USP, NIST & NIIMBL Researchers Collaborate to Improve Measurement of Viral Vectors Used in Cutting-Edge Gene Therapy

By | News | No Comments

New Collaboration Aims to Improve Measurement of Viral Vectors Used in Cutting-Edge Gene Therapies

A large interlaboratory study of adeno-associated virus (AAV), an important tool in gene therapy, will be led by USP and NIST in collaboration with NIIMBL.

Rockville, MD, July 27, 2021 —The United States Pharmacopeia (USP), the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) and The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) have announced a research collaboration to assess analytical methods and develop standards for adeno-associated virus (AAV), an important mechanism for delivering gene therapies.

AAVs are particularly useful for gene therapies because they are not known to cause human disease and cannot replicate on their own. AAV-based therapies are currently used to treat a type of inherited retinal dystrophy that causes blindness and spinal muscular atrophy in children, and treatments for many more diseases are currently being developed. However, to use AAVs most effectively, scientists need to accurately measure attributes related to their quality. These attributes include the purity of the AAV product and the relative number of virus particles that contain the full genetic payload.

At a workshop hosted by NIIMBL in 2019, academic and industry scientists, product developers, instrument manufacturers and other stakeholders identified needs for improved consistency of measurement methods and physical standards for AAV-based products as top priorities.

“AAV is important because these are critical components to manufacture a variety of gene and cell therapy products,” explained Kelvin Lee, NIIMBL institute director. “By addressing the quality attributes assessment of viral vectors, the field of gene therapies as a whole will benefit from access to high quality components to enable the development of a variety of products.”

As part of this collaboration, USP and NIST will conduct an interlaboratory study in which multiple laboratories will measure these critical quality attributes and their results will be compared and analyzed. This will contribute to the standardization of measurement methods and the development of physical reference materials that will improve measurement consistency across the industry. The study will take  two to three years to complete.

“There is great level of synergy between the organizations engaged in this collaboration,” said Fouad Atouf, USP vice president of global biologics. “NIST’s long-standing experience with measurement sciences and USP’s established role in the application of measurement to the development of methods and associated reference standards is a great combination to advance the field of testing of biopharmaceuticals. NIIMBL provides the appropriate collaborative platform and access to the right stakeholders.”

“This work will help build trust in the quality of AAV,” said NIST research scientist and chemical engineer Wyatt N. Vreeland, who will be leading the NIST component of the collaboration. “And it will support the development of promising new gene therapies that will greatly improve peoples’ lives.”

About USP

The United States Pharmacopeia (USP) is an independent scientific organization that collaborates with the world’s top experts in health and science to develop quality standards for medicines, dietary supplements and food ingredients. USP’s standards are used in the U.S. and other countries to ensure the quality of thousands of products including cardiovascular, oncology, endocrine and antibiotic drugs. Through its standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and food for billions of people worldwide.

About NIST

The U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) promotes U.S. innovation and industrial competitiveness by advancing measurement science, standards and technology in ways that enhance economic security and improve our quality of life. NIST supports the biomanufacturing sector by improving measurement science for the accurate and reproducible characterization of a wide range of processes and products and through the development of reference materials and interlaboratory comparisons.

About NIIMBL

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public-private partnership whose mission is to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry. NIIMBL is part of Manufacturing USA®, a diverse network of federally sponsored manufacturing innovation institutes, and is funded through a cooperative agreement with the National Institute of Standards and Technology (NIST) in the U.S. Department of Commerce with significant additional support from its members.

Media Contacts

USP

Anne Bell

ADB@USP.org

NIST

Richard Press

richard.press@nist.gov

NIIMBL

Maria Chacon

mchacon@udel.edu

Tonix Pharmaceuticals Announces Agreement to Acquire Infectious Disease R&D Facility Frederick, MD to Accelerate Development of Vaccines and Antiviral Drugs

By | News | No Comments

R&D Facility in Frederick, MD is Expected to Provide Internal Capacity to Discover and Develop Vaccines and Antiviral Drugs Against COVID-19, its Variants and Other Infectious Diseases

Facility, Currently Owned and Operated by Tonix Partner Southern Research, has Housed Research Relating to Tonix’s COVID-19 Vaccine Candidate, TNX-1800 and Smallpox and Monkeypox Vaccine Candidate, TNX-801

CHATHAM, N.J., July 27, 2021 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the signing of a Purchase and Sale Agreement to acquire an approximately 48,000 square foot research and development (R&D) facility in Frederick, MD to support Tonix’s expanding infectious disease pipeline, including TNX-1800, a live replicating viral vaccine designed to protect against COVID-19, TNX-801, a live vaccine designed to protect against smallpox and monkeypox, and TNX-3500, a small molecule antiviral to inhibit replication of SARS-CoV-2.

Tonix agreed to purchase the R&D facility from Southern Research, a research collaboration partner for TNX-1800 and TNX-801 development. The facility currently operates at biosafety level 2 (BSL-2) containment. Pending transfer and approval of relevant permits, Tonix expects the transaction to close and the facility to be operational in the fourth quarter of 2021. Southern Research plans to consolidate its research activities at its Birmingham, AL campus. Tonix and Southern Research plan to continue those aspects of their collaboration on the development of vaccines and antivirals that are ongoing at the Birmingham, AL campus.

“The Fredrick facility will be a major expansion of our R&D capabilities,” stated Seth Lederman, M.D., President and Chief Executive Officer of Tonix. “We believe this facility will ensure adequate resources and capacity to support and grow our pipeline of vaccines and antiviral therapeutics. In addition, we view control of in-house facilities as a strategic capability to ensure the speed and efficiency with which we can develop vaccines and antiviral products in the future against known, emerging or novel pathogens.”

