Weekly Quick Hits (Greater Philadelphia) – Week of February 13, 2023

By Mark Terry, Alex Keown, and Sarah Ellinwood
February 17, 2023

Funding

Carisma Therapeutics and Sesen Bio Announce Special Cash Dividend Ahead of Merger

Philadelphia-based Carisma Therapeutics and Sesen Bio, Inc. reached a support agreement with The Investor Group, an organization that owns approximately 8.7% of Sesen Bio’s outstanding common stock ahead of the pending merger. The agreement will see The Investor Group throw its support behind the deal. 

The amended agreement will allow for an increase to the one-time special cash dividend expected to be paid to Sesen Bio stockholders to $75 million, or $0.36 per share. It also extends the period of time for payments under the Contingent Value Right related to any potential proceeds from the sale of Vicineum and Sesen Bio’s other legacy assets to March 31, 2027.

TELA Bio Awarded Biosynthetic Mesh Products Agreement

Malvern-based TELA Bio announced a three-year dual-source agreement in the biosynthetic category with one of the Nation’s group purchasing organizations. The agreement, which runs through January 1, 2026, offers sizable growth opportunity over the contract period and provides their GPO members access to substantial cost savings and clinical differentiation, according to the company that developed OviTex Reinforced Tissue Matrix, a next-generation soft tissue repair platform for use in general, plastic and reconstructive surgery.

CHOP Receives Grant to Propel Research in Mitochondrial Space

The Children’s Hospital of Philadelphia received more than $2.3 million from the Bill & Melinda Gates Foundation to advance mitochondrial medicine research. The funds will support greater understanding as to why certain individuals and populations are more severely affected by the SARS-CoV-2 virus than others. 

Galera Therapeutics To Raise $30 Million in Stock Offer

Galera Therapeutics, Inc., a Malvern-based company focused on radiotherapy, will sell shares of common stock in order to raise approximately $30 million. The company did not indicate what the funding will be used to support. 

Ibere Pharmaceuticals Calls to Redeem Public Shares Ahead of Dissolution

Philadelphia’s Ibere Pharmaceuticals announced it will redeem all outstanding ordinary shares that were included in the units issued in its initial public offering, effective as of the close of business on March 2. This is due to the company not consummating an initial business combination prior to that date. 

In the Clinic

Investigational Bladder Cancer Treatment UGN-102 May Be Delivered at Home

Princeton, N.J.-based UroGen Pharma announced preliminary results of a study to assess the feasibility of home use of UGN-102 (mitomycin). UGN-102 is being evaluated for primary chemoablation of low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). UGN-102 was suitable to administer at home by a visiting nurse under the supervision of a treating physician and resulted in 75% of patients achieving a complete response, defined as no detectable disease three months after starting treatment, the company announced.

Passage Bio to Present Updated Interim Data from Imagine-1 Study

Passage Bio, based in Philadelphia, will present updated interim data from the first six patients in the Phase I/II Imagine-1 study of PBGM01 for GM1 Gangliosidosis. The data will be shared at the 19^th Annual WORLDSymposium, a lysomal diseases research conference held Feb. 22-26. 

PBGM01 is an AAV-delivery gene therapy currently being developed for the treatment of infantile GM1. 

VYNE Therapeutics Announces Positive Safety and Tolerability Data from Phase 1a Single and Multiple Ascending Dose Trial for VYN201 in Vitiligo

Single ascending and multiple ascending doses of VYN201 were applied topically once daily to 30 healthy volunteers in five dose cohorts for two weeks. There were no serious adverse events reported, no dose adjustments required, and no healthy volunteers withdrew. In the Phase 1b portion of the study, up to 30 patients with non-segmental vitiligo will receive VYN201 once daily in three dose cohorts: 0.5%, 1.0%, and 2.0%.

Research Roundup

Tonix Pharmaceuticals Licenses Anti-SARS-CoV-2 Monoclonal Antibodies

Tonix Pharmaceuticals obtained an exclusive license from Columbia University for the development of a portfolio of fully human (TNX-3600) and murine (TNX-4100) monoclonal antibodies (mAbs) for the treatment or prophylaxis of SARS-CoV-2 infection. The licensed mAbs were developed as part of a research collaboration and option agreement between Tonix and Columbia University, originally announced in 2020.

