October 2019

The Maryland Technology Development Corporation (TEDCO) held its inaugural Entrepreneur Expo in 2011. The first Expo attracted approximately 300 attendees. Three times that number descended on The Hotel at the University of Maryland for its 9th annual Entrepreneur Expo on October 29th.

Entrepreneurs, thought leaders, small business owners, angel and venture investors, federal and state economic development teams and university leaders from across Maryland, the Biohealth Capital Region (BHCR) and beyond gathered at the event to network, share ideas and showcase their programs, technologies and companies.

If there is one word that could describe what it was like at the daylong event that word is ‘Energy’. There was a buzz felt from the moment you walked into the event that carried into the exhibit hall, through every session and into each keynote, and all the way to the event’s conclusion.

Myra Norton, Chair of TEDCO’s Board of Directors, conveyed that energy with inspirational words and a call for solidarity among the Expo attendees in her opening remarks.

“As I was reflecting on this event, I thought about what it means to be an entrepreneur…The highs are really high but the lows can be really low. Sometimes, it’s lonely to be an entrepreneur. There are sleepless nights worrying about if your idea makes sense or if you will make payroll…or when people tell you to be realistic and have reasonable expectations,” stated Norton.

BALTIMORE, Oct. 29, 2019 /PRNewswire/ — Illumina, Inc., a leading developer, manufacturer, and marketer of life science tools and integrated systems, celebrated today the grand opening of its new training facility in the University of Maryland (UM) BioPark.

The 13,000-square-foot Illumina Solutions Center provides training lab capabilities and office space for customers and commercial teams. It is the company’s first commercial location on the East Coast and will host hundreds of employees and customers annually.

Proximity to the University of Maryland School of Medicine’s Institute for Genome Sciences was a key factor in Illumina’s decision to join the UM BioPark’s thriving community of innovative life sciences companies.

“We believe this location will facilitate collaborative engagement in research activities with our academic partner, University of Maryland, Baltimore (UMB),” shared Mark Van Oene, Senior Vice President and Chief Commercial Officer for Illumina. “We are inspired by all the ways genomics can stimulate economic activity to maximize impact in the region and fuel research with the potential to improve health outcomes for patients.”

Click here to read the entire release.

MCY-M11 is being evaluated in relapsed/refractory ovarian cancer and peritoneal mesothelioma

CARMA platform offers faster manufacturing speeds, broader therapeutic applications, combination opportunities and repeat dosing potential

GAITHERSBURG, Md., Oct. 24, 2019 /PRNewswire/ — MaxCyte, the global cell-based therapies and life sciences company, announces today that, having completed dosing of the second cohort of patients, clinical investigators have initiated dosing in the third cohort of patients of MaxCyte’s Phase I clinical trial with the next higher cell dose of MCY-M11. This lead, wholly-owned, non-viral mRNA-based cell therapy candidate from MaxCyte’s CARMA platform is a mesothelin-targeting chimeric antigen receptor (CAR) therapy being tested in individuals with relapsed/refractory ovarian cancer and peritoneal mesothelioma.

The dose escalation trial is evaluating the safety and tolerability, as well as preliminary efficacy, of MCY-M11 administered intraperitoneally across a series of ascending dose-level cohorts. In the first two cohorts, the infusion of MCY-M11 has been well tolerated in all patients treated. No dose-limiting toxicities, infusion-related adverse events, on-target or off-target toxicities, or other unwanted events were observed.

“We are making significant progress with our lead CAR therapeutic and our proprietary CARMA autologous cell therapy platform. Furthermore, the on-going trial continues to demonstrate the feasibility of our one-day cell therapy manufacturing process,” said Claudio Dansky Ullmann, MD, Chief Medical Officer. “We are very excited about the potential of MCY-M11 as a new, effective therapeutic in solid tumors where the majority of patients still have very limited treatment options.”

Click here to read the entire release.

GAITHERSBURG, Md., Oct. 21, 2019 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) today announced that the company will host an analyst and investor day on November 21, 2019 in New York City. This event, which is designed for sellside research analysts and institutional investors, will begin at 8:00 AM EST and end at 2:00 PM EST.

Institutional and analyst attendees who choose to participate onsite must register, as space is limited. To register for onsite participation at the event or for more information, please contact Robert Burrows, IRO for Emergent BioSolutions at burrowsr@ebsi.com or (240) 631-3280.

Event Agenda

Emergent’s senior management will provide a detailed overview of the company’s 2020-2024 Growth Strategy. Presenters include President and CEO, Robert G. Kramer; EVP, Business Operations, Adam Havey; EVP Corporate Development and General Counsel, Atul Saran; EVP and CFO, Richard Lindahl; and the heads of Emergent’s four business units.

Lunch will be provided following the completion of the formal portion of the event.

Webcast Information

A live audio-only webcast of the formal portion of the event as well as presentation materials will be available on the Investor Relations homepage of the company’s website at https://investors.emergentbiosolutions.com/. The audio and accompanying presentations will be archived on the company’s website after completion of the event.

Click here to read the entire Press Release.

SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Oct. 21, 2019 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplement to the New Drug Application for Orenitram® (treprostinil) Extended-Release Tablets reflecting data from the FREEDOM-EV study in patients with pulmonary arterial hypertension (PAH).

