drug discovery processes.

Browse full report with TOC athttps://www.fiormarkets.com/report/organoids-and-spheroids-market-by-type-organoids-and-418832.html

Regional Segment Analysis of the Organoids and Spheroids Market

On the basis of geography, the global organoids and spheroids market is classified into North America, Europe, South America, Asia Pacific, and the Middle East and Africa. North America region accounted for a significant market share of 43.02% in the year 2019. The region has been lately, investing in the organoid and spheroids based research models. Further, the growing technological advancements provides a platform for extensive research on 3D models of human tissue structure for the development of personalized and regenerative medicines. However, Asia-Pacific is expected to register the highest growth rate during the forecast period. The growing patient population owing to the prevalence of chronic diseases has led to the development of the market in the region. Further, the growth of stem cell research has increased the demand for organoids and spheroids.

Request for Customization:https://www.fiormarkets.com/enquiry/request-customization/418832

About the report:

The global organoids and spheroids market is analyzed on the basis of value (USD Million). All the segments have been analyzed on global, regional and country basis. The study includes an analysis of more than 30 countries for each segment. The report offers in-depth analysis of driving factors, opportunities, restraints, and challenges for gaining the key insight of the market. The study includes porter's five forces model, attractiveness analysis, raw material analysis, and competitor position grid analysis.

For Instant Purchase:https://www.fiormarkets.com/checkout.html?reportid=418832&type=single

Customization of the Report:

The report can be customized as per client requirements. For further queries, you can contact us onsales@fiormarkets.comor +1-201-465-4211. Our executives will be pleased to understand your requirements and offer you the best-suited reports.

About Fior Markets

Fior Markets is a futuristic market intelligence company, helping customers flourish their business strategies and make better decisions using actionable intelligence. With transparent information pool, we meet clients objectives, commitments on high standard and targeting possible prospects for SWOT analysis and market research reports. Fior Markets deploys a wide range of regional and global market intelligence research reports including industries like technology, pharmaceutical, consumer goods, food and beverages, chemicals, media, materials and many others. Our Strategic Intelligence capabilities are purposely planned to boost your business extension and elucidate the vigor of diverse industry. We hold distinguished units of highly expert analysts and consultants according to their respective domains. The global market research reports we provide involve both qualitative and quantitative analysis of current market scenario as per the geographical regions segregated and comprehensive performance in different regions with global approach. In addition, our syndicated research reports offer a packaged guide to keep companies abreast of the upcoming major restyle in their domains. Fior Markets facilitates clients with research analysis that are customized to their exact requirements, specifications and challenges, whether it is comprehensive desk research, survey work, composition of multiple methods, in-detailed interviewing or competitive intelligence. Our research experts are experienced in matching the exact personnel and methodology to your business need.

Contact Us

Avinash D Head of Business Development Phone:+1-201-465-4211 Email:sales@fiormarkets.com Web:www.fiormarkets.com

To Read Top Industries Reports, Visit our Affiliated Website: https://www.marketquest.biz

Related Reports Hydroxychloroquine Market - https://www.fiormarkets.com/report/hydroxychloroquine-market-by-dosage-type-200-mg-400-417942.html Immunotherapy Drugs Market - https://www.fiormarkets.com/report/immunotherapy-drugs-market-by-drug-type-checkpoint-inhibitors-417899.html Bovine Lactoferrin Market - https://www.fiormarkets.com/report/bovine-lactoferrin-market-by-type-freeze-dried-and-milled-417794.html CBD Hemp Oil Market - https://www.fiormarkets.com/report/cbd-hemp-oil-market-by-type-pure-cbd-411566.html

View original post here:
Global Organoids and Spheroids Market Is Expected to Reach USD 2794.79 Million by 2027 : Fior Markets - GlobeNewswire

School of Science grows by 10 – MIT News

Despite the upheaval caused by the coronavirus pandemic, 10 new faculty members have joined MIT in the departments of Biology; Chemistry; Earth, Atmospheric and Planetary Sciences; Mathematics; and Physics. The School of Science welcomes these new faculty, most of whom began their appointment July 1, amidst efforts to update education and research plans for the fall semester. They bring exciting and valuable new areas of strength and expertise to the Institute.

