CELL AND GENE THERAPY

Boston Labs and Germfree Launch Mobile Cell and Gene Therapy (CGT) Manufacturing Platform

BOSTON LABS | September 23, 2021

Clinical logistics and life science manufacturing leaders Boston Labs and Germfree Laboratories Inc. announced their partnership to launch a new network of mobile CGT manufacturing facilities. The two companies are combining deep logistics, CGT manufacturing expertise and mobile cleanroom technology to deliver CGT point-of-care contract manufacturing services.

The CGT mobile manufacturing platform will launch in Boston, MA in the fourth quarter of 2021 and will scale to a network of global point-of-care mobile contract manufacturing centers.

Boston Labs is embedded within the Boston/Cambridge life science community which is home to more than 1000 biotech companies. 18 of the top 20 biopharmas have a major presence in the area, including Biogen, Novartis, Sanofi and Takeda and other leading companies such as Moderna, Crispr Therapeutics, bluebird bio and Avrobio.

As the cell and gene therapy industry continues to grow, easier on-site access to cleanroom manufacturing facilities will likely be highly valued. Our pivotal partnership with Germfree Laboratories, Inc. enables Boston Labs to readily deploy mobile manufacturing platforms to any clinical site globally where CGT trials are enrolling, eliminating logistical risks associated with transporting patient material under a critical timeline. This is the Future of Point-of-Care Cell and Gene Therapy Delivery.

- Jon Mason, CEO of Boston Labs

This groundbreaking collaboration with Boston Labs should deliver much needed process space and opportunities to showcase how next-generation cleanrooms and manufacturing facilities can accelerate the processes needed for the future.

- Kevin Kyle, CEO of Germfree

This partnership, designed to reduce client CGT manufacturing costs and complexities, delivers secure access to mobile GMP-compliant manufacturing facilities wherever they are needed.

About Boston Labs:
Founded in 2003, Boston Labs is a leading clinical logistics company, working with clients to streamline the complexities of biotech and pharmaceutical logistics and manufacturing. 

About Germfree:
Germfree Laboratories Inc. creates environments that serve life science innovation and advance global health. They design and manufacture flexible cGMP-compliant cleanroom buildings and high containment facilities which are process or containment ready upon deployment.

Spotlight

Oxidative stress results from an imbalance between production of reactive oxygen species (ROS) and the ability of cells to scavenge them. ROS play an important role in the progression of several diseases including inflammation, atherosclerosis, aging and age-related degenerative disorders.

Spotlight

Oxidative stress results from an imbalance between production of reactive oxygen species (ROS) and the ability of cells to scavenge them. ROS play an important role in the progression of several diseases including inflammation, atherosclerosis, aging and age-related degenerative disorders.

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INDUSTRIAL IMPACT

Laronde Attracts $440M in First External Financing to Further Advance Endless RNA™ Platform

