Skip to main content
Premium Trial:

Request an Annual Quote

In Brief This Week: Immix Biopharma, Carsgen Therapeutics, Color Health, Immunovia

NEW YORK – The European Commission this week granted orphan drug designation to Immix Biopharma's autologous cell therapy NXC-201 for multiple myeloma. In the EU, orphan drug designation gives a treatment certain benefits including 10 years of market exclusivity, access to the EU centralized authorization procedure, and reduced fees for various protocols related to marketing applications and authorization. 

Carsgen Therapeutics this week submitted a letter to the US Food and Drug Administration in response to a clinical hold on three of Carsgen's cell therapy clinical trials in late 2023. The clinical hold was based on findings during an inspection of Carsgen's manufacturing site in Durham, North Carolina. Carsgen said it has responded to the FDA about the status of the Corrective and Preventive Actions (CAPAs) plan it is taking to address the observations that led to the clinical hold. The firm said its plan is progressing smoothly according to the timetable set to address the issues at the facility. 

The American Cancer Society and Color Health plan to provide free at-home cancer screening, initially for colorectal cancer, starting in June, the Biden Cancer Moonshot initiative said this week. The two organizations plan to partner with federally qualified health centers and community health clinics to make colorectal cancer screening freely available, in particular to people with no or insufficient insurance. Patients will receive a fecal immunochemical test (FIT) that looks for blood in the stool. Individuals will also have access to diagnostic follow-up through Color and ACS’s National Cancer Information Center. Going forward, the partners plan to add other cancer at-home screening tests. 

Immunovia said this week that it plans to move its lab and US headquarters to Research Triangle Park in North Carolina. The move follows its announcement of positive results from a model development study for its pancreatic cancer detection test. Next steps include confirming the analytical validity of its new test and conducting a large clinical validation study, which will now take place at the firm’s new lab in Research Triangle Park. According to Immunovia, the decision to move locations is in line with a strategy it adopted in 2023 to streamline its operations and reduce costs. The new lab is significantly smaller than its prior space in Marlborough, Massachusetts. The firm also expects lower labor costs. 

The US Food and Drug Administration has granted Taysha Gene Therapies' Rett syndrome candidate, TSHA-102, regenerative medicine advanced therapy designation, the Dallas-based biotech firm said this week. The FDA's decision was based on a review of safety and efficacy data from the first three patients treated in an adolescent and adult Phase I/II trial and a pediatric Phase I/II trial of the gene therapy, two dose-escalation studies in which the patients received the low dose of TSHA-102. 

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on Precision Medicine Online.