Monthly Archives

September 2020

BioBuzz: Leading Vaccine Manufacturer Emergent Biosolutions Searching for Quality Talent for Three Facilities Across Maryland

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Emergent Biosolutions (Emergent) is a global biopharmaceutical company, Maryland’s leading vaccine manufacturer, and one of the key life science anchor organizations of the BioHealth Capital Region (BCHR). The company is actively hiring for dozens of full-time Quality Control team positions to support a growing portfolio of programs, including several for COVID-19 vaccine candidate production.

Emergent is currently hiring for the following positions within their Quality Control (QC) teams at several of its Maryland sites, including (click on job for more information):

Click here to read more via BioBuzz

Sanofi and GSK initiate Phase 1/2 clinical trial of COVID-19 adjuvanted recombinant protein-based vaccine candidate

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  • Pre-clinical studies show promising safety and immunogenicity
  • Over 400 participants being enrolled in Phase 1/2 study
  • If Phase 1/2 data positive, companies aim to move into a Phase 3 trial by end of 2020
  • Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant with the target of producing up to one billion doses in 2021

Sanofi and GSK announce today the start of the Phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine. The vaccine candidate, developed in partnership by Sanofi and GSK, uses the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines with GSK’s established pandemic adjuvant technology.

The Phase 1/2 clinical trial is a randomised, double blind and placebo-controlled trial designed to evaluate the safety, reactogenicity (tolerability) and immunogenicity (immune response) of the COVID-19 vaccine candidate. A total of 440 healthy adults are being enrolled in the trial across 11 investigational sites in the United States.

The Companies anticipate first results in early December 2020, to support the initiation of a Phase 3 trial in December 2020.  If these data are sufficient for licensure application, it is planned to request regulatory approval in the first half of 2021.

Sanofi is leading the clinical development and registration of the COVID-19 vaccine. Pre-clinical data showed an acceptable reactogenicity profile and data based on two injections of the adjuvanted recombinant vaccine showed high levels of neutralising antibodies that are comparable to levels in humans who recovered from the COVID-19 infection. Pre-clinical results will be published later this year. In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant with the target of producing up to one billion doses in 2021.

Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur, said: “Sanofi and GSK bring proven science and technology to the fight against the global COVID-19 pandemic, with the shared objective of delivering a safe and effective vaccine. The initiation of our clinical study is an important step and brings us closer to a potential vaccine which could help defeat COVID-19. Our dedicated teams and partner continue to work around the clock as we aim to deliver the first results in early December. Positive data will enable a prompt start of the pivotal phase 3 trial by the end of this year.”

Roger Connor, President of GSK Vaccines said: “Moving this vaccine candidate into clinical development is an important moment in the progress towards addressing the global pandemic we are all facing. This builds on the confidence shown by governments already in the potential of this protein-based adjuvanted vaccine candidate, which utilises established technology from both companies, and can be produced at scale by two of the leading vaccine manufacturers globally. We now look forward to the data from the study, and if positive, beginning a Phase 3 trial by the end of the year.”

The development of the adjuvanted COVID-19 vaccine candidate is being supported through funding and a collaboration with the Biomedical Advanced Research and Development Authority, part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.

Sanofi and GSK are committed to making the vaccine available globally
In July 2020, Sanofi and GSK announced a collaborative effort with the U.S. government to supply up to 100 million doses of their COVID-19 recombinant protein-based vaccine to meet the U.S. government’s Operation Warp Speed goal of making hundreds of millions of doses of safe and effective COVID-19 vaccines available in the United States as quickly as possible. The U.S. government has a further option to discuss the purchase of up to 500 million doses longer term. Both companies also agreed (subject to final contract) with the UK government to supply up to 60 million doses of recombinant protein-based COVID-19 vaccine.

The partners plan to supply a significant portion of total worldwide available supply in 2021/2022 to COVAX, the vaccines pillar of the ACT-Accelerator (Access to COVID‐19 Tools), a global collaboration of leaders of governments, global health organisations, businesses and philanthropies to accelerate development, production, and equitable access to COVID-19 tests, treatments, and vaccines.

GSK commitment to tackling COVID-19
GSK is collaborating with companies and research groups across the world working on promising COVID-19 vaccine candidates through the use of our innovative vaccine adjuvant technology. The use of an adjuvant is of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to protecting more people.  GSK does not expect to profit from COVID-19 vaccines during the pandemic phase, and will invest any short-term profit in coronavirus related research and long-term pandemic preparedness, either through GSK internal investments or with external partners.

