Monthly Archives

December 2020

Virginia Bio Will Direct New “Virginia Bio-Connect” Statewide Consortium to Strengthen Competitiveness of Virginia’s Life Science Ecosystem

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RICHMOND, Va.–(BUSINESS WIRE)–Governor Northam and the Virginia Biotechnology Association announced today that GO Virginia has approved a competitive grant request to help fund Virginia Bio-Connect, a $3.2 million Statewide industry cluster scale up initiative. The project, directed by the Virginia Biotechnology Association, is a multi-regional collaboration designed to increase connectivity and awareness of the existing programs, resources, and communities in the Commonwealth that support the life sciences industry.

Virginia Bio-Connect will be a central hub for the life science community to find relevant resources across the state, including commercialization and entrepreneurship programs, funding mechanisms, accelerators, job boards, internship programs, and core research equipment facilities. The program will provide the pathway for businesses to find the support, expertise, and workforce needed to grow and prosper in the Commonwealth of Virginia.

This effort leverages CvilleBioHub’s regional ecosystem building experience, funded in part by GO Virginia, to inform the further development of four additional BioHubs in Richmond, Northern Virginia, Coastal Virginia, and the Roanoke/Blacksburg/Lynchburg regions. Co-directors who have expertise in economic development, commercialization, life sciences, and workforce development will lead the BioHubs. Each brings deep life science networks to foster new connections.

John Newby, Virginia Bio’s Chief Executive Officer and the designated lead of the new consortium, explained that the biotechnology industry, beyond its work to stimulate innovation and improve health, has an $8 billion economic impact in Virginia. “We have assembled an extraordinary team who are all passionate about working collaboratively, and Virginia’s life science economy stands to grow greatly under this grant.”

CvilleBioHub Executive Director Nikki Hastings said, “CvilleBioHub, a private industry-led non-profit in Charlottesville, has established and demonstrated success for regional biotech industry cluster development. We are excited to expand this concept across Virginia, strengthening the overall network and impact for the state’s bioeconomy.”

The five regional BioHubs and co-leading entities are:

  • Charlottesville/Albemarle: CvilleBioHub and University of Virginia Licensing and Ventures Group
  • Coastal Virginia: City of Virginia Beach Economic Development and Eastern Virginia Medical School
  • Northern Virginia: Prince William County Department of Economic Development and George Mason University
  • Richmond: Activation Capital and VCU Innovation Gateway
  • Roanoke/Blacksburg/Lynchburg: Virginia Tech Fralin Biomedical Research Institute and Carilion Clinic

“This a big win for Virginia’s Life Science community and the larger Biohealth Capital Region, consisting of life science leaders in Virginia and neighboring Maryland and the District of Columbia,” said Alan Connor, CEO of Cadence, Inc. and Chairman of the Virginia Bio Board of Directors. “The $3.2 million two-year program is the Commonwealth’s largest single investment to strengthen Virginia’s statewide biotechnology industry cluster. The need for this support is evidenced by the broad coalition represented above, and the direct financial support of participating localities and industry leaders Pfizer, BIO and PhRMA.”

Wilson Flohr, CEO of GROW Capital Jobs Foundation Region Four, the local GO Virginia region noted, “The Virginia Bio-Connect project supports the priorities and goals of the GO Virginia program by providing significant economic impact and high paying job opportunities vital to the growth and diversification of the Commonwealth of Virginia’s economic development strategies. This is a significant statewide effort, and we applaud the leadership of the GO Virginia Region Four Council, as well as the four other councils collaborating in support of this project.”

During the two year grant period, Virginia Bio-Connect will create a workforce development program to connect graduate and undergraduate students in the Commonwealth with Virginia-based life science and biotechnology companies. This will include the coordination of an industry-specific internship program that will enroll 100 students from our community colleges and universities across the state.

Amy Adams, Executive Director of the Institute for Biohealth Innovation at George Mason University shared, “Students located across the Commonwealth will have the unique opportunity to be part of a statewide cohort and develop meaningful connections with Virginia’s life science industry professionals. It’s a win-win for both our students who will gain practical skills, making them more competitive in the job market and for companies who seek a talented, diverse workforce pipeline.”

