Monthly Archives

June 2020

Charles Andres and Christian Barrow join BioTalk to discuss investing, growth and the BioHealth Capital Region during COVID-19

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Charles Andres, Ph.D., RAC, Associate at Wilson Sonsini Goodrich & Rosati, and Christian Barrow, Executive Director, Life Sciences Banking at JP Morgan, join Rich Bendis for a Virtual BioTalk

Charles Andres, Ph.D., RAC, is an associate in the Washington, D.C., office of Wilson Sonsini Goodrich & Rosati. He focuses on patent prosecution, strategic patent counseling, IP due diligence, drug and medical device FDA regulatory counseling, invalidity and non-infringement opinions, life-cycle management, Supreme Court and Federal Circuit amicus briefs, and related business matters.

Charlie has significant experience drafting patent applications, prosecuting patent applications in the U.S. and abroad, and evaluating the claims of issued patents. He has won cases before the Board of Patent Appeals and Interferences by brief and on oral argument. Patents Charlie has obtained have been listed in the Orange Book and asserted against a generic pharmaceutical manufacturer, and he has drafted and filed multiple applications for patent term extension. Companies he has obtained patents for have been sold for a cumulative total of approximately $4 billion.

Christian Barrow is a senior banker with J. P. Morgan commercial bank. Chris joined J.P. Morgan in 2012 in the Philadelphia office, where he and his team focus on providing financial solutions to life sciences companies located in the Mid-Atlantic – Delaware, Pennsylvania, and Maryland. Chris has over 25 years of experience in the financial services industry with roles that have spanned from public accounting to banking.

Chris’ current job is to help life science companies in biotech, specialty pharmaceutical, specialty pharmacy, medical device, med-tech, medical diagnostics, and contract research organizations, gain access to JPMorgan’s well-known healthcare commercial and investment banking resources.

Prior to his current role, Chris started his career with EY (inactive CA and CPA licenses). He subsequently served as a senior banker for Bank of America. In this capacity, he was responsible for origination and structuring of debt products to general industry companies located in Pennsylvania.

Chris holds a bachelor’s degree in Biology and a graduate diploma in Accounting both from McGill University. He currently resides in Doylestown, Pennsylvania with his wife and two children.

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Children’s National Hospital Ranked a Top 10 Children’s Hospital and No. 1 in Newborn Care Nationally by U.S. News for Fourth Year in a Row

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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:

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

Media contact: | 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, provides consumer advice, rankings and analysis to serve people making complex decisions throughout all stages of life. More than 40 million people visit 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.

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Novavax Appoints Biotechnology Veteran David Mott to Board of Directors

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“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 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, 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.


Novavax, Inc.
Silvia Taylor and Erika Trahan

Brandzone/KOGS Communication
Edna Kaplan

MacroGenics Appoints Dr. Stephen Eck As Chief Medical Officer

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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 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 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.


ITI Enters into License Agreement with Ichor to Use Electroporation (EP) Delivery Technology in Phase I Study of DNA Vaccine Therapy, ITI-1001

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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.”


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

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 or contact May Pidding, Ph.D. at

ITI Company Contact:
Sia Anagnostou

ITI Media Contact:
Amy Conrad
Juniper Point

Emmes Announces Its Work on a Phase 3 Clinical Trial for Breakthrough Therapy Designation Product

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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

BioHealth Capital Region Spotlighted at RESI

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Resi Header

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:

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

Altimmune Inc. (NASDAQ:ALT) Commences T-COVID Clinical Trial for Treatment of Patients With Onset COVID-19 After FDA Approval

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Altimmune Inc. (NASDAQ:ALT) has announced that the FDA has given the company a go-ahead to proceed with its T-COVID clinical trial. T-COVID is Altimmune’s investigational agent for onset COVID-19 treatment.

Altimmune to commence enrolment of Phase 1/2 T-COVID trial

The company expects to begin enrolling patients in the first and second phase trials in June with a readout of data expected in Q4 2020. The investigational agent, T-COVID, is based on the replication-deficient adenovirus five vector technology. RD-Ad5 is the vector tech behind the company’s intranasal vaccines that include Anthrax’s NasoShield, Influenza’s NasoVAX as well as AdCOVID for SARS-COV-2, but its mechanism of action is different.

Recent National Institute of Allergy and Infectious Diseases sponsored preclinical studies to indicate that the intranasal RD-Ad5 vectors administration modulated inherent immune response. There was a significant decline in cellular inflammation due to the immunomodulatory effects and lower IL-6 concentration and inflammatory cytokines in treated animals’ lungs relative to controls.

Usually, excess inflammatory cytokines production, such as IL-6, is linked to lung pathology and mortality on COVID-19 patients. The study showed that protective effects did not depend on a particular vaccine or immunity effects versus the challenge virus. The protective effects were realized in RD-Ad5 intranasal administration with intramuscular administration providing no survival benefit.

