Celyad (CYAD) is an immuno-oncology firm, which created CAR T CELL treatments for cancers, including solid tumors. Celyad announced its consolidated financial results for the six-month period ending 30 June 2018. Celyad’s report is endorsed by Europe.
Dr. Christian Homsy, Celyad’s CEO started by expressing the firm’s great enthusiasm towards the progress it has made in the first half of 2018, which include a significant advancement of CYAD-01, and its positive trial results that demonstrated activity and favorable tolerability profile of the product. Dr. Homsi said, “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.”
Non-editing, in this case, is a keyword, because there are other investigational allogeneic CAR T in trials by other firms, but are all gene-edited.
ACUTE MYELOID LEUKEMIA (AML)
Interim results from the THNK trial demonstrate 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 have been enrolled to date.
A complete second cycle of the investigational therapy was administered in the first AML patient enrolled at the second dose level (1×109). A second AML patient who got 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 EPITHINK trial: Based on feedback from the FDA, Celyad finalized the EPITHINK protocol, which is evaluating the synergetic effect of the concurrent administration of CYAD-01 (CAR-T NKG2D) with a standard of care 5-azacytidine (AZA) in treatment-naïve Acute Myeloid Leukemia (AML) or myelodysplastic syndrome (MDS) patients who are not candidates for intensive therapy.
The DEPLETHINK AML Trial: Based on feedback from the FDA, Celyad finalized the DEPLETHINK AML protocol, which is a trial that evaluates the administration of CYAD-01 following the administration of the traditional preconditioning regimen in refractory/relapsing AML and MDS patients.
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 the Journal Haematologica.
Dates to Remember
– Enrollment for the highest dose (3×109) in AML is expected to be completed in September 2018.
-The preliminary results of dose escalation segment will be reported in December during the American Society for Hematology (ASH) Annual Meeting (December 1-4, San Diego).
PANCREATIC, OVARIAN AND COLORECTAL CANCERS
The THINK Trial: Fourteen solid cancer patients (one pancreas, two ovarian and eleven colorectal (CRC) candidates 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.
A Date to Remember: Preliminary results will be reported during the Society for Immunotherapy of Cancer (SITC) Annual Meeting (November 7-11, Washington).
The SHRINK Trial: Three CRC patients were treated at the first dose level (1×108) with no dose-limiting toxicityreported to date in combination with the current standard of care.
The LINK Trial: One CRC patient has received three local hepatic trans-arterial injections at the first dose level (3×108) with no dose-limiting toxicity reported to date.
The DEPLETHINK CRC Trial: This study evaluates the administration of CYAD-01 after traditional preconditioning regimen in patients with 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.
Margo Roberts, Ph.D., joined Celyad’s Board of Directors and the scientific committee in early August, 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..
Filippo Petti: Appointed as Chief Financial Officer In August, 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.
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 into mid-2020.
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
Long before the half a year report that was just published, we felt good about the fact that Celyad was developing unedited allogeneic CAR T products. We appreciated the fact that this CAR T might work on solid tumors in addition to blood and lymphatic malignancies, which the autologous engineered CAR T Cells are currently struggling to achieve.
From the currently released report, we loved the fact that following the FDA acceptance of Celyad’s IND application for its product CYAD-01, the firm Initiated without delay or hesitation the EPITHINK4 and DEPLETHINK5 clinical trials.
We are impressed with the completion of the dose escalation portion of the THINK1 clinical trial in solid arm. We also appreciate the publication of the THINK study case report in Haematologica publication, In this case, the result was a complete tumor response to the treatment.
Making us feel good also was the availability of cash expected to support Celyad’s expenses until the year 2022.
We also liked the CV of the new appointees.
Yes, this is, indeed, good news.