Category Archives: Gene Medicine

Alliance for Regenerative Medicine, European Federation of Pharmaceutical Industries and Associations, and European Association for Bioindustries Call for Advanced Therapies to be Exempt from EU GMO Legislation

COVID-19 highlights how the EU can adapt legislation to meet urgent health needs

A permanent exemption would help to accelerate access to life-changing medicines for European patients

BRUSSELS, BELGIUM May 25, 2021

The European Commission should exempt advanced therapies from Genetically Modified Organism (GMO) legislation, which hurts Europes ability to attract clinical trials and delays patient access to transformative medicines, said the Alliance for Regenerative Medicine (ARM), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the European Association of Bioindustries (EuropaBio) in a paper published online yesterday in the journal Human Gene Therapy.

The European Commission recognized that GMO requirements hinder the conduct of clinical trials in its April 29 study on new genomic techniques and in the 2020 Pharmaceutical Strategy for Europe, when it called for GMO legislation to be fit for purpose for addressing medicines. The original GMO legislation was primarily enacted to protect food consumers and the environment, but Advanced Therapy Medicinal Products (ATMPs) such as gene therapies are affected as an unintended consequence. The uneven application of GMO requirements across EU Member States causes significant clinical trial delays despite findings that gene therapies pose a negligible risk to the environment.

Galvanized by the pandemic, the European Commission granted a temporary derogation from GMO requirements to investigational COVID-19 medicinal products to accelerate the development of vaccines and treatments. An industry survey suggested that the temporary derogation decreased the amount of time required to complete clinical trials in Europe. A similar, but permanent, exemption is justified for gene therapies -- which often treat life-threatening diseases that have few, or no, treatment options while still preserving high quality and safety standards.

The European Commission recognised that time was of the essence when lifting GMO requirements for COVID-19 vaccines and treatments, said Paige Bischoff, ARMs Senior Vice President of Global Public Affairs. Time is also very much of the essence for people with cancer, inherited disorders and other life-threatening conditions. We call on the European Commission to take the same measures for advanced therapies and remove the unnecessary and unintended burden of GMO legislation so patients have timely access to transformative, potentially curative medicines.

The organisations call on the European Commission to put forward a proposal by 2022, the timeframe proposed by the Pharmaceutical Strategy for Europe. Without an exemption for gene therapies, the GMO requirements threaten the regions competitiveness with other parts of the world where GMO legislation is less complex and cumbersome. A 2019 ARM report, for example, found that the number of ATMP clinical trials in Europe stayed roughly flat over a four-year period (2014-2018) while increasing substantially in North America (+36%) and in Asia (+28%). Europe is at risk of falling further behind: At the end of 2020 the ATMP sector was conducting 1,220 clinical trials worldwide, up from 1,066 in 2019.

"In 2020, we welcomed the derogation from GMO legislation for COVID-19 treatments or vaccines in clinical trials, said Pr Tellner,Director of Regulatory Affairs at EFPIA. Member companies are increasingly reporting how the derogation has removed the significant and time-consuming hurdles associated with GMO submissions, in addition to the clinical trial application. Swift action to a permanent exemption from GMO legislation allows the EU to prosper and most importantly for patients to continue to receive transformative, potentially life-saving therapies."

Freeing the conduct of clinical trials with investigational gene therapies from the heavy EU GMO administrative burden is critical for cutting-edge biotechnology companies, added Violeta Georgieva, EuropaBios Legal Affairs Manager. The use of CRISPR/Cas9, the latest promising tool in genome editing, can be overshadowed in the EU if developers and regulators are to follow the 2018 ruling of the EU Court of Justice, which puts the controversial GMO label on the Nobel Prize-winning CRISPR technology. Our hopes are set on the European Commission to improve patient access to revolutionary treatments by exempting them from the disproportionate and outdated GMO framework.

ARM, EFPIA, and EuropaBio look forward to engaging with the European Commission and other stakeholders to find the best possible solutions to ensure that Europe is a competitive destination for the development of advanced therapies and that European patients have access to the most innovative, life-changing treatments.

Press enquiries

For more information or for media requests, please contact Stephen Majors from the Alliance for Regenerative Medicine at smajors@alliancerm.org, Andy Powrie-Smith from EFPIA at communications@efpia.eu, or Dovile Sandaraite from EuropaBio at d.sandaraite@europabio.org.

