Funding, Awards and Collaborations
OpGen Enters Into Distribution Agreement with Fisher Healthcare
OpGen (Nasdaq: OPGN), a precision medicine company using molecular diagnostics and bioinformatics to help combat infectious disease, has entered into a non-exclusive distribution agreement with Fisher Healthcare, a part of Thermo Fisher Scientific. The agreement is for the distribution of OpGen’s Unyvero A50 platform and in vitro diagnostic (IVD) tests for bacterial pneumonia (Unyvero LRT and LRT BAL) as well as its research use only test for urinary tract infection (Unyvero UTI). The Unyvero LRT cartridge for hospitalized patients with suspected pneumonia is the first ever FDA cleared IVD product specifically targeting bacterial pneumonia and antimicrobial resistance markers.
Mason Engineers and Partners Receive $3M Award to Build New Technology for Personalized Musculoskeletal Injury Rehabilitation to Support Troops
George Mason University bioengineer Dr. Parag Chitnis, an associate professor in the Department of Bioengineering and a member of the Institute for Biohealth Innovation (IBI), and his team are developing quantitative assessments that can both prevent and monitor MSKIs in Service members. In partnership with California-based Cephasonics Ultrasound, an ultrasound systems and technology company, and Maryland-based Infinite Biomedical Technologies, the team has been selected by the United States Army Medical Research and Development Command to receive nearly $3M from the United States Department of Defense, awarded through the Medical Technology Enterprise Consortium (MTEC). The award will support the team’s development of wearable, compact, and hands-free ultrasound systems to assess rehabilitation and recovery from MSKIs through measurements of muscle structure and function during physical activity, with a specific focus on knee injuries.
Aziyo Biologics and LeMaitre Vascular Partner for the Distribution of Aziyo’s Cardiovascular Portfolio
Aziyo Biologics, Inc. (Nasdaq: AZYO), a company that develops biologic products to improve compatibility between medical devices and patients, has entered into a distribution agreement with LeMaitre Vascular, Inc. (Nasdaq: LMAT), a provider of vascular devices, implants and services. Under the agreement terms, Aziyo will grant LeMaitre exclusive U.S. distribution rights for the products within its cardiovascular segment: ProxiCor® PC, ProxiCor® CTR, Tyke® and VasCure®.
In the Clinic
Horizon Therapeutics to Share UPLIZNA® (inebilizumab-cdon) Data in Neuromyelitis Optica Spectrum Disorder (NMOSD) at the 2023 American Academy of Neurology (AAN) Annual Meeting
Horizon Therapeutics (Nasdaq: HZNP) announced that multiple UPLIZNA analyses will be presented at the 2023 American Academy of Neurology (AAN) Annual Meeting, April 22-27 in Boston. UPLIZNA is the first and only anti-CD19 B-cell-depleting humanized monoclonal antibody approved by the FDA, European Commission (EC) and Brazilian Health Regulatory Agency (ANVISA) for the treatment of NMOSD in adults who are anti-aquaporin-4-immunoglobulin G seropositive (AQP4-IgG+).
Innovent Releases Final Results of ORIENT-15: the Phase 3 Study of Sintilimab plus Chemotherapy for the First-Line Treatment of Esophageal Squamous Cell Carcinoma at AACR.
Innovent Biologics (HKEX: 01801), a biopharmaceutical company that develops, manufactures and commercializes high quality medicines to treat cancer, autoimmune, metabolic, ophthalmoogic, and other major diseases, shared that final analysis results of ORIENT-15, the Phase 3 study evaluating sintilimab in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma (ESCC) were released in a poster presentation at the recent AACR Annual Meeting (Abstract CT075). As of data cutoff date (August 28, 2022), a total of 690 patients were randomly assigned and received treatment, and the median follow-up was 32.2 months.
