BHI Weekly Newsletter Archives

ROCKVILLE, Md., Jan. 30, 2024 /PRNewswire/ — NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted NT-I7 (efineptakin alfa) (rhIL-7-hyFc) Orphan Drug Designation (ODD) for the treatment of pancreatic cancer.^[3]

Pancreatic cancer is an aggressive tumor-type associated with extremely poor prognosis. It is the third deadliest cancer in the US and European Union with a combined annual mortality of 139,000.^[1],[4] Advanced pancreatic cancer has a five-year relative-survival-rate of 3%. Pancreatic cancer has been labeled as a “silent killer” because it is normally asymptomatic in the early stages which implies that it is often diagnosed at a late stage when tumors are highly resistant to treatment modalities. This underscores the critical need for new and more effective therapeutic approaches.²

By Jelena Ivanjac | January 30, 2024 – The end of 2023 marked the completion of Virginia’s first statewide life sciences initiative, Virginia Bio-Connect, which started in April 2021. This comprehensive industry cluster strengthening project, supported by Virginia Growth and Opportunity Foundation funding and led by the Virginia Biotechnology Association, engaged thousands of life sciences professionals and hundreds of organizations and companies within the sector with the overarching goal of fostering a more connected life sciences ecosystem, providing support for early-stage companies, and driving workforce development throughout the state.

On January 31, the House passed legislation to restore the immediate expensing of R&D expenses. The Biotechnology Innovation Organization (BIO) has long advocated for this change.

Until 2022, research and development expenses were 100% tax deductible each year. However, the Tax Cuts and Jobs Act of 2017 required companies to amortize domestic expenditures over five years, and international expenditures over 15 years.

The $78 billion Tax Relief for American Families and Workers Act, passed yesterday, would reverse the change and reinstate R&D expensing. R&D expenses would be 100% deductible through 2025.

BioHealth Innovation (BHI) was prominently represented at the 2024 J.P. Morgan Healthcare Conference, with several Entrepreneurs-in-Residence (EIRs) in attendance. The insights gathered by these experienced professionals provide a comprehensive view of the current trends, challenges, and opportunities in the biohealth industry. Here’s a summary of their observations and thoughts.

By Alex Philippidis – February 1, 2024 –  Viewed simply by numbers of merger and acquisition (M&A) deals, 2023 was a down year: 1,078 biotech companies found buyers last year, down from 1,088 in 2022, while the number of pharma companies carrying out buyouts fell more significantly, from 778 two years ago to 679.

These numbers come from LSEG, the global financial markets infrastructure and data provider that owns the London Stock Exchange. LSEG’s data also reveals marked increases in the dollar values assigned to the biotech companies and pharma companies that are being acquired. The total value of biotech M&A in 2023 stood at $122.2 billion, up 45% from $84.2 billion a year earlier. The total value of pharma M&A jumped 38% year over year, from $98.5 billion in 2022 to $135.5 billion in 2023.

The Maryland Department of Commerce invites companies to seize the opportunity to join the Maryland delegation at the BIO International Convention in San Diego, CA, this June 3-6, 2024. This event offers unparalleled networking, learning, and visibility for companies in the biotech sector.

Benefit from a complimentary Premier Access pass, which includes access to key partnering sessions, exhibitor booths, educational content, and exclusive networking receptions. Your company will also gain promotional exposure as part of the delegation.

To be eligible, companies must be registered and in good standing in Maryland. Selected companies are expected to actively participate in pre-conference and event activities, and share insights post-event.

Applications are due by February 21, 2024. Click here to apply now. For queries, contact life.sciences@maryland.gov. This is a valuable opportunity to showcase your company on a global stage. Apply now to join the Maryland delegation at BIO 2024.

BALTIMORE–(BUSINESS WIRE)–Infinity Bio, Inc. announces its new antibody profiling platform, leveraging Molecular Indexing of Proteins by Self-Assembly (MIPSA) technology. This platform offers unparalleled depth in immune system analysis, advancing immunology, virology, autoimmunity, and allergy research, providing new disease insights, and discovering new biomarkers and treatments. The MIPSA technology exploits recent advances in high throughput DNA sequencing and DNA synthesis, to create and analyze the most complete panels of immune targets available.

The immune system crafts antibodies from approximately one quadrillion options, enabling it to identify and neutralize any infectious threat. However, flaws in the immune system can result in excessive inflammation, autoimmunity, or allergies. Infinity Bio’s scientists have developed a novel technique, MIPSA, to examine the extensive array of antibodies present in blood or other fluid, providing comprehensive understanding of individual immune responses.

