CER-1236 / CERo Therap - LARVOL DELTA

CER-1236, an investigational T cell product targeting TIM-4 Ligand, exhibits sustained effector function and resistance to exhaustion (SITC 2025) - "Similar PS upregulation was observed following treatment with recombinant cytokines, suggesting a novel mechanism by which TIM-4-L can be induced on cancer cells.Conclusions Here, we demonstrate a novel engineered T cell targeting TIM-4-L, a cancer-associated antigen that can be upregulated by standard chemotherapeutics and inflammatory cytokines. CER-1236 demonstrated maintenance of proliferative and effector functions and low expression of canonical exhaustion markers after chronic stimulation, suggesting they are resistant to T-cell exhaustion."

IO biomarker • Oncology • Solid Tumor • HAVCR2 • LAG3 • PD-1 • TLR2

CERo Therapeutics Announces Completion of First Cohort of Phase 1 Clinical Trial of CER-1236 in AML (GlobeNewswire) - "The conclusion of the first cohort follows observation of cell expansion consistent with preclinical expectations, with no dose-limiting toxicities observed....Following approval of the Dose Escalation Safety Committee, the investigators have agreed to initiate the second cohort of the study in which three new patients will receive an increase in the starting dosage from the previous cohort."

Trial status • Acute Myelogenous Leukemia

CERo Therapeutics Progresses Phase 1 CER-1236 AML Trial with Dosing of Third Patient in Initial Dose Cohort (GlobeNewswire) - "Per protocol, three patients are planned at this lowest dose level, and enrollment of the third subject may complete the initial cohort pending the outcome of protocol-defined safety assessments, including the dose-limiting toxicity (DLT) evaluation period."

Trial status • Acute Myelogenous Leukemia

CERo Therapeutics Receives Notice of Allowance from U.S. Patent and Trade Office on Composition of Matter and Method of Use for CER-1236 in Cancer with Expected Protection Through 2041 (GlobeNewswire) - "The Company also obtained a patent in Japan, which provides protection for the CER platform.The newly allowed U.S. application and issued Japanese patent join 17 other patents and another allowed application, bringing the total to 18 patents and 2 allowed applications covering CER-1236 and its platform technology internationally."

Patent • Hematological Malignancies

CERo Therapeutics Receives FDA Fast Track Designation for CER-1236 in Acute Myeloid Leukemia (AML) (GlobeNewswire) - "The first-in-human, multi-center, open label, Phase 1/1b study, currently underway, is designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with acute myeloid leukemia that is either relapsed/refractory, or in remission with measurable residual disease, or newly diagnosed patients with TP53 mutated MDS/AML or AML."

Fast track • Trial status • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

First-in-Human Study of Autologous Chimeric Engulfment Receptor T Cell CER-1236 Targeting TIM-4-L in Acute Myeloid Leukemia (CertainT-1) (SOHO 2025) - P1 | "Study Treatment: Patients will receive lymphodepleting chemotherapy (LDC) with fludarabine 30 mg/m2/ d and cyclophosphamide 400 mg/m2/d for 3 days followed by a single infusion of CER-1236 2 days later. Secondary objectives are to measure objective response rate per the ELN 2022 criteria including CR+CRh+CRi+MLFS, cCR, MRD negative rate, pharmacokinetic/pharmacodynamic (PK/PD) profile, and biomarkers of response. (NCT06834282)."

P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • TLR2 • TP53

CERo Therapeutics Holdings, Inc. Announces FDA Orphan Drug Designation Granted to CER-1236 for the Treatment of Acute Myeloid Leukemia (AML) (GlobeNewswire) - "CERo Therapeutics Holdings, Inc...announces that the U.S. Food and Drug Administration (FDA) has granted CERo’s Orphan Drug Designation (ODD) for the company's lead drug candidate CER-1236, for the treatment of acute myeloid leukemia (AML)....CER-1236 is currently in Phase 1 clinical trials for AML."

