Weekly Quick Hits (BHCR) – Week of August 14, 2023

MyMD Pharmaceuticals advances its oral TNF-α inhibitor MYMD-1 into a Phase II study in patients with active rheumatoid arthritis. Non-profit pharma company Caring Cross, a Virginia Tech spinout, is featured in a paper on affordable and accessible gene therapies. Also in Virginia, CvilleBioHub secures an innovation grant from the Virginia Innovation Partnership Corporation.

By Alex Keown | August 18, 2023

Quick Hits is BioBuzz’s weekly round up of all the life science news you don’t want to miss, in your region of interest. Don’t miss a beat; SUBSCRIBE to our weekly Quick Hits newsletter via LinkedIn (BioHealth Capital Region, Greater Philadelphia, Research Triangle Park) or get it delivered to your inbox every week.

Funding, Awards and Collaborations 

RegeneRx Effects Reverse Stock Split and Terminates SEC Reporting Obligations

RegeneRx Biopharmaceuticals announced a 1-for-100 reverse split in the outstanding shares of Common Stock of the Company and has filed the requisite Form 15 to suspend and terminate the company’s continued obligations to file reports with the SEC pursuant to Sections 13(d) and 15(d) of the Securities Exchange Act of 1934, as amended.

Caring Cross Featured in Paper on Strategies for Increasing Gene Therapy Affordability

Caring Cross, a 501(c)(3) non-profit, announced its role in a newly published white paper from the Innovative Genomics Institute, titled “Making Genetic Therapies Affordable and Accessible.” Boro Dropulić, Co-Founder and Executive Director, and Rimas Orentas, Co-founder and Scientific Director, contributed to sections of the report focused on manufacturing, regulation, and funding models, with the report specifically highlighting Caring Cross as a non-profit focused on improving the accessibility, affordability, and applicability of CAR-T technology and stem cell gene therapy. Key findings from the paper can be found here.

VIPC Regional Innovation Fund Grant Awarded to CvilleBioHub 

CvilleBioHub, an industry-led 501c3 nonprofit organization dedicated to accelerating Charlottesville’s biotechnology industry sector, has received a $200,000 Regional Innovation Fund (RIF) grant from the Virginia Innovation Partnership Corporation. The grant will support CvilleBioHub activities across five areas in 2023:

• Host Monthly Speaker Series to bring high profile industry leaders to Charlottesville
• Plan for growth and launch of a wet lab incubator/accelerator in Charlottesville
• Expand and deepen technical assistance and advisory services provided to companies through the Entrepreneur-in-Residence program
• Build the biotech talent pipeline and workforce
• Build out institutional capacity to improve communications and sustainability capabilities

Activation Capital Seeks Anchor Tenant for Forthcoming Richmond Innovation Center

Activation Capital is seeking an anchor tenant for its planned 102,000-square-foot, $53 million innovation center and is looking to Under Armour’s corporate campus in Baltimore and Capital One’s 1717 Michael Wassmer Innovation Center in Richmond for inspiration. The building, to be located in Activation Capital’s VA Bio+Tech Park in Richmond, has been planned for 20 years. The goal is to create an innovative place and add more laboratory space for the region. Kipton Currier, vice president of operations at Activation Capital, said the organization did a study a few years ago to find out what was needed.

Virginia Tech Joins with Universities, Bioscience Companies for Health Care Needs

With funding from Virginia Catalyst, also known as the Virginia Biosciences Health Research Corp., Virginia Tech is engaged in three collaborative bioscience projects to address unmet healthcare needs in Virginia, according to Michael Friedlander, vice president for health sciences and technology at Virginia Tech. The Catalyst awards, which range from $350,000 to $800,000, support joint research projects between industry and Virginia universities that have the potential to significantly improve human health and create high value jobs in the commonwealth.

HemoSonics Receives Innovative Technology Contract for Quantra Hemostasis System

HemoSonics, a medical device technology company focused on acute bleeding management, today announced its Quantra Hemostasis System has received a Technology contract award from Vizient, Inc., the nation’s largest member-driven healthcare performance improvement company. Vizient members include more than half of all acute care hospitals in the United States, including 97% of U.S. academic medical centers.

