Category Archives: Molecular Genetics

The campus of the Technion-Israel Institute of Technology on Mount Carmel, Haifa. Photo: Wikimedia Commons.

JNS.org An international research group from Israel and Scotland has reported in Nature Cancer a breakthrough that may influence the treatment of metastatic leukemia spreading to the brain. The researchers include hematological-oncological experts from Schneider Childrens Medical Center and Tel Aviv University, as well as scientists from the Technion-Israel Institute of Technology and the University of Glasgow.

Their research focuses on acute lymphoblastic leukemia (ALL), the most common type of cancer among children. Although recovery rates for this disease are relatively high, the treatment is harsh and accompanied by numerous side effects that can persist years after the patient is cured. Since one of the main risks of ALL is that the cancer will metastasize to the brain, children diagnosed with this disease receive a prophylactic treatment that protects the brain from metastasized cells.

Currently, this treatment consists of injecting chemotherapy drugs into the spinal fluid and sometimes also radiation to the skull, which carries the risk of side effects for damaged brain function since these chemotherapy drugs also harm healthy brain cells.

For this reason, a worldwide effort is underway to develop more selective treatments that will only affect the leukemia cells and not the brain cells. Research reveals for the first time that the solution lies in fatty acids, an essential resource for cells, including leukemia cells. Leukemia cells obtain sufficient fatty acids in the bone marrow and blood, but when they travel to the brain in a metastatic process, they reach an area that is very poor in such acids.

October 30, 2020 2:54 pm

According to the recently published research, in order to continue to thrive and flourish in the brain, the ALL cells develop an ability to produce fatty acids on their own.

Based on these findings, the researchers infer that treating the patient with drugs that block the production of fatty acids will prevent the leukemia cells from producing these acids, and thereby starve them and stop them from flourishing in the brain. The use of such drugs in mice has stopped the spread of metastatic leukemia to their brains.

The drugs used in the current research are still being developed and therefore not yet approved for use in humans. However, the research findings provide hope for a more precise treatment that will most likely be less toxic for preventing the spread of leukemia to the brain.

The work was carried out by three young female scientists: Dr. Angela Maria Savino from Professor Shai Izraelis lab in the Department of Hematology-Oncology at the Schneider Childrens Medical Center, part of the Clalit Group, and the Department of Human Molecular Genetics and Biochemistry at Tel Aviv Universitys Sackler Faculty of Medicine; Sara Isabel Fernandes (a Ph.D. student) from the lab of Professor Eyal Gottlieb from the Rappaport Institute and Rappaport Faculty of Medicine at the Technion-Israel Institute of Technology; and Dr. Orianne Olivares from the lab of Professor Christina Halsey at the Wolfson Wohl Cancer Research Centre at the University of Glasgow.

Part of the research was also carried out in the lab of Professor Michael Kharas at Memorial Sloan Kettering Cancer Center in New York.

The discovery is also relevant for several other types of cancer in children and adults since most mortalities are not caused by the primary tumor, but by the spread of metastasized cells to distant organs. This research, which demonstrates that cancer cells adapt to the organs to which they spread, paves the way for biological treatments that block these adaptation mechanisms, thereby stopping the cancer cells from metastasizing.

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Breakthrough in Research Could Influence Treatment of Leukemia Spreading to Brain - Algemeiner

Angelika Amon, professor of biology and a member of the Koch Institute for Integrative Cancer Research, died on Oct. 29 at age 53, following a two-and-a-half-year battle with ovarian cancer.

"Known for her piercing scientific insight and infectious enthusiasm for the deepest questions of science, Professor Amon built an extraordinary career and in the process, a devoted community of colleagues, students and friends," MIT President L. Rafael Reif wrote in a letter to the MIT community.

Angelika was a force of nature and a highly valued member of our community, reflects Tyler Jacks, the David H. Koch Professor of Biology at MIT and director of the Koch Institute. Her intellect and wit were equally sharp, and she brought unmatched passion to everything she did. Through her groundbreaking research, her mentorship of so many, her teaching, and a host of other contributions, Angelika has made an incredible impact on the world one that will last long into the future.

A pioneer in cell biology

From the earliest stages of her career, Amon made profound contributions to our understanding of the fundamental biology of the cell, deciphering the regulatory networks that govern cell division and proliferation in yeast, mice, and mammalian organoids, and shedding light on the causes of chromosome mis-segregation and its consequences for human diseases.

Human cells have 23 pairs of chromosomes, but as they divide they can make errors that lead to too many or too few chromosomes, resulting in aneuploidy. Amons meticulous and rigorous experiments, first in yeast and then in mammalian cells, helped to uncover the biological consequences of having too many chromosomes. Her studies determined that extra chromosomes significantly impact the composition of the cell, causing stress in important processes such as protein folding and metabolism, and leading to additional mistakes that could drive cancer. Although stress resulting from aneuploidy affects cells ability to survive and proliferate, cancer cells which are nearly universally aneuploid can grow uncontrollably. Amon showed that aneuploidy disrupts cells usual error-repair systems, allowing genetic mutations to quickly accumulate.