Camilla Cattania is an earthquake scientist. She uses continuum mechanics, numerical simulations, and statistics to study fault mechanics and earthquake physics at different scales, from small repeating events to fault interaction on regional and global scales. The models she has developed can help forecast earthquake sequences caused by seismic or aseismic events, such as aftershocks and swarms induced by forcing mechanisms like magma moving under the Earths surface. She has also developed theoretical models to explain why certain faults rupture in predictable patterns while others do not. Cattanias research plans include widening her focus to other tectonic settings and geometrically complex fault structures.

Cattania earned her bachelors and masters degrees from Cambridge University in experimental and theoretical physics in 2011, after which she completed a PhD in Germany at the GFZ German Research Center for Geosciences and the University of Potsdam in 2015. Subsequently, she spent a few months as a researcher at Woods Hole Oceanographic Institution and as a postdoc at Stanford University and her doctoral institution. She joins the Department of Earth, Atmospheric and Planetary Sciences as an assistant professor.

Richard Fletcher researches quantum physics using atomic vapors one-millionth the density of air and one-millionth the temperature of deep space. By manipulating the gas with intricately sculpted laser beams and magnetic fields, he can engineer custom-made quantum worlds, which provide both a powerful test bed for theory and a wonderful playground for discovering new phenomena. The goal is to understand how interesting collective behaviors emerge from the underlying microscopic complexity of many interacting particles. Fletchers interests include superfluidity in two-dimensional gases, methods to probe the correlations between individual atoms, and how the interplay of interactions and magnetic fields leads to novel physics.

Fletcher is a graduate of Cambridge University, where he completed his bachelor's in 2010. Before returning to Cambridge University to earn his PhD in 2015, he was a research fellow at Harvard University. He originally came to MIT as a postdoc in 2016 and now joins the Department of Physics as an assistant professor. Fletcher is a member of the MIT-Harvard Center for Ultracold Atoms.

William Frank investigates deformation of the Earths crust. He combines seismology and geodesy to explore the physical mechanisms that control the broad continuum of rupture modes and fault instabilities within the Earth. His research has illuminated the cascading rupture dynamics of slow fault slip and how the aftershocks that follow a large earthquake can reveal the underlying behavior of the host fault. Frank considers shallow shifts that cause earthquakes down to deep creep that is all-but-invisible at the surface. His insights work to improve estimates of seismic hazards induced by tectonic dynamics, volcanic processes, and human activity, which can then inform risk prediction and mitigation.

Frank holds a bachelors degree from the University of Michigan in earth systems science, which he received in 2009. The Institut de Physique du Globe de Paris awarded him a masters degree in geophysics in 2011 and a PhD in 2014. He first joined MIT as a postdoc in 2015 before moving to the University of Southern California as an assistant professor in 2018. He now returns as an assistant professor in the Department of Earth, Atmospheric and Planetary Sciences.

Ronald Fernando Garcia Ruizadvances research on fundamental physics and nuclear structure largely through the development of novel laser spectroscopy techniques. He investigates the properties of subatomic particles using atoms and molecules made up of short-lived radioactive nuclei. Garcia Ruizs experimental work provides unique information about the fundamental forces of nature and offers new opportunities in the search beyond the Standard Model of particle physics. His previous research at CERN focused on the study of the emergence of nuclear phenomena and the properties of nuclear matter at the limits of existence.

Garcia Ruizs bachelors degree in physics was achieved in 2009 at Universidad Nacional de Colombia. After earning a masters in physics in 2011 at Universidad Nacional Autnoma de Mxico, he completed a doctoral degree in radiation and nuclear physics at KU Leuven in 2015. Prior to joining MIT, he was first a research associate at the University of Manchester from 2016-17 and then a research fellow at CERN. Garcia Ruiz has now joined the Department of Physics as an assistant professor. He began his appointment Jan. 1. He is also affiliated with the Laboratory for Nuclear Science.