Orphan drug • Acute Myelogenous Leukemia

First-in-human study of autologous chimeric engulfment receptor T-cell CER-1236 targeting TIM-4-l in acute myeloid leukemia (CertainT-1). (ASCO 2025) - "Study treatment: Patients will receive lymphodepleting chemotherapy (LDC) with fludarabine 30 mg/m2/d and cyclophosphamide 400 mg/m2/d for 3 days followed by a single infusion of CER-1236 2 days later. The primary objective of the study is the safety of CER-1236 in terms of dose-limiting toxicities, cytokine release syndrome, and Immune effector cell-associated neurotoxicity syndrome. Secondary objectives are to measure objective response rate per the ELN 2022 criteria including CR+CRh+CRi+MLFS, cCR, MRD negativity by flow cytometry, and PK/PD profile and biomarkers of response."

IO biomarker • P1 data • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Oncology • TLR2 • TP53

CERo Therapeutics Holdings, Inc. Announces Continued Enhancement of Intellectual Property Portfolio with Two Granted U.S. Patents and European Patent Application Allowance Regarding Company’s Lead Compound CER-1236 (The Manila Times) - "The USPTO granted U.S. Patent No. 12,291,557, titled, 'CHIMERIC TIM4 RECEPTORS AND USES THEREOF' on May 6, 2025. The granted claims cover certain design aspects of CER-1236, the Company’s lead compound....The allowance of this European patent application expands protection of additional design aspects of CER-1236, which have already been granted in the U.S., Japan, and China....Finally, the USPTO granted U.S. Patent No. 12,303,551, titled, 'CELLULAR IMMUNOTHERAPY COMPOSITIONS AND USES THEREOF,' on May 20, 2025. This patent provides coverage for combination cellular immunotherapy compositions and methods of use for CER-1236....In the near term, we anticipate updates on our clinical trial progress in AML, and the announcement of initiating human trials to treat ovarian and non-small cell lung cancers."

New trial • Patent • Trial status • Acute Myelogenous Leukemia • Non Small Cell Lung Cancer • Ovarian Cancer

CERo Therapeutics Holdings, Inc. Doses First Patient with CER-1236 in Phase 1 Clinical Trial for Acute Myeloid Leukemia and is Advancing Through Protocol-Defined Evaluations (Yahoo Finance) - "CERo Therapeutics Holdings, Inc...announces it has dosed the first patient in its Phase 1 clinical trial of CER-1236. The patient was dosed at the lead trial site in a study focused on patients with acute myeloid leukemia (AML). Now more than seven days post-infusion, monitoring continues for key safety, tolerability, and efficacy endpoints. The study will be featured in a poster being presented at the 2025 Annual Meeting of the American Society of Clinical Oncology being held in Chicago May 30-June 3, 2025....Protocol-specified evaluations of safety, pharmacodynamic, pharmacokinetic, and efficacy endpoints are in progress. We look forward to communicating results as data matures."

Trial status • Acute Myelogenous Leukemia

CERo Therapeutics, Inc. Announces Up to $8 Million Series D Financing (GlobeNewswire) - "CERo Therapeutics Holdings, Inc...announces that it has entered into a securities purchase agreement for the issuance and sale of securities under a new convertible preferred stock transaction. The gross proceeds to CERo from the offering are expected to be up to $8 million, including $5 million expected to be received through the investment of securities at the first closing, and up to $3 million of cash that may be funded at one or more additional closings, at the election of the investors. CERo intends to use the net proceeds from the offering to take advantage of the two recent FDA IND allowances in liquid and solid tumors and complete the previously announced site activation at MDACC, as well as bring other sites online quickly. "

Financing • Acute Myelogenous Leukemia • Solid Tumor

CERo Therapeutics Holdings, Inc. Announces Sarah Cannon Research Institute at Colorado Blood Cancer Institute as Key Clinical Trial Site for its Phase 1 Clinical Trial of CER-1236 in Acute Myeloid Leukemia (GlobeNewswire) - "CERo Therapeutics Holdings, Inc...announces that Sarah Cannon Research Institute (SCRI) at Colorado Blood Cancer Institute (CBCI) in Denver, Colorado will be a key clinical trial site for the Company’s Phase 1 clinical trial of CER-1236. Partnering with SCRI to advance cancer research, CBCI is the region’s leader in blood cancer care and serves a seven-state region. The trial is focused on patients with acute myeloid leukemia (AML), and patient enrollment is underway with first dosing of the initial cohort of patients expected by June."