Aneuploidy is usually fatal, but in some instances extra copies of specific chromosomes can lead to conditions such as Down syndrome and developmental disorders including those known as Patau and Edwards syndromes. This led Amon to work to understand how these negative effects result in some of the health problems associated specifically with Down syndrome, such as acute lymphoblastic leukemia. Her expertise in this area led her to be named co-director of the recently established Alana Down Syndrome Center at MIT.

Angelikas intellect and research were as astonishing as her bravery and her spirit. Her labs fundamental work on aneuploidy was integral to our establishment of the center, say Li-Huei Tsai, the Picower Professor of Neuroscience and co-director of the Alana Down Syndrome Center. Her exploration of the myriad consequences of aneuploidy for human health was vitally important and will continue to guide scientific and medical research.

Another major focus of research in the Amon lab has been on the relationship between how cells grow, divide, and age. Among other insights, this work has revealed that once cells reach a certain large size, they lose the ability to proliferate and are unable to reenter the cell cycle. Further, this growth contributes to senescence, an irreversible cell cycle arrest, and tissue aging. In related work, Amon has investigated the relationships between stem cell size, stem cell function, and tissue age. Her labs studies have found that in hematopoetic stem cells, small size is important to cells ability to function and proliferate in fact, she posted recent findings on bioRxiv earlier this week and have been examining the same questions in epithelial cells as well.

Amon lab experiments delved deep into the mechanics of the biology, trying to understand the mechanisms behind their observations. To support this work, she established research collaborations to leverage approaches and technologies developed by her colleagues at the Koch Institute, including sophisticated intestinal organoid and mouse models developed by the Yilmaz Laboratory, and a microfluidic device developed by the Manalis Laboratory for measuring physical characteristics of single cells.

The thrill of discovery

Born in 1967, Amon grew up in Vienna, Austria, in a family of six. Playing outside all day with her three younger siblings, she developed an early love of biology and animals. She could not remember a time when she was not interested in biology, initially wanting to become a zoologist. But in high school, she saw an old black-and-white film from the 1950s about chromosome segregation, and found the moment that the sister chromatids split apart breathtaking. She knew then that she wanted to study the inner workings of the cell and decided to focus on genetics at the University of Vienna in Austria.

After receiving her BS, Amon continued her doctoral work there under Professor Kim Nasmyth at the Research Institute of Molecular Pathology, earning her PhD in 1993. From the outset, she made important contributions to the field of cell cycle dynamics. Her work on yeast genetics in the Nasmyth laboratory led to major discoveries about how one stage of the cell cycle sets up for the next, revealing that cyclins, proteins that accumulate within cells as they enter mitosis, must be broken down before cells pass from mitosis to G1, a period of cell growth.

Towards the end of her doctorate, Amon became interested in fruitfly genetics and read the work of Ruth Lehmann, then a faculty member at MIT and a member of the Whitehead Institute. Impressed by the elegance of Lehmanns genetic approach, she applied and was accepted to her lab. In 1994, Amon arrived in the United States, not knowing that it would become her permanent home or that she would eventually become a professor.

While Amons love affair with fruitfly genetics would prove short, her promise was immediately apparent to Lehmann, now director of the Whitehead Institute. I will never forget picking Angelika up from the airport when she was flying in from Vienna to join my lab. Despite the long trip, she was just so full of energy, ready to talk science, says Lehmann. She had read all the papers in the new field and cut through the results to hit equally on the main points.

But as Amon frequently was fond of saying, yeast will spoil you. Lehmann explains that because they grow so fast and there are so many tools, your brain is the only limitation. I tried to convince her of the beauty and advantages of my slower-growing favorite organism. But in the end, yeast won and Angelika went on to establish a remarkable body of work, starting with her many contributions to how cells divide and more recently to discover a cellular aneuploidy program.

In 1996, after Lehmann had left for New York Universitys Skirball Institute, Amon was invited to become a Whitehead Fellow, a prestigious program that offers recent PhDs resources and mentorship to undertake their own investigations. Her work on the question of how yeast cells progress through the cell cycle and partition their chromosomes would be instrumental in establishing her as one of the worlds leading geneticists. While at Whitehead, her lab made key findings centered around the role of an enzyme called Cdc14 in prompting cells to exit mitosis, including that the enzyme is sequestered in a cellular compartment called the nucleolus and must be released before the cell can exit.

I was one of those blessed to share with her a eureka moment, as she would call it, says Rosella Visintin, a postdoc in Amons lab at the time of the discovery and now an assistant professor at the European School of Molecular Medicine in Milan. She had so many. Most of us are lucky to get just one, and I was one of the lucky ones. Ill never forget her smile and scream neither will the entire Whitehead Institute when she saw for the first time Cdc14 localization: You did it, you did it, you figured it out! Passion, excitement, joy everything was in that scream.

In 1999, Amons work as a Whitehead Fellow earned her a faculty position in the MIT Department of Biology and the MIT Center for Cancer Research, the predecessor to the Koch Institute. A full professor since 2007, she also became the Kathleen and Curtis Marble Professor in Cancer Research, associate director of the Paul F. Glenn Center for Biology of Aging Research at MIT, a member of the Ludwig Center for Molecular Oncology at MIT, and an investigator of the Howard Hughes Medical Institute.

