QIAGEN celebrates surpassing 2,500 cumulative placements of QIAsymphony

By | News | No Comments

Hilden, Germany, and Germantown, Maryland, January 9, 2020 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the 2,500th placement of QIAsymphony, the leading Sample to Insight workflow automation solution for molecular laboratories worldwide, in Tübingen, Germany.

Cenata GmbH is a medically led genetic diagnostic laboratory offering prenatal testing, and repeat customer of the QIAsymphony, purchasing this milestone QIAsymphony SP as the third unit in their lab, expanding capabilities for circulating DNA purification and other applications.

“The QIAsymphony in our lab is in near-constant use,” explains Dr. Karina Häbig, Scientific Coordinator of Cenata GmbH in Germany. “For our non-invasive prenatal testing applications, especially the Harmony® Test, it gives us consistent results with automation while lowering our hands-on time and ensuring quality.”

“2,500 cumulative QIAsymphony placements represent a great milestone for QIAGEN and are proof-point for a new era in laboratory automation that began in 2008. Today, QIAsymphony is considered a trusted workhorse in molecular testing labs worldwide whose continuous enhancements and ongoing menu expansion enabled numerous breakthroughs in science and helped diagnostic decision making to improve outcomes for over a million patients,” said Thierry Bernard, Interim CEO of QIAGEN and Senior Vice President, Head of the Molecular Diagnostics Business Area “And the remarkable success story is not over yet. Building on the established market leading position for QIAsymphony, we are further expanding the system’s capabilities. The new QIAsymphony PowerFecal Kits add to the growing number of applications that cover different sample types and testing technologies – from liquid biopsies to tissue samples, from PCR to NGS.”

Click here to read the entire release.

NexImmune Expands Executive Team With Appointments of Chief Medical Officer and Chief Financial Officer

By | News | No Comments

GAITHERSBURG, MD — January 08, 2020 – NexImmune, a clinical-stage biopharmaceutical company developing novel immune-therapeutics based on a proprietary Artificial Immune Modulation (AIM) nanotechnology platform, announced that industry veterans Han Myint, MD, and John Trainer, MBA, have been appointed as the Company’s Chief Medical Officer and Chief Financial Officer, respectively.

Dr. Myint commented, “I am very excited to join NexImmune at such a time where I can leverage my professional experience to oversee the Company’s first two clinical trials for NEXI-001 and NEXI-002 in patients with relapsed forms of Acute Myeloid Leukemia (AML) and Multiple Myeloma, respectively. The Company has developed a novel technology that direcects endogenous T cells against multiple tumor antigen targets. For patients suffering from a variety of cancers, I believe this approach has the potential to deliver potent anti-tumor activity while minimizing potential off-target toxicities, and I am looking forward to working with team to make this a reality for these patients.”

Trainer commented, “The tremendous potential of the NexImmune AIM platform in multiple types of cancer and other disease areas is a significant growth opportunity. Scaling up and financing this growth through additional capital raises, partnerships and a potential IPO will be a top priority. I’m excited to be a part of the NexImmune team as we push forward on our mission to help patients.”

Dr. Myint most recently served as the Vice President of Global Medical Affairs – Myeloid Diseases at Celgene. While in that role, he led the Global Franchise Team – Myeloid, and worked very closely with cross-functional teams representing commercial, market access, regulatory, translational and clinical functions to create a cohesive global disease strategy for all development stage compounds in the Myeloid disease pipeline including AML, Myelodysplastic Syndrome (MDS), Myelofibrosis and Thalassemia. Prior to his six year tenure at Celgene, Dr. Myint practiced academic hematology at multiple prestigious institutions, including Rush University in Chicago, and became a Fellow at the Royal College of Physicians and Royal College of Pathologists in London, England. He has expertise and clinical experience in hematological malignancies and stem cell transplantation. Additionally, Dr. Myint built a FACT-accredited and Center of Excellence-Designated Transplant Program at the University of Colorado, Denver, while becoming a fellow of the American College of Physicians.