Dr. Lederman continued, “While COVID-19 has the appearance of being controlled in certain geographic centers, reports of increasing infections in both unvaccinated and vaccinated individuals, primarily related to new variants, have led to new mask mandates and restrictions in parts of the U.S. as well as new lockdowns and other restrictions in Europe and elsewhere. These concerning trends point to an urgent need for more robust vaccine technology and better overall preparedness. The COVID-19 pandemic revealed weaknesses in the U.S. domestic capability to conduct infectious disease R&D and produce vaccines and therapeutics, particularly in the setting of an interrupted global supply chain. We believe our planned capabilities at the Frederick facility will provide greatly needed domestic resources. The facility is ideally located in Maryland’s ’biotech corridor’, which is rich in highly skilled talent, and is also close to the center of the U.S. biodefense research community.”

Josh Carpenter, PhD, Chief Executive Officer of Southern Research stated, “We are delighted that Tonix will be acquiring the Frederick research campus. This is another chapter in a robust partnership that will be made even stronger. We have enjoyed partnering with Tonix on TNX-1800 and TNX-801 vaccine projects and look forward to continued collaboration on these projects, as well as TNX-3500 with work performed at our Birmingham campus.”

Tonix’s Fredrick R&D facility will complement its Advanced Development Center (ADC) being constructed in New Bedford, MA and the Commercial Manufacturing Center (CMC) that Tonix is planning in Hamilton, MT. The ADC will house laboratories dedicated to process analytical development and pilot manufacturing of its vaccine candidates. The CMC is expected to support commercial scale manufacturing of vaccine products.

Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia. Tonix’s immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Tonix’s lead vaccine candidate, TNX-18002, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8012, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox. TNX-35003 (sangivamycin) is a small molecule antiviral drug in the pre-IND stage of development.

1TNX-102 SL is an investigational new drug and has not been approved for any indication.
2TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.
3TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

About Southern Research

Founded in 1941, Southern Research (SR) is an independent, 501(c)(3) nonprofit affiliated with the University of Alabama at Birmingham. SR is an applied scientific research organization with more than 400 scientists and engineers working across four divisions: CRO services, Drug Discovery, Energy Storage, and Engineering. SR has supported the pharmaceutical, biotechnology, defense, aerospace, environmental, and energy industries. SR works on behalf of the National Institutes of Health, the U.S. Department of Defense, the U.S. Department of Energy, NASA and other major aerospace firms, utility companies, and other external academic, industry and government agencies. SR pursues entrepreneurial and collaborative initiatives to develop and maintain a pipeline of intellectual property and innovative technologies that positively impact real-world problems. SR has numerous ongoing drug discovery programs, which encompass drug discovery programs to combat various forms of cancer, Alzheimer’s, schizophrenia, opioid use disorder, human immunodeficiency virus, disease, Parkinson’s, tuberculosis, influenza, and others. SR’s strong history, which includes nearly 80 years of successful collaborations to solve complex problems, has led to the discovery of seven FDA-approved cancer drugs—a number rivaling any other U.S. research institute. Furthermore, experts at SR are well-equipped to assist with the challenging landscapes of drug design and development technologies and market viability. SR is headquartered in Birmingham, Alabama.

Further information about SR can be found at https://southernresearch.org

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the development of R&D facilities, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the “SEC”) on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com
(646) 942-5588

Peter Vozzo (investors)
Westwicke/ICR
peter.vozzo@westwicke.com
(443) 213-0505

BXP Life Sciences Expands with Montgomery County, Maryland Acquisition

By | News | No Comments

BOSTON PROPERTIES EXPANDS ITS LIFE SCIENCES GROWTH OPPORTUNITY; AGREES TO ACQUIRE 435,000 SQUARE-FOOT CAMPUS FOR LAB REDEVELOPMENT IN THE SHADY GROVE LIFE SCIENCES CLUSTER IN MONTGOMERY COUNTY, MARYLAND

BOSTON – July 27, 2021 – Boston Properties, Inc. (NYSE: BXP), the largest publicly traded developer, owner, and manager of Class A office properties in the United States, announced today that it has agreed to purchase the Shady Grove Bio+Tech Campus in Rockville, Maryland. The property includes seven existing buildings comprising approximately 435,000 square feet across 31 acres in the Shady Grove life sciences cluster, a highly desirable location for leading and emerging companies in the biotechnology sector.

The Company plans to convert the office buildings on the campus to lab to meet current and growing demand in the region from biotechnology companies for new, Class A lab space. The Company expects to begin reconstruction of three of the buildings, which are currently vacant, promptly after closing, which is currently expected to occur in Q3 2021. The Company intends to redevelop or convert the remaining four buildings to lab or life sciences-related uses as each becomes vacant. The gross purchase price for the property is $116.5 million. BXP will own 100% of the campus.

This acquisition builds on BXP’s growing Life Sciences portfolio, which consists of more than 3 million square feet of in-service properties and approximately 1 million square feet of lab development and redevelopment projects that are currently under construction and expected to deliver in the next 36 months. The BXP portfolio also includes approximately 5 million square feet of development opportunities focused on the specific needs of the life sciences sector primarily in Boston, Cambridge, and Waltham/Lexington, Massachusetts, San Francisco, California and now Montgomery County, Maryland.