Florence, Jan. 26, 2024 – PQE Group, the renowned Life Science consulting powerhouse, concludes the fiscal year 2023 with a 10% growth and an upwardly revised income exceeding 100 million euros in revenues. The Italian headquartered global firm, celebrated as a preferred advisor to pharma manufacturing and medical device corporations and SMEs globally, marks this success as a testament to its resilience, adaptability, and strategic vision amid the complex global landscape.

“At a time when many companies grapple with geopolitical challenges, crises, and inflation rates, PQE Group stands out not only for its resilience but for its ability to thrive in uncertain times, showcasing positive growth across all financial indicators,” stated Gilda D’Incerti, CEO & Founder of PQE Group. “This success is rooted in meticulous planning, strategic investments in cutting-edge technologies, and a corporate culture that values agility and innovation.”

BALTIMORE, Jan. 22, 2024 /PRNewswire/ — Haystack Oncology, a Quest Diagnostics (NYSE: DGX) company and developer of best-in-class personalized MRD technology (Haystack MRD™), has entered a research collaboration with TriSalus Life Sciences to evaluate therapeutic response and provide molecular insights in connection with the clinical development of TriSalus’ SD-101, an investigational class C toll-like receptor-9 (TLR9) agonist. SD-101 is delivered via hepatic arterial infusion or pancreatic retrograde venous infusion in their phase 1 and 1b clinical trials using their proprietary Pressure-Enabled Drug Delivery™ (PEDD™) to overcome the challenges associated with intratumoral pressure for patients diagnosed with hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and pancreatic adenocarcinoma.

Johns Hopkins University has launched an ambitious endeavor that the school’s leaders say will make Baltimore a hub of the booming artificial intelligence industry.

The new Data Science and Translation Institute, announced several months ago and planned for the western edge of the Homewood Campus, is expected to be “the leading academic hub for data science and artificial intelligence – a resource that will bring world-class experts to the Baltimore region and drive game-changing innovations,” said Rama Chellappa, interim co-director of the planned institute and a Bloomberg Distinguished Professor at the school.

ROCKVILLE, Md., Jan. 16, 2024 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced positive interim data from the Phase II AAVIATE^® trial of ABBV-RGX-314 for the treatment of wet age-related macular degeneration (wet AMD) using suprachoroidal delivery. Wet AMD is a chronic, life-long disease with available anti-VEGF treatment options that may reduce the risk of blindness, but require frequent injections. Investigational ABBV-RGX-314 using suprachoroidal delivery is designed to be a one-time, in office treatment that has the potential to sustain constant anti-VEGF therapy and stabilize or improve vision long-term for wet AMD patients. The new data presented at the Hawaiian Eye and Retina meeting in Maui, HI by John Pitcher, M.D., Eye Associates of New Mexico, includes 6-month results from two additional dose level 3 cohorts (Cohorts 5 and 6). ABBV-RGX-314, being developed in collaboration with AbbVie, is also being investigated as a potential one-time gene therapy for the treatment of diabetic retinopathy and other chronic retinal conditions.  

The Virginia Catalyst, also known as the Virginia Biosciences Health Research Corporation (VBHRC), today announced that it has awarded $2.2 million in grants to four life and bioscience projects in the Commonwealth of Virginia. These four collaborative projects, involving Virginia research universities and industry partners, were awarded through Virginia Catalyst Grant Round 15 to address major unmet healthcare needs and drive job creation and capital formation in Virginia.

Through this 15^th round of funding, Virginia Catalyst has awarded 61 grants totaling $29.7 million, resulting in over $47 million in matching funds and an additional $821 million in follow-on funding to date.

ROCKVILLE, MARYLAND, January 16, 2024– BioHealth Innovation, Inc. (BHI), a leading public-private non-profit organization dedicated to advancing healthcare innovation in the BioHealth Capital Region, is pleased to announce the appointment of Peter Ronco to its Board of Directors.

Peter Ronco is an accomplished drug developer and innovative senior pharmaceutical executive, currently serving as the Chief Executive Officer of Emmes, a full-service Contract Research Organization (CRO) operating in 30+ countries and across multiple disease areas, including ophthalmology, vaccines, rare diseases, cell & gene therapy, and neuroscience. With extensive global experience spanning therapeutic areas such as oncology, immunology, neuroscience, vaccines, anti-infectives, cardiovascular, and retinal gene therapy, Peter brings a wealth of knowledge and expertise to the BHI Board.

