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Uncategorized

Celyad to Participate at Upcoming Healthcare Conferences

November 15, 2018 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-based therapies, today announced that management will participate at both the Bryan, Garnier & Co 6th European Healthcare Conference and the Piper Jaffray 30th Annual Healthcare Conference.

The Bryan, Garnier & Co 6th European Healthcare Conference will take place in Paris, France, on November 22-23, 2018.  The Company will participate in investor meetings at the Conference.

The Piper Jaffray 30th Annual Healthcare Conference will take place in New York, NY on November 27-29, 2018 and the Company is scheduled to participate in a fireside chat on Tuesday, November 27 at 11:30 am Eastern Time.  A live webcast of the discussion can be accessed here.  An archived webcast recording will also be available under Events & Webcasts in the Investors section of the Company’s website.

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Filed Under: Corporate, Non-regulated, Uncategorized

Celyad to Present New CYAD-01 Data from THINK Study in Relapsed/Refractory Acute Myeloid Leukemia at 2018 ASH Annual Meeting

November 1, 2018 By Celyad

Mont-Saint-Guibert, Belgium – Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of specialized CAR-T cell-based therapies, today announced that two abstracts detailing updated clinical results from the Phase 1 THINK dose-escalation trial and anticipated clinical trials for the CYAD-01 program will be presented at the 60th American Society of Hematology (ASH) Annual Meeting in San Diego, December 1-4, 2018.

  • Oral presentation highlighting updated THINK study data evaluating CYAD-01 without preconditioning chemotherapy in relapsed or refractory (r/r) acute myeloid leukemia (AML)
  • As of July 2018, three out of seven (42%) r/r AML patients evaluable for response achieved a complete response (CRh/CRi) following treatment with the per-protocol dose of CYAD-01
  • Overall, five out of seven (71%) patients achieved meaningful decrease in bone marrow blasts
  • Company to host Analyst/Investor event on Monday, December 3, 2018

Mont-Saint-Guibert, Belgium – Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of specialized CAR-T cell-based therapies, today announced that two abstracts detailing updated clinical results from the Phase 1 THINK dose-escalation trial and anticipated clinical trials for the CYAD-01 program will be presented at the 60th American Society of Hematology (ASH) Annual Meeting in San Diego, December 1-4, 2018. Company management will also review the results of the THINK trial and provide an update on Celyad’s clinical development program for CYAD-01 at an Analyst/Investor event, which will also be available via webcast on December 3, 2018.

“We are encouraged by the preliminary THINK study data evaluating CYAD-01, without preconditioning chemotherapy in patients with relapsed or refractory acute myeloid leukemia,” said Dr. Christian Homsy, CEO of Celyad. “The data supplement a growing body of evidence that CYAD-01 shows encouraging clinical activity and is well-tolerated and suggests its potential for the treatment of acute myeloid leukemia, a challenging disease with limited therapeutic options. In addition to this important milestone, we continue to investigate CYAD-01 in alternative protocols to further optimize its clinical benefit.”

Updated data from the THINK trial of CYAD-01 in patients with r/r AML will be presented by Principal Investigator David A. Sallman, M.D., of the Moffitt Cancer Center, on December 3, 2018. The presentation will include new information on safety, activity and correlative science data of the complete dose-escalation segment of the trial.

Top-line data from the abstract as of a data cut-off date of July 31, 2018, included:

