Weekly Quick Hits (Research Triangle Park) – Week of May 29, 2023

By Alex Keown
June 2, 2023

Funding, Awards and Collaborations

Clinical ink and Teckro Partner to Enhance Site User Engagement

N.C.-based Clinical ink, a pioneering leader in eSource and complex site data collection, will harness Ireland-based Teckro’s unique mobile app to improve Direct Data Capture and drive ease of use for research staff and investigators to significantly improve the clinical trial experience. Together, the two companies aim to propel a new era of engagement and usability for site partners. Immediate benefits of the partnership include one native app for all protocols, decentralized experience for engaging with study experts, interconnected digital protocol and seamless transition to data collection and streamlined communication. 

Genixus Announces 340B Prime Vendor Contract with Apexus 

Genixus, which is focused on transforming acute and critical care medicines, initiated a 340B Prime Vendor Program, managed by Apexus LLC., for KinetiX Propofol 1% ready-to-administer (RTA) syringes, designed to simplify workflow and support effective care delivery. The contract with Apexus is a significant milestone for Genixus, as it expands access and supports their mission of simplifying acute & critical care medicines through innovation. 

Parexel Rated “Top CRO to Work With” for Second Straight Time

Parexel announced it has been rated the “Top CRO to Work With” by investigative sites worldwide in the 2023 WCG CenterWatch Global Site Relationship Benchmark Survey. Among the 34 CROs included in the survey, Parexel received the highest average rating across all 26 performance attributes evaluated. In addition to receiving the highest average rating across all attributes, Parexel ranked highest on four out of the five attributes considered the most important to investigative sites and was selected as the CRO that investigative sites were most willing to recommend to a colleague. This year’s strong rating follows Parexel’s “Top CRO to Work With” rating in the 2021 WCG CenterWatch Global Site Relationship Benchmark Survey, which is the most recent year the survey was conducted.

410 Medical Secures Series B Financing

Medtech company 410 Medical, Inc., which is based in Durham, announced it has completed its $7.5 million Series B financing. This round of funding, with an initial closing late in 2022, was led by Hatteras Venture Partners, with participation from new and existing investors including Orlando Health Ventures, Ballad Ventures, Catalyst by Wellstar, OSF Healthcare, and WakeMed. 410 Medical’s lead product, LifeFlow, cleared by the FDA in 2016, is designed to help clinicians more effectively and efficiently deliver blood and IV fluids to critically ill patients. LifeFlow is used at many leading healthcare systems in the U.S., including Orlando Health, Ballad Health and Wellstar.

Novan Cuts 50% of Staff in Strategic Overhaul

Novan will lay off 50% of its staff and explore the sale or licensing of its commercial assets, Rhofade, Minolira and Cloderm, in order to “sharpen its focus and resources” on berdazimer gel, 10.3%, a potential treatment for molluscum. The Durham-based company will immediately reduce certain of its operating expenses currently supporting its commercial operations. The restructuring will impact 39 employees, a reduction of approximately 50% of employees, primarily among its field sales representatives. 

Fuse Oncology Closes Series A Funding Round

Fuse Oncology, an oncology software solutions company, announced it closed an oversubscribed Series A, raising an undisclosed amount of money. Fuse Oncology will use the investments to accelerate expansion of its first commercial product, S!GNAL, and develop additional solutions in the radiation oncology market. Among the largest contributors were Cone Health Ventures, of Greensboro, N.C., and Northeast Georgia Health Ventures (NGHV), of Gainesville, Ga. 

In the Clinic

Immorna Doses First Patient in Phase I Study of Shingles Vaccine

Morrisville-based Immorna, which is focusing on the development of multi-platform RNA-based therapeutics and vaccines, announced the first subject has been dosed in the company’s first-in-human Phase I multi-center study of JCXH-105, a self-replicating RNA (srRNA) vaccine being developed for the prevention of shingles. JCXH-105 represents Immorna’s first investigational vaccine targeting infection caused by a latent virus. This Phase I study is a randomized, double-blinded, multi-center, active-controlled study to assess the safety, immunogenicity, and determine the recommended Phase II Dose (RP2D) for JCXH-105. The study will enroll healthy subjects aged 50 to 69 years. In this study, JCXH-105 will be compared to GSK’s Shingrix.