About GSK
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

About Sanofi
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

GSK Cautionary Statement Regarding Forward-Looking Statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk Factors” in the company’s Annual Report on Form 20-F for 2019 and as set out in GSK’s “Principal risks and uncertainties” section of the Q2 Results and any impacts of the COVID-19 pandemic.

Altimmune Announces Successful Completion Of Multiple Dose Toxicity And Toxicokinetic Studies Of ALT-801, A GLP-1/Glucagon Dual Receptor Agonist For The Treatment Of NASH

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Company anticipates first-in-human trials to start in Q4 2020

GAITHERSBURG, Md., Sept. 01, 2020 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced the successful completion of multiple dose toxicity and toxicokinetic studies of ALT-801, a GLP-1/glucagon dual receptor agonist for the treatment of NASH. The IND enabling studies were conducted in rats and cynomolgus monkeys. The Company believes the data provide clear validation of previously observed pharmacodynamic effects of the compound and pave the way for the anticipated Phase 1 single (SAD) and multiple ascending dose (MAD) clinical trials to start in Q4 2020, following the submission of a clinical trial application in Australia.

ALT-801 was well tolerated in both rats and cynomolgus monkeys and the no-observed-adverse-effect levels (NOAEL) in both species were at the highest doses tested. The most remarkable finding was significant weight loss versus the control groups in both species, which is an expected and desired property of ALT-801. Importantly, no evidence of significant GI toxicity or intolerability, including vomiting, was observed in the animals. GLP-1 receptor agonists and dual agonists that are approved or in clinical development have been associated with significant levels of nausea and vomiting and have typically required the use of dose-titration over several months. The observations from the recently completed toxicology studies suggest that ALT-801 can be expected to be well tolerated in humans and not require dose titration, potentially enabling higher levels of weight loss and liver fat reduction than existing GLP-1 receptor agonist based compounds.

The nonhuman primate data also showed an ALT-801 pharmacokinetic profile that is expected to support weekly dosing in humans. The Company believes that the proprietary EuPort™ modification on ALT-801 not only provides the longer half-life necessary for weekly dosing but also slows the rate of absorption of the compound into the bloodstream to avoid the tolerability issues typically associated with this class of agents. Based upon the successful completion of these preclinical toxicology studies, Altimmune plans to initiate first-in-human studies of ALT-801 in Q4 2020, with data readouts on safety, pharmacokinetics, and important measures of activity such as weight loss and liver fat reduction in the Spring of 2021.

“Currently there are no approved treatments for NASH, and disease prevalence is growing worldwide as a consequence of an expanding obesity epidemic. These data are right in line with our expectation for ALT-801 and provide additional confidence as we look forward to initiating the first-in-human studies later this year,” said Dr. Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. Dr. Garg continued, “In addition to our significant efforts to develop a vaccine and a treatment for COVID-19, we are pleased to continue the development of other therapeutic candidates of importance to public health across our product portfolio.”

About ALT-801
ALT-801 is a potent, peptide-based therapeutic candidate with balanced agonist activity on the GLP-1 and glucagon (GCGR) receptors. ALT-801 is designed to treat the underlying metabolic dysfunction that leads to NASH, the most severe form of non-alcoholic fatty liver disease (NAFLD). NASH is considered by many to be the liver manifestation of metabolic syndrome and is characterized by abnormal accumulation of fat in the liver, toxic lipid metabolites, inflammation and liver cell damage leading to fibrosis/cirrhosis and liver cancer.

ALT-801 activates both the GLP-1 and the glucagon receptors, resulting in appetite suppression, decreased insulin insensitivity, increased energy expenditure, and substantial decreases in both liver and body fat in relevant animal models. ALT-801 has a similar mechanism of action to the body’s natural dual-acting hormone, oxyntomodulin, which lowers food intake, stimulates energy expenditure and reduces body weight. ALT-801 is designed to achieve glycemic control comparable to or better than the approved GLP-1 agonists but with more robust weight loss with once-weekly subcutaneous dosing.

ALT-801 demonstrated better outcome measures in comparison to semaglutide (an approved GLP-1 receptor agonist) in the Gubra/Amylin biopsy-proven, diet-induced mouse model of NASH. During a 12-week study, treatment with ALT-801 rapidly returned body weight to the range of lean normal animals. Histology revealed a near complete absence of liver steatosis, lobular inflammation and ballooning, as well as a significant reduction of fibrosis. Semaglutide showed only a modest body weight loss and a mild decrease in hepatosteatosis. ALT-801 also resulted in greater suppression of genes involved in de novo lipogenesis and fatty acid uptake, inflammation, hepatocellular death, and fibrosis.

