Source: ir.altimmune.com

WASHINGTON – Children’s National Hospital in Washington, D.C., was ranked No. 7 nationally in the U.S. News & World Report 2020-21 Best Children’s Hospitals annual rankings. This marks the fourth straight year Children’s National has made the list, which ranks the top 10 children’s hospitals nationwide. In addition, its neonatology program, which provides newborn intensive care, ranked No.1 among all children’s hospitals for the fourth year in a row.

For the tenth straight year, Children’s National also ranked in all 10 specialty services, with seven specialties ranked in the top 10.

“Our number one goal is to provide the best care possible to children. Being recognized by U.S. News as one of the best hospitals reflects the strength that comes from putting children and their families first, and we are truly honored,” says Kurt Newman, M.D., president and CEO of Children’s National.

“This year, the news is especially meaningful, because our teams — like those at hospitals across the country — faced enormous challenges and worked heroically through a global pandemic to deliver excellent care.”

“Even in the midst of a pandemic, children have healthcare needs ranging from routine vaccinations to life-saving surgery and chemotherapy,” said Ben Harder, managing editor and chief of Health Analysis at U.S. News. “The Best Children’s Hospitals rankings are designed to help parents find quality medical care for a sick child and inform families’ conversations with pediatricians.”

The annual rankings are the most comprehensive source of quality-related information on U.S. pediatric hospitals. The rankings recognize the nation’s top 50 pediatric hospitals based on a scoring system developed by U.S. News. The top 10 scorers are awarded a distinction called the Honor Roll.

The bulk of the score for each specialty service is based on quality and outcomes data. The process includes a survey of relevant specialists across the country, who are asked to list hospitals they believe provide the best care for patients with the most complex conditions.

Below are links to the seven Children’s National specialty services that U.S. News ranked in the top 10 nationally:

• Neonatology (No. 1), led by Division Chief Billie Lou Short, M.D.
• Neurology and Neurosurgery (No. 3), led by Division Chiefs William D. Gaillard, M.D., and Robert F. Keating, M.D.
• Cancer (No. 6), led by Division Chief Jeffrey S. Dome, M.D., Ph.D.
• Orthopedics (No. 9), led by Division Chief Matthew Oetgen, M.D., M.B.A.
• Pulmonology and Lung Surgery (No.9), led by Division Chief Anastassios Koumbourlis, M.D., M.P.H.

The other three specialties ranked among the top 50 were cardiology and heart surgery, gastroenterology and gastro-intestinal surgery, and urology.

Media contact: Media@childrensnational.org | 202-476-4500

About U.S. News & World Report

U.S. News & World Report is a digital news and information company that empowers people to make better, more informed decisions about important issues affecting their lives. Focusing on Education, Health, Money, Travel, Cars and News, USNews.com provides consumer advice, rankings and analysis to serve people making complex decisions throughout all stages of life. More than 40 million people visit USNews.com each month for research and guidance. Founded in 1933, U.S. News is headquartered in Washington, D.C.

About Children’s National Hospital

Children’s National Hospital, based in Washington, D.C., celebrates 150 years of pediatric care, research and commitment to community. Volunteers opened the hospital in 1870 with 12 beds for children displaced after the Civil War. Today, 150 years stronger, it is among the nation’s top 10 children’s hospitals. It is ranked No. 1 for newborn care for the fourth straight year and ranked in all specialties evaluated by U.S. News & World Report. Children’s National is transforming pediatric medicine for all children. In 2020, construction will be complete on the Children’s National Research and Innovation Campus, the first in the nation dedicated to pediatric research. Children’s National has been designated twice as a Magnet® hospital, demonstrating the highest standards of nursing and patient care delivery. This pediatric academic health system offers expert care through a convenient, community-based primary care network and specialty outpatient centers in the D.C., metropolitan area, including the Maryland and Northern Virginia suburbs. Children’s National is home to the Children’s National Research Institute and Sheikh Zayed Institute for Pediatric Surgical Innovation and is the nation’s seventh-highest NIH-funded children’s hospital. It is recognized for its expertise and innovation in pediatric care and as a strong voice for children through advocacy at the local, regional and national levels.