Ruth Lehmann studies germ cells. The only cells in the body capable of producing an entire organism on their own, germ cells pass genomic information from one generation to the next via egg cells. By analyzing the organization of their informational material as well as the mechanics they regulate, such as the production of eggs and sperm, Lehmann hopes to expose germ cells unique ability to enable procreation. Her work in cellular and developmental biology is renowned for identifying how germ cells migrate and lead to the continuation of life. An advocate for fundamental research in science, Lehmann studies fruit flies as a model to unveil vital aspects of early embryonic development that have important implications for stem cell research, lipid biology, and DNA repair.

Lehmann earned her bachelors degree in biology from the University of Tubingen in Germany. She took an interlude from her education to carry out research at the University of Washington in the United States before returning to Germany. There, she earned a masters equivalent from the University of Freiburg and a PhD from the University of Tubingen. Lehmann was subsequently a postdoc at the Medical Research Council Laboratory of Molecular Biology in the UK, after which she joined MIT. A faculty member and Whitehead Institute for Biomedical Research member from 1988 to 1996, she now returns after 23 years at New York University. Lehmann joins as a full professor in the Department of Biology and is the new director of the Whitehead Institute forBiomedical Research.

As an astrochemist, Brett McGuire is interested in the chemical origins of life and its evolution. He combines physical chemistry experiments and analyses with molecular spectroscopy in a lab, the results of which he then compares against astrophysics observation. His work ties together questions about the formation of planets and a planets ability to host and create life. McGuire does this by investigating the generation, presence, and fate of new molecules in space, which is vast and mostly empty, providing unique physical challenges on top of chemical specifications that can impact molecular formation. He has discovered several complex molecules already, including benzonitrile, a marker of carbon-based reactions occurring in an interstellar medium.

McGuires BS degree was awarded by the University of Illinois at Urbana-Champaign in 2009. He completed a masters in physical chemistry in 2011 at Emory University and a PhD in 2015 at Caltech. He then pursued a postdoc at the National Radio Astronomy Observatory and the Harvard-Smithsonian Center for Astrophysics. He joins the Department of Chemistry as an assistant professor.

Dor Minzer works in the fields of mathematics and theoretical computer science. His interests revolve around computational complexity theory, or more explicitly probabilistically checkable proofs, Boolean function analysis, and combinatorics. With collaborators, he has proved the 2-to-2 Games Conjecture, a central problem in complexity theory closely related to the Unique-Games Conjecture. This work significantly advances our understanding of approximation problems and, in particular, our ability to draw the border between computationally feasible and infeasible approximation problems.

Minzer is not new to online education. After earning his bachelors degree in mathematics in 2014 and a PhD in 2018, both from Tel-Aviv University, he became a postdoc at the Institute for Advanced Study in Princeton, New Jersey. He joins the Department of Mathematics as an assistant professor.

Lisa Piccirillo is a mathematician specializing in the study of three- and four-dimensional spaces. Her work in four-manifold topology has surprising applications to the study of mathematical knots. Perhaps most notably, Piccirillo proved that the Conway knot is not "slice." For all other small knots, "sliceness" is readily determined, but this particular knot had remained a mystery since John Conway presented it in the mid-1900s. After hearing about the problem at a conference, Piccirillo took only a week to formulate a proof. She is broadly interested in low-dimensional topology and knot theory, and employs constructive techniques in four-manifolds.

Piccirillo earned her BS in mathematics in 2013 from Boston College. Her PhD in mathematics was earned from the University of Texas at Austin in 2019, and from 2019-20 she was a postdoc at Brandeis University. She joins the Department of Mathematics as an assistant professor.

Jonathan Weissmans research interest is protein folding and structure, an integral function of life. His purview encompasses the expression of human genes and the lineage of cells, as well as protein misfolding, which can cause diseases and other physiological issues. He has made discoveries surrounding protein folding mechanisms, the development of CRISPR gene-editing tools, and other new therapeutics and drugs, and in the process generated innovative experimental and analytical methods and technologies. One of his novel methods is the ribosome profiling approach, which allows researchers to observe in vivo molecular translation, the process by which a protein is created according to code provided by RNA, a major advancement for health care.

Weissman earned a bachelors degree in physics from Harvard University in 1998 and a PhD from MIT in 1993. After completing his doctoral degree, he left MIT to become a postdoc at Yale University for three years, and then a faculty member at the University of California at San Francisco in 1996. He returns to MIT to join the Department of Biology as a full professor and a member of the Whitehead Institute for Biomedical Research. He is also a Howard Hughes Medical Institute investigator.

