Weekly Quick Hits (Research Triangle Park) – Week of June 5, 2023

By Alex Keown
June 9, 2023

Funding, Awards and Collaborations

NC Biotech Awards $2.3 Million in Grants

The North Carolina Biotechnology Center awarded multiple grants and loans totaling nearly $2.3 million to universities, biopharma companies and non-profit organizations. The financing will support the potential commercialization of assets as well as entrepreneurship. Among the companies receiving financial support are: AGEYE Technologies, QATCH Technologies, Vizma Life Sciences, Integrated Precision Biosystems and Phase, Inc. A more detailed breakdown of the grants can be found here.

ProKidney LLC Growth Includes New Facility, 330 New Jobs

Cell therapy company ProKidney LLC received $15 million in incentives from Guilford County to support the construction of a new facility that will provide 330 new jobs. The $458 million facility is expected to be open in 2027. The average salary would be $74,646, with no new job paying less than $15 an hour, according to reports. 

Labcorp’s Planned Spin-off, Fortrea Hosts 2023 Investor Day

LabCorp announced Fortrea, the new company to be formed by the planned spin-off of Labcorp’s Clinical Development and Commercialization Services business, hosted its inaugural Investor Day on June 6.

AgBiome Harnesses Ginkgo Strain Optimization Services for Agricultural Pipeline

AgBiome, Inc., a leader in global microbial innovation, and Boston-based Ginkgo Bioworks, announced a partnership to optimize the performance of products in AgBiome’s pipeline of agricultural biologicals. Organizations developing next generation agricultural inputs can access Ginkgo’s platform to accelerate discovery and deployment of new products. By leveraging Ginkgo’s ultra high throughput encapsulated screening capabilities, AgBiome aims to provide growers with new and improved live microbial strain products.

Gusto Global and Crohn’s & Colitis Foundation Expand Partnership

Gusto Global, LLC expanded its partnership with the Crohn’s & Colitis Foundation to advance groundbreaking technical development for a prognostic linking predictive microbiome-based biomarkers to sustainable remission. The expansion of the partnership recognizes the computational platform that enables Gusto’s smart Live Biotherapeutic Product design can be advanced to also confirm microbial biomarkers indicative of IBD pathology and offer actionable patient insights. The Crohn’s & Colitis Foundation is providing access to its IBD Plexus platform, one of the world’s most comprehensive collections of IBD data, information, and bio samples.

UNC School of Medicine Launches Clinical Research Alliance

The UNC School of Medicine launched its Clinical Research Alliance (CRA), an organization within the school that will streamline all aspects of its clinical research enterprise. This includes what the university calls ground-up support for scientists conducting multi-site trials, industry partners interested in collaboration leading toward new treatments and discoveries, as well as people interested in joining trials as participants. The CRA is a key component of the School of Medicine’s Forward Together Strategic Plan. The center will provide investigators with new capabilities to lead the design and implementation of multi-site clinical research, while making clinical research more streamlined for researchers, industry partners and trial participants.

In the Clinic

Trilaciclib Increases Pool of Memory T Cells in the Tumor Microenvironment

G1 Therapeutics presented results from 24 patients enrolled in its Phase II, single arm mechanism of action study of trilaciclib administered as a single agent to patients with early-stage triple-negative breast cancer (TNBC) prior to receiving trilaciclib and neoadjuvant therapy. These results highlight the potential for trilaciclib to enhance long term immune surveillance by increasing T cell function and generation of certain memory T cells and demonstrate gene expression profiles that may be associated with improved clinical outcome. These data support earlier findings from this Phase II trial demonstrating an increase in the ratio of CD8+ T cells to regulatory T cells (Tregs); a high ratio of CD8+ T cell to Tregs is predictive of overall survival and is associated with pathologic complete response (pCR). As expected, high rates of pCR were observed in patients with PD-L1(+) tumors and in patients with inflamed tumor immune microenvironments.