About Altimmune
Altimmune is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease. Our diverse pipeline includes proprietary intranasal vaccines for COVID-19 (AdCOVID™), anthrax (NasoShield™) and influenza (NasoVAX™); an intranasal immune modulating therapeutic for COVID-19 (T-COVID™); and next generation peptide therapeutics for NASH (ALT-801) and chronic hepatitis B (HepTcell™). For more information on Altimmune, please visit www.altimmune.com.

Forward-Looking Statement
Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the timing of key milestones for our clinical assets, the initiation and timing of the ALT-801 Phase 1 clinical trial in Q4 2020, its enrollment and the timing of the data readout expected in the spring of 2021, our ability to manufacture ALT-801, and the prospects for regulatory approval, commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. (the “Company”) may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: potential impacts due to the COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, adverse effects on healthcare systems and disruption of the global economy the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to secure regulatory approval for its ALT-801 investigational new drug application submission to the U.S. Food and Drug Administration, the Company’s ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company’s business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2019 and quarterly report on Form 10-Q for the quarter ended March 31, 2020 filed with the SEC, which are available at www.sec.gov.

Investor Contacts:
Will Brown
Chief Financial Officer
Phone: 240-654-1450
wbrown@altimmune.com
Ashley R. Robinson
Managing Director LifeSci Advisors
Phone: 617-430-7577
arr@lifesciadvisors.com
Media Contact:
Warren Rizzi
Sard Verbinnen & Co.
Phone: 212-687-8080
altimmune-svc@sardverb.com

Cartesian Therapeutics Initiates Clinical Trial of First RNA-Engineered Cell Therapy for Acute Respiratory Distress Syndrome and COVID-19

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Descartes-30 engineered to express a unique combination of DNases to eliminate neutrophil extracellular traps (NETs), a key driver of inflammation and clotting in ARDS.

Gaithersburg, MD, September 1, 2020 – Cartesian Therapeutics, a fully integrated, clinical-stage biopharmaceutical company developing cell and gene therapies for cancer, autoimmune diseases and respiratory diseases, today announced that it has initiated a Phase 1/2 clinical trial of its lead RNA-engineered mesenchymal stem cell (MSC) therapy, Descartes-30, in patients with moderate-to-severe ARDS, including that caused by COVID-19. Based upon the company’s research and analysis, this program is understood to be the first RNA-engineered cell therapy to enter clinical development for ARDS and COVID-19. It is also the first cell therapy to specifically degrade NETs, webs of extracellular DNA and histones that entrap inflammatory cells, block alveoli and vessels, and drive the pathogenesis of ARDS and COVID-19.

“Patients with ARDS, especially those with COVID-19 ARDS, generate copious amounts of NETs that physically obstruct alveoli and vessels, which leads to respiratory distress, immune-mediated thrombosis and a vicious cycle of inflammation,” said Bruce Levy, MD, Chief of Pulmonary and Critical Care Medicine at Brigham and Women’s Hospital and Parker B. Francis Professor at Harvard Medical School, and a clinical investigator in the Descartes-30 trial. “We would therefore expect that degrading NETs would improve oxygenation as well as resolve thrombi and quell inflammation in these patients. If successful, Descartes-30 would be a highly differentiated game-changer within our limited toolkit in managing this exceedingly difficult condition.”

Descartes-30 is an off-the-shelf (allogeneic) MSC product engineered with Cartesian’s RNA ArmorySM cell therapy platform. By expressing a unique combination of DNases that work synergistically, Descartes-30 can eliminate large, macroscopic amounts of NETs within minutes. MSCs are inherently immunomodulatory and naturally travel to the lungs, where they are expected to provide continuous, local delivery of DNases to NET-laden lung tissue.

“We engineered Descartes-30 without genomic modification, and therefore the production of DNases is expected to be time-limited to match the acute nature of ARDS,” said Metin Kurtoglu, MD, PhD, Chief Medical Officer at Cartesian. “Given that Descartes-30 will produce DNases locally and transiently, we anticipate that it will have a favorable benefit-to-risk profile. We also anticipate that these properties will enable Descartes-30 to treat a wide array of NET-related autoimmune and cardiovascular diseases.”

About the Phase 1/2a Clinical Trial

The “Phase 1/2a Study of Descartes-30 in Acute Respiratory Distress Syndrome” (NCT04524962) is enrolling patients with ARDS at multiple critical care units in the United States. Patients with ARDS due to COVID-19 are given enrollment priority. This first-in-human study aims to determine the safety and preliminary efficacy of Descartes-30 in patients with moderate to severe ARDS. The study, which is estimated to begin treatment in September, aims to enroll approximately 20 patients prior to initiation of a larger study. For more information visit cartesiantherapeutics.com/Descartes-30-ARDS.

