 Interim analysis from alloSHRINK Phase 1 trial demonstrated mPFS of 3.9 months for mCRC patients with MSS disease treated with CYAD-101 following FOLFOX preconditioning; expansion cohort of alloSHRINK trial on-track to begin by fourth quarter 2020 Phase 1 dose-escalation trial for lead shRNA-based allogeneic CAR T candidate, CYAD-211, for rr MM on-track to initiate by year-end 2020 rr AML and MDS franchise update: Initial results from CYCLE-1 trial compared to DEPLETHINK trial leads to prioritization of CYAD-02 over CYAD-01 following preconditioning chemotherapy; CYAD-01 continues to progress in THINK trial expansion segment; additional data from rr AML and MDS programs are expected by year-end 2020 Conference call and webcast scheduled for August 7 at 2:00 p.m. CEST 8:00 a.m. EDTMONT-SAINT-GUIBERT, Belgium, Aug. 06, 2020 GLOBE NEWSWIRE -- Celyad Oncology SA Euronext Nasdaq: CYAD, a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell CAR T therapies for cancer, today announced its consolidated financial results for the first half of 2020 and provided its second quarter business update.In the first half of 2020, weve further strengthened our position as a leading innovator in the development of CAR T therapies for cancer with a steady stream of clinical and preclinical data across our development pipeline and technology platforms. The advancement of our allogeneic programs, including additional data we recently provided from the Phase 1 alloSHRINK trial evaluating CYAD101 for the treatment of metastatic colorectal cancer, as well as our next-generation, non-gene edited CYAD-200 series of CAR T candidates, led by CYAD-211, for the treatment of multiple myeloma, supports our commitment to delivering next-generation CAR T candidates for the treatment of cancer, commented Filippo Petti, Chief Executive Officer of Celyad Oncology. Our team is very excited by the significant progress we continue to make across our programs and has worked tirelessly throughout the COVID-19 pandemic to keep our programs on track to provide several clinical updates in the second half of 2020.Second Quarter 2020 and Recent Business Highlights Reported updates from the Companys allogeneic CAR T franchise, including additional data from the Phase 1 alloSHRINK trial evaluating CYAD101 for the treatment of metastatic colorectal cancer mCRC and its short hairpin RNA shRNA platform underpinning the next-generation, non-gene edited CYAD-200 series of CAR T candidates Announced that the U.S. Food and Drug Administration FDA accepted the Investigational New Drug IND application for CYAD-211 and permitted it to go into effect for the treatment of relapsed or refractory multiple myeloma rr MM Granted four additional patents associated with the Companys allogeneic CAR T patent estate Awarded 3.3 million in non-dilutive funding from the Walloon Region of Belgium associated with CYAD-101 Launched the Companys corporate rebranding, including changing its name to Celyad Oncology. The new name highlights the Companys significant progress with its next-generation CAR T programs and emphasizes its commitment to cancer patientsUpdate on Clinical and Preclinical ProgramsCYAD-101 Allogeneic TIM-based, NKG2D CAR T for Refractory Metastatic Colorectal Cancer with Microsatellite Stable DiseaseCelyad Oncologys first-in-class, non-gene edited clinical candidate CYAD-101, which co-express NKG2D and the novel inhibitory peptide TIM TCR Inhibitory Molecule, continues to advance in the alloSHRINK Phase 1 trial for the treatment of mCRC. During the American Society of Oncology ASCO Virtual Scientific Program, the Company presented data from the first fifteen patients enrolled in the ongoing alloSHRINK trial assessing safety and clinical activity of CYAD-101 administered following FOLFOX chemotherapy in refractory patients with advanced mCRC with microsatellite stable MSS disease: Treatment with CYAD-101 was well-tolerated, with no clinical evidence of Graft-versus-Host Disease GvHD observed In addition, anti-tumor activity was observed in the trial with two patients who achieved a confirmed partial response PR, according to RECIST 1.1 criteria, and nine patients who achieved stable disease SD, including two patients with SD through six months Recent analysis of the dose-escalation segment of the alloSHRINK trial showed median progression free survival mPFS was 3.9 months for patients treated with CYAD-101 following FOLFOX chemotherapy No correlation was observed between clinical responses and the degree of human leukocyte antigen HLA matching between patients and CYAD-101 donor cells, indicating that CYAD-101 can be used in a broad patient population