According to a June 11 press release from biotechnology company Equillium, Inc. (“Equillium”), positive topline data is now available from the Phase 1b EQUATE clinical trial. Within the clinical trial, researchers are evaluating itolizumab for patients with severe acute graft-versus-host disease (GvHD). Typically, these patients respond poorly to the standard-of-care (SoC), or high doses of corticosteroids. As no current FDA-approved treatments exist, itolizumab could potentially fill an unmet need within this patient community. Researchers presented the topline data during the European Hematology Association (EHA) Virtual Congress 2021, which will take place from June 9-17, 2021.
Itolizumab
According to an unrelated article published in Expert Opinion on Biological Therapy, itolizumab is:
an anti-CD6 humanized IgG1 [monoclonal antibody that] binds to domain-1 of CD-6 that is responsible for priming, activation, and differentiation of T-cells. Itolizumab significantly reduces T-cell proliferation along with substantial downregulation of the production of cytokines/chemokines.
In short, it helps regulate the immune system and reduce inflammatory responses.
Altogether, within the EQUATE clinical trial, 20 patients with high-risk GvHD enrolled. During the trial, researchers sought to understand the pharmacokinetic and pharmacodynamic profile, safety, efficacy, clinical activity, and tolerability of itolizumab as a first-line treatment for acute GvHD. Additionally, researchers are looking to understand what itolizumab doses should be used in further clinical trials. Currently, the suggested dose is 0.8 to 1.6 mg/kg. Data from the trial includes:
- Treatment naive patients, or those who have not previously been treated, achieved 64% complete response rates and 71% overall response rates when receiving itolizumab within 3 days of their first steroid treatment.
- Considering the entire group of patients, the complete response rate (after 29 days) was 55%, with an overall response rate of 70%. Typically, responses occurred within the first 2 weeks (approximately 15 days) and were further sustained.
- Overall survival rate after 6 months was 67%.
- During the trial, many patients were able to reduce the amount of steroids taken.
- Although four patients died during the course of the trial, it was determined that itolizumab treatment did not play a role in these deaths.
- While 60% of patients reported serious side effects, only around 10% were actually related to treatment.
Graft-versus-Host Disease (GvHD)
Graft-versus-host disease (GvHD) is considered a complication stemming from allogeneic bone marrow or stem cell transplants. Allogeneic means it is sourced from a donor and not from one’s own body. Ultimately, GvHD occurs when the transplanted cells begin attacking the recipient’s cells, causing a variety of inflammatory and other health-related issues. Altogether, GvHD can be chronic or acute. In cases of acute GvHD, symptoms usually appear within 6 months following a transplant. Alternately, in chronic GvHD, symptoms appear more than 3 months following a transplant and could last throughout one’s life. Unfortunately, GvHD can be fatal, with a fatality rate of up to 95% in those who do not respond to steroids.
Symptoms of GvHD depend on whether the condition is acute or chronic. For example, patients with Acute GvHD may experience:
- Abdominal pain
- Nausea and vomiting
- Diarrhea
- Jaundice (yellowing of the skin and eyes)
- Skin itching or redness
- Rashes
Alternately, symptoms of chronic GvHD include:
- Rashes
- Dry eyes and/or mouth
- Unintended weight loss
- Joint and muscle pain
- Fatigue
- Changes in vision
- Shortness of breath
