Weekly Quick Hits (BHCR) – Week of July 31, 2023

It was a busy week for financing, partnerships and collaborations within the BioHealth Capital Region. TEDCO and the Lupus Foundation doled out several grant awards, while Emergent BioSolutions snagged a $704 Million BARDA contract. NIH also tapped a new NIAID director.

By Alex Keown

August 4, 2023

Funding, Awards and Collaborations?

Emergent BioSolutions Awarded 10-Year, $704 Million BARDA Contract

Emergent BioSolutions was?awarded?a 10-year contract by the Biomedical Advanced Research and Development Authority (BARDA), valued at up to a maximum of $704 million, for advanced development, manufacturing scale-up, and procurement of Ebanga (ansuvimab-zykl), a licensed treatment for Ebola virus disease (EVD). The 10-year contract consists of a base period of performance with two option periods for advanced development valued at approximately $121 million, and option periods for procurement of Ebanga treatment over five years valued at up to $583 million. If all option periods are exercised, the total contract value will be valued at up to approximately $704 million.

TEDCO Announces 2023 Maryland Makerspace Initiative Program Awardees

TEDCO?awarded the first round of the new Maryland Makerspace Initiative Program. Funding will be awarded to 20 projects spanning 11 counties and Baltimore City. The Makerspace Program provides grants up to $100,000 and technical assistance for qualified entities looking to establish a new Makerspace, expand an existing Makerspace, or develop Makerspace programming. A list of awardees can be found?here.?

Epilepsy Foundation , Vector Solutions to Offer Seizure Trainings to Educators

The Epilepsy Foundation, based in Bowie,?announced?a five-year collaboration with Vector Solutions, the leading provider of training and software solutions for K-12 and higher education institutions, to offer the Epilepsy Foundation’s Seizure Recognition & First Aid Certification training in the Vector Safety and Compliance Course Library. This agreement will provide an easy and convenient way for educators and school personnel, who are already contracted with Vector, to take the seizure first aid training to better serve their students. There are 470,000 children living with epilepsy in the U.S. According to the CDC, the opportunity for academic success is increased when students with chronic health conditions have a safe and supportive learning environment.

Lupus Foundation of America, Inc. Awards 5 Summer Fellowship Grants to Young Scientists

The Lupus Foundation of America?announced?five recipients of the 2023 Gina M. Finzi Memorial Student Summer Fellowship Program. This program supports mentored research experiences for outstanding undergraduate, graduate and medical students conducting lupus research. The program’s focus on young scientists is important for cultivating future lupus researchers and growth in the next generation.

Vector BioMed, Inc. Tapped as Preferred Manufacturing Partner for CIRM

Vector BioMed, a Gaithersburg-based biomanufacturing company specializing in the manufacture of lentiviral vectors,?struck?an agreement with the California Institute for Regenerative Medicine (CIRM) to be a lentiviral vector manufacturer within CIRM’s Industry Alliance Program. Vector BioMed helps design and manufacture high-quality pre-clinical and GMP lentiviral vectors at a speed, price, and scale that provides extraordinary value to its clients.

OpGen, Inc. ’s Subsidiary and FIND Extend R&D Collaboration Agreement

Curetis GmbH , a subsidiary of Rockville’s OpGen, Inc. signed an extended and continued R&D collaboration agreement with FIND. The partners will collaborate on first phases of product development of an antimicrobial resistance (AMR) cartridge from blood culture that is tailored to the needs of low- and middle-income countries.

BioSpark Virginia: Presenting CvilleBioHub’s Inaugural Pitch Competition

BioSpark Virginia is an exciting, live pitch?event?for biotech and life science start-ups in the state of Virginia. The grand prize is a one-year residency at the 强生公司 Innovation Lab – (JLABS) in Washington, DC. The winner will also present at the BioDiscovery Summit. Eight companies will be selected to deliver an eight-minute pitch to a panel of judges and an invite-only audience of investors on October 12.?Application?deadline is Aug. 25.

In the Clinic

TNF Pharmaceuticals, Inc. Posts Statistically Significant Positive Topline Phase II Results

Baltimore-based MyMD Pharmaceuticals?announced?statistically significant positive topline results from its randomized Phase II study of oral TNF-α inhibitor, MYMD-1 in patients with chronic inflammation associated with sarcopenia, or age-related frailty. The study met its primary endpoints of significantly reducing chronic inflammatory markers in participants treated with MYMD-1. The study met both of its primary endpoints, significantly reducing serum levels of three biomarkers, TNF-α, sTNFR1, and IL-6 and maintaining appropriate plasma concentrations and parameters in pharmacokinetic evaluations. The study also achieved all secondary endpoints related to safety and tolerability.?

