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Regulated

Celyad raises $100.1 million gross proceeds with NASDAQ IPO

October 24, 2019 By Celyad

Mont-Saint-Guibert, Belgium – Celyad SA (formerly known as Cardio3 BioSciences, Euronext Brussels and Paris: CYAD), today announced the pricing of its global offering totaling $100.1 million gross proceeds of 1,460,000 new ordinary shares, consisting of 1,168,000 American Depositary Shares (“ADSs”) at $68.56 per ADS, and 292,000 ordinary shares at a price of EUR 60.25 per share, both before underwriting discounts. These shares were placed in a concurrent public offering in the United States and private placement in Europe (together the “global offering”). The price per ADS was based on EUR 60.25 per ordinary share at an exchange rate of $ 1.1380 per Euro.

In addition, Celyad has granted the underwriters an option to purchase up to an additional 175,200 new ordinary shares in the form of ADSs and an option to purchase up to an additional 43,800 new ordinary shares, representing 15% of the ordinary shares and ADSs placed in the global offering. This option can be exercised during the 30 day period commencing 18 June 2015.

The closings of the ADS offering and the concurrent private placement are conditioned on each other and are expected to occur on 24 June 2015, subject to customary closing conditions.

Each of the ADSs offered represents the right to receive one ordinary share.

Celyad’s ordinary shares are currently listed on Euronext Paris and Euronext Brussels, under the symbol “CYAD”. The ADSs are expected to begin trading on the NASDAQ Global

Select Market on 19 June 2015 under the symbol “CYAD”.

UBS Investment Bank and Piper Jaffray & Co. are acting as joint book-running managers, and Petercam SA, Bryan, Garnier & Co., LifeSci Capital LLC and Lake Street Capital Markets LLC are acting as co-managers for the proposed global offering.

A registration statement relating to these securities was declared effective by the U.S. Securities and Exchange Commission on 18 June 2015.

The securities to be issued in the global offering are being offered only by means of a prospectus. A copy of the final prospectus, when available, can be obtained from UBS Securities LLC, Attention: Prospectus Department, 1285 Avenue of the Americas, New York, NY 10019, or by telephone at (888) 827-7275; Piper Jaffray & Co. Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at prospectus@pjc.com.

This press release does not constitute an offer to sell nor a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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Celyad Announces Closing of $20 Million Global Offering

September 16, 2019 By Celyad

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 the closing of a global offering of 2,000,000 ordinary shares comprised of 1,675,000 ordinary shares in the form of American Depositary Shares (“ADSs”) offered in the United States, Canada and certain countries outside of Europe at a price per ADS of $10.00 (the “U.S. offering”), and 325,000 ordinary shares in Europe and certain countries outside of the United States and Canada in a concurrent private placement at a price per share of €9.08 (together with the U.S. offering, the “global offering”). Each ADS represents the right to receive one ordinary share. The gross proceeds to Celyad from the global offering amounted to approximately $20.0 million (approximately €18.2 million), before deducting underwriting discounts and commissions and estimated offering expenses. In connection with the global offering, Celyad has granted the underwriters a 30-day option to purchase up to an additional 300,000 ordinary shares (which may be in the form of ADSs) on the same terms and conditions.

Our ADSs and our ordinary shares are listed under the symbol “CYAD” on the Nasdaq Global Market and on the Euronext Brussels and Euronext Paris, respectively.

Wells Fargo Securities, LLC, William Blair & Company, L.L.C. and Bryan, Garnier & Co. Limited acted as joint bookrunning managers for the offering. Kempen & Co U.S.A., Inc. acted as co-manager for the offering.  LifeSci Capital, LLC is Celyad’s advisor in connection with the offering.

The securities were offered pursuant to an effective shelf registration statement that was previously filed with, and declared effective by, the U.S. Securities and Exchange Commission (SEC). A final prospectus supplement dated September 11, 2019 and accompanying prospectus relating to and describing the terms of the offering was filed with the SEC on September 12, 2019, and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus can be obtained for free from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York, 10152, or by telephone at (800) 326-5897 or by email to cmclientsupport@wellsfargo.com; William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, Illinois 60606, or by telephone at (800) 621-0687, or by email at prospectus@williamblair.com; or from Bryan, Garnier & Co. Limited, Beaufort House, 15 Saint Botolph Street, London EC3A 7BB, United Kingdom, or by telephone at +44 20 7332 2500, or by email at info@bryangarnier.com.