Nanocrine Revamps Website and Online Shop for Next-Gen Cell Culture Solutions 

Nanocrine, a pioneer of innovative cell culture solutions, launched its new and improved website and online shop, at Nanocrine.com. The upgraded platform boasts a user-friendly interface and showcases Nanocrine’s breakthrough technologies that streamline the experimental workflow while offering researchers new standardized tools to study cell behavior. The startup is based at the Frederick Innovative Technology Center, Inc., a nonprofit resource dedicated to helping people create and grow viable businesses, particularly in the realms of life science and technology. 

In the Clinic

MyMD Prepares for Phase II Study of oral TNF-α inhibitor

Baltimore-based MyMD Pharmaceuticals will advance its oral TNF-α inhibitor MYMD-1 into a Phase II study in patients with active rheumatoid arthritis. The FDA greenlit the study based on preclinical data showing that MYMD-1 significantly reduced swelling and other clinical arthritis measures compared to the widely used RA therapy, Enbrel (etanercept). The company plans to initiate discussions with CRO vendor IQVIA on the timing of the Phase II study in this indication. 

Recently, MyMD announced positive, statistically significant Phase II results in participants with sarcopenia/frailty which showed MYMD-1 reduced TNF-α, IL-6 and sTNFR1, biomarkers that are common to a number of chronic inflammatory diseases, and met all safety and tolerability endpoints. 

60 Degrees Pharmaceuticals Registers Phase IIB Study of Tafenoquine for COVID

60 Degrees Pharmaceuticals announced that ACLR8-LR, a double-blind, randomized, placebo-controlled Phase IIB study to determine the efficacy of the Arakoda regimen of tafenoquine in COVID-19 patients with mild-moderate symptoms and low risk of disease progression, is now listed on ClinicalTrials.gov. The trial will be conducted by 60P’s majority-owned subsidiary, 60P Australia Pty Ltd, which opened a new IND on Aug. 14, 2023.

The primary endpoint of ACLR8-LR is time to sustained clinical recovery from COVID-19 symptoms.

Processa Pharmaceuticals Data Update on Potential Personalized Treatment 

Hanover-based Processa Pharmaceuticals, a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for patients suffering from cancer, provides an interim analysis from its ongoing Phase IB trial of Next Generation Capecitabine (NGC-Cap) in patients with gastrointestinal cancer. Processa found that regularly measuring the concentrations of DPD, as expressed by the metabolite FBAL, may provide a method to better understand how each patient responds to different NGC-Cap dosage regimens. This insight potentially allows physicians to develop and administer patient-specific treatment protocols of NGC-Cap for each patient to inhibit the development of side effects and promote broader drug efficacy, patient safety, and tolerability. 

New Products

Kerecis to Donate FDA-Approved Fish Skin for Burn Victims of Maui Wildfires

Virginia-based Kerecis, the company pioneering the use of fish skin and fatty acids for tissue regeneration and protection, is donating its GraftGuide fish-skin burn product for victims of the fires on Maui, Hawaii. Kerecis is dispatching a specialist to train doctors who would be using the product for the first time. Kerecis previously donated its burn products to victims of both the California wildfires in 2020 and the volcanic eruption on White Island in New Zealand in 2019.

Welldoc Receives 10th 510(k) Clearance for Award-Winning Diabetes Platform BlueStar

Columbia, Maryland-based WellDoc, a digital health leader revolutionizing chronic care, announced the receipt of its 10th 510(k) clearance from the FDA for its award-winning diabetes digital health solution, BlueStar. This clearance reinforces Welldoc’s position as a leader in technology in diabetes management. This clearance enables BlueStar to use connected insulin dosing data in personalized bolus insulin dosing recommendations. This enhanced functionality will be made available commercially in 2024.