About the Alliance for Regenerative Medicine (ARM)

The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organisation dedicated to realizing the promise of advanced therapy medicinal products (ATMPs).ARMpromotes legislative, regulatory, reimbursement and manufacturing initiativesin Europe and internationally to advance this innovative and transformative sector, which includes cell therapies, gene therapies and tissue-based therapies.Early products to market have demonstrated profound, durable and potentially curative benefits that are already helping thousands of patients worldwide, many of whom have no other viable treatment options. Hundreds of additional product candidates contribute to a robust pipeline of potentially life-changing ATMPs.In its 11-year history,ARMhas become the global voice of the sector, representing the interests of 380+ members worldwide and 85+ members across 15 Europeancountries, including small and large companies, academic research institutions, major medical centres and patient groups.To learn more aboutARMor to become a member, visithttp://www.alliancerm.org.

About the European Federation of Pharmaceutical Industries and Associations (EFPIA)

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the biopharmaceutical industry operating in Europe. Through its direct membership of 36 national associations, 39 leading pharmaceutical companies and a growing number of small and medium- sized enterprises (SMEs), EFPIAs mission is to create a collaborative environment that enables our members to innovate, discover, develop and deliver new therapies and vaccines for people across Europe, as well as contribute to the European economy

About the European Association for Bioindustries (EuropaBio)

The European Association for Bioindustries (EuropaBio) promotes an innovative and dynamic European biotechnology industry. EuropaBio and its members are committed to the socially responsible use of biotechnology to improve quality of life, to prevent, diagnose, treat and cure diseases, to improve the quality and quantity of food and feedstuffs and to move towards a biobased and zero-waste economy. EuropaBio represents corporate and associate members across sectors, plus national and regional biotechnology associations which, in turn, represent over 1800 biotech SMEs. Read more about our work at http://www.europabio.org.

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ARM, EFPIA and EuropaBio Call for Advanced Therapies to be - GlobeNewswire

Optogenics was used to partially restore a blind mans eyesight; the FDA could soon approve Modernas COVID-19 vaccine for use among adolescents; HHS calls for a new investigation into COVID-19s origins.

Light-catching proteins were grown in the eye of a blind man in France who, with the help of special goggles, can now see blurred outlines of objects, reports an article in Nature Medicine. This novel form of gene therapy is optogenics, and these results mark its first successful use against a neurodegenerative eye disease, which rob[s] the eyes of essential proteins required for vision. The treatment transforms ganglion cells into new photoreceptor cells, with the scientists also utilizing algae-derived proteins to sensitize nerve cells to light.

Hoping to gain approval for its COVID-19 vaccine among adolescents aged 12 to 17 years, Moderna will submit effectiveness data to the FDA in June, reports The New York Times. Currently only available for persons 18 years and older, the new vaccine data comprise results from 3732 participants. Most notably, efficacy was shown to be 100%, following no reports of symptomatic COVID-19 in the two-thirds who received both doses. Pfizers vaccine was similarly approved for use among adolescents aged 12 to 15 years on May 10.

Following US intelligence reports that Chinese virology experts were seriously ill before cases of COVID-19 were ever reported in December 2019, HHS Secretary Xavier Becerra is seeking a more transparent phase 2 investigation into the beginnings of the COVID-19 pandemic, according to Reuters. This new effort should again be headed by an international team, he added. Speaking for the World Health Organization (WHO), whose previous report on the pandemics origins was met with much criticism, spokesperson Tarik Jasarevic noted that the next step will be to present a proposal to WHO Director-General Tedros Adhanom Ghebreyesus on studies that cover early detection of cases and clusters and food chain transmission, among others.

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What We're Reading: Restoring Eyesight; New Moderna Vaccine Indication Possible; COVID-19 Origin Investigation - AJMC.com Managed Markets Network

UMass Amherst pre-veterinary sciences major uses gene sequencing to advance immunology research

As a young girl dreaming of becoming a veterinarian, Kate Loonie may have expected some of the hands-on experiences she had at UMass Amherst. She vaccinated and ear-tagged Belted Galloway cattle, medicated injured horses, helped deliver lambs, and even cared for turtles as a summer intern at the New England Aquarium. But she didnt expect that some of her most fulfilling work would be performing gene sequencing on a computer.

