Weekly Quick Hits (Greater Philly) – Week of May 8, 2023

By Mark Terry
May 12, 2023

Funding, Awards and Collaborations

Interius Announces Manufacturing Partnership with WuXi Advanced Therapies

Philadelphia-based Interius BioTherapeutics announced a manufacturing partnership with WuXi Advanced Therapies, a global CTDMO. Interius has developed a process to manufacture INT-2104, an off-the-shelf lentivector product designed to create CAR T-cells directly in vivo in a patient’s body to treat B-cell malignancies. Interius will use WuXi ATU’s platform for GMP manufacturing of Phase I clinical product.

Wistar, Penn Biotech Center and Baruch S. Blumberg Institute Team Up to Support Biotechs

The Wistar Institute, the Pennsylvania Biotechnology Center (PABC) and the Baruch S. Blumberg Institute have formed a strategic collaboration to accelerate the advancement of “bench to bedside” biomedical research discoveries in the tri-state region. They will do so by supporting the seeding, launching and maturation of life science startups.

Catalent Stocks Plunge After Q3 Report

Catalent, based in Somerset, NJ, saw its stock plunge more than 20% after releasing its fiscal Q3 results. The investor reaction appeared related to the company projecting a major reduction in its FY23 net revenue adjusted EBITDA guidance by more than $400 million each. It also reported expectations that its income statement and balance sheet would reflect a goodwill impairment for its consumer health business of more than $200 million, mostly related to its acquisition of Bettera Wellness in October 2021.

Marinus Pharma Q1: Phase III Data Expected, and CHMP Opinion Coming Soon

Marinus Pharmaceuticals, headquartered in Radnor, Pa., released its first-quarter 2023 financial results and a business update. Milestones expected include an interim analysis of the Phase III refractory status epilepticus trial in the second half of this year and a CHMP opinion in May for ZTALMY in CDKL5 deficiency disorder, and Phase III trial data expected mid-2024 for its tuberous sclerosis complex trial.

GeneOne and Wistar Institute Partner to Develop Treatment for Nipah Virus

The Wistar Institute is partnering with South Korea-based GeneOne Life Science to identify and develop novel small molecules to inhibit Nipah virus. Nipah virus is a zoonotic RNA virus of the genus Henipavirus, that first appeared on farms in Malaysia and Singapore in humans and pigs in 1999..

SERB Pharma and SFJ Pharma Partner on Bentracimab

Philadelphia-based SERB Pharmaceuticals and San Francisco-based SFJ Pharmaceuticals announced that SERB had acquired exclusive U.S. rights to the ticagrelor reversal agent bentracimab from SFJ. Ticagrelor, marketed by AstraZeneca as Brilinta, is a reversible oral P2Y12 platelet inhibitor for patients who have suffered a heart attack or stroke, or who have acute coronary syndromes or coronary artery disease. Bentracimab would help prevent vascular events and decrease the risk of death while giving physicians a way to control bleeding in rare emergency situations like surgery or a major bleeding event.

Annovis Bio Q1: A $9.7 Million Net Loss for the Quarter

In its first-quarter financial report, Berwyn, Pa.-based Annovis Bio focused on its ongoing clinical programs in Alzheimer’s disease and Parkinson’s disease, noting that 27 sites had been activated and 38 patients screened as of April 20 in its AD Phase II/III trial and more than 540 patients had been screened and more than 385 patients dosed as of April 20 in its Phase III trial for Parkinson’s. The company also reported a net loss of $9.7 million for the quarter, and has cash and cash equivalents of $16.8 million.

Real Estate

Janssen Vacates Chesterbrook Building

Janssen, a Johnson & Johnson company, is leaving their 3-story, 131,100-square-foot Chesterbrook building, which it has occupied for several decades. The company indicates it could accommodate its employees at several other locations in the Philadelphia area.

Construction Begins on 2300 Market by Breakthrough in Philadelphia

Construction began on a new life science research building at Philadelphia’s Center City District. The $130 million, 223,000-square-foot research center at S. 23^rd Street has been dubbed 2300 Market by Breakthrough and is being developed by Breakthrough Properties. The building is expected to be completed by the summer of 2024.

In the Clinic

Janssen Phase III Tremfya Data Positive in Ulcerative Colitis

Spring House, Pa.-based Janssen Pharmaceutical, a Johnson & Johnson company, reported new efficacy and safety data from the Phase III QUASAR Induction Study of Tremvya (guselkumab) in adults with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional and/or advanced therapies. The results demonstrated statistically significant and clinically meaningful improvements across symptomatic and histo-endoscopic outcome measures.

New Products

Insmed Describes New Research Platforms and Capabilities

Based in Bridgewater, NJ, Insmed announced progress across its early-stage research programs as part of an investor and analyst event. The company has developed a targeted AAV delivery system to potentially work around some of the key challenges found with current gene therapies, including high dose requirements, systemic toxicities, low efficacy, and off-target transduction.

Research Roundup

SwanBio’s Healthcare Resource Use Study Confirms Impact of AMN on Men and Women

SwanBio Therapeutics, based in Philadelphia, conducted a healthcare resource use study that confirmed the significant burden and economic impact of adrenomyeloneuropathy (AMN) on both men and women. AMN is a progressive and debilitating neurodegenerative disease caused by mutations in the ABCD1 gene that disrupt the function of spinal cord cells and other tissues. The company is working to develop SBT101, an AAV-based gene therapy for AMN.