Yukiko Yamashita, a stem cell biologist, delves into the origins of multicellular organisms, asking questions about how genetic information is passed from one generation to the next, essentially in perpetuity, via germ cells (eggs and sperm), and how a single cell (fertilized egg) becomes an organism containing many different types of cells. The results of her work on stem cell division and gene transmission has implications for medicine and long-term human health. Using fruit flies as a model in the lab, she has revealed new areas of knowledge. For example, Yamashita has identified the mechanisms that enable a stem cell to produce two daughter cells with distinct fates, one a stem cell and one a differentiating cell, as well as the functions of satellite DNA, which she found to be crucial, unlike the waste they were previously thought to be.

Yamashita received her bachelors degree in biology in 1994 and her PhD in biophysics in 1999, both from Kyoto University. After being a postdoc at Stanford University for five years, she was appointed a faculty member at the University of Michigan in 2007. She joined the Department of Biology as a full professor with a July 1 start. She also became a member of the Whitehead Institute of Biomedical Research and is a standing investigator at the Howard Hughes Medical Institute.

The rest is here:
School of Science grows by 10 - MIT News

Faculty of Medicine researchers receive $2.8m for equipment and infrastructure – UBC Faculty of Medicine – UBC Faculty of Medicine

By Stephanie Chow | September 8, 2020

Eleven Faculty of Medicine researchers have received a combined $2.8 million for state-of-the-art labs and equipment.

The funding comes from the Government of Canada, through the Canada Foundation for Innovations (CFI) John R. Evans Leaders Fund. The investment provides researchers with the highly specialized infrastructure they need to be leaders in their field.

Deciphering DNA-encoded Gene-regulatory Logic with Genome-scale Synthetic DNA Carl de Boer, School of Biomedical Engineering

Infrastructure for Developing Pharmacologic Approaches to Modulating Fibrinolysis and Controlling Bleeding Disorders Christian Kastrup, Michael Smith Laboratories

Stem Cell and Genome Editing Lab Timothy Kieffer, Department of Cellular & Physiological Sciences

Community Hub for Arts-based Research and Innovation in Knowledge Translation Andrea Krusi, School of Population and Public Health

Exploring Mitochondria Function as Therapeutic Target in Acute Myeloid Leukemia and Multiple Myeloma Florian Kuchenbauer, Department of Medical Genetics

Hapscreen-RD: A Platform for Large-scale Screening of Human Haploid Cells for Rare Disease Research Josef Penninger, Life Sciences Institute & Department of Medical Genetics

Innovation in Mobility and Balance Rehabilitation Courtney Pollock, Department of Physical Therapy

The Stroke Management and eHealth Innovation Laboratory Brodie Sakakibara, Department of Occupational Science and Occupational Therapy, Southern Medical Program

Cryo-EM of Metabolic Enzymes for Drug Discovery Sriram Subramaniam, Department of Biochemistry

Investigating How Mitochondrial Stress Signaling Maintains Organelle Homeostasis in Health and Disease Hilla Weidberg, Department of Cellular & Physiological Sciences

Investigating the Neurophysiological Effects and Accumulation of Subconcussive Sports Head Impacts Lyndia Chun Wu, School of Biomedical Engineering

See the rest here:
Faculty of Medicine researchers receive $2.8m for equipment and infrastructure - UBC Faculty of Medicine - UBC Faculty of Medicine

BeyondSpring Receives Breakthrough Therapy Designations from Both U.S. FDA and China NMPA for Plinabulin in Chemotherapy-Induced Neutropenia…

September 08, 2020 07:00 ET | Source: BeyondSpring, Inc.