Her pathbreaking research was recognized by several awards and honors, including the 2003 National Science Foundation Alan T. Waterman Award, the 2007 Paul Marks Prize for Cancer Research, the 2008 National Academy of Sciences (NAS) Award in Molecular Biology, and the 2013 Ernst Jung Prize for Medicine. In 2019, she won the Breakthrough Prize in Life Sciences and the Vilcek Prize in Biomedical Science, and was named to the Carnegie Corporation of New Yorks annual list of Great Immigrants, Great Americans. This year, she was given the Human Frontier Science Program Nakasone Award. She was also a member of the NAS and the American Academy of Arts and Sciences.

Lighting the way forward

Amons perseverance, deep curiosity, and enthusiasm for discovery served her well in her roles as teacher, mentor, and colleague. She has worked with many labs across the world and developed a deep network of scientific collaboration and friendships. She was a sought-after speaker for seminars and the many conferences she attended. In over 20 years as a professor at MIT, she has mentored more than 80 postdocs, graduate students, and undergraduates, and received the School of Sciences undergraduate teaching prize.

Angelika was an amazing, energetic, passionate, and creative scientist, an outstanding mentor to many, and an excellent teacher, says Alan Grossman, the Praecis Professor of Biology and head of MITs Department of Biology. Her impact and legacy will live on and be perpetuated by all those she touched.

Angelika existed in a league of her own, explains Kristin Knouse, one of Amons former graduate students and a current Whitehead Fellow. She had the energy and excitement of someone who picked up a pipette for the first time, but the brilliance and wisdom of someone who had been doing it for decades. Her infectious energy and brilliant mind were matched by a boundless heart and tenacious grit. She could glance at any data and immediately deliver a sharp insight that would never have crossed any other mind. Her positive attributes were infectious, and any interaction with her, no matter how transient, assuredly left you feeling better about yourself and your science.

Taking great delight in helping young scientists find their own eureka moments, Amon was a fearless advocate for science and the rights of women and minorities and inspired others to fight as well. She was not afraid to speak out in support of the research and causes she believed strongly in. She was a role model for young female scientists and spent countless hours mentoring and guiding them in a male-dominated field. While she graciously accepted awards for women in science, including the Vanderbilt Prize and the Women in Cell Biology Senior Award, she questioned the value of prizes focused on women as women, rather than on their scientific contributions.

Angelika Amon was an inspiring leader, notes Lehmann, not only by her trailblazing science but also by her fearlessness to call out sexism and other -isms in our community. Her captivating laugh and unwavering mentorship and guidance will be missed by students and faculty alike. MIT and the science community have lost an exemplary leader, mentor, friend, and mensch.

Amons wide-ranging curiosity led her to consider new ideas beyond her own field. In recent years, she has developed a love for dinosaurs and fossils, and often mentioned that she would like to study terraforming, which she considered essential for a human success to life on other planets.

It was always amazing to talk with Angelika about science, because her interests were so deep and so broad, her intellect so sharp, and her enthusiasm so infectious, remembers Vivian Siegel, a lecturer in the Department of Biology and friend since Amons postdoctoral days. Beyond her own work in the lab, she was fascinated by so many things, including dinosaurs dreaming of taking her daughters on a dig lichen, and even life on Mars.

Angelika was brilliant; she illuminated science and scientists, says Frank Solomon, professor of biology and member of the Koch Institute. And she was intense; she warmed the people around her, and expanded what it means to be a friend.

Amon is survived by her husband Johannes Weis, and her daughters Theresa and Clara Weis, and her three siblings and their families.

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Angelika Amon, cell biologist who pioneered research on chromosome imbalance, dies at 53 - MIT News

The ' Molecular Forensics market' study Added by Market Study Report, LLC, provides an in-depth analysis pertaining to potential drivers fueling this industry. The study also encompasses valuable insights about profitability prospects, market size, growth dynamics, and revenue estimation of the business vertical. The study further draws attention to the competitive backdrop of renowned market contenders including their product offerings and business strategies.

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Latest Study explores the Molecular Forensics Market Witness Highest Growth in near future - AlgosOnline

SAN DIEGO--(BUSINESS WIRE)--Boundless Bio, a biotechnology company developing innovative therapeutics directed to extrachromosomal DNA (ecDNA) in aggressive cancers, today will present research highlighting powerful components of its proprietary Spyglass platform at the 2020 American Society of Human Genetics (ASHG) Annual Meeting.

The poster, titled A Robust Imaging and Single-Cell Sequencing Platform to Characterize Tumor Extrachromosomal DNA (ecDNA) in Response to Therapeutic Intervention, describes elements of Boundless Bios broad platform for interrogating ecDNA biology. These elements couple automated cellular imaging with comprehensive single-cell genomic sequencing. The tools are part of an essential toolkit for understanding how ecDNA responds when cancers are treated with various therapeutic pressures and can be broadly applied to track how oncogenes amplify and where they are expressed following therapeutic intervention. Tumors driven by oncogene amplification are aggressive, have poor prognosis, and have proven elusive for targeted therapies. ecDNA frequently harbor oncogene amplifications and promote resistance to cancer treatment by enhancing genomic diversity and enabling cancer cells to rapidly adapt in response to therapeutic pressures.