Laronde | August 30, 2021

Laronde, the company pioneering Endless RNA™ a novel, engineered form of RNA that can be programmed to express therapeutic proteins inside the body, today announced that it has raised $440 Million in a Series B Financing to advance the development of its eRNA platform and a broad pipeline of programs across a number of therapeutic categories. The financing round included the company's founder, Flagship Pioneering, along with funds and accounts advised by T. Rowe Price Associates, Inc., Invus, Canada Pension Plan Investment Board (CPP Investments), Fidelity Management & Research Company, funds and accounts managed by BlackRock, and Federated Hermes Kaufmann Funds, among others. "Endless RNA represents a whole new approach to making medicines and treating disease," said Diego Miralles, M.D., Chief Executive Officer of Laronde and CEO-Partner at Flagship Pioneering. "Laronde is creating a new class of drugs that can be programmed to persistently express proteins in the body, is redosable, and can be administered through simple delivery mechanisms, resulting in highly tunable protein levels. The therapeutic possibilities enabled by eRNA are vast with the potential to greatly improve global human health. Having assembled such a knowledgeable and committed group of investors gives us the ability to not only advance this powerful technology platform but also build a transformative company to support our bold vision." "Over the past few years, we have seen how programmable platforms like translatable mRNA can rapidly bring forward new medicines," said Avak Kahvejian, Ph.D., Co-Founder and Board Member of Laronde, and General Partner, Flagship Pioneering. "eRNA solves many of the limitations of other drug modalities and unlocks new opportunities for creating first- and best-in-class therapeutics. Since launch, we continue to advance the science of eRNA and have been able to precisely demonstrate a controlled expression of secreted peptides, proteins, antibodies, and vaccine constructs in vivo through the use of an array of delivery options, including subcutaneous administration. Given the programmability of the platform and its unique pharmacology, we anticipate accelerated development timelines and a higher rate of program success than traditional biotech programs." "The field of biotech is at the leading edge of technological progress, challenging us to think beyond incremental advances and to take big leaps – Endless RNA is one of those big leaps," said Noubar Afeyan, Ph.D., Co-founder and Chairman of the Board of Laronde and Founder and Chief Executive Officer of Flagship Pioneering. "We are delighted that investors well familiar with the power and potential of Flagship's bioplatforms are fueling Laronde as we scale the company and the platform to realize the potential of this powerful new class of medicines." About Endless RNA™ Ribonucleic Acids, or RNAs, play a significant role in biology. Among their functions, they provide the "code" that instructs cells to produce or regulate proteins, the building blocks of life and important regulators of disease processes. Because RNAs provide coded instructions to cells, they can be programmed to produce specific effects. This approach has been validated by the successful development of several important RNA-based medicines, but RNA's potential as a drug development modality has just begun. Endless RNA™, or eRNA, was invented at Flagship Labs and is a new class of synthetic, closed-loop RNA. Because eRNA has no free ends, it is not recognized by the immune system and is very stable, enabling a long duration of protein expression. In addition, eRNA can serve protein-coding and non-protein-coding functions, and its protein translation capabilities are completely modular switching an eRNA "protein sequence cassette" enables the expression of a different protein or multiple proteins that can be tuned as needed on an application-by-application basis. About Laronde Laronde is pioneering a platform that offers a completely novel way of modulating human biology. Endless RNA™, invented at Flagship Labs, is a uniquely engineered RNA that can be programmed to express diverse proteins inside the body. It is persistent, non-immunogenic, allows for repeat dosing, and offers flexibility in formulation and delivery. Laronde was founded in 2017 by Flagship Labs, the innovation foundry of Flagship Pioneering. The company is rapidly scaling to support the parallel development of multiple programs across many disease areas. About Flagship Pioneering Flagship Pioneering conceives, creates, resources, and develops first-in-category bioplatform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $130 billion in aggregate value. To date, Flagship has deployed over $2.5 billion in capital toward the founding and growth of its pioneering companies alongside more than $19 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 41 transformative companies, including Denali Therapeutics , Indigo Ag, Moderna , Rubius Therapeutics , Sana Biotechnology , Seres Therapeutics , and Valo Health.

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DIAGNOSTICS

Lucid Diagnostics, a Subsidiary of PAVmed, Announced Launch of VA EsoGuard® Study

Lucid Diagnostics | March 25, 2022

Lucid Diagnostics Inc., a commercial-stage cancer prevention diagnostics company and a majority-owned subsidiary of PAVmed Inc, announced that investigators at the Louis Stokes Cleveland Department of Veterans Affairs Medical Center had enrolled their first patient in a Department of Defense ("DoD")- Katarina B. Greer, M.D., an associate professor of medicine at Case Western Reserve University School of Medicine in Cleveland, is the lead investigator of the research. Lucid supplies the study with EsoCheck® Esophageal Cell Collection Devices and will conduct EsoGuard testing on the obtained samples. We are proud to be partnering with Dr. Greer and the Cleveland VA on this important investigator-initiated clinical study, The study will add important clinical evidence on the impact of EsoGuard in enhancing early detection of esophageal precancer to prevent esophageal cancer deaths by reserving endoscopy for those with a positive EsoGuard test.” Lishan Aklog, M.D., Lucid’s Chairman and Chief Executive Officer. Despite strong clinical practice guideline recommendations, endoscopy has had limited success as a widespread screening tool for Barrett’s Esophagus (BE), a precursor for esophageal adenocarcinoma, a highly lethal form of esophageal cancer, We hope to demonstrate that a strategy that incorporates initial office-based non-endoscopic testing of at-risk patients with EsoGuard improves endoscopy yield and overall cost-effectiveness.” Dr. Greer. Only around 10% of at-risk GERD patients advised for esophageal precancer (BE) screening undergo traditional, invasive upper gastrointestinal endoscopy (EGD). Over 80% of people who undergo EGD screening have a negative result, subjecting the overwhelming majority of these patients to a complicated, invasive, expensive, and inconvenient surgery requiring anesthesia in a specialist procedure center or hospital. EsoGuard has been demonstrated to be 90% sensitive and specific for identifying esophageal precancer and cancer when done on EsoCheck samples, potentially removing the bulk of these negative EGDs, benefiting patients, providers, and the healthcare system. The trial will include up to 100 Cleveland VA patients who meet the American College of Gastroenterology's criteria for esophageal pre-cancer screening. The research compares two screening strategies: (1) regular EGD screening; and (2) EsoGuard testing followed by EGD exclusively in individuals with a positive EsoGuard result. The trial will determine if utilizing EsoGuard to triage patients to EGD improves overall BE screening rates and decreases the number of EGDs with negative screening results. Additionally, the research will analyze the economic implications for the VA system of these two options.

