Weekly Quick Hits (Philly) – Week of October 16, 2023

More insights into Long Covid, BMS’s Opdivo approved for Melanoma and more Philly Region life science stories. Check it out.

By Mark Terry | October 20, 2023

Quick Hits is BioBuzz’s weekly round up of all the life science news you don’t want to miss, in your region of interest. Don’t miss a beat; SUBSCRIBE to our weekly Quick Hits newsletter via LinkedIn (BioHealth Capital Region, Greater Philadelphia, Research Triangle Park) or get it delivered to your inbox every week.

Funding, Awards and Collaborations 

2 CHOP Researchers Named 2023 STAT Wunderkinds

Two Children’s Hospital of Philadelphia (CHOP) researchers were selected by publisher STAT as 2023 Wunderkinds. This award recognizes the next generation of scientific researchers making contributions to biomedical research. Emma Sartin, PhD, MPH, a research scientist in CHOP’s Center for Injury Research and Prevention (CIRP) was recognized for her work on disparities in health behaviors and improving physical and social outcomes for marginalized populations. Neonatologist Katharine P. Callahan, MD, was chosen for her research into the ethical and implementation challenges of genomic technologies in newborn medicine.

Palatin Q1: Preliminary Vyleesi Revenue Hit $4.6 Million

Palatin Technologies (Cranbury, NJ) reported preliminary first-quarter (ending September 30, 2023) results, citing Vyleesi product revenue of $4.6 million, an 11% increase over the previous quarter and a 100% increase over the same period last year. Vyleesi is the first and only as-needed FDA approved drug for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). The company also announced plans to initiate a clinical trial of bremelanotide, an FDA-approved drug, in combination with a Glucagon Like Peptide-1 agonist in obese patients in the first quarter of 2024.

ECRI Report: Medication and Equipment Shortages are Harming Patients

ECRI (Plymouth Meeting, Pa.), an independent, nonprofit patient safety organization, and its affiliate, the Institute for Safe Medication Practices (ISMP), found that ongoing national medication, medical supply, and medical equipment shortages harm patients. A recent survey found that appropriate care is becoming increasingly challenging. 

Thomas Scientific Acquires Arrowhead Forensics

Thomas Scientific (Swedesboro, NJ) acquired Lenexa, KS-based forensics product provider Arrowhead Forensics. The addition of the company expands Thomas’ Midwest distribution capabilities and enhances its kitting operation, leveraging support to a broad range of customers.

In the Clinic

Prelude Presented Data from 2 Ongoing Phase I Cancer Trials

Prelude Therapeutics (Wilmington, Del. and Boston) presented four posters at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. Two were data from two ongoing Phase I trials for the company’s CDK9 inhibitor, PRT2527 and CDK4/6 inhibitor, PRT3645, and two preclinical posters for its SMARCA2 degrader compound, PRET3789.

Harmony’s Idiopathic Hypersomnia Trial Shows Mixed Results

Harmony Biosciences (Plymouth Meeting, Pa.) announced topline results from the INTUNE trial in patients with idiopathic hypersomnia (IH). Although the primary outcome for excessive daytime sleepiness between pitolisant and placebo did not hit statistical significance in the randomized withdrawal phase, it did demonstrate clinically meaningful benefit in patients completing the initial open-label phase.

Trevena Reports Favorable Phase I Data on TRV045

Trevena (Chesterbrook, Pa.) reported topline safety and tolerability data for two Phase I proof-of-concept studies of TRV045, a sphingosine-1 phosphate receptor modulator selective for the S1P receptor subtype 1. The drug is being developed for acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy. It is also being investigated as a potential treatment for epilepsy.

Janssen’s Tremfya Maintains Key Efficacy Endpoints Through 3 Years in Crohn’s Study

Janssen Pharmaceuticals (Spring House, Pa.), a Johnson & Johnson Company, announced new data from the long-term extension of the GALAXI Phase II trial of Tremfya (guselkumab) in moderate-to-severe Crohn’s disease through a total of three years. Rates of clinical remission and endoscopic response were maintained through three years, with a consistent safety profile.

