Table 1 Summary of safety study of ERY974 in cynomolgus monkeys.

From: Determination of starting dose of the T cell-redirecting bispecific antibody ERY974 targeting glypican-3 in first-in-human clinical trial

Group

Animals (n)

Autopsy (day)

Dose (μg/kg/dose)

Average maximum IL-6 level (pg/mL)a

Clinical signs/histopathological findings

1 (Control)

3 (M) + 3 (F)

8

0

48

No finding

2 (Low)

3 (M) + 3 (F)

22

0.1

32

No finding (NOAEL)

3 (Middle)

3 (M) + 3 (F)

22

1

231

Red skin, increased body temperature, increased fibrinogen and triglyceride, decreased albumin in blood,

4 (High)

3 (M) + 3 (F)

22

10

2505

Red skin on head and/or complete body, hyperthermia, decreased body weight, low-to-no food consumption, hunched posture, decreased reactivity, decreased lymphocytes in the thymusb, increased infiltration of mononuclear cells and/or granulocytes in multiple tissues, No evidence of damages in tissues (liver, kidney, or gastrointestinal)

5 (High)

3 (M) + 3 (F)

8

10

  1. The symptoms, level of cytokines in the blood, clinical pathological and histopathological findings in animals after administration of ERY974 are summarized. The level of IL-6 has been previously described8.
  2. a8 h after administration.
  3. bObserved on both day 8 and 22 autopsy samples.
  4. M male, F female, NOAEL no observed adverse effect level.
Back to article page