ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., a privately held, clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, today announced dosing of the first patient in its Phase 1 clinical trial evaluating ITI-1001, a plasmid DNA (pDNA) vaccine, for the treatment of Glioblastoma Multiforme (GBM), a rare but aggressive form of brain cancer. The study is being conducted at the Dana-Farber Cancer Institute in Boston, Massachusetts and is being led by Dr. David Reardon, Clinical Director, Center for Neuro-Oncology.

“Dosing of the first patient in the Phase 1 clinical trial of ITI-1001 in patients with GBM is a significant clinical development milestone for Immunomic, representing the first time this pDNA vaccine is being administered in humans,” stated Dr. Teri Heiland, Chief Scientific Officer of Immunomic Therapeutics. “We are eager to evaluate the safety and preliminary efficacy in this patient population, who have only limited treatment options for this devastating disease and expect to read out top-line data in the second quarter of 2025.”

Horizon Therapeutics and Roche rank among the top pharma companies in terms of reputation among rare disease patient groups, according to a recent report compiled by U.K. consultancy PatientView. 

Published Tuesday, the 2022 Corporate Reputation of Pharma survey asked 426 rare disease patient groups representing some 3.3 million patients to assess the performance of 34 drugmakers in the space.

The report noted that pharma has steadily improved its reputation among rare disease patient groups over the past five years. Most respondents praised drugmakers’ abilities to provide products that are beneficial to patients and innovating on breakthrough treatments.

Still, the industry scored lower in 2022 for key activities that are meaningful to these patient populations, including fair pricing policies and access to medicines.

Out of the 34 companies, Horizon was ranked first among rare disease patient groups familiar with the brand, followed by Roche and Takeda Pharmaceuticals. Out of 31 companies, Roche was assessed as the top company by rare disease patient groups working with the company.

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We’re excited to introduce you to the always interesting and insightful Gillian Henker. We hope you’ll enjoy our conversation with Gillian below.

Hi Gillian, thanks for joining us today. So let’s jump to your mission – what’s the backstory behind how you developed the mission that drives your brand?

At Sisu Global, we set our vision for a world where medical technology enables access to healthcare in every community. In 2010 at Komfo Anokye Teaching Hospital (KATH), I set out to create medical devices to fit the unmet needs of those in resource-limited settings — medical devices that are simple in nature yet impactful in design, serve as a lifesaving intervention for patients, and directly influence the entire healthcare ecosystem.

COLUMBIA, Md., August 23, 2023 — Welldoc^®, a digital health leader revolutionizing chronic care, today announced the receipt of its 11th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar^® . This clearance immediately follows Welldoc’s 10th 510(k) clearance announcement earlier this month, solidifying the company’s continued leadership in chronic care innovation.

Welldoc’s latest 510(k) enables BlueStar to provide bolus insulin dose recommendations based on the most recent glucose reading and rate of change from a compatible continuous glucose monitoring (CGM) device. This feature enhances BlueStar’s existing digital coaching capabilities, which guide dietary and lifestyle decisions and assist individuals in self-managing their diabetes. Welldoc is the first company to receive clearance for a CGM-informed bolus calculator specifically designed for adults who manage their diabetes with multiple daily injections of insulin.

What does it take to pioneer groundbreaking T-cell immunotherapies and vaccines for infectious diseases and cancer? Join us for this episode of BioTalk, where we sit down with Bill Enright, a seasoned biotech executive with a remarkable track record spanning over three decades. Bill brings a wealth of experience in building and financing both privately held and publicly traded companies, making his mark in various roles within the life science/biotech industry.

Bill offers a compelling update in this installment since his previous appearance on BioTalk. Learn about the intriguing journey that led Vaccitech, a clinical-stage T cell immunotherapy and vaccine company, to select Montgomery County, MD, within the thriving BioHealth Capital Region, for its new site. Delve into the intricacies of their pioneering platform, which harnesses the power of immunotherapy to elicit robust T cell responses and antibodies against infectious agents and tumors.