I never saw myself doing research, especially in my undergraduate years, Kate says. I didnt think I would enjoy lab work. But it pushed me to places I didnt think Id be able to go.

Working in the lab of Professor of Veterinary and Animal Sciences Cynthia Baldwin beginning in her freshman year, Kate has been involved in three cellular immunology research projects related to tracking down a gene family, known as WC1, in sheep, cattle, and goats. She graduated from UMass with her name on three published research papers.

Although genetic sequences at first looked like alphabet soup to her, Kate learned the Baldwin labs bioinformatics technology quickly. I practiced and practiced that tedious software every moment I could, she recalls. Baldwin noted that Kate is a good collaborator who is proactive in the lab. She is really passionate about learning new techniques and is a very mature, independent, and responsible individual, she said.

Having learned the software, Kate was given an independent projectlooking at the gene sequences of the auroch, the ancient ancestors of our modern-day cattle. The auroch, immortalized in cave paintings, were massive super cattle that lived in Asia, Europe, and North Africa before their extinction in 1627. Kate sequenced the DNA from a 6,000 year-old auroch humerus bone and gathered evidence of the presence of WC1. I concluded that some bovine WC1 molecules were preserved from the ancient auroch, while some molecules seem to have been lost or created from evolution. This shows its possible the aurochs were seeing the same pathogens as were seeing today, she says. This research has important implications for improving the health of ruminants.

For her second published project, Kate amalgamated data from numerous years of study and used gene sequencing technology to investigate WC1 in sheep. Her third published paper is titled, Special features of T cells in ruminants. Kates thesis, Investigating gene expression in T cells, contributes toward understanding cells that could point the way toward more effective vaccines.

For Kate, lab work revealed the true potential of the impact a veterinarian can have in research. Research made me stop and think, she says. I started to think about situations differently and more analytically both in the lab and out of the lab, in classes, at the cattle barn, and everywhere else. I caught a glimpse of the potential I will have with more education, and how much I can contribute to developing science and knowledge in my future. With that, I relit my passion for veterinary science.

Kate will begin studying for her doctor in veterinary medicine degree at Cornell University this summer. After I have established my veterinary career, she says, I can see myself pursuing a masters or PhD in the research realm. I hope to teach the young undergraduate generation of pre-veterinary students.

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Kathleen Loonie '21: Rising Researcher - UMass News and Media Relations

PITTSBURGH, May 25, 2021 (GLOBE NEWSWIRE) -- NeuBase Therapeutics, Inc. (Nasdaq: NBSE) ("NeuBase" or the "Company"), a biotechnology company accelerating the genetic revolution using a new class of precision genetic medicines, today announced the appointment of Kia Motesharei, Ph.D., as Chief Business and Strategy Officer, effective May 24, 2021. Dr. Motesharei has more than 20 years of experience in business development, licensing and transactions, alliance management and strategy in the biotechnology and pharmaceutical industry.

Kia has successfully completed more than 100 deals, with particular expertise in scaling the output of platform biotechnology companies through partnerships to maximize shareholder value, with several drugs on market now as a direct result of his activities. Kia also has expertise in our programmatic areas including in neurology, oncology and rare diseases, said Dietrich A. Stephan, Ph.D., Founder, CEO and Chairman of NeuBase. We are excited to welcome Kia to the NeuBase team, as we evaluate potential partnership opportunities and expand our therapeutic pipeline, leveraging the broad capabilities of our PATrOLTM platform for precision genetic medicines.

Genetic mutations are the fundamental drivers of all diseases, rare and common, so NeuBases ability to specifically modulate mutated DNA and RNA can unlock a whole new class of medicines for diseases that currently have few treatment options, said Dr. Motesharei. I look forward to utilizing partnership strategies to expand the breadth of what we have the potential to accomplish with this technology to benefit patients around the world.

