Weekly Quick Hits (BioHealth Capital Region) – Week of April 10, 2023

By Sarah Ellinwood, Alex Keown, and Mark Terry
April 14, 2023

Funding, Awards and Collaborations

Sysmex Inostics and Genomic Testing Cooperative Partner to Accelerate Therapeutic Discovery and Development

Sysmex Inostics, a subsidiary of Japan’s Sysmex Corporation and Baltimore-based biotechnology firm, and Genomic Testing Cooperative (GTC), based in Irvine, California, formed a strategic partnership for Sysmex Inostics to commercialize GTC’s tissue and liquid biopsy solid tumors and hematology assay services to biopharma customers. The partnership synergizes GTC’s proprietary genomic databases, technology in AI, and DNA and RNA next generation sequencing profiling, with Sysmex Inostics’s global commercial capabilities in biopharma therapeutic development and ultra-sensitive Plasma-Safe-SeqS technology.

CraniUS Partners with Leading Drug and Device Manufacturer Medical Product Laboratories

Baltimore-based CraniUS announced a partnership with leading FDA-registered drug and device manufacturer, Medical Product Laboratories, Inc (Phila. PA). As a key partner, MPL will now support testing for the initial stability and safety studies for drug candidates that will be delivered through the company’s device enabling long-term and direct medicine administration via convection-enhanced delivery, an innovative method developed to bypass the blood-brain-barrier safely and effectively and forever change the way brain disease is treated.

Red Cell Partners Nabs $3 Million in Pre-Seed Funding for Psychedelic Company TARA Mind

TARA Mind is emerging from stealth as more than 70 million Americans grapple with mental health conditions and suicide ranks as a leading cause of death in the United States. The capital will fuel the company’s mission to address the systemic issues of accessibility and affordability, as well as mounting care quality and treatment efficacy hurdles.

Scene Health Secures $17.7 Million Series B Financing Led by ABS Capital Partners

Scene Health closed an oversubscribed $17.7 million Series B growth financing led by ABS Capital Partners with participation from existing investors Claritas Health Ventures, as well as Healthworx, the innovation and investment arm of CareFirst BlueCross BlueShield, PTX Capital, and Kapor Capital. The new capital will enable Scene to further accelerate its ability to serve Medicaid and Medicare managed care plans, pharmaceutical companies, and clinical research organizations. This financing brings the total investment in Scene to over $25 million since its founding in 2014.

Spartan Medical Recognized Among Best Places to Work in Greater Washington, D.C. in 2023

The honorees were determined by surveys that went directly to employees who answered a series of questions. Each company was judged by their company culture, leadership, employee engagement, employment benefits and more. Spartan Medical Inc. was founded in 2008 by Vince Proffitt, a former Air Force Intelligence Officer, to provide an extensive portfolio of advanced medical devices and technologies to surgeons at the VA medical centers, DoD medical facilities, civilian hospitals, and ambulatory surgery centers (ASCs) across the country.

In the Clinic

SciNeuro Kickstarts Phase 1 Clinical Trial with SNP318, a Novel Lp-PLA2 Inhibitor Targeting Neurodegenerative and Inflammatory Diseases

SciNeuro Pharmaceuticals shared that SNP318, a novel Lp-PLA2 inhibitor, is advancing into Phase 1 clinical trials in Australia, positioning it for global development. SNP318 is a small molecule, optimized for CNS penetrance, to induce broader anti-inflammatory benefits. It has potential in the treatment of major neurodegenerative diseases where protection and restoration of vascular health are important.

MyMD Pharmaceuticals Shares Dosing Update on Phase 2 Multi-Center Clinical Trial of MYMD-1 for Delaying Aging and Extending Healthy Lifespan

MyMD Pharmaceuticals (Nasdaq: MYMD) announced a dosing update on its Phase 2 clinical trial of lead drug candidate MYMD-1®, an orally available next-generation TNF-alpha inhibitor, as a therapy for chronic inflammation associated with sarcopenia and frailty (NCT05283486). The Safety Review Committee confirmed no safety or toxicity issues with the first 30 patients enrolled in this study and has voted unanimously to escalate to the final dose level. 