Trial status • Acute Myelogenous Leukemia

CertainT-1: CER-1236 in Patients With Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: CERo Therapeutics Holdings, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

CERo Therapeutics Holdings, Inc. Announces TriStar Centennial Medical Center as a Clinical Trial Site for its Phase 1 Clinical Trial of CER-1236 in Acute Myeloid Leukemia (GlobeNewswire) - "CERo Therapeutics Holdings, Inc...announces that TriStar Centennial Medical Center, through Sarah Cannon Research Institute (SCRI), in Nashville, Tennessee, is a clinical trial site for the Company’s Phase 1 clinical of CER-1236. Collaborating with SCRI to advance cancer research, TriStar Centennial offers innovative clinical research trials for various disease indications. The trial is focused on patients with acute myeloid leukemia (AML), and patient enrollment is underway, with expected dosing of the first patient during the first half of 2025....The first-in-human, multi-center, open label, Phase 1/1b study is designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with acute myeloid leukemia that is either relapsed/refractory, has measurable residual disease, or has a mutation of the TP53 gene."

Trial status • Acute Myelogenous Leukemia

CERo Therapeutics Holdings, Inc. Announces Critical Patent Application Allowances from the U.S. Patent Office Covering Company’s Lead Compound CER-1236 (GlobeNewswire) - "CERo Therapeutics Holdings, Inc...announces the allowance of two patent applications submitted to the U.S. Patent and Trademark Office (USPTO), which materially expands the Company’s intellectual property portfolio. Patent Application No. 17/040,472, titled, 'CELLULAR IMMUNOTHERAPY COMPOSITIONS AND USES THEREOF,' was allowed on March 13, 2025 and provides coverage for composition of matter and methods of use coverage for the Company’s lead compound, CER-1236....Additionally, the USPTO has issued a Notice of Allowance on March 24, 2025 for Patent Application No. 17/040,317, titled, 'CHIMERIC TIM4 RECEPTORS AND USES THEREOF.' The allowed claims encompass some design aspects of CER-1236....CERo’s intellectual property portfolio now includes 9 total patent families with protection out to 2039 in the United States."

Patent • Oncology

CERo Therapeutics Holdings, Inc. Announces Initial Clinical Trial Site for its Phase 1 Clinical Trial of CER-1236 in Acute Myeloid Leukemia (GlobeNewswire) - "CERo Therapeutics Holdings...announces its first clinical trial site for the Company’s Phase 1 clinical trial of CER-1236. The trial is focused on patients with acute myeloid leukemia (AML), and patient enrollment is underway, with expected dosing of the first patient during the first half of 2025....The first-in-human, multi-center, open label, Phase 1/1b study is designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with acute myeloid leukemia that is either relapsed/refractory, has measurable residual disease, or has a mutation of the TP53 gene."

Trial status • Acute Myelogenous Leukemia

CERo Therapeutics Holdings, Inc. Receives FDA Clearance of Second Investigational New Drug Application to Initiate Phase 1 Clinical Trial of Lead Compound CER-1236 in Solid Tumors (GlobeNewswire) - "CERo Therapeutics Holdings, Inc...announces that the Company has received clearance by the U.S. Food and Drug Administration (FDA) for a second Investigational New Drug (IND) application for lead compound CER-1236 for a Phase 1 clinical trial in advanced solid tumors, specifically non-small cell lung cancer and ovarian cancer."

IND • New P1 trial • Non Small Cell Lung Cancer • Ovarian Cancer • Solid Tumor

CERo Therapeutics Holdings, Inc. Poised to Initiate Enrollment of Phase 1 Trial of CER-1236 in AML Following Positive FDA Review of Manufacturing (GlobeNewswire) - "CERo Therapeutics Holdings, Inc...announces that the Company has received positive review from the U.S. Food and Drug Administration (FDA) on an amendment to its IND around Chemistry, Manufacturing and Controls (CMC), which marks completion of the Company’s final commitment to FDA prior to initiating patient dosing and shortens the manufacturing timeline by about a week. With this completion, the Company is on track to meet its anticipated timeline of dosing initial subjects during the first half of 2025....Company reports acceptance of an abstract at the 2025 American Society of Clinical Oncology (ASCO) conference."