Altruix Approved to Dispense Brixadi for Moderate to Severe Opioid Use Disorder

Annapolis-based Altruix, a provider of behavioral health pharmacy solutions, has been selected as a limited distribution partner by Braeburn Inc. for Brixadi (buprenorphine) extended-release subcutaneous injection (CIII). Brixadi is an extended-release injection approved by the FDA to treat moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with a transmucosal buprenorphine-containing product. BRIXADI should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Innovent Announces the NMPA Approval of Sintbilo (Tafolecimab Injection)

Rockville-based Innovent Biologics announced that China’s National Medical Products Administration approved Sintbilo (tafolecimab injection, anti-PCSK9 monoclonal antibody) for the treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia. As the first domestic PCSK9 inhibitor approved in China, Sintbilo is Innovent’s first drug entering the cardiovascular field and the company’s tenth product in its commercial portfolio.

Lupin Launches Tiotropium Dry Powder for Inhaler for the Treatment of COPD

Lupin Pharmaceuticals, Inc., the U.S. based wholly-owned subsidiary of global pharma major Lupin Limited, announced the launch of Tiotropium Bromide Inhalation Powder, 18 mcg/capsule, for the treatment of chronic obstructive pulmonary disease (COPD) in the U.S. Tiotropium Bromide Inhalation Powder, 18 mcg/capsule is a generic equivalent of Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder), 18 mcg/capsule of Boehringer Ingelheim Pharmaceuticals.

Research Roundup

NIH Unveils Comprehensive Dataset to Help Cancer Researchers Unravel Mysteries

The National Institutes of Health is releasing a comprehensive dataset that standardizes genomic, proteomic, imaging, and clinical data from individual studies of more than 1,000 tumors across 10 cancer types. Researchers will be able to use this resource to uncover new molecular insights into how cancers develop and progress. The dataset was generated by the Clinical Proteomic Tumor Analysis Consortium at the National Cancer Institute.

Cerebellar Post-Stroke Deep Brain Stimulation Appears Safe and Feasible in Small Trial

The results of an early-stage clinical trial indicate that deep brain stimulation (DBS) applied to the cerebellum may help the recovery of upper limb function following stroke. The findings, published in Nature Medicine, support the design of larger, blinded clinical trials to fully assess the benefit of such a treatment. This trial, which was conducted at the Cleveland Clinic, Cleveland, is the first-in-human test of post-stroke cerebellar DBS, supported by the National Institutes of Health’s Brain Research through Advancing Innovative Neurotechnologies Initiative, or The BRAIN Initiative.

Zalgen NHP Data Confers Full Protection Against Advanced Multilineage Lassa Infections 

Frederick-based Zalgen Labs published data demonstrating that Arevirumab-3, its lead immunotherapeutic candidate, is an effective therapeutic for the treatment of Lassa virus infections, with activity against all major viral lineages that cause severe disease in humans, and at very low dosages. The just released publication, “A human monoclonal antibody combination rescues nonhuman primates from advanced disease caused by the major lineages of Lassa virus,” in conjunction with previously reported high-resolution structures of Arevirumab-3 antibodies, form the core of a recently reviewed pre-Investigational New Drug application by the FDA. Arevirumab-3 is now on a path toward IND, with projected Phase I clinical studies to assess the safety and immunogenicity of the drug in healthy human subjects.

On the Hill – Regulatory and Advocacy

FDA Approves Liver Cancer Drug

The FDA approved Hepzato Kit (melphalan for Injection/Hepatic Delivery System) containing melphalan (Hepzato, Delcath Systems Inc.) as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Hepzato Kit has a Boxed Warning for severe peri-procedural complications including hemorrhage, hepatocellular injury, and thromboembolic events. The prescribing information also has a Boxed Warning for myelosuppression with resulting severe infection, bleeding, or symptomatic anemia. 

People on the Move

FDA Touts Doctor Inducted into ARA Academy

The FDA’s National Center for Toxicological Research (NCTR), published a Research Highlight about a renowned scientist in NCTR’s Division of Biochemical Toxicology, Dr. Igor Pogribny, who was inducted into the Arkansas Research Alliance (ARA) Academy of Scholars and Fellows. Dr. Pogribny was selected for being a recognized research leader in the field of molecular toxicology and carcinogenesis with an established history of impact.