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mycosis fungoides
The US Food and Drug Administration (FDA) has granted fast track designation to Resimmune® (A-dmDT390-bisFv[UCHT1]) for the treatment of mycosis fungoides (MF).
Resimmune is an anti-CD3 immunotoxin that targets and transiently depletes a high percentage of malignant and normal T cells.
Researchers believe this high rate of T-cell depletion may “reset” a patient’s immune system, leading to immunomodulation. However, the safety and efficacy of Resimmune has not been established.
Resimmune is being developed by Angimmune LLC.
Resimmune research
The FDA’s fast track designation for Resimmune is based on results from a phase 1 trial, which were published in haematologica last year.
The trial included 25 patients with cutaneous T-cell lymphoma (CTCL)—17 with stage IB-IIB disease and 8 with stage III-IV disease. The patients received Resimmune at varying doses—between 2.5 µg/kg and 11.25 µg/kg.
Safety
Drug-related adverse events for the entire study cohort (n=30) included:
- Grade 2-3 AST/ALT elevations (n=6)
- Grade 2 chills (n=10)
- Grade 5 EBV infection (n=1)
- Grade 3 EBV/CMV infection (n=5)
- Grade 2 fever (n=6)
- Grade 5 heart failure (n=2)
- Grade 2-3 hypoalbuminemia (n=11)
- Grade 2 hypomagnesemia (n=1)
- Grade 3 hypophosphatemia (n=3)
- Grade 2-4 hypotension (n=3)
- Grade 4 hypoxia (n=1)
- Grade 4 liver failure (n=1)
- Grade 4 metabolic acidosis (n=1)
- Grade 3 supraventricular tachycardia (n=2)
- Grade 3-4 uremia (n=3)
- Grade 2-4 vascular leak syndrome (n=5).
Efficacy and phase 2
Nine of the CTCL patients (36%) responded to Resimmune, and 4 (16%) had complete responses (CRs). The duration of CR was more than 38 months for 1 patient, more than 60 months for another, and more than 72 months for 2 patients.
Of the 5 partial responses, 2 lasted 3 months, 1 lasted more than 3 months, 1 lasted more than 6 months, and the longest lasted 14 months.
The researchers said this trial revealed a subgroup of CTCL patients with a very high response rate.
When they excluded patients whose mSWAT scores never exceeded 50 and who never had lymph node involvement or stage III disease, the researchers were left with 9 patients. This subgroup had an overall response rate of 89% and a CR rate of 50% (at 6 months of follow-up).
“Results from our phase 1 trial demonstrated a particularly robust response among certain patients with early stage disease, and the randomized phase 2 trial is designed to further explore this potential therapeutic benefit,” said David Neville, MD, president and chief scientific officer of Angimmune.
The objective of this phase 2 trial is to document the incidence of CRs with Resimmune compared to oral vorinostat after a maximum of 12 months of treatment. The trial will enroll patients with stage IB/IIB MF with mSWAT < 50 who have never had lymphoid disease or a prior hematopoietic stem cell transplant.
About fast track designation
The FDA’s fast track program is designed to facilitate and expedite the development and review of new drugs intended to treat serious or life-threatening conditions and address unmet medical need.
Through the fast track program, a product may be eligible for priority review. In addition, the company developing the drug may be allowed to submit sections of the biologic license application or new drug application on a rolling basis as data become available.
Fast track designation also provides the company with opportunities for more frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of the appropriate data needed to support drug approval. And the designation allows for more frequent written communication from the FDA about things such as the design of proposed clinical trials and the use of biomarkers. 
mycosis fungoides
The US Food and Drug Administration (FDA) has granted fast track designation to Resimmune® (A-dmDT390-bisFv[UCHT1]) for the treatment of mycosis fungoides (MF).
Resimmune is an anti-CD3 immunotoxin that targets and transiently depletes a high percentage of malignant and normal T cells.
Researchers believe this high rate of T-cell depletion may “reset” a patient’s immune system, leading to immunomodulation. However, the safety and efficacy of Resimmune has not been established.
Resimmune is being developed by Angimmune LLC.
Resimmune research
The FDA’s fast track designation for Resimmune is based on results from a phase 1 trial, which were published in haematologica last year.
The trial included 25 patients with cutaneous T-cell lymphoma (CTCL)—17 with stage IB-IIB disease and 8 with stage III-IV disease. The patients received Resimmune at varying doses—between 2.5 µg/kg and 11.25 µg/kg.
Safety
Drug-related adverse events for the entire study cohort (n=30) included:
- Grade 2-3 AST/ALT elevations (n=6)
- Grade 2 chills (n=10)
- Grade 5 EBV infection (n=1)
- Grade 3 EBV/CMV infection (n=5)
- Grade 2 fever (n=6)
- Grade 5 heart failure (n=2)
- Grade 2-3 hypoalbuminemia (n=11)
- Grade 2 hypomagnesemia (n=1)
- Grade 3 hypophosphatemia (n=3)
- Grade 2-4 hypotension (n=3)
- Grade 4 hypoxia (n=1)
- Grade 4 liver failure (n=1)
- Grade 4 metabolic acidosis (n=1)
- Grade 3 supraventricular tachycardia (n=2)
- Grade 3-4 uremia (n=3)
- Grade 2-4 vascular leak syndrome (n=5).
Efficacy and phase 2
Nine of the CTCL patients (36%) responded to Resimmune, and 4 (16%) had complete responses (CRs). The duration of CR was more than 38 months for 1 patient, more than 60 months for another, and more than 72 months for 2 patients.
Of the 5 partial responses, 2 lasted 3 months, 1 lasted more than 3 months, 1 lasted more than 6 months, and the longest lasted 14 months.
The researchers said this trial revealed a subgroup of CTCL patients with a very high response rate.
When they excluded patients whose mSWAT scores never exceeded 50 and who never had lymph node involvement or stage III disease, the researchers were left with 9 patients. This subgroup had an overall response rate of 89% and a CR rate of 50% (at 6 months of follow-up).
“Results from our phase 1 trial demonstrated a particularly robust response among certain patients with early stage disease, and the randomized phase 2 trial is designed to further explore this potential therapeutic benefit,” said David Neville, MD, president and chief scientific officer of Angimmune.
The objective of this phase 2 trial is to document the incidence of CRs with Resimmune compared to oral vorinostat after a maximum of 12 months of treatment. The trial will enroll patients with stage IB/IIB MF with mSWAT < 50 who have never had lymphoid disease or a prior hematopoietic stem cell transplant.
About fast track designation
The FDA’s fast track program is designed to facilitate and expedite the development and review of new drugs intended to treat serious or life-threatening conditions and address unmet medical need.
Through the fast track program, a product may be eligible for priority review. In addition, the company developing the drug may be allowed to submit sections of the biologic license application or new drug application on a rolling basis as data become available.
Fast track designation also provides the company with opportunities for more frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of the appropriate data needed to support drug approval. And the designation allows for more frequent written communication from the FDA about things such as the design of proposed clinical trials and the use of biomarkers.
mycosis fungoides
The US Food and Drug Administration (FDA) has granted fast track designation to Resimmune® (A-dmDT390-bisFv[UCHT1]) for the treatment of mycosis fungoides (MF).
Resimmune is an anti-CD3 immunotoxin that targets and transiently depletes a high percentage of malignant and normal T cells.
Researchers believe this high rate of T-cell depletion may “reset” a patient’s immune system, leading to immunomodulation. However, the safety and efficacy of Resimmune has not been established.
Resimmune is being developed by Angimmune LLC.
Resimmune research
The FDA’s fast track designation for Resimmune is based on results from a phase 1 trial, which were published in haematologica last year.
The trial included 25 patients with cutaneous T-cell lymphoma (CTCL)—17 with stage IB-IIB disease and 8 with stage III-IV disease. The patients received Resimmune at varying doses—between 2.5 µg/kg and 11.25 µg/kg.
Safety
Drug-related adverse events for the entire study cohort (n=30) included:
- Grade 2-3 AST/ALT elevations (n=6)
- Grade 2 chills (n=10)
- Grade 5 EBV infection (n=1)
- Grade 3 EBV/CMV infection (n=5)
- Grade 2 fever (n=6)
- Grade 5 heart failure (n=2)
- Grade 2-3 hypoalbuminemia (n=11)
- Grade 2 hypomagnesemia (n=1)
- Grade 3 hypophosphatemia (n=3)
- Grade 2-4 hypotension (n=3)
- Grade 4 hypoxia (n=1)
- Grade 4 liver failure (n=1)
- Grade 4 metabolic acidosis (n=1)
- Grade 3 supraventricular tachycardia (n=2)
- Grade 3-4 uremia (n=3)
- Grade 2-4 vascular leak syndrome (n=5).
Efficacy and phase 2
Nine of the CTCL patients (36%) responded to Resimmune, and 4 (16%) had complete responses (CRs). The duration of CR was more than 38 months for 1 patient, more than 60 months for another, and more than 72 months for 2 patients.
Of the 5 partial responses, 2 lasted 3 months, 1 lasted more than 3 months, 1 lasted more than 6 months, and the longest lasted 14 months.
The researchers said this trial revealed a subgroup of CTCL patients with a very high response rate.
When they excluded patients whose mSWAT scores never exceeded 50 and who never had lymph node involvement or stage III disease, the researchers were left with 9 patients. This subgroup had an overall response rate of 89% and a CR rate of 50% (at 6 months of follow-up).
“Results from our phase 1 trial demonstrated a particularly robust response among certain patients with early stage disease, and the randomized phase 2 trial is designed to further explore this potential therapeutic benefit,” said David Neville, MD, president and chief scientific officer of Angimmune.
The objective of this phase 2 trial is to document the incidence of CRs with Resimmune compared to oral vorinostat after a maximum of 12 months of treatment. The trial will enroll patients with stage IB/IIB MF with mSWAT < 50 who have never had lymphoid disease or a prior hematopoietic stem cell transplant.
About fast track designation
The FDA’s fast track program is designed to facilitate and expedite the development and review of new drugs intended to treat serious or life-threatening conditions and address unmet medical need.
Through the fast track program, a product may be eligible for priority review. In addition, the company developing the drug may be allowed to submit sections of the biologic license application or new drug application on a rolling basis as data become available.
Fast track designation also provides the company with opportunities for more frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of the appropriate data needed to support drug approval. And the designation allows for more frequent written communication from the FDA about things such as the design of proposed clinical trials and the use of biomarkers.