Most recently, Dr. Motesharei was Senior Vice President, Business Development & Corporate Strategy at Akcea Therapeutics, a late-stage development and commercial biopharmaceutical company focused on rare diseases, where he led and executed the regional partnership of Akceas marketed products Tegsedi and Waylivra with Sobi in Europe and the Middle East. Prior to Akcea, Dr. Motesharei headed Global Licensing & Business Development, Neurology & Immunology (N&I) at EMD Serono, the biopharmaceutical business of Merck KGaA. He was a core member of the N&I Franchise Leadership Team that executed the overall strategy of the $1.8 billion franchise, including product and pipeline development, partnering, regulatory and commercial and marketing decisions. He managed the global licensing team responsible for search and evaluation and transactions across the entire R&D spectrum for the immunology, neurology, allergy, fertility, medical device and global health franchises. Previously, Dr. Motesharei was a member of the management team and investor relations team at Dyax Corporation, a pharmaceutical company focused on development and commercialization of novel biotherapeutics for prevention of hereditary angioedema. He led the business development, alliance management and competitive intelligence functions covering Dyaxs phage display platform as well as pipeline products including Kalbitor and DX-2930 (now approved as Takhzyro) that contributed to its approximately $6.5 billion acquisition by Shire. Earlier in his career, he held a series of leadership positions at Genfit Corporation, ActivX Biosciences and Lion Bioscience. He currently serves on the board of Ariana Pharma. Dr. Motesharei received a Ph.D. in organic chemistry from the UCLA and a B.A. in chemistry from Colorado College. He completed his postdoctoral training as an NIH fellow at The Scripps Research Institute.

About NeuBase TherapeuticsNeuBase is accelerating the genetic revolution by developing a new class of precision genetic medicines which can be designed to increase, decrease, or change gene function, as appropriate, to resolve genetic defects that drive disease. NeuBases targeted PATrOL therapies are centered around its proprietary drug scaffold to address genetic diseases at the DNA or RNA level by combining the highly targeted approach of traditional genetic therapies with the broad organ distribution capabilities of small molecules. With an initial focus on silencing disease-causing mutations in debilitating neurological, neuromuscular and oncologic disorders, NeuBase is committed to redefining medicine for the millions of patients with both common and rare conditions. To learn more, visit http://www.neubasetherapeutics.com.

Use of Forward-Looking StatementsThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. These forward-looking statements are distinguished by use of words such as "will," "would," "anticipate," "expect," "believe," "designed," "plan," or "intend," the negative of these terms, and similar references to future periods. These forward-looking statements include, among others, those related to Dr. Moteshareis leadership and development experience guiding the Company as it advances its preclinical portfolio and discovery and drug development platform and towards clinical trials and beliefs that Dr. Moteshareis ability will help the growth of the Company. These views involve risks and uncertainties that are difficult to predict and, accordingly, our actual results may differ materially from the results discussed in our forward-looking statements. Our forward-looking statements contained herein speak only as of the date of this press release. Factors or events that we cannot predict, including those risk factors contained in our filings with the U.S. Securities and Exchange Commission (the SEC), may cause our actual results to differ from those expressed in forward-looking statements. The Company may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements, and you should not place undue reliance on these forward-looking statements. Because such statements deal with future events and are based on the Company's current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of the Company could differ materially from those described in or implied by the statements in this press release, including: the Company's plans to develop and commercialize its product candidates; the timing of initiation of the Company's planned clinical trials; the risks that prior data will not be replicated in future studies; the timing of any planned investigational new drug application or new drug application; the Company's plans to research, develop and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of the Company's product candidates; the Company's commercialization, marketing and manufacturing capabilities and strategy; global health conditions, including the impact of COVID-19; the Company's ability to protect its intellectual property position; and the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all, as well as those risk factors contained in our filings with the SEC. Except as otherwise required by law, the Company disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.

NeuBase Investor Contact:Dan FerryManaging DirectorLifeSci Advisors, LLCdaniel@lifesciadvisors.com OP: (617) 430-7576

NeuBase Media Contact:Jessica Yingling, Ph.D.Little Dog Communications Inc.(858) 344-8091jessica@litldog.com

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NeuBase Therapeutics Appoints Dr. Kia Motesharei Chief Business and Strategy Officer - GlobeNewswire

University of Cambridge researchers published the first preclinical validation for a novel therapeutic strategy targeting epitranscriptomic modifiers of RNA, opening the door for spinout STORM Therapeutics acute myeloid leukemia therapy (AML)and potentially much more.

