Weekly Quick Hits (Research Triangle Park) – Week of May 8, 2023

By Alex Keown
May 12, 2023

Funding, Awards and Collaborations

Humacyte Secures $160 Million in Funding from Oberland Capital

Humacyte, Inc. and Oberland Capital Management LLC announced a $150 million, capped funding arrangement based on future revenues of Humacyte’s Human Acellular Vessel, as well as a $10 million equity investment option. Funding provided to Humacyte under the arrangement includes: Humacyte has also granted an option for Oberland Capital to purchase up to $10 million in common stock priced at the greater of $7.50 per share or the market price per share.

Ag Startup IngateyGen Moves to RTP

Agricultural startup IngateyGen, LLC , a portfolio company of AgTechInventures, LLC, moved cross state from Elizabeth City to Research Triangle Park. IngateyGen LLC is now located in the First Flight Venture Center, an RTP-based non-profit that supports the development and growth of high science, high impact entrepreneurial companies. The incubator facility can house 30 to 40 early-stage companies at any one time, with many of them graduating from First Flight in three to five years, as they move closer to commercialization. The company uses gene-editing technology to produce low allergy peanut varieties.

Bioventus Divests its Wound Business

Bioventus Inc. signed a definitive agreement to sell its Wound business, including the skin substitutes TheraSkin and TheraGenesis, to LifeNet Health. The transaction includes a total cash consideration of $85 million, including $35 million in cash at close, a $5 million cash payment deferred 18 months, and $45 million in potential earn-out payments. Bioventus and LifeNet Health also signed a Sales Agent Agreement under which LifeNet Health will have exclusive rights to sell SonicOne ultrasonic wound debridement products in the US and Canada.

In the Clinic

RedHill Publishes New Talicia Data on Generic Non-Bioequivalence

RedHill Biopharma revealed two new distinct sets of Talicia data focused on generic non-bioequivalence and on dosing regimens. The first new dataset, published in the Journal Alimentary Pharmacology and Therapeutics showed that generically substituted regimens are non-bioequivalent to the low dose rifabutin formulation of Talicia. The second set of data, presented at Digestive Disease Week, supports bioequivalence between Talicia TID and Q8H  dosing regimens for H. pylori eradication therapy. These new data support Talicia’s place as the leading prescribed branded H. pylori therapy by U.S. gastroenterologists, and as an empiric first-line therapy for eradication of H. pylori, a bacterial infection that affects approximately 35% of the U.S. adult population, the comapny announced.

Humacyte Publishes HAV Data in Lancet Regional Health – Europe

Humacyte announced the publication of an article in The Lancet Regional Health – Europe that details the encouraging experience of Humacyte’s investigational Human Acellular Vessel (HAV) in treating battlefield and other vascular trauma injuries suffered in Ukraine-Russia conflict. The letter, titled ‘Use of Bioengineered Human Acellular Vessels to Treat Traumatic Injuries in the Ukraine-Russia Conflict’ reports how Ukrainian surgeons have been using Humacyte’s investigational HAV to save life and limb, and provides data on the clinical outcomes of patients treated with the conduit. Humacyte’s initial shipment of HAVs arrived in Ukraine in May 2022, in response to requests from surgeons on the frontlines in that country.

Phase II Results Confirm Benefit of Trilaciclib

G1 Therapeutics presented preliminary results from 30 patients enrolled in its ongoing Phase 2, single arm study of trilaciclib administered prior to the antibody-drug conjugate, sacituzumab govitecan-hziy in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). These data highlight the potential for trilaciclib to meaningfully reduce adverse events related to use of sacituzumab. As expected, patients with PD-L1(+) tumors appear to respond earlier than patients with PD-L1(-) tumors. The company expects to reach the overall survival  endpoints in the first quarter of 2024.

AskBio Plans Presentations for 2023 American Society of Gene and Cell Therapy Meeting

Asklepios BioPharmaceutical (AskBio), a subsidiary of Bayer AG, will deliver 11 presentations offering insights into the research and development of adeno-associated virus (AAV) therapies for a range of diseases at the American Society of Gene and Cell Therapy annual meeting t in Los Angeles, USA. AskBio presentations cover pre-clinical research into immune responses to AAV, data on methods to improve the efficacy of AAV-gene therapy and research into improved analytics and bioassays. A full list of planned presentations can be found here. 

Aerami to Share Pharmacokinetic Data Supporting Pulmonary Hypertension Asset

Aerami Therapeutics will present non-clinical pharmacokinetic data and details of the completed AER-901 Phase I trial in healthy volunteers at the 2023 American Thoracic Society International Conference. These results demonstrate the potential to achieve therapeutic lung levels with low inhaled doses of AER-901, the company said. AER-901 is entering Phase II clinical development for two serious and rare forms of pulmonary hypertension – pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). By targeting low doses of imatinib to the lung with a high- performance handheld nebulizer, AER-901 has the potential to achieve similar efficacy to oral imatinib as demonstrated in the Phase III IMPRES trial, but with a greatly improved safety profile.