For more information, follow us on Facebook, Instagram and Twitter.

“David’s extensive experience building, leading and financing biopharmaceutical companies will add significant value to Novavax’ board, especially now as we laser-focus on contributing to some of the world’s most daunting healthcare challenges,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We welcome his insights and guidance as we continue rapid clinical development of NVX-CoV2373, our COVID-19 vaccine candidate, prepare for NanoFlu™ regulatory submission, and explore paths forward for ResVax™ against RSV+ (respiratory syncytial virus).”

“I am delighted to join the Board of Directors of Novavax and look forward to working with my fellow Board members to help advance the company’s critical mission to prevent serious infectious disease, which is more important today than ever,” said Mr. Mott. “I look forward to supporting the Novavax team as it continues clinical development of its vaccine candidates and prepares for potential commercialization.”

Mr. Mott is currently a private investor through Mott Family Capital. Mr. Mott has recently acquired nearly 65,000 shares of Novavax common stock prior to his appointment. He serves as Chairman of the Board for Adaptimmune, Ardelyx, Epizyme, Imara and Mersana. From 2008 to 2020, Mr. Mott was general partner at NEA, one of the world’s largest venture capital firms, which invests in companies across all stages in healthcare and technology. He led the NEA healthcare investing practice, with a primary focus on biopharmaceuticals. Mr. Mott served as President and Chief Executive Officer, Vice Chairman of MedImmune from 2000 through 2008, during which he led the sale of the company to AstraZeneca in June 2007 for $15.6 billion. He joined MedImmune in 1992 and served in various senior roles during his tenure, including Chief Operating Officer and Chief Financial Officer. Earlier in his career he was a Vice President in healthcare investment banking at Smith Barney, Harris Upham & Co., Inc. During the course of his career, Mr. Mott has been involved in over $40 billion in corporate acquisitions, fundraising, partnerships and other capital formation. He has been involved in more than 35 initial public offerings or corporate acquisitions, in bringing over a dozen new drugs through development to commercialization and has served on 25 corporate boards. Mr. Mott holds a Bachelor of Arts degree from Dartmouth College.

Mr. Mott will serve on the Compensation Committee of Novavax’ Board.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical trial results expected in July of 2020. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

Forward-Looking Statements

Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products, including statements regarding the manufacturing of vaccine antigen dose amounts and timing, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading “Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (SEC) and updated by any Quarterly Report on Form 10-Q, particularly the risks inherent to developing novel vaccines. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:

Investors
Novavax, Inc.
Silvia Taylor and Erika Trahan
ir@novavax.com240-268-2022

Media
Brandzone/KOGS Communication
Edna Kaplan
kaplan@kogspr.com
617-974-8659

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 the appointment of Stephen Eck, M.D., Ph.D. as Senior Vice President, Clinical Development & Chief Medical Officer, effective beginning July 1, 2020.

“We are excited to announce the addition of Stephen Eck to the MacroGenics leadership team. Stephen is a hematologist/oncologist who brings to MacroGenics more than 20 years of broad pharmaceutical and biotech industry experience with proven leadership in the development and commercialization of oncology therapeutics,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “Stephen will be a tremendous asset to our company.”

Dr. Eck most recently served as chief medical officer of Immatics US, a company focused on TCR-based immunotherapies, and as president and chief executive officer of Aravive Biologics. Prior to these roles, Dr. Eck was Vice President and Global Head of Oncology Medical Sciences at Astellas Pharma, managing a portfolio of assets which included enzalutamide (Xtandi®), erlotinib (Tarceva®) and gilteritinib (Xospata®). Dr. Eck has also held leadership positions in drug development as Vice President of Translational Medicine and Pharmacogenomics at Eli Lilly and as Head of Clinical Oncology at Pfizer. He began his professional career at Monsanto in cancer target discovery and later joined the University of Pennsylvania, where he was the Anne B. Young Assistant Professor of Cancer Research and the Director of the Cancer Gene Therapy Program. Dr. Eck currently serves as a director for Luminex Corporation and Circulogene, and on the boards of directors for the Personalized Medicine Coalition and the Central Pennsylvania Clinic. He is also a fellow of the American Association for the Advancement of Science.