As CEO of Emmes, Peter is responsible for setting the strategic direction and the organization’s day-to-day operations, which collaborates with over 210 sponsors, including pharmaceutical and biotech companies, government agencies, academic institutions, and non-profit foundations.

The Advanced Research Projects Agency for Health (ARPA-H) is soliciting proposals from small business concerns that possess the research and development (R&D) expertise to conduct innovative research that will contribute toward ARPA-H mission needs and Small Business Innovation Research (SBIR) program objectives.

SOLICITATION 75N91024R00006 is anticipated to be made available on or about January 23, 2024 through SAM.gov.  This solicitation is anticipated to have a closing date of February 22, 2024 for receipt of proposals.

The purposes of the SBIR program are to: (a) stimulate technological innovation; (b) strengthen the role of small business in meeting Federal research/research & development (R/R&D) needs; (c) foster and encourage participation by socially and economically disadvantaged small business concerns and women-owned business concerns; and (d) increase private sector commercialization of innovations derived from Federal R/R&D, thereby increasing competition, productivity and economic growth. 

WASHINGTON, D.C., Jan. 16, 2024 (GLOBE NEWSWIRE) — Artificial intelligence (AI) has the potential to detect rheumatic heart disease (RHD) with the same accuracy as a cardiologist, according to new research demonstrating how sophisticated deep learning technology can be applied to this disease of inequity. The work could prevent hundreds of thousands of unnecessary deaths around the world annually. 

Developed at Children’s National Hospital and detailed in the latest edition of the Journal of the American Heart Association, the new AI system combines the power of novel ultrasound probes with portable electronic devices installed with algorithms capable of diagnosing RHD on echocardiogram. Distributing these devices could allow healthcare workers, without specialized medical degrees, to carry technology that could detect RHD in regions where it remains endemic. 

GERMANTOWN, Md., Jan. 16, 2024 /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 European Commission (EC) has granted Orphan Drug Designation for the Company’s first-in-class investigational medicine PRGN-2012 for the treatment of recurrent respiratory papillomatosis (RRP). RRP is a rare, difficult-to-treat and sometimes fatal neoplastic disease of the upper and lower respiratory tracts caused by human papillomavirus type 6 (HPV 6) or HPV type 11 (HPV 11). PRGN-2012 received Orphan Drug Designation from the United States Food and Drug Administration (FDA) and Precigen was the first company to receive Breakthrough Therapy Designation and an accelerated approval pathway from the FDA for an RRP treatment.

ROCKVILLE, Md., Jan. 16, 2024 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced positive interim data from the Phase II AAVIATE^® trial of ABBV-RGX-314 for the treatment of wet age-related macular degeneration (wet AMD) using suprachoroidal delivery. Wet AMD is a chronic, life-long disease with available anti-VEGF treatment options that may reduce the risk of blindness, but require frequent injections. Investigational ABBV-RGX-314 using suprachoroidal delivery is designed to be a one-time, in office treatment that has the potential to sustain constant anti-VEGF therapy and stabilize or improve vision long-term for wet AMD patients. The new data presented at the Hawaiian Eye and Retina meeting in Maui, HI by John Pitcher, M.D., Eye Associates of New Mexico, includes 6-month results from two additional dose level 3 cohorts (Cohorts 5 and 6). ABBV-RGX-314, being developed in collaboration with AbbVie, is also being investigated as a potential one-time gene therapy for the treatment of diabetic retinopathy and other chronic retinal conditions.    

ROCKVILLE, Md., Jan. 15, 2024 /PRNewswire/ — NeoImmuneTech, Inc. (NIT or “NeoImmuneTech”), a clinical-stage T cell-focused biopharmaceutical company, today announces the appointment of Luke Oh, Ph.D., as President, effective immediately.

Dr. Oh is an expert in regulatory policies and drug development, encompassing both biologics and small molecules. He brings over six years of regulatory experience at the U.S. FDA. His recent tenure at Samsung Bioepis as Vice-President in charge of Regulatory Development was marked by the successful preparation and submission of seven biosimilar applications to regulatory agencies in the US, EU, UK, and Canada. Prior to this position, he has worked as Senior Staff Fellow at the U.S. FDA Division of Clinical Pharmacology III and Division of Inflammation and Immune Pharmacology, and he has held various roles in research and development for leading organizations such as Mallinckrodt Pharmaceuticals, Human Genome Sciences, and Vertex Pharmaceuticals. Dr. Oh has a Ph.D. in Neuroimmunology from the McGill University (Montreal, Canada).