New Products

KBI Biopharma Unveils KBI PUREplatform to Redefine Biopharmaceutical Manufacturing

KBI Biopharma launched KBI PUREplatform, a premium microbial cell line development (CLD) platform that features unmatched efficiencies in a microbial expression system for biopharmaceutical production. The platform addresses known industry challenges such as low titers, poor product quality, and capacity constraints, empowering customers to significantly improve processes to bring products to market cheaper and easier. Engineered for commercial use, the platform pairs KBI’s PUREcoli high-producing E. coli cell line with PUREplasmids and PUREmedia. Workflows quickly feed upstream process development and late-stage manufacturing. The company said its protein expression is individually tailored to each customer’s requirements.

Research Roundup

Researchers Target Proteins, Pathways Behind Congenital Heart Disease

Researchers at the University of North Carolina characterized the expression of thousands of cardiac proteins during eight critical stages of embryonic heart development. This research, published in Development Cell, is expected to provide scientists with necessary information that will enable them to identify biological causes for congenital heart disease. In this study, the UNC researchers exploited a technique known as multiplexed quantitative proteomics, an innovative protein labeling technique that allows them to identify and measure the abundance of a large number of proteins from relatively small amounts of heart tissue.

Regulatory and Advocacy

Fennec Pharmaceuticals Announces EU Marketing Authorization for Pedmarqsi

Fennec Pharmaceuticals announced Pedmarqsi, known as Pedmark in the U.S., was granted marketing authorization by the European Commission. Pedmarqsi is the first and only approved therapy in the EU for the prevention of ototoxicity (hearing loss) induced by cisplatin chemotherapy in patients 1 month to less than 18 years of age with localised, non-metastatic, solid tumors. Additionally, Pedmarqsi was granted the marketing authorization under the pediatric-use marketing authorization (PUMA) which includes 8 years plus 2 years of data and market protection. The marketing authorization is applicable to all 27 European Union member states, as well as Iceland, Norway and Liechtenstein. Pedmark was approved by the FDA in September 2022.

People on the Move

Alcami Announces CEO Transition

Contract development and maufacturing organization Alcami Corporation announced the retirement of Patrick Walsh and the appointment of Bill Humphries as the next CEO, effective June 5. Prior to Alcami, Humphries’ executive leadership roles included CEO at Isosceles Pharmaceuticals, president and group company chairman of Ortho-Dermatologics, CEO of Merz North America, president of Stiefel, a GSK Company and vice president of US Skincare at Allergan Pharmaceuticals. Humphries also serves as chairman at Clearside Biomedical, executive chairman of Strata Skin Sciences, and a member of the board of directors at Aclaris Therapeutics, PhaseBio Pharmaceuticals, SKNV, and Bryn Pharmaceuticals.

Gov. Cooper Receives Regenerative Medicine Award

N.C. Gov. Roy Cooper received the Regenerative Medicine Foundation leadership award during the World Stem Cell Summit held in Winston-Salem. The foundation said Cooper spearheaded several strategic investments in North Carolina’s life sciences that promoted the development of the biotechnology workforce and has fostered a favorable environment for innovative biomedical research to accelerate the development of effective treatments and cures. He serves as a national example of effective governmental leadership for the burgeoning field of regenerative medicine and technological innovation, the organization said. 

Labcorp Appoints Former Johns Hopkkins CEO Paul Rothman to Board of Directors

LabCorp announced the appointment of Paul Rothman to its Board of Directors as an independent member. Rothman is a rheumatologist and molecular immunologist who most recently served as CEO of Johns Hopkins Medicine from July 2012 to July 2022. He is a decorated scholar and has received multiple industry awards recognizing his research, including the Pew Scholar Award, the Leukemia Society of America Scholar Award and the Pharmacia Allergy Research Foundation International Award. He currently chairs the Research Committee on the Board of Directors for Merck and Co., and also serves on the Board of the King Faisal Specialist Hospital and Research Center in Saudi Arabia. In addition, he’s a member of the National Academy of Medicine.