ReAlta Life Sciences Doses First Patient in Phase II STAR-Study of RLS-0071

Virginia-based ReAlta Life Sciences?announced?dosing of the first patient in a Phase II clinical trial evaluating the safety and efficacy of RLS-0071 for the treatment of hypoxic ischemic encephalopathy (HIE) in newborns. RLS-0071, an investigational new drug, is the company’s lead dual action complement inhibitor and innate anti-inflammatory peptide. The primary endpoint of the study is safety. Key secondary endpoints include measures of mortality, seizure burden, and neurocognitive development. HIE, also known as birth asphyxia, is a rare disease that affects newborns suffering an abrupt, unexpected loss of oxygenation due to placental rupture, umbilical cord problems, or other factors.?

Altimmune, Inc. Initiates Phase IIb IMPACT Trial Assessing Pemvidutide in NASH

Altimmune has?enrolled?the first subject in the Phase IIb IMPACT trial evaluating the efficacy and safety of pemvidutide in subjects with non-alcoholic steatohepatitis (NASH). Pemvidutide is a novel, investigational GLP-1/glucagon dual receptor agonist under development for the treatment of obesity and NASH. The trial is expected to enroll approximately 190 subjects with and without diabetes. The key efficacy endpoints are NASH resolution and fibrosis improvement at 24 weeks of treatment. Top-line results are expected in Q1 2025.

INTRALYTIX, INC. ’s EcoActive Phase I/IIa Phage Trial Begins Enrollment at Johns Hopkins

Intralytix, Inc. announced today that?the clinical trial?“A Phase 1/2a Double-Blind, Randomized, Placebo-Controlled Trial to Assess the Safety and Efficacy of Oral Administration of EcoActive on Intestinal Adherent Invasive Escherichia coli in patients with inactive Crohn’s disease, will begin enrolling at The Johns Hopkins University at various locations throughout the Baltimore metro area in Maryland.

IGC Pharma Expands Phase II Trial of IGC-AD1 to Include the Universidad de Puerto Rico

Potomac, Maryland-based IGC Pharma?added?a trial site at the University of Puerto Rico network as an expansion of the company’s ongoing Phase II clinical trial assessing its lead asset, IGC-AD1, a potential treatment for lowering agitation in patients with Alzheimer’s disease. According to clinicaltrials.gov, IGC-AD1 is the only natural THC-based investigational drug undergoing FDA trials.?

Theriva Biologics, Inc. Announces Key Progress in Phase IIb VIRAGE Study

Rockville-based Theriva Biologics announced key progress in VIRAGE, a multinational, Phase IIb, randomized, open-label, controlled clinical trial evaluating VCN-01 in combination with standard-of-care chemotherapy (gemcitabine/nab-paclitaxel) as a first-line therapy for patients with metastatic pancreatic ductal adenocarcinoma (PDAC). The trial remains on track to be fully-enrolled in the first quarter of 2024. VCN-01 is a systemic, selective, stroma-degrading oncolytic adenovirus.?

Shuttle Pharmaceuticals, Inc. Completes Manufacturing of API for Use in Clinical Trial

Shuttle Pharmaceuticals Holdings, based in Rockville,?announced?that TCG GreenChem successfully completed the initial manufacturing campaign for the active pharmaceutical ingredient (API) of Ropidoxuridine for use in the company’s upcoming Phase II clinical trial in brain cancer patients undergoing radiation therapy.

NIH Launches Long COVID Clinical Trials Through RECOVER Initiative

The National Institutes of Health ?launched?and is opening enrollment for Phase II clinical trials that will evaluate at least four potential treatments for long COVID, with additional clinical trials to test at least seven more treatments expected in the coming months. Treatments will include drugs, biologics, medical devices and other therapies. The trials are designed to evaluate multiple treatments simultaneously to identify more swiftly those that are effective.

New Patents

Opteev Seeks Patent for World’s First Multiplex Biochip

Baltimore-based Opteev Technologies, Inc., a pioneering technology company at the forefront of diagnostics, filed a patent application for a revolutionary multiplex biochip for respiratory infection diagnostics. The groundbreaking polymer-based biochip offers the potential to test multiple pathogens responsible for respiratory infections, including SARS-CoV-2, RSV, and Influenza, and precisely identify the specific virus or bacteria in under 1 minute. This technology paves the way for an ultra-rapid, portable, and accurate syndromic diagnostic device to empower healthcare providers with immediate results at their fingertips, the company said.?

60 Degrees Pharmaceuticals, INC Wins Tafenoquine Patent in Canada

60 Degrees Pharmaceuticals Inc. announced that the Canadian Intellectual Property Office issued the company a patent covering the use of novel regimens of tafenoquine for the prevention of malaria in malaria-naive individuals. Tafenoquine is the active molecule in the company’s FDA-approved regimen for malaria prevention, Arakodal. The drug is not approved by Health Canada for the prevention of malaria.

Research Roundup

A Novel and Cost-effective Antimicrobial Therapeutic for Drug-resistance

Integrated Pharma Services Founder, Dr. Mina Izadjoo ,?presents research?that is focused on novel and cost-effective antimicrobials, including antifungals, ranging from small molecules to recombinant proteins. The investigators discovered a novel Bacillus strain that, by genomic sequencing, was determined to be a new species. Data were presented at the 2023 Symposium on Advanced Wound Care Spring as a podium presentation.