The program will also launch a Virtual Entrepreneur-in-Residence Network (VERN). Four new entrepreneurs in residence will be hired embodying industry-specific expertise and relevant professional networks necessary to support the advancement of established early-to seed-stage companies.

Deborah Roder, Business Development Manager, Science, Prince William County added, “Virginia Bio-Connect provides the resources life science startups need to navigate the industry specific complex regulatory systems, find their highly skilled workforce, and locate the existing entrepreneur support systems already in place throughout the Commonwealth.”

Virginia Bio-Connect is projected to foster the creation of 15 new life science companies, 254 new jobs, and provide a greater than $25 million boost to the economy.

Major corporate activities are positioning Virginia to be a biotechnology leader, such as Phlow Corporation with its recent $354 million BARDA grant. ATCC, Vibrent Health, kaléo, Embody, ReAlta Life Sciences, Landos, MicroGEM, HemoShear Therapeutics, GPB Scientific are just a few of the life science companies across the Commonwealth also experiencing recent big wins.

About Virginia Biotechnology Association
Established in 1992, Virginia Bio’s mission is to promote innovation and growth through strengthened networks; advocacy; capital investment; talent attraction, development and retention; and advancing the next generation of leaders. For more information, please visit www.vabio.org.

About GO Virginia
GO Virginia is a state funded initiative administered by the Virginia Department of Housing and Community Development (DHCD) that strengthens and diversifies Virginia’s economy and fosters the creation of higher wage jobs in strategic industries. For more information, please visit www.govirginia.org.

Contacts

Caron Trumbo
Vice President of Operation, Virginia Bio
804-643-6360
trumbo.caron@vabio.org

WaPo: D.C. region leaders pitch plan to build stronger post-pandemic economy

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More than 50 local leaders have mapped out an economic recovery strategy for the Washington area that they say would leave it more unified, resilient and prosperous than before the novel coronavirus upended the region.

Connected DMV — a group representing the local academic, nonprofit, public and private sectors — initially came together in March 2019 to drive economic growth in the D.C. area. When the pandemic struck a year later, the group pivoted to creating what it calls a “strategic renewal” task force, which issued a report this month with 12 initiatives to remedy the region’s social and economic challenges.

They range from a coordinated regional contact-tracing system to the creation of a pandemic biodefense facility. One effort calls for an economic development plan that permeates the jurisdictional barriers that have previously caused Maryland, Virginia and the District to operate in silos.

Click here to read more via the Washington Post.

Dr. James Crowe, Director, Vanderbilt Vaccine Center, Guests on BioTalk

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BioTalk Media Award-Winning Podcast BioTalk Welcomes Dr. James Crowe, Director, Vanderbilt Vaccine Center, Professor, Pediatrics and Pathology, Microbiology and Immunology, Ann Scott Carell Chair and Founder of ID Biologics.

Listen now on Apple http://apple.co/34u0kz6, Google http://bit.ly/38jfE2I, Spotify http://spoti.fi/3pddVme, and TuneIn http://bit.ly/37D2M8z.

His laboratory has a broad portfolio of work in the area of viral immunology and antibody sciences, with the goal to discover mechanisms of immunity important to developing new therapeutics and vaccines.

Dr. Crowe received his MD degree from the University of North Carolina at Chapel Hill, where he also completed his pediatrics residency. Following his clinical training, Dr. Crowe received five years of post-doctoral training in the laboratory of Infectious Diseases at the NIH. He completed infectious diseases fellowship training in 1996 at Vanderbilt and has run an independent laboratory at Vanderbilt since that time. He is currently Professor of Pediatrics and of Pathology, Microbiology and Immunology, and the Ann Scott Carell Chair, Vanderbilt University Medical Center.

The laboratory’s work has been published in over 300 publications in high-quality science journals including Cell, Science and Nature and leading medical journals including the New England Journal of Medicine and JAMA.

