HEMO-CAR-T / Hemogenyx, University of Pennsylvania - LARVOL DELTA

Hemogenyx Pharmaceuticals PLC Announces Pediatric Amendment to Clinical Protocol (ACCESSWIRE) - "Hemogenyx Pharmaceuticals plc...is pleased to announce that it has filed an amendment to the clinical protocol for its ongoing Phase I clinical trial of HG-CT-1 to include pediatric patients with relapsed/refractory acute myeloid leukemia ('R/R AML'). HG-CT-1 is the Company's CAR-T therapy, currently undergoing clinical trials in adults for the treatment of R/R AML. This amendment, filed with the U.S. Food and Drug Administration (FDA), seeks to expand eligibility for the trial beyond adult patients to include children and adolescents with R/R AML, an aggressive disease with limited treatment options and poor prognosis in the relapsed/refractory setting."

Clinical protocol • Acute Myelogenous Leukemia

Hemogenyx Pharmaceuticals PLC Announces Second Patient Treated with HG-CT-1 CAR-T Therapy (ACCESSWIRE) - "Hemogenyx Pharmaceuticals plc...is pleased to announce that the second patient has been successfully treated as part of the Company's ongoing Phase I clinical trial of HG-CT-1, its proprietary CAR-T cell therapy for the treatment of relapsed or refractory acute myeloid leukemia ('R/R AML') in adults. This milestone follows the successful first-in-human treatment with HG-CT-1, which demonstrated a favorable initial safety profile with no adverse effects observed, and the subsequent recruitment of the second patient."

Trial status • Acute Myelogenous Leukemia

Hemogenyx Pharmaceuticals PLC Announces Recruitment of Second Patient for Clinical Trials (ACCESSWIRE) - "Hemogenyx Pharmaceuticals...is pleased to announce the recruitment of the second patient for its clinical trial of HG-CT-1, its proprietary CAR-T cell therapy, for the treatment of relapsed or refractory acute myeloid leukemia (R/R AML) in adults. This marks a significant step forward in the Company's clinical development program and underscores the progress toward delivering a potentially life-saving treatment for AML patients with limited therapeutic options. The manufacturing of HG-CT-1 for the second patient, carried out by the Company's team of scientists and quality control professionals, is scheduled to commence shortly. Further updates on the clinical trial will be provided in due course."

Trial status • Acute Myelogenous Leukemia

Hemogenyx Pharmaceuticals PLC Announces Institutional Investment (ACCESSWIRE) - "Hemogenyx Pharmaceuticals plc...is pleased to announce that it was approached by an institution wishing to make an investment into the Company; this investor will subscribe £709,200 for the issue of 394,000 new Ordinary Shares (the 'Subscription Shares') at £1.80 per share....The net proceeds of this subscription will be dedicated to the continuation of the Phase I clinical trials for the Company's Chimeric Antigen Receptor T-cell therapy ('HG-CT-1'), aimed at treating relapsed/refractory acute myeloid leukemia in adults ('R/R AML')....The Company will keep the market informed of future developments as trials proceed."

Financing • Acute Myelogenous Leukemia

First-in-Human Treatment with HG-CT-1 for Relapsed or Refractory Acute Myeloid Leukemia (Hemogenyx Press Release) - "Hemogenyx Pharmaceuticals plc...is pleased to announce the administration of its first-in-human dose of HG-CT-1, its proprietary CAR-T cell therapy, for the treatment of relapsed or refractory acute myeloid leukemia (R/R AML) in adults."

Trial status • Acute Myelogenous Leukemia

Clinical Study of Anti-FLT3 CAR-T Cells for the Treatment of Relapsed/refractory AML (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Hemogenyx Pharmaceuticals LLC

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

Hemogenyx Pharmaceuticals PLC Announces Opening of First Clinical Site (ACCESSWIRE) - "Hemogenyx Pharmaceuticals plc...is pleased to announce the opening of the first clinical site for its lead asset, HG-CT-1, targeting relapsed/refractory (R/R) acute myeloid leukemia (AML) in adults. Recruitment of patients for the trials has begun. This Phase I trial is designed as a dose-escalation study to evaluate the safety profile of HG-CT-1 in adult patients with R/R AML."

Trial status • Acute Myelogenous Leukemia

Hemogenyx Pharmaceuticals PLC Announces IRB Approval for Phase I Clinical Trial (ACCESSWIRE) - "Hemogenyx Pharmaceuticals plc...is pleased to announce that the Institutional Review Board (IRB) of the Company's first clinical site has granted approval to initiate a Phase I clinical trial of the Company's lead asset, HEMO-CAR-T, which has now been given the formal designation HG-CT-1, for the treatment of relapsed/refractory (R/R) acute myeloid leukemia (AML) in adults. The proposed Phase 1 clinical trial is designed as a dose escalation study to assess the safety of HG-CT-1 in adult patients with R/R AML."

