TScan Therapeutics Inc (TCRX)

[FACT-MASTER]

I'm getting back to your question ( even though you are asking jd), because imo, the public reporting on TCRX have missed a critical detail and/or TCRX management may have not been clear enough. I'm referencing the press release of January 23 2023 here:

https://ih.advfn.com/stock-market/NASDAQ/tscan-therapeutics-TCRX/stock-news/90036699/tscan-gets-fda-clearance-for-three-investigational

TScan Gets FDA Clearance for Three Investigational New Drug Apps

TScan Therapeutics Inc. said Monday that the Food and Drug Administration has cleared its investigational new drug applications for T-Plex, TSC-204-A0201 and TSC-204-C0702.

The Massachusetts-based clinical-stage biopharmaceutical company said T-Plex would now be the primary investigational new drug and TSC-204-A021 and TSC-204-C0702 the secondary investigational new drugs for its solid-tumor program.

The company said T-Plex allows patients to customize combinations of T-cell receptor-engineered T-cell therapies (TCR-T), chosen from its proprietary bank of TCRs, to treat cancers based on their specific markers. TSC-204-A0201 and TSC-204-C0702 target cancers associated with melanoma-associated antigen-1, a cancer-associated antigen overexpressed in head, neck, melanoma, cervical, and non-small cell lung cancers.

A Phase-1 clinical trial with a screening protocol expected to begin in the second quarter would assess repeat-dosing of TCR-Ts, and a secondary investigational new drug application would be filed for each unique TCR-T referencing the T-Plex application, TScan said.

The trial would evaluate each TCR-T as a singleplex therapy at two successive dose levels, the company said. Once single-agent safety is established, each TCR would become eligible for multiplexing, or combining it with any other TCR that has passed this threshold, the company said.

The above press release, imo is not clear, especially with the headline reading " TScan Gets FDA Clearance for Three Investigational New Drug Apps"

It may be 3 apps, but only 2 studies.

1. Screening protocol study as the primary investigational new drug application: ( imo, this is where TScan technology of Target Scan / Receptor Scan / Safety Scan - is utilized for patient eligibility and prevent off targets, which is a concern of the FDA.)
This study, imo is the all important starting point for a patient prior to entering any of the additional treatment trials, and maps their oncologous condition - not sure if that is the right term,

https://classic.clinicaltrials.gov/ct2/history/NCT05812027?A=1&B=11&C=merged#StudyPageTop

"Brief Summary: TScan Therapeutics is developing cellular therapies across multiple solid tumors in which autologous participant-derived T cells are engineered to express a T cell receptor that recognizes cancer-associated antigens presented on specific human leukocyte antigen Human Leukocyte Antigen (HLA) molecules. The purpose of this screening study is to collect samples to conduct HLA genotyping, HLA LOH Loss of Heterozygosity (LOH) and expression of tumor antigens Tumor-associated Antigens (TAA) testing. These results will be used to determine if subjects meet the eligibility criteria for these parameters and could potentially be enrolled in a TScan clinical treatment study.
Detailed Description: This multicenter screening study will be conducted to determine a subject's tumor antigen expression profile, HLA genotype and HLA LOH for TScan sponsored clinical treatment study(s). No treatment intervention will occur as part of this screening study.
Subjects will be required to provide a buccal swab to assess their HLA status. If they are positive for certain types of HLA, they will return for a subsequent visit to provide a saliva sample to assess HLA loss of heterozygosity. In parallel, archival tissue (less than 6 months old) will be needed to assess for tumor antigen expression. If archival tissue is older than six months, a fresh tumor biopsy will be required at the time of the second visit.

If eligible, subjects will be referred to appropriate available interventional trial(s) at the discretion of the Investigator.

2. TSC-204-A0201 / TSC-204-C0702

https://classic.clinicaltrials.gov/ct2/history/NCT05973487?A=1&B=5&C=merged#StudyPageTop

Brief Summary: TScan Therapeutics is developing cellular therapies across multiple solid tumors in which autologous participant-derived T cells are engineered to express a T cell receptor that recognizes cancer-associated antigens presented on specific Human Leukocyte Antigen (HLA) molecules.
This is a multi-center, non-randomized, multi-arm, open-label, basket study evaluating the safety and preliminary efficacy of single and repeat dose regimens of TCR'Ts as monotherapies and as T-Plex combinations after lymphodepleting chemotherapy in participants with locally advanced, metastatic solid tumors disease.

Detailed Description: Participants will be screened in a separate screening study, TSCAN-003 (NCT05812027), to assess their HLA type, tumor-associated antigen (TAA) expression and loss of heterozygosity (LOH) status. The results of these tests will be used to determine initial eligibility in this study.
Depending on the genetic type, participants will be assigned to one of the following study groups:

( imo, the dosage part you are asking about is one of the experimental aspects of the trials, the eligibility is related to the above 2 studies.)
All imo.