CHM 0201 / Chimeric Therap, Case Western Reserve University - LARVOL DELTA

PHASE 1B CHM CORE-NK TRIAL ADVANCES TO INITIATE TREATMENT OF NEWLY DIAGNOSED AML PATIENTS (Chimeric Therapeutics Press Release) - "ADVENT-AML is the first clinical trial to evaluate the synergy of CORE-NK in combination with the current standard of care for AML patients. The Phase 1B ADVENT-AML clinical trial has completed enrolment of relapsed/refractory AML subjects in the dose finding portion of the trial. In the next phase of the trial, newly diagnosed AML subjects who are elderly or otherwise unsuitable for transplantation and have not been previously treated for AML, will be eligible for enrolment....Since the combination has demonstrated safety in subjects with relapsed or refractory disease, the study is now open to enrol up to 20 subjects with newly diagnosed AML who are not eligible for intensive chemotherapy or allogeneic stem cell transplant."

Enrollment status • Acute Myelogenous Leukemia

Chimeric Therapeutics (ASX:CHM) Announces AU$5Mn Placement to Advance Cancer Trials (Kalkine Media) - "The company has secured commitments from a range of institutional, sophisticated and professional investors. The funds raised will primarily support Chimeric’s clinical trial programs...The issue price is set at AU$0.008 (0.8 cents) per new fully paid ordinary share...Proceeds from the placement will primarily support Chimeric’s clinical trial pipeline and cell therapy portfolio, including: CHM CDH17 CAR-T Program...in a Phase 1/2 trial for various cancers...CHM CLTX Program: A novel CAR T therapy currently in a Phase 1b clinical trial for glioblastoma...CORE NK Platform: A Phase 1B clinical trial assessing NK cells combined with Vactosertib in patients with advanced colorectal and blood cancers, following a successful Phase 1A trial....Funding will also cover general working capital and capital-raising costs."

Financing • Brain Cancer • CNS Tumor • Colorectal Cancer • Gastrointestinal Cancer • Glioblastoma • Glioma • Hematological Malignancies • Oncology • Solid Tumor

Dose finding complete in ADVENT-AML Phase 1b clinical trial (Chimeric Therapeutics Press Release) - P1b | N=32 | ADVENT-AML (NCT05834244) | "Chimeric Therapeutics...is pleased to announce that the dose-finding portion of the ADVENT-AML Phase 1B clinical trial in Acute Myeloid Leukemia (AML) has completed enrolment with no dose-limiting toxicities or unexpected safety findings...The study is evaluating the synergy of NK cell therapy in combination with the current standard of care, Azacitidine and Venetoclax....Since the combination has demonstrated safety in subjects with relapsed or refractory disease, the study will open soon to enrol 20 subjects with newly diagnosed AML who are not eligible for intensive chemotherapy or allogeneic stem cell transplant."

Enrollment status • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

AML patient achieves Complete Response in CHM CORE-NK Combination Phase 1b trial (Chimeric Therapeutics Press Release) - P1b | N=12 | NCT05400122 | "Chimeric Therapeutics...is pleased to provide an update on the CHM CORE-NK + Vactosertib Phase 1b clinical trial, after a Complete Response from an Acute Myelogenous Leukemia (AML) patient participating in the trial...This is the first and currently only patient treated in the blood cancer arm of the Phase 1b trial...'As the study continues to enrol subjects with advanced cancer, we are pleased to see the clinical combination can be delivered safely, and we are very happy to report that one study subject with advanced Acute Myelogenous Leukemia (AML) experienced a Complete Response at Day 28 after starting treatment with the CHM CORE-NK + Vactosertib combination.' The patient will continue on study and be monitored for up to 15 years....3 patients are currently enrolled in the Phase 1b study with the goal to enrol 12 patients."

P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Chimeric Therapeutics (ASX: CHM) advances ADVENT-AML trial to next cohort (Kalkine Media) - "Chimeric Therapeutics Limited...has announced a significant advancement in its Phase 1B ADVENT-AML trial, which is moving forward to the next cohort. In the upcoming cohort, three patients with refractory or relapsed AML will receive CHM CORE-NK at dose level 2 in combination with venetoclax and azacitidine....Following a thorough review of the data from these three patients, the safety monitoring committee authorised the trial to proceed to the next cohort."

Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Chimeric announces re-opening of Phase 1B study of CHM CORE-NK (BiotechDispatch) - P1b | N=12 | NCT05400122 | "CHM CORE-NK was previously studied in a Phase 1 clinical trial that established safety with no GvHD (Graft versus Host Disease), prolonged NK cell persistence at 28 days, and an encouraging early efficacy signal, particularly in blood cancers where all patients achieved disease control. One patient achieved a complete response that was sustained for over 15 months at the time of study publication."