The Shady Grove Bio+Tech Campus is located in the City of Rockville and is surrounded by the premier cluster for life sciences in Maryland. The campus is situated within a half mile of I-270 with convenient access to MD-355 and other regional arteries. The Montgomery County, Maryland submarket is consistently ranked as one of the top five life sciences clusters in the U.S. and is the epicenter of national public health research and regulatory leadership, hosting the headquarters of the National Institutes of Health (NIH), US Pharmacopeia, the National Institute of Standards and Technology (NIST), the Biomedical Advanced Research and Development Authority (BARDA) and the U.S. Food and Drug Administration (FDA). The area is also supported by several active biotech incubators, both public and private, that accelerate companies and their research. The region is home to more than 400 emerging and established biotechnology and life sciences companies. Top universities in the region, including Johns Hopkins University and the University of Maryland System, produce STEM graduates at a rate that is on par with the regions surrounding other top biotech innovation clusters in the U.S.

“Suburban Maryland benefits from existing dynamics that provide a strong foundation for growth in the life science industry. Growing demand, combined with limited supply, make Montgomery County, Maryland, and this cluster in particular, an attractive opportunity for BXP to expand its life sciences presence,” said Pete Otteni, SVP, Co-Head of the Washington, DC Region, BXP. “We look forward to using our life sciences expertise and real estate skills to transform the property into a leading life sciences campus in the region.”

“We are thrilled to expand our BXP Life Sciences portfolio with the acquisition of Shady Grove Bio+Tech Campus, furthering our ability to create great space and place for scientific discovery,” said David Provost, Co-Head of BXP Life Sciences.

The property’s seller, Lantian Development, was represented by Tommy Cleaver, Dan Grimes, and Stuart Kenny of CBRE.

This press release contains forward-looking statements within the meaning of the Federal securities laws. You can identify these statements by our use of the words “will,” “expects,” “intends” and similar expressions that do not relate to historical matters. You should exercise caution in interpreting and relying on forward-looking statements because they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond Boston Properties’ control and could materially affect actual results, performance or achievements. These factors include, without limitation, Boston Properties’ ability to satisfy the closing conditions and/or complete the transaction on the terms currently contemplated or at all, its ability to complete the conversion and redevelopment projects referenced above on time, within budget or at all, and other risks and uncertainties detailed from time to time in Boston Properties’ filings with the SEC. Boston Properties does not undertake a duty to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

About Boston Properties
Boston Properties (NYSE: BXP) is the largest publicly traded developer, owner, and manager of Class A office properties in the United States, concentrated in five markets – Boston, Los Angeles, New York, San Francisco and Washington, DC. The Company is a fully integrated real estate company, organized as a real estate investment trust (REIT), that develops, manages, operates, acquires and owns a diverse portfolio of primarily Class A office space. Including properties owned by joint ventures, the Company’s portfolio totals 51.6 million square feet and 196 properties, including nine properties under construction/redevelopment. For more information about Boston Properties, please visit our website at www.bxp.com or follow us on LinkedIn or Instagram.

At the Company
Sara Buda
Vice President, Investor Relations
sbuda@bxp.com
617.236.3429

Laura Sesody
Vice President, Corporate Marketing & Communication
lsesody@bxp.com
617.236.3305

The following two tabs change content below.

Charles River Laboratories Completes Acquisition of Rockville’s Vigene Biosciences

By | News | No Comments

June 29, 2021 07:00 AM Eastern Daylight Time

WILMINGTON, Mass.–(BUSINESS WIRE)–Charles River Laboratories International, Inc. (NYSE: CRL) announced today that it has completed the previously announced acquisition of Vigene Biosciences, Inc. for $292.5 million in cash, subject to customary closing adjustments. In addition to the initial purchase price, the transaction includes additional payments of up to $57.5 million, contingent on future performance.

Based in Rockville, Maryland, Vigene Biosciences is a premier, gene therapy contract development and manufacturing organization (CDMO), providing viral vector-based gene delivery solutions. Vigene’s primary area of expertise is CGMP viral vector manufacturing, which is used for gene therapies and gene-modified cell therapies. It also offers high-quality, research grade and CGMP plasmid DNA. The acquisition complements Charles River’s existing cell and gene therapy contract manufacturing capabilities and establishes an end-to-end, gene-modified cell therapy solution in the United States. In addition, the acquisition enables clients to seamlessly conduct analytical testing, process development, and manufacturing for advanced modalities with the same scientific partner, facilitating their goal of driving greater efficiency and accelerating their speed to market.

James C. Foster, Chairman, President and Chief Executive Officer of Charles River Laboratories, commented, “The addition of Vigene Biosciences’ extensive gene therapy capabilities further enhances Charles River’s position as a premier scientific partner for cell and gene therapies. It also accelerates our long-term revenue and earnings growth potential by expanding our portfolio in this emerging, high-growth market sector. We intend to continue to differentiate Charles River by delivering the scientific expertise and customizable approach required to support the complex needs of cell and gene therapy developers and innovators worldwide. Our goal is to become our clients’ scientific partner of choice for advanced drug modalities from discovery and non-clinical development to CGMP manufacturing.”

“We are pleased to welcome the exceptional team at Vigene to the Charles River family, and believe that together, we offer a compelling value proposition for clients and shareholders,” Mr. Foster concluded.

Vigene has become part of Charles River’s Manufacturing Solutions segment, which was renamed from Manufacturing Support to reflect the segment’s broader scientific capabilities with the addition of the Cell and Gene Therapy CDMO business.

