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
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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.
Key Information:
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T-cell lymphoma is a rare blood cancer with no current cure, necessitating effective treatment options for patients.
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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.
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Preclinical research data indicates the drug’s effectiveness against blood tumors and various solid tumors, showing significant therapeutic potential.
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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.
FDA Grants Orphan Drug Designation to SI-101 Novel T-Cell Lymphoma Therapy
Sources:
[1] Onclive
[2] SIRPant Immunotherapeutics
(source:internet, reference only)
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