This week's Lab Notes has details on the latest round of local participants selected for a Science Center program geared to health tech startups, an FDA's ruling on a cell therapy company's investigative new drug application and the start of a mid-stage clinical trial by a Main Line biopharmaceutical company targeting eczema.
Here's the roundup:
University City Science Center
The Philadelphia nonprofit organization has selected 12 health tech startups from across the country, including seven based or with offices in the Philadelphia region, for the third cohort of its Capital Readiness program.
The five-day intensive program, which runs Dec. 4-8, is designed to prepare medtech, digital health, and health care technology startups to raise their first round of capital from institutional investors.
The startups will spend those five days in Philadelphia alongside industry leaders and investors on programs that include stress test scenarios, mock board meetings, and one-on-one feedback sessions.
“Despite challenging market conditions with startup funding down significantly from its 2021 peak, there remains significant potential for health tech and digital health businesses," said Tiffany Wilson, president and CEO of the Science Center. "To be successful, however, startups must demonstrate a level of sophistication across strategy, governance, and operations to earn the trust of already timid investors.”
Wilson said the Capital Readiness program gives startups the "best chance of success" by providing a way for entrepreneurs to engage with local and national experts and investors.
Launched earlier this year, the 18 startups who participated in the first two cohorts of the program have gone on to raise a combined $6.9 million.
The local participants for the third cohort are:
- Behemoth Technologies of Haddonfield, New Jersey, which is developing innovations that streamline dermatologic procedures for health care providers.
- Journal My Health of Philadelphia, which has developed a digital platform that collects and analyzes patient-generated health data with a focus on women with chronic conditions and maternal health needs.
- QuneUp of Philadelphia, the maker of a data-driven software tool that reduces equipment downtime, allowing biopharmaceutical manufacturing companies to better manage equipment assets and meet production goals.
- Vasowatch of Philadelphia, the inventor of clinical decision support technology designed to improve the birthing experience and enhance maternal outcomes.
- Viora Health of Philadelphia, a wellness company seeking to advance health equity by engaging diverse populations at home to improve health and reduce costs of care.
- VitalStart, which has offices in Philadelphia and Princeton, has launched what it describes as the first reproductive and maternity mental health platform using virtual reality for clinically guided care.
- Unio, which has offices in Philadelphia, Pittsburgh and Washington D.C., has developed a software platform designed for long-term care communities that facilitates resident-centered communication, engagement and family connectivity.
The deadline to apply for the fourth cohort of the program, which will take place March 25-29, is Jan. 5.
Carisma Therapeutics
The Philadelphia cell therapy company said it will begin human testing of its lead cancer therapy candidate, CT-0525, next year after its investigational new drug application was approved by the Food and Drug Administration.
The immunotherapy is being developed to treat solid tumors that overexpress human epidermal growth factor receptor 2, or HER2.
Carisma (NASDAQ: CARM) expects to initiate a phase 1 study in the coming months and to treat the first patient in the first half of 2024.
Steve Kelly, president and CEO of Carisma, called the FDA clearance a "significant milestone" in the company's quest to develop new therapies for metastiatic solid tumors.
Founded in 2016, Carisma is pioneering a cell therapy platform involving 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 — called CAR-M cell therapy — to tumor cells.
The company completed a merger with Sesen Bio of Cambridge, Massachusetts, in March.
Opsidio
The Bryn Mawr biotechnology company dosed the first patient in its phase 2 clinical trial of OpSCF, its lead new drug candidate being developed to treat patients with moderate to severe atopic dermatitis.
Opsidio is collaborating with Chicago-based AbbVie (NYSE: ABBV) for the development of OpSCF as a therapy for the skin disorder.
Atopic dermatitis, a type of eczema that is most common in young children, causes dry, itchy and inflamed skin. OpSCF is a monoclonal antibody that is designed to target the stem cell factor that plays a crucial role in the inflammatory pathway that leads to atopic dermatitis. The experimental medicine was previously evaluated in a 115-subject phase 1 study, and was found to be safe and well tolerated, following single or multiple ascending dose administration in healthy volunteers.
Opsidio is led by CEO Dr. Martin Phillips.