Sintilimab plus chemotherapy significantly improved the median overall survival (mOS) over placebo plus chemotherapy with a 33.9% reduction in risk of death (HR 0.661; P<0.0001) and a 4.6-month improvement in mOS (17.4 vs 12.8 months) in all randomized patients (the ITT population); and 36.5% reduction in risk of death (HR 0.635; P=0.0001) and a 3.9-month improvement in mOS (18.4 vs 14.5 months) in PD-L1 positive patients (defined as combined positive score [CPS] ≥10).
Innovent Also Releases Overall Survival Results of Phase 2 Study of Pemazyre® (pemigatinib) in Chinese Patients with Advanced Cholangiocarcinoma Presented at AACR
In addition to the above, Innovent Biologics announced the overall survival (OS) results of the Phase 2 study of pemigatinib in Chinese patients with advanced cholangiocarcinoma (CCA) at AACR (Abstract CT153). This study (CIBI375A201, NCT04256980) is a Phase 2, open-label, multi-center, single-arm study to evaluate the efficacy and safety of pemigatinib – a selective fibroblast growth factor receptor (FGFR) inhibitor – in Chinese patients with unresectable, advanced/recurrent or metastatic cholangiocarcinoma with FGFR2 fusion/rearrangement that failed to prior systemic therapy, which is a bridging study of the FIGHT-202 study (INCB 54828-202, NCT08924376). Among 30 efficacy evaluable subjects (1 participant excluded due to inadequate FGFR2 aberrant frequency), the median follow-up was 25.6 months (95% CI, 23.0-25.8), the median OS was 23.9 months (95% CI, 15.2-NC) with 16 (53.3%) OS events.
United Therapeutics to Feature Clinical Data Across its Commercial and Development Portfolio at Upcoming Scientific Meetings
United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that recent research across its development portfolio will be presented at the International Society for Heart and Lung Transplantation (ISHLT) 43rd Annual Meeting and Scientific Sessions in Denver, Colorado on April 19-22, 2023, and at the American Thoracic Society (ATS) International Conference in Washington, D.C. on May 19-24, 2023. At ATS, United Therapeutics will host an educational symposium on pulmonary hypertension associated with interstitial lung disease (PH-ILD) and is sponsoring the ATS 2023 Women’s Forum.
Senseonics Enrolls the First Pediatric Study Participant in the ENHANCE Clinical Trial, Testing a New Diabetes Medical Device
Senseonics (NYSE-American: SENS), a medtech company developing and manufacturing long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, announced the first pediatric study participant has been inserted with the Eversense® 365-day system as part of the pivotal ENHANCE clinical trial at the AMCR Institute, a clinical research center focused on pre-diabetes, type 1, type 2 diabetes and obesity.
The ENHANCE Trial is designed to evaluate the accuracy and safety of the Eversense system for up to one year. Over 165 adult subjects were inserted with Eversense systems in four centers across the United States. Enrollment was completed in September 2022, and the last patient is expected to complete their 365-day visit during the third quarter of 2023. An investigational device exemption (“IDE”) supplement was submitted and approved for expansion of the trial to allow for pediatric patients 14 to 18 years of age and the first pediatric study participants were enrolled in Q2 2023.
New Products
MediGO’s Latest Solution Digitally Transforms the Organ Recovery Process
MediGO, a Baltimore-based healthcare supply chain technology company, is helping to digitally transform the organ recovery process with the launch of its new software solution known as Recovery TeamLink™. The first-of-its-kind solution provides newfound organ recovery event transparency and coordination for transplant centers, organ procurement organizations, donor hospitals and transportation partners. Recovery TeamLink orchestrates this coordination amongst all stakeholders on a single, easy-to-use HIPAA compliant platform, where they can communicate directly, view precise locations, and access complex estimated times of arrival for recovery teams and organs. This enhanced level of coordination minimizes the cold-ischemic time of the organ and optimizes surgical time to help save more lives.
