Weekly Quick Hits (Research Triangle Park) – Week of October 2, 2023

NCBio is undergoing a rebranding to NCLifeSci, which will reflect the expansion of the state’s ecosystem. Students and alumni from Wake Tech and Durham Tech participated in a massive life sciences jobs fair in Raleigh. Several RTP companies prepare for presentations at CHEST in Hawaii and Syneos Health announced a new CEO.

By Alex Keown | October 6, 2023

Quick Hits is BioBuzz’s weekly round up of all the life science news you don’t want to miss, in your region of interest. Don’t miss a beat; SUBSCRIBE to our weekly Quick Hits newsletter via LinkedIn (BioHealth Capital Region, Greater Philadelphia, Research Triangle Park) or get it delivered to your inbox every week.

Funding, Awards and Collaborations 

NCBIO, North Carolina’s Life Sciences Trade Association, Changes Name to NCLifeSci

The NC Biosciences Organization has changed its name to the NC Life Sciences Organization — or NCLifeSci for short — to reflect the dynamic growth and diversification of North Carolina’s life sciences industry. NCLifeSci is the trade association for the life sciences industry in North Carolina. The organization’s Board of Directors made the name change as part of a strategic planning process begun in 2022. The board chose the new name to better align with the current size and diversity of the industry in North Carolina, which has grown tremendously in the three decades since NCBIO was founded. The change to the new name went into effect Oct. 4 at the organization’s Annual Meeting. The organization will adopt a new domain name for its website, nclifesci.org. Its current website domain and staff email addresses will continue to function in the near future.

Biotech Companies Recruit Students, Alumni

Students and alumni from Wake Tech and Durham Tech prepare to begin new careers in the biotechnology industry about 200 students and alumni from both schools met with representatives from multiple companies at Wake Tech’s RTP Campus. The students and alumni participated in the Biotechnology and Biopharmaceutical Technology associate degree programs and the BioWork non-degree certification. Companies that sent representatives include FujiFilm Diosynth, Eli Lilly, Novo Nordisk, CSL Seqirus and others. The companies aim to fill positions such as bioprocessing technician, lab technician and manufacturing associate.

Syneos Health Closes Acquisition by Private Investment Firms

Syneos Health announced the completion of its acquisition by a consortium of private investment firm affiliates composed of Elliott Investment Management L.P., Patient Square Capital and Veritas Capital. As a result of the transaction, Syneos Health is now a privately held company. With the support of its new investors, the company is poised to accelerate its transformation, fuel investments in technology that better differentiate its integrated solutions and expand its commitment to better serve customers.

Cambrex Completes $38 Million Capacity Expansion in North Carolina 

Cambrex completed its $38 million capacity expansion at its small molecule active pharmaceutical ingredient (API) manufacturing facility in High Point. This expansion doubles the facility’s manufacturing capacity, with new state-of-the-art analytical and chemical development laboratories, two new clinical manufacturing suites, and a small-scale commercial manufacturing operation with three work centers and 2,000 Liter reactors. The High Point capabilities complement those of previously acquired Snapdragon Chemistry, which specializes in R&D for API batch and continuous flow process development. In addition to the new infrastructure, more than 70 new jobs have been created as Cambrex continues to recruit expert pharmaceutical R&D scientists and staff to the region. 

Biotech Startups showcase potential at Triangle Venture Day: Therapeutics

This month, N.C.-based life sciences startups gathered at Apella by Alexandria at the Alexandria Center for Advanced Technologies campus to meet with peers and more than 50 venture capital investors at Triangle Venture Day: Therapeutics 2023. The event was jointly organized by Duke University, UNC-Chapel Hill, NC State University, and NCBiotech, to showcase RTP’s cutting-edge biotech ecosystem and solutions to critical human health challenges. Startups that attended the event were focused on a range of therapeutic approaches and fields, including proteomics to hydrogels, infectious disease to RNA therapeutics, rare diseases to oncology, according to reports. Read more about the event here. 

IQVIA Builds on its Collaboration with argenx to Provide Safety Systems and Services

IQVIA announced a strategic collaboration with argenx to advance treatment to patients with rare autoimmune diseases through innovative and integrated technology-enabled pharmacovigilance (PV) safety services and solutions. IQVIA’s integrated PV services and technology platforms will support argenx to enable efficient integration of safety data and adverse event identification and reporting, ultimately facilitating the delivery of new therapies to patients. This builds on IQVIA and argenx’s existing collaboration which focuses on the accelerated expansion of clinical development and commercialisation of new indications.

Labcorp, Baystate Health Form Strategic Diagnostic Laboratory Service Partnership

N.C.-based Labcorp will acquire Baystate Health’s outreach laboratory business and select operating assets, including laboratory service centers operated by Baystate Health throughout Massachusetts. This strategic relationship will build upon Labcorp’s and Baystate Health’s existing reference laboratory relationship to improve the efficiency of routine and specialty lab testing.