Novel Machine Learning Blood Test Detects Cancers with Genome-Wide Mutations

Novel blood testing technology being developed by researchers at the?Johns Hopkins Kimmel Cancer Center?that combines genome-wide sequencing of single molecules of DNA shed from tumors and machine learning may?allow?earlier detection of lung and other cancers. The GEMINI (Genome-wide Mutational Incidence for Non-Invasive detection of cancer) tes looks for changes to DNA throughout the genome. Following a blood test, machine learning model trained to identify changes in cancer and non-cancer mutation frequencies in different regions of the genome is used to distinguish people who have cancer from those who do not have cancer.

A Protein May Predict Mild Cognitive Impairment Years Before Symptoms: Study

A protein in spinal fluid in cognitively healthy adults?predicted?later onset of mild cognitive impairment and dementia years before symptoms emerge. The study, conducted by Johns Hopkins Medicine scientists established that measurements of NPTX2 in cerebrospinal fluid were predictive of MCI onset within or even beyond seven years before symptoms occurred.?

A report on the study was published in the?Annals of Neurology.

Scrambler Therapy May Offer Lasting Relief for Chronic Pain, Review Paper Suggests

A new review paper co-authored by two Johns Hopkins pain experts?suggests?that scrambler therapy, a noninvasive pain treatment,?can yield significant relief for approximately 80%–90% of patients with chronic pain, and it may be more effective than another noninvasive therapy: transcutaneous electrical nerve stimulation (TENS). The write-up was published in?The New England Journal of Medicine.

On the Hill – Regulatory and Advocacy

United Therapeutics Corporation Wins Appeal in Dry Powder Inhaler Patent Litigation

Silver Springs-based United Therapeutics Corporation?announced?that the United States Court of Appeals for the Federal Circuit affirmed the district court decision in the patent litigation United Therapeutics brought against Liquidia Technologies, Inc. The Federal Circuit affirmed that Liquidia’s proposed Yutrepia product infringes a United Therapeutics’ patent, U.S. Patent No. 10,716,793. As a result, the FDA cannot grant Liquidia final approval for its Yutrepia product until expiration of the ’793 patent, May 14, 2027, except in certain circumstances discussed below.

Nineteen Surgical Organizations Strongly Oppose CMS’ Plan to Implement G2211 Code

The American College of Surgeons , along with 18 other surgical organizations,?expressed?strong opposition to the implementation of Centers for Medicare & Medicaid Services code G2211, which they say would harm surgeons and, in turn, surgical patients. In a letter to CMS, the 19 groups expressed continued opposition to the code, which was first introduced in 2020 but has been delayed for three years. The G2211 add-on code is an effort by CMS to pay more for certain office visits. These additional payments would predominantly help primary care physicians despite the fact that the majority of the office visit codes for this type of care were increased in 2021. The letter can be found?here.

FDA Takes Steps to Foster Innovation for Devices Aimed at Opioid Use Disorder

The U.S. Food and Drug Administration?announced?new steps to help facilitate innovation in devices intended to treat opioid use disorder (OUD). The draft guidance, to help sponsors design clinical studies to evaluate these devices, furthers the FDA’s Overdose Prevention Framework goal of advancing evidence-based treatment for those with substance use disorders. The draft guidance,?Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder, outlines key considerations intended to aid sponsors in designing clinical studies for devices intended to treat OUD.

Lupin Pharmaceuticals , Inc. Issues Nationwide Recall of 2 Lots of Tydemy

Baltimore’s Lupin Pharmaceuticals Inc. is voluntarily?recalling?two lots of Tydemy (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451 mg and Levomefolate Calcium Tablets 0.451 mg) due to out of specification test results at the 12-month stability time point. One lot (L200183) tested low for ascorbic acid (an inactive ingredient) and high for a known impurity. Lupin received no reports of adverse events related to either recalled lots.

People on the Move

MCRA, an IQVIA business Expands Biocompatibility Division with Key Hire of Board-Certified Toxicologist

MCRA, LLC, a leading medical device-focused regulatory advisory firm and clinical research organization?hired?Sharlee L. More, a board-certified toxicologist, as its Associate Director of Toxicology to support the company’s growing biocompatibility service offerings for the medical device industry. More will lead MCRA’s new toxicology service line within the Biocompatibility Division. More joins from Stantec ChemRisk (formerly Cardno ChemRisk), where she spent seven years performing toxicology and human health risk assessments in a wide variety of fields.?

NIH Names Jeanne Marrazzo Director of the NIAID

Jeanne M. Marrazz was?named?director of NIH’s National Institute of Allergy and Infectious Diseases (NIAID). Marrazzo is currently the director of the Division of Infectious Diseases at the University of Alabama at Birmingham. She is expected to begin her role as NIAID Director in the fall. NIAID conducts and supports basic and applied research to better understand, treat and ultimately prevent infectious, immunologic and allergic diseases.