Dr. Crowe was elected to the National Academy of Medicine in 2014 and National Academy of Inventors in 2017. He has been the recipient of investigator awards from the March of Dimes, American Society for Microbiology, Pediatric Infectious Diseases Society, and Society for Pediatric Research. He was awarded the Judson Infectious Daland Prize of the American Philosophical Society, the Oswald Avery Award of the IDSA, the E. Mead Johnson Award for Excellence in Pediatrics, the Outstanding Investigator Award of the American Federation for Medical Research, the Norman J. Siegel Award of the American Pediatric Society, the Samuel Rosenthal Prize for Excellence in Academic Pediatrics, the Stanley J. Korsmeyer Award of American Society for Clinical Investigation, the Distinguished Medical Alumnus Award from UNC School of Medicine, Chapel Hill, NC. He is an elected Fellow of AAM, AAAS, ASCI and AAP, IDSA, APS, and others. His research team was selected as Best Academic Research Team at the 11th Annual Vaccine Industry Excellence Awards. He was awarded the inaugural 2019 Merck Future Insight Prize, a 1M Euro prize shared with Pardis Sabeti.

He is the Founder of IDBiologics, Inc., an early stage biotech company developing human monoclonal antibodies for infectious diseases.

Click her to read the transcript.

Noble Life Sciences announces its collaboration with George Mason University to access the National Center for Biodefense and Infectious Diseases BSL-3 facility

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Sykesville, MD, and Fairfax, VA, December 21, 2020 – Noble Life Sciences (NLS), a preclinical contract research organization located in Sykesville, MD, has signed a Collaboration Agreement with George Mason University (Mason) to access the National Center for Biodefense and Infectious Diseases (NCBID) BSL-3 facility located within their Biomedical Research Laboratory at Mason’s Science and Technology Campus in Manassas. The Agreement enables NLS to perform federal and non-federally funded BSL-3 animal model projects to support the development of new antiviral and antibacterial agents against infectious and resistant pathogens.

Additionally, NLS and Mason have agreed to explore collaborative research opportunities in the following areas

  • Development of animal models for viral diseases.
  • Development of animal tissue-based and cell culture-based assay methodologies for the assessment of the efficacy of vaccines and therapeutics for viral agents.
  • Assay and reagent development for quantification of viral RNA and/or protein.

“Access to the BSL-3 facility through this collaboration agreement with Mason will enable NLS to provide preclinical testing services in support of an immediate need for the development of coronavirus vaccines and therapeutics as well as other emerging infectious diseases,” said Srujana Cherukuri, Chief Executive Officer at NLS

The collaboration with Noble Life Sciences opens doors to new opportunities for the development of novel therapeutics and diagnostics by Mason scientists and enables us to partner with an entity that has extensive experience bringing such new discoveries to the marketplace,” said Ali Andalibi, Chief Scientific Officer of the BRL and Senior Associate Dean in Mason’s College of Science

About Noble Life Sciences: NLS is a preclinical contract research organization (CRO) owned and operated by scientists with decades of experience in drug, vaccine, and medical device development. The company provides integrated GLP and non-GLP preclinical services designed to accelerate development of vaccines and therapeutics in the areas of cancer and infectious diseases.  NLS offers services in pharmacology, disease models, early safety assessments, toxicology, PCR, Flow Cytometry, in vivo imaging, and cell-based assays. Learn more at www.noblelifesci.com

About George Mason University: Mason is an educational institution and agency of the Commonwealth of Virginia. Mason’s Biomedical Research Laboratory’s state-of-the-art biocontainment laboratory leverages the tools of molecular biology proteomics and nanotechnology for the development of diagnostics, therapeutics, and vaccines for emerging and potential biothreat agents. The facility is fully approved and licensed for work by the Center for Disease Control and Prevention (CDC), the U.S. Department of Agriculture (USDA), and fully accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC). Learn more at ncbid.gmu.edu

BRAINBox Solutions Announces Enrollment Begins in Pivotal, HeadSMART II Clinical Study of BRAINBox TBI Concussion Diagnostic and Prognostic Test

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RICHMOND, Va.Dec. 16, 2020 /PRNewswire/ — BRAINBox Solutions today announced it is beginning enrollment in its pivotal clinical trial, HeadSMART II (Head injury Serum markers and Multi-modalities for Assessing Response to Trauma), of the company’s concussion diagnostic and prognostic test, BRAINBox TBI. The multi-national, multi-site trial, which will enroll up to 2,000 patients, aims to generate data to support an application for regulatory clearance by the U.S. FDA.

