CYAD-101 / Celyad Oncology - LARVOL DELTA

Universal CAR-T Cell Therapy for Cancer Treatment: Advances and Challenges. (PubMed, Oncol Res) - "Although trials for solid tumors (e.g., CYAD-101, CTX130) show modest responses, challenges such as tumor heterogeneity and T cell exhaustion remain. Future research should focus on optimizing gene editing precision, integrating combination therapies, and advancing scalable manufacturing platforms. With expanded targets and cell types, UCAR therapies show promise for both hematologic and solid tumors, reshaping cancer treatment and patient outcomes."

Journal • Review • Acute Lymphocytic Leukemia • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • Transplant Rejection • CD52

[VIRTUAL] Updated data from alloSHRINK phase I first-in-human study evaluating CYAD-101, an innovative non-gene edited allogeneic CAR-T in mCRC. (ASCO-GI 2021) - P1 | " Three CYAD-101 infusions, each administered following a FOLFOX standard cycle as preconditioning chemotherapy, were tested in a 3+3 dose-escalation study (dose-levels (DL): 108, 3x108 and 109 T-cells per infusion) in patients with relapsed/refractory mCRC who progressed after previous treatment with oxaliplatin-based chemotherapy, with or without irinotecan-based chemotherapy. These clinical results demonstrate the safety and tolerability of a fist-in-human non-gene edited allogeneic CAR T-cell treatment with early promising anti-tumor activity in advanced mCRC pts. Preliminary translational analysis present intriguing observations that the modulation of systemic cytokine levels may be associated with dose which is uncommon in CAR T-cell therapies reported to date while limited T-cell clonal diversification in the best responding patient underscores the likely central role of the adoptively transferred T-cell in driving therapeutic response in this particular..."

IO biomarker • P1 data • Colorectal Cancer • Gastrointestinal Cancer • KRAS • NKG2D

A Phase 1b KEYNOTE-B79 trial evaluating non-gene edited allogeneic CAR T-cells, CYAD-101, post FOLFOX preconditioning, followed by pembrolizumab, in refractory metastatic colorectal cancer patients (SITC 2021) - P1 | "Methods The KEYNOTE-B79 trial evaluates the safety and clinical activity of multiple infusions of CYAD-101, administered post FOLFOX preconditioning chemotherapy, then followed three weeks after CYAD-101 by a pembrolizumab consolidation treatment (200 mg every three weeks for a maximum two years total treatment duration) in microsatellite stable/mismatch-repair proficient mCRC patients with recurrent/progressing disease after at least one metastatic line of therapy which must include FOLFOX chemotherapy.The schedule of administration of three CYAD-101 infusions at the dose 1x109 cells/infusion Q2W post-FOLFOX preconditioning chemotherapy are based on the alloSHRINK study.This sequencing of checkpoint inhibitor at a timepoint after CYAD-101 therapy ensures that the modulated endogenous immune response is enabled by pembrolizumab. This study is not focused on impacting the CAR T cell itself largely since CYAD-101 cells at the time of manufacture show negligible..."

CAR T-Cell Therapy • Clinical • IO biomarker • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • NKG2D • PD-1

KEYNOTE-B79 phase 1b trial to evaluate the allogeneic CAR T-cells CYAD-101 and pembrolizumab in refractory metastatic colorectal cancer patients. (ASCO-GI 2022) - P1, P1b | "The co-primary endpoints of the trial are the occurrence of dose-limiting toxicities (DLTs) at any time from the first FOLFOX preconditioning treatment up to 3 weeks after the first pembrolizumab treatment and the objective response rate (ORR) at the tumor assessment planned 6 weeks after the first pembrolizumab treatment administration. The KEYNOTE-B79 study will be initiated in Q4-2021 in five sites in USA and Europe."

CAR T-Cell Therapy • Clinical • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • NKG2D

Celyad Oncology Provides Strategic Update (Businesswire) - "CYAD-101 – Allogeneic TIM-based, NKG2D CAR T Candidate for Metastatic Colorectal Cancer (mCRC): Based on a strategic, financial and medical review, taking into account the costs associated with the pursuit of the program and the delays to reach key medical milestones following the resolution of the previous Clinical Hold, the Company has decided to discontinue the development of CYAD-101....All patients currently on CYAD-101 trials will continue to receive their protocol-defined follow-up."