BioCryst to Present New Orladeyo Data at 2023 European Conference

BioCryst Pharmaceuticals will present two abstracts featuring data on oral, once-daily Orladeyo (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) at the 2023 European Academy of Allergy and Clinical Immunology (EAACI) congress. BioCryst will present two posters during the conference: Berotralstat provides sustained reduction in HAE attack rates and improvement in quality of life in adolescent patients: a subgroup analysis from APeX-S and Rapid and sustained reductions in attack rates demonstrated with berotralstat long-term prophylaxis in patients with hereditary angioedema with normal C1 inhibitor: real-world outcomes.

Precision BioSciences Gives Update on Allogeneic CAR T Programs and Regulatory Path 

Precision BioSciences announced program updates across its allogeneic CAR T pipeline. The company highlighted new interim clinical data for its lead candidate, azercabtagene zapreleucel (azer-cel), as a potential first-in-class allogeneic CD19 CAR T for the growing CAR T relapsed patient population with DLBCL. As of May 30, 2023, the company observed continued high response rates with an acceptable safety profile in r/r NHL patients. Among all evaluable subjects ORR was 58% with 41% achieving a CR, across all doses and lymphodepletion regimen. Precision Biosciences also provided the first clinical update on PBCAR19B stealth cell, which is in development as a potential best-in-class allogeneic CAR T therapy for patients with relapsed or refractory (r/r) non-Hodgkin lymphoma (NHL), with primary focus on DLBCL. As of May 30, 2023, in Phase 1 results the company observed an acceptable safety profile with high overall response rates among all evaluable subjects with evidence of molecular remission (MRD-) and preliminary durability at Dose Level 2 (540 million cells).

Pathalys Pharma, Launch Therapeutics Enroll First Patient in Pivotal Phase III Program

RTP-based Pathalys Pharma., a private, late-stage biopharma company co-founded by Catalys Pacific and DaVita Venture Group, and its partner Launch Therapeutics enrolled the first patient in the PATH (PTH Attenuation Trial in Hemodialysis) program, consisting of two identical Phase III trials, to assess upacicalcet for the treatment of secondary hyperparathyroidism (SHPT) in end-stage kidney disease (ESKD) patients on hemodialysis. The PATH study program is designed to assess the efficacy of upacicalcet as measured by its ability to reduce intact parathyroid hormone (iPTH) by 30 percent or more in participants with secondary hyperparathyroidism (SHPT) and currently on hemodialysis.

Brii Biosciences Doses First Subject in Phase I Trial of BRII-297

Brii Biosciences announced the first subject has been dosed in a Phase 1 clinical trial evaluating BRII-297, a first-of-its-kind long-acting injectable, in development for the treatment of various anxiety and depressive disorders. This Phase I study is examining the safety, tolerability and pharmacokinetics of BRII-297 in healthy volunteers in Australia. BRII-297 is a new chemical entity (NCE) discovered internally. It acts as a novel gamma-aminobutyric acid A (GABA_A) receptor positive allosteric modulator (PAM) with a LAI formulation.

Sprout Pharmaceuticals Shares Positive Interim Results at ASCO

Raleigh-based Sprout Pharmaceuticals published an abstract reporting positive interim results for the use of Addyi (flibanserin) tablets in breast cancer patients with low libido at the ASCO 2023 Annual Meeting. Addyi is an FDA-approved non-hormonal pill for acquired, generalized hypoactive (low) sexual desire disorder (HSDD) in certain premenopausal women. It is estimated that 70% of women diagnosed with breast cancer report having sexual dysfunction, including disorders of sexual desire and sexual response. However, there are no FDA-approved medications for women with HSDD secondary to cancer or its treatment. 

New Products

Labcorp Plasma Focus Liquid Biopsy Test Now Available

Labcorp launched Labcorp Plasma Focus, a new liquid biopsy test enabling targeted therapy selection for patients with advanced or metastatic solid tumors. The test allows treating oncologists to evaluate circulating cell-free DNA (cfDNA) released by tumor cells and better manage the care of their patients through a personalized, targeted therapy plan. Labcorp Plasma Focus allows providers to earlier and more quickly identify biomarkers for which targeted therapies are available, with the goal of improving survival outcomes and reducing disease-related costs.