Caution Concerning Forward-Looking Statements

This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “expect,” “will,” “may,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements include statements in this news release regarding the acquisition of Vigene Biosciences, Inc., Charles River’s expectations with respect to the impact of Vigene on the Company, its product and service offerings, client perception, revenue, revenue growth rates, and earnings per share; Charles River’s projected future performance including revenue and earnings per share; as well as Charles River’s future growth in the area of cell and gene therapy CDMO services. Forward-looking statements are based on Charles River’s current expectations and beliefs, and involve a number of risks and uncertainties that are difficult to predict and that could cause actual results to differ materially from those stated or implied by the forward-looking statements. Those risks and uncertainties include, but are not limited to, our ability to successfully integrate Vigene, and risks and uncertainties associated with Vigene’s products and services. A further description of these risks, uncertainties, and other matters can be found in the Risk Factors detailed in Charles River’s Annual Report on Form 10-K as filed on February 17, 2021, and the Quarterly Report on Form 10-Q as filed on May 4, 2021, as well as other filings we make with the Securities and Exchange Commission. Because forward-looking statements involve risks and uncertainties, actual results and events may differ materially from results and events currently expected by Charles River, and Charles River assumes no obligation and expressly disclaims any duty to update information contained in this news release except as required by law.

About Charles River

Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.

Contacts

Investor Contact:
Todd Spencer
Corporate Vice President, Investor Relations
781.222.6455
todd.spencer@crl.com

Media Contact:
Amy Cianciaruso
Corporate Vice President, Public Relations
781.222.6168
amy.cianciaruso@crl.com

Childrens National Hospital joins pediatric health challenge led by Center for Advancing Innovation

By | News | No Comments

Leading children’s hospital provides clinical validation, IP for health challenge designed to advance pediatric innovation

Reinforcing its commitment to expanding innovation in pediatric care, Children’s National Hospital is joining with the Center for Advancing Innovation (CAI), and collaborators Resonance Philanthropies and Digital Infuzion, to launch the 2021-2022 Innovate Children’s Health Challenge to encourage the commercialization of technologies that improve children’s health care. This year’s event, Innovate Children’s Health II, focuses on technologies that address pandemic resiliency and prevention in the pediatric population and seeks to advance diagnostics, therapeutics and digital health tools that address pediatric mental health.

Led by CAI, a Maryland-based 501(c)(3) nonprofit, the initiative matches entrepreneurial talent with breakthrough inventions to launch startups and connect them with capital. For this challenge, more than 15 startups will compete for the opportunity to commercialize promising mental health solutions from a variety of research partners, including Children’s National. Nationally recognized for its expertise and commitment to innovation in pediatric care, Children’s National will contribute to the clinical validation of selected technologies.

“In addition to our role in providing clinical validation, this initiative provides the opportunity for intellectual property (IP) developed by leading clinicians at Children’s National Hospital, as well as other great pediatric institutions, to be considered for partnership with entrepreneurs who can help bring these technologies to market,” says Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer at Children’s National. “Our mission is to improve children’s health care and Innovate Children’s Health II is a great way to harness this trifecta model – innovation, talent and capital – in order to develop breakthrough solutions that address the unique needs of pediatric patients.”

There are three ways to participate in Innovate Children’s Health II:

  • Entrepreneurial-minded people – alone or as members of multidisciplinary teams – may compete to commercialize vetted inventions, selected out of patents and patent applications from CAI’s research partners by a committee of industry experts and potential investors.
  • Existing startups may enter the challenge with other public health-related inventions, including their own and/or others to which they have access.
  • Participants may submit ideas that they believe will improve emergency preparedness and pandemic response. CAI will help ideators create a business model to advance their solutions.

Eskandanian highlights the unique model of this challenge, which matches intellectual property with ambitious entrepreneurs and capital, as a critical step in leveraging existing patents that would help improve care for pediatric patients but, under traditional industry conditions, would not make it to market.

Inventors and technology licensing officers may submit inventions to be evaluated and made available for licensing to challenge winners. Innovate Children’s Health II will accept invention submissions until Sept. 1, 2021. Anyone with an entrepreneurial spirit and interest in stopping current and future pandemics is invited to sign up to learn more about the challengeTeams may also enroll in the challenge to choose a featured invention, bring in a third-party invention or get matched with an invention based on area of interest.

“The COVID-19 pandemic has made our children anxious, depressed and pessimistic about their futures. Through Innovate Children’s Health II, CAI and our strategic partner Children’s National, we will strive to give our children hope,” says Rosemarie Truman, founder and CEO of CAI. “We are grateful to Digital Infuzion and Resonance Philanthropies for their support, which makes this challenge possible.”

Eskandanian adds that supporting and expanding pediatric innovation is a key focus of the new Children’s National Research & Innovation Campus, the first-of-its-kind focused on pediatric health care innovation, with the first phase currently open on the former Walter Reed Army Medical Center campus in Washington, D.C. With its proximity to federal research institutions and agencies, universities, academic research centers, as well as on-site incubator Johnson and Johnson Innovation – JLABS, the campus provides a rich ecosystem of public and private partners which will help bolster pediatric innovation and commercialization.

Media Contact: Samantha Desmond | 713-524-8170


About The Center for Advancing Innovation (CAI)

The Center for Advancing Innovation (CAI) is a global public-private partnership, non-profit focused on creating a virtuous circle of innovation and driving growth breakthroughs through novel, creative paradigms, and models. CAI’s mission is to accelerate and increase the volume of technology commercialization to ignite entrepreneurship, bolster the global economy, and maximize the potential of promising inventions. CAI’s award-winning challenge-based accelerator, rigorous evidence-based due diligence, and capital-efficient lean management models serve to hyper-accelerated “gazelle” high-performing startups for outsized investor returns. For additional information about CAI, please visit http://www.thecenterforadvancinginnovation.org.


