eq-8k_20210212.htm

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549  

 

FORM 8-K  

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

February 12, 2021

Date of Report (Date of earliest event reported) 

 

Equillium, Inc.

(Exact name of registrant as specified in its charter)  

 

Delaware

 

001-38692

 

82-1554746

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

 

2223 Avenida de la Playa, Suite 105

La Jolla, CA

 

92037

(Address of principal executive offices)

 

(Zip Code)

Registrant’s telephone number, including area code: (858) 412-5302  

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) 

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class

Trading Symbol

Name of Each Exchange on Which Registered

Common Stock, par value $0.0001 per share

EQ

The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b2 of the Securities Exchange Act of 1934 (§ 240.12b2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 


 

Item 7.01

Regulation FD Disclosure.

 

On February 12, 2021, Equillium, Inc. (the “Company”) is providing a presentation at the 2021 TCT Meetings Digital Experience (the “TCT Meetings”). The presentation, which is filed as Exhibit 99.1 to this Current Report on Form 8-K, includes information the Company expects to disclose, and which the Company intends to place on its website, which may contain nonpublic information. The presentation is incorporated herein by reference.  

 

On February 12, 2021, the Company issued a press release announcing that it presented interim data from the EQUATE clinical trial at the TCT Meetings. A copy of the Press Release is furnished hereto as Exhibit 99.2 and is incorporated by reference herein.

 

The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the United States Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the United States Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.    

 

Item 9.01

Financial Statements and Exhibits.

 

Exhibit

Number

  

Description

 

 

99.1

  

Presentation by the Company at the 2021 TCT Meetings Digital Experience

 

 

99.2

  

Press release, dated February 12, 2021, issued by Equillium, Inc.

 

 


 

SIGNATURES 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

 

Equillium, Inc.

 

 

 

 

Dated: February 12, 2021

 

 

 

By:

 

/s/ Bruce D. Steel

 

 

 

 

Bruce D. Steel

 

 

 

 

President and Chief Executive Officer

 

 

Slide 1

Exhibit 99.1 John Koreth, Alison W. Loren, Ryotaro Nakamura, Marco Mielcarek, Trent Wang, George L. Chen, Sarah Anand, Joseph A. Pidala, Edmund K. Waller, Gabrielle Meyers, Daanish Hoda, Mark Schroeder, Jeremy Pantin, Nosha Farhadfar, Cherie Ng, Lisette M. Acevedo, Maple Fung, Joel Rothman, Stephen Connelly, Krishna R. Polu, Corey Cutler Interim results from the EQUATE Study: Preliminary safety and efficacy of itolizumab, a novel targeted anti-CD6 therapy, in newly diagnosed severe acute graft-versus-host disease

Slide 2

Research Support: BMS, Miltenyi, Clinigen, Amgen, Regeneron Advisory Board: Therakos, Cugene, Regeneron Consulting: EMD Serono/Merck, Biolojic Design, Gentibio, Moderna Therapeutics, Equillium, Inc Investigational use of Itolizumab (EQ001) for aGVHD Disclosures 2

Slide 3

CD6 is a co-stimulatory receptor expressed on CD4 and CD8 effector T cells (Teff) Multiple CD6 ligands, including activated leukocyte cell adhesion molecule (ALCAM), expressed on both APCs and tissues, including the skin and GI tract CD6 and ALCAM both overexpressed during GI inflammation CD6-ALCAM pathway modulates both T cell activity and trafficking Prior studies performed at DFCI validated CD6 as a target relevant to GVHD pathogenesis CD6-ALCAM Pathway Central to Immune Inflammation Consuegra-Fernandez et al., Cell Mol Immunol 2018; Ma et al., J Crohns & Colitis 2019; Soiffer et al., JCO 1992 3 CD6high High proliferation Pathogenic phenotypes Pro-inflammatory cytokines CD6low/- Low proliferation Regulatory phenotype Anti-inflammatory cytokines