- FDA Breakthrough Designation for CIN Indication: Plinabulin for Concurrent Administration with Myelosuppressive Chemotherapeutic Regimens in Patients with Non-Myeloid Malignancies for the Prevention of Chemotherapy-Induced Neutropenia (CIN) -

- Designation Based on PROTECTIVE-2 Phase 3 Interim Data, Reinforcing Significant Treatment Need in CIN -

- Among the First Three Innovative Drugs to Receive Breakthrough Therapy Designations in China -

NEW YORK, Sept. 08, 2020 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the Company or BeyondSpring) (NASDAQ: BYSI), a global biopharmaceutical company focused on developing innovative immuno-oncology cancer therapies to transform the lives of patients with unmet medical needs, today announced that its lead asset, first-in-class agent Plinabulin, has received the Breakthrough Therapy Designation (BTD) for the chemotherapy-induced neutropenia (CIN) indication from both the U.S. Food and Drug Administration (FDA) and Chinas Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).

The FDA's BTD is intended to expedite the development and review of a drug candidate that is planned to treat a serious or life-threatening disease or condition in which clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.The CDE in China established its BTD program in July 2020 to facilitate the research and development of innovative drugs that treat severe life-threatening or quality-of-life impairing diseases with no existing therapy or with proven evidence to demonstrate clear clinical benefits compared to existing therapies. Products with BTD from the CDE may be considered for conditional approval and priority review when submitting New Drug Applications (NDAs).

"Receipt of Breakthrough Therapy Designation from the FDA acknowledges both the significant unmet need among patients with CIN and the highly encouraging clinical results generated by Plinabulin, said Douglas Blayney, M.D., global Principal Investigator for Plinabulins CIN studies and Professor of Medicine at the Stanford University School of Medicine. This should expedite Plinabulins move into the clinic, which is beneficial for patients. The currently approved CIN prevention agents are all G-CSF-based and not available to all patients. Even with the use of G-CSFs, over 80 percent of cancer patients undergoing chemotherapy may still experience Grade 4 neutropenia, which could lead to severe infection, hospitalization and even death. Thus, CIN still represents an unmet medical need.

"The clinical profile Plinabulin has shown truly represents a breakthrough in the CIN space since G-CSFs," added Ramon Mohanlal, M.D., Ph.D., MBA, Chief Medical Officer and Executive Vice President, Research and Development, at BeyondSpring. We look forward to continuing to work with the FDA as we advance the development of Plinabulin to address this urgent medical need.

The Breakthrough Therapy application is based on the strength of the totality of the clinical data generated so far:

The Company expects to report the full PROTECTIVE-2 Phase 3 topline data in Q4 2020 and file an NDA with the FDA by the end of 2020. The Company has submitted an NDA for Plinabulin for the CIN indication to the NMPA on a rolling basis in Q1 2020.

About Chemotherapy-Induced Neutropenia (CIN) CIN is a common side effect in cancer patients undergoing treatment that involves the destruction of a type of white blood cell, the neutrophil, which is a patients first line of defense against infections. Patients with Grade 4 (severe) neutropenia have an abnormally low concentration of neutrophils, which may lead to infections, hospitalization and death.

G-CSFs are the current standard of care for CIN prevention. However, G-CSFs have limitations in reducing Grade 4 neutropenia with high-risk chemotherapy. Neutropenia, if severe enough, may cause doctors to lower target doses of chemotherapy, end therapy early and / or delay chemotherapy cycles, each of which has a negative effect on long-term outcomes of cancer care.

Despite these limitations annual global use of G-CSFs is more than 4.3 million cycles per year (CPY). The U.S. (1.3 million CPY) and China (1.6 million CPY) account for more than two-thirds of the global CIN market. Plinabulins demonstrated clinical profile in combination with G-CSFs has the potential to build on this existing base and improve the standard of care for patients and practitioners.

About Plinabulin Plinabulin, BeyondSprings lead asset, is a differentiated immune and stem cell modulator. Plinabulin is currently in late-stage clinical development to increase overall survival in cancer patients, as well as to alleviate chemotherapy-induced neutropenia (CIN). The durable anticancer benefits of Plinabulin have been associated with its effect as a potent antigen-presenting cell (APC) inducer (through dendritic cell maturation) and T-cell activation (Chem and Cell Reports, 2019). Plinabulins CIN data highlights the ability to boost the number of hematopoietic stem / progenitor cells (HSPCs), or lineage-/cKit+/Sca1+ (LSK) cells in mice. Effects on HSPCs could explain the ability of Plinabulin to not only treat CIN but also to reduce chemotherapy-induced thrombocytopenia and increase circulating CD34+ cells in patients.