About Children’s National Hospital

Children’s National Hospital, based in Washington, D.C., celebrates 150 years of pediatric care, research and commitment to community. Volunteers opened the hospital in 1870 with 12 beds for children displaced after the Civil War. Today, 150 years stronger, it is among the nation’s top 10 children’s hospitals. It is ranked No.1 for newborn care for the fifth straight year and ranked in all specialties evaluated by U.S. News & World Report. Children’s National is transforming pediatric medicine for all children. In 2021, the Children’s National Research & Innovation Campus opened, the first in the nation dedicated to pediatric research. Children’s National has been designated three times in a row as a Magnet® hospital, demonstrating the highest standards of nursing and patient care delivery. This pediatric academic health system offers expert care through a convenient, community-based primary care network and specialty care locations in the D.C. metropolitan area, including Maryland and Virginia. Children’s National is home to the Children’s National Research Institute and Sheikh Zayed Institute for Pediatric Surgical Innovation and is the nation’s seventh-highest NIH-funded children’s hospital. It is recognized for its expertise and innovation in pediatric care and as a strong voice for children through advocacy at the local, reg ional and national levels.

For more information, follow us on FacebookInstagramTwitter and LinkedIn.

Cartesian Therapeutics President & Chief Executive Officer, Murat Kalayoglu, MD, PhD, Returns to BioTalk

By | BioTalk, News | No Comments

Dr. Murat Kalayoglu, President and CEO at Cartesian Therapeutics, provides an update since his last visit on their cell and gene therapies, as well as fundraising successes.

Listen now on Apple https://apple.co/2SuVe2M, Google https://bit.ly/35Uq6wV, Spotify https://spoti.fi/3w3d7nd, or TuneIn https://bit.ly/2U9zYjL

Dr. Murat Kalayoglu is President and CEO at Cartesian Therapeutics, a fully integrated, clinical-stage biopharmaceutical company pioneering RNA cell therapy in and beyond oncology. The company, founded in 2016, with three assets in clinical trials, is the leader in RNA cell therapy with products in development for autoimmune, oncologic and respiratory disorders. Cartesian’s investigational therapies are manufactured at a wholly owned, state-of-the-art cGMP manufacturing facility in Gaithersburg, MD. Prior to Cartesian, Dr. Kalayoglu was co-founder and CEO of Topokine, which he led from concept to late-stage clinical trials, followed by a successful sale to Allergan. Dr. Kalayoglu was also co-founder and COO of HealthHonors Corporation, which he led from concept to commercialization, followed by a successful sale to Healthways. Dr. Kalayoglu is a board-certified ophthalmologist who completed his residency and research Fellowship at Harvard, MD/PhD in immunology at the University of Wisconsin-Madison, and MBA from the MIT Sloan School of Management.

Click here for the transcript.

The Life Sciences Expansion Capitol: How Montgomery County, MD, Became a Top Life Sciences Destination

By | News | No Comments

By Max Donley

EVP, Internal Operations and Strategy at Aurinia Pharmaceuticals Inc.

Last month, I was chosen to speak on a panel with leaders in the biotech industry and we all had two things in common: a great appreciation for this emerging life sciences region along with office headquarters in Montgomery County, MD.

It’s no secret the Maryland/DC region has been up-and-coming as a Life Sciences hub over the last decade or so, and I’m proud to say that Aurinia is part of leading this growth. With our move last year to establish a U.S. hub here in Rockville and build on our headquarters in Victoria, B.C., we’ve played a role in making this area a more powerful life sciences destination.

At Aurinia, our mission is to transform people’s lives by delivering therapeutics that change the course of autoimmune disease. We view improving the health of patients and helping patients with chronic unmet needs like lupus nephritis as our responsibility. It is not just a privilege to be working in the lupus space, but an obligation, and the county and the state’s recognition and support of this obligation is a tremendous resource for our ability to support our patients.

We established our U.S. commercial headquarters in Montgomery County in the midst of lockdown with a long-term view that this move to a growing life sciences sector would only serve to advance the development of our company over the coming months and years. We were not alone – as Washington Post columnist Robert McCartney noted in a recent article, the area has continued to grow and thrive through the pandemic, a small silver lining in this unimaginable crisis. Since establishing our local presence, the Aurinia team has been proud to have received FDA approval for our new therapy earlier this year, and for our new Montgomery County hub to serve as home base for our early commercialization efforts.

I feel fortunate to have witnessed the growth in the Montgomery county area over my career, with companies including Medimmune, Sucampo and now Aurinia, and to have seen and worked with the strong talent that exists in this region. It shouldn’t be a huge surprise that Montgomery County has attracted such strong biopharma expertise over the years. Home of the National Institutes of Health (NIH), the FDA and 38 federal labs, and with nearly $8 billion in funding flowing into the life sciences sector in 2020 alone, this area is a hotbed of scientific research and accomplishment.

Over the years, the investment that the county, the state and the region have put into supporting biopharma here has transformed the landscape and we’re now seeing the fruits of this labor in the incredible accomplishments achieved throughout the region. This has created a more diverse and supportive landscape for companies like ours to grow and flourish in the biopharma space. It’s been a fun journey, and there is certainly plenty more opportunities for those currently here and future tenants to make meaningful impacts in treating diseases for patients and their families in need of support.

I couldn’t be happier to be able to call Montgomery County my home for over 20 years. Not only is it a fantastic place to both work, but live as well. The Nation’s capital is right down the road, there is a fantastic network of school systems across all levels of education and the more people that flock towards the region only increase its liveliness and diversity. Not to mention our hometown Washington Nationals and Capitals bringing two championships home to add to our hometown pride!