Tony Kouzarides, cofounder and director of Milner Therapeutics Institute at Cambridge and a Storm co-founder, led the team that published the paper in Nature in April, which was the first published data showing the efficacy of a catalytic METTL3 inhibitor in mouse models of AML.

Consistent with earlier findings on METTL3s role in regulating disease, Storms STM2457 decreased AML engraftment and increased survival. Last year the company nominated a related compound as its lead clinical candidate, and Kouzarides said Storm expects it will reach clinical testing early next year.

This is the first published in vivo data for a small molecule inhibiting an epitranscriptomic disease target, but the approach has been brewing for years. Just as epigenetic modifications to DNA can directly control gene expression, epitranscriptomic modifications control RNA gene expression indirectly via RNA translation, making them potential therapeutic targets. While the first epigenetic therapy was approved in 2004, the connection between epitranscriptomic modifiers and disease pathways have only begun to be characterized.

METTL3 is an epigenetic writer of N6-methyladenosine (m6A) modifications, the most prevalent reversable epitranscriptomic modification in human cells. METTL3 and other writers form m6A modifications via methylation of certain RNA sequences, which is key for numerous processes in normal cells. This would seem to make it an unlikely therapeutic target.

But in 2017, two key publications began to elucidate the role of m6A in AML and demonstrate the possibility of targeting the pathway without toxicity in healthy cells. Kouzarides and colleagues published findings showing the role of METTL3 in both establishing disease and in leukemia cell differentiation.

Separately, a team from Weill Cornell Medicine and Memorial Sloan Kettering Cancer Center showed in a Nature Medicine paper that leukemia cells were more dependent on METTL3 than normal hematopoietic cells. Samie Jaffrey, an author on the paper and a professor of pharmacology at Weill Cornell, said that the abnormal differentiation seen in leukemia cells was abrogated by only mild inhibition of METTL3important because a complete METTL3 inhibitor delivered systemically would be highly toxic.

The new paper from the Cambridge researchers was therefore a proof-of-concept for Jaffreys approach as well.

I think a lot of other people were cautious because they felt it was a fools errand to go after METTL3, he said. I think this makes the METTL3 target seem much more validated.

Researchers from both groups founded companies to exploit the therapeutic pathway in leukemia. Kouzarides and fellow Cambridge professor Eric Miska co-founded Storm Therapeutics in 2015 to develop first-in-class therapies against RNA epigenetic targets. Jaffrey co-founded Gotham Therapeutics in 2017. Storm has raised 42 million ($59.4 million) seed and Series A rounds, while Gotham raised $54 million in a Series A.

At least one other company appears to be chasing METTL3: Accent Therapeutics, which last year raised a $63 million B round and announced a co-development deal with AstraZeneca utilizing its RNA-modifying protein platform, has presented in vitro data in AML for its inhibitors of METTL3 and METTL14, another m6A writer.

Additional publications have shown more therapeutic possibilities for targeting the m6A pathway, suggesting it may be possible to increase sensitivity to existing therapies in pancreatic and ovarian cancer, for example. m6A methylation has also been linked to a suppressed immune response in infectious diseases like Zika and HIV, and in April a team led by University of California San Diego School of Medicine professor Tariq Rana published in vitro data showing METTL3 inhibition could suppress SARS-CoV-2 replication.

Ranas team has previously shown that the inhibition of ALKBH5, an m6A eraser, can improve the efficacy of cancer immunotherapies in mice, and Rana has spun out ViRx Pharmaceuticals with plans to license intellectual property from the university around RNA therapeutics for broad-spectrum antivirals.

But Storm, Accent and Gotham are starting in AML for a reason. Optimizing compounds for AML is an easier task because unlike other cancers, when you inhibit the METTL3 pathway, you can see the cells differentiating with your eyes, Jaffrey said. In most cancers, you can inhibit METTL3 and they will die but youre inhibiting it to such a degree that probably normal cells will die too. it all comes down to one thing: therapeutic index.

Gotham has identified several solid tumor types with comparable m6A addictions it is looking at closely, he added.

Several other companies are likely targeting different epitranscriptomic targets. Academic work by an Accent scientific cofounder, Chuan He, has focused on YTHDF1, an RNA reader that could function as an immune system control switch for modulating the response to cancer immunotherapy. He is also a chemistry professor at the University of Chicago. Accent is also pursuing ADAR1 inhibitors for cancer.