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CELL AND GENE THERAPY

MUSC and Helix launch In Our DNA SC, first-of-its-kind population genomics program to drive preventive, precision health care for South Carolinians

Helix | September 21, 2021

The Medical University of South Carolina (MUSC) and Helix have announced a strategic collaboration to develop a first-of-its-kind population genomics initiative in South Carolina called In Our DNA SC. The large-scale program is designed to improve health care outcomes by integrating genetic insights into clinical care and research. The statewide initiative will enroll 100,000 patients in genetic testing over the next four years at no cost to the patient. The program will enable the use of genomic insights with an initial focus on actionable information regarding a patient's risk for certain forms of cancer and cardiovascular disease. The genetic reports will allow patients and their health providers to develop precision health care plans to proactively mitigate the conditions and take a more preventive approach to patient care. Patient enrollment in In Our DNA SC is expected to begin in the fall. Medical University of South Carolina and Helix to develop a first-of-its-kind genomics initiative called In Our DNA SC. In addition, MUSC and Helix will be developing a robust clinico-genomic dataset from consenting participants that will help researchers learn what can cause certain diseases, how we may be able to treat them more effectively and, possibly, improve the standard care for everyone. This is expected to lay the groundwork for a broader collaboration with other organizations across the health care value chain. As South Carolina's only comprehensive academic health sciences center, delivering the highest quality care throughout the state is our top priority. Precision medicine is an emerging field that is going to transform the future delivery of health care. Being a leader and helping to define this path is core to our mission. We are excited to have the opportunity to partner with Helix to deploy this first-of-its-kind population genomic program for our patients. This collaboration will help drive preventive, precision health care for South Carolinians. - David J. Cole, M.D., FACS, MUSC president The strategic relationship with Helix allows MUSC to leverage Helix's unique Sequence Once, Query Often™ model and its end-to-end integration platform to enable immediate application and continual on-demand use of genetic insights throughout a patient's life. By working with South Carolina's only integrated academic health sciences center in the state, Helix gains access to thousands of providers and research staff dedicated to understanding how to deliver the highest quality patient care available to serve the people of South Carolina and beyond. Enrollment in the program will initially be available to patients who sign up at select MUSC clinics and locations, later expanding to participants throughout the community and state in collaboration with MUSC's clinical affiliates and partners. Additionally, participants who consent to securely contribute their genetic data will help MUSC develop one of the largest clinico-genomic datasets in the country. Analyses from this platform will be used to pioneer and further advance genomics research. About the Medical University of South Carolina Founded in 1824 in Charleston, MUSC is home to the oldest medical school in the South as well as the state's only integrated academic health sciences center, with a unique charge to serve the state through education, research and patient care. Each year, MUSC educates and trains more than 3,000 students and nearly 800 residents in six colleges: Dental Medicine, Graduate Studies, Health Professions, Medicine, Nursing and Pharmacy. MUSC brought in more than $271 million in biomedical research funds in fiscal year 2020, continuing to lead the state in obtaining National Institutes of Health funding, with more than $129.9 million. As the clinical health system of the Medical University of South Carolina, MUSC Health is dedicated to delivering the highest quality and safe patient care while training generations of compassionate, competent health care providers to serve the people of South Carolina and beyond. Close to 25,000 care team members provide care for patients at 14 hospitals with approximately 2,500 beds and 5 additional hospital locations in development, more than 300 telehealth sites and nearly 750 care locations situated in the Lowcountry, Midlands, Pee Dee and Upstate regions of South Carolina. In 2021, for the seventh consecutive year, U.S. News & World Report named MUSC Health the No. 1 hospital in South Carolina.MUSC and its affiliates have collective annual budgets of $4.4 billion. The more than 25,000 MUSC team members include world-class faculty, physicians, specialty providers and scientists who deliver groundbreaking education, research, technology and patient care. About Helix Helix is the leading population genomics company operating at the intersection of clinical care, research, and genomics. Its end-to-end platform enables health systems, life sciences companies, and payers to advance genomic research and accelerate the integration of genomic data into clinical care. Powered by one of the world's largest CLIA / CAP next-generation sequencing labs and the first and only FDA authorized whole exome sequencing platform, Helix supports all aspects of population genomics including recruitment and engagement, clinically actionable disease screening, return of results, and basic and translational research. In response to the COVID-19 public health crisis, Helix has launched a sensitive and scalable end-to-end COVID-19 test system to meet the needs of health systems, employees, governments, and other organizations across the country.

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