Weekly Quick Hits (Research Triangle Park) – Week of March 20, 2023

By Alex Keown, Mark Terry, and Sarah Ellinwood
March 24, 2023

Funding, Awards and Collaborations

Syneos Health and Microsoft Partner to Accelerate AI

Syneos Health and Microsoft announced a strategic multi-year agreement focused on the use of artificial intelligence and machine learning in clinical trials. Through this collaboration, Morrisville-based Syneos Health will deliver technology and data solutions with Microsoft that accelerate clinical development and elevate commercial performance for biopharma customers. Using its AI-enabled platform, Syneos Health is able to process and analyze data to fast-track timelines, optimize resource allocation and unlock clinical trial efficiencies. These capabilities will allow for superior site selection and reduced enrollment timelines to bring new treatments to patients faster, the company said in its announcement. 

Congruence Therapeutics Closes Series A Extension

Congruence Therapeutics, a biotechnology company that has offices in Raleigh, closed an extension to its Series A financing, which brought the total raised amount to more than $65 million. This extension was led by new investor BDC Capital’s Thrive Venture Fund, with participation from current investors Amplitude Ventures, Fonds de solidarité FTQ, OrbiMed, Investissement Quebec (IQ), SilverArc, and others. Congruence initially closed its Series A financing round last year. In that initial round, the company raised $50 million. 

RedHill Initiates Warranty Program to Refund Talicia Non-Responders

RedHill Biopharma Ltd. announced the availability of a warranty program for its Helicobacter pylori (H. pylori) eradication therapy, Talicia-4. The company commits to reimburse patient out of pocket costs should Talicia not work. Talicia is the most prescribed branded agent by gastroenterologists2 and this warranty commitment extends to all commercially insured and non-insured Talicia patients who complete the full 14-day treatment course and whose infection is not eradicated based on post-treatment confirmation testing.

Oerth Bio Accelerates Operations, Partners with N.C. Plant Sciences Initiative

The North Carolina Plant Sciences Initiative (N.C. PSI) entered into a research and facilities collaboration with Raleigh-based Oerth Bio, an agricultural biotechnology company developing targeted protein degraders for plants. Oerth Bio will be the first company to conduct independent research at N.C. PSI, and the first company to occupy the rooftop greenhouse facility. Oerth’s novel degrader technology aims to set a new standard in crop protection solutions, as the company develops PROTAC degraders for weed control, disease control, insect control, and crop efficiency. 

Dignify Therapeutics Secures NIH Award Supporting Novel, On-Demand, Voiding Therapy

Dignify Therapeutics received the Blueprint Neurotherapeutics Network grant from the National Institutes of Health. This 4-year award provides over $4 million in funding to support preclinical and clinical development of the company’s lead drug candidate, DTI-117, to treat bladder and bowel dysfunction.

Titan Medical Plans Delisting with the SEC

After facing financial and operational challenges, Chapel Hill medtech Titan Medical will file a Form 25 with the U.S. Securities and Exchange Commission in early April to delist from public trading. 

In the Clinic

Brii Bio Halts COVID-19 Program

Durham-based Brii Biosciences will discontinue its amubarvimab/romlusevimab antibody combination program for COVID-19. The company stopped manufacturing efforts in order to redirect resources to high-priority programs, according to its year-end financial report. The company based its decision on “constantly evolving COVID-19 trends and policy updates,” as well as “protracted regulatory inspections at our contract development and manufacturing organization sites.”

New Products

CoImmune Obtains License to IL-18 Armored CAR Technology

CoImmune, Inc., a Durham-based clinical stage immuno-oncology company, obtained an exclusive license from Memorial Sloan Kettering Cancer Center for a IL-18 Armored Chimeric Antigen Receptor (CAR) technology. Colummune plans to couple the technology with allogeneic Cytokine Induced Killer (CIK) cells to launch the clinical development of CMN-008 (Armored CAR-CIK cells) with CD19 as the initial target in B-cell malignancies. The company intends to file an Investigational New Drug application with the FDA later this year for the new asset, dubbed CMN-008.

New Patents

Tenax Receives U.S. Patent for IV Levosimendan in PH-HFpEF

Chapel Hill-based Tenax Therapeutics, formerly known as Oxygen Biotherapeutics, received a patent from the United States Patent and Trademark Office covering the use of IV levosimendan in the treatment of pulmonary hypertension associated with HFpEF. The patent, “Levosimendan For Treating Pulmonary Hypertension With Heart Failure With Preserved Ejection Fraction (PH-HFpEF),” expires December 2040 and provides the company substantial added intellectual property (IP) protection for the use of levosimendan. 

Research Roundup

Researchers highlight nucleolar DNA damage response in fight against cancer

University of North Carolina, Charlotte researchers encapsulated the young field of nucleolar DNA damage response (DDR) pathways. A new review highlights six mechanisms by which cells repair DNA damage. By attacking these mechanisms, future applied researchers will be able to trip up cancer’s reproduction and growth. 

Regulatory and Advocacy

Asensus Surgical Receives FDA 510(k) Clearance for Senhance Surgical System

Asensus Surgical (formerly known as TransEnterix) received 510(k) clearance from the FDA for an expanded indication to treat pediatric patients with the Senhance System. the company believes the Senhance System is positioned to bring the benefits of surgical robotics to pediatric patients in a way that no other platform on the market can. Asensus believes this can be done by offering a “unique and unmatched reduction in invasiveness on a robotic platform.” The Senhance System is already approved for pediatric patients in the EU and Japan.

People on the Move

APIE Therapeutics Adds Jim Greenwood to Board of Directors

Cary-based APIE Therapeutics, a preclinical pharmaceutical company pioneering novel and proprietary drugs to activate the apelin receptor (APJ), added Jim Greenwood, former president & CEO of the Biotechnology Innovation Organization (BIO), to its board of directors. Greenwood is currently a senior policy advisor at DLA Piper. During his 18-year tenure as president and CEO of BIO, Greenwood was a driving force behind the establishment of the biosimilars industry, which creates more affordable biologic medicines following patent expiry, and led industry negotiations to help pass the 21st Century Cures Act.