Theriva Biologics to Present Cohort 1 Data from the Phase 1b/2a Clinical Trial of SYN-004 (ribaxamase) in Allogeneic Hematopoietic Cell Transplant Recipients

Theriva Biologics (NYSE: TOVX) will be presenting the previously disclosed blinded safety and pharmacokinetic (PK) data from the ongoing Phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease (aGVHD). These data will be featured in a poster presentation at 33rd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), being held virtually and in-person in Copenhagen, Denmark from April 15-18, 2023.

Altimmune Completes Enrollment in Phase 2 Clinical Trial of HepTcell™, an Immunotherapeutic for Chronic Hepatitis B

Altimmune (Nasdaq: ALT) announced that it has completed enrollment in its Phase 2 clinical trial of HepTcell, an immunotherapeutic for the treatment of chronic hepatitis B (CHB). Data readout is planned for the first quarter of 2024. The multicenter clinical trial, which is being conducted at 26 sites in North America, Europe and Southeast Asia, enrolled approximately 80 subjects with inactive CHB and low levels of hepatitis B surface antigen (HBsAg). 

Sirnaomics Launches Phase 1 Trial for GalNAc Factor XI Program 

Sirnaomics announced the launch of a Phase I clinical trial of STP122G based on the Group’s GalNAc Factor XI Program. Factor XI (FXI) is an enzyme produced predominantly by hepatocytes in the liver and it plays an important role in the body’s blood clotting cascade. This study marks the first time that Sirnaomics is utilizing its proprietary GalNAc RNAi platform technology, GalAhead™, in one of its siRNA-based candidates and conducting a trial for a patient population with high unmet need in anticoagulation disorders. 

NaxSwab™ OTC Novel Naloxone Nasal Swab Successfully Administered by Children and Adults in Study

Pocket Naloxone Corp., announced results from a human factors validation study, using the intend-to-market packaging and labeling, demonstrated that laypersons of varied ages and reading comprehension levels and HCPs (healthcare professionals) were successfully able to administer its novel naloxone nasal swab NaxSwab™ in a simulated emergency rescue environment to potentially revive someone from an opioid overdose. The study enrolled sixty participants in four 15-member cohorts, pre-defined by the FDA, encompassing Naïve Passersby, Adult Patients and Lay Caregivers, Adolescents with ages 10-17 years and a mix of HCPs comprising paramedics, pharmacists and nurses.

New Products

Latham BioPharm Group Expands Offering into Digital Health

Latham BioPharm Group, part of Sia Partners, announced the addition of a new capability centered around Digital Health Consulting. LBG is now better positioned to support the recent transformations in healthcare fueled by factors such as wearable technologies, evolution of AI, growth of decentralized trials, etc.

Regulatory and Advocacy

FDA Publishes Final Question-and-Answer Guidance on a Risk-Based Approach to Monitoring Clinical Investigations  

The purpose of the guidance is to provide industry with recommendations on implementing a risk-based approach to monitor investigational studies on human drugs, biologics, medical devices, and combinations of these products. It expands on FDA’s 2013 guidance for industry “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring” with additional recommendations to facilitate and encourage sponsors to implement risk-based monitoring. This guidance complements and does not supersede the 2013 guidance. The new guidance focuses on FDA’s recommendations for planning a monitoring approach, developing content for monitoring plans, and addressing and communicating results from monitoring.

REGENXBIO Receives FDA Fast Track Designation for RGX-202, a Novel Gene Therapy Candidate for the Treatment of Duchenne Muscular Dystrophy

The FDA has granted RGX-202 Orphan Drug Designation and Rare Pediatric Disease Designation. The Fast Track designation will facilitate the development and expedite the review of new therapeutics that are intended to treat serious or life-threatening conditions. Therapies granted this designation are given the opportunity for more frequent interactions with the FDA and may qualify for priority review. 