About ARDS and NETs

ARDS is a severe inflammatory lung disease with a mortality of over 40%. Inflammation leads to injury of lung tissue and leakage of blood and plasma into air spaces, resulting in low oxygen levels and often requiring mechanical ventilation. Inflammation in the lung may lead to inflammation elsewhere, causing shock and injury or dysfunction in the kidneys, heart, and muscles. Some causes of ARDS include COVID-19, severe pneumonia (including influenza), sepsis, trauma, and smoke inhalation.

NETs are inflammatory webs of DNA and proteins produced by neutrophils. NETs are commonly found in ARDS and are thought to exacerbate the disease by physically occluding air spaces and vessels, leading to reduced oxygenation and increased risk of immune thrombi. NETs are implicated in a variety of conditions beyond ARDS, including autoimmune and cardiovascular diseases.

About the RNA ArmorySM

The RNA ArmorySM is Cartesian’s proprietary RNA-based cell engineering platform that activates and arms cells with carefully selected, mRNA-based therapeutics. Unmodified donor cells enter the RNA ArmorySM in the millions; a battle-ready cell army leaves the RNA ArmorySM in the tens of billions. Each cell is equipped with a combination of therapeutics rationally chosen to have a synergistic effect on the disease. In the body, the cells deliver a precision-targeted treatment regimen directly to the site of disease. The cells express therapeutics with a defined half-life, enhancing their safety profile and making repeat dosing and outpatient administration possible. The platform is agnostic to cell type: we choose the best cell for the job, whether autologous or off-the shelf. For more information visit cartesiantherapeutics.com/rna-armory.

About Cartesian Therapeutics

Founded in 2016, Cartesian is a fully integrated, clinical-stage biopharmaceutical company developing potent yet safer cell and gene therapies designed to benefit the broadest range of patients with cancer, autoimmune and respiratory diseases. Cartesian has three products in clinical development under four open investigational new drug application (INDs) with the U.S. Food & Drug Administration (FDA). All investigational therapies are manufactured at Cartesian’s wholly owned, state-of-the-art cGMP manufacturing facility in Gaithersburg, MD. Cartesian’s commanding IP position benefits in part from a broad, exclusive patent license from the National Cancer Institute. For more information visit www.cartesiantherapeutics.com/trials.

Media Contacts:

Robert Conrad for Cartesian Therapeutics
PressComm PR
robertconrad@presscommpr.com

703-980-0997

Economic Alliance of Greater Baltimore (EAGB), President and CEO, Michele L. Whelley, Joins Rich Bendis on BioTalk

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Economic Alliance of Greater Baltimore (EAGB), President and CEO, Michele L. Whelley, joins BioTalk to discuss her career, the economic development environment in Baltimore, and how to create a greater sense of partnership between perceived competing regions.

Listen now via Apple https://apple.co/2DikZfg, Google https://bit.ly/2Exq5oD , Spotify https://spoti.fi/31GmIUV, TuneIn https://bit.ly/32FjGQ5, and YouTube Audio https://bit.ly/31IwGFl.

Michele L. Whelley, President & CEO, is an economic development professional who is well-known throughout the region’s business community, Whelley brings new energy and focus to marketing the region, ensuring that EAGB will continue to strengthen its marketing platform as a critical component of fostering and supporting a vibrant and growing economy throughout the Greater Baltimore region.
Whelley’s diverse career as an economic development leader includes serving as the CEO of the Central Maryland Transportation Alliance, as the founding CEO of the Economic Development Corporation of New Haven, CEO of the Downtown Partnership of Baltimore and executive vice-president of the Baltimore Development Corporation.  Additionally, she has provided consulting services for Johns Hopkins Medical Institutions, several private sector development companies and staffed an economic development practice at Colliers Pinkard, a real estate brokerage company. More recently, Whelley has provided a full range of economic development consulting services to organizations including Howard Hughes Corporation, Baltimore Integration Partnership, Southern Management Corporation, Network Rail Consulting, Inc., and Betamore.

Whelley received both her Bachelor of Arts and Master of Arts from the University of Maryland. She then attended the University of Maryland School of Law where she received her Juris Doctor. She sits on the board of directors for The Hippodrome Foundation, Baltimore Design School and Downtown Partnership of Baltimore.

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