HG-CT-1 / Hemogenyx, University of Pennsylvania - LARVOL DELTA

Hemogenyx Pharmaceuticals PLC Announces Clinical Trial Update… (ACCESS Newswire) - "Hemogenyx Pharmaceuticals plc...is pleased to announce that the independent Data Safety Monitoring Board ('DSMB') overseeing the Company's ongoing Phase I clinical trial of HG-CT-1...has reviewed safety data from the first three patients treated at the initial dose level and has recommended continuation of the trial with escalation to the next dose level....The trial will now proceed to the next planned dose cohort in accordance with the FDA-approved clinical protocol."

DSMB • Trial status • Acute Myelogenous Leukemia

Hemogenyx Pharmaceuticals PLC Announces…Grant of Share Awards (ACCESS Newswire) - "As a reward for the Hemogenyx team's outstanding contribution to the HG-CT-1 program and their dedication to advancing this groundbreaking therapy, the Company has granted a total of 6,000 Restricted Share Units ('RSUs') to key team members under its existing equity incentive arrangements."

Commercial • Acute Myelogenous Leukemia

Hemogenyx Pharmaceuticals PLC Announces Clearance to Initiate Pediatric Enrolment (ACCESS Newswire) - "Hemogenyx Pharmaceuticals...s pleased to announce that the Institutional Review Board ('IRB') at MD Anderson Cancer Center ('MD Anderson') has approved an amendment to the clinical protocol of the Company's ongoing Phase I trial of HG-CT-1, its proprietary CAR-T cell therapy for the treatment of relapsed or refractory acute myeloid leukemia ('R/R AML'). The approved amendment expands the eligibility criteria for the trial to include children and adolescents with R/R AML..."

Trial status • Acute Myelogenous Leukemia

Hemogenyx Pharmaceuticals Signs Letter of Intent with Cellin Technologies to Advance Commercialization of HG-CT-1 CAR-T Therapy in Estonia (ACCESS Newswire) - "Under the LOI: Hemogenyx Pharmaceuticals will retain full ownership of all intellectual property, know-how, data and regulatory rights relating to HG-CT-1 and will be entitled to revenues from commercialization. Cellin will act as Hemogenyx Pharmaceuticals' local partner in Estonia, providing manufacturing, regulatory, and operational support..."

Licensing / partnership • Acute Myelogenous Leukemia

Hemogenyx Pharmaceuticals…is pleased to announce a manufacturing partnership with Made Scientific…, to advance HG-CT-1, the Company's autologous Chimeric Antigen Receptor T-cell (CAR-T) therapy for the treatment of relapsed/refractory acute myeloid leukemia (r/r AML) in adults (ACCESS Newswire) - "The collaboration is expected to accelerate Company's ongoing Phase I clinical trial of HG-CT-1 in adult patients and to support the potential inclusion of additional cohorts for pediatric r/r AML patients."

Licensing / partnership • Acute Myelogenous Leukemia

Hemogenyx Pharmaceuticals Awarded G-Rex Grant to Support Scalable, Cost-Optimized CAR-T Manufacturing (ACCESSWIRE) - "Hemogenyx Pharmaceuticals ...is pleased to announce that it has been awarded a $120,000 G-Rex grant from ScaleReady, in collaboration with Wilson Wolf Manufacturing and Cell Ready (the 'Grant'), to support the optimization and scale-up of the manufacturing process for its lead CAR-T product candidate, HG-CT-1, currently in a Phase I clinical trial for relapsed/refractory acute myeloid leukemia (R/R AML) in adults. The Grant will enable the Company to further develop a closed-system, G-Rex-based, manufacturing platform, which is expected to reduce production complexity, streamline regulatory compliance, and significantly lower per-patient manufacturing costs. These advances are critical to the long-term commercial viability of autologous CAR-T therapies such as HG-CT-1."

Financing • Acute Myelogenous Leukemia

Regulatory Clearance to Proceed with Pediatric Expansion of HG-CT-1 Clinical Trial (Hemogenyx Press Release) - "Hemogenyx Pharmaceuticals plc (LSE: HEMO) is pleased to announce that the 30-day review period by the U.S. Food and Drug Administration (FDA) for the Company’s previously submitted amendment to the clinical protocol of its ongoing Phase I trial of HG-CT-1 has concluded without a clinical hold. As a result, the Company is now cleared to proceed with the next steps required to initiate pediatric enrolment in the trial. The protocol amendment expands the eligibility criteria for the Phase I trial of HG-CT-1, Hemogenyx’s proprietary CAR-T therapy for relapsed/refractory acute myeloid leukemia (R/R AML), to include children and adolescents with this aggressive and hard-to-treat disease. The Company will now move forward with Institutional Review Board (IRB) submissions and associated site activation procedures to enable the opening of pediatric cohorts."

Clinical protocol • Acute Myelogenous Leukemia

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