  • Of the seven response-evaluable r/r AML patients enrolled in the trial who received the per-protocol dose of CYAD-01, the best overall response rate was 42% (three patients). Two additional patients experienced important clinical benefit with hematologic improvement and bone marrow blasts decrease, leading to clinical activity of 71% (five patients).
  • One patient experienced a complete remission with partial hematologic recovery (CRh) and two patients experienced a complete remission with incomplete marrow recovery (CRi). One CRh and one CRi occurred at dose level 1 (DL1) with an additional CRi at dose level 3. All three responders achieved a response by day 29 (i.e., prior to the third administration of CYAD-01).
  • The patient with CRh from DL1 was bridged to allogeneic hematopoietic stem cell transplantation (allo-HSCT) on day +97 post treatment with CYAD-01. This patient remains in durable complete molecular remission (CRMRD-) for more than one year (ongoing). A detailed case report of this patient was published in Haematologica in April 2018.
  • Of the two additional r/r AML patients who experienced a clinical benefit, one patient had a decrease in blast counts from 24% to 10%, while a second patient had a decrease from 9.8% to 5.5%. Disease stabilization in these patients were observed for three months and over four months (ongoing), respectively. Both patients were treated in dose level 2 of the study.
  • Overall, 12 patients with hematological malignancies (AML, myelodysplastic syndrome and multiple myeloma) treated with CYAD-01 in the cohort had reached the safety follow-up. The most common treatment-related adverse events (AEs) included pyrexia, cytokine release syndrome (CRS), hypoxia, lymphopenia, fatigue and nausea. CRS occurred in five patients (three grade 1/2 AEs and two grade 3 AEs), with rapid resolution following the appropriate treatment, including tocilizumab. Overall, five patients experienced grade 3/4 treatment-related AEs. No neurotoxicity AEs were observed in patients treated with CYAD-01.

CYAD-01 and THINK Trial Design

CYAD-01 is an investigational CAR-T therapy in which a patient’s T cells are engineered to express the chimeric antigen receptor NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands expressed on tumor cells.

The THINK trial (NCT03018405) is an open-label, dose-escalation Phase 1 trial assessing the safety and clinical activity of multiple CYAD-01 administrations without prior preconditioning in two parallel cohorts: i) patients with hematological malignancies, including r/r AML, and ii) patients with metastatic solid tumors. The dose escalation segment of the study evaluates three dose levels (300 million, 1 billion and 3 billion cells per injection) of one cycle of three CYAD-01 administrations with two-week intervals.

ASH Analyst/Investor Event and Webcast Information

Celyad will host an Analyst/Investor event on Monday, December 3, 2018, beginning at 8:30 p.m. PT to review data presented at ASH. The event will be webcast live and can be accessed under Events & Webcasts in the Investors section of the Company’s website.

A complete list of Celyad and collaborator presentations to be made at ASH appears below:

Oral Presentation

Remissions in Relapse/Refractory Acute Myeloid Leukemia Patients Following Treatment with NKG2D CAR-T Therapy Without a Prior Preconditioning Chemotherapy (Abstract #111326 – Publication Number 902)

Presenter: David A. Sallman, M.D., Moffitt Cancer Center

Date: Monday, December 3, 2018, 4:45 p.m. Pacific Time

Location: Manchester Grand Hyatt San Diego, Seaport Ballroom F

Poster Presentation

Phase 1 Studies Assessing the Safety and Clinical Activity of Multiple Doses of a NKG2D-based CAR-T Therapy, CYAD-01, in Acute Myeloid Leukemia (Abstract #114747 – Publication Number 1398)

Presenter: Jason B Brayer, MD, Moffitt Cancer Center

Date: Saturday, December 1, 2018, 6:15 PM – 8:15 PM

Location: San Diego Convention Center, Hall GH

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Celyad Reports First Half 2018 Financial Results and Operational Progress

August 23, 2018 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 six-month period ending 30 June 2018 prepared in accordance with IFRS as endorsed by the European Union.

Conference call scheduled for Thursday, 23 August at 2:00 p.m. CEST / 8:00 a.m. EDT

  • Dose escalation portion of THINK[1] clinical trial in solid arm completed
  • Successful administration of CYAD-01 in first patients in SHRINK[2] and LINK[3]trials
  • Initiation of EPITHINK[4] and DEPLETHINK[5] clinical trials following FDA acceptance of IND applications
  • Haematologica publication of THINK study case report
  • Strong cash position after completion of Celyad’s €46.1 million global offering
  • Strengthening of the Board of Directors and Scientific Committee with the appointment of the former CSO of Kite Pharma, Dr. Margo Roberts

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 six-month period ending 30 June 2018 prepared in accordance with IFRS as endorsed by the European Union. The full interim financial report is available on Celyad’s website in the “Investors” section. The half year 2018 consolidated financial statements were subject to a limited review by the company’s statutory auditors.