New P1 trial • Acute Myelogenous Leukemia

Hemogenyx Pharmaceuticals PLC Announces Ultrafast CAR-T Manufacturing (ACCESSWIRE) - "Hemogenyx Pharmaceuticals plc...and Kure.ai...are pleased to announce a strategic collaboration to advance the production of CAR-T cell therapies for acute myeloid leukemia (AML) and a subset of acute lymphoblastic leukemia (ALL). This partnership aims to integrate Kure's ultrafast manufacturing (UM) technology with Hemogenyx Pharmaceuticals's proprietary CAR-T therapy, HG-CT-1 (formerly known as HEMO-CAR-T) to enable faster, more efficient production of CAR-T cells, significantly reducing manufacturing timelines while maintaining therapeutic potency."

Commercial • Acute Myelogenous Leukemia

Hemogenyx Pharmaceuticals PLC Announces Site Initiation Visit Completed (ACCESSWIRE) - "Hemogenyx Pharmaceuticals plc...is pleased to announce the successful completion of the Site Initiation Visit at the first clinical site for its Phase I clinical trial of HG-CT-1 (also known as HEMO-CAR-T). The Phase I clinical trial is designed as a dose escalation study to assess the safety of HG-CT-1 in adult patients with relapsed/refractory (R/R) acute myeloid leukaemia (AML)."

Trial status • Acute Myelogenous Leukemia

Hemogenyx Pharmaceuticals PLC Announces Institutional Investment (ACCESSWIRE) - "Hemogenyx Pharmaceuticals...is pleased to announce that it was approached by an institutional investor and that this investor has subscribed £600,000, for the issue of 60,000,000 new Ordinary Shares at 1p per share...The net proceeds of this subscription will be dedicated to the imminent commencement of the Phase I clinical trials for the Company's Chimeric Antigen Receptor T-cell therapy ('HEMO-CAR-T' or 'HG-CT-1'), aimed at treating acute myeloid leukemia ('AML')....The Company will keep the Market informed of future developments as trials commence and develop."

Financing • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Hemogenyx Pharmaceuticals PLC Announces Schedule for Phase I Clinical Trial Opening (ACCESSWIRE) - "Hemogenyx Pharmaceuticals plc...is pleased to announce the schedule for the opening of the first clinical site for its lead asset, HEMO-CAR-T, formally designated HG-CT-1, targeting relapsed/refractory (R/R) acute myeloid leukemia (AML) in adults. The Company has successfully completed the necessary contracts and budgeting preparations to advance HG-CT-1 into clinical testing. Institutional Review Board (IRB) approval at the initial clinical site is anticipated by the second week of November. Following IRB clearance, a Site Initiation Visit (SIV) is expected to take place in the third week of November, marking the official launch of the Phase I clinical trial."

New P1 trial • Acute Myelogenous Leukemia

Hemogenyx Pharmaceuticals up 9% after it receives further investment from partner Prevail (Proactiveinvestors) - "Shares in Hemogenyx Pharmaceuticals PLC...rose 9% after it secured a new $350,000 investment from Prevail Partners, an investment fund, as it gears up for important clinical trials. The investment, which comes at a price significantly above the company’s current share value, follows a similar injection of funds in September...The money will support Hemogenyx’s work on its HEMO-CAR-T therapy, a cutting-edge treatment for blood cancers....In addition to the financial backing, Prevail’s affiliate, Prevail InfoWorks, will handle clinical research for the pediatric trials. This includes overseeing the trial sites, managing data, and ensuring patient safety. The goal is to push forward with new treatments that could offer hope to patients with relapsed or resistant forms of blood cancer."

Financing • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Hemogenyx Pharmaceuticals PLC Announces Half-year Report (ACCESSWIRE) - "The trials are expected to begin shortly at MD Anderson in Texas...As shareholders know, we have been collaborating with the University of Pennsylvania Medical Center ('Penn') to conduct the trials at their facility...We are now in the final stages of the opening a clinical site at MD Anderson and expect to treat the first patient soon. Penn remains eager to participate in the trials at a later stage, and we hope they will do so, though likely not until 2025...If approved as expected, we plan to initiate clinical trials for pediatric AML and a subset of ALL at MD Anderson....CDX is designed to prepare patients with AML for bone marrow transplants and, we believe, may also be directly capable of treating relapsed or refractory AML. Meanwhile, we have developed a new and improved version of CDX. Our scientists used bispecific pairing technology to create this version, and it has shown significantly enhanced effectiveness in the laboratory (in vitro) tests...."