January 09, 2024 05:52 AM Eastern Standard Time

SAN FRANCISCO & LONDON–(BUSINESS WIRE)–GSK plc (LSE/NYSE: GSK) and Aiolos Bio, Inc. (Aiolos) today announced that they have entered into an agreement under which GSK will acquire Aiolos, a clinical-stage biopharmaceutical company focused on addressing the unmet treatment needs of patients with certain respiratory and inflammatory conditions, for a $1 billion upfront payment and up to $400 million in certain success-based regulatory milestone payments.

The acquisition provides GSK with access to Aiolos’ AIO-001, a potentially best-in-class, long-acting anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody ready to enter phase II clinical development for the treatment of adult patients with asthma, with potential for additional indications including chronic rhinosinusitis with nasal polyps. AIO-001 was exclusively licensed to Aiolos outside of Greater China by Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui).

Tony Wood, Chief Scientific Officer, GSK, said: “We have a proud heritage and deep development expertise in respiratory medicines, especially addressing diseases driven by IL-5 with high levels of eosinophils or high T2 inflammation. Adding AIO-001, a potentially best-in-class medicine targeting the TSLP pathway, could expand the reach of our current respiratory biologics portfolio, including to the 40% of severe asthma patients with low T2 inflammation where treatment options are still needed.”¹

KeifeRx is currently advancing programs investigating KFRX03, KFRX04, KFXR05 and KFX06 in neurodegenerative, neuroinflammatory, and mast cell-associated diseases

WASHINGTON, Jan. 8, 2024 /PRNewswire/ — KeifeRx, an emerging clinical-stage biopharmaceutical company specializing in the discovery and development of new treatment options for neurodegenerative and immune diseases, announced today entry into an amended exclusive licensing agreement with Georgetown University to advance the development of novel tyrosine kinase inhibitor (TKI) chemical entities (NCE) for the treatment of multiple disease indications. The amendment provides an extension of the exclusively licensed rights to these four novel chemical entities for the treatment of new disease conditions including inflammatory, mast-cell associated diseases, and oncology, in addition to existing rights in neurodegenerative diseases. KeifeRx is currently conducting optimizing and IND-enabling studies involving four separate formulations of the TKI (renamed KFRX03, KFRX04, KFRX05, and KFRX06) with patent life through 2037.

January 9, 2024 / By Clary Estes – National wastewater viral activity levels for COVID-19 have been  very high since December. (It wasn’t your imagination that everyone seemed sick over the holidays.) Currently, wastewater data is the best way to track COVID infections as most people are testing at home and not reporting their status. And currently, wastewater levels indicate that about 2 million Americans are getting infected each day.

This means that we are now in the second-highest COVID surge, after Omicron. As we hover around the fourth year of living with COVID, it is clear COVID could be endemic. With surges such as we are seeing now, personal safety measures are still very much needed—including (and especially) staying up to date on COVID vaccines.

ROCKVILLE, Md., Jan. 4, 2024 /PRNewswire/ — MaximBio, a leading Maryland-based manufacturer specializing in lateral flow and diagnostic devices, is announcing the receipt of a $49.5 million award from the U.S. Department of Health and Human Services (HHS) through the Administration for Strategic Preparedness and Response (ASPR). This funding is designated to fortify the domestic manufacturing capabilities for diagnostic tests and enhance preparedness for potential future pandemics. The award is part of a broader initiative awarding $600 million to 12 domestic COVID-19 test manufacturers.

Project NextGen is a $5 billion initiative to develop next-generation medical countermeasures, including vaccines and therapeutics, to enhance preparedness for future COVID-19 strains and variants.

MANASSAS, Va.–(BUSINESS WIRE)–ATCC, the world’s premier biological materials management and standards organization, today announced a five-year, $87 million award from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, to support the development of next-generation medical countermeasures (MCMs) to protect Americans from public health security threats such as coronaviruses.

Through Project NextGen, BARDA is collaborating with the National Institute of Allergy and Infectious Diseases (NIAID), as well as the private sector, to enable decreased cost, accelerated production, increased efficacy and improved access, strengthen a diverse pipeline of next-generation, innovative vaccines through clinical trials, and support the development of next-generation therapeutics. ATCC will provide cold-chain and lifecycle management of biological specimens from Project NextGen clinical studies.