“We are very pleased with the progress made by Celyad in the first half of 2018, with significant advancement of our clinical programs for CYAD-01 across a number of programs in which, to date, we have observed preliminary signs of activity and a favorable tolerability profile”, commented Dr. Christian Homsy, CEO of Celyad. “We are particularly encouraged by the progress we have made in the hematological arm of our THINK trial and are thrilled that last month the FDA permitted our IND application to go into effect for CYAD-101, the world’s first non-gene edited allogeneic CAR-T clinical program. We are confident that 2018 will be a milestone year for Celyad as we continue to advance our platform across multiple indications.”

Operational Highlights

Progress made in Acute Myeloid Leukemia (AML)

THINK Trial

  • Interim results demonstrate signs of clinical activity ranging from complete responses to stable diseases at lower doses in AML patients receiving one cycle of CYAD-01 per protocol.
  • Twelve patients[6] have been enrolled to date. Enrollment for the highest dose (3×109) is expected to be completed in September 2018.
  • A complete second cycle of investigational therapy was administered in the first AML patient enrolled into the second dose level (1×109).  A second AML patient at the third dose level (3×109) has received the first injection of the second cycle. The second cycle is administered to determine the impact of the clinical benefit of additional CYAD-01 administrations. No dose-limiting toxicity has been observed to date.
  • The first ever reported complete response by an investigational CAR-T cell therapy without preconditioning in a patient with refractory and relapsed AML was published as a case study in Haematologica.
  • Preliminary results of the dose escalation segment will be reported in December during the American Society for Hematology (ASH) Annual Meeting (December 1-4, San Diego).

EPITHINK Trial

  • Based on feedback from the FDA, we finalized the EPITHINK protocol – a trial evaluating the synergetic effect of the concurrent administration of CYAD-01 (CAR-T NKG2D) with a standard of care hypomethylating agent (HMA) i.e. 5-azacytidine (AZA) in treatment-naïve Acute Myeloid Leukemia (AML) or myelodysplastic syndrome (MDS) patients not candidates for intensive therapy.

DEPLETHINK AML Trial

  • Based on feedback from the FDA, we finalized the DEPLETHINK AML protocol – a trial to evaluate administration of CYAD-01 after a traditional preconditioning regimen in refractory/relapsing AML and MDS patients.

Progress made in Colorectal Cancer (CRC)

THINK Trial

  • Fourteen solid cancer patients (one pancreas, two ovarian and eleven CRC) completed the three dose-levels evaluated in the dose escalation segment.
  • One dose-limiting toxicity (DLT) was reported at the highest dose-level (3×109) triggering the enrollment of three additional patients. No other DLT was reported in the three additional patients treated at the third dose level.
  • Preliminary results will be reported during the Society for Immunotherapy of Cancer (SITC) Annual Meeting (November 7-11, Washington).

SHRINK Trial

  • Three CRC patients were treated at the first dose level (1×108) with no dose-limiting toxicity reported to date in combination with current standard of care.

LINK Trial

  • One CRC patient has received three local hepatic transarterial injections at the first dose level (3×108) with no dose-limiting toxicity reported to date.

DEPLETHINK CRC Trial

  • This study evaluates the administration of CYAD-01 after traditional preconditioning regimen in patients suffering from colorectal cancer. The first patient has been registered.

Subsequent Operational Events to First Half

In July, Celyad’s Investigational New Drug (IND) application went into effect with the FDA for CYAD-101, the world’s first non-gene edited allogeneic CAR-T clinical program. CYAD-101 is the first of a family of investigational non-gene edited allogeneic CAR-T cell therapies that will draw on the experience from the SHRINK autologous CAR-T program to target colorectal cancer. The FDA also indicated that the Allo-SHRINK trial, evaluating the safety and clinical activity of CYAD-101 in patients with unresectable colorectal cancer in combination with standard chemotherapy, is allowed to proceed.  