Discontinued • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

"#CelyadOncology reported that it has decided to discontinue the development of #CYAD101 $CYAD https://t.co/my9watrsH4" (@1stOncology)

Oncology

Celyad Oncology Announces FDA Lifts Clinical Hold of CYAD-101-002 Phase 1b Trial (GlobeNewswire) - "Celyad Oncology SA...announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the CYAD-101-002 (KEYNOTE-B79) Phase 1b trial after the Company made changes to the eligibility criteria for the trial....The CYAD-101-002 Phase 1b trial evaluates the TCR Inhibitory Molecule (TIM)-based allogeneic NKG2D CAR T cell investigational therapy CYAD-101 with MSD’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with refractory metastatic colorectal cancer (mCRC) with microsatellite stable (MSS) / mismatch-repair proficient disease."

Trial status • Colorectal Cancer • Gastrointestinal Cancer • Oncology

Celyad Oncology Reports Full Year 2020 Financial Results and Recent Business Highlights (GlobeNewswire) - “Upcoming Milestones; Additional proof-of-concept data from the initial dose cohorts of the Phase 1 IMMUNICY-1 trial of CYAD-211 for r/r MM are expected by the end of Q2 2021; Preliminary data from the expansion segment of the alloSHRINK trial evaluating CYAD-101 following FOLFIRI preconditioning chemotherapy in refractory mCRC patients are expected in Q2 2021; Initiation of the Phase 1b KEYNOTE-B79 trial evaluating CYAD-101 with KEYTRUDA® in mCRC patients with MSS/pMMR disease is anticipated by in the first half of 2021; Additional data from dose level 3 of Phase 1 CYCLE-1 trial of CYAD-02 for r/r AML and MDS are anticipated in the first half of 2021.”

New P1 trial • P1 data • Acute Myelogenous Leukemia • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Leukemia • Multiple Myeloma • Myelodysplastic Syndrome • Oncology • Solid Tumor

KEYNOTE-B79: Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal Cancer (clinicaltrials.gov) - P1 | N=34 | Recruiting | Sponsor: Celyad Oncology SA | Not yet recruiting ➔ Recruiting | Phase classification: P1b ➔ P1

Enrollment open • Phase classification • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • MSI

Celyad Oncology Announces Voluntary Pause of CYAD-101-002 Phase 1b Trial (GlobeNewswire) - "Celyad Oncology SA...announced it has taken the decision to voluntarily pause the CYAD-101-002 (KEYNOTE-B79) Phase 1b trial (NCT04991948)...The Company is informing regulatory agencies, which may require additional actions of the Company. The Company expects to provide additional updates on the trial in the near future."

Trial suspension • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Clinical Grade Manufacture of CYAD-101, a NKG2D-based, First in Class, Non-Gene-edited Allogeneic CAR T-Cell Therapy. (PubMed, J Immunother) - P1 | "Moreover, CYAD-101 cells failed to respond to TCR stimulation, indicating a lack of allogeneic potential. This bank of clinical grade, non-gene-edited, allogeneic CYAD-101 cells are used in the alloSHRINK clinical trial (NCT03692429)."

CAR T-Cell Therapy • IO biomarker • Journal • Graft versus Host Disease • Immunology • Oncology • CD4 • NKG2D

Celyad Oncology Provides Outlook for 2022 (Businesswire) - "Enrollment continues in the KEYNOTE-B79 Phase 1b trial for CYAD-101. Preliminary data from the trial are expected in the second half of 2022; In addition, the KEYNOTE-B79 study will be the subject of a presentation at the upcoming American Society of Clinical Oncology Gastrointestinal Cancers (ASCO GI) Symposium being held from January 20-22, 2022; Investigational New Drug (IND)-enabling studies continue for CYAD-203. Submission of the IND application for CYAD-203 is expected in the second half of 2022."

IND • P1 data • Trial status • Colorectal Cancer • Gastrointestinal Cancer • Oncology

Celyad Oncology Announces First Patient Dosed in KEYNOTE-B79 Phase 1b Trial (GlobeNewswire) - "Celyad Oncology SA...announced the first patient was dosed in the KEYNOTE-B79 Phase 1b trial (NCT04991948)...' We are grateful to MSD for collaborating with us on this trial and expect to share preliminary data next year.'"

