Weekly Quick Hits (Research Triangle Park) – Week of February 6, 2023

By Alex Keown, Mark Terry, and Sarah Ellinwood
February 10, 2023

Funding & Partnerships

RedHill Biopharma and HealthCare Royalty Strike Deal for Movantik

Specialty pharmaceutical company RedHill Biopharma announced the end all debt obligations under the credit agreement between the company nd HCR in exchange for the transfer of its rights in Movantik (naloxegol) to Movantik Acquisition Co., an affiliate of HealthCare Royalty.

Tenax Therapeutics Announces $15.6 Million Public Offering

Formerly known as Oxygen Biotherapeutics, Tenax Therapeutics announced a public offering of common shares expected to raise approximately $15.6 million. The Chapel Hill-based company will use the proceeds to advance the clinical development of imatinib for the treatment of pulmonary arterial hypertension into Phase III. Funds will also be used to advance levosimendan, a treatment of PH-HFpEF, toward regulatory approval. 

Virscidian Forges Medicinal Chemistry Collaboration with Biosero, Inc.

Cary-based Virscidian teamed up with San Diego’s Biosero to support fully automated analytical workflows for medicinal chemistry as well as other scientific applications, including accelerated screening for drug metabolism and pharmacokinetics.

Virscidian’s Analytical Studio platform was developed to accelerate drug discovery. The software automates analysis of mass spectrometric and chromatographic data. Biosero provides Green Button Go laboratory automation software. By working together, Biosero and Virscidian are enabling customers to transfer data between these software platforms so that full medicinal chemistry and analytical workflows can be automated.  

Syneos Health, Haystack Health Partner to Accelerate Clinical Trials 

Morrisville-based Syneos Health, announced a strategic partnership with Haystack Health, a Roivant Health portfolio company developing advanced Artificial Intelligence (AI) and Natural Language Processing (NLP) solutions, to improve the identification and enrollment of patients for clinical trials.

In the Clinic

CoImmune’s CAR-T Cells Improve Anti-Tumor Activity, Reverse Immunosuppression 

Durham-bsaed Colmmune, Inc. announced preclinical models of its engineered CAR-T cells, which secrete the checkpoint blocker CD47-SIRPα, have improved anti-tumor activity and reverse myeloid immunosuppression in tumors. The data demonstrate that OrexiCAR T cells plus rituximab were additive in effect on lymphoma tumor regressions and mouse survival without new toxicities. The results are published in Blood, a highly cited peer-reviewed publication in the field of hematology.

Atsena Therapeutics to Present Positive Interim Data from Phase I/II Trial of ATSN-101 

Durham-based Atsena Therapeutics will present positive interim data from an ongoing Phase I/II trial assessing  ATSN-101 at the 46^th Annual Macula Society Meeting, in Miami. ATSN-101, Atsena’s lead investigational gene therapy product, is being evaluated in patients with Leber congenital amaurosis caused by biallelic mutations in GUCY2D (LCA1). LCA1 is a monogenic eye disease that disrupts the function of the retina and results in early and severe vision impairment or blindness.

On the Hill – Regulatory and Advocacy

Fennec Pharma’s Pedmark Receives Orphan Drug Exclusivity from U.S. FDA

Fennec Pharma’s pediatric oncology drug Pedmark secured Orphan Drug designation from the FDA for the reduction of ototoxicity, or hearing loss, associated with cisplatin use in pediatric patients one month of age and older with localized, non-metastatic solid tumors. 

Pedmark is the first FDA-approved therapy for the reduction of otoxicity associated with cisplatin in pediatric patients with localized solid tumors. 

FLAG Therapeutics Receives Rare Pediatric Disease Designation for FLAG-003

Raleigh-based FLAG Therapeutics, Inc. secured Rare Pediatric Disease designation from the FDA for FLAG-003, an investigational small molecule therapy for the treatment of Diffuse Intrinsic Pontine Glioma (DIPG). FLAG-003 is engineered to cross the blood brain barrier and target and kill cancer cells by blocking the formation of a tumor vascular system and disrupting cancer cell replication by inhibiting tubulin. FLAG-003 was previously granted Orphan Drug Designation for the treatment of all gliomas, including glioblastoma multiforme and DIPG.

Labcorp Unveils New Name for Clinical Development Business – Fortrea

Burlington-based Labcorp announced the new company to be formed by the planned spin-off of its Clinical Development business will be known as Fortrea. Upon completion of the spin-off from Labcorp, Fortrea will operate as an independent, publicly traded global CRO that offers comprehensive drug and medical device development services. With over 19,000 people, Fortrea will provide Phase I through IV clinical trial management and commercialization solutions to pharmaceutical and biotechnology organizations around the world.

People on the Move

Elizabeth Keiley Named Executive Vice President, General Counsel of vTv Therapeutics

vTv Therapeutics, which is developing orally-administered treatments for type 1 diabetes, named Elizabeth Keiley as its new EVP and General Counsel. 

Keiley is an accomplished life science industry attorney who has served in multiple senior-level legal positions at multiple botechnology, diagnostic and medical device companies. She joins vTv from Entasis Therapeutics Holdings Inc., where she served as General Counsel. Prior to Entasis, she was Senior Vice President, General Counsel at Oxford Immunotec, where she simultaneously served for seven years as Chief Compliance Officer. She was also Assistant General Counsel, Americas, of Zimmer, Inc., a subsidiary of Zimmer Holdings, Inc.