UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 6-K

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the Month of June 2021

Commission File Number: 001-37452

 

 

CELYAD ONCOLOGY SA

(Translation of registrant’s name into English)

 

 

Rue Edouard Belin 2

1435 Mont-Saint-Guibert, Belgium

(Address of principal executive offices)

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F  ☒             Form 40-F  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  ☐

 

 

 


Celyad Oncology SA

On June 11, 2021, Celyad Oncology SA (the “Company”) issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated by reference herein.

The Company will be presenting a poster presentation at the European Hematology Association Virtual Congress 2021 on June 11, 2021. Following the release of the poster presentation, the Company will deliver the slide presentation furnished to this report as Exhibit 99.2 and which is incorporated herein by reference.

The information contained in this Current Report on Form 6-K, including Exhibit 99.1 and 99.2, except for the quotes of Filippo Petti and Sébastien Anguille contained in Exhibit 99.1, is hereby incorporated by reference into the Company’s Registration Statements on Form F-3 (File No. 333-248464) and Form S-8 (File No. 333-220737).


EXHIBITS

 

Exhibit

  

Description

99.1    Press release issued by the Company on June 11, 2021
99.2    Presentation furnished by Celyad Oncology SA


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, thereunto duly authorized.

 

    CELYAD ONCOLOGY SA
Date: June 11, 2021     By:  

/s/ Filippo Petti

     

Filippo Petti

Chief Executive Officer and Financial Officer

Exhibit 99.1

 

LOGO

Celyad Oncology Presents Preliminary Data from Phase 1 IMMUNICY-1 Trial of shRNA-based Allogeneic CAR T Candidate CYAD-211 in Relapsed/Refractory Multiple Myeloma at the European Hematology Association Virtual Congress

 

   

Treatment with CYAD-211 generally well-tolerated at first two dose levels, with no evidence of Graft-versus-Host Disease observed

 

   

Two partial responses observed among five evaluable patients

 

   

Cell engraftment of CYAD-211 observed in all patients from dose level 2, with evidence of CAR T cells in all patients enrolled in first two dose cohorts

 

   

Additional clinical data from the dose escalation trial are expected during second half 2021

 

   

Management to host conference call later today, June 11, at 2 p.m. CET / 8 a.m. ET

June 11th, 2021 – 08:59 a.m. CET

Mont-Saint-Guibert, Belgium – Celyad Oncology SA (Euronext & Nasdaq: CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, today announced preliminary data from the Phase 1 IMMUNICY-1 trial of CYAD-211 for the treatment of relapsed/refractory multiple myeloma (r/r MM) patients were presented at the European Hematology Association (EHA) 2021 Virtual Congress.

Filippo Petti, Chief Executive Officer of Celyad Oncology, commented, “We believe the initial data presented today are meaningful beyond the demonstrated clinical activity of CYAD-211. This is the first clinical trial evaluating the potential of shRNA as an allogeneic technology to underpin off-the-shelf CAR T candidates for the treatment of cancer, and today’s data continue to demonstrate the potential value of non-gene edited technology to generate allogeneic CAR T cells. We are extremely encouraged by the cell kinetic, clinical activity and tolerability data for CYAD-211. As we work to establish shRNA as a platform for developing allogeneic CAR T therapies, these early data from the IMMUNICY-1 trial are key. In addition, we believe our future ability to employ multiple shRNAs in our CAR T candidates while leveraging our streamlined All-in-One Vector approach could be fundamental to the allogeneic CAR T landscape.”

Dr. Sébastien Anguille, IMMUNICY-1 trial investigator and professor in the Division of Hematology of the Antwerp University Hospital said, “Even with great strides made in recent years, multiple myeloma remains largely incurable, creating a need for new therapeutic options. Unfortunately, most patients eventually relapse and we observe shorter duration and depth of responses to treatments over time. We are pleased with the encouraging initial data from the IMMUNICY-1 trial and we’re eager to move forward with higher doses and continue to evaluate CYAD-211 in treating myeloma patients.”

CYAD-211 and IMMUNICY-1 Phase 1 Trial Update

Background:

 

   

CYAD-211 is an allogeneic CAR T candidate engineered to co-express a BCMA targeting chimeric antigen receptor and a single short hairpin RNA (shRNA), which interferes with the expression of the CD3V component of the T cell receptor complex.

 

   

IMMUNICY-1 is a first-in-human, open-label, dose-escalation Phase 1 trial to determine the recommended dose of CYAD-211 in patients with r/r MM following preconditioning with cyclophosphamide (300 mg/m²) and fludarabine (30 mg/m²) given three consecutive days.