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On August 16th, BioHealth Innovation, Inc. (BHI) in Rockville, Maryland, hosted a distinguished group of professionals from Japan, representing the International Visitor Leadership Program (IVLP) in collaboration with the U.S. Department of State. This visit marked a significant step towards fostering international relations in the biotechnology sector.

The delegation from Japan arrived with specific objectives for their visit. They aimed to deepen their understanding of technology transfer and the best practices in commercialization. Additionally, they sought to forge strong ties with U.S. technology transfer experts, laying the groundwork for future collaborations. A significant focus was on amplifying biotechnology research and fostering commercial partnerships between the U.S. and Japan. They also aspired to strengthen Japan’s bioeconomy sector, envisioning it as a global epicenter for biotech products and ensuring its biotechnology ecosystems resonate with democratic principles. Furthermore, the delegation intended to heighten the interest of U.S. investors in early-stage biotechnology towards Japanese startups and to broaden the horizons for Japanese companies in the global venture capital arena.

The esteemed group from Japan comprised:

• Dr. Rei Uematsu, Deputy Director, R&D Division, Industrial Science, Technology and Environment Policy Bureau, Ministry of Economy, Trade, and Industry (METI)
• Dr. Jun Sato, Attending Physician, Department of Experimental Therapeutics, National Cancer Center Hospital of Japan
• Dr. Eriko Ogawa, Manager, R&D Division, Amino Up Co., Ltd.
• Dr. Noriyuki Nishimura, Principal Scientist, National Agriculture and Food Research Organization (NARO)
• Dr. Masahiro Taniguchi, R&D General Manager, KAICO Ltd.
• Dr. Minako Sumiyoshi, Regulatory Affairs Officer, Sanatech Seed Co., Ltd.

Representing BioHealth Innovation were Rich Bendis, President and CEO; Luis Gutierrez, Executive in Residence; Albine Martin, Entrepreneur in Residence; and Ethel Rubin, Entrepreneur in Residence.

The visit provided an opportunity for the delegation to learn more about BHI’s mission and services, fostering a deeper understanding and potential for future collaborations.

Rich Bendis, President and CEO of BHI, remarked, “It’s always an honor to host international delegations, especially one as esteemed as this group from Japan. Collaborative efforts like these pave the way for global advancements in biotechnology. We look forward to a future filled with shared knowledge and mutual growth.”

This visit underscores the importance of international collaboration in the biotechnology sector. As the world becomes more interconnected, partnerships like these will be crucial in driving innovation and ensuring the global community benefits from advancements in biotechnology.

FREDERICK, Md., Aug. 18, 2023 /PRNewswire/ -- Zalgen Labs LLC (Zalgen), a biotechnology and diagnostics company focused on high-impact, neglected infectious diseases, including Lassa Fever (LF), today announced publication of data demonstrating that Arevirumab-3^®, its lead immunotherapeutic candidate, is an effective therapeutic for the treatment of Lassa virus infections, with activity against all major viral lineages that cause severe disease in humans, and at very low dosages. 

The study emanated from an extensive and ongoing research collaboration of Zalgen, Tulane University (Tulane), UTMB, and other members of the Viral Hemorrhagic Fever Consortium (VHFC) [www.vhfc.org] and the Viral Hemorrhagic Fever Immunotherapeutic Consortium (VIC) [www.vhfimmunotherapy.org] working on advanced alternatives to treat Lassa fever and other hemorrhagic viral infections.

COLUMBIA, Md. (August 17, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent Social Impact Builder Fund investment of $250,000 into Nostopharma, LLC., a small business developing treatments to restore the health of orthopedic patients.