Trainer most recently served as Vice President and Head of Partnering & Strategy for MedImmune, the biologics-focused R&D unit of AstraZeneca. There, he led all in-licensing, out-licensing and collaboration work for MedImmune including such transactions as the spin-out of Viela Bio (which raised a $250m Series A). Trainer was also responsible for working with partners such as Johns Hopkins University and the NIH to help develop promising new companies and technologies. Previous to that role, Trainer was Vice President, Corporate Development for AstraZeneca and the commercial leader for AstraZeneca’s Infection, Neuroscience and Gastrointestinal group globally, as well as holding a variety of financial, transactional and commercial roles at MedImmune. He received his MBA from Harvard Business School and his undergraduate degree from Harvard College.

Scott Carmer, President and CEO of NexImmune, commented on the additions to the Company’s Executive Leadership Team, “I am thrilled to have both Han and John join our team. Individually, each is a highly respected and accomplished industry leader. Together, their combined experience, expertise and leadership will be a strong complement to those of our existing executive team. As we initiate our first clinical trials in 1Q2020, NexImmune is now poised to exploit the full potential of our unique technology platform for the benefit of patients in need.”

Click here to read the entire press release.

TEDCO’s Maryland Innovation Initiative Infuses $2.63M in New Round of Projects

By | News | No Comments

COLUMBIA, Md.Jan. 8, 2020 /PRNewswire/ — TEDCOMaryland’s economic engine for technology companies, announced its recent round of funding for select projects through the Maryland Innovation Initiative (MII). This round of funding includes project grants for technology assessment and investments in the spin-out companies, from its five partner universities for a total of $2.63M.

Established in 2012, the MII program was created as a partnership between the State of Maryland and five Maryland academic research institutions: University of Maryland, College ParkUniversity of Maryland, Baltimore CountyUniversity of Maryland, BaltimoreJohns Hopkins University; and Morgan State University. The program’s mission is to accelerate promising technologies with significant commercial potential to market while leveraging each partner University’s strengths.

“MII is an ideal representation of the support TEDCO gives to companies from idea and development phases to successful commercialization,” said Arti Santhanam, executive director of MII. “We are especially proud that the MII portfolio is a reflection of the diversity of technology space and applicants that these partner universities bring to the table. Our companies have leveraged these strengths to jumpstart their innovative products and bolster the innovation ecosystem in Maryland.”

Click here to read the entire press release.

Emmes Studies Contribute to FDA Approval of a Medical Device That Estimates the Weight of Infants

By | News | No Comments
Monday, January 6, 2020

Emmes today announced that the U.S. Food and Drug Administration (FDA) has approved a prescription-only medical device used to estimate the weight of infants who are up to 90 days of age.

The Mercy babyTAPE is a tape-measure-like device that permits health care professionals to estimate the body weight of preterm and full-term infants when a scale may not be available or practical to use. Accurately estimating pediatric patient weight is important for drug dosing, resuscitation interventions, and nutritional assessments. This easy-to-produce device could be especially useful in emergency or resource-constrained situations such as remote or rural areas, and in developing countries.

The Mercy babyTAPE was developed under the Best Pharmaceuticals for Children Act, which mandates the National Institutes of Health (NIH) to prioritize therapeutic areas in critical need of pediatric-specific treatment information, sponsor pediatric clinical trials, and submit the data for review by the U.S. Food and Drug Administration (FDA) for action on affected products.

Emmes coordinated operations and analyzed the data from the NIH-funded studies for the original Mercy TAPE devices, which are used in children ages 2-16 years. These were the first weight estimation devices developed under the BPCA program and the first weight estimation devices to be cleared by the FDA. The Mercy babyTAPE now brings the same weight estimation process to infants.

Click here to read the entire press release.

Precigen Receives FDA Orphan Drug Designation for PRGN-3006 UltraCAR-T™ in Patients With Acute Myeloid Leukemia (AML)

By | News | No Comments

GERMANTOWN, Md.Jan. 6, 2020 /PRNewswire/ — Precigen, Inc., a biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to PRGN-3006, a first-in-class investigational therapy using Precigen’s non-viral UltraCAR-T™ therapeutic platform for patients with relapsed or refractory acute myeloid leukemia (AML) (clinical trial identifier: NCT03927261). Precigen announced in Q3 2019 that it had completed enrollment for the first cohort of this clinical trial and expects an initial data readout in the second half of 2020.

