Weekly Quick Hits (BioHealth Capital Region) – Week of February 13, 2023

By Sarah Ellinwood, Alex Keown, and Mark Terry
February 17, 2023

Funding & Collaborations

U.S. Government, Novavax Extend COVID-19 Vaccine Partnership

Novavax Inc. announced a modification to its existing agreement with the U.S. government to deliver up to 1.5 million doses of the Novavax COVID-19 Vaccine, Adjuvanted. This agreement will maintain the public’s access to Novavax’ vaccine.

Emergent BioSolutions Sells Travel Health Business to Bavarian Nordic for Up To $380M

Gaithersburg’s Emergent BioSolutions will sell its travel health business to Bavarian Nordic for up to $380 million. Under the terms of the definitive agreement, Bavarian Nordic will acquire the rights to Vivotif, which is indicated for the active immunization to prevent typhoid fever. The deal also includes Vaxchora, indicated for the active immunization to prevent cholera. The development-stage chikungunya vaccine candidate CHIKV VLP is also included in the sale. Bavarian Nordic will also acquire Emergent’s manufacturing site in Bern, Switzerland, and development facilities in San Diego, California. Approximately 280 current Emergent employees are expected to join Bavarian Nordic as part of the transaction.

Viz.ai Collaborates with Johns Hopkins to Expedite Enrollment in Brain Injury Trial

Bay Area-based  Viz.ai, a leader in AI-powered disease detection and care coordination, announced a collaboration with BIOS Clinical Trials Coordination Center (BIOS CTTC) at Johns Hopkins University. The collaboration will expedite patient enrollment for the National Institutes of Health (NIH) funded Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) study. The BEACH trial is studying the safety and tolerability of MW189.BEACH research teams will have access to Viz.ai’s clinical trial acceleration platform, Viz RECRUIT software, which has demonstrated a 3X acceleration in clinical trial enrollment. 

TEDCO Invests SSBCI Funds in JuneBrain

TEDCO announced that it has invested a State Small Business Credit Initiative of $150,000 into Baltimore-based JuneBrain, which is creating new ways for remote patient monitoring. Through the creation of a telehealth eye-scanning system, JuneBrain’s AI-based eye-scanning solution allows providers to identify and monitor disease activity in their patients without requiring appointments.

In the Clinic

MacroGenics Shares Preliminary Results from Single Arm Study of Lorigerlimab

Rockville-based MacroGenics, Inc. will present preliminary data from a single-arm dose expansion phase of an ongoing Phase I trial assessing lorigerlimab. The bispecific, tetravalent PD-1 × CTLA-4 DART molecule was designed to block PD-1 with enhanced CTLA-4 blockade on dual PD-1/CTLA-4-expressing cells. Confirmed objective responses were observed across the histology-specific cohorts. The preliminary data is being presented at the American Society of Clinical Oncology Genitourinary (ASCO-GU) Cancers Symposium in San Francisco from Feb. 16-18.

Acumen Pharmaceuticals Completes Enrollment in Phase 1 Trial of ACU193

Charlottesville-based Acumen Pharmaceuticals Inc. completed enrollment of its Phase I INTERCEPT-AD study assessing ACU193 in patients with early Alzheimer’s disease. Acumen is on track to report topline results, including safety and proof-of-mechanism data, in the third quarter of 2023, which is earlier than previously expected.

ACU193 is a clinical-stage monoclonal antibody developed to selectively target soluble AβOs, which are among the most toxic and pathogenic forms of Aβ relative to Aβ monomers and deposited amyloid plaque.

Innovent Doses First Patient in Phase 2 Study of IBI311 

Rockville-based Innovent Biologics dosed the first patient in a mid-stage clinical trial evaluating IB1311 in people with thyroid associated ophthalmopathy. This study is a randomized, double-blinded, placebo-controlled, Phase II clinical study in TAO subjects. The primary objective was to evaluate the efficacy of IBI311 in improving proptosis in TAO subjects to support further clinical development of IBI311 advancing into pivotal studies. IBI311 is an IGF-1R targeting monoclonal antibody independently developed by Innovent. 

Innovent Doses First Patient Dosed in Phase 3 Picankibart Trial 

Innovent also dosed the first patient in a Phase III study evaluating picankibart, a recombinant anti-interleukin 23p19 subunit (IL23p19) antibody injection. The drug candidate is being assessed in a study of patients with moderate-to-severe plaque psoriasis. The company intends to enroll approximately 500 patients in the study being conducted in China. 

GlycoMimetics Continues Phase III Study of E-selectin Antagonist Uproleselan

GlycoMimetics, Inc.’s Phase III trial of uproleselan in relapsed/refractory (R/R) acute myeloid leukemia will continue following a review from the independent Data Monitoring Committee. The committeerecommended the study should continue to the originally planned final overall survival event trigger, the company announced. Uproleselan is an investigational first-in-class, E-selectin antagonist. 

Theriva Biologics to Present Safety and PK Data from Phase 1b/2a Trial of SYN-004 in Allogeneic Hematopoietic Cell Transplant Recipients

Rockville-based Theriva Biologics, presented the data from Cohort 1 at the 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR. The Cohort enrolled 19 patients. Both Adverse Events and Serious Adverse Events observed with expected in this patient population and were determined to not be related to the study drug. The study is ongoing and remains blinded.

Preclinical Data Show NexImmune’s AIM ACT T cells Enhance the Response to Bispecific T cell Engager Therapy
NexImmune presented the data at the 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR. Data show that multi-TAA AIM ACT T cells are able to work synergistically with BiTE therapy. Following withdrawal of BiTE therapy, recipients of the AIM ACT T cell combination remained tumor free or had a low tumor burden, while those that received a mulk CD8+ T cell combination as a comparator died within two weeks.

On the Hill – Regulatory and Advocacy

FDA Advisory Committee Backs Emergent BioSolutions’ OTC NARCAN Nasal Spray

Emergent BioSolutions moved one step closer to being able to sell its NARCAN nasal spray over the counter. This week, the FDA’s Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee unanimously voted in support of Emergent’s over-the-counter NARCAN nasal spray. The committees said the benefit-risk profile of NARCAN (naloxone HCl) Nasal Spray is supportive of its use as a nonprescription opioid overdose reversal agent. The Prescription Drug User Fee Act goal date is March 29, 

People on the Move

CareMetx Taps George Moore as Chief Technology and Information Officer

Bethesda-based CareMetx, LLC, a leading technology-enabled services company focused on improving patient access to specialty medications, appointed George Moore as the company’s Chief Technology and Information Officer. Moore most recently served as CTO of Signant Health.

Cartesian Therapeutics Names Christopher M. Jewell as Chief Scientific Officer

Gaithersburg-based Cartesian Therapeutics appointed Christopher M. Jewell to the role of Chief Scientific Officer. Jewell’s predecessor, Michael Singer, has been named Chairman of the Board and Chief Strategy Officer. Over the past decade at the University of Maryland as the MPower Professor and Minta Martin Professor, Jewell secured over $25 million in funding and published 125 manuscripts and patents. Jewell’s translational medicine skills benefit from his experience at Boston Consulting Group and as an advisor to dozens of drugmakers over the past 15 years.

Delfi Brings on Lee-Ann Smith-Freeman as VP of LegalSmith-Freeman recently served as Associate General Counsel at Twist Bioscience, and prior to that she specialized in patent preparation, prosecution, and strategy in the biotech, biopharma, medical device, computer and chemical fields as a patent attorney at Sheppard, Mullin, Richeter & Hampton LLP and at Zilka-Kotab, PC.