P1 data • Trial status • Colorectal Cancer • Gastrointestinal Cancer • Oncology

Celyad Oncology Announces Closing of $32.5 Million Private Placement with Fortress Investment Group Affiliate (GlobeNewswire) - "The Company intends to use net proceeds from the private placement to fund research and development expenses, including the clinical development of its allogeneic CAR T candidates CYAD-101 and CYAD-211, to advance the current pipeline of preclinical CAR T candidates, to discover and develop additional preclinical product candidates using its proprietary non-gene edited short hairpin RNA (shRNA) technology platform, as well as for working capital, other general corporate purposes, and the enhancement of the Company’s intellectual property."

Commercial • Oncology

Celyad Oncology Announces $32.5 Million Private Placement with Fortress Investment Group (GlobeNewswire) - "Celyad Oncology SA...announced that it has entered into a subscription agreement with an affiliate of Fortress Investment Group...for the private placement of 6,500,000 ordinary shares for gross proceeds of USD 32.5 million (about EUR 28.7 million)...The Company intends to use net proceeds from the private placement to fund research and development expenses, including the clinical development of its allogeneic CAR T candidates CYAD-101 and CYAD-211, to advance the current pipeline of preclinical CAR T candidates, to discover and develop additional preclinical product candidates using its proprietary non-gene edited short hairpin RNA (shRNA) technology platform, as well as for working capital, other general corporate purposes, and the enhancement of the Company’s intellectual property."

Financing • Oncology

Celyad Oncology Presents Preclinical Data on Allogeneic CAR T Therapy Program and Highlights KEYNOTE-B79 Clinical Trial Design at the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting (GlobeNewswire) - '"We believe our CAR T cells are the only allogeneic CAR T cells currently in human clinical trials that avoid generating double-strand DNA breaks. Combining with multiplexed shRNA and cytokine armoring, we believe this approach provides us with a dynamic platform for the generation of future allogeneic candidates'...The KEYNOTE-B79 trial will therefore evaluate the safety and clinical activity of multiple infusions of CYAD-101 administered post FOLFOX preconditioning chemotherapy, followed by treatment with KEYTRUDA® (pembrolizumab) in mCRC patients with microsatellite stable disease, according to a Simon’s two stage trial design. The KEYNOTE-B79 clinical trial is expected to begin in fourth quarter 2021."

Clinical protocol • Preclinical • Trial status • Colorectal Cancer • Gastrointestinal Cancer • Oncology

The Society for Immunotherapy of Cancer (SITC) invites you to attend the virtual press briefing of the society’s 36th Anniversary Annual Meeting (PRWeb) - "The abstracts selected for the press briefing represent an array of the top advances in cancer immunotherapy research. Regular and late-breaking abstracts are embargoed until 8 a.m. EST, Nov. 9, 2021. Data shared during the presentation is embargoed until that date unless otherwise stated during the press briefing."

Clinical data • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Melanoma • Oncology • Prostate Cancer

Celyad Oncology to Present New Data on Allogeneic CAR T Therapy Program at the Society for Immunotherapy of Cancer Annual Meeting (Businesswire) - "Celyad Oncology SA...announced that three abstracts about the Company’s allogeneic CAR T therapy programs will be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting taking place in Washington D.C. and virtually November 10-14, 2021. Posters will include additional information on Celyad’s multiplexing capabilities using short hairpin RNA (shRNA) technology, the Company’s first allogeneic, IL-18-armored CAR T candidate, CYAD-203, and the Phase 1b KEYNOTE-B79 trial of CYAD-101 in refractory metastatic colorectal cancer patients."

Clinical data • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology

Phase 1 studies assessing the safety and clinical activity of autologous and allogeneic NKG2D-based CAR-T therapy in metastatic colorectal cancer (ESMO-GI 2019) - P1; "The SHRINK study (NCT03310008) evaluates the autologous product CYAD-01 while the alloSHRINK study (NCT03692429) evaluates an allogeneic analog of CYAD-01, i.e. CYAD-101.   Safety, clinical and translational research data comparing autologous and allogeneic approaches at the end of the dose-escalations will be presented, including any potential difference in terms of cell engraftment. These studies will provide critical information to support the development of CAR-T therapy in solid tumors."

