Weekly Quick Hits (Greater Philly) – Week of June 5, 2023
By Mark Terry
June 9, 2023
Funding, Awards and Collaborations
Colorcon Invests in Manufacturing Plant in Malaysia
Harleysville, Pa.-based Colorcon announced it is investing in a new manufacturing facility in Johor State, Malaysia for its film coating products. Construction will begin in August and is expected to be completed by July 2025.
The Chemours Company to Sell Glycolic Business for $137 Million
Wilmington, Del.-based The Chemours Company inked a definitive agreement to sell its Glycolic Acid business for $137 million in cash to PureTech Scientific. PureTech is positioning itself to become a global leader in organic synthesis of ultra-high purity alpha hydroxy acids for the life sciences and specialty chemical industries.
Lotus Clinical Research Enters Partnership with Trialogics
Lotus Clinical Research (New Providence, NJ) entered into a strategic partnership with Trialogics (Wilmington, Del.) to strengthen their existing relationship and expand Lotus’ use of Trialogics’ clinical trial software offering. The partnership will expand on work to data collection methods, streamline trial processes, and strengthen the quality of data collection.
Ecolab to Build Medical Resigns Manufacturing Site in Landenberg
Ecolab announced plans to expand its Purolite business by building a new biologics resin manufacturing plant in Landenberg, Pa., near the Delaware state line. The new location will include resin production facilities, cleanrooms, laboratories and new office space.
In the Clinic
AstraZeneca Reports Broad Results at ASCO
AstraZeneca, with U.S. offices in Wilmington, Del., presented a number of findings at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. The company reported positive results from the Phase III ADAURA trial of Tagrisso (osimertinib), which demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to placebo in the adjuvant treatment of early-stage EGFR-mutated non-small cell lung cancer (NSCLC) after complete tumor resection with curative intent. The company reported on ANNEXA-I, a post-marketing Phase IV trial of Andexxa (andexanet alfa) in patients on oral FXa-inhibitor treatment including apixaban and rivaroxaban experiencing an intracranial hemorrhage.
The study will be halted early based on it achieving pre-specified stopping criteria of superior hemostatic efficacy. With Daiichi Sankyo, AstraZeneca reported on interim analysis of the ongoing DESTINY-PanTumor-2 Phase II trial of Enhertu (trastuzumab deruxtecan), which showed clinically meaningful and durable responses across a broad range of HER2-expressing advanced solid tumors in previously treated patients. And AstraZeneca provided updated results from the TROPION-Lung02 Phase Ib study, with additional enrollment and follow-up from the initial presentation, of datopotamab deruxtecan in combination with Merck’s Keytruda (pembrolizumab) with or without platinum-based chemotherapy. It demonstrated promising clinical activity and no new safety signals in both previously untreated or pretreated patients with advanced or metastatic NSCLC without actionable genomic alterations.
Janssen’s Rybrevant Associated with Sustained Antitumor Activity in NSCLC
Located in Raritan, NJ, The Janssen Pharmaceutical Companies of Johnson & Johnson presented long-term results from the CHRYSALIS study at ASCO. The trial demonstrated the combination of Rybrevant (amivantamab) and lazertinib with associated with sustained antitumor activity as a first-line treatment in EGFR-_mutated non-small cell lung cancer (NSCLC). Additional data and these findings included an analysis of predictive biomarkers from Cohort D of the Phase I/Ib CHRYSALIS-2 trial evaluating a chemotherapy-free regimen of Rybrevant in combination with lazertinib, as well as updated safety results from the Phase I PALOMA trial of SC administration of Rybrevant as a monotherapy.
Teleflex’ Arrow EZ-IO Needle Cleared by FDA for MRI Environment
Wayne, Pa.-based Teleflex announced the Arrow EZ-IO Needle is the first and only Intraosseous (IO) Needle to receive 510(k) clearance from the FDA for MR Conditional Labeling. The new labeling allows physicians to continuously care for patients who require MRI scans without interruption to the established site for vascular access.
Penn Research: RWD Suggests Halting Immunotherapy After 2 Years Reasonable in Advanced Lung Cancer
Presenting at the 2023 ASCO Annual Meeting, researchers from Penn Medicine’s Abramson Cancer Center provided data suggesting it is reasonable to halt immunotherapy at two years as long as the advanced NSCLC patients’ cancer hasn’t progressed. They found no statistically significant difference in overall survival between patients who stopped treatment at 2 years and ones who continued treatment indefinitely.
