Weekly Quick Hits (BioHealth Capital Region) – Week of July 3, 2023

The BioHealth Capital Region, which includes Washington, DC, Maryland and Virginia, has generated a lot of life science news this week. Here’s a look.

By Alex Keown
July 7, 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 

EDIRNA, Inc. establishes Executive Team, Global Strategic Partnership

Germantown-based EDIRNA, Inc., an RNA-Editing therapeutics company, established its executive management team led by president and chief executive officer, Christopher W. Kennedy. Additionally, the company secured initial funding from RNA biopharmaceutical company, Sirnaomics Ltd. The agreement includes an exclusive licensing of Sirnaomics’ proprietary delivery technologies for RNA-Editing applications. This strategic partnership accelerates EDIRNA’s proprietary Edit-to-Cure Therapeutics platform targeting diseases with high unmet clinical needs.

IGC Pharma Announces a $3 Million Private Placement of Common Stock

Potomac-based IGC Pharma, Inc. announced a strategic investment from four investment funds managed by Bradbury Asset Management (Hong Kong) Limited. This investment, along with additional contributions from three unrelated investors, has resulted in approximately $3 million in gross proceeds, further strengthening IGC’s working capital. The funds support the advancement of the company’s Phase-II clinical trial of IGC-AD1, a promising investigational drug candidate designed to address agitation in dementia caused by Alzheimer’s disease.

MaxCyte Signs Strategic Platform License with Lyell Immunopharma

Rockville-based MaxCyte, Inc. signed a strategic platform license (SPL) with Lyell Immunopharma, Inc., a clinical-stage T-cell reprogramming company. Under the terms of the agreement, Lyell Immunopharma obtains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation technology and ExPERT platform. In return, MaxCyte is eligible to receive platform licensing fees, clinical milestone payments, and sales-based payments.

In the Clinic

GCANRx Gains Approval for Phase II Trial to Treat Autism-Related Spectrum Disorders

Baltimore-based Greater Cannabis Company, Inc. (GCANRx)  was granted approval for its double-blind, placebo-controlled Phase II Clinical Trial for the treatment of Autism Spectrum Disorder (ASD) from the Israel Ministry of Health. The primary objective of the trial is to evaluate the efficacy, safety, and tolerability of GCANRx’s proprietary therapeutic in pediatric patients (between 4 and 13 years of age) using a daily oral treatment.

I-Mab Publishes Claudin18.2 x 4-1BB Bispecific Antibody Givastomig Manuscript in JITC

I-Mab, which is based in Gaithersburg, announced the publication of a manuscript entitled “CLDN18.2 and 4-1BB bispecific antibody givastomig exerts antitumor activity through CLDN18.2-expressing tumor-directed T-cell activation” in the latest issue of The Journal for Immuno-Therapy of Cancer (JITC). Results from this study demonstrated that 4-1BB⁺ T cells co-exist in close proximity to CLDN18.2⁺ gastric cancer cells in patients. It is believed the findings from this study demonstrate the significant potential of givastomig in treating gastric cancer patients with varying levels of CLDN18.2 expression. Givastomig is engineered to bind to CLDN18.2-expressing cancer cells and co-stimulatory receptor 4-1BB on adjacent T-cells, with the aim of activating T-cells specifically within CLDN18.2-expressing tumors and triggering a potent tumor-killing effect.

Phase III Trial of Olverembatinib for the 1st-Line Treatment of Ph+ ALL Approved in China

Rockville-based Ascentage Pharma announced that the Center for Drug Evaluation of the China National Medical Products Administration approved a registrational pivotal Phase III study of olverembatinib, Ascentage Pharma’s lead drug candidate, in combination with chemotherapy for treatment of patients with naïve Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). This approval marks a major milestone that could potentially pave the way for olverembatinib to become the first China-approved tyrosine kinase inhibitor (TKI) for the treatment of patients with Ph+ ALL in the first-line setting.

Theradaptive Receives Manufacturing Assistance Grant by the MSCRF

Theradaptive has been awarded the Manufacturing Assistance Program grant by the Maryland Stem Cell Research Fund. The grant will help Theradaptive develop its GMP Manufacturing Facility in Frederick, stimulating economic development in the state and bolstering Maryland’s reputation as a hub of biotechnological innovation. Theradaptive’s proprietary protein-engineering platform aims to provide greater efficacy, safety, and ease of use across multiple clinical indications including orthopedics, immuno-oncology, and dental.

