Funding, Awards and Collaborations
The Innovation Space Joins Delaware Business Roundtable
Wilmington, Del.-based The Innovation Space joined the Delaware Business Roundtable. The two organizations will focus on attracting and supporting science startups in Delaware as they build and scale their businesses.
Two Penn Med Researchers Receive AAN Awards
Virginia MY Lee, Ph.D., the John H. Ware 3rd Professor in Alzheimer’s Research in Pathology and Laboratory Medicine, and Roy H. Hamilton, MD, MS, an associate professor of Neurology and Physical Medicine and Rehabilitation, and director of the brainSTIM Center, both with the Perelman School of Medicine at the University of Pennsylvania received awards at the American Academy of Neurology (AAN) Annual Meeting. Lee received the Sheila Essey Award for research contribution into ALS. Hamilton received the AAN Changemaker Award for dedication to increasing diversity, equity, and inclusion efforts within the department of Neurology at Penn Medicine.
West Pharma Services Announces Q1 Results and Q3 Dividend
West Pharmaceutical Services, headquartered in Exton, Pa., announced financial results for Q1 2023. It is also updating full-year 2023 financial guidance up from $2.935 billion to $2.960 to a range of $2.965 billion to $2.990 billion. The company has also approved a $0.19 per share dividend to be paid on August 2, 2023, to shareholders of record as of July 26, 2023.
Integra Q1 Financials Highlight Strength of Portfolio
Integra LifeSciences, based in Princeton, NJ, a medical technology company, reported Q1 2023 financials. Revenues increased 1.1% to $380 million with an emphasis on the strength of its diverse portfolio. Of note, they expanded the CUSA Clarity portfolio with the launch of the single-sided bone tip in the U.S., Canada, Australia and New Zealand and launched MicroMatrix in Europe.
Baudax Bio Announces Pricing of $4 Million Public Offering
Baudax Bio, based in Malvern, Pa., announced the pricing of its public offering of an aggregate of 3,478,262 shares of its common stock at a price of $1.15 per share. It is expected to raise about $4 million, which it will use for pipeline development and general corporate activities.
Avantor Q1: Net Sales Dropped 8.7%
Radnor, Pa.-based Avantor reported its first-quarter financials. Net sales were $1.78 billion, a decrease of 8.7% from the same period in 2022, with a net income drop to $121.5 million from $190.4 million in the same period.
In the Clinic
AstraZeneca and Ionis Report Positive Phase III Data for ATTRv-PN
AstraZeneca, with U.S. offices in Wilmington, Del., and Ionis Pharmaceuticals (Carlsbad, Calif.) presented positive Phase III NEURO-TTRansform data. The trial of eplontersen in hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) hit all co-primary endpoints and secondary endpoints at 66 weeks compared to an external placebo group.
Sunovion and Otsuka Dosed 1st Patient in Phase II/III Generalized Anxiety Disorder Trial
Sunovian Pharmaceuticals (Marlborough, Mass.) and Otsuka Pharmaceutical Development & Commercialization (Princeton, NJ) randomized the first patient in a Phase II/III trial of ulotaront to treat generalized anxiety disorder (GAD). The drug is a trace amine-associated receptor 1 (TAAR1) agonist with 5-HT1A agonist activity.
Arbutus Presents Clinical and Preclinical Hepatitis Data
Arbutus Biopharma, located in Warminster, Pa., announced clinical data for AB-729, an RNAi therapeutic, and preclinical data for AB-161, a next-generation oral HBV-specific RNA destabilizer. The data were presented at the Global Hepatitis Summit 2023 in Paris.
New Products
FDA Approves Otsuka and Lundbeck’s ABILIFY ASIMTUFII for Schizophrenia and Bipolar Disorder
The FDA approved Otsuka America Pharmaceutical (Princeton, NJ) and Lundbeck (Deerfield, Ill.)’s New Drug Application (NDA) for ABILIFY ASIMTUFII (aripiprazole) extended-release injectable suspension for intramuscular use. The drug is a once-every-two-months injection to treat schizophrenia in adults or maintenance monotherapy for bipolar I disorder in adults.
Research Roundup
Palatin Presented ARVO Data on Intraocular Pressure
Palatin Technologies, based in Cranbury, NJ, presented a poster describing data on PL9588 from a number of dose-ranging and duration-of-effect studies to determine its effects on intraocular pressure (IOP) in rabbits. The drug showed decreases in IOP similar or greater to the positive controls, natanoprost and timolol, FDA-approved drugs for glaucoma.
Uvax Bio Publishes Preclinical HIV Data
Newark, Del.-headquartered Uvax Bio published preclinical studies in Nature Communications describing research about its single-component multilayered self-assembling protein nanoparticles as potential HIV vaccines. Based on the data, the NIH agreed to sponsor a Phase I study in healthy volunteers expected to trigger in the first quarter of 2024.
Drexel Research: Gestational Weight Gain May Be Linked to Autism-Related Behaviors in Children
Researchers with Drexel University published research suggesting that excessive gestational weight may be associated with autism-related behaviors in children who have a greater predisposition to these behaviors and whose mothers had pre-pregnancy overweight or obesity. The research was published in Obesity, The Obesity Society’s flagship journal.
Temple Research: Existing Drugs Appear to Prevent Alzheimer’s-Related Cognitive Impairment
Silvia Fossati, PhD, Associate Professor of Neural Sciences and
Cardiovascular Sciences at the Lewis Katz School of Medicine at Temple University published research suggesting that FDA-approved drugs, carbonic anhydrase inhibitors (CAIs), in mice at least, promoted the clearance of amyloid-beta from blood vessels and glial cells, controlling brain inflammation and appears as well to restore cell function, preventing cognitive impairment.
CHOP Research: Role for ALT in Treatment-Resistant CNS Tumors
Two recent studies from Children’s Hospital of Philadelphia (CHOP) Cancer Center described a novel treatment and characterizing the role of alternative lengthening of telomeres (ALT) in treatment-resistant pediatric tumors. One study evaluated the use of adavosertib and irinotecan for relapsed neuroblastoma, medulloblastoma and rhabdomyosarcoma. The second study used lab and computational approaches to catalog ALT in about 900 pediatric brain tumors.
Regulatory and Advocacy
FDA Places Clinical Hold on Arbutus’s IND for AB-101 for Hepatitis B
Warminster, Pa.-based Arbutus Biopharma Corporation reported the FDA
had placed a clinical hold on its Investigational New Drug (IND) application for AB-101. The drug is a novel, oral PD-L1 checkpoint inhibitor designed to reawaken and increase the immune system of chronic hepatitis B virus patients.
Ocugen’s Retinopathy Drug Receives Orphan Drug Designation
Ocugen, headquartered in Malvern, Pa., announced the FDA had granted its OCU410ST Orphan Drug Designation. OCU410ST is an AAV serotype 5 capsid protein containing gene construct encoding human retinoic acid receptor-related orphan receptor alpha, for treatment of ABCA4-associated retinopathies, including Stargardt, Retinitis Pigmentosa 19, and Cone-rod dystrophy 3 diseases.