FDA event • Trial status • Acute Myelogenous Leukemia

CERo Therapeutics Holdings, Inc. Continues to Progress Toward Initial Dosing of Patients in Phase 1 Trial with Agreement with University of California Davis for Manufacturing Services (GlobeNewswire) - "CERo Therapeutics Holdings, Inc...announces an agreement with the University of California Davis for the manufacturing of CER-1236 to be used in the Company’s upcoming Phase 1 clinical trial for Acute Myeloid Leukemia (AML). The Company believes it is on track for dosing the first patient in the first half of 2025."

Trial status • Acute Myelogenous Leukemia

CERo Therapeutics Holdings, Inc. Presents Encouraging Preclinical Data Demonstrating CER-1236 May be Targeted to Ovarian Cancer Cells Without Toxicities at 2025 SITC Spring Scientific Cellular Therapy for Solid Tumors Meeting (GlobeNewswire) - "CERo Therapeutics Holdings, Inc...announces it is presenting encouraging preclinical results of lead compound CER-1236 in ovarian cancer during the 2025 SITC Spring Scientific Cellular Therapy for Solid Tumors in San Diego, March 12-14. In the poster...investigators demonstrated that CER-1236 treated ovarian cancer cells and did not generate toxicity in animal models (mice). Investigators found that following dosing, assessment of clinical and anatomic pathology after CER-1236 infusion showed T cell engraftment in lymphoid organs, but there were no in-life observations, clinical pathology, nor histopathological evaluations indicating toxicity caused by the compound."

Preclinical • Ovarian Cancer

CERo Therapeutics Holdings, Inc. to Present Data at the Society for Immunotherapy of Cancer Spring Scientific March 12-14 (GlobeNewswire) - "CERo Therapeutics Holdings, Inc...announces it will be presenting preclinical results of lead compound CER-1236 in ovarian cancer during the Spring Scientific from the Society for Immunotherapy of Cancer (SITC) in San Diego, March 12-14...The Company will announce the data concurrently with the presentation at the conference by making the poster available on its website at 9:00AM ET on March 13, 2025...'We have significant data in multiple liquid and solid tumors for CER-1236 demonstrating tremendous potential across many cancer types. Moreover, we will not only be testing CER-1236 shortly in AML but anticipate doing so as well in ovarian cancer and non-small cell lung cancer in 2025.'"

New trial • Preclinical • Acute Myelogenous Leukemia • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer

CERo Therapeutics Holdings, Inc. Announces Progress in Initiation of Phase 1 Clinical Trial by Executing an Agreement with Contract Research Organization CellCarta to Manage Translational Assays (GlobeNewswire) - "CERo Therapeutics Holdings, Inc...announces the execution of an agreement with contract research organization (CRO) CellCarta to manage translational assays for the Company’s upcoming Phase 1 clinical trial of CER-1236 for Acute Myeloid Leukemia (AML). This is important progress as the Company prepares to enroll patients in the trial, as CellCarta will be responsible for key data elements, including pharmacokinetics, cytokine secretion, and target detection. The CRO will also support our clinical trial sites with sample kitting, shipment, and overall logistics to ensure clinical sample integrity is maintained during transport to testing sites."

Commercial • Acute Myelogenous Leukemia

CertainT-1: CER-1236 in Patients With Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: CERo Therapeutics Holdings, Inc.

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

CERo Therapeutics, Inc. Receives FDA Clearance of Investigational New Drug Application to Initiate Phase 1 Clinical Trial of Its Lead Compound CER-1236 in Acute Myelogenous Leukemia (GlobeNewswire) - "CERo Therapeutics Holdings, Inc...announces that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug Application (IND) for Phase 1 clinical trials of its lead compound, CER-1236, in acute myelogenous leukemia (AML)."

IND • New P1 trial • Acute Myelogenous Leukemia

TIM-4-L expression on ovarian cancer can be targeted by engineered chimeric engulfment receptor T cells without toxicity (SITC 2024) - "CER-1236 can kill ovarian cancer cell lines in culture and further increase cell surface TIM-4-L on ovarian cancer through secreted factors. CER-1236 shows specificity to TIM-4-L and is not associated with any clinically relevant toxicities in a relevant preclinical murine model, making them an attractive option for treating ovarian cancer."

Oncology • Ovarian Cancer • Solid Tumor • IFNG • TLR2