This week's local life sciences industry news includes updates on a Philadelphia biopharma firm's partnership with the National Institutes of Health for a potential Covid-19 vaccine, a Bucks County-based generic drug manufacturer's second stock exchange delisting notice in the past few months, a Chester County company's name change, and more.
Here is the roundup:
Chimeron Bio
The Philadelphia-based developer of RNA vaccines and therapeutics has signed a non-clinical evaluation agreement with the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health, to evaluate the potential of the company's vaccine for Covid-19.
Chimeron Bio's lead candidate, CB-106, delivers the spike gene as a self-amplifying mRNA vaccine. Preliminary data on the vaccine candidate obtained in collaboration with George Mason University demonstrated positive results in pre-clinical models with nanogram quantities of RNA, a significant dose advantage over other RNA-based technologies.
Jolly Mazumdar, co-founder and CEO of Chimeron Bio, said the company's Covid-19 vaccine program is its first foray into infectious diseases.
"We expect the data from the current study to offer critical validation to advance CB-106 into non-human primates and demonstrate the applicability of [Chimeron's] ChaESAR technology for vaccines at large," she said.
The company's ChaESAR (Chimera Encased Self Amplifying RNA) technology is designed to harness the properties of self-amplifying RNA, a newer type of RNA vaccine, and synthetic genomics to engineer novel RNA drugs. RNA drugs are short sequences of RNA that attach to messenger RNA in order to stop a particular gene from producing the protein for which it encodes.
Under the new agreement, Chimeron Bio will use the pre-clinical services program offered by the National Institute of Allergy and Infectious Diseases. Chimeron Bio will provide its vaccine candidate to test in the hamster model of Covid-19 which has previously been used for the assessment of other Covid-19 vaccines.
“A successful outcome from this study will further validate ChaESAR technology in pre-clinical models and boost the design of a next-generation, single-shot RNA vaccine that is durable, low-dose, low-cost, scalable and can render broad-spectrum protection against multiple variants or infectious agents,” said Thimmaiah Chendrimada, co-founder and chief scientific officer of Chimeron Bio.
Lannett Co.
The Trevose-based generic drug manufacturer, for the second time this month, received a notification from the New York Stock Exchange that it is not in compliance with the exchange's continued listing requirements.
Lannett (NYSE: LCI) is not in compliance because the average closing price of the company's common stock was less than $1 per share over a consecutive 30 trading-day period.
The company said it is evaluating all available options to regain compliance with the NYSE's continued listing standards. Lannett has notified the NYSE that it will submit a business plan by the middle of April to demonstrate how it intends to regain compliance.
Earlier this month, the NYSE informed Lannett that the company was not in compliance with exchange listing requirements because its average market capitalization was less than $50 million over a consecutive 30 trading-day period.
Lannett CEO Tim Crew said earlier in March that "ongoing and increasing competitive pricing pressure" across its product offerings negatively impacted both net sales and gross margin. The company markets more than 100 mostly generic medicines across a wide range of therapeutic areas.
Recro Pharma
The Exton-based contract development and manufacturing organization has changed its name to Societal CDMO.
The change was made, according to the company, "to reflect the corporate transformation that has taken place primarily as a result of its acquisition and successful integration of [San Diego-based] IriSys, Inc. into the organization."
The company, which also has a manufacturing plant in Gainesville, Georgia, as well as operations in San Diego, has changed its Nasdaq ticker symbol to SCTL.
“When we set out to rebrand Recro, we sought a name and identity that carried with it a purpose, one which exemplified the commitment our employees demonstrate every day to making a positive impact within communities across the country and around the world," said David Enloe, CEO of Societal CDMO. "We believe the name Societal CDMO, along with our new tagline of ‘Bringing Science to Society,’ captures not only where we find ourselves as a company today, but it reflects our inspiration for future growth as an organization.”
Quick hits
A team of University of Pennsylvania researchers, in partnership with the Family Heart Foundation, has received a $2 million grant from the National Heart Lung and Blood Institute to test two promising approaches to implement cascade screening in individuals with familial hypercholesterolemia, a genetic disorder characterized by high cholesterol levels that affects 1 in 250 people. Cascade screening involves contacting and screening first-degree biological relatives of an individual diagnosed with the disorder. Family screening helps quickly identify and diagnose individuals with familial hypercholesterolemia, which can be addressed with early diagnosis and appropriate care to reduce morbidity rate cost-effectively. … Warrington-based Windtree Therapeutics (NASDAQ: WINT) reported positive results from mid-stage testing of its new drug candidate lucinactant as a potential treatment for patients with severe Covid-19-associated acute respiratory distress syndrome and lung injury. … Ocugen (NASDAQ: OCGN) of Malvern promoted Jessica Crespo to chief accounting officer and senior vice president, finance. She assumed the role effective March 18. Crespo joined the company in 2019 and previously served as vice president, corporate controller and treasurer. Before joining Ocugen, she held financial leadership roles within Aerie Pharmaceuticals, Aralez Pharmaceuticals and Cubist Pharmaceuticals.
