Hemogenyx Pharmaceuticals PLC Announces Clinical Trial Update and Grant of Share Awards
Hemogenyx Pharmaceuticals (HOPHF) announced that an independent DSMB has cleared its Phase I CAR-T candidate HG-CT-1 to escalate to the next adult dose cohort after reviewing safety data from the first three patients, with no dose-limiting toxicities observed.
The clearance also permits initiation of pediatric recruitment at the same lowest dose used in adults. The Phase I trial evaluates safety, tolerability and preliminary efficacy with secondary endpoints including AML-specific responses, progression-free survival, duration of response and overall survival. The company also granted 6,000 Restricted Share Units to key team members under existing equity incentive arrangements.
Hemogenyx Pharmaceuticals (HOPHF) ha annunciato che un DSMB indipendente ha autorizzato il suo candidato CAR-T di Fase I HG-CT-1 a passare al prossimo cohort di dose per adulti dopo aver esaminato i dati di sicurezza dei primi tre pazienti, senza toxicità dose-limiting osservate.
Anche l'autorizzazione consente l'avvio del reclutamento pediatrico alla stessa dose più bassa usata negli adulti. Lo studio di Fase I valuta sicurezza, tollerabilità ed efficacia preliminare con endpoint secondari che includono risposte specifiche all'AML, sopravvivenza libera da progressione, durata della risposta e sopravvivenza globale. L'azienda ha inoltre concesso 6.000 Restricted Share Units a membri chiave del team nell'ambito degli accordi esistenti di incentivo azionario.
Hemogenyx Pharmaceuticals (HOPHF) anunció que un DSMB independiente ha autorizado a su candidato CAR-T de Fase I HG-CT-1 para escalar al siguiente coorte de dosis en adultos tras revisar los datos de seguridad de los primeros tres pacientes, sin haber observado toxicidades limitantes de dosis.
La aprobación también permite iniciar el reclutamiento pediátrico con la misma dosis más baja utilizada en adultos. El ensayo de Fase I evalúa seguridad, tolerabilidad y eficacia preliminar, con endpoints secundarios que incluyen respuestas específicas a AML, supervivencia libre de progresión, duración de la respuesta y supervivencia global. La compañía también concedió 6.000 Restricted Share Units a miembros clave del equipo bajo los actuales acuerdos de incentivos de acciones.
Hemogenyx Pharmaceuticals (HOPHF)는 독립적 DSMB가 1상 CAR-T 후보물질 HG-CT-1의 성인 다음 용량 코호트로의 상승을 안전 데이터를 검토한 후 승인했다고 발표했습니다. 용량 제한 독성이 관찰되지 않았습니다.
승인은 또한 성인에서 사용된 동일한 최저 용량으로 소아 등록을 시작할 수 있도록 허용합니다. 1상 임상은 안전성, 내약성 및 초기 효과를 평가하며 보조 종결점인 AML 특이 반응, 무진행 생존, 반응 지속 기간 및 전체 생존을 포함합니다. 또한 회사는 기존 주식 인센티브 제도에 따라 핵심 팀 구성원에게 6,000 Restricted Share Units를 부여했습니다.
Hemogenyx Pharmaceuticals (HOPHF) a annoncé qu’un DSMB indépendant a autorisé son candidat CAR-T de phase I HG-CT-1 à passer au prochain cohort d’adulte de dose après examen des données de sécurité des trois premiers patients, sans toxicités limitantes de dose observées.
Cette autorisation permet également de lancer le recrutement pédiatrique à la même dose la plus basse utilisée chez les adultes. L’essai de phase I évalue la sécurité, la tolérance et l’efficacité préliminaire, avec des endpoints secondaires incluant des réponses spécifiques à la LAM (AML), la survie sans progression, la durée de la réponse et la survie globale. La société a également accordé 6 000 Restricted Share Units à des membres clés de l’équipe dans le cadre des accords d’incitation existants.
Hemogenyx Pharmaceuticals (HOPHF) gab bekannt, dass ein unabhängiges DSMB seinen CAR-T-Kandidaten der Phase-I HG-CT-1 freigegeben hat, in die nächste adulte Dosiskohorte zu eskalieren, nachdem Sicherheitsdaten der ersten drei Patienten geprüft wurden, ohne Dosisbeschränkende Toxizitäten beobachtet.
Die Freigabe erlaubt auch den Beginn der paediatrischen Rekrutierung mit derselben niedrigsten Dosis, die bei Erwachsenen verwendet wird. Die Phase-I-Studie bewertet Sicherheit, Verträglichkeit und vorläufige Wirksamkeit mit sekundären Endpunkten, einschließlich AML-spezifischer Antworten, progressionsfreier Überleben, Dauer der Reaktion und Gesamtüberleben. Das Unternehmen gewährte außerdem 6.000 Restricted Share Units an Schlüsselteammitglieder im Rahmen bestehender Aktienanreizvereinbarungen.
