Monthly Archives

October 2020

Johnson & Johnson JLABS

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Johnson & Johnson Innovation, JLABS (JLABS) is a global network of open innovation ecosystems, enabling and empowering innovators to create and accelerate the delivery of life-saving, life-enhancing health and wellness solutions to patients around the world. JLABS achieves this by providing the optimal environment for emerging companies to catalyze growth and optimize their research and development by opening them to vital industry connections, delivering entrepreneurial programs and providing a capital-efficient, flexible platform where they can transform the scientific discoveries of today into the breakthrough healthcare solutions of tomorrow.

George Mason University Institute for Biohealth Innovation

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George Mason University is Virginia’s largest public university and the country’s fastest growing research university. Located near Washington, D.C., Mason enrolls 39,000 students from 130 countries and all 50 states. Mason has grown rapidly over the past half century and is recognized for its innovation and entrepreneurship, remarkable diversity, and commitment to accessibility.

The Institute for Biohealth Innovation (IBI) at Mason bridges faculty and students from 34 disciplines to promote progress and share innovation with the goal of enhancing health and wellbeing through new ideas to predict, prevent, treat, and eradicate disease. Our portfolio consists of major research thrusts including cancer, infectious diseases, brain and behavior, injury and performance, reproductive and family health, cardiovascular and metabolic health, digital health and informatics, and policy and economics. The IBI connects Mason researchers with potential collaborators, both within the university and externally, to take on some of biohealth’s biggest challenges.

For more information, follow the IBI on Twitter and LinkedIn

FDA Grants GlycoMimetics Rare Pediatric Disease Designation for Rivipansel for Treatment of Sickle Cell Disease

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ROCKVILLE, Md.–(BUSINESS WIRE)–Oct. 5, 2020– GlycoMimetics, Inc. (Nasdaq: GLYC) today announced that the U.S. Food and Drug Administration (FDA) has granted the Company a Rare Pediatric Disease designation for rivipansel for the treatment of sickle cell disease in patients 18 years old and younger. This designation recognizes the significant needs in pediatric patients.

“The FDA’s designation recognizes the morbidity and mortality burdens of sickle cell disease as well as its significant impact during childhood with life-long implications. With this designation, the agency acknowledges the urgent need for improved treatment of children living with sickle cell disease,” stated Helen Thackray, Chief Medical Officer of GlycoMimetics.

“With global rights for rivipansel in our hands, we are exploring options to move forward in sickle cell disease, including discussions with the FDA as to whether there is a regulatory path to approval,” added Rachel King, Chief Executive Officer. “We plan to roll out the full data set from the Phase 3 RESET program at upcoming medical meetings, based on the acceptance of abstract submissions.”

About Rare Pediatric Disease Designation

The FDA defines a “rare pediatric disease” as a serious or life-threatening rare disease in which the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years. Under the FDA’s Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives an initial approval for a drug or biologic for a “rare pediatric disease” may qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product.

About Sickle Cell Disease (SCD) and VOC

SCD is the most common inherited blood disorder in the United States, impacting approximately 100,000 people. Worldwide, approximately 100 million people carry the SCD trait and an estimated five million live with the disease. While the majority of people with SCD are of African descent, the disease can affect all ethnic groups, especially those from areas where malaria is or was endemic, such as the Middle East, India and the Southern Mediterranean. Acute pain crises or VOCs are the most common clinical manifestation of SCD. A VOC occurs when hypoxia and inflammation lead to vascular occlusion, tissue ischemia and pain.

About Rivipansel

Rivipansel, a glycomimetic drug candidate that binds to all three members of the selectin family (E-, P- and L-selectin), was GlycoMimetics’ first drug candidate to enter clinical development. After the Phase 3 RESET trial conducted by Pfizer, GlycoMimetics’ former collaborator, produced disappointing results in 2019, new clinical outcome data from a post hoc analysis of early treatment with rivipansel were published in June 2020 in advance of a poster shown at the Foundation for Sickle Cell Disease Research Meeting on September 24, 2020.

