BioBuzz by Workforce Genetics

Weekly Quick Hits (Research Triangle Park) – Week of March 13, 2023

Funding and Collaborations

9 Meters Biopharma Secures $5 Million Direct Offering 

9 Meters Biopharma, Inc., a clinical-stage company pioneering novel treatments for people with rare or debilitating digestive diseases, raised $5 million from a definitive securities purchase agreement. The Raleigh-based company intends to use the funding to support the clinical development of vurolenatide for the treatment of short bowel syndrome. The financing will also support the development of the company’s other pipeline programs, as well as for working capital and general corporate purposes.

Premier Research Partneres with InSilicoTrials for Rare Disease Therapies

A transatlantic partnership between Morrisville-based Premier Research and Italy’s InSilico Trials, will focus on the discovery of faster, and more efficient pathways to regulatory approval for rare disease treatments. Premier Research has a long-term commitment to orphan drug development. Partnering with InSilicoTrials, whose in silico study design will result in faster submission-ready studies and more effective preclinical review of trial design parameters, will continue that investment in rare disease trials, the company said. 

Novan Secures $6 Million Registered Direct Offering

Durham-based Novan, Inc. raised $6 million from a registered direct offering. Novan intends to use the proceeds fund its berdazimer gel, 10.3% (SB206) development program activities, support sales and marketing efforts for the company’s marketed products and for general working capital purposes and other operating expenses. 

Thermo Fisher Scientific Selected to Support NIH’s Blueprint MedTech program

The PPD clinical research business of Thermo Fisher Scientific Inc. was awarded a five-year contract to provide regulatory affairs support and related services for the Blueprint MedTech (BPMT) program, a new multi-institute/center initiative at the National Institutes of Health. The program supports development of translational neurological devices. The BPMT program is a new NIH incubator with a collaborative reach across 11 NIH institutes, whose goal is to accelerate patient access to safe, effective, cutting-edge medical devices to diagnose and/or treat disorders of the nervous system. During each year of the contract, the BPMT incubator aims to support the development of multiple novel technologies from pharmaceutical, biotechnology and device companies.

Advanced Animal Diagnostics Launches New Subsidiary

Morrisville-based Advanced Animal Diagnostics launched a human diagnostics-focused subsidiary, Ad Astra Diagnostics. The company’s animal technology has applications in humans. One of the applications is “rapid, early intervention for sepsis, the body’s toxic response to widespread infection,” NC BIotech reported. The technology, known as QScout RLD, can detect one of the earliest known markers of sepsis using a single drop of blood from a finger stick or a traditional blood sample.

RedHill Biopharma Announces Plan to Implement ADS Ratio Change

RedHill Biopharma Ltd. will implement a ratio change of the company’s American Depositary Shares from the current ratio of one ADS representing 10 ordinary shares to a new ratio of one ADS representing 400 ordinary shares. 

Enzo Biochem Agrees to Sell Clinical Laboratory to N.C.-Based Labcorp

Labcorp entered into an agreement to acquire the assets of Enzo Biochem’s clinical laboratory division, Enzo Clinical Labs. For Enzo, the deal follows a 2022 strategic restructuring initiative. 

In the Clinic

Evecxia Therapeutics Posts Favorable Phase I Data for EVX-301

Evecxia Therapeutics, Inc. reported favorable safety, tolerability, pharmacokinetics, and pharmacodynamics data from a double-blind, placebo-controlled Phase I single ascending dose study of EVX-301 in healthy volunteers pre-treated with escitalopram for three weeks. EVX-301 is a proprietary intravenous infusion of 5-hydroxytryptophan (5-HTP), the natural precursor to serotonin. The company announced the planned design of a Phase IIa study to treat ongoing suicidal ideation in patients with Major Depressive Disorder responding inadequately to a first-line antidepressant.