Corporate and Financial Highlights for the First Half of 2018

In May, Celyad successfully completed a global offering with gross proceeds of approximately $54.4 million (approximately €46.1 million). At the end of June 2018, the Company reported total cash and short-term investments of €63 million, which are expected to be sufficient to support its operating capital expenditure into mid-2020.

In early August, Margo Roberts, Ph.D., joined Celyad’s Board of Directors and scientific committee. Dr. Roberts was Chief Scientific Officer at Kite Pharma, Inc., before becoming Senior Vice President of Discovery Research where she focused on next therapeutic approaches including Kite’s allogeneic T-cell programs. With Dr. David Gilham, Celyad’s VP of R&D, she will provide input into the scientific strategy of the company.

Also, in August, the Company announced the appointment of Filippo Petti as Chief Financial Officer as from 3 September, succeeding Patrick Jeanmart. Prior to joining Celyad, Mr. Petti served as VP of Healthcare Investment Banking at Wells Fargo Securities and William Blair & Company. His deep industry expertise, experience in oncology and connectivity within the U.S. investor community will help Celyad’s development in the U.S. capital and financial market.

Commenting on the 2018 half year results, Patrick Jeanmart, Chief Financial Officer of Celyad, said: “Thanks to the successful capital raise made last May, we reported a comfortable cash position which we expect will be sufficient to support Celyad’s operating expenses and capital expenditure requirements, based on the current scope of our activities, into mid-2020. We are committed to careful oversight of our cash and resource management allowing the meaningful advancement of our preclinical and clinical CAR-T platform across multiple indications.”

Selected First Half 2018 Financial Results

In million eurosH1 2018H1 2017
Revenues2.53.5
Research & development expenses(11.1)(11.1)
General & administrative expenses(5.5)(4.2)
Other income/(expenses)(4.7)(1.3)
Operating loss(18.8)(13.7)
Loss of the period(18.5)(14.4)
Loss per share (in €)(1.79)(1.52)
Net cash used in operations(13.9)(14.5)
Cash and short-term investment63.268.8

Conference Call Details

Celyad’s management will host a conference call on Thursday, 23 August 2018 at 2:00 p.m. (CEST) / 8:00 a.m. (EDT) to comment on the mid-year operational and financial results. Patrick Jeanmart, CFO, will deliver a brief presentation followed by a Q&A session.

Participants are asked to call the assigned numbers approximately five minutes before the conference call begins.

The call can be accessed by dialling the numbers below and using the passcode: 1835859

International:  +44 (0) 2071 928338
Belgium:02 793 3847
France:0805 101465
UK:0800 2796619
US:1 877 870 9135

***END***


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

[2] SHRINK – Standard cHemotherapy Regimen and Immunotherapy with CAR-T NKG2D

[3] LINK – Locoregional Immunotherapy with CAR-T NKG2D

[4] EPITHINK – EPIgenetic drug treatment and THerapeutic Immunotherapy with CAR-T NKG2D

[5] DEPLETHINK – LymphoDEPLEtion and THerapeutic Immunotherapy with CAR-T NKG2D

[6] Eight AML patients, one MDS (myelodysplastic syndrome) and three MM (Multiple Myeloma) patients

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Celyad announces launch of proposed global offering

May 15, 2018 By Celyad

Mont-Saint-Guibert, Belgium – Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of specialized CAR-T cell based therapies, today announces that it intends to offer and sell, subject to market and other conditions, up to 1,800,000 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, and an offer of ordinary shares in Europe and certain countries outside of the United States and Canada in a concurrent private placement (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 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 additional ordinary shares, which may be in the form of ADSs, in an aggregate amount of up to 15% of the total number of ordinary shares (including in the form of ADSs) proposed to be sold in the global offering, on the same terms and conditions. 

The U.S. offering and the European private placement together constitutes 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.  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.

