Weekly Quick Hits (Research Triangle Park) – Week of February 13, 2023

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

Funding and Collaborations

Syneos Health Partners with Equicare, Optimizing Data Capture and Integration to Accelerate Clinical Trial Research

Syneos Health forged a strategic partnership with Equicare to use proXimity, an innovative cloud-based software platform that accelerates the transfer of clinical trial subject data from multiple electronic health records (EHR) to the sponsor’s electronic data capture systems (EDC). Through the partnership, Syneos Health will use the proXimity platform to automate sponsor data transfers from EHRs to EDCs for clinical trials, helping to accelerate the performance of new therapies for patients. This collaboration support’s the company’s commitment to listening and learning from sites and adapting to meet their most critical needs.

Asensus Surgical Strikes Machine Learning, Cloud Infrastructure Collab with Google

Asensus Surgical, Inc. announced a multi-year collaboration with Google Cloud to integrate that company’s secure cloud data architecture and machine learning technologies to further expand the capabilities of the Asensus Surgical’s Performance-Guided Surgery. Performance-Guided Surgery can help surgeons perform procedures more accurately and efficiently, and ultimately help surgeons avoid complications and improve patient outcomes.

Xilis and MD Anderson Forge Strategic Collaboration

Durham-based Xilis and The University of Texas MD Anderson Cancer Center forged a strategic collaboration to deploy Xilis’s proprietary MicroOrganoSphere (MOS) technology in support of preclinical research to accelerate the development of novel cancer therapies. The two organizations plan to advance drug development and discovery programs with the MOS technology. The MOS technology is designed to assess how a patient’s tumor responds to a wide variety of cancer drug modalities. This is essential for determining the full spectrum of therapeutic effects, including immuno-oncology, in the clinic.

Duke University School of Medicine Ranked Ninth in NIH Funding

Duke University School of Medicine was awarded more than $527 million in federal funding from the National Institutes of Health (NIH) in 2022. This put Duke in ninth place nationally among academic medical centers, according to the Blue Ridge Institute for Medical Research. Duke has ranked in the top 10 in NIH research funding nationally in 19 of the last 22 years. 

Biotech Center Awards $2.3 Million in Grants, Loans

The North Carolina Biotechnology Center awarded 19 grants and loans that totaled more than $2.3 million. The grants were awarded in the second quarter of the organization’s fiscal year. They were made to universities, bioscience companies and nonprofit organizations. The funds are expected to support research and technology, as well as commercialization and entrepreneurship efforts. The funding will also help universities and companies attract follow-on funding from other sources.

In the Clinic

G1 Therapeutics Announces Mixed Top Line Phase III Trilaciclib Data

G1 Therapeutics posted positive mixed data from its pivotal Phase III PRESERVE trial assessing trilaciclib in combination with FOLFOXIRI + bevacizumab in patients with metastatic colorectal cancer. The trial achieved its co-primary endpoints related to severe neutropenia with statistical significance. However, early anti-tumor efficacy data, including overall response rate (ORR) and preliminary measures of survival, favored the placebo arm, the company said. Other clinical trials of trilaciclib in combination with different chemotherapies in patients with extensive-stage small cell lung cancer and triple negative breast cancer did not demonstrate this adverse survival signal. 

Given that placebo outperformed trilaciclib in these analyses of PRESERVE 1, the company made the decision to discontinue the colorectal trial. 

GreenLight Biosciences to Test COVID-19 Vaccine Candidate in Rwanda

The Rwanda FDA gave approval to RTP-based GreenLight to initiate a Phase I/II clinical trial of its mRNA-based COVID-19 vaccine candidate in that country. The study will evaluate the vaccine candidate as a booster dose. 

The Phase I/II study is designed to assess safety and immunogenicity of the vaccine candidate, GLB-COV2-043. This vaccine candidate is part of GreenLight’s broader Covid-19 strategy, which includes the development of a universal Covid-19 vaccine with broader and more durable protection.

