Weekly Quick Hits (BHCR) – Week of August 21, 2023

FDA approves RSV vaccine for pregnant mothers, Adial regains Nasdaq listing, and Jane Carlton joins Johns Hopkins Malaria Research Institute. For more BioCapital life science news, keep reading.

By Mark Terry | August 25, 2023

Quick Hits is BioBuzz’s weekly round up of all the life science news you don’t want to miss, in your region of interest. Don’t miss a beat; SUBSCRIBE to our weekly Quick Hits newsletter via LinkedIn (BioHealth Capital Region, Greater Philadelphia, Research Triangle Park) or get it delivered to your inbox every week.

Funding, Awards and Collaborations 

Aditxt Provided Shareholder Update and Strategy Plans

Richmond, Va.-based Aditxt provided an update about its innovation programs and strategic M&A initiations. The company noted two current programs in monitoring and treating autoimmunity and organ transplantation, Adimune and Pearsanta. A clinical trial with the Mayo Clinic is evaluating the CNS disorder Stiff-Person Syndrome using the company’s ADI-100. The company also terminated the non-binding letter of intent with Natural State Genomics and Natural State Laboratories.

Novavax’s Updated COVID Vaccine-Induced Responses Against Emerging Subvariants

Novavax (Gaithersburg, Md.) reported that its updated protein-based XBB COVID vaccine candidate induced neutralizing antibody responses to the EG.5.1 and XBB.1.16.6 subvariants in small animal and non-human primate studies. The XBB sublineage variants are the dominant strains seen currently in the U.S. and EU.

Adial Pharma Q2: To Focus its Efforts on FDA Approval for AD04

Adial Pharmaceutical (Charlottesville, Va.) reported its second-quarter financials and business update. It noted that after meetings with the FDA and European regulators, it had decided to focus its efforts on obtaining FDA approval because the “U.S. standard should translate to acceptance in other international markets.” This is for AD04 for treatment of Alcohol Use Disorder. 

Innovent Bio Interim Results and Business Updates

Innovent Biologics (Rockville, MD and Suzhou, China) announced its 2023 interim results and major company business updates. Total revenue RMB2,701.5 million in the first half of the year, an increase of 20.65% compared to the first half of 2022, and product sales revenue of RMB2,457.5 million an increase of 20.4% in the same period.

Whitman-Walker, Cancer Support Community and Grail Collaborate on Cancer Health Equity

The Whitman-Walker Institute, a leader in LGBT health, research, education and policy, the Cancer Support Community (CSC), a global nonprofit, and Grail, a cancer diagnostics tech company, announced a research collaboration. The goal is to advance health equity in cancer screening and care with Galleri, a multi-cancer early detection test, in diverse patient populations.

Adial Regains Nasdaq Listing Compliance

Charlottesville, Va.-based Adial Pharmaceuticals regained compliance from the Nasdaq with its minimum bid price requirement. For the last 10 consecutive business days, from August 7 through August 18, 2023, the closing bid price of the company’s common stock was $1.00 per share or greater.

Johns Hopkins Provides Update on New Public Health Building

Johns Hopkins Bloomberg School of Public Health provided an update on its new planned building. The 250,000-square-foot, seven-story facility will be located on Johns Hopkins property at the corner of McElderry and Washington, next to the division’s main Wolfe Street building. Groundbreaking is expected in early 2024 with completion in 2026.

In the Clinic

Immunomic Dosed 1^st Patient in Phase I Glioblastoma Trial

Immunomic Therapeutic (Rockville, Md.) dosed the first patient in its Phase I study of ITI-1001 for Glioblastoma Multiforme. The therapy is a plasmid DNA vaccine.

New Products

Thermo Fisher Scientific Introduces New Chromosomal Microarray

Thermo Fisher Scientific launched a new chromosomal microarray designed to improve cytogenetics research lab productivity with a two-day turnaround time. The Applied Biosystems CytoScan HD Accel array can analyze the entire human genome and provide improved coverage in more than 5,000 critical genome regions.