We are building our Spyglass platform to serve as the first robust, objective, and high-resolution tool for characterizing ecDNA and how they respond to therapeutic pressures, said Jason Christiansen, Chief Technology Officer of Boundless Bio. This new research presented at ASHG demonstrates that our platform can successfully track how the behavior of ecDNA in cancer shifts in the face of treatment; these insights are enabling us to develop more effective, highly-targeted treatments for patients with cancers driven by ecDNA.

Study Details

Utilizing key analytical tool elements of the Spyglass platform, scientists studied colorectal cancer cells with amplified oncogenes in the presence and absence of cytotoxic chemotherapy, demonstrating the ability to robustly characterize changes in ecDNA and chromosomally-amplified genes at the phenotypic and molecular level.

The researchers studied Colo320DM cells, containing a mixture of the MYC oncogene on ecDNA and chromosomally amplified gene populations; Colo320HSR cells with a pure chromosomally amplified MYC population; and DLD1 cells as a non-amplified control. Each arm was treated for 2 weeks with a cytotoxic chemotherapeutic agent. Cells in metaphase were collected, stained with DAPI and probed for the MYC oncogene by Fluorescence In Situ Hybridization (FISH). Whole-slide images (~10mm2) were collected using automated imaging; and custom-built software was used to automatically identify and quantify ecDNA in individual metaphase spreads. Relative changes in MYC FISH signal and localization were used to quantify the changes in ecDNA and chromosomal amplification populations before and after drug treatment.

In addition, single-cell sequencing techniques revealed molecular level information about the amplified gene regions that is complementary to the spatial information provided by image analysis. Regions of increased gene expression and open chromatin around the MYC gene are indicative of ecDNA and were not identified in the chromosomally amplified line. Further, although chromosomally amplified regions exist in both model lines, molecular level evidence demonstrated divergence in this region not discernable by imaging. When treated with cytotoxic chemotherapy, the ecDNA population was reduced and the chromosomally amplified region was selected. Together these tools demonstrated Boundless Bios ability to monitor and quantify dynamic changes in ecDNA in cancer cells under selective pressure.

About ecDNAExtrachromosomal DNA, or ecDNA, are distinct circular units of DNA containing functional genes, including oncogenes, that are separated from tumor cell chromosomes. ecDNA rapidly replicate within cancer cells, causing high numbers of oncogene copies and can be passed to daughter cells asymmetrically during cell division, driving tumor heterogeneity. Cancer cells have the ability to increase or decrease copy number of oncogenes located on ecDNA to enable survival under selective pressures, including chemotherapy, targeted therapy, immunotherapy, or radiation, making ecDNA one of cancer cells primary mechanisms of recurrence and treatment resistance. ecDNA are rarely seen in healthy cells but are found in many solid tumor cancers. They are a key driver of the most aggressive and difficult-to-treat cancers, specifically those characterized by high copy number amplification of oncogenes.

About Boundless BioBoundless Bio is a next-generation precision oncology company interrogating a novel area of cancer biology, extrachromosomal DNA (ecDNA), to deliver transformative therapies to patients with previously intractable cancers.

For more information, visit http://www.boundlessbio.com.

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About Boundless Bios Spyglass PlatformBoundless Bios Spyglass platform is a comprehensive suite of proprietary ecDNA-driven and pair-matched tumor models along with proprietary imaging and molecular analytical tools that enables Boundlesss researchers to interrogate ecDNA biology and maintain a robust pipeline of novel oncotargets essential to the function of cancer cells that are enabled by ecDNA. The Spyglass platform facilitates Boundless innovation in the development of precision therapeutics specifically targeting ecDNA-driven tumors, thereby enabling selective treatments for patients whose tumor genetic profiles make them most likely to benefit from our novel therapeutic candidates.

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Boundless Bio Presents Research Showcasing its Imaging and Single-Cell Sequencing Platform for Extrachromosomal DNA (ecDNA) Detection at the 2020...

Electromagnetic energy in the brain enables brain matter to create our consciousness and our ability to be aware and think, according to a new theory developed by Professor Johnjoe McFadden from the University of Surrey.Publishing his theory in the eminent Oxford University Press journal Neuroscience of Consciousness, Professor McFadden posits that consciousness is in fact the brains energy field. This theory could pave the way towards the development of conscious AI, with robots that are aware and have the ability to think becoming a reality.

Early theories on what our consciousness is and how it has been created tended towards the supernatural, suggesting that humans and probably other animals possess an immaterial soul that confers consciousness, thought and free will capabilities that inanimate objects lack. Most scientists today have discarded this view, known as dualism, to embrace a monistic view of a consciousness generated by the brain itself and its network of billions of nerves. By contrast, McFadden proposes a scientific form of dualism based on the difference between matter and energy, rather than matter and soul.

The theory is based on scientific fact: when neurons in the brain and nervous system fire, they not only send the familiar electrical signal down the wire-like nerve fibres, but they also send a pulse of electromagnetic energy into the surrounding tissue. Such energy is usually disregarded, yet it carries the same information as nerve firings, but as an immaterial wave of energy, rather than a flow of atoms in and out of the nerves.