“Nostopharma is on a mission to revolutionize orthopedic surgery. We hope to offer a complication-free future for trauma patients, athletes and chronic inflammation victims and are developing treatments to help surgeons control trauma complications, including trauma induced abnormal bone growth, a problem that the first application of our platform is looking to solve,” said Ekaterina Vert-Wong, cofounder and CEO of Nostopharma. “We are creating products that minimize abnormal bone growth from the start, helping patients avoid painful and costly revision surgeries.”

BALTIMORE, MARYLAND, UNITED STATES, August 15, 2023/EINPresswire.com/ -- Linshom Medical, a Maryland startup medical device company producing innovative advances in respiratory monitoring, received investments of $250K and $400K from Abell Foundation and TEDCO respectively as part of a Series A preferred equity round.

Accurate respiratory monitoring and rapid detection of early respiratory decline are foundational to ensuring positive patient outcomes. Linshom is first to deliver operating room (OR) quality respiratory data to the patient’s bedside. Patients on the general care floor, in the emergency room, in the post anesthesia care unit, and at home do not have the quality of monitoring available in the OR or intensive care unit (ICU). Those technologies are too big, complex and expensive for bedside use. Linshom addresses these barriers by delivering a small, low cost, wearable sensor that delivers highly accurate, continuous, predictive respiratory monitoring (CPRM) to the patient’s bedside.

How does a BioPharma Cluster ascend the ranks to secure a Top 3 position? What are the key factors propelling the BioHealth Capital Region to achieve its ambitious goal of ranking 3rd by 2023? Join us in this episode of BioTalk, where our host Rich Bendis speaks with Alex Philippidis, Senior Business Editor at Genetic Engineering & Biotechnology News.

In this installment, Alex unveils the intricacies behind his latest Top 10 U.S. Biopharma Clusters, highlighting the impressive rise of the BioHealth Capital Region to its 3rd position. Learn about the origins of these rankings, the trends that have been identified for 2023, and the dynamic shifts within the BioPharma landscape on a regional scale.

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With federal funding and solutions that address major risks and aim to improve outcomes for warfighters and civilians, Polaris and Neuroene are set to continue their momentum as showcase companies in the DMV life science scene.

By Sam Hopkins

August 8, 2023

As the BioHealth Capital Region and other life sciences sectors continue to evolve and innovate, it’s crucial for start-ups and entrepreneurs to seize every opportunity to showcase their groundbreaking work. 

One of those incredible opportunities is this year’s 8th Annual BioHealth Capital Region Crab Trap competition, part of the 9th Annual BioHealth Capital Region Forum. This event has evolved significantly over the years, attracting applicants not only from the region but also from across the country and around the world. 

GAITHERSBURG, Md., Aug. 9, 2023 /PRNewswire/ -- Today, Georgiamune Inc., a privately held, clinical stage biotechnology company, announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for GIM-122, a dual-functioning monoclonal antibody. Furthermore, the company successfully completed a $75M Series A financing, positioning Georgiamune as a promising new biotechnology company in the fields of oncology and autoimmune diseases.

GERMANTOWN, Md., Aug. 9, 2023 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has agreed that the ongoing Phase 1/2 single arm study (NCT04724980) of the first-in-class investigational PRGN-2012 AdenoVerse^™ immunotherapy for the treatment of recurrent respiratory papillomatosis (RRP) will serve as pivotal for the purpose of filing an accelerated approval request for licensure. The FDA also confirmed no additional randomized, placebo-controlled trial will be required to support submission of a biologics license application (BLA). Based on the FDA guidance, the Company plans to initiate a confirmatory study prior to submission of the BLA.

The Technology Transfer Society – Washington D.C. Chapter will be offering an Introduction to Technology Transfer and Commercialization Fall 2023 course in conjunction with Montgomery College. The course will be given in a hybrid format to allow for both virtual and in-person attendance.

This course is intended to provide students with an overview of the entire technology transfer process – moving technologies from the lab to market. This course is a great overview for anyone interested in learning more about the operations of a technology transfer office or those looking to understand how to commercialize their own invention. Students will hear from experienced professionals, including those from federal labs, to broaden their understanding of technology transfer.

