This week's Philadelphia-area life sciences news includes the latest developments for a Montgomery County biotechnology company's Covid-19 vaccine candidate, an update on a Main Line company's Covid-19 therapy, a label expansion bid for a drug already generating billions of dollars in annual sales, and more.
Here's the roundup:
Inovio
The Plymouth Meeting biotechnology company said it is expanding late-stage testing of its Covid-19 vaccine candidate to Colombia after the country's Instituto Nacional de Vigilancia de Medicamentos y Alimentos granted Inovio approval to conduct the Phase 3 segment of its trial there.
Inovio, working with its partner Advaccine Biopharmaceuticals Suzhou Co. Ltd. of China, is conducting the trial in multiple countries — with a focus on countries in Latin America, Asia, and Africa. Inovio (NASDAQ: INO) previously announced it has received regulatory authorization to proceed with the studies in Brazil, Mexico, China and the Philippines.
"With Covid-19 rates continuing to rise in many areas, and with continued limitations to vaccine access in many countries globally, we are grateful to the multiple health authorities who are supporting our efforts to advance the efficacy evaluation of our Covid-19 vaccine," said J. Joseph Kim, Inovio' CEO. "INO-4800 is well-positioned to support vaccination efforts in Colombia and beyond, if approved – with the prospects of potentially serving both as a primary series and as a booster vaccine."
Inovio conducted clinical trials for INO-4800 in the United States, through funding by the U.S. Department of Defense, that generated positive results. The company shifted its focus to conducting late-stage testing outside the country after the Food and Drug Administration raised questions about Inovio's Cellectra delivery device for INO-4800 and the government pulled funding for the company's Phase 3 study after other vaccines were approved and available.
Janssen Pharmaceutical Companies
The division of Johnson & Johnson, which has operations in Horsham, submitted a supplemental biologics license application to the FDA seeking expanded approval of Stelara to treat pediatric patients ages 5 years and older with juvenile psoriatic arthritis. The condition afflicts an estimated 20 to 45 children per 100,000 in this country.
Stelara, an injectable drug that generated sales of $7.7 billion last year, first received FDA approval in September 2009 as a treatment for moderate to severe plaque psoriasis. It later was cleared as a treatment for adult psoriatic arthritis, Crohn’s disease and ulcerative colitis.
A decision on the application from the FDA is anticipated in late 2022.
NRx Pharmaceuticals
The Radnor-based biopharmaceutical company submitted a revised investigational new drug module for manufacturing of Zyesami with the Food and Drug Administration.
NRx Pharmaceuticals (NASDAQ: NRXP) in June submitted to the FDA an emergency use authorization for Zyesami as a treatment of respiratory failure in critically-ill patients with Covid-19. It is getting ready to file similar applications with European Union and United Kingdom health regulatory authorities. The drug has received emergency use authorization in the nation of Georgia.
The revised application confirms Nephron Pharmaceuticals Inc. of South Carolina is prepared to supply Zyesami on a commercial scale.
"As thousands of people around the world continue to die each day from Covid-19, we are continuing our efforts to ensure that NRx has the supply and logistics in place to provide Zyesami to patients where it is granted regulatory approval," said Dr. Jonathan Javitt, CEO of NRx.
Quick hits
Synaptix Bio, an Oxford-based biotechnology startup, has entered into a sponsored research agreement with Children’s Hospital of Philadelphia related to a new method for treating TUBB4a leukodystrophy, a nervous system disorder that delays motor skill development. Synaptix Bio also has an option to exclusively license CHOP research related to this project. Financial terms of the deal are being kept confidential. … Verismo Therapeutics, a University of Pennsylvania cell therapy spinout, has hired tumor-immunologist and gene-engineered T-cell therapy pioneer Dr. Laura A. Johnson to serve as its chief scientific officer. Johnson was previously at GlaxoSmithKline Oncology, where she was head of preclinical translational medicine for the oncology cell therapy research unit. She also worked with Carl June at Penn, where she built the university's solid tumor immunotherapy lab. … Galera Therapeutics (NASDAQ: GRTX) added two people to its management team. Mark J. Bachleda joined the biopharmaceutical company as chief commercial officer. He was previously vice president and U.S. business unit head for Bristol Myers Squibb’s CAR T-cell therapy franchise. Jennifer Evans Stacey was named Galera's chief legal and compliance officer and secretary. She was previously vice president, general counsel, and secretary at The Wistar Institute.
