Mont-Saint-Guibert, Belgium - Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, today announced an update on its operational developments for the third quarter ended September 30, 2019.

Filippo Petti, CEO of Celyad stated, “We have reported a steady stream of encouraging news from our pipeline throughout the third quarter and subsequent weeks, including preliminary Phase 1 data for our first-in-class, non-gene edited allogeneic CYAD-101 CAR-T product candidate, the introduction of our proprietary OptimAb manufacturing process to our autologous relapsed/refractory acute myeloid leukemia program led by CYAD-01, and CYAD-02, the acceptance of the IND application for our next-generation candidate CYAD-02, and the advancement of our shRNA technology platform related to our CYAD-200 series of allogeneic product candidates. We continue to establish our position as innovative leaders in the industry as we focus on our core mission of developing innovative CAR-T therapies for cancer patients.”

“In addition, with the closing of our global equity offering in September, we believe the company has sufficient capital resources to enable it to complete its next major clinical milestones, including the upcoming data releases from the CYAD-01 program in relapsed/refractory acute myeloid leukemia,”  continued Filippo Petti.

Third Quarter 2019 and Recent Business Highlights

  • Successfully dosed the first relapsed/refractory (r/r) acute myeloid leukemia (AML) patient in the DEPLETHINK Phase 1 trial with CYAD-01 produced with OptimAb manufacturing process.
  • Presented preliminary data from the ongoing dose-escalation Phase 1 alloSHRINK trial evaluating CYAD-101 at the Society for Immunotherapy of Cancer (SITC) 34th Annual meeting.
    • Results from the trial demonstrated a favorable tolerability profile for CYAD-101, with encouraging anti-tumor activity in the refectory metastatic colorectal cancer (mCRC).  Two patients experienced a confirmed partial response, and five patients experienced stable disease for a period of three months or more. In addition, there was no clinical or laboratory evidence of graft-versus-host disease (GvHD).
    • Completed enrollment in the dose-escalation segment of the alloSHRINK trial with additional results from the trial anticipated during first half 2020.
  • Continued advancement of proprietary non-gene edited allogeneic short hairpin RNA (shRNA) platform related to the CYAD-200 series of shRNA-based allogeneic CAR-T candidates.
  • Closed global equity offering with gross proceeds of $20.0 million (approximately €18.2 million) in September 2019.

Third Quarter 2019 Financial Review

As of September 30, 2019, the Company ended the quarter with a treasury position of €44.6 million ($48.8 million), which includes net proceeds of €17.0 million from the global equity offering in September 2019. Net cash burn over the third quarter of 2019 amounted to €6.1 million, in line with expectations. The Company confirms its previous guidance that its treasury position should be sufficient, based on the current scope of activities, to fund operating expenses and capital expenditure requirements into first half 2021.

Pipeline Updates

CYAD-01 – Autologous NKG2D-based CAR-T

CYAD-01 continues to advance the Phase 1 THINK and DEPLETHINK clinical trials for the treatment of patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). In September, the Company successfully administered CYAD-01 produced with the OptimAb manufacturing process to a patient enrolled in cohort 3 (300 million cells) of the Phase 1 DEPLETHINK trial. The proprietary OptimAb manufacturing process utilizes a shortened cell culture and incorporates a selective PI3K inhibitor. This results in a product that is enriched for T cells with a memory-like phenotype. Preclinical data demonstrate that CYAD-01 produced using the OptimAb manufacturing process drives improved anti-tumor activity in an aggressive AML model compared to CYAD-01 produced with the mAb manufacturing process.

The Company is scheduled to present the latest clinical results from the Phase 1 THINK and DEPLETHINK trials, which utilized CYAD-01 produced with the previous mAb manufacturing process, as well as provide updates on the development program for r/r AML and MDS and proprietary OptimAb manufacturing process at the 61st American Society of Hematology (ASH) Annual Meeting being held on December 7-10 in Orlando, Florida.

CYAD-02 – Autologous NKG2D-based CAR-T

In June, the U.S. Food & Drug Administration accepted the Investigational New Drug (IND) application for CYAD-02, a next-generation, autologous NKG2D-based CAR-T candidate. CYAD‑02 incorporates short hairpin RNA (shRNA) technology to target the NKG2D ligands MICA and MICB. The single shRNA modulates the expression of both ligands, which translates to encouraging increases in vivo engraftment and anti-tumor activity in preclinical studies.

