This week's Lab Notes has details on a new service launched by a local contract development and manufacturing organization, an independent research institute's genetic discovery, early positive clinical trials results for a company focused on women's cancers and more.
Here's the roundup:
Center for Breakthrough Medicines
The King of Prussia contract development and manufacturing organization has launched a new business unit called Precision Plasmids.
Plasmids — genetic structures in a cell that can replicate independently of its chromosomes — are the starting material for mRNA vaccines and a key component for vector-based cell and gene therapies.
Precision Plasmids was launched to provide phase-appropriate plasmids on-demand and at scale for companies working on cell and gene therapies.
"Plasmids are in high demand for the foreseeable future,” said Dana Cipriano, the center's senior vice president for testing and analytical services and plasmids.
The Center for Breakthrough Medicines other manufacturing services including process development, vector manufacturing, cell banking, and cell processing.
The Wistar Institute
Scientists at the independent Philadelphia research institute have identified a gene signature that accurately predicts the functioning of p53 variants, which is considered important information for assessing cancer risk and optimizing cancer therapy choices.
The research project was led by Maureen Murphy, deputy director of Wistar’s Ellen and Ronald Caplan Cancer Center and a professor and program leader in the institute's molecular and cellular oncogenesis program.
Murphy said many p53 variants are classified as having uncertain significance with current methods of testing, and does not help people determine an increased cancer risk. She said the variant identified by Wistar will change that.
The Murphy lab monitored differences in activity in mutant and normal p53 proteins to determine any genetic markers that would flag if a p53 variant is functioning less than normal. The research team collaborated with Andrew Kossenkov, an assistant professor in Wistar’s Vaccine and Immunotherapy Center, to use machine learning to identify a gene signature that consistently and accurately predicted the difference between a normal functioning or benign p53 and a lower functioning variant of the protein.
Murphy's next goal is to turn the gene signature discovery into a blood-based genetic test someone could take to learn about their p53 status. “The promise of this research is personalized medicine,” she said.
Context Therapeutics (NASDAQ: CNTX)
The Philadelphia biopharmaceutical company focused on female cancers said this week that two of the first 12 patients enrolled in its phase 2 clinical trial evaluating the potential of Context’s new drug candidate targeting metastatic endometrial cancer have achieved a confirmed partial response.
The clinical trial is testing Context's extended-release oral progesterone receptor antagonist, known as ONA-XR, in combination with the hormone treatment anastrozole.
"We are encouraged by these findings and look forward to continued enrollment in the trial,” said Martin Lehr, CEO of Context Therapeutics.
Metastatic endometrial cancer is an aggressive cancer of the uterus that is the fourth leading cause of cancer-related mortality in women. It results in an estimated 13,000 deaths per year in the U.S.
Quick Hits
Philadelphia cell therapy developer Century Therapeutics dosed its first patient in a phase 1 clinical trial testing its new drug candidate CNTY-101 as a treatment for certain relapsed or refractory B-cell lymphomas drug candidate.… Annovis Bio (NYSE: ANVS) of Berwyn received approval for additional 48 European clinical trial sites for its ongoing phase 3 study testing buntanetap as a potential treatment for Parkinson's disease. The company has 50 clinical trial sites open and currently enrolling in the U.S. Annovis is adding additional sites in five European Union countries: Italy, Spain, Hungary, Poland and Germany.… Wilmington-based Lava Therapeutics (NASDAQ: LVTX) hired Dr. Charles Morris to serve as its chief medical officer. Morris, who began his career at AstraZeneca and was once a research executive at Cephalon, was most recently chief medical officer at Belgium's Celyad Oncology. He replaced Dr. Benjamin Winograd in the CMO post.… A week after completing a merger and becoming a publicly traded company, New Hope-based Orchestra BioMed Holdings (NASDAQ: OBIO) has bolstered its senior leadership team with two new hires and two promotions. Dr. Avi Fischer, previously CEO of ElectroPhysiology Frontiers, has joined the medical device company as senior vice president for medical affairs and J.C. Simeon, previously senior director at Amring Pharmaceuticals, joined as senior vice president for quality. The company also promoted George Papandreou to general manager and senior vice president for focal therapies. Kunal Faldu was promoted to vice president of pharmaceutical development.