P1 data • Hematological Malignancies • Oncology

Chimeric announces re-opening of Phase 1B study of CHM CORE-NK (BiotechDispatch) - "...Chimeric Therapeutics...has announced that the investigator-sponsored Phase 1B study of CHM CORE-NK plus vactosertib has re-opened for enrolment....Chimeric said the Phase 1B study (NCT05400122) is intended to build upon the clinical responses seen in the initial CHM CORE-NK Phase 1A clinical trial by adding the oral TGF-β receptor inhibitor vactosertib. The study is designed to treat 12 patients with either locally advanced/metastatic colorectal cancer or relapsed/refractory blood cancers."

Enrollment open • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Solid Tumor

Chimeric Therapeutics secures US patent for groundbreaking ‘killer cell’ cancer therapy (Small Caps) - "Australian cell therapy specialist Chimeric Therapeutics...has achieved another milestone in its efforts to commercialise its CHM 0201 (CORE-NK) 'killer cell' technology...Chimeric has received confirmation from the US Patent & Trademark Office (USPTO) that it will allow the issuance of a patent application covering the CHM 0201 technology....Chimeric’s chief executive officer and managing director Jennifer Chow said the successful application will provide patent protection until 2039."

Patent • Hematological Malignancies • Oncology • Solid Tumor

Chimeric Therapeutics highlights key cell therapy targets in treatment of various cancers (Small Caps) - "...ADVENT Phase 1B clinical trial investigating CHM 0201 NK cells in combination with current standard of care therapy for patients with newly-diagnosed AML...It is believed to be the first clinical trial to evaluate NK cell therapy in combination with standard-of-care drugs Azacitidine and Venetoclax...The study will recruit up to 20 patients with newly-diagnosed AML who are not eligible for intensive chemotherapy or allogeneic stem cell transplant....Chimeric anticipates completion of the patient cohort this year with preliminary clinical data available before year end."

Enrollment status • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

First AML Patient Treated in Chimeric's CHM 0201 Trial (Mirage News) - "Cell therapy company Chimeric Therapeutics...has announced that the first patient in the ADVENT-AML Phase 1B clinical trial in Acute Myeloid Leukemia (AML) has received treatment with CHM 0201 in combination with azacitidine and venetoclax....The study is designed to enrol up to 20 subjects with newly diagnosed AML who are not eligible for intensive chemotherapy or allogeneic stem cell transplant, following a dose confirmation cohort assessing the safety of this novel combination treatment in subjects with relapsed or refractory AML."

Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Chimeric Therapeutics begins innovative therapy trial for acute myeloid leukaemia (Small Caps) - "Australian cell therapy specialist Chimeric Therapeutics...has opened the door for enrolment in its international trial of a potential treatment for acute myeloid leukaemia (AML). The phase 1B ADVENT-AML clinical trial is to be conducted at the University of Texas (UT) MD Anderson Cancer Centre. It will evaluate Chimeric’s off-the-shelf universal donor NK cell therapy CHM 0201 in combination with standard-of-care therapy for patients with newly-diagnosed AML."

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

Chimeric Therapeutics set to trial groundbreaking AML cell therapy (Small Caps) - "Chimeric Therapeutics...has successfully completed the good manufacturing practice (GMP) test to support the company’s ADVENT-AML Phase 1B clinical trial. Under that trial, Chimeric’s off-the-shelf universal donor natural killer (NK) cell therapy will be evaluated in combination with standard-of-care therapy for patients with newly-diagnosed acute myeloid leukemia (AML)."

Commercial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A Phase Ib Trial of Azacitidine, Venetoclax and Allogeneic NK Cells for Acute Myeloid Leukemia (ADVENT-AML) (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • BCL2 • FLT3 • IDH1 • IDH2

Chimeric Therapeutics to supply CHM 0201 for cell study into treatments for acute myeloid leukaemia (Small Caps) - "Cell therapy specialist Chimeric Therapeutics...has entered into an agreement with The University of Texas MD Anderson Cancer Center to support the ADVENT-AML Phase 1B study, in which its off-the-shelf universal donor NK cell therapy CHM 0201 will be evaluated alongside the standard of care treatment for patients with newly-diagnosed acute myeloid leukaemia (AML)...Under the terms of the agreement, Chimeric will provide CHM 0201 for the purposes of the study as well as partial financial support....Additional grant funding will come from multiple sources including the US non-profit organisation Gateway for Cancer Research."

Licensing / partnership • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Chimeric Therapeutics doses first patient in Phase 1B colorectal and blood cancer trial (Proactiveinvestors) - "Chimeric Therapeutics Ltd...has dosed the first patient in its Phase 1B CHM 0201 + Vactosertib clinical trial. The new trial is led by UH Seidman oncologist J Eva Selfridge and is designed to treat 12 patients with either locally advanced/metastatic colorectal cancer or relapsed/refractory blood cancers."

Trial status • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Oncology