FDA approves NasoVAX Influenza vaccine for T-COVID study

Altimmune believes that its T-COVID agent given in single intranasal doses alongside other treatment in COVID-19 patients with onset symptoms or with a recent diagnosis can halt disease progression. This prevents progression to acute lung inflammation and thus decreasing the development of coronavirus and the need for hospitalized patients. The FDA has approved the existing RD-Ad5 lot of NasoVAX influenza inoculation for the anticipated T-COVID clinical study, which allows Altimmune to commence the study.

The anticipated clinical study will evaluate T-COVID’s potential in preventing clinical deterioration in early COVID-19 patients. The company will enroll around 100 patients in the double-blind study who are above 35 years. They will be randomized 1:1 for intranasal T-COVID administration or placebo.


Sirnaomics Announces Decision to Spin off RNAimmune to Develop Novel mRNA Therapeutics and Vaccines

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Sirnaomics, Inc., a leading biopharmaceutical company engaged in the discovery and development of RNAi therapeutics, today announced a corporate technology spinoff establishing an independent biopharmaceutical company, RNAimmune, Inc. This new entity is focusing on and specializing in messenger RNA (mRNA) based therapeutics and vaccine development, with exclusively licensed Polypeptide-Lipid Nanoparticle (PLNP) delivery technology and large scale GMP manufacturing knowledge from Sirnaomics, plus a proprietary artificial intelligence Algorithm for Epitope Prediction and Validation (ALEPVA).

As a clinical stage RNAi therapeutics company, Sirnaomics’ proprietary polypeptide-based delivery technology has been validated in various preclinical and clinical settings, for both local and systemic drug administrations, especially the process development know-how for large scale GMP manufacturing of the drug products, with a global exclusive right. Further evaluation and validation of these technologies including PLNP delivery technology with mRNA vaccine and drug product candidates warrant an expansion of the technology into mRNA delivery beyond siRNA drug products, which led to the creation of RNAimmune earlier this year. Sirnaomics is providing RNAimmune with the increased independence and will have the right to retain an equity investment in RNAimmune.

“This is a remarkable development for Sirnaomics, further leveraging our robust technology platform and early-stage product opportunities while maintaining our primary focus on our growing RNAi product clinical pipeline,” stated Patrick Lu, PhD, President and Chief Executive Officer, Sirnaomics, Inc. “RNAimmune is developing a new class of potentially transformative medicines to treat and prevent diseases caused by protein dysfunction and pathogen infections. We continue to believe that our PLNP delivery technology offers advantages over other approaches, especially for the large-scale manufacture, long term storage and remote transportation. We are excited about the robust mRNA delivery effort underway and the promise of further leveraging Sirnaomics broad RNA technology.”

“The decision to spinoff RNAimmune as an independent company is the logical next step to unlock value, which will facilitate the ability of RNAimmune to fund itself primarily from sources outside Sirnaomics. After evaluating a variety of approaches, we have concluded that spinning off our mRNA-based therapeutics platform as an independent company offers Sirnaomics the best opportunity to accelerate the development of this exciting technology while enabling additional value creation for its stakeholders from the intellectual property and proprietary technology assets that we have accumulated over the years,” said Allan L. Shaw, Chief Financial Officer, Sirnaomics, Inc.

RNAimmune expects to emerge as one of the leading groups for vaccine development against COVID-19 with unique mRNA vaccine design and effective mRNA delivery, under the leadership of Dong Shen, MD & PhD, founder, president and CEO of RNAimmune.  Dr. Shen has extensive drug development experience in AstraZeneca and Johnson & Johnson, having led projects across multiple therapeutic areas with high unmet medical need. He has held leadership across early and late programs in the areas of infectious disease, oncology and rare disease. Dr. Shen received numerous awards, including Johnson & Johnson’s Leadership Award in 2018 and Innovation Award in 2017. He received his PhD in molecular oncology from Johns Hopkins University School of Medicine and MD from Shanghai Jiao Tong University School of Medicine.

RNAimmune's logo

About RNAimmune, Inc.
RNAimmune is a leading biopharmaceutical company in the field of messenger RNA (mRNA) therapeutics and vaccines. RNAimmune leverages mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a wide range of diseases. RNAimmune is a spin-off venture from Sirnaomics, receiving a global exclusive right of the proprietary PLNP technology for mRNA delivery, and proprietary know-how for large scale cGMP production of its mRNA products, possesses an in-house developed proprietary AI algorithm (ALEPVA) for antigen prediction and vaccine design. The company’s leading product candidate for mRNA-based COVID-19 vaccines has been recognized by the World Health Organization (WHO), and currently is under a collaborative effort with the National Institute of Allergy and Infectious Diseases (NIAID) for evaluation of its anti-COVID-19 activity with animal models. The Company also believes its technology is applicable to a broad range of diseases: the prophylactic and therapeutic vaccines against SARS-CoV-2 and Influenza; cancer therapeutics with neoantigen vaccine and antibodies; and rare diseases. The company’s headquarters locate in suburban Maryland. Learn more at

Read the original news from PR Newswire

About Sirnaomics, Inc.

