This week's happenings in the Philadelphia region's life sciences industry include a new development for a Covid-19 vaccine candidate, a key milestone for a functional food product, and a cancer drug candidate licensing deal. Here's the rundown:
Inovio
The Plymouth Meeting-based biotechnology company received regulatory authorization from Brazil's Agência Nacional de Vigilância Sanitária to initiate the global Phase 3 segment of its late-stage clinical trials for INO-4800, Inovio's experimental Covid-19 vaccine. The company plans to conduct the study in multiple countries, including Brazil, with partner Advaccine Biopharmaceuticals Suzhou Co. Ltd. "With many countries in the world experiencing low vaccination rates and seeing an increase in infections, we feel the urgency to advance INO-4800 globally," said J. Joseph Kim, CEO of Inovio (NASDAQ: INO).
Cerecor
The biopharmaceutical company with operations in Wayne and Rockville, Maryland, has changed its name to Avalo Therapeutics and its NASDAQ stock symbol to AVTX. “The rebranding from Cerecor to Avalo Therapeutics comes at a defining moment in our company's history and better reflects who we are today with our increased focus on immunology, immuno-oncology, and rare genetic diseases," said Michael F. Cola, the company's CEO. Avalo has six new drug candidates in clinical testing targeting conditions that include inflammatory bowel disease, multiple myeloma and complex lymphatic malformations.
Envara Health
The Malvern clinical nutrition company said the Centers for Medicare and Medicaid Services has issued a product code for Envara's first functional food, called Encala.
Encala is a medical food formulated to address fat malabsorption in patients with cystic fibrosis and other pancreatic diseases. The product provides easily absorbable fat calories and improves the absorption of fat and nutrients in accompanying meals and beverages. The company describes Encala as a "taste-neutral, gluten-free, non-GMO, plant-based powder."
A company spokeswoman said getting the code is important because it should assist payors with efficient adjudication and reimbursement, when the payor deems Encala medically necessary for the patient. Without the code, some payors had difficulty processing an order for Encala, often assessing a miscellaneous code that was used in the interim. That caused lengthy reimbursement processes that, at times, delayed shipments of the product to patients, the spokeswoman said. The new Encala code will go into effect on Oct. 1.
Tabula Rasa Healthcare
Tabula Rasa, a Moorestown-based health care technology company focused on advancing the safe use of medications, and Hesperos Inc. received a $1.9 million grant from the National Institutes of Health to investigate drug-induced dementia and develop new models for Alzheimer's research. Florida-based Hesperos is the developer of "human-on-a-chip" microfluidic systems used for toxicology testing.
The project will involve leveraging Tabula Rasa's MedWise technology, which uses advanced proprietary algorithms to help quantify a patient's risk for adverse drug events and assess the impact of certain drug properties and multi-drug interactions. The results of that effort, combined with Hesperos' technology, will help identify which medications and medication regimens correlate with the greatest risk of drug-induced dementia.
Context Therapeutics
The Philadelphia-based women’s oncology company, which is developing advanced small molecule and immunotherapy treatments for hormone-driven breast and gynecological cancers, and Tyligand Bioscience Ltd., a Chinese biotechnology company, said they have successfully completed "manufacturing process optimization" for ONA-XR — Context's lead new drug candidate targeting breast, ovarian and endometrial cancers — pursuant to the collaboration agreement the companies entered into in March 2020. As a result of the successful optimization, Context and Tyligand of Shanghai have entered into a license agreement whereby Tyligand was granted the exclusive rights and sole responsibility for the development and commercialization of ONA-XR in China, Hong Kong and Macau. Context holds rights to commercialize ONA-XR in the rest of the world.
“This work represents another major step forward for Context’s ability to efficiently scale our manufacturing and clinical capacity to support the development and future commercialization of ONA-XR to address the unmet need in treating women with hormone receptor-positive cancers,” said Martin Lehr, CEO of Context.