Dr. Eck holds a B.A. from Kalamazoo College, an M.S. and a Ph.D. from Harvard University, and an M.D. from the University of Mississippi School of Medicine with Residency and Fellowship training at the University of Michigan.

“MacroGenics has a rich pipeline of immuno-oncology programs,” said Dr. Eck. “I look forward to working together with the MacroGenics team to advance these promising programs and bring new treatment options to patients.”

Ezio Bonvini, M.D., Senior Vice President, Research and Chief Scientific Officer, who was overseeing MacroGenics’ clinical development and related functions on an interim basis will return to serving as the Company’s Chief Scientific Officer.

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. The combination of MacroGenics’ technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company’s website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART 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.

Attachment

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms and Ichor Medical Systems (“Ichor”), a privately held biotech company based in San Diego, CA, announced today that the companies have entered into a license agreement to support the development of ITI’s investigational plasmid DNA vaccine therapy, ITI-1001.

ITI will leverage Ichor’s TriGrid® Electroporation technology to increase cellular uptake of ITI-1001 when administered to patients with newly diagnosed Glioblastoma, or GBM. DNA vaccines delivered by conventional injection have experienced challenges to delivery efficiency, resulting in suboptimal immune responses in clinical trials. Ichor’s TriGrid technology utilizes the application of electrical fields in a target tissue to increase intracellular nucleic acid uptake in the local area, resulting in enhanced gene expression.

“We are excited to partner with Ichor on our ITI-1001 program. Their TriGrid® technology is a great match for our nucleic acid approach. By combining our technologies, we aim to enhance immune responses to the viral antigens of Cytomegalovirus (CMV) expressed in GBM patients, and potentially achieve immune responses that target CMV-expressing GBM tumor tissue in the brain in our upcoming Phase I study with ITI-1001,” said Dr. William Hearl, CEO of Immunomic Therapeutics. “We are pleased to collaborate with a recognized leader in the delivery of nucleic acid-based medicines and we look forward to initiating patient dosing in 2021.”

ITI-1001, which leverages ITI’s proprietary and investigational UNITE platform to treat patients with newly diagnosed GBM, is designed to target the pp65, IE-1, and gB viral antigens of CMV, expressed in GBM, but not in normal brain cells. In March 2020, ITI announced that it had completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding its First-In-Human (FIH) Phase I trial and development plans for ITI-1001. The FDA addressed the Company’s questions and provided feedback on key components of the planned IND application for the candidate, ITI-1001, for the treatment of newly diagnosed Glioblastoma Multiforme (GBM).

In the planned First-In-Human Phase I trial, ITI will evaluate the safety, tolerability, immunogenicity and preliminary efficacy of ITI-1001 in patients with newly-diagnosed GBM having unmethylated MGMT promoter mutations. The Phase I trial is anticipated to start in 2021.

“DNA vaccines are a promising platform for both therapeutic and prophylactic applications. Randomized, placebo-controlled trials have demonstrated that the TriGrid improves the potency of DNA vaccines compared to conventional injection,” said Ichor CEO Bob Bernard. “We are eager to deploy our TriGrid technology with ITI’s UNITE-based GBM DNA vaccine to target an aggressive cancer for which novel therapies are desperately needed.”

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein, an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

About Immunomic Therapeutics, Inc.

Immunomic Therapeutics, Inc. (ITI) is a privately-held, clinical stage biotechnology company pioneering the development of vaccines through its proprietary technology platform, UNiversal Intracellular Targeted Expression (UNITE), which is designed to utilize the body’s natural biochemistry to develop vaccines that generate broad immune responses. UNITE has a robust history of applications in various therapeutic areas, including infectious diseases, oncology, allergy and autoimmune diseases. ITI is primarily focused on applying the UNITE platform to oncology, where it could potentially have broad applications, including viral antigens, cancer antigens, neoantigens and antigen-derived antibodies as biologics. The Company has built a large pipeline from UNITE with six oncology programs and two allergy programs. ITI has entered into a significant allergy partnership with Astellas Pharma and has formed several academic collaborations with leading Immuno-oncology researchers at Fred Hutchinson Cancer Research Institute, Johns Hopkins University of Medicine, and Duke University. ITI maintains its headquarters in Rockville, Maryland. For more information, please visit www.immunomix.com.

