Weekly Quick Hits (BHCR) – Week of August 7, 2023
Johns Hopkins’ Wilmer Eye Institute receives $20 million from The T. Boone Pickens Foundation, Emergent cuts jobs and programs to save $100 million per year, and more.
August 11, 2023
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Funding, Awards and Collaborations
Johns Hopkins’ Wilmer Eye Institute Receives $20 Million from The T. Boone Pickens Foundation
The Wilmer Eye Institute at Johns Hopkins Medicine received a $20 million donation from the T. Boone Pickens Foundation. The donation will fund various research projects and the T. Boone Pickens Professorship, and additional Rising Professorships for young investigators.
Emergent Announces Strategy to Strengthen Core Business and Save $100 Million
Gaithersburg, Md.- based Emergent BioSolutions announced that it is reducing investment in and de-emphasizing focus on growth in its CDMO services business. As a result, it is cutting operations at its Bayview facility in Baltimore and at its facility in Canton, Massachusetts, and in Rockville, Maryland. It expects to focus on its core products business and believes these changes will prove more than $100 million in annual savings.
Thermo Fisher Scientific Prices Offering of USD-Denominated Senior Notes
Thermo Fisher Scientific announced it has priced an offering of $2.95 billion aggregate principal amount of several different notes. The offering is expected to close on or about August 10. The company expects to use the net proceeds from the sale to redeem all of the outstanding $500 million aggregate principal amount of its Floating Rate Senior Notes due 2023 that mature on October 18, 2023, and all of the outstanding $500 million aggregate principal amount of its Floating Rate Senior Notes due 2024.
Novel Microdevices Received $1.4 Million from NIH RADx Tech for Next-Gen POC RT-PCR Test
Baltimore-based Novel Microdevices was awarded $1.4 million from the NIH Rapid Acceleration of Diagnostics (RADx) Tech program to support its high-performance, rapid, point-of-care, RT-PCR platform for a multiplex diagnostic test for RSV, influenza A and B and COVID-19. The target is to complete the test in under 15 minutes. The award potentially will be used for Phase II funding if Phase I is successfully completed.
Novavax Q2: Total Revenue of $424 Million and Net Income of $58 Million
Gaithersburg, Md.-based Novavax reported its second-quarter financials and operational highlights. Total revenue hit $424 million with net income of $58 million for the quarter. The company’s top priority was delivering an updated COVID-19 vaccine for the upcoming 2023 fall vaccination season.
Theriva Q2: Initiated Dosing in US for Phase IIb Pancreatic Ductal Adenocarcinoma Trial
Theriva Biologics (Rockville, Md.) reported its second-quarter financials and company updates. The company focused on the initial dosing at U.S. sites for the Phase IIb VIRAGE trial of VCN-01 in combination with chemotherapy for Pancreatic Ductal Adenocarcinoma. Second doses in Spain were well received and the clinical trial is on schedule for full enrollment in the first quarter of 2024. The company reported $34.2 million in cash as of June 30.
Precigen Q2: FDA Confirms Ongoing Phase I/II PRGN-2012 Study Will Serve as Pivotal Study
Germantown, Md.-based Precigen reported second-quarter financials and a portfolio update. The FDA confirmed the ongoing Phase I/II trial of PRGN-2021 will act as the pivotal study to support accelerated approval for treatment in recurrent respiratory papillomatosis (RRP). The company is prioritizing its portfolio to accelerate PRGN-2012 and continue the advancement of other key programs. As of June 30, Precigen reported $95.6 million in cash.
Thermo Fisher Scientific Picked as the NIAID’s Transplantation Statistical and Clinical Coordinating Center
The PPD clinical research business of Thermo Fisher Scientific was granted a five-year award to be the Transplantation Statistical and Clinical Coordinating Center for the National Institute of Allergy and Infectious Diseases (NIAID). The center will offer a range of support services critical to the design, development, execution and analysis of NIAID transplantation clinical trials and research.
OpGen Q2: Running Out of Money and Considering All Alternatives
OpGen reported its second-quarter financial results and provided a business update. Total revenue for the second quarter was about $0.7 million, with first-half revenue growing 15% to $1.65 million. The company reported about $3.2 million in cash as of June 30. The company has expressed concerns about its ability to continue operations, without enough cash to run beyond September. It is considering all alternatives.
In the Clinic
FDA Clears Ascentage for Phase III CLL/SLL Trial
Ascentage Pharma (Rockville, Md. and Suzhou, China) received clearance from the FDA for a global Phase III trial of lisaftoclax. The study will evaluate the drug, a novel Bcl-2 inhibitor, in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who were BTKi previously treated.
BD Launches Portal Hypertension Study
Becton, Dickinson and Company (BD) announced the enrollment of the first patient in the investigational device exemption (IDE) study, ARCH. The global study will assess the safety and effectiveness of the BD Liverty TIPS Stent Graft.
New Products
OpGen’s Ares Genetics Released New Features to its AREScloud
Rockville, Md.-based OpGen and its subsidiary, Ares Genetics, announced a major feature upgrade for the AREScloud platform to improve genomic surveillance. The new features include a new SNP analysis module, a new module for the interpretation of genetic elements such as plasmids, and reporting specifically for hospital epidemiologists.
New Patents
Thermo Fisher Scientific Announces New Line of Refrigerators
Thermo Fisher Scientific announced a new line of Thermo Scientific TSG Series Refrigerators to ensure the safe storage of critical vaccines and drugs for labs, pharmacies and clinics. The new TSG series complies with NSF 456 performance standards.
Research Roundup
Johns Hopkins Research: Novel Machine Learning Blood Test for Cancers
Researchers at Johns Hopkins Medicine have developed a novel blood testing technology that combines genome-wide sequencing of single DNA molecules shed from tumors. It leverages machine learning and may allow for earlier detection of lung and other cancers.
Johns Hopkins Research: Nanoscale Tattoos for Individual Cells
Researchers at Johns Hopkins University developed nanoscale tattoos, which are described as “dots and wires that adhere to live cells.” The tech allows for the placement of optical elements or electronics on live cells with tattoo-like arrays.
On the Hill – Regulatory and Advocacy
Qiagen’s PDGFRA Kit Approved as Companion Diagnostic to Ayvakit
The FDA approved Qiagen’s (The Netherlands and Germantown, Md.) therascreen PDGFRA RGQ PCR kit as a companion diagnostic to Blueprint Medicine’s Ayvakit (avapritinib) in gastrointestinal stromal tumors (GIST). The diagnostic will help physicians identify patients with GIST who could potentially be treated with Ayvakit.
FDA Clears Georgiamune’s IND; Pulls in $75 Million in Series A
Georgiamune (Gaithersburg, Md.) announced the FDA had cleared its Investigational New Drug (IND) application for GIM-122, a dual-functioning monoclonal antibody for cancer. The company also completed a $75 million Series A financing round.
People on the Move
Processa Appoints George Ng as CEO
Hanover, Md.-based Processa Pharmaceuticals appointed George Ng as CEO and as director of the board. His most recent position was as Director, President and COO at Calidi Biotherapeutics.
Inteleos Names Jasmine Rockett Director of Point of Care Ultrasound Certification Academy
Rockville, Md.-based Inteleos appointed Jasmine Rockett as director of its Point of Care Ultrasound Certification Academy. Rockett has worked at the company for 10 years supporting the Academy with product development, philanthropic initiatives, and program operations.