For all of the above reasons I’m proud to be a part of the change happening in Montgomery County, to build our Aurinia team in the U.S. here, and to share our culture with the local community.

Vita Therapeutics Raises $32 Million in Oversubscribed Series A Financing Led by Cambrian Biopharma to Advance the Development of Therapies to Treat Muscular Dystrophies

By | News | No Comments

June 23, 2021 07:05 AM Eastern Daylight Time

BALTIMORE, Md.–(BUSINESS WIRE)–Vita Therapeutics, a cell engineering company harnessing the power of genetics to develop cellular therapies that follow an autologous and universal hypoimmunogenic approach, today announced the completion of an oversubscribed $32 million Series A. The financing was led by Cambrian Biopharma with participation from Kiwoom Bio, SCM Life Sciences, and Early Light Ventures.

“At Vita Therapeutics our mission is to deliver long-term disease-modifying cell engineered treatments for patients living with muscular dystrophies and other high unmet medical needs,” said Douglas Falk, M.S., Chief Executive Officer of Vita Therapeutics. “We are pleased this high-caliber group of new and existing investors share our enthusiasm and belief in Vita’s ability to progress our innovative treatments to help these patients. This oversubscribed round of financing will enable the company to take the next steps toward achieving our mission.”

“Cell therapies have two grand challenges – getting enough cells and differentiating them into the right cell type to make a long-term impact on a patient’s disease,” said James Peyer, PhD., newly appointed board member of Vita and Chief Executive Officer of Cambrian Biopharma. “By mastering the transition from iPSC to muscle stem cell, Vita can make an unlimited amount of carefully defined muscle stem cells, which has never been possible before. I am so glad to count Vita as a Cambrian affiliate, and I have no doubt Vita will become a genre-defining cell therapy company.”

Vita’s lead therapy, VTA-100, is currently undergoing investigational new drug (IND)-enabling studies for the treatment of limb-girdle muscular dystrophy (LGMD) 2A/R1. It is designed to be an autologous treatment that combines gene correction and induced pluripotent stem cell (iPSC) technology to help repair and replace muscle cells. Vita’s second therapeutic, VTA-200, is a genetically engineered iPSC derived hypoimmunogenic treatment designed to treat multiple types of muscular dystrophy.

The Series A financing will support the completion of all remaining IND-enabling studies for VTA-100 and its subsequent IND submission to the U.S. Food and Drug Administration. This funding will also support the manufacturing of cells needed for clinical evaluation as well as patient recruitment efforts for the first clinical trial. In addition, this financing will be used to further the development of VTA-200 and the development of VTA-300, an undisclosed cell type.

About Limb-Girdle Muscular Dystrophy

Limb-girdle muscular dystrophy (LGMD) is a group of disorders that cause weakness and wasting of muscles closest to the body (proximal muscles), specifically the muscles of the shoulders, upper arms, pelvic area, and thighs. The severity, age of onset, and disease progression of LGMD vary among the more than 30 known sub-types of this condition and may be inconsistent even within the same sub-type. As the atrophy and muscle weakness progresses, individuals with LGMD begin to have trouble lifting objects, walking, and climbing stairs, often requiring the use of assistive mobility devices. There is currently no cure for LGMD, with treatments limited to supportive therapies such as corticosteroids.

About Vita Therapeutics

Vita Therapeutics, a Cambrian Biopharma affiliate, is a cell engineering company harnessing the power of genetics to develop cellular therapies that follow a dual manufacturing strategy, first beginning autologously before moving to a universal hypoimmunogenic cell line. Vita was originally founded out of the labs of Dr. Gabsang Lee and Dr. Kathryn Wagner at Johns Hopkins University and the Kennedy Krieger Institute in 2019 by Douglas Falk, M.S. and Peter Andersen, PhD. The company utilizes induced pluripotent stem cell (iPSC) technology to engineer specific cell types designed to replace those that are defective in patients. We are currently working to progress our lead therapeutic, VTA-100, for the treatment of limb-girdle muscular dystrophy (LGMD), into clinical trials. For more information and important updates, please visit www.vitatx.com or follow us on Twitter @Vita_Tx and LinkedIn.

Contacts

info@vita-therapeutics.com

MacDougall
Susan Sharpe
ssharpe@macbiocom.com
781-235-3060

Connected DMV Released First Cross-Sector Regional Economic Development Strategy (REDS) 1.0 Report”

By | News | No Comments

June 3, 2021 (Washington, D.C.)— The once-in-a-generation pandemic highlighted both the region’s continued lag in economic competitiveness and the absence of a cohesive and coordinated economic development strategy. The Regional Economic Development Strategy (REDS) initiative, launched by Connected DMV, has released the first regional cross-sector blueprint to advance economic opportunity and social equity in Greater Washington, the culmination of a year of work by the REDS Steering Committee.

 

The REDS 1.0 Report, “One: A Blueprint for Enduring Collaboration to Advance Economic Opportunity and Equity in Greater Washington,” lays the foundation for a long-term collaborative framework to improve the competitive advantage of the region both nationally and around the world by operationalizing an enduring cross-sector model made up of leaders from the public sector, industry, academia, community nonprofits and philanthropy working together to advance equitable economic development to improve opportunity for all. Further, it makes the case that the region can only solve structural regional problems that have been endemic constraints by coming together as a table of equal stakeholders across jurisdictions and sectors.

