Hemogenyx Pharmaceuticals PLC Announces First Patient Treated in Second Adult Dose Cohort
Five consenting patients could not receive treatment because their disease progressed before manufacturing could be completed.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Hemogenyx Pharmaceuticals (HOPHF) has treated the first patient in the second adult cohort of its Phase I HG-CT-1 trial. The trial tests a CAR-T therapy, which uses engineered T cells, for acute myeloid leukemia that has returned or resisted treatment. The dose is twice the initial adult dose; an independent safety board recommended escalation after no dose-limiting toxicities in the first three patients.
The interval between cohorts reflected a manufacturing transfer to Made Scientific and rapid disease progression that prevented five consenting patients from receiving treatment. The newly administered dose is the first Made Scientific product used in the trial. Adult and pediatric recruitment continues. Initial-cohort findings included CAR-T cell expansion and persistence in all three patients and reductions in leukemia cells in blood and/or marrow. Findings remain preliminary given the small patient count.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Minor pointSecond adult cohort dosing began at twice the first cohort's dose following independent safety-board recommendation.
- Minor pointFirst-cohort safety findings showed no dose-limiting toxicities or immune effector cell-associated neurotoxicity syndrome.
- Minor pointCAR-T cell expansion and persistence occurred in all three initial patients; leukemia-cell reductions were recorded in blood and/or marrow.
- Minor pointMade Scientific manufacturing transfer reached first administration of its HG-CT-1 product in the trial.
- Minor point. Forward-looking: it has not happened yet and may not happen.Recruitment continues for the adult cohort and pediatric arm, which opens at the initial adult dose.
Negative
- Moderate pointFive consenting patients could not be treated because rapid disease progression outpaced manufacturing; two had poor-quality collected cells.
- Minor pointInitial clinical findings remain preliminary given the small number of patients treated.
AI-generated analysis. How Rhea-AI works. Not financial advice.
LONDON, UK / ACCESS Newswire / November 12, 2026 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the clinical-stage biopharmaceutical group, is pleased to announce that the first patient in the second adult dose cohort has been treated in the Company's ongoing Phase I clinical trial of HG-CT-1, its proprietary Chimeric Antigen Receptor T-cell ("CAR-T") therapy for relapsed or refractory acute myeloid leukemia ("R/R AML").
The patient received HG-CT-1 at the second dose level: twice the dose administered to the three patients in the first adult cohort. Escalation follows the recommendation of the independent Data Safety Monitoring Board ("DSMB"), which reviewed the safety data from the first cohort, in which no dose-limiting toxicities were observed.
The interval between completion of the first cohort and the start of the second reflects two factors. First, the Company transferred manufacturing of HG-CT-1 to Made Scientific, a contract development and manufacturing organization, completion of which was announced in March 2026. Second, five patients who consented to participate in the second cohort could not be treated because of rapid disease progression, which did not allow manufacture of their HG-CT-1 CAR-T cells to be completed before they were taken off the study. In two of these cases, the cells obtained from the patient were of very poor quality, itself a reflection of rapidly progressing disease. Rapid progression of this kind is characteristic of R/R AML and underlines the need for new treatments.
The patient's dose was manufactured by Made Scientific and is the first HG-CT-1 product manufactured by Made Scientific to be administered in the trial.
The patient will now be monitored for safety in accordance with the trial protocol, and the Company continues to recruit further patients to the cohort. Recruitment to the pediatric arm of the trial, which opens at the initial adult dose level, is also under way.
The Phase I trial is a dose-escalation study designed to assess the safety of HG-CT-1 and to collect data on key secondary endpoints, including anti-leukemic activity, overall survival, progression-free survival and duration of response. As previously reported, CAR-T cell expansion and persistence were observed in all three patients treated at the first dose level, and reductions in leukemic blast burden were recorded in peripheral blood and/or bone marrow, with no immune effector cell-associated neurotoxicity syndrome and no dose-limiting toxicities. These findings are preliminary, given the small number of patients treated to date.
Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented:
"Treating the first patient at the higher dose marks the start of dose escalation in our Phase I trial of HG-CT-1. The first cohort gave us an encouraging safety profile at the lowest dose, together with early signs of biological activity; the second cohort will begin to show how safety and anti-leukemic activity respond to dose. We are grateful to the patient and their family, and to our clinical investigators, and we look forward to updating shareholders as the cohort progresses."
Market Abuse Regulation (MAR) Disclosure
Certain information contained in this announcement would have been deemed inside information for the purposes of Article 7 of Regulation No 596/2014 (as it forms part of UK domestic law by virtue of the European Union (Withdrawal) Act 2018) until the release of this announcement. The person responsible for arranging for the release of this announcement on behalf of Hemogenyx Pharmaceuticals plc is Dr Vladislav Sandler, Chief Executive Officer & Co-Founder.
Enquiries:
Hemogenyx Pharmaceuticals plc | |
Dr Vladislav Sandler, Chief Executive Officer & Co-Founder | |
Peter Redmond, Director | |
SP Angel Corporate Finance LLP | Tel: +44 (0)20 3470 0470 |
Matthew Johnson, Vadim Alexandre, Caroline Rowe |
About Hemogenyx Pharmaceuticals plc
Hemogenyx Pharmaceuticals is a publicly traded company (LSE:HEMO) headquartered in London, with its US operating subsidiaries, Hemogenyx Pharmaceuticals LLC and Immugenyx LLC, located in New York City at its state-of-the-art research facility.
The Company is a clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune diseases. Hemogenyx Pharmaceuticals is developing several distinct and complementary product candidates, as well as platform technologies that it uses as engines for novel product development.
This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.
SOURCE: Hemogenyx Pharmaceuticals PLC
View the original press release on ACCESS Newswire
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What dose did Hemogenyx use in the second adult HG-CT-1 cohort?
The first patient in the second adult cohort received twice the dose administered to the three patients in the first adult cohort. The independent Data Safety Monitoring Board recommended escalation after reviewing first-cohort safety data.
What does Hemogenyx's Phase I HG-CT-1 trial measure?
The dose-escalation trial assesses safety and collects secondary data on anti-leukemic activity, overall survival, progression-free survival and duration of response. The newly treated patient will be monitored for safety under the trial protocol.