New Products

NatureMetrics Adopts Sapio Science’s No-Code LIMS/ELN Platform

Sapio Sciences, the science-aware lab informatics platform, announced that since recently launching in the EMEA geography, NatureMetrics, the nature intelligence technology company, has adopted Sapio’s platform to power its use of eDNA surveys and sequencing to identify and explore biodiversity. Sapio’s best-in-class platform unifies lab informatics with an all-in-one laboratory information management system, electronic laboratory notebook, and scientific data management solution.

Research Roundup

Johns Hopkins Study Identifies Biomarker for Allergic Reaction in Kidneys

Johns Hopkins Medicine researchers, in collaboration with Yale School of Medicine, identified a biomarker found via a simple urine test that can be used to diagnose acute tubulointerstitial nephritis (AIN), a medical condition that causes inflammation of the kidneys and can lead to acute kidney injury (AKI), which causes a sudden loss of kidney function. Experts say a kidney biopsy is often required to diagnose AIN because there are no disease-specific signs or symptoms. However, testing for a protein called CXCL-9 in a person’s urine could be a noninvasive way to diagnose AIN without having to do a kidney biopsy. Results of the study, which overall looked at more than 180 potential immune system biomarkers, were published in the Journal of Clinical Investigation.

NIH Study Offers Insights into How Cells Reverse Their Decision to Divide

A new study conducted by researchers at the National Cancer Institute (NCI), part of the National Institutes of Health, suggests that cells preparing to divide can reverse this process and return to a resting state. This challenges long-held beliefs about cell division, known as mitosis. In the study, scientists captured videos of thousands of cells undergoing mitosis and watched what happened to those cells when mitogens were withdrawn. In experiments with many different kinds of cells, researchers found that all types of cells were capable of exiting the cell cycle if it was early enough, the NIH announced. Researchers are examining whether they can take advantage of this new molecular mechanism to design a more durable therapy by combining CDK4 and CDK6 inhibitors with traditional chemotherapy drugs that induce DNA damage. The findings were reported in Nature.

Investigational Three-Month TB Regimen Is Safe but Ineffective, NIH Study Finds

A clinical trial of a three-month tuberculosis treatment regimen is closing enrollment because of a high rate of unfavorable outcomes with the investigational course of treatment. AIDS Clinical Trials Group 5362, the CLO-FAST trial, sought to evaluate the safety and efficacy of a three-month clofazimine- and high-dose rifapentine-containing regimen. An interim data analysis showed that participants taking the investigational regimen experienced ongoing or recurring TB at rates above thresholds set in the study protocol. Based on these findings, the study’s independent Data Safety and Monitoring Board recommended closing enrollment and modifying the treatment and follow-up of participants who received the investigational regimen to optimize outcomes. 

On the Hill – Regulatory and Advocacy

Kleine-Levin Syndrome Foundation Announces Updated Diagnostic Criteria for KLS

The Kleine-Levin Syndrome Foundation, based in Washington, D.C., announced updated diagnostic criteria for Kleine-Levin Syndrome (KLS). The criteria were published in the International Classification of Sleep Disorders Third Edition (ICSD-3). The updated information about KLS in the ICSD-3 is based in large part on medical research funded by the KLS Foundation. The updated diagnostic criteria are expected to improve clinicians’ ability to recognize and accurately diagnose cases of KLS. The revised language will also help shorten the diagnostic journey for patients and caregivers in search of answers.

Novavax’s Nuvaxovid Receives Full Authorization in the EU for the Prevention of COVID

Novavax has been granted full Marketing Authorization by the European Commission in the European Union for Nuvaxovid (NVX-CoV2373). This decision follows positive opinion for a full MA from the Committee for Medicinal Products for Human Use of the European Medicines Agency. The vaccine is now fully authorized for use as a primary series in individuals aged 12 and older and as a booster dose in adults aged 18 and older for the prevention of COVID-19. Nuvaxovid was originally granted a conditional MA in the EU for these indications.

People on the Move

University of Maryland Medical System Sees Change In Finance Leadership

The University of Maryland Medical System announced Michelle Lee, who had served as Chief Financial Officer for UMMS since 2018, has stepped down from her role. Joseph E. “Joe” Hoffman III will serve as CFO on an interim basis as a national search commences to identify a permanent finance leader. Hoffman re-joins UMMS, having served as CFO for UMMC until his retirement in 2022 and prior as CFO for University of Maryland Upper Chesapeake Health.