This press release does not constitute an offer to sell nor a solicitation of an offer to buy, nor shall there be any sale of securities in any state or jurisdiction in which such an offer, solicitation or sale is or would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

***END***

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Celyad Announces Pricing of $20.0 Million Global Offering

September 12, 2019 By Celyad

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 the pricing of a global offering of 2,000,000 ordinary shares, comprised of 1,717,391 ordinary shares in the form of American Depositary Shares (“ADSs”) offered in the United States, Canada and certain countries outside of Europe at a price per ADS of $10.00 (the “U.S. offering”), and 282,609 ordinary shares in Europe and certain countries outside of the United States and Canada in a concurrent private placement at a price per share of €9.08 (together with the U.S. offering, the “global offering”). Each ADS represents the right to receive one ordinary share.  The price per ADS was determined based on an exchange rate of $1.1008 per €1.  The gross proceeds to Celyad from the global offering are expected to be approximately $20.0 million (approximately €18.2 million), before deducting underwriting discounts and commissions and estimated offering expenses.

In connection with the global offering, Celyad has granted the underwriters a 30-day option to purchase up to an additional 300,000 ordinary shares (which may be in the form of ADSs) on the same terms and conditions. The closing of the global offering is expected to occur on September 16, 2019, and is subject to customary closing conditions. Our ADSs and our ordinary shares are listed under the symbol “CYAD” on the Nasdaq Global Market and on the Euronext Brussels and Euronext Paris, respectively.

Wells Fargo Securities, LLC, William Blair & Company, L.L.C. and Bryan, Garnier & Co. Limited are acting as joint book-running managers for the offering. Kempen & Co U.S.A., Inc. is acting as co-manager for the offering.  LifeSci Capital, LLC is Celyad’s advisor in connection with the offering.

The securities are being offered pursuant to an effective shelf registration statement that was previously filed with, and declared effective by, the U.S. Securities and Exchange Commission (SEC). A preliminary prospectus supplement dated September 10, 2019 and accompanying prospectus relating to and describing the terms of the offering was filed with the SEC on September 10, 2019.  The final prospectus supplement relating to the offering will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement, the accompanying prospectus and the final prospectus supplement, when available, can also be obtained for free from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York, 10152, or by telephone at (800) 326-5897 or by email at cmclientsupport@wellsfargo.com; William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, Illinois 60606, or by telephone at (800) 621-0687, or by email at prospectus@williamblair.com; or from Bryan, Garnier & Co. Limited, Beaufort House, 15 Saint Botolph Street, London EC3A 7BB, United Kingdom, or by telephone at +44 20 7332 2500, or by email at info@bryangarnier.com.

This press release does not constitute an offer to sell nor a solicitation of an offer to buy, nor shall there be any sale of securities in any state or jurisdiction in which such an offer, solicitation or sale is or would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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Celyad Announces Launch of Proposed Global Offering

September 10, 2019 By Celyad

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, announced today that it intends to offer and sell, subject to market and other conditions, up to 2,000,000 ordinary shares in a global offering, which is comprised of an offer of ordinary shares in the form of American Depositary Shares (“ADSs”) in the United States, Canada and certain countries outside of Europe (the “U.S. offering”), and an offer of ordinary shares in Europe and certain countries outside of the United States and Canada in a concurrent private placement (the “European private placement” and, together with the U.S. offering, the “global offering”). Investors other than qualified investors under applicable law will not be eligible to participate in the ordinary share private placement. Each ADS offered in the U.S. represents the right to receive one ordinary share.

In connection with the global offering, Celyad intends to grant the underwriters a 30-day option to purchase up to an additional 300,000 ordinary shares (which may be in the form of ADSs). The U.S. offering and the European private placement together constitute a single offering of securities that will occur simultaneously. The total number of ordinary shares in the U.S. offering and the European private placement is subject to reallocation between them. Our ADSs and our ordinary shares are listed under the symbol “CYAD” on the Nasdaq Global Market and on the Euronext Brussels and Euronext Paris.

The closing of the global offering is subject to market and other conditions, and there can be no assurance as to whether or when the global offering may be completed or as to the actual size or terms of the global offering. The size of the global offering and the price per share of the ordinary shares and the ADSs placed in the global offering will be determined following the bookbuilding process.

Trading of Celyad’s ordinary shares will be suspended on the Euronext Brussels and Euronext Paris pending announcement of the pricing of the global offering.

Wells Fargo Securities, LLC, William Blair & Company, L.L.C. and Bryan, Garnier & Co. Limited are acting as joint book-running managers for the offering. Kempen & Co U.S.A., Inc. is acting as co-manager for the offering. LifeSci Capital, LLC is Celyad’s advisor in connection with the offering.