The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. Medicines that receive the ODD designation may qualify for a number of incentives that help to expedite and reduce the cost of development, approval and commercialization.

“This regulatory designation underscores the critical medical need for new therapies to treat AML patients. AML is a progressive, debilitating and often fatal disease with limited treatment options,” said Helen Sabzevari, PhD, President and CEO of Precigen*. “As the first regulatory designation for our proprietary UltraCAR-T platform, this orphan drug designation helps to advance the PRGN-3006 investigational therapy and provides important incentives and support to deliver this medicine as rapidly as possible for those patients suffering from this disease.”

Click here to read the entire press release.

Biotech firm, RoosterBio looks to expand

By | News | No Comments

FREDERICK COUNTY, Md. (WDVM) — 2020 is already shaping up to be a big year for RoosterBio, now that they are expanding.

The Frederick based, biotech company is expanding its home base for the second time. Mid-December of 2019, they announced they would be adding an additional 5,000 SF of space.

RoosterBio is focused on developing and manufacturing human adult stem cells and stem cell-based products. The company is the leading supplier of human mesenchymal stem/stromal cell (hMSC) working cell banks and hMSC bioprocess systems. This expansion is a result of an increase in global need. They’ve been distributing in the U.S. market for about 5 years, and now they are moving into global markets like Asia and Europe.

Many of their products are used for research and clinical trials in humans. They can make these products much faster and cheaper than their competitors. Biotech companies like this are important for the future of innovation and medicine because they can help companies looking for a cure for aging stem cells and degenerative diseases, and gene therapy for cancer, therapeutics, etc.

Click here to read more via WDVM

GlycoMimetics and Apollomics Announce Exclusive Collaboration and License Agreement to Develop and Commercialize Uproleselan and GMI-1687 in Greater China

By | News | No Comments

ROCKVILLE, Md. & FOSTER CITY, Calif. & HANGZHOU, China–(BUSINESS WIRE)–Jan. 6, 2020– GlycoMimetics, Inc. (NASDAQ: GLYC), a leader in the field of applied glycotechnology for cancer, and Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of oncology combination therapies, announced today an exclusive collaboration and license agreement for the development and commercialization of uproleselan and GMI-1687 in Mainland China, Hong Kong, Macau and Taiwan, also known as Greater China.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200106005583/en/

Under the terms of the agreement, Apollomics will be responsible for clinical development and commercialization in Greater China. The companies will also collaborate to advance the preclinical and clinical development of GMI-1687, a highly potent, subcutaneous E-selectin antagonist with broad clinical potential. Subject to the terms of the agreement, GlycoMimetics will receive an upfront cash payment of $9 million and will be eligible to receive potential milestone payments totaling approximately $180 million, as well as tiered royalties on net sales. Apollomics will be responsible for all costs related to development, regulatory approvals, and commercialization activities for uproleselan and GMI-1687 in Greater China. GlycoMimetics will supply uproleselan and GMI-1687 to Apollomics via a clinical and commercial supply agreement. GlycoMimetics retains all rights for both compounds in the rest of the world.

“We believe Apollomics is the ideal long-term strategic partner for uproleselan and GMI-1687 in Greater China. The company has a highly experienced leadership team and drug development capabilities that complement our desire to bring these novel therapies to patients with AML and other hematologic malignancies,” said Rachel King, GlycoMimetics Chief Executive Officer. “We are excited about the opportunity to expand the reach of uproleselan and GMI-1687 with this agreement.”

Click here to read the entire press release.

GEN: 8 Biopharma Trends to Watch in 2020

By | News, Uncategorized | No Comments

2019 saw a new record set for a list price of a prescription therapy—$2.1 million for the gene therapy Zolgensma® launched by AxeVis, a Novartis Company—and resulting renewed concerns over the price of treatments and whether politicos will ever be able to address the issue as the nation’s presidential election campaign season heats up.