NEW YORK CITY, NEW YORK and ROCKVILLE, MARYLAND, Aug. 09, 2023 (GLOBE NEWSWIRE) -- NEW YORK CITY, NEW YORK and ROCKVILLE, MARYLAND, Aug. 9, 2023 (GLOBE NEWSWIRE) – American Gene Technologies International Inc. (“AGT”) and 10X Capital Venture Acquisition Corp. III (“10X III”) (NYSE: VCXB), a special purpose acquisition company, today announced that they have entered into a merger agreement for a business combination that would result in the combined company being a publicly listed company (the public company following the business combination to be renamed “Addimmune”). The combined company is expected to trade under the ticker symbol “HIV”. Addimmune is a clinical-stage gene and cell therapy company developing a functional cure for HIV. Prior to the combination, the non-HIV assets will spin-off into an entity that will retain the American Gene Technologies name.

How does a region evolve to become a leading driver in the BioHealth Capital Region? What are the secrets behind the successful collaboration between various organizations like MCEDC (Montgomery County Economic Development Corporation), MTC (Maryland Tech Council), and the Maryland Department of Commerce? How does a serial biotech entrepreneur leverage his experience to grow a diverse cross-section of businesses, including life sciences, technology, cybersecurity, defense, and hospitality?

In this episode of BioTalk, host Rich Bendis chats with Brad L. Stewart, SVP of Economic Development for Montgomery County Economic Development Corporation (MCEDC). Brad's multifaceted career spans from being a Chief Executive Officer to leading expert teams in strategy and innovation, plus economic development specialists in Montgomery County.

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The Association of University Technology Managers (AUTM) has released its annual Licensing Survey for 2022, revealing promising trends in technology transfer across the United States and Canada. The survey's findings underscore the significant growth in research funding, the robustness of startup companies, and the evolving landscape of licensing.

U.S. Survey Highlights

In the United States, the survey reported record-breaking research expenditures, topping $91 billion in 2022. This marks a 9.5% increase from the previous year and the highest total in the survey's 30-year history.

QIAGEN’s therascreen PDGFRA RGQ PCR kit approved in U.S. to aid in identifying patients with unresectable or metastatic gastrointestinal stromal tumors positive for the PDGFRA D842V mutation who may be eligible for treatment with AYVAKIT® (avapritinib) // First FDA-approved companion diagnostic to detect mutation in the platelet-derived growth factor receptor alpha gene associated with primary resistance to other drugs // Approval adds to QIAGEN’s leading portfolio in precision medicine, including now 12 FDA approved companion diagnostics

Prime Medicine to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to advance their innovative Prime Editing technology and develop a new class of one-time, potentially curative therapies

ROCKVILLE, Md., Aug. 01, 2023 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and to support innovative, cell-based research, today announced the signing of a strategic partnership with Prime Medicine, Inc., a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies.

GAITHERSBURG, Md., July 31, 2023 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) announced today that it was awarded a 10-year contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), valued at up to a maximum of $704 million, for advanced development, manufacturing scale-up, and procurement of Ebanga™ (ansuvimab-zykl), a licensed treatment for Ebola virus disease (EVD).

“For almost 25 years, Emergent has tackled the most serious diseases to assist governments in their preparedness and response strategies,” said Dr. Kelly Warfield, senior vice president, science and development at Emergent. “Ebola virus has the ability to emerge unexpectedly posing a risk to global health. Its elusive nature makes it difficult to predict when and where an outbreak may occur, which underscores the importance of preparedness efforts against this public health threat.”

Virginia officials recognized AMPEL BioSolutions today for their dedication to identifying, training, and retaining STEM-trained workers, especially in the area of precision medicine.

