On May 9, 2019 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, reported an update on operational developments for the first quarter ended March 31, 2019 (Press release, Celyad, MAY 9, 2019, View Source [SID1234536079]).
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"We began the year with the announcement that treatment with CYAD-01 demonstrated a 40% complete response rate in patients with relapsed/refractory acute myeloid leukemia. As we continue to advance the development of our pipeline of CAR-T cells therapies, we are scheduled to provide an update on our allogeneic and autologous NKG2D-based CAR-T candidates for the treatment of refractory metastatic colorectal cancer at the ESMO (Free ESMO Whitepaper) 21st World Congress on Gastrointestinal Cancer in July", stated Filippo Petti, CEO of Celyad.
"As I stepped into the CEO role at the beginning of the second quarter of 2019, my strategy for Celyad is to keep our focus on the optimization of our NKG2D-based programs while leveraging our shRNA platform to develop a deep pipeline of next-generation NKG2D-based and off-the-shelf non-gene edited CAR-T candidates. We anticipate that the shRNA platform will enable Celyad to continue to deliver innovative CAR-T therapeutics and potentially surpass the competition in the allogeneic CAR-T landscape."
First Quarter 2019 and Recent Business Highlights
Appointment of Filippo Petti as Chief Executive Officer and Anne Moore, PhD as Vice President Corporate Strategy as part of a strategic evolution of the management team;
Research & Development Day in NYC showcased the Company’s preclinical candidates based on its shRNA platform including next-generation NKG2D-based CAR-T candidates and the novel, non-gene edited allogeneic CYAD-200 series;
Scheduled to present an update on autologous and allogeneic NKG2D-based CAR-T candidates, CYAD-01 and CYAD-101, for the treatment of refractory metastatic colorectal cancer (mCRC) at European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 21st World Congress on Gastrointestinal Cancer (WCGIC) on July 3-6, 2019 in Barcelona, Spain.
First Quarter 2019 Financial Review
The Company ended the quarter with €40.5 million ($45.4 million) in cash, cash equivalents and short-term bank deposits. Net cash burn over the first quarter of 2019 amounted to €8.6 million, in line with expectations. The Company confirms its previous guidance that its treasury position should be sufficient to fund operating expenses and capital expenditure requirements, based on the current scope of activities, until mid-2020.
Update on Clinical Programs
CYAD-01 – Autologous NKG2D-based CAR-T
The Company’s lead asset CYAD-01 continues to advance in clinical trials for the treatment of patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Additional dosing and schedule optimization are under evaluation in the THINK Phase 1 trial. Interim data from the DEPLETHINK Phase 1 trial evaluating CYAD-01 following preconditioning chemotherapy showed the CAR-T cell therapy is well-tolerated at the initial dose levels following preconditioning chemotherapy.
CYAD-101 – Allogeneic NKG2D-based CAR-T
Celyad’s non-gene edited clincial candidate CYAD-101 continues to advance in the alloSHRINK Phase 1 trial assessing the ‘off-the-shelf’ NKG2D-based therapy administered concurrently with FOLFOX chemotherapy in patients with refractory metastatic colorectal cancer.
Update on Preclinical Programs
In March, the Company announced that utilization of the shRNA platform allowed the Company to develop the next generation of autologous, NKG2D-based CAR-T candidate, CYAD-02, and the novel, non-gene edited allogeneic CYAD-200 series of CAR-T candidates.
CYAD-02 incorporates shRNA technology to target NKG2D ligands MICA/MICB. In preclinical AML models, CYAD-02 shows an encouraging increase in in vitro proliferation and in vivo persistence and anti-tumor activity.
In the CYAD-200 series, shRNA technology is used to target the CD3ζ component of the T-cell receptor (TCR) to knockdown the expression of the TCR/CD3 complex on the surface of the T-cell. In vivo data demonstrate that shRNA targeting of CD3ζ effectively protects against Graft-versus-Host Disease (GvHD) to a level equivalent to CRISPR-Cas9 based knock-out. Furthermore, results from preclinical tests show significant increase in persistence of allogeneic T-cells using shRNA targeting when compared to gene editing technologies, such as CRISPR-Cas9.
Expected milestones for 2019
Clinical data from the SHRINK and alloSHRINK Phase 1 trials, evaluating the safety of NKG2D-based autologous and allogeneic CAR-T candidates, CYAD-01 and CYAD-101, respectively, will be presented at the upcoming European Society for Medical Oncology 21st World Congress on Gastrointestinal Cancer to be held on July 3-6, 2019, in Barcelona, Spain;
Clinical updates from the Phase 1 THINK and DEPLETHINK trials are anticipated by mid-2019;
Advancement towards an IND application with the preclinical development of next-generation NKG2D-based CAR-T, CYAD-02 ; and
Further pursue the development of the proprietary non-gene edited allogeneic shRNA platform and progress towards IND applications for the CYAD-200 series of shRNA-based CAR-T candidates.