About Ichor Medical Systems, Inc.

Ichor® Medical Systems’ clinical stage TriGrid® Delivery System is the first integrated and fully automated device for electroporation-mediated nucleic acid administration in humans. Ichor, a privately held biotech company based in San Diego, CA, is collaborating with partners to provide its enabling TriGrid platform as a means for delivery of nucleic acid-based drugs and vaccines in disease indications such as cancer, hepatitis B virus (HBV) infection, human papillomavirus (HPV) infection, and human immunodeficiency virus (HIV) infection, COVID-19, as well as for multiple biodefense agents. The TriGrid platform is also being developed for nucleic acid-based antibody delivery as a rapid countermeasure in the event of an infectious disease outbreak or biological weapons attack. For more information or a full listing of Ichor’s partnered programs please visit http://www.ichorms.com or contact May Pidding, Ph.D. at mpidding@ichorms.com.

Contacts
ITI Company Contact:
Sia Anagnostou
aanagnostou@immunomix.com
717-327-1822

ITI Media Contact:
Amy Conrad
Juniper Point
amy@juniper-point.com
858-366-3243

ROCKVILLE, Md., June 15, 2020 /PRNewswire/ — Emmes today announced that it provided the Phase 3 clinical trial support for a new investigational cell therapy that offers a promising treatment opportunity for patients who need an allogeneic bone marrow transplant. Emmes’ work for Gamida Cell Ltd., an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases, involved full scope clinical trial support for this study that was conducted at more than 50 centers in the United States, Latin America, Europe and Asia. Emmes also supported the early development Phase 1 and 2 trials that began in 2010.

The therapy in development, omidubicel, is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration. The intent-to-treat results of this study in 125 patients showed that omidubicel was generally well tolerated and that the median time to neutrophil engraftment was 12 days for patients randomized to omidubicel compared to 22 days for the comparator group of patients who received standard umbilical cord blood (p<0.001).

The chief medical officer for Gamida Cell, Dr. Ronit Simantov, stated, “We are very proud of this rigorous, well-executed trial, and we truly appreciate the support of everyone who partnered with us to help move the field forward. We truly value the work and expertise that Emmes provided, and the agility and commitment of the Emmes staff played a critical role in achieving this clinical development milestone.”

Dr. Anne Lindblad, president and chief executive officer at Emmes, added, “Gamida Cell’s positive topline data from the trial is very encouraging, and we are hopeful that it represents a life-saving treatment option for bone marrow transplant candidates. Our employees are proud to work on therapies like this that bring hope to people who are suffering, and I’m proud that we’ve partnered with Gamida on this effort for 10 years.”

The international, multi-center, randomized Phase 3 study was designed to evaluate the safety and efficacy of omidubicel in patients with high-risk hematologic malignancies undergoing a bone marrow transplant. The study included patients aged 12-65 years with acute lymphoblastic leukemia, acute myelogenous leukemia, chronic myelogenous leukemia, myelodysplastic syndrome, or lymphoma.

Omidubicel is an investigational therapy, and its safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

About Emmes
Emmes is a leading Contract Research Organization working with both public and private sector organizations. We collaborate with our clients to produce valued, trusted scientific research, and our team members are passionate about making a difference in the quality of human health. Emmes has supported more than a thousand studies across a diverse range of diseases since our formation in 1977. Our research is contributing to a healthier world. For more information, visit the Emmes website at www.emmes.com.

The BioHealth Capital Region featured at last week’s Redefining Early Stage Investments Conference (RESI) where speakers from the region discussed a range of topics of interest to early stage companies including:

• Collaborating for Growth in the BioHealth Capital Region
• International Biohealth Companies Entering the U.S. Market
• Advancing Your Technology through Non-Dilutive Grants
• Raising Early Stage Capital in Difficult Times

For more information, check out the RESI Conference site or contact BHI.

Source: biopharmajournal.com