CytoMed Therapeutics (GDTC) FDA Approvals

CytoMed Therapeutics' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by CytoMed Therapeutics (GDTC). Over the past two years, CytoMed Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ANGELICA. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

ANGELICA FDA Regulatory Timeline and Events

ANGELICA is a drug developed by CytoMed Therapeutics for the following indication: allogeneic chimeric antigen receptor T cell (CAR-T cell) against blood and solid tumors. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Dose escalation - July 21,2025

Phase 1

• Drug: ANGELICA
• Announced Date: July 21, 2025
• Target Action Date: Q3 2025
• Estimated Target Date Range: July 1, 2025 - September 30, 2025
• Indication: allogeneic chimeric antigen receptor T cell (CAR-T cell) against blood and solid tumors

CytoMed Therapeutics Limited is pleased to announce the successful completion of dose level 1 for its first-in-human Phase I dose-escalation clinical trial (NCT05302037) ("ANGELICA Trial") for four late stage cancer patients and is scheduled to start dose level 2 of the ANGELICA Trial in third quarter of 2025.

CytoMed Therapeutics Limited has successfully completed dose level 1 of its first-in-human Phase I dose-escalation clinical trial (NCT05302037), called the ANGELICA Trial. This milestone involved treating four late-stage cancer patients with CTM-N2D, an allogeneic chimeric antigen receptor (CAR) gamma delta T cell therapy targeting NKG2DL, a marker found on many solid and blood cancers. CTM-N2D cells are derived from healthy donors, expanded in the lab, and engineered to attack cancer cells without needing compatibility matching between donor and patient.

The ANGELICA Trial evaluates CTM-N2D safety and tolerability in a basket of advanced solid and blood cancers. After completing the initial safety check at dose level 1 with no major adverse events, CytoMed is set to begin dose level 2 in the third quarter of 2025. The trial will further explore CTM-N2D as a targeted, off-the-shelf immunotherapy that may offer advantages over conventional treatments.

Dose Update - November 20,2024

• Drug: ANGELICA
• Announced Date: November 20, 2024
• Indication: allogeneic chimeric antigen receptor T cell (CAR-T cell) against blood and solid tumors

CytoMed Therapeutics Limited is pleased to announce that the first patient has been dosed in its first-in-human Phase I dose-escalation clinical trial (NCT05302037) ("ANGELICA Trial").

CytoMed Therapeutics Limited, a Singapore-based biopharma company, has marked an important milestone by dosing the first patient in its first-in-human Phase I dose-escalation clinical trial (NCT05302037), also called the ANGELICA Trial. This study evaluates a new allogeneic therapy that uses donor-derived gamma delta T cells, modified with a chimeric antigen receptor, to target advanced solid tumors and blood cancers. Unlike traditional CAR-T treatments that rely on a patient’s own cells, this innovative approach uses cells from eligible donors, which could lead to higher quality cells, lower production costs, and improved patient access. The ANGELICA Trial is now running under clinical trial authorization from Singapore’s Health Sciences Authority, marking a significant step forward in exploring novel immunotherapies to treat various challenging cancer types.

Provided Update - October 7,2024

• Drug: ANGELICA
• Announced Date: October 7, 2024
• Indication: allogeneic chimeric antigen receptor T cell (CAR-T cell) against blood and solid tumors

CytoMed Therapeutics Limited a Singapore-based biopharmaceutical company focused on harnessing its proprietary technologies to develop novel donor blood-derived, cell-based allogeneic therapies for the treatment of various cancers including blood and solid cancers has obtained full approval for its first-in-human Phase I clinical trial ("ANGELICA Trial") using its patented allogeneic chimeric antigen receptor T cell ("CAR-T cell") against several blood and solid tumors in collaboration with the National University Hospital ("NUH") of Singapore.

CytoMed Therapeutics Limited, a Singapore-based biopharmaceutical company, has received full approval to start its first-in-human Phase I clinical trial, called the ANGELICA Trial. The trial will test their patented allogeneic chimeric antigen receptor T cell (CAR-T cell) therapy. Unlike traditional CAR-T therapies that use a patient’s own cells, CytoMed’s approach uses cells taken from healthy donors, which may improve the quality of the treatment and lower production costs. This novel treatment targets both blood and solid tumors and is conducted in collaboration with the National University Hospital of Singapore. The ANGELICA Trial represents an important step in developing off-the-shelf cell therapies that do not require patient-specific matching, potentially increasing timely access to cancer treatment. The trial has received support from Singapore’s Ministry of Health through the NMRC Clinical Trial Grant scheme.