Celyad’s ADSs are currently listed on the NASDAQ Global Select Market under the symbol “CYAD” and Celyad’s ordinary shares are currently listed on Euronext Brussels and Euronext Paris. 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 and Bryan, Garnier & Co. are acting as joint bookrunning managers for the offering. Bank Degroof Petercam NV and LifeSci Capital LLC are acting as co-managers for the offering.  Kempen & Co NV 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, at (800) 326-5897 or email a request to cmclientsupport@wellsfargo.com; or from Bryan, Garnier & Co., 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 Letter to Shareholders

July 15, 2016 By Celyad

Dr. Christian Homsy – CEO of Celyad

Dear Celyad Shareholders,

We entered into the very promising field of immuno-oncology in 2015 with the goal of offering truly transformational treatment options to patients and emerging as a world leader in cell therapy. We were pleased to announce this past Monday, July 11, that we have taken a significant step in achieving these objectives by entering into a collaboration with ONO Pharmaceutical to enhance the development of our innovative Natural Killer Receptor (NKR) based T-Cell platform.

Our license agreement with ONO Pharmaceutical Co., Ltd: an opportunity to expand Celyad’s reach globally.

We are thrilled that one of the preeminent immuno-oncology companies in the world is as excited as we are about the potential of our NKR-2 program and the opportunity this presents us to expand Celyad’s reach globally. The license agreement with ONO grants them the exclusive right to develop and commercialize our allogeneic NKR-2 T-Cell immunotherapy in Japan, Korea and Taiwan. In exchange for receiving a license in these countries, ONO will pay Celyad up to $311.5 million (plus double-digit royalties on net sales) in development and commercial milestones, including an upfront payment of $12.5 million. ONO’s impressive experience in developing and launching drugs in Asian countries, including the blockbuster PD-1 inhibitor Opdivo, significantly accelerates our progress in these new markets, which account for 10% of the world population that have access to advanced medical care, and ensures that our program is in the best position to succeed worldwide. Having such a strong regional partner allows us to concentrate on the continued development of NKR-2 for the largest opportunities in the US and EU, where we maintain full ownership and development of the entire
NKR platform. In addition to the monetary and regional benefits of the agreement, we look forward to the clinical expertise that will be shared amongst our teams, which should lead to us exploring the full potential of NKR-2 T-Cell immunotherapies worldwide. Collectively, we will also be capable of conducting global registration and combination trials.

To read the full Letter to Celyad shareholders, please click here.

Pour lire l’intégralité de la Lettre aux actionnaires de Celyad en français,cliquez ici.

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Celyad enters into license agreement with ONO PHARMACEUTICAL CO., LTD. to develop allogeneic NKR-2 T-cell immunotherapy

July 11, 2016 By Celyad

  • Celyad grants an exclusive license to ONO for the development and commercialization of Celyad’s unique allogeneic NKR-2 T-cell in Japan, Korea and Taiwan.
  • Celyad also grants to ONO an exclusive option to license its autologous NKR-2 T cell product in the above ONO territories.
  • Total deal value of up to 31.325 JPY B (€282 million or $311.5 million) plus double digit royalties on net sales in ONO territories.

Mont-Saint-Guibert, Belgium – Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of cell therapies, today announced an exclusive license agreement with the leading Japanese immuno-oncology company, ONO Pharmaceutical Co., Ltd. (TSE: 4528), for the development and commercialization of Celyad’s allogeneic NKR-2 T-cell immunotherapy in Japan, Korea and Taiwan. This license agreement opens new markets to Celyad and expands the global footprint of its NKR-2 T-cell cancer immunotherapy treatment and potentially for other disease conditions.

Celyad will receive an upfront payment of 1.25 JPY B (€11.25 million or $12.5 million) and is eligible of up to 30.075 JPY B (€270.75 million or $299 million) in development and commercial milestones. Celyad will also receive double digit royalties based on net sales of the licensed product in ONO’s territories.

Under the terms of the agreement, Celyad will continue developing its allogeneic NKR-2 T-cell immunotherapy in the EU and US territories, and ONO will be responsible for future development and commercialization in ONO’s territories (Japan, Korea and Taiwan). Both companies will also explore the opportunity to collaborate to collectively run global registration trials and combination trials. In addition, Celyad grants to ONO an exclusive option to license for development and commercialization of its autologous NKR-2 T cell product in the above ONO territories.