About Plinabulin in CIN Study The PROTECTIVE-1 (Study 105) and PROTECTIVE-2 (Study 106) trials are both multicenter, double-blind, active controlled Phase 3 trials to support Plinabulins broad application in preventing CIN: Plinabulin for concurrent administration with myelosuppressive chemotherapy regimens in patients with non-myeloid malignancies for the presentation of chemotherapy-induced neutropenia (CIN).

PROTECTIVE-1 (Study 105)This study was designed to evaluate the safety and efficacy in non-small cell lung cancer (NSCLC), breast cancer and prostate cancer patients with risk factors, treated with docetaxel (Day 1 dose) in a 21-day cycle with a single dose of Plinabulin (40mg, Day 1 dose) versus a single dose of Neulasta (6mg, Day 2). Docetaxel is one example of an intermediate-risk chemotherapy. This is a non-inferiority study in CIN efficacy comparing Plinabulin and Neulasta in high-risk patients (intermediate chemotherapy, plus one or more additional risk factor). Study 105 Phase 3 interim data had achieved statistical significance based on the primary endpoint of the Duration of Severe Neutropenia (DSN) in the first cycle.

PROTECTIVE-2 (Study 106)This study was designed to evaluate the safety and efficacy in breast cancer, treated with docetaxel, doxorubicin and cyclophosphamide (TAC, Day 1 dose) in a 21-day cycle with Plinabulin (40 mg, Day 1 dose) in combination with Neulasta (6 mg, Day 2 dose) versus a single dose of Neulasta (6 mg, Day 2 dose) alone. TAC is an example of high-risk chemotherapy. Plinabulin and G-CSFs have complementary mechanisms in preventing chemotherapy-induced neutropenia (CIN). This is a superiority study in CIN efficacy in the rate of Grade 4 neutropenia prevention (primary endpoint), comparing the combination head-to-head against Neulasta, and is currently enrolling. Literature shows that the Grade 4 neutropenia rate for TAC and Neulasta at 6 mg is 83 to 93 percent, which presents severe unmet medical needs.

Covance is the clinical contract research organization (CRO) for patient recruitment and monitoring of global sites for this study. The CIN studies are conducted in over 60 clinical centers in the U.S., China and Europe. In addition, Absolute Neutrophil Count (ANC) data, which is used to calculate these endpoints, was obtained through central laboratory assessments by Covance Bioanalytical Methods using standardized and validated analytical tests.

About BeyondSpring Headquartered in New York, BeyondSpring is a global, clinical-stage biopharmaceutical company focused on developing innovative immuno-oncology cancer therapies to improve clinical outcomes for patients with high unmet medical needs. BeyondSprings first-in-class lead immune asset, Plinabulin, is a potent antigen-presenting cell (APC) inducer. It is currently in two Phase 3 clinical trials for two severely unmet medical needs indications: one is for the prevention of chemotherapy-induced neutropenia (CIN), the most frequent cause for a chemotherapy regimen doses decrease, delay, downgrade or discontinuation, which can lead to suboptimal clinical outcomes. The other is for non-small cell lung cancer (NSCLC) treatment in EGFR wild-type patients. As a pipeline drug, Plinabulin is in various I/O combination studies to boost PD-1 / PD-L1 antibody anti-cancer effects. In addition to Plinabulin, BeyondSprings extensive pipeline includes three pre-clinical immuno-oncology assets and a drug discovery platform dubbed molecular glue that uses the protein degradation pathway.

Cautionary Note Regarding Forward-Looking Statements This press release includes forward-looking statements that are not historical facts. Words such as "will," "expect," "anticipate," "plan," "believe," "design," "may," "future," "estimate," "predict," "objective," "goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company's future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, and other risks described in BeyondSprings most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Media Contacts Caitlin Kasunich / Raquel Cona KCSA Strategic Communications ckasunich@kcsa.com / rcona@kcsa.com

Read more from the original source:
BeyondSpring Receives Breakthrough Therapy Designations from Both U.S. FDA and China NMPA for Plinabulin in Chemotherapy-Induced Neutropenia...