Propella Therapeutics Presents Updated Phase I/IIa Data of PRL-02 at ASCO GU

Privately-held Propella Therapeutics will present updated data from the company’s ongoing Phase I/IIa study of PRL-02 for the treatment of advanced prostate cancer at the 2023 ASCO Genitourinary Cancers Symposium. PRL-02 is a next generation androgen biosynthesis inhibitor being developed for the treatment of prostate cancer. The presentation will highlight results from the ongoing dose-escalation part of the Phase 1/2 study. PRL-02 was well tolerated; dose-dependent androgen suppression was associated with clinical benefit including PSA responses and radiographic improvement.

New Patents

Mazen Animal Health Wins Patent for Oral Animal Vaccine Technology

Mazen Animal Health, Inc., which has R&D facilities in RTP, was issued a key patent for its oral delivery technology for animal vaccines. The United States Patent and Trademark Office issued the patent for “Expression of PEDV Sequences in Plants and Plant Produced Vaccine for Same.” This patent covers foundational technology for the company’s first vaccine product, which is anticipated for launch in 2024, the comapny said.

Research Roundup

Bryn Pharma’s Phase III UTULY Data Accepted at 2023 AAAAI Annual Meeting

Privately-held Bryn Pharma LLC will present results from its Phase III UTULY (intranasal epinephrine spray) trial at the American Academy of Allergy, Asthma and Immunology (AAAAI) annual meeting, Feb. 24-27, 2023. The trial evaluated if the nasal spray could achieve a successful release profile with both short- and long-term pharmacokinetic (PK) and pharmacodynamic (PD) outcomes comparable to those seen with administration of the 0.3mg epinephrine autoinjector (EpiPen, generic).

Single Dose of Azithromycin Reduces Maternal Sepsis or Death

Research conducted by the University of North Carolina School of Medicine and the University of Alabama at Birmingham found that a single oral dose of the common antibiotic azithromycin reduced the risk of maternal sepsis or death by 33% in women who delivered vaginally. Data from the study conducted in multiple low- and middle-income countries was published in The New England Journal of Medicine.

Platform Identifies Brain Regions that Control Large-scale Brain Network

UNC School of Medicine researchers created an experimental platform able to optically record local neuronal activity during brain-wide functional magnetic resonance imaging in rodents. The study, published in the journal Science Advances, examined and analzyzed the activity of Default Mode Network (DMN)-related brain regions. Multiple brain disorders, including Alzheimer’s, attention-deficit/hyperactivity disorder, and mood disorders, have been linked to issues with the DMN. The UNC team found that activation of the anterior insular cortex is associated with suppressing the Default Mode Network.

On the Hill – Regulatory and Advocacy

RedHill Biopharma Announces Positive FDA Meeting Regarding Opaganib

RedHill Biopharma reports a positive meeting with the FDA regarding the development of opaganib for Acute Radiation Syndrome. Raleigh-based RedHill said the provided guidance on opaganib’s developmental pathway to potential approval under the Animal Rule. Under the Animal Rule, companies can establish efficacy in animal models when human trials are not feasible or ethical. Opaganib is an oral, novel, highly stable, small molecule pill with a five-year shelf life that is potentially suitable, if approved, for central stockpiling by governments against mass casualty nuclear radiation incidents. RedHill plans to work closely with the FDA on development of opaganib as a nuclear medical countermeasure and is set to continue to collaborate with a range of U.S. agencies and other governments on this and other indications.

Novan Submits NDA for Berdazimer Gel, a Treatment of Molluscum Contagiosum

Durham-based Novan, Inc. submitted a New Drug Application to the FDA for approval of berdazimer gel, 10.3%, a topical treatment of molluscum contagiosum. Novan anticipates a potential first quarter 2024 approval. If approved, berdazimer gel, 10.3% is poised to be a first-in-class topical treatment for molluscum. 

RedHill Holds Positive MHRA Meeting, Plans UK Marketing Authorisation

RedHill Biopharma plans to submit a Marketing Authorisation Application to the UK Medicines & Healthcare products Regulatory Agency for its oncology support therapy RHB-102 following a positive pre-MAA meeting with that organization. RHB-102 is a potential therapy for management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy in adults and children over the age of 12.

People on the Move

Pamela Read to Head Business Development and Operations at AESARA.

After five years with Chapel Hill-based Aesera, Pamela Reed will take on the role of head of Business Development and Operations. This is a newly created role at the company.