Clinical • IO biomarker • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Results from the completed dose-escalation of the alloSHRINK phase I study evaluating the allogeneic NKG2D-based CAR T-cell therapy CYAD-101 in metastatic colorectal cancer patients (SITC 2019) - P1; "As of August 2019, no GvHD has been observed following infusions of non-gene edited allogeneic CAR T-cells to mCRC patients at the first two DLs, with preliminary signals of clinical activity. The study will have reached protocol-specified endpoints for analysis at the time of presentation and safety, clinical and cell engraftment will be presented. The results from this study, in comparison with a study evaluating the autologous analog of CYAD-101 in mCRC will provide critical information to support the development of CAR-T therapy in solid tumors."

CAR T-Cell Therapy • Clinical • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Solid Tumor

Results from the completed dose-escalation phase I SHRINK study evaluating the autologous NKG2D-based CAR T-cell therapy CYAD-01 in metastatic colorectal cancer patients (SITC 2019) - P1; "Early data show preliminary signs of clinical activity with the concurrent administration of CYAD-01 and FOLFOX chemotherapy in the present SHRINK study. Safety, clinical and translational research data (cell engraftment) will be presented. The results from this study, in comparison with the results from a similar Phase I study evaluating the allogeneic analog of CYAD-01 in mCRC patients (i.e."

CAR T-Cell Therapy • Clinical • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

[VIRTUAL] CYAD-101: An innovative non-gene edited allogeneic CAR-T for solid tumor cancer therapy. (ASCO 2020) - P1 | "Fifteen refractory metastatic CRC patients who had previously failed at least one line of oxaliplatin—containing therapy were treated with three doses of CYAD-101 cells given on Day 3 of three successive FOLFOX chemotherapy cycles. These early clinical results demonstrate the safety and tolerability of a non-gene edited predominantly CD4+ CAR-T therapeutic approach. The initial observations of clinical activity in metastatic CRC patients warrants the continued development of this therapy. Research Funding: Celyad SA"

IO biomarker • Graft versus Host Disease • Oncology • Solid Tumor • CD27 • IFNG • IL2 • IL2RA • IL4 • IL5 • LAG3 • NKG2D • PD-1

[VIRTUAL] Updated data from alloSHRINK phase I first-in-human study evaluating CYAD-101, an innovative non-gene edited allogeneic CAR-T in mCRC. (ASCO-GI 2021) - P1 | " Three CYAD-101 infusions, each administered following a FOLFOX standard cycle as preconditioning chemotherapy, were tested in a 3+3 dose-escalation study (dose-levels (DL): 108, 3x108 and 109 T-cells per infusion) in patients with relapsed/refractory mCRC who progressed after previous treatment with oxaliplatin-based chemotherapy, with or without irinotecan-based chemotherapy. These clinical results demonstrate the safety and tolerability of a fist-in-human non-gene edited allogeneic CAR T-cell treatment with early promising anti-tumor activity in advanced mCRC pts. Preliminary translational analysis present intriguing observations that the modulation of systemic cytokine levels may be associated with dose which is uncommon in CAR T-cell therapies reported to date while limited T-cell clonal diversification in the best responding patient underscores the likely central role of the adoptively transferred T-cell in driving therapeutic response in this particular..."

IO biomarker • P1 data • Colorectal Cancer • Gastrointestinal Cancer • KRAS • NKG2D

Phase 1b Study to Evaluate the Addition of a Pembrolizumab Treatment After Treatment With CYAD-101 With a FOLFOX Preconditioning in Metastatic Colorectal Cancer Patients (clinicaltrials.gov) - P1b; N=34; Not yet recruiting; Sponsor: Celyad Oncology SA

New P1 trial • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • MSI

Celyad Oncology Presents Updates on Allogeneic CAR T Clinical Candidates and shRNA-based Preclinical Concepts at Research & Development Day (GlobeNewswire) - "Upcoming milestones: (i) Additional clinical activity data for the Phase 1 IMMUNICY-1 trial of CYAD-211 for r/r MM are expected during second half 2021; (ii) Study initiation for KEYNOTE-B79 Phase 1b is expected early fourth quarter 2021; (iii) Submission of an IND application for CYAD-203 is expected in mid-2022; (iv) Report additional data from the dose-escalation Phase 1 CYCLE-1 trial evaluating CYAD-02 in relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome in mid-2021."

IND • New P1 trial • P1 data • Acute Myelogenous Leukemia • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Leukemia • Microsatellite Instability • Multiple Myeloma • Myelodysplastic Syndrome • Oncology