Also renewed in 2019 was hope that a first treatment indicated for reducing clinical decline in people with Alzheimer’s disease may finally be approved, perhaps as soon as 2020—as well as the ongoing legal wrangle over who invented CRISPR-Cas9, thanks to a second interference proceeding now winding its way through the Patent Trial and Appeal Board.

Also “new” heading into 2020 is a wave of consolidation among gene therapy contract developers and manufacturers; and new concerns among investors as both mergers and acquisition activity and venture capital investment slow down (yet remain strong compared to some recent years), reflecting a cooling of financial markets also reflected in postponement of some IPOs, one of which was launched after being scaled down significantly.

Below is a list of eight biopharma-related trends cited by experts and others with a stake in the industry, as articulated in interviews with GEN, or in reports and other public statements.

Click here to read more via genengnews.com

BioBuzz: After Leading a Dozen Startups Here is What Four Biotech Founders Had To Share About Their Success

By | News | No Comments

In the heart of Montgomery County, Maryland’s premier biotech district there is a 42,000 SF facility with 17,000 SF vacant lab/office suite located at 9900 Medical Center Drive. The newly delivered and available lab space was designed to foster collaboration and learning with an open layout, a welcoming courtyard and an inside common area that is shared with other local tenants.

Collaboration and learning are exactly what was happening on a Wednesday evening in December as nearly 100 biotech professionals, entrepreneurs and leaders from across the BioHealth Capital Region’s (BHCR) gathered for a ‘CEO Talks’ panel to hear from four CxO’s who are leading the regions most exciting biotech companies.

Hosted by Alexandria Real Estate (ARE) and CBRE, the event was moderated by BioHealth Innovation, Inc. (BHI) Founder, President, and CEO, Rich Bendis. As a renowned innovator, investor and regional ecosystem builder, Bendis has played a part in the success stories for many founders and knows what it takes for a biotech startup to become successful.

The CxO panel featured Greg Merril, CEO of Adaptive Phage Therapeutics; Dr. Murat Kalayoglu, CEO at Cartesian Therapeutics; and the dynamic husband and wife duo, Matt Mulvey, Ph.D. BeneVir CEO at The Janssen Pharmaceutical Companies of Johnson & Johnson and Katherine Sacksteder, Ph.D. and BeneVir COO at The Janssen Pharmaceutical Companies of Johnson & Johnson.

Click here to read more via BioBuzz

Viela Bio Announces Initiation of Phase 2b Trial of VIB4920 in Sjögren’s Syndrome

By | News | No Comments

GAITHERSBURG, Md., Dec. 11, 2019 (GLOBE NEWSWIRE) — Viela Bio (Nasdaq:VIE), a clinical-stage biotechnology company pioneering treatments for autoimmune and severe inflammatory diseases, today announced that the first patient has been dosed in a Phase 2b trial of VIB4920 for the treatment of Sjögren’s syndrome—a chronic, systemic autoimmune disease involving inflammation and destruction of the salivary and lacrimal glands which leads to severe dryness and chronic pain.

“Sjögren’s is a common rheumatic disease for which there are currently no approved disease-modifying therapies. Patients with this disease suffer from debilitating fatigue and extensive mouth and eye dryness, and in some cases, lung and kidney disease as well as an increased risk of lymphoma,” said Jorn Drappa, M.D., Ph.D., Chief Medical Officer, Head of Research and Development at Viela Bio. “The initiation of this trial is an important milestone in our research and development efforts involving the CD40/CD40L co-stimulatory pathway. We believe that treatment with our product candidate VIB4920—a fusion protein designed to bind to CD40L—could address immune overactivation in T and B cell-driven diseases such as Sjögren’s syndrome.”

The Phase 2b trial is a randomized, double-blind and placebo-controlled trial designed to evaluate the efficacy and safety of VIB4920 in participants with Sjögren’s syndrome. For additional information about this clinical trial, please visit clinicaltrials.gov, identifier NCT04129164.

Click here to read the entire press release.

Join our Mailing List