Slide 4

Itolizumab Causes Antigenic Modulation of Cell Surface CD6 Levels of CD6 on itolizumab treated cells normalized to isotype treated cells IgG binds to domain-1 of CD6 causing shedding Dose-dependent CD6 loss results in hyporesponsive T cells CD6 pharmacodynamic marker can be monitored in patients Clinically relevant Itolizumab dose range ~ 1-10µg/mL Pathogenic Teff Cells Non-pathogenic Teff Cells Antigenic Modulation (shedding) 4

Slide 5

≥ 18 years of age Recipients of first allogeneic HSCT Grade III-IV aGVHD by MAGIC criteria Initial dose of systemic corticosteroid ≤ 72 hours Safety and tolerability of intravenous (IV) dosing of itolizumab Determine itolizumab RP2D EQUATE Part A Phase 1b Study Design Screening Treatment Period Safety Follow-Up Long-term Follow-Up Day 1 Day 15 Day 29 Day 43 Day 57 Day 169 Day 337 Open label, 3+3 dose escalation design 5 doses Q2W Eligibility Criteria Currently enrolling additional subjects in Part A, Cohorts 2 & 3 Dosing day Primary Objectives Data presented is from an interim analysis of subjects who completed visits through at least Day 85 Part B will be a Ph2 randomized, placebo-controlled study design 5 Day 85

Slide 6

Baseline Demographics and Disease Characteristics Abbreviations: ALL, acute lymphoblastic leukemia; AML, acute myeloid leukemia; HLA, human leukocyte antigen; M, male; SD, standard deviation Data presented is from an interim analysis of subjects who completed visits through at least Day 85 6

Slide 7

GVHD Characteristics Ann Arbor Score: 1, MAP <0.141; 2, MAP 0.141-0.290; 3, MAP >0.290 Abbreviations: GVHD, graft versus host disease; LGI; lower gastrointestinal; MAP; MAGIC algorithm probability; UGI, upper gastrointestinal. 1Highest clinical grade at screening or baseline Data presented is from an interim analysis of subjects who completed visits through at least Day 85 7

Slide 8

Summary of Treatment Emergent Adverse Events 8 AEs were collected through Day 169 for subjects who completed dosing and Day 85 for subjects who discontinued study treatment early; treatment related is defined as possibly related, probably related, and related DLT is defined as ≥Grade 3 infusion reaction or clinical finding associated with hypersensitivity or any ≥Grade 3 AE that is not related to underlying disease that is at least possibly related to study treatment as per the investigator Data presented is from an interim analysis of subjects who completed visits through at least Day 85 Abbreviations: AE, adverse event; DLT, dose limiting toxicity; SAE, serious adverse event; SOC, system organ class

Slide 9

Transient decrease in lymphocytes (predominantly in CD6 expressing cells) in the first week Not associated with infection or clinical sequelae Absolute Lymphocyte Change from Baseline Data presented is from an interim analysis of subjects who completed visits through at least Day 85. Data presented as mean (SD)  9

Slide 10

Efficacy: Response over time 10 Abbreviations: CR, complete response; ORR, overall response rate= CR+ VGPR + PR; NR, no response; PR, partial response; VGPR, very good partial response defined as achieving all the criteria for skin, liver, and gut involvement per Martin 2009 Consensus criteria without meeting the criteria for CR Data presented is from an interim analysis of subjects who completed visits through at least Day 85 One subject in Cohort 1 received 1 dose of study treatment; all others received between 2-5 doses ORR 75% 100% 100% 50% 100% 100% 50% 100% 100% 50% 100% 67% Post-treatment Treatment Period

Slide 11

Itolizumab Associated with Dose Reduction in Systemic Steroid Use 11 Data presented is from an interim analysis of subjects who completed visits through at least Day 85 Data presented as mean (SD); equivalent prednisone dose was calculated for methylprednisolone and dexamethasone to determine total systemic corticosteroid use at each visit Median % steroid dose reduction at Day 85 was 93%, 87%, and 91% for Cohorts 1, 2, and 3, respectively