First Clinical Scan with Xenoview Marks Key Milestone for Imaging of Lung Ventilation

Medical imaging company Polarean Imaging announced the first clinical scan utilising its Xenoview (xenon Xe 129 hyperpolarized) technology in the United States has taken place at Cincinnati Children’s Hospital Medical Center. Xenoview is the only hyperpolarised contrast agent approved by the FDA for use with magnetic resonance imaging for the evaluation of lung ventilation in adults and pediatric patients aged 12 years and older. The first patient to receive a clinical scan using XENOVIEW is a 19-year-old male with cystic fibrosis. 

New Products

Pedmark Delivers for Fennec

In its quarterly financial report, RTP-based Fennec Pharmaceuticals reported positive commercial momentum for Pedmark, the first FDA-approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients with localized, non-metastatic, solid tumors. In addition to receiving Orphan Drug designation, the company reported broad payor coverage, with the largest commercial payors and Medicaid coverage in place across all fifty states.

Milestone Pharmaceuticals Plans NDA for PSVT Therapeutic

Milestone Pharmaceuticals anticipates filing a New Drug Application with the FDA in the third quarter of 2023 for etripamil, a potential therapy for paroxysmal supraventricular tachycardia (PSVT). n March 2023, the company announced completion and database closures of the NODE-303 open-label safety and RAPID extension studies of etripamil. Data from these studies are being included in the PSVT NDA for etripamil which is currently expected to be submitted to the FDA in the third quarter of 2023. 

Research Roundup

UNC Researcher Authors Extracellular Vesicles Protocol

A study published in PLOS ONE titled, “A Standardized Method For Plasma Extracellular Vesicle Isolation and Size Distribution Analysis,” led by first author, J. Nathaniel Diehl, a fourth-year medical student at the UNC School of Medicine, described the workflow for isolation and quantification of plasma Extracellular vesicles (EVs) – a protocol to help labs in the field measure the quantity and size of EVs in the blood stream of patients. EVs are fragments of cells that break off and circulate through the body. EVs exert their biological functions by delivering proteins, metabolites, and nucleic acids to recipient cells. They also play important roles in disease development, such as pancreatic cancer, multiple myeloma, or possibly Marfan syndrome – an inherited disorder that affects connective tissue.

Study: 12 Months of Treatment with EPIT Desensitizes Children to Peanuts

Currently there are no FDA approved treatment options for peanut-allergic children under the age of 4 years, but further research into the safety, efficacy, and tolerability of epicutaneous immunotherapy (EPIT) could play a significant role in novel options for immunotherapy. The EPITOPE trial, led by senior author A. Wesley Burks, CEO of UNC Health and dean of the UNC School of Medicine, evaluating the safety profile of Viaskin, a novel form of EPIT, among peanut-allergic toddlers shows that after 12 months of treatment in children aged 1-3 years, the treatment was found to be statistically superior to placebo in desensitizing participants to peanuts, increasing the peanut dose triggering allergic symptoms. 

People on the Move

Inceptor Bio Appoints Matthias Schroff as Chief Executive Officer

Inceptor Bio announced the appointment of Dr. Matthias Schroff as CEO effective today. Schroff succeeds Mr. Shailesh Maingi, who will remain as Executive Chairman. Schroff was most recently Chief Executive Officer of Exicure, which focuses on the development of gene regulatory and immunotherapeutic drugs. Prior to Exicure, Schroff was CEO of Vaximm AG and held several positions on management levels at Mologen, ultimately rising to CEO. 

KBI Biopharma Adds Two to C-Suite

Durham’s KBI Biopharma appointed Marykay Marchigiani to the position of Chief Financial Officer and Sigma Mostafa was named Chief Scientific Officer, a newly-created position. The additions will allow KBI to fulfill its growth strategy of becoming a next-generation CDMO. Prior to KBI, Marchigiani served as the Global CFO at Advanced Bioscience Laboratories. In addition, she served as CFO of the Battelle National Biodefense Institute and Censeo Consulting Group. She also held senior financial roles at MedImmune, LLC, and Science Applications International Corporation. Mostafa was previously KBI’s Senior Vice President and Site Head for its largest site. She has a 13-year tenure at the company, building KBI’s North Carolina mammalian process and analytical development departments from a five program per year to a 50 program per year organization and recruiting and mentoring a best-in-class team of scientists. 

Pranam Chatterjee wins 2022 Hartwell Biomedical Research Award

Pranam Chatterjee, assistant professor of biomedical engineering and computer science, is one of ten recipients of the 2022 Hartwell Individual Biomedical Research Award. Chatterjee will receive $100,000 a year for the next three years for his project, “Targeted Protein Degradation for the Treatment of Ewing Sarcoma,” Duke University announced. Ewing sarcoma is a rare form of cancer that primarily affects children, adolescents, and young adults. For patients with localized Ewing sarcoma tumors, the five-year survival rate is over 80%, but for those patients whose tumors have metastasized or recurred after remission, the survival rate plummets to less than 15%.