Penn Research: Low-Cost Human Biomarker Sensor Designs
Researchers at Penn State have developed a low-cost, RNA-based technology to detect and measure biomarkers. The new tech can perform the same measures that other tech approaches do for $100 to $1000 for only $1. They published their research in Nature Communications.
CHOP Research: Lab-Grown “Mini-Intestines”
Researchers with Children’s Hospital of Philadelphia (CHOP) developed “mini-intestines” generated from patient tissue samples and grown in a lab to replicate certain aspects of Crohn’s disease. This inflammatory condition is one of the most common forms of inflammatory bowel disease (IBD). The mini-intestines allow researchers to study the epithelium, which degenerates in patients with inflammatory bowel disease.
Penn Research: Chronic Stress Linked to Inflammatory Bowel Disease
Researchers at the Perelman School of Medicine at the University of Pennsylvania published research that found glial cells, which support neurons, communicate stress signals from the CNS to the semi-autonomous nervous system within the GI tract (enteric nervous system, or ENS). These psychological stress signals can lead to inflammation and worsen symptoms of inflammatory bowel disease (IBD).
Penn Research: Better Understanding of Actin Filament in Cells and Muscles
Investigators with the Perelman School of Medicine at the University of Pennsylvania found key atomic structures at the ends of actin filaments, which are protein structures important to living movement from single cells to animals. Using cryo-electron microscopy, the research offered new insights into how these actin filaments behave, which may help better understand muscle, bone, heart, neurological, and immune systems disorders.
Penn Research: New Bacterial Species Linked to Tooth Decay
Researchers from the University of Pennsylvania School of Dental Medicine and the Adams School of Dentistry and Gillings School of Global Public Health at the University of North Carolina identified a bacterial species, Selenomonas sputigena, which can have a major role in tooth decay. It was previously only linked to gum disease, but now it has been found to work with Streptococcus mutans to worsen tooth decay.
Regulatory and Advocacy
Legend Biotech and Janssen Submit Supplemental BLA to FDA for Carvykti
Legend Biotech, based in Somerset, NJ, and The Janssen Pharmaceutical Companies of Johnson & Johnson (Raritan, NJ), submitted a supplemental Biologics License Application (sBLA) to the FDA to expand the label for Carvykti (ciltacabtagene autoleucel) to include adults with relapsed and lenalidomide-refractory multiple myeloma who have received at least one previous line of therapy, including a protease inhibitor and an immunomodulatory agent. The sBLA is supported by data from the CARTITUDE-4 Phase III trial.
Rocket’s ACM PKP2 ACM Gene Therapy Receives Fast Track and Orphan Designation
Rocket Pharmaceuticals, headquartered in Cranbury, NJ, received Fast Track and Orphan Drug designations from the FDA for RP-A601, the company’s gene therapy for plakophilin-2 related arrhythmogenic cardiomyopathy (PKP2-ACM). The disease is an inherited heart disease linked to life-threatening arrhythmias, cardiac structural abnormalities, and sudden cardiac death.
Coeptis Approved to Transfer to The Nasdaq Capital Market
Coeptis Therapeutics, based in Wexford, Pa., reported it has received approval from the Nasdaq Stock Market to transfer its listing to the Nasdaq Capital Market from the Nasdaq Global Select Market. It will begin trading on June 13, 2023, under the current ticker symbols COEP and COEPW.
People on the Move
Seneca Appoints Cuong Do to Board of Directors
Philadelphia-based Seneca Therapeutics appointed Cuong Do to its board of directors. Do has over two decades of experience in biopharma. He is currently CEO of BioVie. He was previously President of Samsung Electronics Co.
Innovation Space CEO Judged Science Start-Up Pitches at BIO
Bill Provine, President and CEO of Wilmington, DE-based The Innovation Space served as a judge at the Start-Up Stadium pitch competition at this year’s BIO International Convention. The event featured 48 presenting companies from 12 countries across 15 therapeutic areas.
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Mark Terry is a freelance writer, editor, novelist and ghostwriter. He holds a degree in microbiology & public health and spent 18 years in infectious disease research and clinical and research genetics prior to his transition to a writing career. His areas of expertise include biotechnology, pharma, clinical diagnostics, and medical practice management. He has written literally thousands of articles, as well as market research reports, white papers, more than 20 books, and many other written materials. He currently lives in Michigan with his family.