Slide 12

Dose Responsive Reduction of CD6 with Itolizumab Treatment Interim pharmacodynamic data from first three cohorts suggests optimal dose range at 0.8 to 1.6 mg/kg 12 Data from 9 subjects, 3 per cohort. One subject in Cohort 1 was not included due to receiving only a single dose of study drug * adjusted p<0.05;  ** adjusted p<0.01 Data presented is from an interim analysis of subjects who completed visits through at least Day 85

Slide 13

The CD6-ALCAM pathway modulates activity and trafficking of Teff cells CD6high Teff cells are known to be more pathogenic, showing increased proliferation and cytokine secretion Treatment with itolizumab leads to antigenic modulation of CD6 and inhibition of Teff cell responses Itolizumab was generally well tolerated across all doses in high risk aGVHD patients Lymphocyte count changes are monitored carefully and have been manageable Only one acute infusion reaction was noted early in the study (Cohort 1, first subject dosed) Direct drug toxicities have not been noted; though relationship to infection in this vulnerable population will need continued assessment Key findings for itolizumab Dose-dependent reduction of CD6 expression on CD4+ and CD8+ T-cells is consistent with proposed MoA Strong response for higher dose level cohorts (0.8 and 1.6 mg/kg) with ORR of 100% (N=6) at Day 29, most have been complete responses (one VGPR) Clinical responses have been sustained through Day 57 – all subjects in CR Reduction in baseline corticosteroid use at Day 29 was ~40 - 80% Summary and Conclusions 13 Itolizumab demonstrates a favorable benefit-risk profile that supports further characterization of safety and efficacy in future studies

Slide 14

Thank you to our patients, sites, and advisors! Leslie Kean, MD, PhD Jerome Ritz, MD Robert Soiffer, MD Jamie Ferrara, MD EQUATE DSMC Committee 14 For more information: clinicaltrials@equilliumbio.com

eq-ex992_9.htm

 

 

EXHIBIT 99.2

 

Equillium Presents Positive Interim Clinical Data of Itolizumab in First-line
Treatment of Acute Graft-Versus-Host Disease at the 2021
Transplantation and Cellular Therapy Meetings Digital Experience

Higher dose cohorts demonstrated 100% overall response rate, resulting in substantial
reduction in baseline corticosteroid use

Dose-dependent reduction of CD6 expression on CD4+ and CD8+ T cells is consistent with itolizumab mechanism of action

 

LA JOLLA, California, February 12, 2021 - Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, presented interim data from the EQUATE clinical trial supporting itolizumab’s potential as a first-line treatment for acute graft-versus-host disease (aGVHD). The study, described in the late-breaking oral presentation titled “Preliminary Safety and Efficacy of Itolizumab, A Novel Targeted Anti-CD6 Therapy, in Newly Diagnosed Severe Acute Graft-Versus-Host Disease: Interim Results from Equate Study,” was presented earlier today by John Koreth, MBBS, DPhil, Associate Professor of Medicine, Harvard Medical School, Director of Translational Research – Stem Cell Transplantation, Dana-Farber Cancer Institute, at the 2021 TCT Meetings Digital Experience.

 

“Itolizumab’s favorable safety and tolerability profile, combined with preliminary efficacy results and the ability to reduce corticosteroid use, bodes very well for treating aGVHD patients in the first-line setting,” said Dr. Koreth. “There is a critical need for new treatments for aGVHD, and this study supports further evaluation of itolizumab as a novel immunomodulatory treatment for this life-threatening condition.”