Research Roundup
ZielBio Presents Preclinical Data on the Utility of Cancer-Specific Plectin (CSP) and ZB131 in Antibody-Drug Conjugates at AACR
Charlottesville-based ZielBio, a clinical stage biotech discovering new treatments for cancer and other serious diseases, presented new preclinical data showing that its lead asset, ZB131, which targets cancer-specific plectin (CSP), is a promising approach for antibody-drug conjugates (ADCs). Research presented at AACR focused on CSP as a target for ADCs, demonstrating its abundance on the surface of cancer cells (and not healthy tissue), its bioavailability in humans, and its application across multiple cancer indications. ZB131 shows favorable pharmacokinetics, is rapidly internalized by CSP-expressing tumor cells in mouse models, and can be conjugated to multiple cytotoxic payloads.
Precigen Presents Preclinical Data for the Next Generation Mesothelin UltraCAR-T® with Intrinsic PD-1 Blockade at the AACR Annual Meeting 2023
Precigen (Nasdaq: PGEN), who is developing gene and cell therapies, presented preclinical data for the next generation UltraCAR-T platform utilizing MSLN CAR from Precigen’s library of non-viral plasmids at AACR.. The abstract, titled “Next Generation UltraCAR-T® Cells with Intrinsic Checkpoint Inhibition and Overnight Manufacturing Overcome Suppressive Tumor Microenvironment Leading to Sustained Antitumor Activity” was presented as a poster presentation (Abstract #1791). Collectively, data demonstrate the potential of UltraCAR-T cells to persist long-term in vivo, prevent CAR-T cell exhaustion, and mount a durable anti-tumor response with the ability for continued response upon tumor rechallenge.
University of Maryland School of Medicine Study Finds ChatGPT Helpful for Breast Cancer Screening Advice, With Certain Caveats
In February 2023, UMSOM researchers created a set of 25 questions related to advice on getting screened for breast cancer. They submitted each question to ChatGPT three times to see what responses were generated. Three specialized radiologists evaluated the responses; they found that the responses were appropriate for 22 out of the 25 questions. The chatbot did, however, provide one answer based on outdated information. Two other questions had inconsistent responses that varied significantly each time the same question was posed. Findings were published today in the journal Radiology.
Ascentage Pharma Presents Results from Three Studies Underscoring Exploratory Efforts in Potential New Indications
Ascentage Pharma (6855.HK), a global biopharma developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, released results from three preclinical studies of the company’s China-approved novel third-generation BCR-ABL inhibitor olverembatinib (HQP1351), and two key investigational apoptosis-targeted drug candidates of Ascentage Pharma, the Bcl-2 inhibitor lisaftoclax (APG-2575) and the MDM2-p53 inhibitor alrizomadlin (APG-115), in Poster Presentations at AACR.
Regulatory and Advocacy
OpGen Submits De Novo request to the U.S. FDA for Unyvero Urinary Tract Infection Panel
OpGen, Inc. (Nasdaq: OPGN), submitted a De Novo classification request to the U.S. Food and Drug Administration (FDA) seeking marketing authorization for its Unyvero UTI Urinary Tract Infection (UTI) panel, following successful completion of its clinical trial. OpGen’s Unyvero UTI Panel tests for a broad range of bacterial and fungal pathogens as well as antimicrobial resistance markers directly from urine specimens. The test aims at quantitative detection of microorganisms.
People on the Move
RS BioTherapeutics Appoints Curtis R. Rhine as Chief Financial Officer
Rhine is a finance leader with nearly 40 years of extensive experience across all finance disciplines including strategy, financial planning and analysis, long-term and short-term budgeting and forecasting, treasury including heavy bank financing experience, and accounting, financial reporting and tax. Rhine’s pharmaceutical experience includes serving as CFO of Ovation Pharmaceuticals where he readied them for acquisition by Lundbeck Inc. and Vice President, Finance of Takeda Pharmaceuticals North America (Takeda) where he oversaw all financial functions as the company grew annual revenues from launch to $3.5 billion.
