FDA Grants Orphan Drug Designation to SI-101 Novel T-Cell Lymphoma Therapy

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FDA Grants Orphan Drug Designation to SI-101 Novel T-Cell Lymphoma Therapy

FDA Grants Orphan Drug Designation to SI-101 Novel T-Cell Lymphoma Therapy

Lymphoma Welcomes New Treatment: US T-Cell Lymphoma Therapy SI-101 Receives Orphan Drug Designation.

The United States Food and Drug Administration (FDA) has granted orphan drug designation to the cell immunotherapy SIRPant-M™ (SI-101), developed by the American biopharmaceutical company SIRPant Immunotherapeutics, for the treatment of T-cell lymphoma, offering a potential therapeutic option for patients.

Orphan drug designation is awarded to drugs designed to treat rare diseases. Once designated, these drugs receive a series of incentives to accelerate their clinical trials and regulatory approval.

FDA Grants Orphan Drug Designation to SI-101 Novel T-Cell Lymphoma Therapy

Key Information:

T-cell lymphoma is a rare blood cancer with no current cure, necessitating effective treatment options for patients.
SIRPant-M™ (SI-101) can be used as a monotherapy or in combination with other treatments such as radiotherapy and immune checkpoint inhibitors for cancer treatment, helping patients reduce the risk of relapse.
Preclinical research data indicates the drug’s effectiveness against blood tumors and various solid tumors, showing significant therapeutic potential.
The drug is currently undergoing its first phase of human clinical trials, targeting patients with relapsed/refractory non-Hodgkin lymphoma.

Research Details (For Professionals):

The FDA has granted orphan drug designation to SIRPant Immunotherapeutics’ cell immunotherapy SIRPant-M™ (SI-101) for the treatment of T-cell lymphoma, offering a potential therapeutic choice for patients.

About T-Cell Lymphoma:

T-cell lymphoma is a rare blood cancer, categorized as non-Hodgkin lymphoma, primarily affecting T lymphocytes, a crucial type of white blood cell in the immune system. Originating in the skin, T-cell lymphoma typically results in skin redness, rashes, or even tumors.

Unlike B-cell lymphoma and classical Hodgkin lymphoma, T-cell lymphoma, currently incurable, lacks suitable drug targets for many subtypes. Additionally, there are currently no approved cell immunotherapies specifically for T-cell lymphoma.

About SIRPant-M™ (SI-101):

SIRPant-M™ (SI-101) is a cell immunotherapy developed by the American biopharmaceutical company SIRPant Immunotherapeutics. Its mechanism involves using an advanced non-genetic approach to activate and educate the patient’s own macrophages to recognize and eliminate cancer cells.

SI-101 can be used as a monotherapy or in combination with other treatments, such as radiotherapy and immune checkpoint inhibitors, for cancer treatment, helping patients reduce the risk of relapse.

Clinical Trial Progress of SI-101:

Recent clinical trials of SI-101 have demonstrated promising therapeutic potential. Preclinical research data indicates its effectiveness against blood tumors and various solid tumors.

Currently, SI-101 is undergoing its first phase of human clinical trials (NCT05967416) for the treatment of relapsed/refractory non-Hodgkin lymphoma (NHL) patients.

This open-label phase 1 clinical trial includes B-cell NHL and T-cell NHL patients aged at least 18 years who have previously received at least 2 lines of treatment and cannot undergo other therapeutic interventions. The study will assess the safety and tolerability of SI-101 monotherapy or in combination with low-dose radiotherapy, with the primary objective being to evaluate safety and tolerability. Key secondary endpoints include recommended phase 2 doses and objective response rates.

SIRPant Immunotherapeutics is set to submit a second new drug clinical trial application for SI-101, focusing on research in solid tumors, particularly head and neck cancer.