The Company is scheduled to present preclinical data for CYAD-02 at the upcoming ASH conference. In addition, the company plans to initiate the Phase 1 CYCLE-01 study evaluating the CYAD-02 following preconditioning chemotherapy in r/r AML in early 2020.

CYAD-101 – TIM-based Allogeneic NKG2D-based CAR-T

Celyad’s first-in-class, non-gene edited allogeneic clinical candidate CYAD-101 continues to advance in the alloSHRINK Phase 1 trial. At the SITC 34th Annual Meeting, the Company presented preliminary data from the ongoing alloSHRINK trial assessing safety and clinical activity of CYAD-101 in patients with relapsed or refractory metastatic colorectal cancer (mCRC) who had progressed beyond second line metastatic chemotherapy. Preliminary data showed no clinical evidence of GvHD has been observed following 35 injections of CYAD-101, supporting the ability of the company’s novel inhibitory peptide T cell receptor (TCR) inhibiting molecule (TIM) to reduce signaling of the TCR complex through a non-gene edited approach. Treatment with CYAD-101 with prior FOLFOX preconditioning chemotherapy to control the host-versus-graft (HvG) reaction was well-tolerated, with no report of dose-limiting toxicity. No patients discontinued treatment due to adverse events. In addition, the regimen demonstrated encouraging anti-tumor activity, with two patients experiencing a confirmed partial response according to RECIST 1.1 criteria, and five patients experiencing stable disease of more than or equal to three months of duration. Tumor burden decrease was observed in six out of 12 patients in total.

Preliminary results from the completed dose-escalation segment of the alloSHRINK trial are expected in the first half of 2020. This will include three additional patients at dose level three (one billion cells per infusion) of the trial, for a total of nine patients in the cohort, as planned per the protocol.

Based on the data presented to date, the Company plans to expand the trial to further evaluate CYAD-101 with prior FOLFOX chemotherapy in refractory mCRC patients. Enrollment in the expansion segment of the trial is expected to begin in mid-2020 following the production of additional CYAD-101 cells.

CYAD-200 Series – shRNA-based Allogeneic CAR-Ts

The Company continues to pursue the development of the proprietary non-gene edited allogeneic shRNA SMARTvector platform and progress towards filing IND applications for the CYAD-200 series of shRNA-based allogeneic CAR-T candidates, including CYAD-211, the Company’s CAR-T therapy targeting B-cell maturation antigen (BCMA) for the treatment of multiple myeloma.

Key Upcoming Milestones

  • Poster presentations of THINK Phase 1 trial and DEPLETHINK Phase 1 trial evaluating CYAD-01 produced with the mAb manufacturing process for the treatment of r/r AML and MDS at the 61st ASH Annual Meeting, which will be accompanied by an investor and analyst event (live and webcast) hosted by company on Monday, December 9th.
  • Initiation of the Phase 1 dose-escalation CYCLE-01 trial evaluating CYAD-02, following preconditioning chemotherapy, for the treatment of r/r AML and MDS is expected in early 2020.
  • Anticipated completion of enrollment of the DEPLETHINK Phase 1 trial evaluating CYAD-01 produced with the OptimAb manufacturing process during first half 2020.
  • Updated results from the completed dose-escalation segment of the alloSHRINK trial are expected in first half 2020, including an additional three patients at dose level three (one billion cells per infusion) of the trial.
  • Submission of IND application for CYAD-211 (shRNA-based allogeneic BCMA CAR-T candidate) for the treatment of patients with multiple myeloma is anticipated during first half 2020.
  • Initiation of the dose-expansion segment of the alloSHRINK trial is anticipated to begin in mid-2020.

 

Upcoming Conferences

Celyad’s management team is scheduled to participate in the following conferences during the remainder of 2019:

  • Jefferies London Healthcare Conference, November 20 - 21
  • Evercore ISI HealthCONx Conference, December 3 - 5
  • 61st ASH Annual Meeting, December 7-10

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