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type1.science

Alefacept (CD2 memory T-cell targeting)

Astellas / Biogen (Amevive; withdrawn)

A memory T-cell targeting fusion protein tested in the T1DAL phase-2 trial. It missed the 12-month primary 2-hour C-peptide endpoint but improved key secondary and 24-month outcomes. The product was withdrawn from the market, so it is mainly a mechanistic lesson, not a practical candidate.

DiscontinuedModerate evidenceimmunotherapycd2memory-t-cellsdiscontinuedbeta-cell-preservation

The scorecard

Delay of onset35

Did not meet its 12-month primary endpoint, though secondary and 24-month C-peptide outcomes favored alefacept.[1]

Durability55

At 24 months, over a year after the final dose, C-peptide AUC remained significantly higher and hypoglycemia lower versus placebo.[2]

Safety55

The T1DAL reports did not show a major safety imbalance, but the drug is no longer marketed and depleted memory T-cell subsets.[2]

Stage breadth20

Tested only in new-onset stage 3; no proven presymptomatic prevention use.[3]

Access & cost5

Alefacept was withdrawn from the market, so it is not a practical therapy even if the biology remains informative.[3]

Editor’s take

Alefacept is not coming back as a product, but T1DAL is too informative to omit. It showed that selectively targeting memory T cells could produce a delayed, durable C-peptide signal, while also showing why old discontinued biologics are not the answer by themselves.

The full picture

Why it matters even though it is discontinued

Alefacept targeted CD2-high memory T-cell populations. T1DAL missed its 12-month primary endpoint, but the pattern at 12 and 24 months suggested that selective memory T-cell targeting can preserve beta-cell function and reduce hypoglycemia after diagnosis.12

That makes alefacept a "lesson" record rather than a practical coming therapy: the product is withdrawn, and no T1D approval pathway exists.

References

  1. Rigby MR, et al. Targeting of memory T cells with alefacept in new-onset type 1 diabetes (T1DAL study). Lancet Diabetes & Endocrinology (2013). https://doi.org/10.1016/S2213-8587%2813%2970111-6 ↩

  2. Rigby MR, et al. Alefacept provides sustained clinical and immunological effects in new-onset type 1 diabetes patients. Journal of Clinical Investigation (2015). https://doi.org/10.1172/JCI81722 ↩

Coming soon

ETA · Discontinued product; mechanistic evidence only

Sources

  1. [1]Targeting of memory T cells with alefacept in new-onset type 1 diabetes (T1DAL study): 12 month results · peer-reviewed · 2013-09-23 — PMID 24622414. NCT00965458. Primary 2-hour C-peptide endpoint at 12 months not significant (P=0.065), but 4-hour C-peptide, insulin use and hypoglycemia favored alefacept.
  2. [2]Alefacept provides sustained clinical and immunological effects in new-onset type 1 diabetes patients · peer-reviewed · 2015-07-20 — PMID 26193635. At 24 months, 2-hour and 4-hour C-peptide AUCs were higher; insulin use and major hypoglycemia were lower.
  3. [3]Inducing Remission in Type 1 Diabetes With Alefacept · registry · 2017-07-06 — ClinicalTrials.gov NCT00965458; terminated after enrollment 49.