Weekly Quick Hits (Research Triangle Park) – Week of May 1, 2023

By Alex Keown
May 5, 2023

Funding, Awards and Collaborations

D2V Clinical Launches to Support Early-Phase Oncology

Dose2Value Clinical (D2V Clinical), a full-service global CRO based in Durham, launched to address challenges of early-phase oncology studies faced by biotech companies. Founded by seasoned industry and regulatory veterans, D2V Clinical focuses on asset value creation and expedited program advancement. 

Science 37 Joins Partnership in Support of White House CancerX and Cancer Moonshot

Science 37 Holdings, Inc. announced its partnership with the Digital Medicine Society (DiMe) in support of the CancerX inaugural project. CancerX is part of the reignited national Cancer Moonshot initiative. It will unite the diverse stakeholders and innovators necessary to unleash the power of innovation to design and create a future that’s free of the burden of cancer.

Labcorp and Jefferson Health Enter into Strategic Laboratory Partnership

Labcorp entered into a strategic relationship with Jefferson Health, the largest health system serving the greater Philadelphia area and Southern New Jersey. When complete, the arrangements between Jefferson and Labcorp will serve to build academic collaborations around teaching and the development of innovative tests. The relationship will “expand the scope and productivity of specialty lab testing” used by Jefferson, and will further the academic and research missions of Thomas Jefferson University. Jefferson and Labcorp will work together to establish the Innovation Driving Excellence in Academics initiative, with a goal of advancing testing capabilities and technologies to improve health outcomes. Additionally, the parties will work together to improve healthcare services for underserved communities in Philadelphia and surrounding areas by using advanced population health digital solutions to deliver enhanced efficiency for patients.

Quest Diagnostics Extends Alzheimer’s Portfolio with AI-Powered Test Service

Quest Diagnostics announced nationwide availability of the RestoreU Dementia Panel, a risk assessment and care plan service created by uMETHOD Health, a health technology company specializing in precision medicine for chronic diseases, to help physicians close care gaps for patients with cognitive decline. The RestoreU service employs artificial intelligence (AI) developed by uMETHOD to create personalized care plans aimed at helping physicians improve patient care.

In the Clinic

FDA Clears Atsena Therapeutics’ IND Application for ATSN-201

Atsena Therapeutics will initiate a Phase I/II clinical trial for its investigational gene therapy ATSN-201. The therapy will be aimed at patients with X-linked retinoschisis (XLRS). The disease is characterized by abnormal splitting of the layers of the retina. This causes impaired visual acuity not correctable with glasses and leads to progressive vision loss. ATSN-201 leverages one of the company’s novel spreading capsids, AAV.SPR, to overcome the challenges associated with intravitreally delivered AAVs in the treatment of XLRS, the company said. 

Verona Pharma to Present Expanded Analyses of Phase III Studies in COPD at ATS 2023

Verona Pharma will present 12 abstracts, including a mini symposium, and a clinical trials symposium, on additional analyses from its successful Phase III ENHANCE studies with ensifentrine for the treatment of chronic obstructive pulmonary disease at the 2023 American Thoracic Society International Conference. An overview of the ENHANCE trial results will be presented as part of the clinical trials symposium “Breaking News: Clinical Trial Results in Pulmonary Medicine” reserved for highlighting new breakthroughs. The abstracts are published on the ATS website and in the publication, American Journal of Respiratory and Critical Care Medicine.

G1 Therapeutics Eyes 2024 for Interim Phase III Breast Cancer Data

In a quarterly financial report, G1 Therapeutics announced it expects interim overall survival analysis from its Phase III trial of Trilaciclib in patients with mTNBC will be available in the first quarter of 2024. The primary endpoint of PRESERVE 2 is to evaluate the effect of trilaciclib on OS compared with placebo in patients receiving first-line gemcitabine/carboplatin. G1 now expects the interim OS analysis to be conducted by its data monitoring committee at 70% of events in the first quarter of 2024. If the trial meets the interim analysis stopping rule, it will terminate, and G1 will report the top line results. If it does not, the trial will continue to the final analysis, the company said. 

New Products

Brii Bio Publishes 2022 Environmental, Social and Governance Report

Brii Biosciences Limited, a Durham-based biotechnology company, published its 2022 Environmental, Social and Governance Report that outlinies its progress and performance toward long-term growth and success in key ESG areas. The report is available on the Company’s website under the About Us section.

BioCryst Surpasses Orladeyo Patient Growth Expectations

In its quarterly financial report, BioCryst Pharmaceuticals reported the number of patients prescribed Orladeyo at the end of the first quarter of 2023 increased by 46% compared to the same period in 2022. The number of patients increased by 8% compared to numbers reported at the end of the fourth quarter of 2022. Net revenue in the first quarter of 2023 for Orladeyo was $68.4 million, a 37% increase compared to 2022.

New Patents

RedHill’s RHB-102 and Opaganib Granted New Patents in Oncology

Raleigh-based RedHill Biopharma secured two new EU and U.S. patents for RHB-102 (Bekinda) and opaganib in the oncology setting. The European Patent Office granted RHB-102 a patent covering antiemetic extended-release solid dosage forms for the prevention of nausea and vomiting (CINV/RINV). The patent provides the potential for UK and EU protection of RHB-102 to March 2034. RHB-102 is a 24-hr bimodal release, once-daily oral tablet formulation of ondansetron. Additionally, the U.S. Patent and Trademark Office granted a new patent for opaganib in respect to combination compositions for treatment of cancer, extending protection to October 2036, the company announced. 

Research Roundup

Mammalian Evolution Provides Hints for Understanding the Origins of Human Disease

Researchers from UNC School of Medicine’s and a team of scientists in the Psychiatric Genetic Consortium created a new manual researchers can use to learn more about the origins of human diseases with high genetic risk through evolutionary genomics. 

Regulatory and Advocacy

Humacyte’s Human Acellular Vessel Receives FDA’s RMAT Designation

Humacyte was granted the U.S. Food and Drug Administration’s Regenerative Medicine Advanced Therapy (RMAT) designation for its Human Acellular Vessel (HAV) for urgent arterial repair following extremity vascular trauma. The FDA’s RMAT designation is for breakthrough therapy of regenerative medicine. This is the second RMAT designation granted by the FDA for Humacyte’s HAV, in addition to a previous RMAT granted for arteriovenous (AV) access in hemodialysis. Humacyte’s HAV is designed to be a universally implantable vascular conduit for use in vascular repair. 

People on the Move

Velocity announces three C-Suite hires to fuel growth

Velocity Clinical Research made three hires to bolster its C-Suite. Nick Campbell joins as Chief Commercial Officer, Nick Spittal is the company’s new Chief Operating Officer, and Steph Anderson has been promoted to Chief of Staff. Campbell gained extensive experience of contract research organization sales at both Covance and IQVIA, before spending the last six years in high-growth technology companies, assuming Board-level positions. Spittal joins from Syneos Health where he was Executive Vice President and General Manager of CNS Clinical Development. He previously held roles of increasing seniority with Inveresk, Charles River, Kendle, Chiltern, ZeeCRO, and INC Research. Anderson was previously Chief People Officer at Meridian Clinical Research, which Velocity acquired in 2022.

Latticework Capital Management’s American Clinical Research Services Names New CEO 

Raleigh-based American Clinical Research Services announced Dustin Owen is the new Chief Executive Officer.  Owen joins ACRS from Thermo Fisher Scientific/PPD, where he was Senior Vice President and General Manager of Accelerated Enrollment Solutions.  In his role, Owen was responsible for more than 160 clinical research sites, spanning 15 countries and 2,000 employees. Prior to leading AES at Thermo Fisher/PPD, Owen served as PPD’s Head of Asia Pacific Clinical Operations and board member for PPD-SNBL Laboratories joint venture in Japan preceded by Vice President of Strategic Laboratory Operations.  Before PPD, he held roles at LabCorp, Biogen, and Manhattan Associates.

Syneos Health Appoints Michael Bonello as Chief Financial Officer

Syneos Health named Michael Bonello as Chief Financial Officer, effective July 1, 2023. Stanford Rudnick will serve as Interim CFO until that time. Bonello most recently served as CFO of Clario, Inc., a clinical trial data collection company. From 2008 to 2021, Bonello held roles of increasing responsibility at Nasdaq-listed PRA Health Sciences, Inc., including Executive Vice President and CFO from 2018 through the company’s sale to ICON plc, and previously as Senior Vice President, Accounting and Corporate Controller from 2008 to 2018. Earlier in his career, he held financial leadership roles at Cree, Inc. and Genworth Financial, and was a senior manager in the audit practice at PricewaterhouseCoopers LLP. Mr. Bonello is a certified public accountant.

Bryn Pharma Expands Leadership with Three New Executives and a Board Member

Privately-held Pharma added three new executives to its leadership team: Nurry Hong, Chief Strategy and Business Development Officer; Steve Killmeyer, CFO; and, Lisa Lucifero, VP, Head of Human Resources. Michael Kaseta, CFO of Liquidia Corporation, has also been appointed to Bryn’s Board of Directors. Hong most recently served as CEO of Pareto Bio, a seed-stage biopharma company. He previously served as Chief of Strategy and Innovation for Food Allergy Research & Education. Killmeyer’s most recent role was the Head of Finance and Strategy for Aimmune Therapeutics, the startup pharmaceutical venture of Nestle Health Science. Killmeyer joined Aimmune after more than five years in the Life Science M&A practice at Deloitte Consulting where he worked with Pfizer, Johnson & Johnson, Becton Dickinson, ICU Medical, and other companies. Before joining Bryn, Lucifero held leadership roles across the biopharma and drug delivery space including DBV Technologies, Mallinckrodt Pharmaceuticals, Catalent Pharma Solutions, and Sanofi. The addition of these key leadership team members comes at a time when Bryn prepares for potential approval of its innovative intranasal spray Utuly, a self-administered form of epinephrine being studied for the treatment of type 1 allergic reactions, including anaphylaxis.

Keyur Mehta Appointed Chief Executive Officer of AOM Infusion

AOM Infusion, a specialty infusion provider, announced that Keyur Mehta has been named Chief Executive Officer. Christopher York will continue in his position as Chairman of the Company. Mehta has been an entrepreneur in the infusion pharmacy and healthcare consulting spaces and has held executive roles in both public and private companies, including DaVita, Option Care Health, BioScrip and InfuScience. Mehta joined AOM in 2022 as Chief Operating Officer

Aerami Therapeutics Mourns Loss of CEO

Lisa Yañez, chief executive officer of Durham-based Aerami Therapeutics died suddenly on May 2. Effective immediately, Anne Whitaker, executive chairwoman of the board of directors, will step in to lead Aerami and ensure all operations move forward as planned. Whitaker has held leadership positions at Aerami since 2018, first as CEO overseeing the in-license and early development of the company’s AER-901 (inhaled imatinib) program, and then as chairwoman since 2020.