Dr. Christian Homsy, CEO of Celyad, said: “We are very pleased to collaborate with ONO and to activate the development of our NKR-2 T-cell allogeneic platform in Japan, Korea and Taiwan. This license agreement is a great opportunity for Celyad to expand the scope of its immuno-oncology clinical programs and bring this breakthrough science to numerous patients around the world. Further, this license agreement with ONO, the leader in immuno-oncology in Asia, validates our NKR-2 approach and its tremendous potential.”

Georges Rawadi, VP Business Development of Celyad, said: “Celyad surrounds itself with the best immuno-oncology experts in the world to develop its NKR T-cell platform. This is why we have entered this agreement with ONO. Through this commercial license agreement, Celyad aims to expand the clinical and commercial potential of its allogeneic NKR-2 T-cell immunotherapies worldwide.”

Gyo Sagara, President, Representative Director and CEO of ONO, said: “We are very delighted to collaborate with the leading cell therapy company, Celyad, for its distinct immuno-oncology candidates. Celyad’s NKR-2 is backed by cutting-edge science and we believe that it can be a new therapeutic option for patients who are not cured with existing therapies.”

Conference Call Details

A conference call will be held on Monday, July 11, 2016 at 2:00pm (CEST) / 8:00am (EDT) to review the licensing agreement with ONO Pharmaceutical. Christian Homsy, Chief Executive Officer, will deliver a brief presentation followed by a Q+A session.

Participants are asked to call the assigned numbers approximately five minutes before the conference call begins.

The call can be accessed by dialing the numbers below and using the passcode: 30423803

International:                                +44 (0) 1452 584233
Belgium:                                            024003425
France:                                               0800947325
UK:                                                        08002795994
US:                                                        1 866 629 0057

About Celyad’s NKR Platform

Celyad is developing a unique Natural Killer Receptor (NKR) based T-Cell platform to target a wide range of solid and hematological tumors. Unlike traditional CAR-T cell therapy, which target only one tumor antigen, Natural Killer (NK) cell receptors enable a single receptor to recognize multiple tumor antigens.

Celyad’s lead candidate, NKR-2, is a T-Cell engineered to express the human NK receptor, NKG2D, which is an activating receptor that triggers cell killing through the binding of NKG2D to any of eight naturally occurring ligands that are known to be overexpressed on more than 80% of tumors.

Preclinical results indicate that NKR-2 has multiple mechanism of actions and goes beyond direct killing by signifying that its encoded T-Cells attack the tumor cells, inhibit the mechanisms that enable tumors to evade the immune system, activate and recruit anti-tumor immune cells and disrupt the blood supply to the tumor. These mechanisms promote the induction of adaptive immunity, meaning the body develops a long-term cell immune memory against specific tumor antigens of the targeted tumor.

In contrast to traditional CAR-T therapeutic approaches, and based on strong preclinical evidence, Celyad’s current NKR-2 program does not employ patient lymphodepleting pre-conditioning, thereby avoiding the toxicities associated with chemotherapy and allowing the immune system to remain intact.

Celyad is developing both autologous and allogeneic NKR-2 administrations. For autologous NKR-2, Celyad collects the patient’s own T-Cells and engineers them to express NKG2D in order to target cancer cells effectively. Celyad’s allogeneic platform engineers the T-Cells of healthy donors, that also express TCR Inhibitory Molecules (TIMs), to avoid having the engineered donor cells be rejected by the patient’s normal tissues.

The preclinical research underlying this technology was originally conducted at Dartmouth College by Dr. Charles Sentman and has been published extensively in peer-reviewed publications.

NKR-2 is currently being tested in a Phase I trial in acute myeloid leukemia and multiple myeloma patients. The trial is designed to assess the safety and feasibility of NKR-2, with secondary endpoints including clinical activity. Key research investigations include understanding the persistence of NKR-2 cells within the patient.

About ONO PHARMACEUTICAL CO., LTD.
ONO PHARMACEUTICAL CO., LTD., headquartered in Osaka, Japan, is an R&D-oriented pharmaceutical company committed to create innovative medicines in specific areas. It focuses especially on the oncology and diabetes areas. For more information, please visit the company’s website at http://www.ono.co.jp/eng/index.html

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