regardless of the HLA haplotypeThe expansion cohort of the alloSHRINK trial will evaluate CYAD-101 following FOLFIRI preconditioning chemotherapy in refractory mCRC patients with MSS disease, at the recommended dose of one billion cells per infusion. Enrollment in the expansion cohort of the study is expected to begin during the fourth quarter of 2020.CYAD-211 Allogeneic shRNA-based, BCMA CAR T for Relapsed or Refractory Multiple MyelomaCYAD-211 is the lead program from the Companys CYAD-200 series of proprietary non-gene edited allogeneic short hairpin shRNA-based CAR T candidates. CYAD-211 is engineered to co-express a BCMA-targeting chimeric antigen receptor and a single shRNA, which interferes with the expression of the CD3ζ component of the T-cell receptor TCR complex. In July 2020, the IND application for CYAD-211 went into effect with the FDA, and the Company plans to initiate the Phase 1 IMMUNICITY trial evaluating CYAD-211 following preconditioning chemotherapy in rr MM by year-end 2020.CYAD-01 Autologous NKG2D CAR T for Relapsed or Refractory Acute Myeloid Leukemia and Myelodysplastic SyndromeThe Companys first-in-class NKG2D CAR T clinical candidate CYAD-01 continues to advance in the ongoing Phase 1 THINK trial for the treatment of patients with relapsed or refractory acute myeloid leukemia rr AML and myelodysplastic syndrome MDS. Based on preliminary clinical activity data from the dose-escalation Phase 1 DEPLETHINK trial, the Company has deprioritized the trial and stopped enrollment. The Company expects to announce preliminary data from CYAD-01 produced with the OptimAb manufacturing process from the expansion cohort of the Phase 1 THINK trial by year-end 2020.CYAD-02 Autologous NKG2D CAR T for Relapsed or Refractory Acute Myeloid Leukemia and Myelodysplastic SyndromeIn January 2020, the Company announced that the first patient was dosed in the Phase 1 dose-escalation CYCLE-1 trial evaluating CYAD-02 for the treatment of rr AML and MDS. In July 2020, the Company began enrollment in the third dose cohort of the trial. The CYCLE-1 trial is assessing the safety and clinical activity of a single infusion of CYAD-02 produced with the OptimAb manufacturing process following preconditioning chemotherapy with cyclophosphamide and fludarabine. Preliminary data from CYCLE-1 trial are expected by year-end 2020.Upcoming Milestones Plan to begin enrollment in the expansion cohort of the Phase 1 alloSHRINK trial evaluating CYAD-101 following FOLFIRI preconditioning chemotherapy in refractory mCRC patients with MSS disease during the fourth quarter of 2020 Report additional data from the CYAD-01 program in rr AML and MDS, including the dose-expansion cohort of the Phase 1 THINK trial by year-end 2020 Report preliminary data from the dose-escalation Phase 1 CYCLE-1 trial evaluating CYAD-02 in rr AML and MDS by year-end 2020 Expect to initiate the dose-escalation Phase 1 trial evaluating CYAD-211 in rr MM by year-end quarter 2020 COVID-19 Update On March 11, 2020, the World Health Organization declared the novel strain of coronavirus COVID-19 a global pandemic and recommended containment and mitigation measures worldwide. As of the date of our half year report, Belgium and United States, where the Company operates, continues to be impacted by the pandemic. The length or severity of this pandemic cannot be predicted, but the Company anticipates that there may be an additional impact from a prolonged COVID-19 environment on the planned development activities of the Company.To date, COVID-19 has had no impact on the Companys financial statements and corporate cash flow, and the Company expects that its existing treasury position will be sufficient, based on the current scope of activities, to fund operating expenses and capital expenditure requirements into third quarter 2021.As previously disclosed, the coronavirus pandemic has led to enrollment delays in the Companys Phase 1 clinical trials within its relapsedrefractory acute myeloid leukemia and myelodysplastic syndromes program. Principally, for several weeks between March and April 2020, the Company experienced a delay in enrollment in the CYAD-01 THINK and DEPLETHINK trials as multiple clinical trial sites, both in Belgium and the United States, paused activities associated with new patient enrollment to prioritize resources to patients with COVID-19. By the end of the second quarter, recruitment in the CYAD-01 THINK and DEPLETHINK trials had recovered. In comparison, enrollment in the CYAD-02 CYCLE-1 dose-escalation trial was less affected by the coronavirus pandemic, partially due to the staggered enrollment associated with the trial. 