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.

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.

ROCKVILLE, Md., Jan. 8, 2024 /PRNewswire/ -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) ("Shuttle Pharma") today announced they have received the 'Safe to Proceed' letter from the U.S. Food and Drug Administration (FDA) for the Company's investigational new drug (IND) application for its Phase II study of Ropidoxuridine (IPdR) as a radiation sensitizing agent during radiotherapy in patients with newly diagnosed IDH-wildtype glioblastoma with unmethylated MGMT promoter. Receipt of the letter allows Shuttle to commence the Phase II study.

Shuttle Pharma is currently finalizing site enrollment with 'first patient, first dose' expected in the coming months. Ropidoxuridine is Shuttle Pharma's lead radiation sensitizer candidate for use in combination with radiation therapy (RT) to treat glioblastoma, a deadly malignancy of the brain with no known cure.

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. 

Are you prepared to discover a transformative shift in orthopedic innovation? Join us in this episode of BioTalk with Rich Bendis as step into the world of Nanochon with CEO Ben Holmes.

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.

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.

• NeuMoDx CT/NG Assay designed to improve accessibility, affordability and timeliness in sexually transmitted infection (STI) testing in the U.S.

• U.S. regulatory clearance of new assay for use on both NeuMoDx 96 and 288 versions of integrated PCR-based clinical molecular testing system

• Global presence anchored by 16 EU-certified in-vitro diagnostics (CE-IVD) tests, positioning NeuMoDx as having one of the broadest test menus available to customers

Germantown, Maryland, and Venlo, the Netherlands, Jan. 08, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. Food and Drug Administration (FDA) clearance for the NeuMoDx CT/NG Assay 2.0, growing its test menu for its integrated PCR-based clinical molecular testing systems NeuMoDx 96 and 288 in the United States.

This assay is designed for direct detection of asymptomatic and symptomatic bacterial infections involving Chlamydia trachomatis (CT) and / or Neisseria gonorrhoeae (NG) – the most common type of bacterial infection among sexually transmitted infections (STIs), according to the U.S. National Institutes of Health. The majority of these infections are asymptomatic and generally curable with existing single-dose regimens of antibiotics. However, the time it takes for results to be received is often long, impeding follow-up care.

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.

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."

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.

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.

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.

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.

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.

FDA IDE approval of Sonavex's randomized trial comes months after meeting the endpoint of its first clinical study

BALTIMORE, Jan. 2, 2024 /PRNewswire-PRWeb/ -- Sonavex, Inc., a privately held medical device company with ultrasound technologies that deliver quantitative blood flow and other critical vascular data at the point of care, announced that it completed its initial clinical study evaluating the ability to use EchoMark & EchoSure to improve the assessment of arteriovenous (AV) fistula maturation for dialysis patients. Following the positive findings from this study, Sonavex was granted approval from the U.S. Food and Drug Administration under an Investigational Device Exemption (IDE) for its randomized controlled trial, MAFASA (Maturation of Arteriovenous Fistula with Automated Sonography Assessments).

In this episode of BioTalk with Rich Bendis, we’re joined by three guests from Solaxa: CEO & Founder Christian Walker, Chief Operating Officer Luis T. Gutierrez, Jr., and Chief Commercial Officer Jennifer Butler. Solaxa is a pioneering biotech company with a mission to revolutionize the treatment of cerebellar ataxias and acute nerve injuries caused by trauma and chemotherapy.

Discover the compelling story behind Solaxa’s choice to establish its roots in Montgomery County and how the BioHealth Capital Region has played a crucial role in its growth. Learn how Solaxa’s team was assembled, including the inspiring success stories of Luis and Jennifer, both part of the BioHealth Innovation and Montgomery County Maryland’s Executive in Residence program.

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• The year “gaslighting” of women with hard-to-diagnose maladies was finally given the kabosh?
• The year we found the hormone causing acute morning sickness?
• Impressive and large funding rounds despite a bleak funding environment?
• “Birth control for men” makes it to the clinical trial stage?

By Anna Zornosa - In the shadow of one very bad, no-good horrible development setting women’s health back decades (the overturning of Roe V. Wade), I spent the year taking note of some amazing advances happening in the pursuit of health solutions for women. Curious if others were also seeing bright spots, I asked some of the smartest women I know if they’d also seen events signaling notable progress.

My timing was bad: with the holidays upon us I knew some could not answer. But to my delight I got observations Barbara Levy, MD, FACOG, FACS : from CEO/Founders Somer Baburek, MBA (Hera Biotech), Melody Roberts (Liv Labs), and Melissa Bowley (Flourish Care); from author Susan Salenger; medtech designer and diversity driver Nada (Osman) Hanafi ; investors Jessica Karr and Susan Solinsky; and Ayse McCracken, Founder of the Ignite Accelerator for women leading life science companies.

What did we miss? A lot, certainly. Please add your own “brightspots of note” to comments. This will create something we can all turn to if (when) bad developments happen in 2024.