 

   

The trial is designed to evaluate proof-of-concept that shRNA-mediated knockdown of the CD3V can generate allogeneic CAR T cells.

Safety and tolerability data:

Of the six patients dosed at the first two dose levels (30×106 and 100×106 cells per infusion):

 

   

No dose limiting toxicity (DLT), Graft-versus Host disease (GvHD) or CAR T-cell-related encephalopathy syndrome (CRES) were observed in the first two dose cohorts.

 

   

One cytokine release syndrome (CRS) Grade 1 (fever) requiring hospitalization occurred 10 days post CYAD-211 administration in patient 1 (dose level 1) who achieved a partial response (PR).

 

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Celyad Oncology SA | Rue Édouard Belin 2, 1435 Mont-Saint-Guibert, Belgium | +32 10 39 41 00


   

One patient experienced an anemia adverse event (Grade 3) and neutropenia (Grade 4) possibly related to CYAD-211.

Clinical activity:

Of the five evaluable patients at the first two dose levels (30×106 and 100×106 cells per infusion):

 

   

Two patients achieved a PR. Both patients were ‘triple-therapy exposed’ (previously treated with an immunomodulator (IMiD), a proteasome inhibitor and an anti-CD38 antibody).

 

   

The three additional patients had stable disease (SD).

Cell kinetics:

 

   

CYAD-211 cells were detected by PCR-based methods in all six patients from dose cohorts 1 and 2.

 

   

Cell engraftment was seen in all three patients at dose level 2 at a similar magnitude. In addition, preliminary data suggest that all patients in dose level 2 showed deep lymphodepletion. Across dose level 1, the depth of lymphodepletion appears to correlate with the degree of observed systemic CAR T engraftment.

Next steps:

 

   

Enrollment in dose cohort 3 (300×106 cells per infusion) is ongoing.

 

   

Additional clinical data from the dose escalation trial are expected during second half 2021.

 

   

shRNA technology platform to be highlighted at upcoming virtual R&D Day in Q3 2021.

Conference Call and Webcast Details

Celyad Oncology will host a conference call to discuss the update from EHA on Friday, June 11, 2021 at 2 p.m. CET / 8 a.m. ET. The conference call can be accessed through the following numbers:

United States: #1 877-407-9208

International: #1 201-493-6784

The conference call will be webcast live and can be accessed here. The event will also be archived and available on the “Events ” section of the company’s website. Please visit the website several minutes prior to the start of the broadcast to ensure adequate time for registration to the webcast.

About CYAD-211

CYAD-211 is an investigational, shRNA-based allogeneic CAR T candidate for the treatment of r/r MM. CYAD-211 is engineered to co-express an anti-BCMA targeting chimeric antigen receptor and a single shRNA to knockdown the CD3V component of the T cell receptor complex.

About IMMUNICY-1 Phase 1 trial

The open-label, dose-escalation trial will evaluate the safety and clinical activity of CYAD-211 following cyclophosphamide and fludarabine preconditioning chemotherapy in patients with relapsed or refractory multiple myeloma. The trial will evaluate multiple dose levels of CYAD-211: 30×106, 100×106 and 300×106 cells per infusion. For more information, please visit www.clinicaltrials.gov, study identifier number NCT04613557.

About Celyad Oncology

Celyad Oncology is a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer. The Company is developing a pipeline of allogeneic (off-the-shelf) and autologous (personalized) CAR T cell therapy candidates for the treatment of both hematological malignancies and solid tumors. Celyad Oncology was founded in 2007 and is based in Mont-Saint-Guibert, Belgium and New York, NY. The Company has received funding from the Walloon Region (Belgium) to support the advancement of its CAR T cell therapy programs. For more information, please visit www.celyad.com.

Forward-looking statements

This release may contain forward-looking statements, within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the clinical activity and safety and tolerability of CYAD-211 and expectations regarding enrollment and the announcement of additional clinical data. Forward-looking statements may involve known and unknown risks and uncertainties which might cause actual results, financial condition,


performance or achievements of Celyad Oncology to differ materially from those expressed or implied by such forward-looking statements. Such risk and uncertainty include the duration and severity of the COVID-19 pandemic and government measures implemented in response thereto. A further list and description of these risks, uncertainties and other risks can be found in Celyad Oncology’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in its Annual Report on Form 20-F filed with the SEC on March 24, 2021 and subsequent filings and reports by Celyad Oncology. These forward-looking statements speak only as of the date of publication of this document and Celyad Oncology’s actual results may differ materially from those expressed or implied by these forward-looking statements. Celyad Oncology expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless required by law or regulation.