New Products

Accord Healthcare Adds Generic Relapsing MS Drug

Accord Healthcare, Inc. added Teriflunomide to its portfolio of oral medications. The drug is formulated as a film-coated tablet. Accord’s Teriflunomide is therapeutically equivalent to Sanofi Genzyme’s Aubagio and approved for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. Teriflunomide is approved by the FDA for use as an immunomodulatory agent in patients 18 and older to decrease the frequency and severity of disease flare-ups, called relapses, to prevent new symptoms or a worsening of old symptoms related to the disease’s neurologic impact.

Research Roundup

NC State: Right Combination of Probiotics can Halt C. Diff

Researchers from NC Sate University found certain enzymes within a class known as bile salt hydrolases (BSHs) can restrict Clostridioides difficile (C. diff.) colonization by altering existing bile acids, as well as by creating a new class of bile acids within the gut’s microbial environment, the university announced. The research could support the future development of designer probiotics that protect against disease through the introduction of specific BSHs to the gut after antibiotic treatment. The study found interactions between BSHs and bile acids differ depending upon the type of bacteria the BSHs come from. This will make the selection process critical, the university reported. 

NIH Study Links Low Birthweight to Prenatal PFAS Exposure

High exposure to per- and polyfluoroalkyl substances (PFAS) during pregnancy may be associated with lower birthweights, according to a new study funded by Durham-based Environmental influences on Child Health Outcomes Program (ECHO) at the National Institutes of Health. PFAS are widely used and long lasting chemicals that can be found in drinking water, food, household products, personal care products, manufacturing facilities, and other sources.

To date, this is the largest study to examine the role of PFAS in birth outcomes. The study involves more than 3,000 pregnant participants from 11 different ECHO research sites across the United States. 

Burt’s Bees products improve photodamaged and hyperpigmented facial skin

Durham-based Burt’s Bees, which manufactures natural skin care products, announced its latest research findings on the benefits of a topical bakuchiol-containing sunscreen in treating redness and pigmentation of photodamaged facial skin. Burt’s Bees also published research findings on a topical treatment in improving the appearance of post-inflammatory hyperpigmentation associated with acne. These studies were developed for the American Academy of Dermatology 2023 Annual Meeting in New Orleans. 

Regulatory and Advocacy

Animal Cancer Dx Rebrands with New Name

Raleigh-based animal health and diagnostics company Animal Cancer Dx changed its name to Oncotect. The company provides a non-invasive test that dog owners can use to screen their pets for cancer. The comapny intends to broaden its offerings to other areas of veterinary health and potentially make the jump into human health services.

People on the Move

Bryn Pharma Appoints Sandy Loreaux as CEO

Bryn Pharma LLC, a privately-held pharmaceutical company in Raleigh, tapped  pharmaceutical industry veteran Sandy Loreaux as chief executive officer. David Dworaczyk is transitioning from the CEO role and will stay on as a senior advisor and head of R&D, Regulatory, and production efforts as Bryn works toward the completion and filing of the NDA for the company’s lead candidate, investigational epinephrine nasal spray, Utuly. Pivotal trial results demonstrate that Utulyhas quick uptake, with higher and more sustained epinephrine levels than the current standard of care, the epinephrine autoinjector (EpiPen), the company noted. Loreaux most recently led Covis Pharma’s U.S. Operations as U.S. President. She joined Covis after serving as Senior Vice President and General Manager, U.S. Critical Care for Mallinckrodt Pharmaceuticals. Loreaux spent the first 19 years of her career at Sanofi and its legacy companies in various roles of increasing responsibility.

Alcami Announces Chief Financial Officer Transition

Contract development and manufacturing organization Alcami Corporation announced Ken Morgan was promoted to chief financial officer. Morgan joined AAIPharma (now Alcami) in 1997 and has served in numerous financial leadership roles throughout his tenure. Before rejoining Alcami, he was the vice president and controller of TriPharm Services, a parenteral contract manufacturing organization acquired by Alcami.