 

Key Highlights, Summary and Conclusions from Oral Presentation:

 

The CD6-ALCAM pathway modulates both the activity and trafficking of pathogenic CD6high T effector cells, which play an important role in the immuno-inflammatory cascade

 

Itolizumab causes antigenic modulation of CD6, yielding hyporesponsive T cells

 

Itolizumab was generally well tolerated across all doses in high-risk aGVHD patients

 

Key findings for itolizumab:

 

o

Dose-dependent reduction of CD6 expression on CD4+ and CD8+ T cells is consistent with proposed mechanism of action

 

o

Strong response for higher dose level cohorts (0.8 and 1.6 mg/kg) with overall response rate (ORR) of 100% (N=6) at Day 29; 5 patients demonstrated complete responses (CR) and one patient, a very good partial response (VGPR)

 

o

Clinical responses have been sustained through Day 57

 

o

Reduction in baseline corticosteroid use at Day 29 was ~40 - 80%

 

o

Dose-dependent reduction in the pharmacodynamic marker of CD6 expression on effector T cells was observed as early as 24 hours after treatment

 

“The data highlighted in the presentation underscore itolizumab’s potential as a first-line treatment in patients with acute GVHD, as well as a reduction in steroid use by as much as eighty percent in the first

 


 

 

four weeks.  Building on favorable safety data and durable response rates demonstrated so far, we look forward to the topline data results of the EQUATE study towards the middle of the year,” said Stephen Connelly, Ph.D., chief scientific officer of Equillium.

 

Full text of the abstract can be found on the conference website and the presentation is available on the Publications page, under the Our Science section of Equillium’s website.

 

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 recognizing and attacking the recipient’s body. Symptoms of GVHD include rash, itching, skin discoloration, nausea, vomiting, diarrhea, and jaundice, as well as eye dryness and irritation.

 

GVHD is the leading cause of non-relapse mortality in cancer patients receiving allo-HSCT, and the risk of GVHD limits the number and type of patients receiving HSCT. GVHD results in very high morbidity and mortality, with five-year survival of approximately 53% in patients who respond to steroid treatment and mortality as high as 95% in patients who do not respond to steroids. In the first-line aGVHD setting, published literature (MacMillan et al., 2015) describes background response rates to high-dose steroid administration in less severe standard risk patients as 69% overall response rate (ORR) and 48% CR, whereas in more severe high-risk patients response rates observed were 43% ORR and 27% CR.    

 

About the EQUATE Study

The EQUATE study is a Phase 1b/2 trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of itolizumab for first-line treatment in patients who present with aGVHD (NCT 03763318). The Phase 1b part of the trial is an open-label dose escalation study in adult patients who present with high-risk aGVHD and typically respond poorly to steroids. The Phase 1b data will inform selection of the dose to be used in the next phase of development for the program.

 

About Itolizumab

Itolizumab is a clinical-stage, first-in-class 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 number of immuno-inflammatory diseases. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.

 

About Equillium

Equillium is a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop novel products to treat severe autoimmune and inflammatory disorders with high unmet medical need. Equillium is developing itolizumab for multiple severe immuno-inflammatory 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 contained 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. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to statements regarding the potential benefit of treating patients with aGVHD with itolizumab, the ability of Equillium to transition to later-stage development, the expected timing of further results from the EQUATE study, Equillium’s plans and expected timing for developing itolizumab and potential benefits of itolizumab. Risks that contribute to the uncertain nature of the forward-looking statements include: Equillium’s ability to execute its plans and strategies; risks related to performing clinical trials; the risk that interim results of a clinical trial do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; potential delays in the commencement, enrollment and completion of clinical trials and the reporting of data therefrom; the risk that studies will not be completed as planned; Equillium’s plans and product development, including the initiation and completion of clinical trials and the reporting of data therefrom; whether the results from clinical trials will validate and support the safety and efficacy of itolizumab; and changes in the competitive landscape. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and elsewhere in Equillium's filings and reports with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Equillium undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

 

Investor Contact

Michael Moore

Vice President, Investor Relations & Corporate Communications

+1-619-302-4431

ir@equilliumbio.com

 

Media Contact

Katherine Carlyle Smith

Senior Account Associate

Canale Communications

+1-805-907-2497

katherine.smith@canalecomm.com