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Anti-CD22 Immunotoxin
Anti-CD22 Immunotoxin is a Immunotoxin Small molecule drug developed by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS. It is currently in Phase 2 development for B-cell lymphomas (CD22-positive), Acute lymphoblastic leukemia (ALL, CD22-positive).
An immunotoxin that binds to CD22 on B-cell lymphomas and delivers a cytotoxic payload to kill malignant cells.
Anti-CD22 Immunotoxin is a treatment studied for various conditions, including Acute Lymphoblastic Leukemia, Relapsed/Refractory Hairy Cell Leukemia, and Lymphoma, according to ClinicalTrials.gov. The mechanism of Anti-CD22 Immunotoxin is unknown, as per ChEMBL.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Anti-CD22 Immunotoxin |
|---|---|
| Sponsor | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS |
| Drug class | Immunotoxin |
| Target | CD22 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
Anti-CD22 immunotoxins are fusion proteins combining an anti-CD22 antibody or antibody fragment with a toxin (typically a bacterial or plant-derived toxin like diphtheria toxin or pseudomonas exotoxin). The antibody component targets CD22, a B-cell-restricted antigen, while the toxin moiety is internalized upon binding and inhibits protein synthesis, leading to cell death. This approach aims to selectively eliminate CD22-expressing B-cell malignancies while sparing normal tissues.
Approved indications
- B-cell lymphomas (CD22-positive)
- Acute lymphoblastic leukemia (ALL, CD22-positive)
Common side effects
- Vascular leak syndrome
- Hepatotoxicity
- Immunogenicity/anti-drug antibodies
- Infusion-related reactions
Key clinical trials
- ItaliaN Observational Study of Patients With Acute Lymphoblastic Leukemia Treated With Anti-CD22 Immunoconjugate
- Anti-CD19 and Anti-CD22 Immunotoxins in Treating Patients With Refractory or Relapsed B-Cell Acute Lymphoblastic Leukemia (PHASE1)
- An Early Access Programme for Moxetumomab Pasudotox in Relapsed/Refractory Hairy Cell Leukemia
- Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia (PHASE3)
- Immunotoxin Therapy and Cytarabine in Treating Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia (PHASE1)
- DT2219ARL for Relapsed or Refractory CD19 (+), CD 22 (+) B-Lineage Leukemia Or Lymphoma (PHASE1)
- Moxetumomab Pasudotox (CAT-8015, HA22) in Children With B-lineage Acute Lymphoblastic Leukemia and Minimal Residual Disease Prior to Allogeneic Hematopoietic Stem Cell Transplantation (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Anti-CD22 Immunotoxin CI brief — competitive landscape report
- Anti-CD22 Immunotoxin updates RSS · CI watch RSS
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS portfolio CI
Frequently asked questions about Anti-CD22 Immunotoxin
What is Anti-CD22 Immunotoxin?
How does Anti-CD22 Immunotoxin work?
What is Anti-CD22 Immunotoxin used for?
Who makes Anti-CD22 Immunotoxin?
What drug class is Anti-CD22 Immunotoxin in?
What development phase is Anti-CD22 Immunotoxin in?
What are the side effects of Anti-CD22 Immunotoxin?
What does Anti-CD22 Immunotoxin target?
Related
- Drug class: All Immunotoxin drugs
- Target: All drugs targeting CD22
- Manufacturer: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for B-cell lymphomas (CD22-positive)
- Indication: Drugs for Acute lymphoblastic leukemia (ALL, CD22-positive)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing