This week's rundown of Philadelphia-area life sciences news has details on a cell therapy manufacturing deal, a biotechnology company's debt financing, an agricultural collaboration, and more.
Here's the roundup:
Carisma Therapeutics
Novartis has signed a manufacturing agreement with Philadelphia cell therapy developer Carisma Therapeutics.
Under the deal, the financial terms of which are being kept confidential, Novartis will manufacture Carisma's targeted CAR-M cell therapy, which is being tested in early-stage clinical trials as a treatment of solid tumors.
The agreement calls for Carisma's manufacturing process to be transferred to the Novartis cell therapy site in Morris Plains, New Jersey. Clinical manufacturing is planned to begin in 2023.
Steven Kelly, Carisma's CEO, noted Novartis is an "early pioneer and leader" in cell therapy. "They have the expertise and capabilities to support the expansion of our promising CT-0508 clinical program [targeting HER2-positive solid tumors] and help us bring CAR-M cell therapy to patients in an even more reliable and efficient process," he said.
Carisma, founded in 2016, is pioneering CAR-M cell therapy, a type of cell therapies that involves macrophages. Macrophages are a type of cell found in stationary form in tissue, or as a mobile white blood cell, at sites of infection. The company's researchers, in collaboration with University of Pennsylvania scientists, have developed a way to genetically engineer macrophage cells with chimeric antigen receptors, or CARs, to direct a therapy to tumor cells. Its in vivo approach means cells do not need to be manipulated outside the body and re-infused in patients.
Chimeron Bio Corp.
The Philadelphia biotechnology company has raised $782,000 in a debt financing.
The debt sale was disclosed in documents Chimeron filed with the Securities and Exchange Commission.
Chimeron, founded in 2015, is focused on developing a novel class of self-amplifying RNA vaccines and therapeutics. The company's pipeline includes a variety of gene therapy candidates targeting various cancers, along with vaccines targeting infectious diseases, in preclinical development.
Chimeron is led by CEO Dr. Jolly Mazumdar, who previously served in clinical development leadership roles at GlaxoSmithKline.
Earlier this year, Chimeron expanded it Philadelphia footprint by taking space in the BioLabs co-working space at The Curtis.
The company previously raised $300,000 in an equity financing that closed in 2020.
AUM LifeTech
The Philadelphia biotechnology company has formed a collaboration with Colorado State University on a project backed by a $496,965 grant from the U.S. Defense Advanced Research Projects Agency (DARPA).
The research project involves the use of AUM LifeTech's self-deliverable RNA Silencing FANA Antisense Oligonucleotides technology to develop non-GMO, non-viral RNA-targeting products for advances in agriculture management and to improve disease and insect resistance. The specific goal of the partnership is to develop a better approach for crop management that can be used to specifically target invasive plants.
Dr. Todd Gaines, an associate professor at Colorado State, is heading up the project for the university.
DARPA is a research and development agency of the United States Department of Defense.
"The DARPA grant will allow us to conduct some key studies and develop innovative RNA-targeting approaches and products for sustainable agriculture," said Veenu Aishwarya, founder and CEO of AUM LifeTech.
Gaines called the project the "most exciting" he has worked on in terms of promise. "If we can solve this problem, then this will be something every person out there managing weeds will be affected by," he said.
Incyte Corp.
The Food and Drug Administration has extended by three months its review period for the supplemental new drug application filed by the Wilmington biotechnology company for its experimental vitiligo treatment Opzelura.
The federal agency extended its action date to July 18 to review additional data from ongoing Phase 3 studies submitted by Incyte (NASDAQ: INCY) in response to the FDA’s information request.
The study is evaluating Opzelura, a cream containing the active ingredient ruxolitinib, in more than 600 adolescent and adult patients with non-segmental vitiligo, a depigmented skin disorder.
Opzelura is approved for use in the United States for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis.
Quick hits
Philadelphia-based Proscia has entered into a multiyear original equipment manufacturer agreement with Siemens Healthineers, which will give Siemens an entrance into the digital pathology marketplace with Proscia’s Concentriq Dx platform. Financial terms of the deal are being kept confidential. … Windtree Therapeutics (NASDAQ: WINT), a Warrington biotechnology company, completed enrollment of 60 patients for its Phase 2 study of istaroxime in early cardiogenic shock caused by heart failure. Results from the study are expected in April. Cardiogenic shock is a serious condition that occurs when the heart is failing significantly and cannot pump enough blood and oxygen to the brain, kidneys, and other vital organs. … Impulse Dynamics of Mount Laurel, New Jersey, enrolled the first patient in a clinical study evaluating its cardiac contractility modulation (CCM) therapy in heart failure patients. The study will be conducted at about 150 centers worldwide. The South Jersey firm's CCM therapy is delivered by its proprietary minimally invasive implantable device, called The Optimizer, which provides precisely timed electric pulses to the heart.