The BRAINBox TBI (Traumatic Brain Injury) test will be the first objective test designed to assist in the diagnosis of concussion and provide an assessment of the risk of chronic injury. The FDA has granted the test Breakthrough Device designation.

“We do not have a validated objective method to determine an early TBI diagnosis. While a head CT identifies anatomic abnormality, it does not predict post-concussive symptoms or disability at the time when interventions change outcomes. We need an early objective test,” said W. Franklin Peacock MD FACEP, the Principal Investigator of the study. Dr. Peacock is Professor of Emergency Medicine and Vice Chair for Research in the Department of Emergency Medicine at Baylor College of Medicine.

“The start of the HeadSMART II study is a key step in our program to bring this urgently needed capability to the emergency medicine community,” said Donna Edmonds, CEO of BRAINBox Solutions. She noted the company’s Series A financing is supporting the study.

The BRAINBox TBI test will include a panel of blood biomarkers, and a battery of  neurocognitive tests combined in an easy to use application, using proprietary AI algorithms to generate an objective score for diagnosis up to 96 hours from the time of injury and a prognosis report for likely injury related symptoms up to three months after the event. The test can be used either at point of care or in clinical settings.

The study plans to enroll up to 2,000 patients from more than 18 sites across the US, and eventually the United Kingdom and New Zealand. The sites include Level I Trauma Centers, Emergency Departments and Urgent Care settings in systems and community-based hospitals. The range of sites is aimed at ensuring representation of real-world practice.

The first patients are being enrolled at several sites which have been intimately involved in the study’s protocol design and development. They include:  John Peter Smith Hospital under the clinical leadership of James d’Etienne, MD, FACEP, MBA and Integrated Emergency Services group in Dallas; Stony Brook Hospital (State University of New York) under the leadership of Adam Singer, MD; Carilion Clinic in Virginia under the leadership of Vice Chair of Emergency Medicine Damon Kuehl, MD; Baylor School of Medicine in Houston under the leadership of Zubaid Rafique, MD, and University of Pennsylvania in Philadelphia under the leadership of Danielle Sandsmark, MD, PhD.

The data collected from the HeadSMART II study will be used to analyze the BRAINBox TBI test’s sensitivity and specificity of concussion diagnosis compared to expert clinical diagnosis, and the sensitivity and specificity of the risk for chronic symptoms as compared to the post-concussion symptoms at predefined time points.

Additional information on the clinical trial can be found at here at clinicaltrials.gov.

About BRAINBox Solutions
BRAINBox Solutions is developing the first AI–enabled, multi–modality approach for the diagnosis and prognosis of Mild Traumatic Brain Injury, commonly referred to as a concussion. The company seeks to establish a clinical best–practice standard for the diagnosis and prognosis of concussion. The product incorporates a panel of proprietary, patented blood biomarkers that can be read in a few moments on a point–of–care instrument or using standard laboratory systems, as well as neurocognitive testing, to provide a single–system score that measures the severity of the injury and post-concussive symptoms. The company is led by key physician and scientific thought leaders in the field and an experienced, clinically focused management team. Learn more at: www.brainboxinc.com

For more information, contact:
Donna Edmonds
CEO
1–804–724–0009

SOURCE BRAINBox Solutions, Inc.

Meet Your 2020 BioBuzz Award Winners

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oday, we are excited to announce the winners of our inaugural BioBuzz Awards. The BioBuzz Awards are a celebration of the exciting and groundbreaking work being done by the BioHealth Capital Region (BHCR) life science community and the individuals that make innovation happen across Maryland, Virginia, and Washington, D.C.

The award categories include:

  • The Community Impact Leader Award
  • The John Holaday BioHealth Leadership Award
  • The BioBuzz Media Award
  • Workforce Program of the Year
  • The COVID-19 Impact Award
  • Breakthrough Company of the Year
  • Life Science Employer of the Year

Nearly 2,000 of you voted to determine the winners of this first annual awards program and it was amazing to see the outpouring of support for the finalists across social media. Your engagement in the awards not only gave recognition to these great companies and people, but it raised the visibility for the Biohealth Capital Region as a whole, showing just how strong this biotech community is.

