UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events. |
On January 23, 2023, TScan Therapeutics, Inc. (“TScan” or the “Company”), issued a press release announcing that the U.S. Food and Drug Administration has cleared its investigational new drug (“IND”) applications to evaluate T-Plex, TSC-204-A0201 and TSC-204-C0702. T-Plex will now serve as the primary IND for TScan’s solid tumor program, enabling customized combinations of T cell receptor-engineered T cell therapies to be administered to patients based on targets and HLAs expressed in their tumors. The press release also announced that TScan also filed secondary INDs for two initial TCR-T products, TSC-204-A0201 and TSC-204-C0702, that target melanoma-associated antigen 1 (MAGE-A1) on HLA types A*02:01 and C*07:02. MAGE-A1 is a cancer-associated antigen overexpressed in 45% of head and neck cancers and 50% of melanoma, cervical, and non-small cell lung cancers. With these INDs cleared, the Company announced that it is now working to open a multicenter Phase 1 clinical trial to establish the safety, preliminary efficacy, and feasibility of repeat dosing of multiplexed TCR-T.
The full text of the press release issued in connection with the announcement is filed as Exhibit 99.1 on this Current Report on Form 8-K.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
The following exhibits are filed as part of this report:
| Exhibit |
Description | |
| 99.1 | Press release, dated January 23, 2023. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| TScan Therapeutics, Inc. | ||||||
| Date: January 23, 2023 | By: | /s/ Brian Silver | ||||
| Brian Silver | ||||||
| Chief Financial Officer | ||||||