On November 17, 2017 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of specialized CAR-T cell based therapies, reported an update on key clinical and operational developments for the third quarter ended Sept. 30, 2017 (Press release, Celyad, NOV 17, 2017, View Source [SID1234522222]).
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THIRD QUARTER 2017 AND RECENT HIGHLIGHTS
• Reported first complete response by a CAR-T therapy in a patient with relapsed refractory AML (Acute Myeloid Leukemia) in the Phase 1b THINK1 trial
• Reported promising safety and clinical activity of CYAD-01 (CAR-T NKG2D) in all AML patients treated so far in THINK trial
• Announced amended agreements with Celdara Medical and Dartmouth College following encouraging results from the THINK trial
• Initiated the Phase 1 SHRINK2 study in Belgium to evaluate the synergetic effect of the concurrent administration of CYAD-01 with standard chemotherapy in patients suffering from metastatic colorectal cancer
Christian Homsy, CEO of Celyad commented: "We are pleased with our progress during the third quarter, particularly with the complete response in a relapse refractory AML patient to the CYAD-01 therapy in our THINK trial. This, together with the clinical activity detected in all AML patients treated so far encourages us to rapidly progress in our development. Having seen this activity, we want to build upon it and explore how to strengthen it and make it more robust. The research steps are behind us now, and the development strategy we are engaged in will investigate approaches that will both strengthen the responses and make them more durable, when needed."
The clinical responses obtained by Celyad are perceived as a key milestone not only for the company, but also for the CAR-T field as a whole, as this is the first time that a patient has shown a complete response to a CAR-T therapy without pre-conditioning. Christian Homsy added: "The results validate CYAD-01 and NKG2D as a target in AML, a severe disease that affects approximately 20,000 people in the US and almost as many people in Europe. Celyad will further investigate CYAD-01 in this indication as well as in colorectal cancers, an indication for which CYAD-01 has also demonstrated interesting results."
1 THINK: THerapeutic Immunotherapy with CAR-T NKG2D
2 SHRINK: Standard CHemotherapy Regimen and Immunotherapy with CAR-T NKG2D
www.celyad.com | 1
LOGO Press Release
17 November 2017
07:00 am CET
Regulated Information
THIRD QUARTER 2017 OPERATIONAL AND FINANCIAL REVIEW
In July 2017, Celyad initiated the SHRINK trial, an open-label Phase 1 study evaluating the safety and clinical activity of multiple doses of CYAD-01, administered concurrently with the neoadjuvant FOLFOX treatment in patients with potentially resectable liver metastases from colorectal cancer. The trial includes a dose escalation and an extension stage. The dose escalation design will include three dose levels adjusted to body weight: up to 1×108, 3×108 and 1×109 CYAD-01 cells. At each dose, patients will receive three successive administrations, two weeks apart, at the specified dose. The dose escalation portion of the study will enroll up to 18 patients and the extension phase will enroll 21 additional patients. SHRINK is being conducted in oncology centers in Belgium.
In August 2017, Celyad amended its existing agreements with Celdara Medical LLC and Dartmouth College. Under the amended agreements, Celyad will receive an increased share of future revenues generated by these assets, including revenues from its sublicensees. In return, Celyad paid Celdara Medical and Dartmouth College an upfront payment of $12.5 million (€10.6 million) and $12.5 million worth of Celyad shares at a share price of €32.35 corresponding to a 14% premium versus the prior trading day.
Patrick Jeanmart, CFO of Celyad, added, "Our revised agreements with Celdara Medical and Dartmouth College reflect our strong belief in the value-creating potential of our allogeneic CAR-T cell patent portfolio and our ongoing confidence in CYAD-01. By shifting some of the value of the original deal upfront, we have increased our share of potential future revenues from sublicenses."
The Company ended the quarter with €40 million in cash. Use of cash over the third quarter of 2017 amounted to €29 million, of which €18 million paid to Celdara Medical and Dartmouth College as a result of our new license agreements. The cash burned by our operations was €11 million over the third quarter and €27 million over 2017, in line with our expectations. The company confirms its previous guidance, that existing cash, cash equivalents and short-term investments are sufficient to fund operating expenses and capital expenditure requirements, based on the current scope of activities, through to the first half 2019.
www.celyad.com | 2
LOGO Press Release
17 November 2017
07:00 am CET
Regulated Information
EVENTS SUBSEQUENT TO QUARTER-EN
In October 2017, Celyad announced a first ever morphologic complete response (MLFS3) with gene-engineered T-cells without prior pre-conditioning chemotherapy for a patient with relapsed refractory AML. At the first dose-level, 3×108, CYAD-01 T-cells were administered without any prior conditioning chemotherapy to a cohort of three patients with hematologic cancer (two with AML and one with multiple myeloma): One AML patient achieved a MLFS administered at the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida. A second AML patient treated also reached a Complete Response (CR) and more precisely a Complete Response with incomplete hematologic recovery. Unlike the patient that reached MLFS, this second patient progressed after a while and has since moved to another treatment.
The first AML patient treated at the second dose-level (1×109) was reported as Stable Disease with improvement of his hematological parameters at 2-month follow-up post treatment.
To date, all AML patients have shown varying clinical responses that are attributed to the CYAD-01 treatment.