The annual Virginia Talent + Opportunity (V-TOP) award is given on National Intern Day to employers who provide work-based learning opportunities, particularly to interns, who are essential to Virginia's economy and play a crucial role in developing the necessary skills for career success, as stated by Kirk Cox, President of VA Bus Higher Ed Council. Internships are the foundation for workforce development.

Perceptive Advisors leads round to execute study in patients with wet age-related macular degeneration (wet AMD)

BALTIMORE, MD, July 26, 2023– AsclepiX Therapeutics, Inc., a clinical-stage biotech company leveraging computational biology from Johns Hopkins to identify and develop peptides for improved treatments of retinal diseases, announced today that it has secured a $10 million Series A-3 financing. The round was led by Perceptive Advisors with participation from the existing investors Hibiscus Capital Management Fund II and Rapha Capital Management and its managed fund, Rapha Capital PE Life Sciences Fund VI, in addition to a new outside investor.

CHARLOTTESVILLE, VA, JULY 26, 2023 — RIVANNA®, developers of imaging-based medical solutions, announced that they have received funding totaling $30.5 million over 39 months from early execution of an option by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). The funding will support the further advanced development of the Accuro® XV for comprehensive point-of-care musculoskeletal diagnostics as well as submission of an application for FDA clearance.

"Completing our base-stage performance milestones ahead of schedule is a testament to our organization's dedication and commitment to healthcare innovation," said Delphine Le Roux, PhD, PMP, Director of Program Management. “As a direct consequence of this accomplishment, the project received early option one funding, expediting Accuro XV's product development and initial clinical evaluations for FDA clearance. The continued support of our funding partners underscores the strong collaboration built on trust among all stakeholders involved in this effort," added Le Roux.

NORTON, Va. and PETERBOROUGH, ON, July 25, 2023 /PRNewswire/ - Solar Biotech Inc., a Norton, Virginia-based provider of complete sustainable and scalable biomanufacturing solutions, continues to build out its vertically integrated organization by acquiring Noblegen, an advanced digital biology company based in Peterborough, Ontario, Canada.

Noblegen will now operate under the name Solar Biotech Canada, continuing as the organization's food-grade-certified (SQF9) biomanufacturing and research & development hub in Canada. The new company will leverage both partners' strengths in microbiology and biomanufacturing to offer revolutionary biotech and synthetic biology ("SynBio") solutions for a wide range of applications.

The 6th Annual BioHealth Capital Region Investor Conference is just around the corner! Taking place on September 21st, 2023, at the US Pharmacopeia, this in-person event brings together ambitious entrepreneurs, startup-up companies and innovative BioHealth companies with a diverse group of influential investors, offering funding opportunities ranging from pre-seed to Series A.

The BioHealth Capital Region is renowned for its vibrant biotechnology and life sciences community, a breeding ground for groundbreaking advancements and success stories. The conference's history is marked with exceptional achievements, from initial funding rounds to subsequent financings, successful IPOs, and engaging M&A activities.

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the United States Court of Appeals for the Federal Circuit affirmed the district court decision in the patent litigation United Therapeutics brought against Liquidia Technologies, Inc. The Federal Circuit affirmed that Liquidia’s proposed Yutrepia™ product infringes a United Therapeutics’ patent, U.S. Patent No. 10,716,793 (the ’793 patent). As a result, the U.S. Food and Drug Administration (FDA) cannot grant Liquidia final approval for its Yutrepia product until expiration of the ’793 patent, May 14, 2027, except in certain circumstances discussed below.

Galen Robotics has claimed a de novo device clearance from the FDA for its digital surgical assistant, designed to provide a helping hand during ear, nose and throat operations.

The motorized ES system helps stabilize the surgeon’s direct manual control of their instrument—with the goal of reducing natural hand tremors and other movements—to supply greater precision in minimally invasive procedures on soft tissue, as well as offer the ability to let go of the swappable tool and have it remain in place.

The Baltimore-based company, with technology originally spun out of Johns Hopkins University, also aims to promote the device through a “digital-surgery-as-a-service” platform. 