Thermo Fisher Launches EXENT Solution with IVDR Certification

Thermo Fisher Scientific announced the commercial launch of the EXENT Solution after receiving IVDR certification. The EXENT solution is a fully integrated and automated mass spectrometry system. It is now available in Belgium, France, Germany, Italy, the Netherlands, Spain and UK.

New Patents

60 Degrees Pharma Receives Additional U.S. Patent Protection for Malaria Prevention

60 Degrees Pharmaceuticals (Washington, DC) was awarded a patent covering the use of tafenoquine for the prevention of Plasmodium falciparum malaria. Tafenoquine is the active molecule in Arakoda, the company’s FDA-approved drug for malaria prevention.

Research Roundup

Zalgen Published Data Demonstrating Arevirumab-3’s Effectiveness Treating Lassa Infections

Zalgen Labs (Frederick, Md.) published data demonstrating that Arevirumab-3, its lead immunotherapeutic candidate, is effective for the treatment of Lassa virus infections. The research came out of a collaboration of Zalgen, Tulane University, UTMB, and other members of the Viral Hemorrhagic Fever Consortium (VHFC) and the Viral Hemorrhagic Fever Immunotherapeutic Consortium (VIC).

Novavax’s Updated COVID Vaccine-Induced Responses Against Emerging Subvariants

Novavax (Gaithersburg, Md.) reported that its updated protein-based XBB COVID vaccine candidate induced neutralizing antibody responses to the EG.5.1 and XBB.1.16.6 subvariants in small animal and non-human primate studies. The XBB sublineage variants are currently the dominant strains seen in the U.S. and EU.

UVA Research: Sounds Waves to Quit Cocaine

Researchers at the University of Virginia Health System have initiated a clinical trial to test if low-intensity focused ultrasound can help reprogram brain cells to wean patients off cocaine. The sound waves focus on the part of the brain called the insula, which is believed to play a critical role in multiple forms of addiction.

NIH Research: Parkinson’s Gene Variant Found in Some People of African Ancestry

Researchers with the National Institutes of Health, the University College, London, and the University of Lagos, Nigeria, evaluated almost 198,000 people and found a gene variant that increased the risk of developing Parkinson’s disease almost exclusively in people of African ancestry. The gene variant encodes B-glucocerebrosidase (GBA1), a protein that controls how cells in the body recycle proteins.

Johns Hopkins Research: Fully Sequenced Y Chromosome

Researchers at Johns Hopkins University along with more than 100 researchers around the globe completed sequencing of the male sex chromosome, the Y chromosome. New information included the structures of sperm-regulating gene families and 41 additional genes.

On the Hill – Regulatory and Advocacy

FDA Approved Pfizer’s RSV Vaccine for Pregnant Mothers

The FDA approved Pfizer’s Abrysvo (Respiratory Syncytial Virus Vaccine), the first ever for use in pregnant women to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth through six months of age. It is approved for use at 32 through 36 weeks gestational age of pregnancy.

FDA Approves 1^st Biosimilar for Multiple Sclerosis

The FDA approved Sandoz’s Tyruko, the first biosimilar to Biogen’s Tysabri (natalizumab) for adults with relapsing forms of multiple sclerosis (MS). Both drugs are also indicated for inducing and maintaining clinical response and remission in adults with moderately to severely active Crohn’s Disease with evidence of inflammation in patients who have had an inadequate response to or are unable to tolerate, conventional Crohn’s therapies and inhibitors of TNF-alpha.

People on the Move

Jane Carlton Joins Johns Hopkins Malaria Research Institute

Jane Carlton was appointed director of the Johns Hopkins Malaria Research Institute. She was previously the Julius Silver, Roslyn S. Silver, and Enid Silver Winslow Professor in the Department of Biology and the School of Public Health at New York University, as well as faculty director of Genomic Sequencing at the Center for Genomics & Systems Biology, and program director of an NIH-funded International Center of Excellence for Malaria Research based in India.

Jeffrey Kahan Appointed to New Term as Johns Hopkins’ Berman Institute of Bioethics

Jeffrey Kahn has been appointed to a second term as Andreas C. Dracopoulos Director of the Johns Hopkins Berman Institute of Bioethics. He has served as director since 2016.