This electromagnetic field is well-known and is routinely detected by brain-scanning techniques such as electroencephalogram (EEG) and magnetoencephalography (MEG) but has previously been dismissed as irrelevant to brain function. Instead, McFadden proposes that the brains information- rich electromagnetic field is in fact itself the seat of consciousness, driving free will and voluntary actions. This new theory also accounts for why, despite their immense complexity and ultra-fast operation, todays computers have not exhibited the slightest spark of consciousness; however, with the right technical development, robots that are aware and can think for themselves could become a reality.

Johnjoe McFadden, Professor of Molecular Genetics and Director of the Quantum Biology Doctoral Training Centre at the University of Surrey, said: How brain matter becomes aware and manages to think is a mystery that has been pondered by philosophers, theologians, mystics and ordinary people for millennia. I believe this mystery has now been solved, and that consciousness is the experience of nerves plugging into the brains self-generated electromagnetic field to drive what we call free will and our voluntary actions.

Reference: McFadden J. Integrating information in the brains EM field: the cemi field theory of consciousness. Neurosci Conscious. 2020;2020(1). doi:10.1093/nc/niaa016

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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New Theory Suggests Consciousness Is the Brain's "Energy Field" - Technology Networks

According to a new theory developed by Professor Johnjoe McFadden from the University of Surrey, consciousness is the brains energy field. The brains electromagnetic energy enables brain matter to create our consciousness and our ability to be aware and think.

Prof. McFadden believes that this theory could help develop conscious AI, with robots aware and can think of becoming a reality.

Early hypotheses on our consciousness and how it has been created tended toward the supernatural, recommending that humans and probably different animals have an immaterial soul that confers consciousness, thought, and choiceabilities that inanimate objects lack.

Today, most researchers have disposed of this view, known as dualism, to grasp a monistic perspective on consciousness produced by the brain itself and its network of billions of nerves. Conversely, McFadden proposes a scientific form of dualism dependent on the contrast among issue and energy, as opposed to matter and soul.

The hypothesis depends on scientific fact: when neurons in the brain and nervous system fire, they not just impart the recognizable electrical sign down the wire-like nerve fibers, yet they likewise send pulse of electromagnetic energy into the surrounding tissue. Such energy is normally dismissed, yet it conveys similar data as nerve firings, however, as an irrelevant wave of energy, instead of a progression of particles all through the nerves.

McFadden proposes that the brains information-rich electromagnetic field is, in fact, itself the seat of consciousness, driving free will and voluntary actions. This new theory also accounts for why, despite their immense complexity and ultra-fast operation, todays computers have not exhibited the slightest spark of consciousness; however, with the right technical development, robots aware and can think for themselves could become a reality.

Johnjoe McFadden, Professor of Molecular Genetics and Director of the Quantum Biology Doctoral Training Centre at the University of Surrey, said:How brain matter becomes aware and manages to think is a mystery that has been pondered by philosophers, theologians, mystics and ordinary people for millennia. I believe this mystery has now been solved. That consciousness is the experience of nerves plugging into the brains self-generated electromagnetic field to drive what we call free will and our voluntary actions.

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A new theory of consciousness - Tech Explorist

HAMBURG, GERMANY / ACCESSWIRE / October 19, 2020 / Topas Therapeutics GmbH (Topas), a Hamburg, Germany-based private platform company leveraging the natural immune tolerance induction capabilities of the liver, today announced the appointment of Klaus Martin, Ph.D., as Chief Executive Officer. Effective August 1, 2020, Dr. Martin replaced Timm Jessen, Ph.D., who resigned for personal reasons. Dr. Jessen will remain with Topas in a consulting capacity to ensure a smooth transition.

Dr. Martin joins Topas from Toronto-based Apobiologix, Apotex' biotechnology division, where he had served as President since 2018. During his tenure, he led the development, sales & marketing and operational organization and played a key role in Apobiologix' registrations, partnerships and in achieving a market leadership position. Prior to that, he was Chief Scientific Officer of Polpharma Biologics, the biologics arm of Polpharma S.A., where he set up the organization and managed all portfolio, licensing and late-stage development activities for biosimilar and innovative biologics. Previously, he worked at Sandoz Biopharmaceuticals, both in Germany and Austria, most recently serving as Global Head Business Development & Licensing (BD&L) and Portfolio Management where he drove the portfolio strategy and managed all licensing negotiations. While at Sandoz Biopharmaceuticals, he also served in global development management functions and during that time supported the registration of Sandoz's first three biosimilars in the U.S., Europe, Canada and Japan. Dr. Martin holds a Ph.D. in molecular genetics from Cambridge University and Darwin College, United Kingdom.

Erich F. Greiner, M.D., Chairman of the Supervisory Board, said: "We are delighted to have Klaus join Topas. He is an accomplished biotech leader with a proven track record in development and operations, as well as partnering and commercialization. His transatlantic experience managing all stages of the biotechnology value chain and in growing businesses are a great fit for Topas as the Company advances its pipeline."

Dr. Greiner continued: "On behalf of the entire Board, I would like to warmly thank Timm Jessen, who founded Topas and has served as CEO since the Company's inception. He has successfully led Topas from discovery into the clinic, secured several pharmaceutical collaborations and successfully completed all financing rounds. We are extremely pleased that he will remain as a consultant to ensure a smooth transition and very much look forward to working with him in his new role."

Klaus Martin, Ph.D., Chief Executive Officer, said: "Topas has a novel and compelling technology platform with the potential to develop promising treatments where new options for patients are urgently needed. I am excited to lead the Company and work with the Topas team to continue to grow and build our pipeline."

