Monthly Archives

December 2019

GEN: 8 Biopharma Trends to Watch in 2020

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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.

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

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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

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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, identifier NCT04129164.

Click here to read the entire press release.

Kite Submits Biologics License Application to U.S. Food and Drug Administration for Company’s Second CAR T Cell Therapy

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— Investigational KTE-X19 To Be First Chimeric Antigen Receptor (CAR) T Cell Therapy for Mantle Cell Lymphoma if Approved —

— Filing for Kite’s Second CAR T Therapy Marks Potential Expansion of Company’s Cell Therapy Portfolio —

SANTA MONICA, Calif.–(BUSINESS WIRE)–Dec. 11, 2019– Kite, a Gilead Company (Nasdaq: GILD), today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the investigational chimeric antigen receptor (CAR) T cell therapy, KTE-X19, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

The BLA submission is based on data from the Phase 2 ZUMA-2 trial, which demonstrated an overall response rate of 93 percent, including 67 percent with complete response, as assessed by an Independent Radiologic Review Committee (IRRC) following a single infusion of KTE-X19. In the safety analysis, Grade 3 or higher cytokine release syndrome (CRS) and neurologic events were seen in 15 percent and 31 percent of patients, respectively. No Grade 5 CRS or neurologic events occurred. Detailed findings from this trial were recently presented at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando.

“There remains a significant need for new treatments for patients with relapsed/refractory MCL despite recent advances, so this regulatory filing is an especially important milestone for the MCL community,” said Ken Takeshita, MD, Kite’s Global Head of Clinical Development. “We look forward to working with the FDA to bring KTE-X19 to appropriate patients as quickly as possible and continuing to deliver on the promise of our industry-leading cell therapy development program with a second CAR T therapy.”

Click here to read the entire press release.

Avantor® Opens Innovation and Customer Support Center in Shanghai to Boost Biopharmaceutical Innovation in China

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SHANGHAIDec. 11, 2019 /PRNewswire/ — Avantor, Inc. (NYSE: AVTR), a leading global provider of mission-critical products and services to customers in the life sciences and advanced technologies & applied materials industries, today opened an innovation and customer support center in Shanghai, China to support biopharma research and technology development in the region. Avantor now has nine innovation centers worldwide.

The new Avantor® laboratory will help biopharmaceutical companies accelerate the development of life-changing treatments for patients in the region. It will specifically focus on enhancing industry capabilities in the development and manufacture of safe and effective biological medicines such as monoclonal antibodies (mAbs) and cell & gene therapy. These treatments show great potential in China and are a fast-growing segment of the bioprocessing industry worldwide.

Dr. Ger Brophy, Executive Vice President, Biopharma Production at Avantor, said, “As demand for therapeutic biologics increases worldwide, our latest investment in Asia is a testament to our belief in the potential of China as a critical innovation hub in the global biopharma industry. International leaders and local innovators alike will benefit from enhanced in-country access to Avantor’s workflow expertise, advanced raw material products and exacting quality standards.”

Click here to read the entire press release.

Chuck Morton, Partner, Venable, LLP, guests on BioTalk

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Chuck Morton, Partner, Venable, LLP, joins BioTalk host Rich Bendis to discuss the local entrepreneurial and business ecosystem, regionalism, and the BioHealth Capital Region

Chuck Morton is co-chair of Venable’s Corporate Group. Chuck is recognized for his abilities in guiding financing, mergers and acquisitions (M&A), and other transactions involving middle-market companies. Chuck assists lenders, investors, and entrepreneurs as they create, build, and buy or sell businesses, primarily in the healthcare, technology, and consumer products industries. He regularly acts on behalf of private equity groups and banks. Chuck currently serves as the Secretary on the BioHealth Innovation Board of Directors.

Listen now on Apple Podcasts, Google Podcasts, and TuneIn

MaxCyte and KSQ Therapeutics Announce Development and Commercialization Agreement to Enable the Advancement of KSQ’s Adoptive Cell Therapy Programs

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Gaithersburg, MD and Cambridge, MA – December 4, 2019: MaxCyte, the global cell-based therapies and life sciences company, and KSQ Therapeutics, a biotechnology company using its proprietary CRISPRomics® discovery platform to achieve higher probabilities of success in drug development, announced today that the companies have entered into a new development and commercialization agreement. Under the agreement, KSQ gains rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ instruments for the advancement of KSQ’s engineered tumor-infiltrating lymphocyte (eTIL™) programs, which the company is developing for the treatment of PD-1 refractory solid tumors.

Under the terms of the agreement, KSQ obtains non-exclusive clinical and commercial use rights to MaxCyte’s cell engineering platform to develop multiple adoptive cell therapies. In return, MaxCyte is eligible to receive certain milestone payments in addition to other licensing fees.

“Adoptive cell therapies hold significant potential to improve outcomes for patients that are otherwise unresponsive to current treatments,” said David Meeker, M.D., Chief Executive Officer of KSQ. “MaxCyte’s technology will play an important role in enabling the further development of our eTIL™ programs as we work to bring best-in-class, cell-based medicines forward for difficult to treat solid tumors.”

Click here to read the entire press release.

Ben Wu Named New CEO for Montgomery County Economic Development Corporation

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Ben Wu, the deputy secretary of the Maryland Department of Commerce, has been named as the new CEO for the Montgomery County Economic Development Corporation.

MCEDC is a public-private economic development nonprofit for the county.

The Montgomery County agency’s board of directors announced the appointment in a press release on Wednesday afternoon. Wu’s first day is Dec. 18.

A Montgomery County native, Wu brings years of experience at the local, state, and federal level. Before joining the state Department of Commerce in 2015 as deputy secretary and chief operating officer, he served as a U.S. deputy undersecretary of commerce and U.S. assistant secretary of commerce for technology policy under then-President George W. Bush.

Wu previously worked at the state Department of Commerce as assistant secretary of business and economic development and senior technology policy advisor before returning as deputy secretary in 2015.

At the U.S. Department of Commerce, he served as chief operating officer, overseeing more than 3,000 employees and a $500 million budget for a bureau that included the National Institute of Standards and Technology (NIST) in Gaithersburg.

Click here to read more via Bethesda Magazine

Emmes Will Support Development of a New Universal Flu Vaccine for The National Institute of Allergy and Infectious Diseases

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Monday, December 2, 2019

Emmes today announced that it is part of a team of medical centers, universities and private industry supporting the development of a “universal influenza vaccine” that could provide longer-lasting protection than current vaccines and combat a wider variety of influenza viruses.

This is part of the newly launched Collaborative Influenza Vaccine Innovation Centers (CIVICs) program, under the direction of the National Institute of Allergy and Infectious Diseases (NIAID). According to NIAID, which is part of the National Institutes of Health, the network of research centers will work together in a coordinated, multidisciplinary effort to develop more durable, broadly protective and longer-lasting influenza vaccines.

Dr. Anne Lindblad, president and chief executive officer of Emmes, said, “This project builds upon our experience in supporting clinical trials of influenza vaccines and other emerging infectious diseases, such as Zika and Ebola. It’s exciting to be on the ground floor of this innovative program for NIAID.”

Emmes is working with two other companies to provide the data management and statistical support for the CIVICs program. Digital Infuzion is the prime contractor, with Emmes and Gryphon Scientific, LLC, as subcontractors. All three companies are headquartered in Maryland.

According to the Centers for Disease Control and Prevention, influenza causes hundreds of thousands of hospitalizations and tens of thousands of deaths every year. The time it can take to develop vaccines, plus the fact that existing vaccines do not always protect against the continually changing strains of influenza, led to the new NIAID program.

Click here to read more.

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