BMS’s Clear Cell Renal Cell Carcinoma Trial Hits Co-Primary Endpoints

Bristol Myers Squibb (Princeton, NJ) announced that the Phase III CheckMate -67T trial of the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) compared to IV Opdivo hit the co-primary PK endpoints and a key secondary endpoint. The drug reformulation was evaluated in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received previous systemic therapy.

Research Roundup

Penn Research: Long Covid Associated with Serotonin Reduction

Researchers from the Perelman School of Medicine at the University of Pennsylvania published a study that found in Long Covid, tryptophan absorption is reduced by persistent viral inflammation, causing serotonin to be depleted. This in turn led to disrupted vagus nerve signaling, which causes several of the Long Covid symptoms, such as memory loss. They further found that by replenishing tryptophan or serotonin in patients, the memory impairment could be reversed.

Onconova Presents Promising Preclinical Mantle Cell Lymphoma Data

Onconova Therapeutics (Newtown, Pa.) presented promising ongoing preclinical data for narazaciclib, in combination with ibrutinib and other targeted therapies used to treat mantle cell lymphoma (MCL). Narazaciclib is the company’s proprietary multi-kinase inhibitor.

Penn Research: iNKT Cell Platform Shows Promise for Treating Cancer

Researchers at the University of Pennsylvania’s School of Veterinary Medicine and Perelman School of Medicine published research that suggested allogeneic invariant natural killer T cells (allo-iNKTs) from healthy donors with specific characteristics could combat their own rejection without additional gene editing. The research tested the theory in healthy dogs. Dogs develop cancers that are similar to human cancers and both human and canine cancers receive some of the same chemotherapeutic agents.

Penn Research: High Pregnancy Weight Gain Tied to Higher Risk of Death Later in Life

Researchers with the Perelman School of Medicine at the University of Pennsylvania analyzed 50 years of data and found that pregnant women who gained more than the now-recommended amount of weight had a higher risk of death from heart disease or diabetes in the following decades. The research was published in The Lancet.

On the Hill – Regulatory and Advocacy

FDA Approves BMS’s Opdivo as Adjuvant for Melanoma

The FDA approved Bristol Myers Squibb’s Opdivo (nivolumab) for adjuvant treatment of adult and pediatric patients 12 years and older with completely resected IIB or IIC melanoma. The approval is built on data from the Phase III CheckMate -76K trial.

FDA Grants Priority Review to AstraZeneca’s Tagrisso Plus Chemotherapy in Lung Cancer

The FDA granted AstraZeneca’s (Wilmington, Del.) supplemental New Drug Application (sNDA) for Tagrisso (Osimertinib) in combination with chemotherapy Priority Review for treatment of adults with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). The PDUFA action date is in the first quarter of 2024.

Penn State Research: Females Less Likely to Heal from ACL Injuries

Penn State Researchers analyzed an animal model of the anterior cruciate ligament (ACL) and found that, although most common ACL injuries are caused by acute trauma, they can also be the result of chronic overuse. More importantly, they found that females were less able to heal from the microtraumas than males.

People on the Move

SwanBio Brings on John Tsai and Christopher “Topher” Brooke

SwanBio Therapeutics (Philadelphia) announced that John Tsai, MD was joining the company as executive chair and Christopher “Topher” Brooke was joining as chief operating officer. Tsai is currently an executive partner at Syncona and CEO at Forcefield Therapeutics. Brooke joins SwanBio from Aytu BioPharma, which recently acquired Rumpus Therapeutics, which he founded.

Intravent Names Kevin Foley as Chief Innovation Officer

Intravent Medical (Hershey, Pa.) appointed Dr. Kevin Foley as Chief Innovation Officer. Foley most recently served as Chief Robotics Officer at Accelus. He is a professor of neurosurgery, orthopedic surgery and biomedical engineering at the University of Tennessee Health Science Center and chair of Semmes Murphey Clinic in Memphis, Tennessee.

Wistar Announces Dean Stoios as CFO

The Wistar Institute announced the appointment of Dean Stoios as Chief Financial Officer. Most recently, Stoios was CFO of the Coriell Institute for Medical Research.

Immunone Appointed Bob Lechleider as CMO

Immunome (Seattle & Exton, Pa.) appointed Bob Lechleider, MD, as Chief Medical Officer. Lechleider was previously the CMO at OncoResponse.