About Topas Therapeutics

Topas Therapeutics GmbH is a private Hamburg, Germany-based biotechnology company focused on developing nanoparticle-based therapeutics to address areas of major unmet need, including autoimmune diseases, allergies and anti-drug antibodies. The Topas Particle Conjugates technology platform induces antigen-specific immune tolerance by harnessing the liver's natural immunology capabilities. The Company has several proprietary programs; lead product candidate TPM203 has recently entered clinical testing for pemphigus vulgaris, an orphan disease. A second program, TPM 501, is being developed for the treatment of celiac disease. Other programs are in the area of anti-drug immune responses, such as in gene therapy and with anti-drug antibodies, and are available for partnering. Topas' investors are: BioMedPartners, Boehringer Ingelheim Venture Fund, EMBL Ventures, Epidarex Capital, Evotec, Gimv and Vesalius Biocapital III. For additional information, please visit http://www.topas-therapeutics.com.

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SOURCE: Topas Therapeutics GmbH via EQS Newswire

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Topas Therapeutics Appoints Klaus Martin, Ph.D. as Chief Executive Officer - BioSpace

As the Jonas Salk Chair for Vaccine Research and professor of microbiology and molecular genetics at the University of Pittsburgh, Paul Duprex has been leading the local effort to create candidate vaccines for COVID-19.

In March, he joined an international team of scientists in using the tried and true measles vaccinea weakened form of the virus Duprex has been studying for decadesas the basis for a new candidate vaccine against SARS-CoV-2. Phase 1 testing began in August.

More recently, Duprex joined forces with the massive global vaccine maker Serum Institute of India, which already produces vaccines for two-thirds of the worlds children, to manufacture a similar measles-based SARS-CoV-2 candidate vaccine developed solely at Pitt.

On Oct. 15 from 10 to 11:30 a.m. ET, Duprex will sit on a panel with vaccine experts from March of Dimes, Johns Hopkins, CDC Foundation and Pitt for a discussion about the challenges that lay ahead. The event is free and open to the public.Attendees must register at the Wilson Center website.

UPMC science writer Erin Hare caught up with Duprex in the Center for Vaccine Research, where he serves as director.

Think of a telephone. A telephone is very different in the 1960s compared to the cell phone that you carry in your pocket today. So, just imagine the same analogy and apply that to vaccines.

We can make vaccines in new ways. The toolkit is enormously large now, compared to what it was way back when. That doesn't mean that we don't do the same types of vaccines that were made in the 1960syes, that's part of the portfolio of vaccines, but there are many more vaccines available.

For instance, we can genetically engineer viruses. We can make one virus look like another virus. Or, we can take bits of genetic material and not even introduce proteins, which are normally recognized by the immune system. We can introduce the RNA, which makes the protein, which then is recognized by the immune system.

That's just examples of new ways to think about new vaccines, 65 years on.

One of the advantages is that we have studied coronaviruses for many years. So, we understand a bit about which parts of the coronavirus can be used to make a good immune response.

The other thing which is interesting about coronaviruses is they're really big viruses, and they have the ability to correct mistakes whenever they replicate, so any mutation gets fixed straight away. That's good for us because that means the virus doesn't change much the way some other viruses do.

Like, for example, influenza. Influenza mixes it up all the time. HIV mixes it up all the time. But because SARS-CoV-2 has this drive to keep itself the same, that means the likelihood of changing is less. Plus, the virus just has one genetic segment, so it's not like influenza. So, instead of shuffling a pack of cardsthe genetic material of influenzaSARS-CoV-2 can just play around with one sequence.

So those are all good things for us.

Hard things for us? Well, it's a brand-new virus. So, we still have to understand this relatively young virus. We have to understand a lot more about the biology of it. And, of course, the world is working hard on understanding the biology of SARS-CoV-2.

We need so many because the first vaccine may not always be the best vaccine. It may work, but it might not work as efficiently as some of the other ones, which just take a bit longer to bring through the pipeline of development.

So, it's the same as that old analogy: You shouldn't keep all of your eggs in one basket. It's good to have multiple baskets for your eggs. And it's pretty good to have multiple approaches to deal with a virus that's rather new. The other part of having multiple approaches is we just don't know how long the immune response will last. And therefore we can't assume too much until we have the data.

So, it's all driven by science. Science is creative. People are creative. People come up with many ways to get to the same end point, and that's why we need lots of different sorts of vaccines.

Well, I think one of the things that gives me hope is there are a lot of individuals working on the problem. The world is focusedthe virology community, the immunology community and many other disciplinesare laser focused on solving this problem. People have developed vaccines in the past. So, that gives me hope. But also what we have to remember is vaccines are not easy.

The average time to make a vaccine is 10 and a half years. And if you think about HIV, it pulls that average way up, because 36 years after identifying that virus, we still don't have a vaccine. So therefore vaccines are hard, but vaccines have led to the eradication of infectious diseases, and vaccines have done so much for human health. They consistently deliver, they consistently live up to their expectations, and they have delivered so many people who otherwise would not be here because vaccines actually work.

So, what gives me hope? Vaccines work.