Diagnostic • New P1 trial • Preclinical • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Hemogenyx Pharmaceuticals PLC - FLT3 Assay Ready for Phase I Trials at MD Anderson (Yahoo Finance) - "Hemogenyx Pharmaceuticals plc...is pleased to announce the successful completion of the development of a clinical-grade assay ('Assay') designed to assess FLT3 protein expression in acute myeloid leukemia ('AML') cells. Assessing FLT3 protein expression in AML cells is crucial for the accurate identification and recruitment of patients for the imminent Phase I clinical trials of the Company's HEMO-CAR-T product candidate. The trials are expected to commence shortly at MD Anderson Cancer Center ('MD Anderson'), one of the world's most respected centers devoted exclusively to cancer patient care, research, education and prevention. The Phase I clinical trials are planned to expand to the University of Pennsylvania Medical Center thereafter."

Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Hemogenyx Pharmaceuticals PLC Announces Operations Update (ACCESSWIRE) - "Hemogenyx Pharmaceuticals...is pleased to provide an update on its ongoing activities and progress...HEMO-CAR-T...Clinical Trials Progress...The Company has added an additional prestigious US medical center to its list of clinical trial sites. This will enhance the scope and expedite the timeline for the implementation of clinical trials...The setup of clinical sites at the University of Pennsylvania ('PENN') and the new medical centre is underway....The Company is seeking to expand the HEMO-CAR-T indication to include pediatric acute myeloid leukemia...and a subset of pediatric acute lymphoblastic leukemia...patients. An amendment to the clinical protocol to include pediatric AML is currently under review by third party experts. If approved, the Company will seek to implement the clinical trials for pediatric AML at the newly established clinical site."

Clinical protocol • Trial status • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Hemogenyx Pharmaceuticals discusses successful £3.5M capital raise as it advances HEMO-CAR-T program (Yahoo Finance) - "Hemogenyx Pharmaceuticals PLC...Dr Vladislav Sandler joins Proactive's Stephen Gunnion after the pre-clinical stage biopharmaceutical group raised £3.5 million, which will be utilized to progress its lead product candidate, Chimeric Antigen Receptor T-cells (HEMO-CAR-T), into human trials following the lifting of a clinical hold...The HEMO-CAR-T therapy is focused on treating relapsed and refractory acute myeloid leukaemia...Looking forward, Sandler said the company plans to advance its clinical trials and continue development on its CBR platform and CDX bispecific antibody, albeit at a potentially slower pace due to funding limitations....As a development-stage company, HemoGenyx anticipates further funding needs but remains committed to efficient and fast-paced progress, seeking various funding sources."

Financing • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Hemogenyx Pharmaceuticals PLC Announces Placing to Raise US$4.2 million (ACCESSWIRE) - "Hemogenyx Pharmaceuticals plc...is pleased to announce that it has successfully raised US$4.2 million (£3.325 million) before expenses through the allotment and issue of 166,250,000 new ordinary shares at 2 pence per share....The net proceeds from the Placing will be used to facilitate the development of the Company's Chimeric Antigen Receptor T-cells ('HEMO-CAR-T') for the treatment of acute myeloid leukaemia ('AML')....The funds have been raised to allow the Company to progress HEMO-CAR-T to phase 1 clinical trials."

Commercial • Acute Myelogenous Leukemia

Hemogenyx Pharmaceuticals PLC Announces FDA Consents to Phase I Trials of HEMO-CAR-T (Yahoo Finance) - "Hemogenyx Pharmaceuticals plc...is pleased to announce that it has been informed by the U.S. Federal Food and Drug Administration ('FDA') that it has lifted the clinical hold on the Investigational New Drug (IND) application for HEMO-CAR-T for the treatment of acute myeloid leukemia ('AML'). The FDA confirmed that the Company had addressed all issues identified in its prior clinical hold letter satisfactorily and consents to the Company proceeding with its Phase I clinical study of HEMO-CAR-T."

FDA event • IND • New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Submission of Complete Response to Clinical Hold for HEMO-CAR-T IND (Financial Times) - "Hemogenyx Pharmaceuticals plc...announces the submission of a complete response to the previously announced Clinical Hold ('CH') of the Investigational New Drug ('IND') application to the US Food and Drug Administration ('FDA') for HEMO-CAR-T. A complete response is necessary to apply for the lifting of the CH which is needed to obtain consent from the FDA to commence Phase I clinical trials of HEMO-CAR-T."