Horizon Therapeutics plc Announces FDA Approval of an Update to the Indication Language for TEPEZZA® (teprotumumab-trbw) to Specify its Use in Thyroid Eye Disease (TED) Patients Regardless of Disease Activity or Duration

Horizon Therapeutics (Nasdaq: HZNP) announced that the FDA has approved an update to the Indications and Usage section of the TEPEZZA label to specify its use for the treatment of “Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration.” TEPEZZA is the first and only medicine approved by the FDA for the treatment of TED – a serious, progressive, debilitating and potentially vision-threatening rare autoimmune disease. The label update follows positive topline results from a randomized, double-masked, placebo-controlled Phase 4 clinical trial (NCT04583735) that were announced earlier this week.

People on the Move

RS BioTherapeutics Appoints Pharmaceutical Industry Veteran Dean Hart as Chief Executive Officer

Hart has 40 years of biopharmaceutical experience and has helped multiple well-known brands from pre-launch/early commercialization to achieving blockbuster status. Notable successes include Eisai, where he created and built the U.S. sales force and successfully launched Eisai’s first product in the U.S., Aricept™, a blockbuster product for treating Alzheimer’s; and Takeda Pharmaceuticals North America where he led the sales force, sales operations, sales training, market access, pricing, and trade functions. Mr. Hart played a key role in the significant growth of Takeda’s flagship brand, Actos™ from $400 million to $3.5 billion while successfully building and leading a team of 3,000.

Gain Therapeutics Appoints C. Evan Ballantyne as Chief Financial Officer

Gain Therapeutics (Nasdaq: GANX) announced the appointment of C. Evan Ballantyne as the Company’s Chief Financial Officer, effective immediately. Ballantyne succeeds Salvatore Calabrese, who is expected to remain employed for a reasonable transition period to enable an orderly transition of duties. Ballantyne is an experienced CFO with more than 20 years of experience managing the financing and corporate strategy of publicly traded and private companies in the healthcare industry. Most recently he was Chief Financial Officer of OncXerna Therapeutics, where he helped raise $30 million in an equity financing round.

Neuronascent Expands Board of Directors With Addition of Emer Leahy, PhD

Leahy holds a PhD in neuropharmacology from University College Dublin, Ireland, and an MBA from Columbia University. She is the long-standing President and CEO of PsychoGenics, as well as an adjunct associate professor of Neuroscience at Mount Sinai School of Medicine in New York City. Leahy has more than 30 years of experience in drug discovery, clinical development and business development for pharmaceutical and biotechnology companies, including extensive knowledge of technology assessment, licensing, mergers and acquisitions, and strategic planning.

BioMech Holdings Appoints Athanassios Diplas, PhD to its Board of Directors

BioMech Holdings, announced the appointment of Athanassios Diplas, PhD to its board of directors. In his capacity, Diplas will act in an advisory role, utilizing vast experience in global finance and science to provide strategic counsel as BioMech expands into diverse markets. As Principal at Diplas Advisors, Diplas functions as the advisor to major financial institutions and law firms with expertise on derivatives related to issues with emphasis on CDS, Initial Margin, CCPs, Counterparty Risk, and Bankruptcy related Derivatives Closeout issues.

Catalent Names Ricky Hopson as Interim Chief Financial Officer

Ricky Hopson, who had been serving as the Company’s President, Division Head for Clinical Development & Supply, will assume the role of the Company’s Interim Chief Financial Officer, effective today, April 14, 2023, following the departure of Thomas Castellano as the Company’s Senior Vice President and Chief Financial Officer on April 13, 2023. Hopson has served as President, Division Head for Clinical Development & Supply since July 2022. Prior to that, he served the Company for more than 20 years in a variety of finance roles, most recently as the Company’s Vice President & Chief Accounting Officer since June 2021. Hopson graduated from the University of Portsmouth and is a chartered management accountant in the U.K.