The FDA-approved labeling has now been updated to indicate that Orenitram delays disease progression when used in conjunction with an approved oral background PAH therapy. The primary efficacy endpoint of the FREEDOM-EV study was time to first clinical worsening (morbidity or mortality) event. The new label notes that treatment with Orenitram resulted in a significant increase in the time to first clinical worsening event compared with patients who received placebo, which was associated with a reduction in the risk of an event. The treatment effect on time to first clinical worsening due to disease progression was consistent across subgroups.

“We are pleased that the FDA has approved the updated Orenitram label, which should bolster the competitive positioning of this important prostacyclin analogue therapy,” said Leigh Peterson, Ph.D., United Therapeutics’ Vice President, Product Development. “We believe this improved label will provide physicians and patients with even more confidence in the efficacy and benefit of Orenitram.”

“Data from the FREEDOM-EV study have already been well-received by the PAH community throughout the course of scientific and medical discourse,” said Michael Benkowitz, President and Chief Operating Officer of United Therapeutics. “We believe this FDA approval will continue to expand the commercial opportunity for Orenitram.”

Click here to read the entire Press Release.

BALTIMORE, Md., Oct. 21, 2019 (GLOBE NEWSWIRE) — CoapTech LLC announced today that the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) within the National Institutes of Health (NIH) awarded the company a two-year, $1.2M R44 Small Business Innovation Research (SBIR) Phase II grant on August 29, 2019. This builds on a $225,000 Phase I SBIR R43 grant and a $200,000 Maryland Industrial Partnerships (MIPS) grant awarded to the company last year.

The new $1.2M grant will support a 40-patient clinical trial at the University of Maryland Medical Center (UMMC) evaluating safety and cost-effectiveness characteristics of a novel medical procedure known as percutaneous ultrasound gastrostomy (PUG), which is enabled by CoapTech’s PUMA-G device.

The PUG procedure is the world’s first and only ultrasound-based procedure for placing semi-permanent feeding tubes into the stomach. These feeding tubes are vital for patients who cannot eat or swallow, and require liquid nutrition (known as enteral feeding). Common conditions that require enteral nutrition include cancer, diabetes, and recovery after stroke – all of which are on the rise.

R. Gentry Wilkerson, MD, assistant professor of emergency medicine at the University of Maryland School of Medicine, will serve as the principal investigator for the study. According to Dr. Wilkerson, “This study aims to demonstrate that a broad, multidisciplinary team of physicians, including critical care intensivists, interventional radiologists, and interventional pulmonologists, will be able to complete feeding tube placement using point-of-care ultrasound. The expansion of types of providers that will be able to place feeding tubes may benefit patients by decreasing delays in having the procedure performed. In addition, the medical system can benefit through improved resource utilization.”

The grant will also fund an evaluation of training and workflow approaches for the new PUG procedure. This evaluation will inform and optimize best practices, leading to a validated training methodology for new users, aiding in rapid dissemination of this novel option for feeding tube placement to physicians around the world. Experts in human factors and ultrasound-procedures from the Johns Hopkins Medicine Armstrong Institute for Patient Safety and Quality will inform the training and workflow evaluation.

Click here to read the entire Press Release.

Gentian’s CEO Dr. Hilja Ibert, Ph.D., guests on BioTalk from the BioHealth Capital Region Investor Conference to talk about their presence in the US market, Biomarkers, and Innovate Diagnostic Efficiency.

Listen now on Google Podcasts http://bit.ly/2MwE0w8, Apple Podcasts https://apple.co/2P7e5Nw, and TuneIn http://bit.ly/2oZkv6x

Dr. Hilja Ibert has over 25 years’ experience from the international diagnostic industry, from which she also has extensive leadership experience. She is a hands-on CEO, driving development and commercialization of product solutions for the clinical diagnostics market.

Gentian is a research-driven company that Dr. Ibert knows to appreciate, as she has gained experience with the development and market introduction of innovative technology throughout her career. Gentian develops and manufactures immunoassays based on unique and proprietary technologies, which enables these products to run on a wide range of high-throughput clinical chemistry analyzers. This results in significant workflow advantages for the laboratories. Through Dr. Ibert’s leadership, the company innovates and focuses on diagnostic efficiency through development and production of accurate and high throughput immunoassays that save time and costs for the laboratories and which provide relevant information earlier to clinicians. By doing so, Gentian contributes to improved patient outcomes. Gentian’s current products and pipeline cover kidney, infectious, inflammatory and cardiovascular diseases.

The biotech company is developing a cell therapy that could help patients who have suffered a heart attack. It’s the latest company led by medtech entrepreneur Bill Niland.

NeoProgen, a Baltimore-based company led by medtech entrepreneur Bill Niland, raised $1.5 million in seed funding as it develops a cell therapy for patients following a heart attack.

The round featured an all-Maryland lineup of investors: The University System of Maryland’s Momentum Fund, which contributed $245,000; TEDCO; and UM Ventures, which is the commercialization arm of the University of Maryland.

Like his earlier venture, Harpoon Medical, NeoProgen has origins in research at the University of Maryland, Baltimore. That’s where Dr. Sunjay Kaushal, a leading pediatric cardiac surgeon, found that a specific kind of stem cells are extremely effective in regenerating muscle tissue in the heart.

While they are normally discarded following surgery on infants with congenital heart disease, the regenerative properties of these still-growing cells can be particularly effective in healing, Niland said. They can be put to use to help patients who suffered a heart attack, a group of which 40% experience heart failure.

Through research studies, “what we’re seeing is that the cells greatly diminish the damage to the heart from the heart attack,” Niland said.

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