First and foremost, I'm sympathetic to individuals who are trying their best to understand something which is familiar to scientiststhe process of vaccine developmentbut very foreign to the general public. No vaccine has ever been developed under the microscope like these candidate vaccines for SARS-CoV-2.

We also get our news from many different sources. We have social media, we have regular mediawe have this tsunami of information. And that's what makes it really hard for the public to weed through, because not all of that information is equivalent.

So, what's important is to get information from verified, validated, sound sourcesto look at the evidence produced by science. And the evidence says that vaccines work. That does not mean that vaccines work perfectly. Sometimes the influenza vaccine's great, sometimes in one particular year, for whatever reason, it just doesn't work as well. But we don't undermine all the vaccines because we do not get to perfection.

And we do realize that there are side effects, adverse events that happen. And that's why it's really important as we do vaccine development, clinical trials in the here and now, that we use all of the standard approaches in phase 1, phase 2, phase 3 clinical trials, to understand any potential effects, whatever that could be. And we only license safe, efficacious and life-giving vaccines.

What you also have to remember is these companies do much more than make a coronavirus vaccine. Some of them have made vaccines for many years. Some of them have never made a vaccine at all. So, there's an example of why I could be sympathetic and understand the population looking at it and thinking we're going to license something that has never been used before. But remember that these companies have reputations, they have other products, they have history, they have a brand, they are known and it's very unlikely a private company will throw all of that reputation in the air just to be first with unsafe, untested, non-satisfactory coronavirus vaccine.

Vaccines are not just produced and marketed and sold without a lot of care and a lot of attention to how they are made, tested and licensed.

This interview has been edited for length and clarity.

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Q&A: Paul Duprex on the Promise of a COVID-19 Vaccine - UPJ Athletics

As flu season approaches and scientists continue to work on a vaccine for COVID-19, Andrea Amalfitano, dean of the College of Osteopathic Medicine and Osteopathic Heritage Foundation Endowed Professor of Pediatrics, Microbiology and Molecular Genetics, uses his expertise to shed light on how vaccines work and the process for creating new ones. The first of this two-part series addresses general questions about vaccines. The second part will address development of the COVID-19 vaccine.

How do vaccines work?

Vaccines work by introducing specific sub-portions, or antigens, of a desired target, like COVID-19, to the immune system in a manner that is safe and results in a training of the immune system should a vaccine recipient be subsequently exposed to COVID-19 naturally.The vaccinated individual will be able to ramp up an immune response that eliminates the COVID-19 much more rapidly than someone who was not vaccinated, thereby minimizing or completely preventing illness.

Our laboratories previously developed, for example, a vaccine platform for use against a variety of targets. This platform was created by genetically engineering a common cold virus to present antigens safely to the immune system. This unique vaccine platform has been safely used in hundreds of clinical trial participants targeting their cancers, and that safety record has allowed researchers to now test the platforms ability to induce beneficial immunity against the COVID-19 virus in human subjects as part of an FDA-approved Phase I clinical trial.

Confirming safety is key, and at this time it is more critical than ever that FDA regulations are maintained and followed, as these will help confirm that an approved vaccine is both effective and safe.Suspending FDA regulations at this crucial time would be the last thing I would recommend, for example, to hasten the approval of any potential COVID-19 vaccine.Suspending FDA oversight would undermine the trust the public would have in any other vaccine, therapeutic, test or other medical device subsequently approved by the FDA.

We hear a lot about the fast-tracking of a coronavirus vaccine. What is the usual time frame for creating a new vaccine?

Andrea Amalfitano, dean of the College of Osteopathic Medicine and Osteopathic Heritage Foundation Endowed Professor of Pediatrics, Microbiology and Molecular Genetics.

In my experience as a clinician/scientist who has developed new vaccine technologies for various purposes, the track typically is multiple years. Fast-tracking is not the typical term applied to vaccines, as the brunt of the time required to get a new vaccine approved is devoted to confirming the vaccine can be scaled up consistently and also has no untoward side-effects, especially when it is planned to be administered to potentially millions of people.

Given that, the annual flu vaccine is what I would consider a fast-tracked vaccine, as it is essentially a novel vaccine every year. The reasons it can be fast-tracked are: 1) the long-standing safety record (decades) of developing and producing flu vaccines using tried and true scale-up methods, 2) long-standing blood tests that consistently measure, and then correlate the amount of anti-flu antibodies generated by each annual flu vaccine with ultimate potential for efficacy.

What are the steps or phases of researching a new vaccine?

Typically, any new drug, vaccine or other form of medical therapeutic or device goes through three phases of clinical trials prior to receiving approval for generalized usage. Phase I studies typically involve dose testing and safety studies in normal human volunteers, as appropriate. Phase II studies involve using optimal doses of the new drug or vaccine in those potentially benefitting from the therapeutic, for example, a new drug to treat high blood pressure being evaluated in patients with high blood pressure. For flu vaccines, this phase would attempt to note how many anti-flu antibodies are produced by the potential new vaccine, and if these antibody levels are above the known thresholds required to have a good vaccine. Phase III studies typically involve testing the new therapeutic in trial subjects as compared to use of currently available therapeutics for the same disease indication to verify it is an improvement.