Sirnaomics, Inc., a leading privately held biopharmaceutical company for discovery and development of RNAi therapeutics, is a Delaware corporation headquartered in Gaithersburg, Maryland, USA, with subsidiaries in Suzhou and Guangzhou, China. The Company’s mission is to develop novel therapeutics to alleviate human suffering and advance patient care in areas of high unmet medical need. The guiding principles of the company are: Innovation, Global Vision with a Patient Centered focus. Members of the senior management team have a great deal of combined experience in the biopharmaceutical industry, financial, clinical and business management in both the USA and China. The company is supported by funding from institutional investors, corporate partnerships and government grants. Sirnaomics has developed a strong portfolio of intellectual property with an enriched product pipeline. The therapeutic areas of focus include oncology and anti-fibrotic therapeutics. Learn more at

Glyscend Therapeutics Completes $20.5M Financing Round to Advance Novel Oral Polymer Therapy for Type 2 Diabetes

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–Patient-Friendly Therapy Designed to Mimic the Dramatic Metabolic Benefits of Bariatric Surgery –

–Company Aims to Begin First-in-Human Trials in Australia Next Year –

Karen Talmadge, PhD, Industry Veteran and Past Chair of the American Diabetes Association’s Board of Directors, Joins Glyscend’s Board –

BALTIMORE, June 11, 2020 (GLOBE NEWSWIRE) — Glyscend Therapeutics, a privately held biopharmaceutical company developing novel treatments for type 2 diabetes (T2D) and related metabolic conditions, today announced the closing of a $20.5 million Series A financing round. Healthcare investors Brandon Capital Partners, through its Medical Research Commercialisation Fund (MRCF), and Santé Ventures led the round of funding, which will be used to support the development of the company’s novel oral polymer therapy for patients with T2D and other metabolic diseases. Breakout Labs (a fund in the Thiel Foundation) provided seed funding in 2019.

“The technology we are developing was inspired by the remarkable efficacy of gastric bypass surgery in correcting the metabolic disorder associated with T2D. Our goal is to develop an oral medication that works locally in the gastrointestinal (GI) tract to provide the benefits of gastric bypass surgery while greatly reducing the potential risks and complications,” said Ashish Nimgaonkar, MD, Co-Founder, President and CEO of Glyscend.

The upper intestinal tract is now appreciated to play a critical role in metabolic regulation. Gastric bypass surgeries that divert intestinal contents away from the upper GI tract (via duodenal exclusion mechanism) or endoscopic interventions that create a barrier can induce dramatic changes in hormonal signaling between the gut, liver and brain.i,ii The result is often dramatic improvement in blood glucose levels and the ability of cells to respond to insulin, in addition to weight loss and improvement in many other markers of abnormal metabolism seen with T2D over time.i,iii,iv Bariatric surgeries, such as gastric bypass, are so effective that some T2D patients can maintain normal blood sugars without further medication, but the procedures have been reserved for the most obese patients because of the cost and potential complications. Roughly a quarter-million bariatric surgery procedures are performed yearly in the United States (US).

“To mimic the benefits of these invasive procedures using a pill, Glyscend’s R&D team drew from the experience of Thomas Jozefiak, PhD, a medicinal polymer chemist who pioneered non-absorbable compounds when he was at GelTex Pharmaceuticals (later Genzyme) that have become blockbuster drugs for Sanofi in the treatment of chronic kidney disease,” Dr. Nimgaonkar added.

“Having seen the potential of non-absorbed drugs, I was immediately drawn to the challenge of creating a proprietary family of non-absorbed polymers that uniquely interacts with the intestinal mucosa to create a temporary barrier effect as food passes through. Extensive preclinical studies support safety and efficacy of our compounds in relevant animal models of T2D,” said Dr. Jozefiak, Co-Founder and Chief Scientific Officer of Glyscend.

“I’ve had the privilege of watching the Glyscend team for several years as they developed and validated their compounds,” said Bob Soh, MD, Investment Manager at Brandon Capital Partners. “Clinical investigators in our Australian network endorsed the approach early on and are keen to begin first-in-human trials next year.”