About GlycoMimetics, Inc.

GlycoMimetics is a biotechnology company with two late-stage clinical development programs and a pipeline of novel glycomimetic drugs, all designed to address unmet medical needs resulting from diseases in which carbohydrate biology plays a key role. GlycoMimetics’ drug candidate, uproleselan, an E-selectin antagonist, was evaluated in a Phase 1/2 clinical trial as a potential treatment for acute myeloid leukemia (AML) and is being evaluated across a range of patient populations including a Company-sponsored Phase 3 trial in relapsed/refractory AML under breakthrough therapy designation. Rivipansel, a pan-selectin antagonist, is being explored for use in treatment of acute VOC in SCD. GlycoMimetics has also completed a Phase 1 clinical trial with another wholly-owned drug candidate, GMI-1359, a combined CXCR4 and E-selectin antagonist. GlycoMimetics is located in Rockville, MD in the BioHealth Capital Region. Learn more at www.glycomimetics.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding the clinical development and potential benefits and impact of the Company’s drug candidates. These forward-looking statements include those relating to the planned or potential clinical development of the Company’s product candidates, including the presentation of data from clinical trials. Actual results may differ materially from those described in these forward-looking statements. For a further description of the risks associated with these statements, as well as other risks facing GlycoMimetics, please see the risk factors described in the Company’s annual report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 28, 2020, and other filings GlycoMimetics makes with the SEC from time to time. Forward-looking statements speak only as of the date of this release, and GlycoMimetics undertakes no obligation to update or revise these statements, except as may be required by law.

Investor Contact:
Shari Annes
Phone: 650-888-0902
Email: sannes@annesassociates.com

Media Contact:
Jamie Lacey-Moreira
Phone: 410-299-3310
Email: jamielacey@presscommpr.com

Source: GlycoMimetics, Inc.

Jeff Galvin, CEO and Founder of American Gene Technologies (AGT), Returns to BioTalk with Rich Bendis

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American Gene Technologies International Inc. (AGT) CEO and Founder, Jeff Galvin returns to update us of their Phase 1 Clinical Trial of their lead #HIV Program, their expansion in a new facility, and what’s next!

Listen now on Apple https://apple.co/2Gi2GIF, Google https://bit.ly/2GizVvu, Spotify https://spoti.fi/2GxROGd, and TuneIn https://bit.ly/3l9HK56.

Jeff Galvin is the CEO and Founder of American Gene Technologies™ (AGT). He earned his BA degree in Economics from Harvard in 1981 and has more than 30 years of business and entrepreneurial experience including founder or executive positions at a variety of Silicon Valley startups. Several of his companies were taken public and/or sold to public companies, including one in the medical-technology arena that was sold to Varian, the leading maker of linear accelerators used in cancer therapy. Following his startup experience, he retired to become an Angel Investor in real estate and high tech. He came out of retirement to found and fund AGT after meeting Roscoe Brady at NIH.

Click here for the transcript.

BioBuzz – Maryland Startup Apsis Healthcare Systems Striving to Simplify Drug Development Where Technology and Biology Meet

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University of Maryland alumni, Sathya Janardhanan, founded Apsis Healthcare Systems in 2018 to help biotech and pharma companies of all sizes simplify drug development through process automation and leveraging the power of Big Data.

Janardhanan, a chemical engineer by trade, started his career in the oil industry but was inspired by what he saw as the growing promise of technology applications in biotech. He pivoted to biotech, joining Amplimmune, Inc. in 2015; he then worked for MedImmune as an analytical development scientist, and eventually became an early employee at NextCure, Inc. and served the company as a senior scientist before launching Apsis Healthcare (Apsis), which is located in Gaithersburg, Maryland.

“I started off as a chemical engineer, and where I studied, this was geared towards the petroleum industry and the chemical sector. As an undergraduate student, I was inspired by the innovation happening in the petroleum sector and saw that a lot of this technology could be applied in the biotech industry to improve drug development,” stated Janardhanan.

Click here to read more via BioBuzz

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