• CEPI to invest funding of up to $34.8 million to Barinthus Bio in addition to funds previously committed to the University of Oxford to develop and stockpile a ready reserve of emergency MERS vaccine candidate, VTP-500.
• VTP-500 project with Barinthus Bio and University of Oxford uses tested ChAdOx1 platform.
• If successful in Phase II trials, this will progress VTP-500 significantly towards regulatory approval and doses could be rapidly deployed in a clinical trial setting in response to a substantial outbreak.

OXFORD, United Kingdom, Dec. 21, 2023 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), formerly Vaccitech plc, today announced a project with the Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Oxford, aiming to fast-track the development of a vaccine candidate known as VTP-500 for the prevention of Middle East Respiratory Syndrome (MERS), the often fatal disease caused by the MERS coronavirus. Barinthus Bio is a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases, autoimmunity, and cancer.

Read more ...

GERMANTOWN, Md., Dec. 19, 2023 /PRNewswire/ -- Deka Biosciences ("Deka") today announced the appointments of Stanley Frankel, M.D., FACP, as senior clinical advisor, interim chief medical officer and scientific advisory board member, and Stuart Chaffee, Ph.D. as an independent director and chairman of the Board. Deka is a privately held biotech company developing next-generation cytokine therapies to treat cancer and inflammatory diseases based on a patient's individual immune response. Deka's lead asset, DK2¹⁰ (EGFR), is currently being evaluated for the treatment of multiple solid tumors in a Phase 1 clinical trial.

On December 8, 2023, the National Institute of Standards and Technology (NIST) published a draft guidance document regarding the government’s exercise of “march-in” rights under the Bayh-Dole Act. The following Q&A, in connection with our previously published Client Alert, illuminates the details of the Proposed Framework.

Q: If my company takes SBIR/STTR funding from a federal agency, does the Bayh-Dole Act apply?

A: Yes. A company that receives Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) funding is considered a “contractor” under the Bayh-Dole Act. As such, inventions conceived of or first actually reduced to practice using SBIR or STTR funds will be subject to the Bayh-Dole Act. This applies even if the funds are used only to develop confirmatory data for an invention conceived of without the use of SBIR or STTR funds.

Have you ever wondered about the true impact of Artificial Intelligence (AI) in the BioHealth industry? In this episode of BioTalk with Rich Bendis, we have the privilege of hosting Dr. Juergen Klenk, a Principal at Deloitte and a Board Member at BioHealth Innovation. Dr. Klenk brings a wealth of expertise and experience with a unique background combining formal scientific training and entrepreneurial ventures.

Join us as we embark on an insightful discussion about the current state of AI in the BioHealth industry, diving deep into the realities and challenges of this cutting-edge technology. Dr. Klenk shares his interest in AI and the reasons behind its increasing prominence in the field. We explore the historical origins of the AI hype cycle and how we've reached the stage we're in today.

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Irazu Oncology, which is using a platform built by researchers at University of Maryland, Baltimore to develop cancer vaccines, has secured $2.6 million in debt from an undisclosed source, according to a recent listing on Crunchbase.

Founded by Marco A. Chacón, an industry veteran who founded and ran Paragon Bioservices for over two decades, Irazu Oncology is commercializing UMB’s novel immunotherapeutic vaccine technology. It operates out of the University of Maryland BioPark. The company is a winner of TEDCO’s Maryland Innovation Initiative Company Formation Awards.

Novel Approach

Irazu Oncology has a licensing deal with UMB to commercialize a membrane vesicle vaccine development platform built at the university by a research team led by James Galen, Ph. D. The platform uses the outer membrane of vesicles — a structure within or outside a cell — as cancer vaccines that can stimulate an immune response. Irazu Oncology’s proprietary, attenuated bacteria are engineered to produce OMVs bearing tumor antigens on their surface. These antigens are delivered to various sites in the body, stimulating a natural immune system that can destroy cancerous cells.

by Ellen D. Harpel | Dec 17, 2023

As Smart Incentives marks its 10th year, we have been revealing the top ten ways that incentives have changed since 2013. We are pleased to share the full list of incentive trends here in our last blog article of 2023. 

1. Big incentive deals are getting bigger. Top projects receive significantly higher offers than in the past. The most prominent incentive packages are for new electric vehicle and semiconductor facilities. However, looking past these high profile projects, the average incentive offer has been surprisingly stable over the past decade.

2. The rise of remote work. Remote and hybrid work continue to reshuffle our living and working patterns. Incentives to attract remote workers have become part of the landscape. Many traditional business incentive programs are adjusting how they count workers to account for remote or hybrid work.

3. Better project compliance and reporting. State and local governments have improved their ability to track incentivized projects, monitor performance, and share results with internal and external stakeholders. 

In a landmark study led by the University of Maryland School of Medicine, researchers discovered for the first time that a certain kind of protein similar to hemoglobin, called cytoglobin, plays an important role in the development of the heart. Specifically, it affects the correct left-right pattern of the heart and other asymmetric organs. The findings, published today in the journal Nature Communications, could eventually lead to the development of new therapeutic interventions to alter the processes that lead to these defects.