Lion TCR to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to develop and scale TCR-T cell therapies for solid tumors and viral-related diseases.

ROCKVILLE, Md. and SINGAPORE, Jan. 03, 2024 (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 therapeutics and innovative bioprocessing applications, and Lion TCR, an Asia-based, clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-T cell therapies for solid tumors and life-threatening viral infections today announced the signing of a strategic platform license (SPL). This partnership will enhance MaxCyte’s presence in Asia, with anticipated expansion into the US and European markets.

Maryland biotechnology company promotes improved patient outcomes for infants with body deformities

COLUMBIA, Md. (January 3, 2024) – TEDCO, Maryland’s economic engine for technology companies, announced a recent $200,000 investment from its Life Science Investment Fund (LSIF) into PediaMetrix, a biotechnology company working to detect body deformities in infants and improve patient outcomes. TEDCO’s LSIF lives under the Seed Funds umbrella and invests in companies that have a Federal Drug Administration (FDA) pathway. Participating in this round were also Blu Ventures, as well as a pediatrician.

ROCKVILLE, Md.–(BUSINESS WIRE)–GlycoMimetics, Inc. (Nasdaq: GLYC), a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, today announced positive initial safety, tolerability, and pharmacokinetic results from a Phase 1a study of GMI-1687 in healthy volunteers.

“These positive results represent an important milestone in the development of GMI-1687 as a potential point-of-care treatment option intended to help people living with sickle cell disease when they need it most, at the onset of pain crises,” said Harout Semerjian, Chief Executive Officer of GlycoMimetics. “Our Phase 1a data confirm this highly potent, second-generation E-selectin antagonist has an excellent profile for further development, with no dose-limiting toxicities or safety signals observed along with linear pharmacokinetics. We look forward to completing analysis of the study and advancing partner and financing discussions that support further development of this potentially important new therapeutic option for SCD.”

The overall deal flow in biopharma tapered off in 2023 but the big companies sure know what they want (what they really, really want), according to a new report from J.P. Morgan.

And that’s antibody-drug conjugates, which drove a fourth-quarter spike in licensing deal proceeds and provided a glimmer of hope to an industry battered by outside forces and grim financing prospects.

J.P. Morgan’s annual 2023 Biopharma Licensing and Venture Report arrived on the eve of the firm’s famous conference, which is set to welcome thousands of attendees in San Francisco today—East Coast weather permitting.

2023 was tough, but clinical biotechs still had a lot of opportunities to wheel and deal, according to J.P. Morgan. While licensing deals, venture investments, M&A and IPOs were down overall in the fourth quarter, deal values stayed fairly high thanks to a flurry of late-stage tie ups.

Thomas (Tommy) Luginbill has accepted the position of executive director of the Pinkney Innovation Complex for Science and Technology at Montgomery College (PIC MC). PIC MC is part of Montgomery College’s efforts to grow a hub of education, business, and entrepreneurship, where industry partners co-locate and actively interact with faculty and students to achieve both educational and economic success. In this capacity, Luginbill will continue to advance the development of this innovative science and technology hub in collaboration with academic, corporate and government partners. 

“I am honored to follow in the footsteps of those who have paved the way before me at PIC MC. Their dedication and hard work have laid the foundation for our mission,” Luginbill said. “We are committed to building upon this legacy, creating a vibrant hub for education, business, and innovation that will continue to thrive and benefit the Montgomery County community. Together with our partners, we are ready to embrace this challenge and honor the past while shaping the future.”

Board appointees represent expertise of Maryland’s academic research institutions

COLUMBIA, Md., Jan. 4, 2024 /PRNewswire/ — TEDCO, Maryland’s economic engine for technology companies, announced the recent appointment of Christina DeMur, director of technology development at Johns Hopkins Technology Ventures, to the Maryland Innovation Initiative Board of Directors.

The Maryland Innovation Initiative (MII) was created as a collaboration between the State of Maryland and five Maryland academic research institutions: Johns Hopkins University (JHU); Morgan State University (MSU); University of Maryland, College Park (UMCP); University of Maryland, Baltimore (UMB); University of Maryland, Baltimore County (UMBC).

Recently this collaboration has expanded to include two more comprehensive universities – Frostburg State University and Bowie State University. This expansion will allow MII to further its reach and help bring more innovative research to the market.

There’s a lot of talk about artificial intelligence, or AI, these days. AI is everywhere—from virtual assistants to facial recognition software. The technology is even assisting doctors and scientists. So what exactly is AI? And how is it helping advance scientific research?