 

“This moment is a turning point for Greater Washington. Let’s choose to work together. Only then can we recover from the losses suffered during the pandemic and achieve unimaginable results to ensure no matter what neighborhood you’re from, Greater Washington becomes an even better place to live and work,” the Steering Committee wrote in the Report’s foreword.

 

The report lays out key challenges that have historically kept many communities within the region from prospering, often starkest along an east-west divide in the region, and outlines the planned path forward through 2024. It also confirms the early focus areas for joint programming to be further designed, developed, and implemented, aligned with an integrated vision for social equity and economic development.

 

Key recommendations for high-potential entry points for greater regional collaboration:

Regional Economic Growth

  • Plan, design and build the first release of a collaborative, data-driven DMV Atlas (DMV Atlas: Accelerating Equitable Regional Growth) with pilot use cases synthesizing cross-sector data sets to unearth new equitable growth opportunities and improve regional planning, investment, and programming

  • Launch a regional leadership workstream focused on closing the region’s East-West divide along ten equity impact areas, and informing DMV Atlas development, as well as other REDS join programs

 

Regional Branding and Marketing

  • Host visioning sessions to include full cross-sector representation to define a joint regional branding and marketing program

  • Organize the first joint regional outreach delegation to attend a national or global tradeshow

  • Launch planning of a major, local, net-new event focused on a regional industry cluster growth area

 

Regional Talent Pipeline

  • Initiate development of a regional career opportunities platform with available upskilling/reskilling resources, internships, apprenticeships, and jobs

  • Establish a forum to develop coordinated regional actions to secure federal, state, and philanthropic funds, resources, and programs related to talent and workforce development

 

In addition to REDS, Connected DMV’s COVID-19 Strategic Renewal Task Force has launched a number of other specific initiatives that provide early proof points in shaping large-scale, net-new growth opportunities across the region through deliberate public-private-academia-community collaboration. They include the Global Pandemic Prevention & Biodefense Center, the National Capital Hydrogen Center, Connectivity for All and the Potomac Quantum Innovation Center (PQIC). REDS will serve as a mechanism to deepen coordination around these initiatives and other regional strategic initiatives with broad economic development scope or potential.

 

About REDS and Next Steps:

REDS 1.0 is the culmination of intensive work that was undertaken from September 2020 to May 2021 by the REDS Steering Committee and Working Group. The Steering Committee consists of 23 results-driven cross-sector leaders from across the region. Their work represents the first time that a cross-sector and cross-jurisdictional group has come together with a shared vision and purpose of laying out guiding principles and goals for collaborative regional economic development. The initiative was approved by Connected DMV’s COVID-19 Strategic Renewal Task Force, a group formed to improve the long-term social, physical and digital infrastructures for inclusive economic growth and renewal across the entire DMV region, post-pandemic.

 

Over the remainder of 2021, the REDS team will continue to convene regional stakeholders, launch joint economic development programs, unearth new opportunities for equitable growth, and take the necessary steps to formalize an enduring regional economic development collaborative.

 

While REDS 1.0 laid the groundwork, two other phases will build a structured, long-term cooperative mechanism to drive equitable economic growth through joint programs. In REDS 2.0 (Timeframe: June-December 2021) the blueprint will continue to be refined and REDS stakeholders will formalize collaboration and launch joint programs. In REDS 3.0 (Timeframe: 2022-2024), the focus will be on operationalizing collaboration and delivering sustained programs.

 

Quotes from REDS Steering Committee members follow below:

“We are creating something new: a more economically equitable and collaborative region. Imagine what we could achieve by doing bigger and better things together, from developing a regional talent pipeline to marketing the region to the world. Only by collaborating regionally on economic development can the entire Washington region reach its full potential as a global technology and innovation hub.”

  • Victor Hoskins, Fairfax County Economic Development Authority

 

“Years and years of fragmented policy and decision-making by both the public and private sectors has led to inequitable and non-inclusive economic development in the region. Instead of every jurisdiction fending for itself, we need new thinking to place facilities and capacity equitably across the entire region as one marketplace. Working together on economic development activities collectively as a region would be an important step in that direction.”

  • David Iannucci, Prince George’s County Economic Development Corporation

 

“Working within each of our jurisdictions, we have found that we share similar interests in certain sector strategies and local priorities. Coming together to find common ground as a region allows us to amplify our individual assets and strengths. A strong, resilient, and inclusive regional economy in the Greater Washington area benefits us all.”

  • Benjamin H. Wu, Montgomery County Economic Development Corporation

 

“In order to reach our region’s true economic and equitable growth potential, we must meaningfully collaborate to jointly tackle our shared regional challenges and opportunities. We are in a much stronger position to do this, building on the success that the NOVA EDA has experienced since our establishment in 2019 – and with the understanding that success grows exponentially as the entire region collaborates on shared economic development goals.”

  • Stephanie Landrum, Alexandria Economic Development Partnership

 

“The Washington DC region is uniquely positioned for economic prosperity, both nationally and internationally. The Regional Economic Development Strategy provides economic development leaders with the framework and tools necessary to work collaboratively and ensures that we realize our potential and grow together.”

  • Keith Sellars, Washington DC Economic Partnership

 

“The DMV has lacked a strategy and forum for cross-sector regional economic development. REDS fills this void, as commissioned by the COVID-19 Strategic Renewal Task Force. Connected DMV will continue to bring the region together to drive collaborative net-new economic growth opportunities that deliver tangible social equity benefits.”

  • Stu Solomon, Connected DMV

 

“The unique neighborhoods and jurisdictions that make up our region are deeply interconnected. That’s why our region deserves a collaborative approach to economic development that includes everyone and lets all our assets shine. The work highlighted in this report represents another step forward towards that goal.”