FDA event • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Hemogenyx Pharmaceuticals PLC Announces HEMO-CAR-T Process Qualification Run Completed (ACCESSWIRE) - "Hemogenyx Pharmaceuticals plc...is pleased to announce the successful completion of its Process Qualification ('PQ') run of the end-to-end process for the manufacture of HEMO-CAR-T cells. This PQ run was a part of the Company's plan to address the U.S. Food and Drug Administration ('FDA') concerns that resulted in a Clinical Hold ('CH') of the HEMO-CAR-T Investigational New Drug ('IND') application, as announced previously. The FDA has accepted the Company's plan. The process was carried out in the Company's current Good Manufacturing Practice compliant clean rooms....This PQ run is the only manufacturing run required for the submission of a complete response to the CH of the IND application to the FDA for HEMO-CAR-T....'We are now working hard to re-submit the IND as expeditiously as possible to move forward with clinical trials of HEMO-CAR-T'."

Commercial • IND • Acute Myelogenous Leukemia

Hemogenyx Pharmaceuticals PLC Announces Lentivirus Re-manufacturing Completed (Yahoo Finance) - "Hemogenyx Pharmaceuticals plc...is pleased to announce the successful completion of the re-manufacturing of an improved lentivirus ('LVV') devoid of splice variants. The LVV is used to programme the Company's Chimeric Antigen Receptor ('CAR') T-cells ('HEMO-CAR-T') for the treatment of acute myeloid leukaemia ('AML'). Spontaneous splicing during the manufacturing of LVV was the only reason for the clinical hold imposed by the U.S. Food and Drug Administration ('FDA') on the Investigational New Drug ('IND') application for the Company's HEMO-CAR-T product candidate. As agreed with the FDA, before the resubmission of the IND, the Company will perform an additional process qualification run of the end-to-end process for the manufacture of HEMO-CAR-T cells using the new LVV and we will now put this process into effect."

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

Hemogenyx Pharmaceuticals PLC Announces Strategic Investment from Prevail Partners, LLC (Issuer Direct) - "Hemogenyx Pharmaceuticals plc...announces that Prevail Partners, LLC...has agreed to invest in the Company through a subscription for 11,066,667 ordinary shares (the 'New Ordinary Shares') at a price of US$0.075 per share (approximately £0.06) for the total sum of $830,000 (approximately £668,000)....Under the terms of the MSTA, InfoWorks is to provide clinical services and technologies for the Company's upcoming Phase I study of its anti-FLT3 chimeric antigen receptor-redirected T cells ('CAR-T cells') in subjects with relapsed/refractory acute myeloid leukemia (AML)....The MSTA has an initial term of 40 months, and Hemogenyx Pharmaceuticals LLC has agreed an initial statement of works relating to the Phase I AML study."

Financing • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Hemogenyx Pharmaceuticals PLC - Clinical Hold Lift Plan is accepted by FDA (Issuer Direct) - "Hemogenyx Pharmaceuticals plc...announces that the U.S. Food and Drug Administration ('FDA') has accepted the Company's plan to address the FDA's concerns that resulted in a Clinical Hold ('CH') of the HEMO-CAR-T Investigational New Drug ('IND') application....The Company has now received confirmation from the FDA that the Company's plan satisfactorily addresses the agency's comments....'We are now working hard to complete the schedule of work set out in the plan and to re-submit the IND as expeditiously as possible in order to move forward with clinical trials of HEMO-CAR-T'."

FDA event • Acute Myelogenous Leukemia

Hemogenyx Pharmaceuticals PLC Announces Full FDA Review for HEMO-CAR-T IND (Issuer Direct) - "Hemogenyx Pharmaceuticals plc...announces that the Company has received a full review letter from the U.S. Food and Drug Administration ('FDA') regarding the Investigational New Drug ('IND') application for the Company's product candidate Chimeric Antigen Receptor ('CAR') T-cells ('HEMO-CAR-T') for the treatment of acute myeloid leukaemia ('AML') to the effect that HEMO-CAR-T be put on clinical hold ('CH'). The letter contains a detailed description of the rationale for the decision to put HEMO-CAR-T IND on CH. The reason for the CH relates to a splicing that occurs during the manufacturing process of the lentivirus that is used to produce CAR-T cells. The Company has identified the source of the splicing deficiency and has already developed a method to eliminate it. The lentivirus is being remanufactured. The CH letter also contains several suggestions on how to improve the safety of HEMO-CAR-T."

FDA event • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology