Itolizumab continues to demonstrate a favorable safety and efficacy profile
Fast and durable responses resulted in a clinically significant reduction in the use of corticosteroids
Data support the clinical advance of itolizumab in the first-line treatment of aGVHD
Conference call today at 8:00 am Eastern Time
LA JOLLA, Calif., June 11, 2021 (GLOBE NEWSWIRE) – Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory diseases, today announced positive first-line data of the Phase 1b EQUATE study in first-line acute graft-versus-host disease (aGVHD). The EQUATE study is evaluating itolizumab in patients with severe GVHD concomitant with standard care, which is typically high-dose corticosteroids. There are no approved treatments for this serious, life-threatening disease. The results were presented this morning in an oral presentation at the European Hematology Association’s Virtual Congress 2021 by John Koreth, M.D., associate professor of medicine, Dana Farber Cancer Institute, Harvard Medical School.
All patients in the study (N = 20) were assessed as high risk (grades 3 and 4) aGVHD and had complete response (CR) and overall response rates (ORR) at day 29 of 55% and 70%, respectively. Observed responses were generally quick – within 15 days – and durable – through day 29 and beyond. Six patients received therapy between four and nine days after steroid administration and were generally characterized as steroid refractory. Fourteen patients were characterized as treatment naive – receiving itolizumab within three days of the first steroid administration – and achieved a CR and ORR of 64% and 71%, respectively. In addition, responding patients experienced clinically significant reductions in steroid administration. Across all dosing cohorts, 60% of patients (12/20) reported serious adverse events with only 10% (2/20) of these events reported as related to treatment. There were 4 (20%) adverse events that led to death and none were treatment-related. Overall survival at month six in all dosing cohorts was 67%. Reported adverse events are consistent with a population of hospitalized high-risk GVHD patients.
“Topline’s results from the EQUATE study highlight that itolizumab continues to demonstrate promising safety and efficacy data in the first-line treatment of acute graft-versus-host disease,” said Dolca Thomas, executive vice president of research and development and director Equillium doctor. “The clinical responses obtained were quick and lasting. Complete response rates are particularly attractive, considering that all patients in the study had high-risk GVHD. These data support clinical advancement in pivotal studies in this critically ill patient population, where no drug is approved and the standard of care remains high-dose corticosteroid treatment.”
“Itolizumab has shown highly promising results in the large unmet medical need for first-line aGVHD, as evidenced by early clinical responses associated with a rapid reduction in systemic corticosteroid use,” said Dr. Koreth. “The complete response rates in this study are impressive, which are critical to long-term durability and, ultimately, overall survival for these extremely ill and high-risk patients with GVHD. The 71 percent ORR and 64 percent CR at the Day 29 endpoint, for patients who received less than 4 days of steroid treatment, compare very favorably with historical data and demonstrate the need to advance this clinical program. ”
EQUATE Study Results: Itolizumab Response Rates in First-Line aGVHD
|Final answer point:
|Native Response to Treatment:
≤3 days treatment with steroids
|All subjects, n (%)|
|0.4 mg / kg (N = 4)||2 (50.0)||3 (75.0)||2 (50.0)||2 (50.0)||4||2 (50.0)||2 (50.0)|
|0.8 mg / kg (N = 7)||5 (71.4)||5 (71.4)||5 (71.4)||5 (71.4)||5||4 (80.0)||4 (80.0)|
|1.6 mg / kg (N = 9)||4 (44.4)||7 (77.8)||4 (44.4)||7 (77.8)||5||3 (60.0)||4 (80.0)|
|TOTAL (N = 20)||11 (55.0)||15 (75.0)||11 (55.0)||14 (70.0)||14||9 (64.3)||10 (71.4)|
Equillium has received FDA fast track designation for the treatment of itolizumab in patients with aGVHD and FDA orphan drug designations for the prevention and treatment of aGVHD. Equillium expects to engage with regulatory agencies in mid-2021 to discuss the company’s plans to proceed with a pivotal study on world-class aGVHD.
EQUATE’s main discoveries
- Responses were rapid, typically achieved within 15 days and maintained on day 29 and beyond; in all patients 55% (11/20) achieved CR and 70% (14/20) achieved ORR on Day 29
- In previously untreated patients, 64% (9/14) achieved CR and 71% (10/14) achieved ORR on Day 29
- Responses were durable, with most patients maintaining response off treatment for six months (visit on day 169)
- Patients experienced rapid and robust reduction of steroids; in all cohorts, the mean steroid dose reduction was 67% at day 29 and maintained for six months
- Overall survival in all treatment groups was 67% at six months
- Across all cohorts, 60% of patients (12/20) reported serious adverse events with only 10% (2/20) of these events reported as related to treatment; there were 4 (20%) adverse events that led to death, and none were treatment-related
- Itolizumab was well tolerated and adverse events were consistent with those common in high-risk GVHD
- Optimal observed dose range from 0.8 to 1.6 mg/kg; no further dose increases anticipated
Webcast and conference calling
Management will hold a conference call accompanied by a slide presentation to discuss key EQUATE data for analysts and institutional investors at 8:00 am Brasília time today, June 11, 2021. To access the conference call, dial (866) 930-5156 North America) or (409) 937-8975 (International) and, if necessary, provide confirmation number 4794299. A live webcast of the call will also be available on the company’s Investor Relations page at https://ir.equilliumbio.com/events-and-presentations. The webcast will be archived for 90 days.
About Graft-Versus-Host Disease (GVHD)
GVHD is a multisystem disorder that is a common complication of allogeneic hematopoietic stem cell transplants (allo-HSCT) caused by the transplanted immune system that recognizes and attacks the recipient’s body. Symptoms of GVHD include skin rash, itching, skin discoloration, nausea, vomiting, diarrhea and jaundice, as well as dryness and irritation of the eyes.
GVHD is the leading cause of relapse-free mortality in cancer patients who receive allo-HSCT, and its risk limits the number and types of patients who receive HSCT. GVHD results in high morbidity and mortality, with a five-year survival of approximately 53% in patients who respond to steroid treatment and mortality of up to 95% in patients who do not respond to steroids. There are no approved treatments for first-line aGVHD. Published literature (MacMillan et al., 2015) describes background response rates to high dose steroid administration in critically ill high-risk patients as 43% overall response and 27% complete response.
About the EQUATE Study
The EQUATE study is a Phase 1b/2 study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of itolizumab for first-line treatment in patients with GVHD (NCT 03763318) The Phase 1b portion of the study is an open-label, dose-escalation study in adult patients who have high-risk aGVHD and generally respond poorly to steroids. Phase 1b data will inform the selection of the dose to be used in the next phase of program development.
Itolizumab is a first-in-class, clinical-stage anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a range of immunoinflammatory diseases. Equillium acquired the rights to itolizumab through an exclusive partnership with Biocon Limited.
Equillium is a clinical-stage biotechnology company that leverages a deep understanding of immunobiology to develop new products to treat severe autoimmune and inflammatory diseases with a high unmet medical need. Equillium is developing itolizumab for several serious immunoinflammatory diseases, including acute graft versus host disease (aGVHD), lupus/lupus nephritis and uncontrolled asthma.
For more information visit www.equilliumbio.com.
Forward Looking Statements
Statements in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. As such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These statements include, but are not limited to, statements about the potential benefit of treating aGVHD patients with itolizumab, Equillium plans, and the expected time to develop itolizumab, including expected time to start, complete, and announce additional results of the EQUATE study, the potential for any of Equillium’s ongoing or planned clinical trials to show safety or efficacy, statements about the impact of new leadership team members, Equillium’s anticipated regulatory review and feedback schedule, Equillium’s cash trail and Equillium’s plans and expected timetable for developing itolizumab and potential itolizumab benefits. Risks that contribute to the uncertain nature of forward-looking statements include: uncertainties related to the abilities of new leadership team members to integrate and execute as expected; Equillium’s ability to execute its plans and strategies; risks related to conducting clinical studies; the risk that the interim results of a clinical trial do not necessarily predict the final results and that one or more of the clinical results may materially change as the patient record continues, after more comprehensive data reviews, and as more patient data make available; potential delays in starting, enrolling, and completing clinical trials and reporting clinical trial data; the risk that studies are not completed as planned; Equillium’s product plans and development, including initiating and completing clinical trials and reporting data from them; whether clinical trial results will validate and support the safety and efficacy of itolizumab; changes in the competitive landscape; uncertainties related to Equillium’s capital requirements; and having to use money in ways or at a different time than expected and the impact of market volatility on cash reserves. These and other risks and uncertainties are further described in the caption “Risk Factors” in Equillium’s Annual Report on Form 10-K for the year ended December 31, 2020, and elsewhere in Equillium’s files and reports with SEC. All forward-looking statements contained in this press release speak only as of the date they were made. Equillium assumes no obligation to update such statements to reflect events that occur or circumstances that exist after the date they were made.
Vice President, Investor Relations and Corporate Communications
Wheelhouse Life Science Advisors