• Emergent has been delivering CYFENDUS™ vaccine to the U.S. Department of Health and Human Services since 2019, under pre-Emergency Use Authorization status, and will continue to work with the U.S. government to transition to post-approval procurement

GAITHERSBURG, Md., July 20, 2023 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) has approved CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted), previously known as AV7909, for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs. The efficacy of CYFENDUS™ vaccine for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax.

“The approval of CYFENDUS™ vaccine is symbolic of Emergent's longstanding partnership with the U.S. government and our shared commitment to helping protect public health,” said Dr. Kelly Warfield, Emergent’s senior vice president, science and development. “The 20-year journey from early development to approval is a major milestone that attests to Emergent's scientific and technical prowess and partnering capabilities. We are grateful for the yearslong collaboration with the Biomedical Advanced Research and Development Authority (BARDA) and early support from the Defense Advanced Research Projects Agency (DARPA) and the National Institute of Allergy and Infectious Diseases (NIAID). Congratulations to the Emergent team and all our partners for advancing this product to approval.”

Talented, diverse, and experienced leaders tapped to support Maryland’s economic engine for technology companies

COLUMBIA, Md. (July 20, 2023) – TEDCO, Maryland’s economic engine for technology companies, held its annual election for the board of directors’ executive officers, reaffirming another term for Chair Omar Muhammad of Morgan State University (MSU).

TEDCO’s full slate of executive officers are:

• Chair – Omar S. Muhammad
• Vice Chair – Ellen Flowers-Fields
• Secretary – Kathie Callahan Brady
• Treasurer – Jeffrey Rhoda
• Assistant Treasurer – Eben Smith

“I’m excited to continue serving on the board of directors. Our work has focused on supporting TEDCO’s mission of creating an enhanced, diverse and inclusive ecosystem throughout the state, and we look forward to continuing this mission through the various resources and programs TEDCO has to offer,” said Omar Muhammad, chair of the board. “In particular, I am excited to move forward with the Cultivate Maryland initiative, a major project that will support the growth of a diverse innovation economy thereby increasing Maryland’s competitiveness as an innovation economy and supporting larger retention and attraction of trained workers.”

Andrew Lees has received The Derek Horton Award in Industrial Carbohydrate Chemistry for outstanding contributions to industrial carbohydrate chemistry.

The Derek Horton Award in Industrial Carbohydrate Chemistry is awarded by the CARB division of the American Chemical Society and acknowledges distinguished achievements in and outstanding contributions to industrial carbohydrate chemistry.  Lees’ award was for his contributions to the field of protein polysaccharide conjugate vaccines, including the development of CDAP chemistry and a low-cost CRM₁₉₇ carrier protein.

Licensing agreement utilizing MilliporeSigma’s CRISPR genome-editing technology supports the advancement of Vita’s pipeline

‍Baltimore, MD, July 18, 2023 – Vita Therapeutics, Inc. today announced a licensing agreement between Vita and MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany. Under the agreement, Vita will leverage MilliporeSigma’s foundational CRISPR patents to advance the development of its preclinical asset VTA-100 for the treatment of limb-girdle muscular dystrophy (LGMD2A). Financial and other terms of the agreement were not disclosed.

“Our purpose is to impact life and health with science, empowering customers to deliver breakthroughs such as Vita's impactful, health-advancing research,” said Christopher Arnot, Director of Licensing and Business Development, Gene Editing, MilliporeSigma.

“For people with limb-girdle muscular dystrophy, the calpain 3 (CAPN3) gene is mutated in satellite cells,” said Douglas Falk, MS, Chief Executive Officer at Vita Therapeutics. “MilliporeSigma’s proprietary CRISPR genome-editing technology will allow us to insert a functional copy of the gene into those cells, taking us an important step forward in advancing the development of VTA-100 as a potential cell therapy.”