Congrats to all our winners this year, as well as those that were finalists and nominees. We look forward to the 2021 BioBuzz Awards and are excited to see what’s on the horizon for the BHCR.

Without further adieu, the first annual BioBuzz Award winners are…

Click here to view the winners via BioBuzz.

Qiagen will expand its Germantown manufacturing facility, pursue new space as it ramps up Covid testing

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Qiagen NV, a Dutch molecular diagnostics company, is expanding its Germantown headquarters and launching plans to grow elsewhere around the area.

The company announced Friday it’s renovating its 146,000-square-foot manufacturing facility in the Maryland suburb in order to expand the production of tests for Covid-19 and other diseases. Qiagen’s already added 80 employees and spent $7 million on the renovation and new equipment, according to a release.

Qiagen also plans to lease “additional space in the area” as it adds to its existing local workforce of more than 300 employees. The company did not specify how much new space it’s seeking, or where it’s looking.

Click here to read more.

BRAINBox Solutions Announces First Close in $23 Million in Series A Financing to Support Development and Pivotal Clinical Trial of ‘Breakthrough’ Concussion Diagnostic/Prognostic Test

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RICHMOND, Va.Dec. 8, 2020 /PRNewswire/ — BRAINBox Solutions today announced the initial closing on a $23 million Series A financing to support the clinical development of the company’s BRAINBox TBI (Traumatic Brain Injury) Test to aid both in the diagnosis and prognosis of mild TBI (concussion). BioVentures Investors led the financing round and was joined by the Tauber Foundation, the Virginia Tech Carilion Innovation and Seed Funds, Genoa VC, Pharmakon Holdings LLC, Astia Angels and additional qualified investors, including Kevin Love, professional basketball player and mental health advocate.

“The BRAINBox TBI test has enormous potential to significantly improve patient care as an aid to objectively diagnosing and managing the treatment of concussion patients,” said Marc Goldberg, BioVentures Investors Co-Founder and Managing Partner. “The company has made great progress, particularly in this challenging COVID-19 environment, in advancing the development of the BRAINBox TBI testing system, including laying the groundwork for the pivotal, HeadSMART II clinical trial and securing ‘Breakthrough Designation’ from the FDA.” He noted there are more than five million patients evaluated in emergency rooms annually for mild TBI as well as additional patients in urgent care settings.

Bob Sledd, a BRAINBox Director and immediate past chairman of the board of Owens & Minor, added, “With this funding, the company is well positioned to take the key future steps necessary for a FDA regulatory filing for product approval and commercialization.”

BRAINBox TBI is the first test designed to assist in both the diagnosis and prognosis of concussion. The multi-marker and multi-modality test, which can be used in either point of care or clinical laboratory settings, includes a panel of blood biomarkers as well as advanced digital neurocognitive testing in partnership with BrainCheck, Inc. Using proprietary AI algorithms, BRAINBox TBI combines the results of the test components and patient reported outcomes to generate a single, objective score for diagnosis up to 96 hours from the time of injury and a prognosis report for likely injury-related symptoms up to three months post-event.

FDA granted BRAINBox TBI Breakthrough Device designation in June 2019. The program is designed to accelerate the development, assessment and review of products with potential to provide more effective diagnosis or treatment of life–threatening or irreversibly debilitating conditions.

“With funding from the Series A we are well positioned to conduct the HeadSMART II study, and pending its successful completion, file for U.S. FDA approval,” said Donna Edmonds, BRAINBox’s CEO. “Support from this investor group is a strong vote of confidence in our strategy and our vision for changing the paradigm and setting the Standard of Care for Diagnosis and Prognosis with BRAINBox TBI.” She added that the HeadSMART II trial is expected to begin enrolling patients in the very near future.

