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 provides an update on its recent operations and reported consolidated financial results for the twelve-month period ended 31 December 2017, prepared in accordance with IFRS.

Conference call scheduled for Friday, 23 March, at 2:00 p.m. CET / 9:00 a.m. EDT

  • NKG2D CARs demonstrate validity of the target with the clinical activity observed in solid and hematological cancers in the THINK[1] trial
  • First ever Complete Response for a relapsed refractory AML patient and without preconditioning
  • Stability of disease in ovarian and colorectal cancer provide first proof of potential importance in solid tumors
  • Established feasibility of multiple dose CAR-T therapy
  • Strengthened allogenic CAR-T cell IP position through Novartis licensing

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 provides an update on its recent operations and reported consolidated financial results for the twelve-month period ended 31 December 2017, prepared in accordance with IFRS.

Christian Homsy, CEO of Celyad:2017 has been another milestone year for Celyad. The responses obtained to date in AML, and in solid tumors, we believe validate NKG2D as a target and allow us to move rapidly forward with the development of this product candidate in 2018. Our intellectual property related to the allogeneic technology, another of our core strengths, has been further strengthened: it was upheld by the US Patent and Trademark Office as part of multiple ex-parte re-examination requests and its importance has been recognized through our licensing agreement with Novartis. As far as 2018 is concerned: we believe it will be an exciting year as we expect to – among other things– complete the dose escalation segment of THINK and explore the various conditions that could lead to a potential registrational Phase 2 trial.”

Key 2017 Highlights

  • First complete response by a CAR-T cell therapy reported in a patient with relapsed and refractory AML in the Phase 1 THINK trial. Complete response obtained without preconditioning therapy
  • CYAD-01 (CAR-T NKG2D) well tolerated and clinical activity seen in AML patients treated in THINK trial to date
  • First signs of clinical activity in Colorectal and Ovarian cancers
  • Phase 1 SHRINK[2] study initiated to evaluate the synergetic effect of the concurrent administration of CYAD-01 with standard chemotherapy in metastatic colorectal cancer patients 
  • Non-exclusive license agreement signed with Novartis for its allogeneic TCR-deficient CAR-T cell patents
  • New agreements with Celdara Medical LLC and Dartmouth College following encouraging results from the THINK trial, giving right to an increased share of future revenues generated by our CAR-T platform
  • Strong central IP position in the allogeneic CAR-T cell field confirmed by USPTO

Expected Milestones for 2018 and Beyond

  • Dose escalation segment of THINK trial; Enrolment according to plans
  • Interim read-outs of the LINK[3] and the SHRINK clinical trials
  • Initiation of DEPLETHINK[4] study (non-myeloablative preconditioning chemotherapy in relapse/refractory AML or myelodysplastic syndrome (MDS) patients)
  • Initiation of EPITHINK[5] study (CYAD-01 treatment administered concurrently with 5-azacytidine in treatment-naïve AML or MDS patients not candidates for intensive therapy).
  • Investigational New Drug (IND) filing for our allogeneic CYAD-101 product candidate and enrolment of the first patient of the trial
  • Finalization of preclinical development of CYAD-02, a CYAD-01 iteration aimed at enhanced in-vivo expansion and persistence
  • Proof of concept of the CARGO platform, a next generation CAR-T engineered with tumor micro-environment targeting tools and enhanced tumor infiltration capabilities (a cargo CAR). CYAD-03 is the NKG2D CAR of the CARGO platform

Commenting on the 2017 results, Dr. Debasish Roychowdhury, Member of the Board, said:“2017 was a watershed year for Celyad. We saw promising signs of tolerability and clinical activity in the THINK trial, validating NKG2D as a target, thus allowing us to be well positioned to broaden the scope of NKG2D platform and to initiate potential pivotal studies, respectively planned for 2018 and 2019.”

Conference Call Details

A conference call will be held on Friday, 23 March 2018, at 2:00 p.m. CET / 9:00 a.m. EDT to review the financial results. Christian Homsy, Chief Executive Officer, and Patrick Jeanmart, Chief Financial Officer will deliver a brief presentation followed by a Q&A session.

Joining the Conference Call:

  1. In the 10 minutes prior to the call start time, call the appropriate participant dial-in number.
  • Standard International Dial-In Number: +44 (0) 2071 928338

Local Call Dial-In Numbers:

  • Belgium              027933847
  • France                0170700781
  • UK                     08444819752
  • Netherlands        0207956614
  • US                      18778709135
  1. Provide the operator with the conference ID: 4391809

Helpful keypad commands: *0 - Operator assistance.

 

[1] THINK: THerapeutic Immunotherapy with CAR-T NKG2D

2 SHRINK: Standard CHemotherapy Regimen and Immunotherapy with CAR-T NKG2D  

[3] LINK: Locoregional Immunotheraoy with NKG2D

[4] DEPLETHINK: LymphoDEPLEtion and THerapeutic Immunotherapy with NKG2D

[5] EPITHINK: EPIgenetic drug treatment and THerapeutic Immunotherapy with NKG2D

 

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About Celyad

Developing breakthrough pioneering therapies for life-threatening diseases.

Celyad is a biopharmaceutical company, specialized in cell therapy, that is developing landmark technologies aimed at treating severe diseases with poor prognosis. Our scientific approach is inspired by the natural mechanisms that are used by the body to fight disease.

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