For flu vaccines, and more specifically COVID-19-specific vaccines, this phase may include asking clinical trial participants to receive a potential COVID-19 vaccine and monitor the rate of COVID-19 infection by these vaccine recipients over time. If the COVID-19 vaccine is good, those who receive the potential vaccine should have a much lower rate of acquiring COVID-19 infection than those trial participants who receive a placebo vaccine.

What are the risks associated with getting a new vaccine?

Vaccines are some of, if not the safest, types of medications doctors can provide to their patients. In fact, if you look back through time, beyond clean water, vaccines have saved more lives and decreased morbidity of the human race more so than any other medicine.

Risks can occur, as with anything administered to a human even excess water consumption can be dangerous to humans. Clinical trials in hundreds or thousands of trial participants serve to identify potential side effects. Furthermore, many times the FDA will also add Phase IV studies, even after a new therapeutic or vaccine is approved, typically to monitor for very low-frequency side effects not identified in prior clinical trials.

Do vaccines have to be kept at a certain temperature to be effective?

This depends on the type of vaccine platform. Some can be dehydrated and/or delivered as an oral pill, while others may require refrigeration at specific temperatures to maintain viability. It is not clear what these viability requirements will be of the several potential COVID-19 vaccines currently being tested.

Obviously, this also has to be a consideration in regard to scalability. For example, if a vaccine can be delivered at room temperature and remain effective as an orally ingestiblepill or tablet, this vaccine will be much more likely to succeed, versus a different vaccine that requires refrigeration until the time of a required administration.

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Ask the expert: How vaccines are created | MSUToday | Michigan State University - MSUToday

NEW YORK, Oct. 21, 2020 (GLOBE NEWSWIRE) -- n (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, announced today that it will present two poster presentations covering AT-007 in Galactosemia at the upcoming American Society of Human Genetics (ASHG) 2020 Annual Meeting. The presentations include animal model efficacy data and adult clinical data on the safety and biomarker efficacy of Applied Therapeutics investigational candidate for Galactosemia, AT-007, a Central Nervous System (CNS) penetrant Aldose Reductase Inhibitor (ARI).

We are pleased to present data on our Galactosemia program at the ASHG conference, said Riccardo Perfetti, MD, PhD, Chief Medical Officer of Applied Therapeutics. Our preclinical data demonstrates that reduction in galactitol, a toxic metabolite of galactose, prevents long-term CNS complications in an animal model of Galactosemia. In parallel, our clinical data from the ACTION-Galactosemia study demonstrates rapid and sustained reduction in galactitol with once-daily AT-007 treatment. Together, this data represents an important advancement in our understanding of the disease and a potential therapeutic intervention to halt disease progression.

Presentation Details

Poster #1881 (Abstract #3646): Positive Biomarker Efficacy Results from the ACTION-Galactosemia StudyPresenter: Riccardo Perfetti, M.D., Ph.D., Chief Medical Officer of Applied TherapeuticsTime: Monday, October 26, 6:00 a.m. 11:59 p.m. EDT

Poster #1958 (Abstract #3647): Post-Natal Galactitol Reduction is Associated with Normalization of CNS Phenotype in Animal Model of GalactosemiaPresenter: Riccardo Perfetti, M.D., Ph.D., Chief Medical Officer of Applied TherapeuticsTime: Monday, October 26, 6:00 a.m. 11:59 p.m. EDT

Slides will be available on the Presentations and Publications section of the Applied Therapeutics website following the conference.

About Applied TherapeuticsApplied Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need. The Companys lead drug candidate, AT-007, is a novel central nervous system penetrant aldose reductase inhibitor (ARI) for the treatment of Galactosemia, a rare pediatric metabolic disease. The Company initiated a pivotal Phase 1/2 clinical trial in June 2019, read out positive top-line biomarker data in adult Galactosemia patients in January 2020 and announced full data from the trial in April 2020. A pediatric Galactosemia study commenced in June 2020. The Company is also developing AT-001, a novel potent ARI that is being developed for the treatment of Diabetic Cardiomyopathy, or DbCM, a fatal fibrosis of the heart. The Company initiated a Phase 3 registrational study in DbCM in September 2019. The preclinical pipeline also includes AT-003, an ARI designed to cross through the back of the eye when dosed orally, for the treatment of diabetic retinopathy, as well as novel dual PI3k inhibitors in preclinical development for orphan oncology indications.

About AT-007

AT-007 is a central nervous system (CNS) penetrant Aldose Reductase inhibitor (ARI) in clinical development for treatment of Galactosemia. AT-007 has been studied in an animal model of Galactosemia, which demonstrated that AT-007 reduces toxic galactitol levels and prevents disease complications. Applied Therapeutics is conducting a biomarker based development program in patients with Galactosemia, based on the recently released industry guidance on drug development for low prevalence, slowly progressing rare metabolic diseases. The company received Orphan Designation for AT-007 for Galactosemia in May 2019 and Pediatric Rare Disease Voucher (PRV) designation in 2020.

Investors:Maeve Conneighton(212) 600-1902 orappliedtherapeutics@argotpartners.com

Media:Gleb Sagitovmedia@appliedtherapeutics.com

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Applied Therapeutics to Present Data on AT-007 for the Treatment of Galactosemia at the American Society of Human Genetics (ASHG) 2020 Annual Meeting...