Along with the financing, the company announced two key appointments to its Board of Directors and Scientific Advisory Board. Joining the Board of Directors is Scott Gazelle, MD, PhD, FACR, Professor of Radiology at Harvard Medical School and Vice Chair of the MGH Department of Radiology. Damon Kuehl, MD, FACP, Vice Chair of Emergency Medicine, Associate Professor of Emergency Medicine at Virginia Tech’s Carillon School of Medicine, and Director of the School’s Emergency Medicine Residency Program has been appointed to the company’s Scientific Advisory Board and its Sports Advisory Board.

“We are fortunate these two opinion leaders have agreed to help guide our efforts to develop BRAINBox TBI, which has great potential to become the gold standard in concussion diagnosis and prognosis,” said Ms. Edmonds. “Dr. Gazelle is a physician-scientist and academic entrepreneur who has been involved in the development, commercialization and assessment of new medical technologies for more than 25 years. Dr. Kuehl brings extensive clinical expertise in TBI, along with commitments to improving diagnosis and treatment, and youth sports.”

About BRAINBox Solutions
BRAINBox Solutions is developing the first AI–enabled, multi–modality approach for the diagnosis and prognosis of Mild Traumatic Brain Injury, commonly referred to as a concussion. The company seeks to establish a clinical best–practice standard for the diagnosis and prognosis of concussion. The product incorporates a panel of proprietary, patented blood biomarkers that can be read in a few moments on a point–of–care instrument or using standard laboratory systems, as well as neurocognitive testing, to provide a single–system score that measures the severity of the injury and guide treatment. The company is led by key physician and scientific thought leaders in the field and an experienced, clinically focused management team.

For more information, contact:
Donna Edmonds, CEO
1-804-724-0009

Connected DMV President & CEO Stu Solomon joins Rich Bendis on BioTalk

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Stu Solomon, President & CEO, Connected DMV joins BioTalk to discuss formation of the Strategic Renewal Task Force, their Covid-19 Pandemic Pivot, the Global Pandemic Prevention and Bioterrorism Center, and much more.

Listen now on Apple https://apple.co/3gqmJlB, Google https://bit.ly/3mVtled, Spotify https://spoti.fi/3mO0j05, and TuneIn https://bit.ly/37FMf2t.

Click here to read the transcript.

MacroGenics Announces Achievement of $25 Million in Milestones Related to Retifanlimab Collaboration with Incyte

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MacroGenics, Inc.,  (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that $25 million in milestones have been achieved under its exclusive global collaboration and license agreement with Incyte for retifanlimab, an investigational anti-PD-1 monoclonal antibody designed by MacroGenics and licensed to Incyte (as INCMGA0012). The milestones were triggered by clinical and regulatory activities related to the further advancement of the molecule, including the recent initiation of POD1UM-303, Incyte’s Phase 3 global study in patients with metastatic squamous cell anal carcinoma (SCAC).

MacroGenics and Incyte have each established multiple development programs for retifanlimab, evaluating the anti-PD-1 molecule either as monotherapy or in combination with other agents. Incyte is conducting clinical trials that are potentially registration-enabling for patients with metastatic non-small cell lung cancer, SCAC, microsatellite instability high endometrial cancer and Merkel cell carcinoma. MacroGenics is conducting a potentially registration-enabling study of retifanlimab in combination with margetuximab, an investigational Fc-engineered, anti-HER2 mAb, in HER2-positive gastric cancer.

“We are excited to see the continued advancement of the development of retifanlimab across a broad set of monotherapy and combination regimens,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “We look forward to continued progress on this program over the coming months.”

Under the collaboration agreement with Incyte, MacroGenics is eligible to receive up to a total of $365 million in potential remaining development and regulatory milestones and up to $330 million in potential commercial milestones. If retifanlimab is approved and commercialized, MacroGenics would be eligible to receive royalties, tiered from 15 to 24 percent, on future worldwide net sales of the molecule.

About MacroGenics, Inc.

MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. For more information, please see the Company’s website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

Cautionary Note on Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development of the Company’s therapeutic candidates, milestone or opt-in payments from the Company’s collaborators, the Company’s anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words “subject to”, “believe”, “anticipate”, “plan”, “expect”, “intend”, “estimate”, “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company’s product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19), and other risks described in the Company’s filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.

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