Investor and Media Contacts:

Sara Zelkovic

Communications & Investor Relations Director

Celyad Oncology

investors@celyad.com

Daniel Ferry

Managing Director

LifeSci Advisors, LLC

daniel@lifesciadvisors.com

 

LOGO

Source: Celyad Oncology SA

SLIDE 0

European Hematology Association Virtual Congress 2021 Redefining Allogeneic CAR Ts Using a Non-Gene Edited Approach June 11, 2021 Exhibit 99.2


SLIDE 1

Forward Looking Statements


SLIDE 2

EHA 2021 Virtual Webcast – Agenda Topic Discussant Welcome & Introductions Filippo Petti Chief Executive Officer shRNA and CYAD-211 Overview David Gilham, Ph.D. Chief Scientific Officer IMMUNICY-1 Phase 1 Trial – Preliminary Data Sébastien Anguille, M.D. University of Antwerp Final Remarks Charles Morris, M.D. Chief Medical Officer Q&A All


SLIDE 3

David Gilham, Ph.D. Chief Scientific Officer shRNA and CYAD-211 Overview


SLIDE 4

shRNA – Non-gene Editing Technology to Engineer Allogeneic CAR Ts Short hairpin RNA (shRNA) interferes with the expression of the T Cell Receptor (TCR) through targeting of the CD3ζ subunit


SLIDE 5

CYAD-211 – shRNA-based Allogeneic CAR T Candidate for r/r MM Background on CYAD-211 CYAD-211 is our first allogeneic CAR T candidate using shRNA technology utilizing our All-in-One vector approach CYAD-211 co-expresses: CAR – BCMA specific engager Allogeneic technology – single shRNA targeting CD3ζ component of TCR complex Selection marker – truncated cell surface CD34 tag allows for positive cell enrichment during manufacturing BCMA: B-cell maturation antigen; r/r MM: relapsed/refractory multiple myeloma.


SLIDE 6

Anti-BCMA CAR T cells with shRNA targeting CD3ζ component exhibited no signs of TCR activation with anti-tumor activity in preclinical models No demonstrable evidence of GvHD when CYAD-211 was infused in sub-lethally irradiated NSG mice, the gold standard preclinical model of GvHD, confirming efficient inhibition of alloreactivity BCMA: B-cell maturation antigen; GvHD: Graft-versus-Host Disease; shRNA: short hairpin RNA. TCR Knock Down Anti-Tumor Activity CYAD-211 – Anti-Tumor Activity With No Evidence of GvHD Graft-versus-Host Disease Control CYAD-211 TCRα/β


SLIDE 7

shRNA Knocks Down TCR Expression to Undetectable Levels CYAD-211 cell bank generated through a single production run using a proportion of a single healthy donor apheresis Efficient knock down of cell surface TCR expression to undetectable levels was confirmed in the final CAR T-cell product candidate TCR Expression 0.048% TCR+ TCRab staining 99.9% TCR- Clinical-grade CYAD-211 TCR: T cell receptor.


SLIDE 8

shRNA as a Novel Allogeneic Technology for CAR T No evidence of GvHD Initial clinical activity Cell engraftment Keys to establishing proof-of-concept GvHD: Graft-versus-Host Disease.


SLIDE 9

Sébastien Anguille, M.D. University of Antwerp IMMUNICY-1 Phase 1 Trial – Preliminary Data


SLIDE 10

CYAD-211 – IMMUNICY-1 First-in-Human Trial Open-label, Phase 1 dose-escalation trial in r/r multiple myeloma patients Study Design Treatment Schedule Primary objective: Safety and identification of recommended dose of CYAD-211 Secondary objective: Clinical anti-tumor activity and CYAD-211 cell expansion, persistence and trafficking Dose Escalation: 30x106, 100x106 and 300x106 per infusion Preconditioning chemotherapy: Cyclophosphamide: 300 mg/m2 x 3 days Fludarabine: 30 mg/m2 x 3 days NCT04613557: Safety, Activity and Cell Kinetics of CYAD-211 in Patients With Relapsed or Refractory Multiple Myeloma (IMMUNICY-1). International Myeloma Working Group (IMWG); MM: Multiple myeloma; r/r: Relapsed / refractory. Eligibility Criteria At least two prior MM treatment regimens At least 1 complete cycle of treatment At least 1 response to a prior treatment regimen Measurable disease as per the IMWG Response Criteria


SLIDE 11

IMMUNICY-1 – Patient Demographics and Clinical Characteristics Six patients enrolled across first two dose levels Three of six patients showed high-risk cytogenetics according to mSMART Four of six patients were refractory to last line of therapy Heavily pre-treated patients: Median prior lines of therapy: four Five of six patients exposed to all three major MM drug classes: Immunomodulatory drugs (IMiDs), proteasome inhibitors and CD38-directed therapies Mayo Stratification of Myeloma and Risk-Adapted Therapy (mSMART). Patient Background


