Weekly Quick Hits (Research Triangle Park) – Week of April 24, 2023

By Alex Keown, Mark Terry, and Sarah Ellinwood
April 28, 2023

Funding, Awards and Collaborations

Tavros Therapeutics, OpenBench Expand Small Molecule Drug Discovery Collaboration

Durham-based Tavros Therapeutics, Inc., a precision oncology platform company, and OpenBench, Inc., a screening platform pioneering success-driven small molecule discovery partnerships, entered into a collaboration to discover small molecule modulators of up to five oncology targets across an initial 18-month term. Under terms of the agreement, Tavros gains exclusive access to OpenBench’s proprietary screening technology with respect to the promising cancer targets. Financial terms were not disclosed. The agreement expands the companies’ original collaboration to pursue a first-in-class cancer target, announced in December 2021.

MD Logistics Opens Pharmaceutical Logistics Center

TMD Logistics, LLC, a subsidiary of Nippon Express Holdings, opened a new pharmaceutical logistics center in Garner. The new center will support global pharmaceutical customers through the building of a reliable and secure global pharmaceutical logistics platform.

Humacyte, JDRF Partner to Develop Insulin-Producing Biovascular Pancreas

Humacyte, Inc., based in Durham, and JDRF International announced a new collaboration to advance the development of Humacyte’s Biovascular Pancreas (BVP) product candidate. 

Humacyte’s BVP is designed to deliver insulin-producing islets using Humacyte’s investigational tissue-engineered blood vessel, the Human Acellular Vessel. The BVP would enable the delivery and survival of insulin-producing islets inside the body, using Humacyte’s bioengineered HAV as a “carrier” for delivery of the islets into the patient. JDRF will provide Humacyte with funding to support the development and testing of the BVP.

In the Clinic

BioCryst Orladeyo Shows High Attack-free Status in HAE Patients

BioCryst Pharmaceuticals announced new data from the APeX-S clinical trial, which evaluated oral, once-daily Orladeyo (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE), showing sustained reduction in disease burden for patients across multiple subgroups through 96 weeks of treatment. Data showed long-term prophylaxis with Orladeyo continues to help patients achieve consistently high attack-free days regardless of gender, age and prior HAE therapy after 96 weeks of treatment. The data shared at the 3th C1-inhibitor Deficiency & Angioedema Workshop in Hungary was compiled from post-hoc analyses of the Phase II APeX-S trial. That study evaluated the efficacy of Orladeyo 110 mg and 150 mg once daily (QD) in patients with HAE Type I or Type II.

New Products

Fukuoka Tokushukai Hospital to Initiate Asensus Surgical Senhance Surgery Program

Asensus Surgical, which was formerly known as TransEnterix,  Inc., announced that Fukuoka Tokushukai Hospital in Kasuga City, Japan entered into an agreement to lease and utilize a Senhance Surgical System. The Senhance Surgical System is a commercially available robotic surgery system with haptic feedback, whcih the medical device company calls a differentiating feature for surgeons.

New Patents

Evecxia Therapeutics Receives Patent Covering Lead Drug Candidate EVX‑101

Evecxia Therapeutics received a patent that covers the composition of EVX-101, a bilayer tablet comprising one swelling layer, providing gastro-retention, and one modified release layer, providing parallel sustained-release of 5‑hydroxytryptophan (5-HTP) and low-dose carbidopa. The claims further cover specific physical characteristics, excipients, 5-HTP and carbidopa doses, in vitro dissolution profiles, and human in vivo pharmacokinetics profiles. EVX-101 is a novel, proprietary gastro-retentive, sustained-release tablet formulation of 5-HTP, the natural precursor to serotonin, and low-dose carbidopa. EVX-101 is in clinical development for adjunctive therapy in major depressive disorder patients responding inadequately to first-line serotonin reuptake inhibitor antidepressants.

Research Roundup

Life Edit Therapeutics to Present Preclinical Data Demonstrating Platform Potential

Life Edit Therapeutics Inc., which has a significant presence in Durham, is presenting the first preclinical data from its Huntington’s disease program at CHDI’s 18th Annual Huntington’s Disease Therapeutics Conference. The company will share preclinical data demonstrating therapeutically relevant reductions of mutant huntingtin protein following allele-specific editing of the HTT gene in murine disease models. AAV5-delivered Life Edit gene editing systems enabling allele-specific targeting of mutant HTT demonstrated dose-response reductions in striatal mutHTT protein with clinically meaningful reductions of greater than 50% observed. These results support continued evaluation and identification of a development candidate, the company said. 

Dentsply Sirona, Collaborators Deliver First Global Protocols for Digital Cleft Treatment

North Carolina’s Dentsply Sirona, in partnership with Smile Train and FDI, announced a major milestone in the push to advance global cleft care. The collaborators developed the first-ever global standard protocols for digitalized cleft treatment. These protocols are expected to improve the accuracy and efficacy of the current treatments significantly by providing dental professionals with a comprehensive digital clinical approach across all stages of care.

Study Finds Significant Variation in Anatomy of Human Guts

New research from N.C. State University revealed there is “significant variation in the anatomy of the human digestive system.” The study found there are pronounced differences possible between healthy individuals. The finding has implications for understanding the role that the digestive tract’s anatomy can play in affecting human health, as well as providing potential insights into medical diagnoses and the microbial ecosystem of the gut, the researchers said. 

Regulatory and Advocacy

Novan Publishes Psoriasis Patient Data Showing Need for Rapid Symptom Improvement

Durham’s Novan, Inc. and Denmark-based MC2 Therapeutics shared results of a survey assessing psoriasis patients’ topical treatment experience, expectations that found nearly 80% of participants said they would discontinue a topical treatment if they did not notice an improvement in their symptoms in two weeks or less1. Only 5% of patients surveyed would be willing to persevere for more than a month without seeing results, according to the survey, which was published in the Journal of Drugs in Dermatology (JDD). Additional findings included reports that 40% of patients stated they would call a different dermatologist if a treatment they were prescribed caused an unwanted reaction. The survey was conducted by the National Psoriasis Foundation and was sponsored by the Company. Most of the participants self-reported having moderate psoriasis (83.9%); most were using systemic therapies (73.5%) and employing topical medications at least once per week (84%).

People on the Move

KBI Biopharma Names David Stewart Site Head of Mammalian Manufacturing Facility

KBI Biopharma Inc. named CDMO veteran David Stewart as the new Site Head of KBI’s 150,000-square-foot mammalian cGMP manufacturing facility in Durham.  In this role, Stewart will leverage his extensive science, technical, and business background to help fuel the facility and KBI to a new level of growth. Stewart brings to KBI more than 20 years of insight gained from leadership roles at Genentech, Biogen, and, most recently, Fujifilm Diosynth Biotechnologies. 

Science 37 Taps SVP, Erica Prowisor, to Bolster Patient Recruitment Velocity, Diversity

Science 37 Holdings named Erica Prowisor as SVP of Patient and Provider Networks to accelerate patient recruitment, ensure participant diversity and gain operational efficiencies.

Prowisor has been forging new ground as a leader in patient recruitment for nearly 20 years, most notably with IQVIA where she was Global Head of Recruitment and Retention for more than three years and led the company’s direct-to-patient recruitment and retention efforts. Prior to IQVIA, she spent 11 years with Acurian where she was Head of Enrollment Operations, and in charge of global operations for the company’s Accelerated Enrollment Solutions business.