Weekly Quick Hits (Research Triangle Park)
– Week of February 27, 2023

By Alex Keown, Mark Terry, and Sarah Ellinwood
March 3rd, 2023

Funding and Collaborations

Praetego Awarded $300,000 by National Eye Institute

Praetego Inc, a Durham-based company developing therapeutics for neurodegenerative diseases related to aging, secured a $300,000 grant from the National Eye Institute to support development of the company’s lead candidate, PTG-630. Praetego is advancing PTG-630 into preclinical proof of concept in diabetic retinopathy. 

BioCryst Reports Inducement Grants

BioCryst Pharmaceuticals announced the company’s compensation committee granted 12 newly-hired employees with stock options. The options have an exercise price of $8.85 per share, which is equal to the closing price of BioCryst common stock the day the grants were awarded. Each stock option has a 10-year term.

In the Clinic

Bryn Pharma’s Epinephrine Spray Provides Higher, More Sustained PK

Data shows Bryn Pharma’s intranasal epinephrine spray offers a higher and more sustained pharmacokinetic/pharmacodynamic profile than current standard of care auto-injector treatment. The Raleigh-based company’s Utuly is an investigational self-administered form of epinephrine being studied for the treatment of type 1 allergic reactions, including anaphylaxis. Trial results were presented at the American Academy of Allergy, Asthma and Immunology annual meeting in San Antonio, Texas.

RedHill Biopharma Ltd Announces RDHL Opaganib Selected by NIH For Development

RedHill Biopharma announced the NIH’s Radiation and Nuclear Countermeasures Program selected opaganib for the nuclear medical countermeasures product development pipeline as a potential treatment for Acute Radiation Syndrome (ARS). Studies will be undertaken to validate opaganib’s efficacy in established pre-clinical animal models of ARS

Incyclix Bio Receives IND Clearance for INX-315 

The FDA cleared Incyclix Bio’s Investigational New Drug application for the comapny’s lead asset, INX-315, a novel, potent and selective CDK2 inhibitor. The Phase I/II study will evaluate the safety, pharmacokinetics (PK), and preliminary antitumor activity of INX-315 in patients with advanced/metastatic cancers. The trial will include patients with ER+/HER2- breast cancer who have progressed on a prior CDK4/6i regimen and patients with CCNE1-amplified solid tumors that have progressed on standard of care treatment.

Novel Peanut Allergy Treatment Shown to be Safe, Effective, and Lasting

A four-year clinical trial at the UNC School of Medicine has found that an increased dosage of a unique type of peanut allergy immunotherapy continues to show promise for children. Data fom a four-year Phase II clinical trial showed a peanut allergy treatment called sublingual immunotherapy, or SLIT, is effective and safe. The data also showed SLIT offered durable desensitization to peanuts in peanut-allergic children.

New Patents

Cancer Advances, Inc. Secures New U.S. Patent 

Durham-based Cancer Advances, Inc, which is developing therapeutics for gastrointestinal cancers, secured a patent for its lead asset Polyclonal Antibody Stimulator (PAS) vaccine. The new patent titled “Compositions and Methods for Inducing Humoral and Cellular Immunities against Tumors and Cancer” covers a method for treating and/or preventing and/or inhibiting development of a tumor and/or a cancer associated with gastrin signaling in a subject. Gastrin mediated tumors include, but are not limited to, gastrointestinal cancers.

Research Roundup

NIH Study: Potential Link Between Pregnancy Complications and Slower Development 

Gestational diabetes and preeclampsia may be linked to slower biological development in infants, according to a new study funded by the Environmental influences on Child Health Outcomes Program at the National Institutes of Health. The study found that newborns exposed to these complications were biologically younger than their chronologic gestational age. This was most noticeable in female infants, the study said. 

Cessation Therapeutics’ Anti-Fentanyl Monoclonal Antibody Treatment Shows Promise

A single administration of Chapel Hill-based Cessation Therapeutic’s experimental treatment blocked life-threatening, fentanyl-induced respiratory depression in non-human primates for at least three weeks, the company announced. With NIH funding, Cessation is evaluating its pioneering anti-fentanyl monoclonal antibody treatment, CSX-1004. CSX-1004 targets fentanyl molecules as they enter the bloodstream, effectively “sponging them up in the blood before they reach the brain.” The Cessation treatment does not enter or bind to receptors in the brain, thereby avoiding the risk of addiction, the company said. 

Regulatory and Advocacy

AskBio Receives Orphan Drug Designation In Europe for AAV Gene Therapy

Asklepios BioPharmaceuticals, a division of Bayer, announced the European Commission has granted orphan drug designation for AB-1003 (also known as LION-101) for the treatment of limb-girdle muscular dystrophy (LGMD). AB-1003 is a novel investigational recombinant adeno-associated virus (AAV) based gene therapy being assessed in a Phase I/II trial as a one-time intravenous (IV) infusion for the treatment of patients with LGMD type 2I/R9 (LGMD2I/R9), a disease subtype affecting 4.5 people per million worldwide.

People on the Move

Zymtronix Adds Thomas Videbaek to Board of Directors

Zymtronix, Inc. added biotech veteran Thomas Videbaek, a former executive vice president at Novozymes, to its Board of Directors. At Novozymes, Videbaek held multiple leadership roles including chief operating officer for global R&D,Manufacturing and Supply Chain, M&A, Sustainability and Regional Leadership. He was also head of Corporate Strategy & Business Transformation and Bio-business.

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