Atsena Therapeutics Raises $24.5 Million for Gene Therapy Development

Durham-based Atsena Therapeutics raised about $24.5 million in private investment and aims to raise about $7.5 million more. The funding, detailed in a filing with the Securities and Exchange Commission, was provided by 10 investors. The investment follows a $55 million Series A round of venture capital raised in 2020. The company is developing novel treatments to prevent or reverse certain types of inherited blindness.

In the Clinic

Evecxia Therapeutics Sees No Toxicology Findings in EVX-101 Nonclinical GLP Studies

Evecxia Therapeutics announced the absence of toxicity findings associated with the co-administration of EVX-101 in conjunction with the first-line antidepressant fluoxetine in nonclinical GLP toxicology studies. These favorable results support the safety profile of the lead drug candidate, EVX‑101, in a planned Phase II clinical trial in patients with major depressive disorder inadequately responding to first‑line antidepressant therapy. EVX‑101 is being developed as an adjunctive treatment for depression when first-line SSRI/SNRI antidepressants alone are inadequate. 

Verona Pharma to Present Additional Analyses of Positive Phase 3 ENHANCE Studies

Verona Pharma will make four presentations of additional analyses from its successful Phase III ENHANCE studies with ensifentrine for the treatment of chronic obstructive pulmonary disease at CHEST Annual Meeting 2023. Ensifentrine is Verona Pharma’s investigational dual PDE3 and PDE4 inhibitor. The presentations will include pooled analyses from the ENHANCE-1 and ENHANCE-2 studies which demonstrated treatment with ensifentrine resulted in substantial reductions in the rate and risk of COPD exacerbations regardless of recent exacerbation history and was well-tolerated. In addition, the presentations will include subgroup data analyses which demonstrate improvements in lung function, symptoms, quality of life endpoints and reductions in the rate and risk of exacerbations regardless of background therapy as well as reduction in daily rescue medication use.

T3D Therapeutics to Present Topline Results from Phase II PIONEER Study of T3D-959 

T3D Therapeutics been selected to present, as late-breaking news, topline results from its Phase 2 PIONEER clinical trial of T3D-959 in mild-to-moderate severity AD patients at the 16^th international conference on Clinical Trials in Alzheimer’s Disease (CTAD). T3D-959 is an orally administered drug intended for the treatment of mild-to-moderate Alzheimer’s disease.

Aerami Therapeutics to Present Data Supporting AER-901 Dosing at CHEST 2023

Aerami Therapeutics announced that pharmacokinetic modeling data for AER-901, a proprietary liquid formulation of imatinib for inhalation that is administered by a breath-activated, high-performance, handheld, smart nebulizer, will be presented at the upcoming CHEST 2023 conference in Hawaii. The presentation will include findings from the completed Phase 1 clinical trial of AER-901 that will support dose and dosing regimen selection for the planned “uniPHied” Phase 2 platform trial in PH-ILD and PAH. 

New Products

Fuse Oncology Unveils FuseDocs: Newest RadOnc Solution for Clinical Documentation

Fuse Oncology, a leader in radiation oncology software solutions, unveiled its latest pioneering product, FuseDocs. This groundbreaking software leverages generative artificial intelligence (AI) to transform radiation oncology documentation, allowing oncologists to refocus their energies on patient care. FuseDocs automatically generates clinical documentation, drastically reducing the time needed to produce essential records. By accurately generating the correct documents at the right time, human errors are reduced while ensuring compliance with regulatory requirements.

Research Roundup

RedHill, U.S. Army Announce Opaganib’s Ebola Survival Benefit in In-Vivo Study

RedHill Biopharma announced that the novel, twice daily, oral opaganib, delivered a statistically significant increase in survival time in an in vivo Ebola virus study conducted by the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). The in vivo study makes opaganib the first host-directed molecule to show activity in Ebola virus disease, the company announced. Opaganib is a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity. It has the potential as a therapeutic for multiple diseases, including gastrointestinal acute radiation syndrome (GI-ARS), COVID-19, other viruses as part of pandemic preparedness, and cholangiocarcinoma (bile duct cancer).

People on the Move

Dentsply Sirona Announces Planned Board Succession

Dentsply Sirona announced that as part of its planned succession process and consistent with its commitment to periodic Board refreshment in line with Corporate Governance Guidelines, the Board has appointed Gregory T. Lucier as Chairman of the Board and as a member of the Corporate Governance and Nominating Committee, effective Jan. 1, 2024. Following six years as Chairman of the Board, Eric K. Brandt will rotate from his role as non-Executive Chairman at the end of the year and will continue to serve as a member of both the Board and the Corporate Governance and Nominating Committee.

Syneos Health Appoints Colin Shannon as Chief Executive Officer

Syneos Health announced that Colin Shannon has been appointed Chief Executive Officer, effective immediately. Shannon succeeds Michelle Keefe, who will continue her tenure with Syneos Health as a key member of the Executive Leadership Team. Shannon and Keefe will remain on the Board of Directors. During his 14 years at PRA Health Sciences, Shannon served in executive roles, most recently as Chairman and CEO. Prior to PRA Health Sciences, he held various executive roles at Pharmaceutical Product Development Inc., including EVP of Global Clinical Operations, COO and CFO of Europe and Chief Financial and Administrative Officer for International Operations.