December 2019

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

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.

— 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 61^st 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.

SHANGHAI, Dec. 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.

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, 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