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.

BioBuzz: Five Female Investors Who Are Making Their Mark in Life Science

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Less than 10% of decision-makers at U.S. venture capital (VC) firms are women and a whopping 74% of U.S. VC firms have no female investors at all, according to TechCrunch. While the number of female VC decision-makers has increased over the last few years, progress has been painfully slow.

The life science industry, and the venture capital ecosystem that supports it reflects this broader U.S. gender gap. A 2017 Lifestream study found that only 10.9% of publicly-traded biotech board seats were held by women and less than 8% of public biotech CEOs were female. (The survey included 177 biotech companies that were publicly listed between 2012 and 2015.)

The national biotech and VC gender gap are at play here in the BioHealth Capital Region (BHCR) as well. However, increased BHCR support for women in the life sciences and the emergence of several prominent female VC decision-makers are two signs the region is making steady progress in this area, though it still has a long way to go.

TEDCO’s Task Force for Women Entrepreneurs is the most recent example of a concerted effort to support women in the technology and life science industries. The Task Force’s mission is to “…assess the challenges that women entrepreneurs in Maryland face when accessing capital and implement strategies to overcome those challenges.”

The Task Force, chaired by TEDCO board member Myra Norton, who is also President and COO of Baltimore’s Arena, is dedicated to the recruitment, funding and operational support of women-owned and led startups in Maryland.

Women in Bio’s (WIB) Capital Region Chapter offers two programs, MAPS (Mentors, Advisors, Peers, and Sponsorship) groups, and the YWIB (Young Women In Bio) program, both of which are designed to help women thrive in a wide array of STEM fields.

The support ecosystem for women in tech and the life sciences is growing within the BHCR at the same time several prominent female investors and fund directors are making their mark on the field.

If you’ve been making the rounds at regional events like TEDCO’s Entrepreneur Expo, BioHealth Innovation’s (BHI) BioHealth Capital Region Forum or the Maryland Tech Council’s Bioinnovation Conferencesessions and panels involved these VC thought leaders are can’t miss.

Here are the five trailblazing investors shaping the future of life science investing in the region.


BioBuzz: Kite Energizes Maryland’s Cell Therapy and Biomanufacturing Community Around Mission to Cure Cancer

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In May of 2018 Kite Pharma, a Gilead Company, announced the opening of a new Neo Antigen Facility in Gaithersburg, MD. Less than one year later in April of 2019, the company, announced that it was building a new biomanufacturing facility on a 20-acre site in Frederick, MD. Since then, Kite has been diligently working to build a world-class leadership team at both sites to achieve an important mission.

Those leaders are now onboard and are out sharing their important mission by engaging the regional community to recruit and hire the talent they need to fill more than 360 job openings across Maryland..

This November, in one of its first regional community events, Kite sponsored a BioBuzz ‘Meet and Greet’ networking event to get their message out to the local industry.  A few dozen of Kite’s employees, including Chris McDonald, VP of Manufacturing and Frederick Site Head, and Wayne Hardy, Senior Director of Manufacturing and Site Head at Kite’s Neo Antigen Facility, shared the powerful, patient-focused “why” behind Kite’s mission.

“Kite is pleased and happy to be part of this community. We’re here to make a difference. We’re on a mission to cure cancer,” stated Hardy.

“There are a lot of people out there who are suffering… there is probably not a single person in this room untouched by cancer. Think about 10 years from now. You could be telling your kids or grandkids ‘I was part of the team focused on the cure.’ That’s why we’re here in this room right now,” he added.

Click here to read more via BioBuzz

Emergent BioSolutions Announces Growth Strategy and 2024 Goals at Analyst and Investor Day

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GAITHERSBURG, Md., Nov. 21, 2019 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (EBS) today outlined its growth strategy over the next five years and announced its 2024 financial and operational goals during the company’s Analyst and Investor Day held in New York City. Emergent’s senior management shared their vision for continuing to build leadership positions in select public health threat markets and contract development and manufacturing (CDMO), leveraging the company’s unique set of assets, and realizing sustained financial performance and shareholder value creation.

Robert G. Kramer Sr., president and chief executive officer of Emergent BioSolutions, said, “Emergent has developed a growth strategy that supports our desire to make a significant impact on global public health in pursuit of our mission – to protect and enhance life. We are pleased to share this plan, which serves as a roadmap towards our long-term vision of becoming a Fortune 500 company recognized for protecting and enhancing life, driving innovation, and living our values. We are excited by the opportunities ahead and remain steadfastly committed to our patients, customers, employees, and communities.”

2020-2024 Corporate Growth Strategy
The new five-year plan builds upon the successful execution of the previous 2016-2020 plan and is guided by a core strategy focused on five pillars:

  • Execute core business – Deliver core business in products and services;
  • Grow through M&A – Expand impact on patients and customers while profitably delivering incremental topline revenue;
  • Strengthen R&D portfolio – Ensure R&D becomes a more meaningful contributor to growth after 2024;
  • Build scalable capabilities – Invest in operational excellence and innovation to support a growing enterprise that will deliver greater impact; and
  • Evolve culture – Evolve the organization’s culture to support employee engagement and empowerment.

Click here to read the entire Press Release.

BioTalk Host Rich Bendis Guests on The ZIDDANDFIXX Show: Angels Talk Podcast

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Usually BioHealth Founder and CEO, Rich Bendis, is the host asking questions of his guests on the BioTalk Podcast. However, Rich was recently a guest on the “The ZIDDANDFIXX Show: Angels Talk” Podcast for their 26th Episode titled “The Golden Triangle: DC joins San Francisco and Boston.” They discussed Venture Capital, Angel Investment, and the BioHealth Capital Region.

Ziad Moukheiber of Boston Harbor Angels (East Coast), and Faz Bashi (West Coast) of Life Science Angels have a good time chatting about Angel Investing, Entrepreneurship, Restaurants, Politics with good friends and always with great humor and lots of laughter!

Click the link above to listen!


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