GeneCentric Therapeutics PurIST Test for Pancreatic Cancer Now Available

GeneCentric Therapeutics, a company making precision medicine more precise through RNA-based diagnostics, announced its PurIST test is now commercially available through Tempus for clinical use. PurIST is a novel RNA-expression test that identifies patients with the classical subtype of pancreatic ductal adenocarcinoma (PDAC) who are likely to experience longer overall survival (OS) with standard-of-care (SOC) FOLFIRINOX than patients with the basal subtype of PDAC.

New Patents

Tenax Therapeutics Secures Patent Covering Use of Oral Levosimendan (TNX-103) 

Chapel Hill-based Tenax Therapeutics, formerly known As Oxygen Biotherapeutics, received a Notice of Allowance from the United States Patent and Trademark Office for its patent application with claims covering the use of TNX-103, oral levosimendan, titled: “LEVOSIMENDAN FOR TREATING PULMONARY HYPERTENSION WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (PH-HFpEF).” The patent is based on key discoveries from the HELP Study, in which levosimendan-treated PH-HFpEF patients benefited from a statistically significant improvement in 6-minute walk distance of 29 meters when compared with placebo. The patent, once granted, will provide protection through December 2040. Tenax will now have secured IP rights surrounding the use of oral, subcutaneous, and intravenous (IV) administration of levosimendan for the treatment of PH-HFpEF.

Research Roundup

Chemical Found in Common Sweetener Damages DNA, Research Shows

A joint study with researchers from N.C. State University and the University of North Carolina at Chapel Hill found a chemical formed when we digest a widely used sweetener is “genotoxic,” meaning it breaks up DNA. The chemical is also found in trace amounts in the sweetener itself, and the finding raises questions about how the sweetener may contribute to health problems. At issue is sucralose, a widely used artificial sweetener sold under the trade name Splenda. The team found sucralose-6-acetate, which is produced in the gut after sucralose ingestion, is genotoxic, and that it effectively broke up DNA in cells that were exposed to the chemical. This can create a situation known as “leaky gut” that can allow toxins normally flushed by the body to enter the bloodstream.

People on the Move

9 Meters Biopharma CEO Steps Down

John Temperato, president and chief executive officer of 9 Meters Biopharma resigned from his role with the RTP company. In its announcement, 9 Meters did not provide a reason for the resignation. At the same time the company announced Temperato’s resignation, 9 Meters also revealed it will not initiate a Phase III trial of vurolenatide in patients with short bowel syndrome. Following a conversation with the FDA, the company said it believes another Phase II trial will allow it to “maximize the potential for vurolenatide.” No timeline for the Phase II was revealed due to financial concerns. Two months ago, the company laid off approximately half its staff to preserve cash runway. Chief Financial Officer Bethany Sensenig will serve as interim CEO in addition to her current responsibilities.

Aerami Therapeutics Strenghtens Leadership Team

Aerami Therapeutics appointed Joshua Ziel as chief operating officer. He will also act as interim CEO. Additionally, he company has appointed Gary Burgess, as chief medical officer, and Sarah Fritchley, as senior vice president, clinical development and operations. The comapny strengthened its management team as it advances AER-901 (inhaled imatinib) into Phase II for treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH).

EmVenio Research Establishes Advisory Board

Clinical trial organization EmVenio Research announced the inception of an advisory board of veteran industry leaders. The board will provide strategic oversight and facilitate new partnerships as the newly founded company grows its operations and expands its capabilities to conduct a variety of clinical trials. EmVenio appointed Dr. Neil Kurtz as the first member and chair of the board. As a board-certified psychiatrist and neurologist, Kurtz previously held senior executive positions at top pharmaceutical and post-acute care organizations. His leadership experience includes his time as president and CEO of Golden Living, one of the nation’s largest, diversified providers of post-acute care. He was also a founding board member of Medidata, the world’s leading e-clinical company.