The securities are being offered pursuant to an effective shelf registration statement that was previously filed with, and declared effective by, the U.S. Securities and Exchange Commission (“SEC”). A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities, when available, can also be obtained for free from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York, 10152, or by telephone at (800) 326-5897 or by email at cmclientsupport@wellsfargo.com; William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, Illinois 60606, or by telephone at (800) 621-0687, or by email at prospectus@williamblair.com; or from Bryan, Garnier & Co. Limited, Beaufort House, 15 Saint Botolph Street, London EC3A 7BB, United Kingdom, or by telephone at +44 20 7332 2500, or by email at info@bryangarnier.com.

This press release does not constitute an offer to sell nor a solicitation of an offer to buy, nor shall there be any sale of securities in any state or jurisdiction in which such an offer, solicitation or sale is or would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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Celyad Reports Half Year 2019 Financial Results and Second Quarter Business Highlights

August 22, 2019 By Celyad

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 its consolidated financial results for the first half of 2019 and provided its second quarter business update. The full interim financial report is available on Celyad’s website in the “Investors” section.

Filippo Petti, CEO of Celyad commented“As we enter the second half of the year, we continue to execute on our strategic plan for becoming a leader in the field of CAR-T development. Over the past few months we have  presented encouraging data from both our autologous and allogeneic NKG2D-based clinical candidates for the treatment of hematological malignancies and solid tumors. We also received positive feedback from the FDA regarding our proposal to utilize the OptimAb manufacturing process with CYAD-01 under the current IND. In addition, the FDA recently cleared the IND application for our next-generation NKG2D-based CAR-T candidate CYAD-02, another testiment of our team’s focus on operational excellence. We are excited about our recent achievements and look to build upon our momentum as we approach several clinical milestones expected over the next several months.”

Second Quarter 2019 and Recent Business Highlights

  • In June, the Company announced a strategic update to its autologous relapse/refractory (r/r) acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) program, including that the U.S. Food and Drug Administration (FDA) accepted the Company’s proposal to utilize the OptimAb manufacturing process with CYAD-01 under the current Investigational New Drug (IND) application.

The OptimAb manufacturing process utilizes a shortened eight-day cell culture and incorporates a selective PI3K inhibitor. This results in a product that is enriched for T cells with a memory-like phenotype while maintaining the high level of manufacturing reliability required to support clinical development. 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 previous mAb manufacturing process.

Following additional assessment of the r/r AML and MDS program for CYAD-01, Celyad plans to treat the first patient using the recently accepted OptimAb manufacturing process for CYAD-01 in cohort 3 (300 million cells) of the Phase 1 DEPLETHINK trial.

  • The Company also announced that the FDA accepted the IND application for CYAD-02, a next-generation, autologous NKG2D-based CAR-T candidate, and permitted it to go into effect. 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 in vitro proliferation, in vivo engraftment and anti-tumor activity in preclinical studies. CYAD-02 also incorporates the OptimAb manufacturing process.

Pipeline Updates

CYAD-01 – Autologous NKG2D-based CAR-T

The Company’s lead asset, CYAD-01 continues to advance in 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 June, Celyad presented preliminary data at the European Hematology Association (EHA) meeting that demonstrated that a denser schedule of infusions of CYAD-01 without preconditioning in Cohort 10 (Schedule Optimization) of the THINK trial was well tolerated and led to better time-averaged engraftment of the CAR-T cells compared to biweekly injections of CYAD-01 without preconditioning. Also at EHA, the Company reported that a single infusion of low dose CYAD-01 (100 million cells) following preconditioning chemotherapy consisting of cyclophosphamide and fludarabine was well-tolerated and led to better time-averaged engraftment of the CAR-T cells compared to the dose-escalation segment of the THINK trial.

In July, the Company also provided an update on CYAD-01 for the treatment of patients with metastatic colorectal cancer (mCRC) at the European Society for Medical Oncology (ESMO) 21st World Congress on Gastrointestinal Cancer (WCGIC) in Barcelona. Professor Dr. Eric Van Cutsem from the University Hospital of Leuven (Universitair Ziekenhuis Leuven, UZ Leuven) presented preliminary data from the ongoing Phase 1 SHRINK trial assessing safety and clinical activity of CYAD-01 infused concurrently with FOLFOX chemotherapy for the treatment of mCRC. Data from the trial showed the regimen to be generally well-tolerated and with initial observations of disease control.