“AI is basically trying to teach computers to ‘think’ in the same way as the human brain,” says Dr. Despina Kontos, an AI researcher at Columbia University.

One approach to AI uses a process called machine learning. In machine learning, a computer model is built to predict what may happen in the real world. The model is taught to analyze and recognize patterns in a data set. This training enables the model to then make predictions about new data. Some AI programs can also teach themselves to ask new questions and make novel connections between pieces of information.

Sue Carr clearly remembers the moment that pushed her to become a full-time entrepreneur.

In 2018, Carr was working at a hospital in Montgomery County and responding to a critical situation in the emergency room. She had to administer life-saving medication that was packaged in a glass ampoule — a small glass vial with a bottle head — to a patient.

To open the ampoule, the bottle head must be broken off, which Carr said results in glass shards getting in medication.

• The collaboration will evaluate the ability of NeoImmuneTech’s immune cell amplifier NT-I7 to increase the number of azer-cel allogeneic CAR T cells per batch during manufacturing.
• The combination potential of azer-cel and NT-I7 to increase the number and cancer-fighting properties of the patients own T cells during their treatment with azer-cel, will be evaluated in preclinical work.

ROCKVILLE, Md., Dec. 11, 2023 /PRNewswire/ — Imugene Ltd (“Imugene”) (ASX: IMU), a clinical stage immuno-oncology company, and NeoImmuneTech, Inc. (“NIT”), (KOSDAQ: 950220) a clinical-stage T-cell-focused biopharmaceutical company, today announced a strategic collaboration to evaluate Imugene’s allogeneic CAR T, azer-cel, in combination with NIT’s proprietary immune T cell amplifier “Fc-fused recombinant human interleukin-7”, NT-I7, for the treatment of cancer.

Azer-cel is an allogeneic CD19 CAR T cell therapy program with extensive clinical data and a potentially fast-to-market development strategy. Azer-cel has demonstrated clinically meaningful activity with an acceptable safety profile in blood cancers such as lymphoma and leukemia.  

BALTIMORE, Dec. 7, 2023 /PRNewswire/ — BioGenCell, a pioneer in personalized cell therapy solutions, is excited to announce the launch of its fifth Phase II clinical trial site in the United States at the University of Maryland. The trial is focused on significantly reducing the need for amputation in patients with Chronic Limb-Threatening Ischemia (CLTI). The University of Maryland has joined this ambitious, global, placebo-controlled trial designed to offer transformative results for patients.

The prognosis for CLI patients is currently disheartening: within a year of diagnosis, nearly 20% of patients succumb to the disease while 30% will undergo amputation. Tragically, nearly 70% of these amputees do not survive beyond five years post-amputation.

ROCKVILLE, Md., Nov. 29, 2023 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced that the first patient received RGX-202 at dose level 2 in the Phase I/II AFFINITY DUCHENNE^® trial. RGX-202 is an investigational one-time AAV Therapeutic for Duchenne muscular dystrophy (Duchenne), using the NAV^® AAV8 vector to deliver a transgene for a novel microdystrophin that includes the functional elements of the C-Terminal (CT) domain as well as a muscle-specific promoter to support a targeted therapy for improved resistance to muscle damage associated with Duchenne.

“Progressing to dose level 2 is an important milestone in our updated strategic plans and for accelerating the development of RGX-202,” said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. “There is a large unmet need for new therapies for boys with Duchenne, and the market is capable of supporting multiple gene therapies. We believe RGX-202 has unique, differentiating features that support its potential to be a best-in-class product.”

LOWER GWYNEDD, Penn.–(BUSINESS WIRE)–ChromaTan, Inc., a bioprocess development company revolutionizing the 123-year-old traditional batch biopurification process through transformational next-generation biomanufacturing solutions, announced today that it has been selected as a BLUE KNIGHT™ company.

Blue Knight is a joint initiative between Johnson & Johnson Innovation – JLABS (JLABS) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), dedicated to the acceleration of transformative technology and science that will enable a swift and targeted response to evolving threats to public health and safety.

As a Blue Knight company, ChromaTan will gain access to the global JLABS ecosystem, a premier life science incubator program. In contrast to batch and simulated moving bed techniques, ChromaTan has developed the first-ever, columnless, single-use, steady-state continuous elution chromatography platform (Kascade™ BioRMB™) derived from the real moving bed technique that provides dramatic improvements in productivity and enhanced purities compared to conventional column chromatography in any of its current forms of usage.