Silicon Therapeutics, which uses a physics-based approach to drug design for intractable protein targets, is developing an ADAR1 antagonist for cancer. The company said inhibiting ADAR1 can both activate innate antitumor immune cells and directly kill tumors.

Gotham is also looking into additional epitranscriptomic regulators that are much less prevalent than m6A, Jaffrey says, using its screening platform to identify and analyze RNA modifiers.

Kouzarides envisions a lot more opportunities ahead for the burgeoning space. These enzymes can potentially regulate many different processes in many different diseases, he said. He declined to specify which other epitranscriptomic targets Storm is chasing, but the company is currently raising a Series B round to support its anticipated clinical testing for a METTL3 inhibitor in 2022.

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Companies Unlocking a New Class of Cancer Therapies with Sensitive METTL3 Tuning - BioSpace

HILDEN, Germany & GERMANTOWN, Md.--(BUSINESS WIRE)--QIAGEN N.V. (NYSE:QGEN; Frankfurt Prime Standard:QIA) today announced a global collaboration with Mirati Therapeutics Inc. (NASDAQ:MRTX) to continue developing a tissue-based KRAS companion diagnostic to identify patients with cancers that have a KRASG12C mutation who may benefit from treatment with adagrasib, Miratis investigational, highly selective and potent oral small molecule inhibitor of KRASG12C.

The agreement initially focuses on a companion diagnostic test for non-small cell lung cancer (NSCLC), and allows for further development of tests for other Mirati oncology programs.

The planned companion diagnostic would expand upon QIAGENs therascreen KRAS testing portfolio based on real-time qualitative PCR for the QIAGEN Rotor-Gene Q MDx instrument, a member of the modular QIAsymphony family of automation solutions, and builds upon the Companys nearly decade of experience in KRAS companion diagnostic test development and commercialization. QIAGEN and Mirati have previously partnered for the development of a companion diagnostic.

We are pleased Mirati recognizes the success of QIAGENs therascreen platform and continues to partner with us to develop a tissue-based companion diagnostic to identify patients who may benefit from adagrasib. QIAGENs experience and expertise in developing diagnostic solutions for Precision Medicine are well-suited to evaluate patients with non-small cell lung cancer, said Jean-Pascal Viola, Senior Vice President and Head of QIAGENs Molecular Diagnostics Business Area. Our collaboration with Mirati is a demonstration of QIAGENs capabilities as a preferred partner of pharmaceutical and biotech companies for the creation of companion diagnostics.

The therascreen-based companion diagnostic detects KRASG12C, a genetic mutation that is one of the most common KRAS alterations linked to cancer. The RAS gene family is the most frequently mutated oncogene in human cancer, with KRAS being the most prevalent driver mutation in NSCLC.

QIAGEN is a pioneer in Precision Medicine and the global leader in collaborations with pharmaceutical and biotechnology companies to co-develop companion diagnostics, which detect clinically relevant genetic abnormalities to provide insights that guide clinical decision-making in diseases such as cancer. QIAGEN has an unmatched depth and breadth of technologies from next-generation sequencing (NGS) to polymerase chain reaction (PCR) for companion diagnostic development. QIAGEN has nine PCR based companion diagnostics that are FDA approved, including therascreen EGFR for non-small cell lung cancer, therascreen KRAS for colorectal cancer, therascreen FGFR for urothelial cancer, therascreen PIK3CA for breast cancer based on tissue or plasma samples and the therascreen BRAF kit for colorectal cancer.

Currently, QIAGEN is working under master collaboration agreements with more than 25 companies to develop and commercialize companion diagnostic tests for their drug candidates a deep pipeline of potential future products to advance Precision Medicine for the benefit of patients. QIAGEN is partnering with Illumina to broaden the availability and use of NGS-based in-vitro diagnostic (IVD) kits, including companion diagnostics, for patient management.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare), Applied Testing (primarily forensics), Pharma (pharma and biotech companies) and Academia (life sciences research). As of March 31, 2020, QIAGEN employed approximately 5,700 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

Forward-Looking Statement

Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).

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QIAGEN Partners With Mirati Therapeutics Inc. to Develop KRASG12C Companion Diagnostic for Non-Small Cell Lung Cancer (NSCLC) - Business Wire