Penn Med Research: Remote BP Monitoring Post-Pregnancy 

Researchers at the Perelman School of Medicine at the University of Pennsylvania published research showing that new mothers with high blood pressure who took part in a post-partum remote blood pressure monitoring program were less likely to have post-partum complications, hospitalizations, and incurred less health care costs in the six months after delivery compared to mothers with high BP who did not participate. The research was published in the journal Obstetrics and Gynecology.

CHOP Research: Peanut Patch Effective in Toddlers

Researchers at the Children’s Hospital of Philadelphia (CHOP) released research showing that daily use of a “peanut patch” for one year worked to desensitize a majority of toddlers with peanut allergies. This decreased the chances of an allergic reaction from accidental exposure. The data was published in the New England Journal of Medicine.

Temple Research: How a Calcium Sensor Regulates Mitochondrial Ultrastructure

Researchers at the Lewis Katz School of Medicine at Temple University published research in Science Signaling demonstrating that mitochondrial ultrastructure is regulated by the calcium-binding protein MICU1. MICU1 is necessary for the function of the mitochondrial contact site and cristae organizing system (MICOS), which governs the structure of the inner and outer mitochondrial membranes.

Regulatory and Advocacy

Rocket Pharma’s IND Cleared for Arrhythmogenic Cardiomyopathy Trial

Cranbury, NJ-based Rocket Pharmaceuticals received clearance from the FDA for its IND application for RP-A601 to treat arrhythmogenic cardiomyopathy due to plakophilin 2 pathogenic variants (PKP2-ACM). The disease is an inherited heart disease that can lead to life-threatening arrhythmias, cardiac structural abnormalities, and sudden cardiac death. RP-A601 is an AAV.rh74-based gene therapy.

CovationBio Released First Sustainability Report

Newark, Del.-based CovationBio, a biomaterials company, released its first sustainability report. This report reinforced the company’s commitment to contribute to sustainability advancement in four key areas aligned with the UN Development Goals: Decent Work and Economic Growth, Responsible Production and Consumption, Climate Action, and Commitment to Life on Land.

FDA Approves sNDA for Otsuka and Lundbeck’s Rexulti for Alzheimer’s Agitation

Otsuka Pharmaceutical, with offices in Princeton, NJ, and Lundbeck (Deerfield IL), announced the FDA had approved the supplemental New Drug Application (sNDA) of Rexulti (brexpiprazole) for treatment of agitation associated with dementia due to Alzheimer’s disease. This makes the drug the first and only pharmacological treatment in the U.S. for this indication.

FDA Approves Endovascular Catheter Developed at Temple University

The FDA approved the BASHIR Endovascular Catheter (THROMBOLEX, Inc.), invented at the Lewis Katz School of Medicine at Temple University. It was approved to treat acute pulmonary embolism. The approval was based on data from the NIH-sponsored RESCUE study.

People on the Move

Envision Pharma Appoints Deepti Sodhi Jaggi to Board

Envision Pharma Group (Philadelphia) appointed Deepti Sodhi Jaggi, PharmD, MBA, to its board of directors. Dr. Jaggi was most recently Chief Strategy & Commercial Officer at Better Therapeutics, a digital therapeutic company.

AdaptHealth Q1: Sleep Categories Grew 17.6% for Quarter; CEO Griggs to Step Down

In addition to its first-quarter report, Plymouth Meeting, Pa.-based AdaptHealth announced that Stephen Griggs will step down as CEO effective June 30, 2023. The company is leading a search now. Richard Barasch, board chairman, will act as interim CEO if they don’t find a replacement by June 30. For the quarter, net revenue was $774.6 million compared to $706.2 million in the first quarter last year, an increase of 5.4%. Its Sleep categories reported 17.6% growth.

Three Penn Researchers Receive Helen Keller Prize for Vision Research

Jean Bennett, MD, PhD, the FM Kirby Emeritus Professor of Ophthalmology and Cell and Development Biology, Albert Maguire, MD, the FM Kirby Professor of Molecular Ophthalmology, and the late Samuel Jacobson, MD, PhD, Professor of Ophthalmology at Penn Medicine, received the Helen Keller Prize for Vision Research from the Helen Keller Foundation and BrightFocus Foundation, for excellence and career-long contributions to vision science.

Bruce Levine at Penn Med Receives Jerry Mendell Award

Bruce Levine, PhD, a professor of Pathology and Laboratory Medicine at Penn Medicine, received the Jerry Mendell Award for Translational Science from the American Society of Cell + Gene Therapy in recognition of his work on the first FDA-approved gene therapy and for multiple first-in-human adoptive immunotherapy trials.

Josh Gladden Named Temple University VP for Research

Josh Gladden, PhD, has been named Temple University’s Vice President for Research. He will begin the role on Aug. 1, 2023. He was previously the University of Mississippi’s Vice Chancellor for Research and Sponsored Programs. Gladden earned his PhD in Physics from the Pennsylvania State University.