Hemogenyx Pharmaceuticals (HOPHF) أعلنت أن مجلس مراقبة البيانات المستقل (DSMB) قد صادق على مرشح CAR-T من المرحلة الأولى HG-CT-1 ليصعد إلى المجموعة التالية من الجرعات للبالغين بعد مراجعة بيانات السلامة من أول ثلاثة مرضى، مع عدم وجود سمية مرتبطة بالجرعة ملحوظة.
الإذن يتيح أيضًا بدء تجنيد الأطفال عند نفس أقل جرعة مستخدمة لدى البالغين. تقيّم تجربة المرحلة الأولى السلامة والتحمّل والاستجابة الفعلية الأولية مع نقاط نهاية ثانوية تشمل الاستجابات المرتبطة بـ AML، البقاء دون تقدم المرض، مدة الاستجابة والبقاء الكلي. كما منحت الشركة 6,000 وحدة أسهم مقيدة لأعضاء رئيسيين في الفريق بموجب ترتيبات حوافز ملكية قائمة.
Hemogenyx Pharmaceuticals (HOPHF) 宣布，独立的 DSMB 已批准其一阶段 CAR-T 候选药物 HG-CT-1 在审查前3名患者的安全性数据后升级至下一成人剂量队列，未观察到任何 剂量限制性毒性。
此外，该批准也允许以成年人使用的同一最低剂量启动 儿科招募。 一期试验评估安全性、耐受性和初步疗效，二级终点包括 AML 相关反应、无进展生存、反应持续时间和总生存期。 公司还在现有股权激励安排下向关键团队成员授予 6,000 受限股单位。
- DSMB clearance to escalate to next adult dose cohort
- Pediatric recruitment initiated at lowest adult dose
- No dose-limiting toxicities in first three patients
- Grant of 6,000 RSUs to key team members
- Safety data based on only three patients at initial dose
- No efficacy readouts reported yet from dose escalation
DSMB Clearance to Proceed to the Next Dose Level of HG-CT-1 in Adult Patients, Opening Pediatric Recruitment, and Grant of Restricted Share Units to Hemogenyx Team
LONDON, UK / ACCESS Newswire / October 29, 2025 / Hemogenyx Pharmaceuticals plc (LSE:HEMO) 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, its proprietary Chimeric Antigen Receptor T-cell (CAR-T) therapy for the treatment of relapsed or refractory acute myeloid leukemia ("R/R AML") in adults, 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 DSMB's positive recommendation follows the successful completion of initial safety assessments for all three patients treated at the lowest dose, with no dose-limiting toxicities observed. The trial will now proceed to the next planned dose cohort in accordance with the FDA-approved clinical protocol.
Importantly, clearance to proceed to the next adult dose also enables the initiation of pediatric patient recruitment for the Phase I clinical trial at the lowest dose of HG-CT-1, the same dose level already used in the first cohort of adults. This expansion reflects the Company's ongoing commitment to extending the potential benefits of HG-CT-1 to children and adolescents suffering from this aggressive and difficult to treat form of leukemia.
The Phase I study of HG-CT-1 is a dose-escalation trial designed to evaluate the safety, tolerability, and preliminary efficacy of the Company's proprietary CAR-T therapy in adult and pediatric patients with R/R AML. In addition to safety, the trial includes secondary endpoints such as assessment of AML-specific responses, progression-free survival, duration of response, and overall survival.
The DSMB's clearance to proceed represents a key de-risking milestone in the clinical development of HG-CT-1. It reinforces the favorable safety profile observed to date and signals continued regulatory and operational momentum. For investors, this milestone marks a potential value-inflection point as the Company advances into higher dose cohorts where enhanced efficacy signals are anticipated, paving the way toward broader clinical validation and future pivotal studies.
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. These RSUs align the team's interests with those of shareholders and recognize their ongoing efforts in driving Company's clinical and operational success.
Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: "We are very pleased to have received DSMB clearance to advance HG-CT-1 to the next dose level. This important milestone marks continued progress in our clinical development program and further validates the safety profile of our CAR-T therapy.
I would also like to express my deep appreciation to the entire Hemogenyx Pharmaceutical team, whose dedication, scientific rigor, and perseverance have made this achievement possible. Their commitment to excellence continues to drive our success and to move this potentially life-saving therapy closer to patients in need.
We remain encouraged by the early clinical findings and are committed to advancing HG-CT-1 through its dose-escalation phase to unlock its full therapeutic potential for patients with relapsed or refractory AML."
Further updates will be provided as the trial progresses.
Market Abuse Regulation (MAR) Disclosure
Certain information contained in this announcement would have been 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.
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, Adam Cowl | |
Peterhouse Capital Limited | Tel: +44 (0)20 7469 0930 |
Lucy Williams, Duncan Vasey, Charles Goodfellow | |
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.
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.
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SOURCE: Hemogenyx Pharmaceuticals PLC
View the original press release on ACCESS Newswire
FAQ
What did Hemogenyx (HOPHF) announce on October 29, 2025 about HG-CT-1?
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