SLIDE 12

CYAD-211 – Preliminary Data Show Favorable Tolerability Profile No DLTs, no GvHD and no CAR‑T‑cell‑related encephalopathy syndrome (CRES) One cytokine release syndrome (CRS) Grade 1 (fever) reported at dose level 1 CRS onset was at the time of the first PR onset in patient #01 One patient experienced an anemia adverse event (Grade 3) and neutropenia (Grade 4) possibly related to CYAD-211 1. As per CAR-T-cell-therapy-associated TOXicity (CARTOX) Working Group criteria from Neelapu (2018) Nat Rev Clin Oncol. 15(1):47-62. 2. Including bacterial, viral and fungal infections. AE: Adverse event; GvHD: Graft versus Host Disease; PR: Partial response. Data from uncleaned database (May 24, 2021). AE of interest Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 All Grades AE related to CYAD-211 5 (83%) 2 (33%) 1 (17%) 1 (17%) - 5 (83%) CRS 1 1 (17%) - - - - 1 (17%) CRES 1 - - - - - - GvHD - - - - - - Infection 2 1 (17%) 1 (17%) - - - 2 (33%) Infusion reaction to CYAD-211 - - - - - -


SLIDE 13

CYAD-211 – Encouraging Initial Clinical Activity in Allogeneic Setting Two patients achieved partial response (PR) Three additional patients presented with stable disease (SD) Patient bar stopped at the first documented progression of the disease or * when the patient discontinued follow-up on study prior to disease progression. Data from uncleaned database (May 24, 2021). PD: Progressive disease; MR: Marginal response Duration of Best Response to Treatment


SLIDE 14

CYAD-211 – Positive Cell Kinetic Data Engraftment was seen in all three patients at dose level 2 at a similar magnitude Duration and depth of lymphodepletion was variable and may explain differences in engraftment for dose level 1 Patient #03 showed a surprisingly high level of engraftment compared to other dose level 1 patients CYAD-211 cell levels detected by PCR-based methods in all patients Peripheral Blood Lymphocyte Count CYAD-211 Cell Engraftment


SLIDE 15

IMMUNICY-1 Preliminary Results – Summary Favorable tolerability profile for CYAD-211 was observed at the first two dose-levels (30x106 and 100x106) across six patients enrolled Two objective responses in conjunction with the current levels of cell engraftment of CYAD-211 are encouraging at these initial dose levels Observed levels of systemic engraftment of CYAD-211 cells with no evidence of GvHD at low cell doses following standard preconditioning are encouraging


SLIDE 16

Charles Morris, M.D. Chief Medical Officer Final Remarks


SLIDE 17

Advantages of Non-gene Edited Allogeneic CAR Ts using shRNA Less potential tolerability issues due to no genome modification Level of gene knockdown can be titrated Ability to knockdown multiple targets simultaneously All-in-One vector approach (single vector for all elements) Minimized cell manipulation Shorter manufacturing process Not all allogeneic CAR Ts are created equal


SLIDE 18

CYAD-211 – Closer Look at Cell Engraftment from IMMUNICY-1 Even with relatively modest doses of lymphodepleting chemotherapy, there is evidence of a dose dependent increase in cell engraftment Engraftment of shRNA-based allogeneic CAR Ts could offer potential key differentiation to cells developed using alternative technologies Systemic Cell Engraftment of CYAD-211 CyFlu: Cyclophosphamide (300 mg/m2 x 3 days) and fludarabine (30 mg/m2 x 3 days)).


SLIDE 19

shRNA as a Novel Allogeneic Technology for CAR T No evidence of GvHD Initial clinical activity Cell engraftment Keys to establishing proof-of-concept after dose level 1 and 2 ü ü ü GvHD: Graft-versus-Host Disease.


SLIDE 20

Next Steps for CYAD-211 IMMUNICY-1 Trial Enrollment in dose level 3 (300x106 cells per infusion) ongoing Additional data from the dose escalation trial are expected during second half 2021


SLIDE 21

CYAD-211 IMMUNICY-1 Trial – Key Takeaways Safety data, clinical activity and cell kinetic data from IMMUNICY-1 support further development of CYAD-211 Preliminary data support shRNA as a novel allogeneic platform technology to develop future product candidates Additional next-generation shRNA-based preclinical allogeneic CAR T candidates currently under development shRNA potentially provides many benefits over gene editing technologies for the development of allogeneic CAR T candidates


SLIDE 22

European Hematology Association Virtual Congress 2021 Redefining Allogeneic CAR Ts Using a Non-Gene Edited Approach June 11, 2021