  • Jack McDougle, Greater Washington Board of Trade

 

“COG recognizes the great strides that have been made recently in economic development collaboration with the NOVA EDA and MDNCREDA. Charting a more equitable development path for Metropolitan Washington is needed, and we look forward to further alignment between REDS and COG planning committees and the Region Forward Coalition moving forward.”

  • Chuck Bean, Metropolitan Washington Council of Governments

 

“Greater Washington’s racial and socioeconomic divisions are real, and they are regional. It is critical for leaders across business, government, civil society, academia, and philanthropy to come together now to do the hard work of creating a better regional environment for uplifting all of our communities.”

  • Rosie Allen-Herring, United Way of the National Capital Area

 

As a long-standing anchor institution in the region, Pepco applauds the development of a regional forum for economic development collaboration that enables dialogue across sectors to shape data-driven inclusive growth opportunities for the communities we serve.”

  • Felecia Greer, Pepco

 

“Every decision we make as regional economic development and planning leaders should be addressing the socioeconomic divide through an equitable growth lens. We must engage existing residents who are chronically and structurally marginalized first. This region is fortunate to have the resources to resolve our persistent and inexcusable economic disparities, and we will become a more desirable region for growth and investment by letting the outside world know that we take care of our own.”

  • Shyam Kannan, Washington Metropolitan Area Transit Authority

 

“Metropolitan Washington is the world’s greatest college town, research park, and showcase for human intellectual and cultural excellence. In many ways, the region leads the world in scientific research, education, culture, and the arts in addition to power and policy. The region is intertwined with, and inseparable from, its educational and research institutions, museums, and international presence. We don’t acknowledge this boldly enough as a community.”

  • Andrew Flagel, Consortium of Universities of the Washington Metropolitan Area

 

“The Regional Economic Development Strategy initiative is about finding what we can do together as a region that we can’t do alone, showing the world that we are ready for the next iteration of how we’re going to live, work, and thrive. Regional interconnectivity will be even more important going forward.”

  • Bob Buchanan, The 2030 Group

 

“As the official destination marketing organization for Washington, DC, we focus on economic development through business and leisure travel. Working with regional partners to market Greater Washington and plan events that attract national and international attention makes economic sense and can move the needle for our region in the long term.”

  • Elliott L. Ferguson, II, Destination DC

 

“As a region, we must build a talent and workforce pipeline that is interconnected and multi-level, one that provides more equitable economic opportunity. It is critical that we work together to attract a more diverse, future-focused talent pool. Collectively, we can address talent development from a supply and demand side, delivering an inclusive labor market that complements the needs of emerging industries in the region such as Healthcare, IT, Cybersecurity, and Quantum.”

  • Dr. Anne Kress, Northern Virginia Community College

 

“Equitable places are attractive places. Especially in light of the past year’s long-overdue racial justice reckoning, creating a diverse and well-educated talent pipeline is a stake in the ground for regional longevity and attracting private sector investment.”

  • Travis Reindl, Bill and Melinda Gates Foundation

 

“We must build a broader pipeline and network for investing that is reflective of the diversity of our region. Venture capital and other forms of private investment must be at the table to contribute to equitable economic development in our region.”

  • Phil Bronner, Ardent Ventures

About Connected DMV

Connected DMV is an initiatives-based, charitable 501(c)(3) organization that works with regional organizations across Washington D.C., Maryland, and Virginia – the DMV – to help drive ongoing improvements to social, digital, and physical infrastructure. Connected DMV focuses on initiatives that span local jurisdictions and require public-private-academia-community collaboration to best achieve the dual objectives of enduring economic health and social equity. https://www.connecteddmv.org/

 

FOR IMMEDIATE RELEASE

Contact:

Toni DeLancey

tonidelancey@connecteddmv.org (703) 980-5935

Dr. Laurie E. Locascio, Vice President for Research at both the University of Maryland College Park and Baltimore, Joins Rich Bendis on a New Episode of BioTalk

By | BioTalk, News | No Comments

Dr. Laurie E. Locascio, Vice President for Research at both the University of Maryland College Park and Baltimore, Visits BioTalk to Discuss Her Career, Tech Transfer, and the Two Institutions Working Together

Listen now on Apple https://apple.co/3oZKsNP, Google https://bit.ly/3vpYr1T, Spotify https://spoti.fi/2QZm3vd, and TuneIn https://bit.ly/2RQqs40.

Laurie E. Locascio, Ph.D., is the Vice President for Research at the University of Maryland, College Park and the University of Maryland, Baltimore.

In this role, Dr. Locascio oversees the University of Maryland’s vibrant research and innovation enterprise at these two campuses, which garner a combined $1.1 billion in external research funding each year. Within Locascio’s purview are the development of large interdisciplinary research programs, technology commercialization, innovation and economic development efforts, and strategic partnerships with industry, federal, academic, and nonprofit collaborators. She is a professor in Maryland’s Fischell Department of Bioengineering, and professor (secondary) in the Department of Pharmacology at the University of Maryland School of Medicine.

Dr. Locascio previously worked at the National Institute of Standards and Technology (NIST), most recently as Acting Principal Deputy Director and Associate Director responsible for leading the internal scientific research and laboratory programs across two campuses in Gaithersburg, MD and Boulder, CO.

Locascio received a B.Sc. in chemistry from James Madison University, a M.Sc. in bioengineering from the University of Utah, and a Ph.D. in toxicology from the University of Maryland, Baltimore. As a biomedical researcher, she published more than 100 scientific papers and 12 patents.

Click here to download the transcript.

Join our Mailing List