According to the International Diabetes Federation (IDF), there are approximately 500 million people living with T2D worldwide, including 34 million in the US. Current therapies, including pills and injectable treatments, often fail to improve blood glucose levels even as patients are stepped up from simple to more complex medication regimens. Poor glucose control can lead to severe and life-threatening complications, including heart attack, stroke, kidney failure, blindness and amputation.

“Glyscend’s non-absorbed compounds have the potential to create an entirely novel category of safe and effective metabolic pharmaceuticals,” said Dennis McWilliams, Venture Partner of Santé Ventures. “Moreover, the team’s experience in GI science, metabolic physiology and unique polymer chemistry gives us significant confidence in the company’s T2D development program.”

Glyscend is also pleased to announce that industry entrepreneur Karen Talmadge, PhD, has joined its Board of Directors as an independent director. Dr. Talmadge has been an active member of the American Diabetes Association (ADA) for 27 years, most recently serving as Chair of the ADA National Board in 2013 and 2018. She was previously the co-founder of Kyphon, where she developed minimally invasive solutions for the spine (commonly known as kyphoplasty) and held various leadership roles, including CEO and CSO, until Kyphon’s acquisition by Medtronic in 2007 for $4.2 billion. Prior to Kyphon, she held multiple science and business positions at the biotech company Scios, including VP of R&D for its diabetes and obesity program.

“Type 2 diabetes is a terrible disease whose personal and societal impact is both underappreciated and deeply misunderstood. I am honored to join Glyscend’s board to help fulfill the company’s mission of providing life-changing benefits to patients with diabetes by reducing or eliminating the burden of disease,” said Dr. Talmadge.

“We are delighted to welcome Dr. Talmadge to our Board, and to close this financing round with world-class investors who believe in the bold vision of our company. The Series A funding will support ongoing product development, manufacturing scale-up, and proof-of-concept clinical trials,” added Dr. Nimgaonkar.

About Glyscend, Inc.
Glyscend, Inc. is a venture-backed biopharmaceutical company developing novel orally- delivered compounds that work on targets inside the GI tract to treat a variety of metabolic disorders, including T2D. Glyscend’s polymer technology platform evolved from research at Johns Hopkins University, where scientists were evaluating the mechanisms that result in significantly improved glucose and metabolic regulation following certain types of bariatric surgery. They discovered that specifically designed polymers, delivered orally in animal model, could mimic this post-surgical effect. Glyscend’s technology was invented through research that originated at the Center for Bioengineering Innovation & Design (CBID) at Johns Hopkins University and was licensed from the University. The project received grants and recognition from the Maryland Innovation Initiative, the National Science Foundation, Johnson & Johnson Innovation, and Janssen Research & Development 2016 World Without Disease QuickFire Challenge. The company is headquartered in Baltimore, MD, and performs materials science R&D at JLABS @ M2D2 in Lowell, MA. For more information, please visit

About Glyscend’s Polymer-based Therapy
Glyscend’s patient-friendly, orally administered polymer therapy is intended to work locally in the GI tract by creating a temporary barrier in specific portions of the intestine. This barrier would alter food uptake in those portions of intestine to induce dramatic changes in hormonal signaling via the gut-liver-brain axis. Glyscend aims to replicate the beneficial effects of Bariatric surgery via the “duodenal exclusion” mechanism, without the need for surgery. Bariatric surgery has been shown to have immediate and profound effects on improving blood glucose while reducing body weight and reducing long-term micro- and macro-vascular complications related to T2D. Glyscend’s technology could enable, not just the treatment but potentially a reversal of T2D. Glyscend’s novel synthetic polymers are inert, non-absorbed, and naturally eliminated through the GI tract within 24 hours. Polymer-based therapies are a proven unique class of therapeutics with more than three decades of clinical experience in a wide range of applications. Ongoing research and development continue to provide further understanding of the impact that polymer science can play in shaping future therapies in the metabolic disease space.

About Santé Ventures
Santé Ventures is an Austin-based healthcare and life sciences investment firm specializing in early-stage companies developing innovative new medical technologies, biotechnologies, digital health technologies, and healthcare services. Santé focuses on developing lasting, well-aligned partnerships with exceptional entrepreneurs and executives to build valuable companies. For more information, please visit

About Brandon Capital Partners and the Medical Research Commercialisation Fund (MRCF)
Headquartered in Melbourne, Australia, Brandon Capital Partners is a venture capital firm that manages the Medical Research Commercialisation Fund (MRCF), Australia and New Zealand’s largest life science investment fund. The MRCF is a unique collaboration between major Australian pension funds, the Australian and New Zealand governments, Australian state governments and more than 50 leading medical research institutes and research hospitals. The MRCF supports the development and commercialization of early-stage biomedical discoveries originating from member research organizations, providing both capital and expertise to guide the successful development of new therapies. For more information, please visit

Media Contact:
Glenn Silver
Phone: 1-973-818-8198

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