CYAD-101 – Allogeneic NKG2D-based CAR-T

Celyad’s first-in-class, non-gene edited clinical candidate CYAD-101 continues to advance in the alloSHRINK Phase 1 trial. At the 21st ESMO-WCGIC, the Company presented preliminary data from the ongoing alloSHRINK trial assessing safety and clinical activity of CYAD-101 administered concurrently with FOLFOX chemotherapy in patients with relapsed or refractory mCRC. Preliminary data showed no clinical evidence of Graft-versus-Host Disease post-infusion of allogeneic candidate CYAD-101. In addition, the regimen demonstrated encouraging anti-tumor activity with one patient experiencing a partial response and three patients experiencing stable disease at the three-month assessment.

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 the 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

  • Treatment of the first patient with CYAD-01 (300 million cells) produced with the OptimAb manufacturing process in the Phase 1 DEPLETHINK trial is expected by the end of September
  • Results from Cohort 11 (Schedule Optimization) of THINK Phase 1 trial and Cohort 3 of DEPLETHINK Phase 1 trial evaluating CYAD-01 produced with the mAb manufacturing process for the treatment of r/r AML and MDS are anticipated by year-end 2019
  • Additional results from the dose-escalation Phase 1 alloSHRINK trial evaluating CYAD-101 for the treatment of mCRC are anticipated by year-end 2019
  • Initiation of the Phase 1 dose-escalation trial evaluating CYAD-02, following preconditioning chemotherapy, for the treatment of r/r AML and MDS is expected in early 2020
  • 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

First Half 2019 Financial Review

The Company ended the quarter with a treasury position of €33.7 million ($38.3 million). Net cash burn over the first half of 2019 amounted to €16.1 million, in line with our financial planning. The Company confirms its previous position that its treasury position should be sufficient, based on the current scope of activities, to fund operating and capital expenditure requirementsuntil mid-2020.

Key financial figures for the first six months of 2019 compared with the same period of the previous year are summarized below:

Selected key financial figures (€ millions)Half Year
As of June 30, 2019
Half Year
As of June 30, 2018
Revenue                            –                         2.5
Research and development expenses                   (12.7)                   (11.1)
General and administrative expenses                     (4.5)                     (5.5)
Other income/(expenses)                       1.3                     (4.7)
Operating loss                   (15.9)                   (18.8)
Loss for the period/year                   (16.0)                   (18.5)
Net cash used in operations                   (16.1)                   (13.9)
Treasury position(1)                     33.7                     62.4
  1. Treasury position’ is an alternative performance measure determined by adding Short-term investments and Cash and cash equivalents from the statement of financial position prepared in accordance with IFRS.

The Company’s license and collaboration agreements have generated no revenue in the first half of 2019 compared to €2.5 million during first half 2018. Research and Development expenses totalled €12.7 million during first half 2019, a €1.6 million increase compared to first half 2018, driven by increased spending related to our key clinical studies for CYAD-01 and CYAD-101 as well as an increased spending associated with the development of our allogeneic platform (CYAD-200 series). Over the same period, General and Administrative expenses were €4.5 million for first half 2019, a decrease of €1.0 million compared to first half 2018, driven primarily by the decrease of non-cash expense associated with the vesting of warrants and by lower consulting fees for the period.

The Company’s other income/other expenses mainly include non-cash expenses relating to liability reassessment required by International Financial Reporting Standards (IFRS) related to the advancement in the Company’s NKG2D-based CAR-T candidates. Overall, the Company has posted €0.4 million in net income for first half 2019, against a €3.9 million net loss for first half 2018.

Due to the increase in net income, the Company’s loss for the period decreased to €16.0 million for the first half 2019 compared to €18.5 million for the first half of 2018.

Net operational cash burn, which excludes non-cash effects, was €16.1 million for first half 2019, compared to €13.9 million for first half 2018, driven primarily by an increase in Research and Development spend as described above.

Conference Call and Webcast Details

Celyad will host a conference call on Friday, 23 August at 2:00 pm CEST / 8:00 am EDT accessible through the following numbers: 

Belgium                               +32 (0) 24 01 70 35

France                                  +33 (0)1 76 72 89 28

United States:                   +1 917 720 0181

International:                    +44 (0) 2071 928501

Conference ID:                 3547725

The event will also be archived and available on the “Events & Webcasts” section of the Company’s website.

Financial Calendar

Third quarter 2019 business update               November 19, 2019

Full-year results 2019                                   March 25, 2020

Annual shareholders meeting                         May 5, 2020

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Celyad Announces First Quarter 2019 Financial Results and Recent Business Highlights

May 9, 2019 By Celyad

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 operational developments for the first quarter ended March 31, 2019.

“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 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) 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.
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