Weekly Quick Hits (BioHealth Capital Region) – Week of March 27, 2023

By Sarah Ellinwood, Alex Keown, and Mark Terry
March 31, 2023

Funding, Awards and Collaborations

10Pearls Acquires Consulting Firm Inspirant Group to Accelerate Digital Transformation in the Healthcare Industry

10Pearls, located out of Vienna, acquired Inspirant Group, a boutique healthcare strategy consulting firm based in Chicago, IL. The acquisition positions 10Pearls to further expand its presence in the healthcare industry and provide a comprehensive range of services. Some of the notable business transformation solutions include Care Management, Utilization Management, Clinical Decision Support, and Claims Management. Co-founders Meighan Newhouse, Amir Azarbad, and Chris VanAvermaete will join the 10Pearls healthcare division with their team of experienced consultants.

EIP Pharma and Diffusion Pharmaceuticals Merge to Create Leading CNS-focused Company Treating Neurodegenerative Diseases

EIP Pharma and Charlottesville-based Diffusion Pharmaceuticals (NASDAQ: DFFN) have entered into a definitive merger agreement for an all-stock transaction forming a publicly traded, combined company that will focus on the advancement of EIP Pharma’s pioneering pipeline of oral stress kinase inhibitors, including its lead drug candidate neflamapimod, which is currently being developed for the treatment of dementia with Lewy bodies (DLB).

BD² Snags First $15 Million in Grants to Advance Genetic and Biological Understanding of Bipolar Disorder

BD²: Breakthrough Discoveries for Thriving with Bipolar Disorder announced its first grants, totaling $15 million, to advance scientific understanding of the genetic and biological foundations of bipolar disorder. These efforts aim to accelerate discovery and improve diagnosis and care for the more than 40 million people with bipolar disorder. The Broad Institute of MIT and Harvard; the University of California, Los Angeles (UCLA); and the New York Genome Center will create the BD² Genetics Platform, performing genetic sequencing on one of the largest and most diverse populations of people with bipolar disorder.

In the Clinic

Neuraly’s NLY01 Does Not Meet Primary Endpoint in Ph2 Parkinson’s Trial

Gaithersburg-based Neuraly announced topline results from the Phase 2 trial with NLY01 in patients with early, untreated Parkinson’s disease. While NLY01 was safe and well tolerated, it did not achieve statistical significance compared to placebo for the primary endpoint, which was change from baseline to Week 36 in the sum of MDS-UPDRS Parts II (Motor Experiences of Daily Living) and III (Motor Examination) after 36 weeks of NLY01 treatment. Neuraly CEO Seulki Lee said that the company will thoroughly analyze the data from the study to better understand the outcomes and determine the next steps for NLY01.

Precigen Doses First Patient in PRGN-3007 Phase I/Ib Study in Advanced ROR1+ Tumors

PRGN-3007 UltraCAR-T is a first-in-class investigational multigenic, autologous CAR-T cell therapy utilizing Precigen’s clinically validated advanced non-viral gene delivery system and well-established overnight, decentralized manufacturing process.The target patient population for the study includes chronic lymphocytic leukemia, mantle cell lymphoma, acute lymphoblastic leukemia, and diffuse large B-cell lymphoma and  various solid tumors, including triple negative breast cancer (TNBC).

New Products

MediMergent Uses Patient-Centric Real-World Data and Evidence Platform to Capture the Voice of the Patient in National Cancer Trial

MediMergent has implemented its digital clinical trials platform for the collection and analysis of real-world data in a large multicenter study entitled EIMPRIS (Engaging Immuno-Protection Intervention Study) focused on the prevention of symptomatic SARS-CoV-2 infection in cancer patients. EIMPRIS is leveraging MediMergent’s technology to capture the Voice of the Patient and comparing it to other (proxy) sources including patient medical records, pharmacy, and claims data. When integrated with data related to Social Determinants of Health, Quality of Life and other behavioral and attitudinal data, the study will measure, among other endpoints, how real-world data impacts treatment and outcomes.

Research Roundup

Gain Therapeutics to Share GBA1 Program Preclinical Data

Gain Therapeutics (Nasdaq: GANX) is presenting new pre-clinical data supporting the potential of its structurally targeted allosteric regulators (STARs) of glucocerebrosidase (GCase) to prevent neurodegeneration in Alzheimer’s disease (AD). The data will be shown in a poster presentation at the 2023 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders (AD/PD) being held March 28 – April 1, 2023 in Gothenburg, Sweden. The poster is available on Gain’s website.

Acumen Pharmaceuticals Presents Data on in vitro Human Neuron Model for Evaluating Amyloid Beta Oligomer Binding in Alzheimer’s Disease

Acumen Pharmaceuticals (NASDAQ: ABOS) has shown the utility of a human in vitro model of iPSC-derived excitatory neurons for a better understanding of which forms of amyloid beta oligomers contribute to the pathogenesis of AD in the human brain. This research will be presented in a poster at the International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders (AD/PD) March 28 – April 1, 2023.

Regulatory and Advocacy

FDA Approves Over-the-Counter Designation for Emergent BioSolutions’ NARCAN® Nasal Spray

The FDA has approved Emergent BioSolutions (NYSE: EBS)’ NARCAN^® Naloxone HCl Nasal Spray 4 mg as an over-the-counter (OTC) emergency treatment of opioid overdose. This decision comes at a time when approximately every eight minutes, a person dies from an opioid overdose and research shows the epidemic is escalating in the U.S. with the rise in synthetic opioids. By offering NARCAN^® Nasal Spray as an OTC treatment, anyone will be able to access it without a prescription, which is an important step in the fight to reduce the number of opioid overdose deaths occurring each day.  

PathoVax’s HPV Vaccine IND Receives Green Light from FDA

PathoVax’s Phase 1 clinical trial for HPV16 RG1-VLP has been given the go-ahead to proceed. The first-in-human, global multicenter clinical study seeks to demonstrate the safety and immunogenicity responses to HPV16 RG1-VLP in healthy volunteers. The underlying RGVax foundational technology was licensed from Johns Hopkins University and the subsequent GMP as well as Phase 1 development of this vaccine was supported by the NCI PREVENT cancer program.

People on the Move

EMIT IMAGING Appoints Matthew Silva, PhD as Chief Executive Officer

Silva brings diverse experience and expertise in both science and business to the role, specifically drawing on technical training in biomedical engineering and previous executive positions in pharma and scientific services. Recently, Silva served as CEO of Invicro, LLC, an imaging contract research organization and subsidiary of REALM IDx/Konica Minolta.

MaxCyte Appoints Douglas Swirsky as Chief Financial Officer

Swirsky is a seasoned financial leader with over two decades of experience in the healthcare sector, including as a public company executive at Nasdaq-listed organizations. Prior to joining MaxCyte, Swirsky served as Chief Financial Officer and Treasurer of AavantiBio, Inc. a gene therapy company, from February 2021 until its acquisition by Solid Biosciences, Inc. in December 2022.

Altimmune Appoints Former GSK Executive Catherine Angell Sohn, Pharm.D. to its Board of Directors

Sohn brings over 30 years of life sciences, biopharmaceutical and business development experience to Altimmune’s Board. Her business development and partnering expertise enhance her biopharmaceutical operating and strategy experience which spans Phase 2 strategic product development through commercialization across multiple therapeutic areas.