Centinel Spine Hits Milestone with Total Disc Replacement System

West Chester-based Centinel Spine Inc. announced the 500^th procedure in with its FDA-approved total disc replacement (TDR) system of prodisc cervical solutions, prodisc C Vivo and prodisc C SK. The milestone comes less than two months after Centinel Spine announced the completion of 250 procedures with the system and validates the benefit of matching the implant to meet surgeon preference and patient needs.

CHOP Researchers Identify Underreported Symptoms in Genetic Epilepsy Patients
Researchers from the Epilepsy Neurogenetics Initiative at Children’s Hospital of Philadelphia created a comprehensive disease model for one of the most common genetic causes of childhood epilepsies and neurodevelopmental disorders. Through systematic mapping of symptoms, the researchers identified previously underreported issues beyond neurological symptoms. These results may serve as an important foundation for future trials assessing the effectiveness of therapeutic interventions for all related symptoms. The findings were published in Epilepsia Open.

Helius Medical Technologies Showcases PoNS Therapy at APT Association

Newtown, Penn.-based Helius Medical Technologies will showcase its Portable Neuromodulation Stimulator (PoNS) technology at the American Physical Therapy Association Combined Sections Meeting. The PoNS device delivers electrical impulses through nerve fibers on the tongue, stimulating the flow of neural impulses to brain structures that control gait and balance. Not only will the neurotech company highlight the capabilities of the technology, it will also offer on-site training to teach physical therapists how to apply it.

PDS Biotech Publishes Preclinical CD4 T Cell Transduction Data by Infectimune™

In a publication in the journal Viruses, titled “R-DOTAP cationic lipid nanoparticles outperform squalene-based adjuvant systems in elicitation of CD4 T cells after recombinant influenza hemagglutinin vaccination,” PDS Biotech found that Infectimune™ (R-DOTAP) nanoparticles significantly enhance cytokine-inducing, CD4 T cell responses compared to leading commercial adjuvants being used in approved vaccines.

On the Hill – Regulatory and Advocacy

Galera Snags Priority Review for Avasopasem NDA

Galera Therapeutics, based in Malvern, Penn., secured Priority Review for its recently-accepted New Drug Application of avasopasem manganese for radiotherapy (RT)-induced severe oral mucositis (SOM) in patients with head and neck cancer (HNC) undergoing standard-of-care treatment. A PDUFA target date of Aug. 9 has been set by the FDA. Currently, the FDA does not intend to hold an advisory committee meeting for the NDA. There are currently no FDA-approved drugs to reduce SOM for these patients.  Avosopasem previously picked up Breakthrough Therapy and Fast Track designations from the FDA. 

FDA Accepts New Drug Application for Iveric Bio’s Avacincaptad Pegol for the Treatment of Geographic Atrophy

IVERIC bio (Nasdaq: ISEE) announced that the FDA accepted the company’s New Drug Application (NDA) for avacincaptad pegol (ACP), an investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to Age-Related Macular Degeneration (AMD). The NDA has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of August 19, 2023.

People on the Move

Two CHOP Physicians Receive Awards at 27th Annual Penn Medicine Awards of Excellence

Two physicians from the Children’s Hospital of Philadelphia were honored at the 27th Annual Penn Medicine Awards of Excellence. Joseph W. St. Geme, Physician-in-Chief and Chairman of the Department of Pediatrics, and Andrew J. Bauer, Medical Director of the Pediatric Thyroid Center and Professor of Pediatrics at CHOP, were both recognized. 

Dr. St. Geme received the Christian R. and Mary F. Lindback Award for Distinguished Teaching at the University of Pennsylvania. This award recognizes faculty teaching. Dr. Andrew Bauer received the Louis Duhring Outstanding Clinical Specialist Award, which recognizes a clinical specialist physician who strives for continuous improvement and maintains a commitment to patients that goes beyond the norm and exemplifies Penn Medicine and CHOP’s goals for clinical care and professionalism.