The team, led by senior author Paola Corti, PhD, along with along with University of Maryland School of Medicine Dean Mark T. Gladwin, MD, as senior co-author, used CRISPR gene editing technologies to knock out the cytoglobin gene in zebrafish. The lack of cytoglobin caused the development of embryos with a mirrored heart, meaning the heart had a reversed left-right pattern. In humans, cytoglobin is involved in processes involving nitric oxide, a compound that helps regulate healthy blood flow to organs.

By Dan Brendel – Staff Reporter, Washington Business Journal Dec 15, 2023 - 

United Therapeutics Corp. is teeing up major organ production facility at its Silver Spring biotech campus through a proposed land swap with Montgomery County.

The company (NASDAQ: UTHR), a longtime drugmaker of pulmonary hypertension therapies that in recent years has expanded into bioengineered organs, has agreed to trade several parcels it owns for a county-owned site on 3.8 acres adjacent to its headquarters at 1000 Spring St.

The site, now home to a parking garage and other county operations, could yield up to 831,000 square feet under existing zoning.

The U.S. National Science Foundation today announced the first-ever Accelerating Research Translation (ART) investment — more than $100 million to 18 teams at academic institutions across the nation. NSF's investment will enable academic institutions to accelerate the pace and scale of translational research that will grow the nation's economy.

"NSF endeavors to empower academic institutions to build the pathways and structures needed to speed and scale their research into products and services that benefit the nation," said NSF Director Sethuraman Panchanathan. "The Accelerating Research Translation program in NSF’s new Technology, Innovation and Partnerships (TIP) Directorate identifies, and champions institutions positioned to expand their research translation capacity by investing in activities essential to move results to practice."

• 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.  

By Anastassia Gliadkovskaya - Dec 11, 2023 4:00pm - 

Floreo, maker of virtual reality (VR) behavioral therapy content, has received the Food and Drug Administration’s breakthrough device designation. 

The company has also been accepted into the newer Total Product Life Cycle Advisory Program (TAP). While the breakthrough device designation helps streamline the process for medical device premarket approval, the TAP Program offers insights and resources to assist with the path to commercialization. 

“Floreo is seeking full market authorization and a label to further recognize its effectiveness in augmenting therapy and outcomes,” Vijay Ravindran, co-founder and CEO of Floreo, told Fierce Healthcare. The other goal with full market authorization is “opening up any and all reimbursement pathways so that Floreo can reach the million-plus families searching for better outcomes,” he added.

BALTIMORE, Maryland, December 11, 2023 – GlycoMantra, a University of Maryland, Baltimore (UMB) startup company developing therapeutics for unmet medical needs in metastatic castration-resistant prostate cancer (mCRPC), MASH liver fibrosis, and type 2 diabetes (T2D), was recently awarded a two-year, $3.7 million Small Business Innovation Research (SBIR) Phase II grant from the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health, to advance their therapeutic pipeline.

Currently, there are no United States Food and Drug Administration-approved drugs for mCRPC patients who develop a resistance to second-line hormonal therapies, or for the treatment of liver fibrosis or lung fibrosis. GlycoMantra is working to develop a therapeutic that will halt or reverse these diseases. The Phase II SBIR award will support the Company’s development of mammalian cell lines, a master cell bank (MCB), and the cGLP manufacturing for this drug.

Are you ready to dive into the world of groundbreaking biotechnology and the fight against chronic diseases? In this episode of BioTalk with Rich Bendis, we bring you an enlightening conversation with Dr. Nehal Mehta, Founder and CEO of Mobius Scientific, Inc. Dr. Mehta is not only a distinguished Professor of Medicine but also a visionary entrepreneur on a mission to revolutionize healthcare.

Join us as we explore the journey of Mobius Scientific, an early-stage biotechnology company with a transformative approach. Mobius is developing cutting-edge biologic therapies targeting the root cause of chronic diseases, starting with lipid accumulation. This innovative platform has the potential to change the lives of millions suffering from debilitating conditions.

Today, the U.S. Food and Drug Administration approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older. Additionally, one of these therapies, Casgevy, is the first FDA-approved treatment to utilize a type of novel genome editing technology, signaling an innovative advancement in the field of gene therapy. 

Sickle cell disease is a group of inherited blood disorders affecting approximately 100,000 people in the U.S. It is most common in African Americans and, while less prevalent, also affects Hispanic Americans. The primary problem in sickle cell disease is a mutation in hemoglobin, a protein found in red blood cells that delivers oxygen to the body’s tissues. This mutation causes red blood cells to develop a crescent or “sickle” shape. These sickled red blood cells restrict the flow in blood vessels and limit oxygen delivery to the body’s tissues, leading to severe pain and organ damage called vaso-occlusive events (VOEs) or vaso-occlusive crises (VOCs). The recurrence of these events or crises can lead to life-threatening disabilities and/or early death.