News

NEW YORK – AMPEL BioSolutions is recruiting individuals with systemic lupus erythematosus (SLE) into an observational study of its blood-based prognostic gene expression assay LuGene to demonstrate a correlation between test results and standard clinical evaluations.

In addition, the company has been conducting a study to see whether different lupus subtypes as defined by its test correlate with therapeutic response.

These studies follow another one published in October in the journal Genome Medicine that showed evidence for eight transcriptionally defined SLE endotypes, or subgroups, and demonstrated LuGENE’s ability to predict patients at risk for episodes of worsening symptoms called flares with high sensitivity and specificity.

MANASSAS, Va.–(BUSINESS WIRE)–ATCC, the world’s premier biological materials management and standards organization, today announced that it has been awarded a task order with a ceiling value of $15.5 million, inclusive of base and options, by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Under this task order 75N93019D00002-75N93024F00001, ATCC will develop well-characterized challenge material (WCCM) for the In Vitro Assessment for Antimicrobial Activity (IVAAA) program. This program aims to evaluate candidate countermeasures against microbial pathogens and vectors, including those derived from clinical specimens. The assessments are conducted in vitro and focus on antiviral screening assays for biosafety level (BSL)-3/4 viruses relevant to human diseases, as well as other rapidly emerging viruses that employ similar assay methodologies.

The acquisition adds two proprietary clinical technologies to its portfolio and enhances Precision’s global capabilities in clinical data management, biostatistics and programming.

BETHESDA, Maryland, May 29 – Precision for Medicine, a global leader in biomarker-driven clinical research and development supporting life sciences companies, today announced the acquisition of Algorics, one of the fastest-growing clinical technologies and biometrics service providers to the biopharma industry. The addition of Algorics brings two innovative clinical technologies and further bolsters Precision for Medicine’s reach in the Asia-Pacific region. The acquisition also enhances Precision’s global capabilities in clinical data management, biostatistics, and programming.

BioHealth Innovation Inc. (BHI) congratulates the outstanding winners of the 2024 ICON Awards announced by the Maryland Tech Council. These awards recognize the incredible contributions of individuals and companies in the fields of technology and life sciences, highlighting their impact on millions of lives.

AstraZeneca: with a member of our BHI Board of Directors, Tyrell Rivers, Ph.D., has been honored as the Life Science Company of the Year. Their continued dedication to advancing healthcare through groundbreaking research and development is truly commendable.

Nanochon: We are particularly proud of Nanochon and Benjamin Holmes, the recipients of the Chief Executive Officer of the Year—Life Sciences award. Nanochon is a previous winner of our BioHealth Capital Region Crab Trap, and it’s exciting to see their sustained excellence and innovation being recognized on a larger stage.

Solaxa: A special congratulations to Solaxa, who was awarded the Venture Mentoring Services Venture of the Year. We are pleased to note that two members of Solaxa’s leadership team, Luis T. Gutierrez, Jr. and Jennifer Butler, are part of the BHI/Montgomery County Executive-In-Residence Program. This recognition underscores their remarkable leadership and commitment to advancing technology and life sciences.

ROCKVILLE, Md., May 23, 2024 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced data from the planned interim analysis of the exploratory open-label Phase 2a clinical study of SPN-817 for treatment-resistant seizures. The study is examining the safety and tolerability of SPN-817 as adjunctive therapy in adult patients with treatment-resistant seizures, as well as finding effective doses in various treatment-resistant seizure types. The interim analysis is as of May 1, 2024, and is based on 41 enrolled subjects, of which 19 completed the maintenance period. Of these 19 subjects, 16 subjects had focal seizures.

RICHMOND, Va., May 23, 2024 /PRNewswire/ — Activation Capital announces the launch of Frontier BioHealth, an educational and support program designed to provide highly specialized training, targeted mentorship, and relationship building to help scale pharmaceutical, biotech, medical device, and health-focused consumer products companies. The inaugural four-month program will be critical in bringing research-intense products and companies to market. It will broaden the continuum of regional early-stage support – additive to Virginia Commonwealth University’s proof of concept fund and newly launched pre-accelerator program – and continue to coalesce the emerging private investment ecosystem in Central Virginia.

Program performer teams to develop innovative ways for joints to heal themselves 

The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced the Novel Innovations for Tissue Regeneration in Osteoarthritis (NITRO) program’s five teams receiving awards to create and commercialize injectable and implantable regenerative therapies for osteoarthritis (OA). NITRO’s goal is to eradicate OA, a common and irreversible condition where bones and cartilage break down, and that often involves debilitating pain and loss of functional movement, and complex and costly reconstructive surgery.  

ROCKVILLE, Md., May 23, 2024 (GLOBE NEWSWIRE) — Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to lead clinical candidate VCN-01 in combination with gemcitabine and nab-paclitaxel to improve progression-free survival and overall survival in patients with metastatic pancreatic adenocarcinoma. In VIRAGE, the ongoing multinational Phase 2b clinical study, intravenous VCN-01 is being evaluated in combination with standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy for patients with pancreatic ductal adenocarcinoma (PDAC). Previously, the FDA granted orphan drug designation to VCN-01 for treatment of PDAC.

Nona Biosciences, a global biotechnology company providing a total solution from “Idea to IND” (I to ITM), ranging from target validation and antibody discovery through preclinical research, announced today that it has entered into a license agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) for preclinical monoclonal antibodies that will be used to create targeted therapies in oncology.

Under the terms of the agreement, Nona Biosciences shall receive US$19 million upon completion of the transaction. Nona is eligible to receive an additional US$10 million in potential near-term milestone payments and up to US$575 million upon achieving specified development, regulatory, and commercial milestones, as well as tiered royalty payments on net sales. In addition, Nona is eligible to receive payments for the option programs should AstraZeneca exercise these options.

FREDERICK, Md., May 22, 2024 /PRNewswire/ — Theradaptive, Inc., a regenerative medicine company developing targeted therapeutics, announced today it has been awarded funding from the Maryland Stem Cell Research Fund (MSCRF) to support human clinical trials for its lead product, OsteoAdapt SP.  OsteoAdapt SP is currently in Phase I/II clinical studies for transforaminal lumbar interbody spinal fusion (TLIF) to treat degenerative disc disease, spondylolisthesis, and retrolisthesis.

Theradaptive was granted an Investigational Device Exemption (IDE) in January 2024 by the U.S. Food and Drug Administration (FDA) to begin its human clinical trial. This $1 million award from the MSCRF Clinical Program will enable Theradaptive to expand its OASIS human clinical study to sites in Maryland. More details can be found at ClinicalTrials.gov: identifier NCT06154005. Theradaptive also holds three Breakthrough Medical Device designations for various spine indications including TLIF, ALIF, and PLF.