Hemogenyx Pharmaceuticals PLC Announces Manufacturing Partnership with Made Scientific
Hemogenyx Pharmaceuticals (HOPHF) has announced a strategic manufacturing partnership with Made Scientific to advance its HG-CT-1 CAR-T therapy for relapsed/refractory acute myeloid leukemia (r/r AML) in adults. The collaboration will utilize Made Scientific's GMP facilities in Newark and Princeton, NJ, for both clinical and commercial supply of cell therapies.
The partnership aims to accelerate Hemogenyx's ongoing Phase I clinical trial of HG-CT-1 and potentially expand to include pediatric r/r AML patients. Early clinical data has shown promising results in both safety and potential efficacy. Made Scientific will provide specialized expertise in CAR-T cell therapy technology transfer and manufacturing support.
Hemogenyx Pharmaceuticals (HOPHF) ha annunciato una partnership strategica di produzione con Made Scientific per portare avanti la terapia CAR-T HG-CT-1 destinata agli adulti con leucemia mieloide acuta refrattaria o recidivante (r/r AML). La collaborazione sfrutter脿 gli impianti GMP di Made Scientific a Newark e Princeton, NJ, per la fornitura sia clinica sia commerciale delle terapie cellulari.
L'accordo mira ad accelerare l'attuale studio clinico di Fase I su HG-CT-1 e, possibilmente, ad estenderne l'applicazione ai pazienti pediatrici con r/r AML. I primi dati clinici hanno evidenziato risultati promettenti in termini di sicurezza e potenziale efficacia. Made Scientific fornir脿 competenze specializzate nel trasferimento tecnologico e nella produzione di cellule CAR-T.
Hemogenyx Pharmaceuticals (HOPHF) ha anunciado una asociaci贸n estrat茅gica de fabricaci贸n con Made Scientific para avanzar su terapia CAR-T HG-CT-1 dirigida a adultos con leucemia mieloide aguda recidivante/refractaria (r/r AML). La colaboraci贸n utilizar谩 las instalaciones GMP de Made Scientific en Newark y Princeton, NJ, para el suministro cl铆nico y comercial de las terapias celulares.
La alianza pretende acelerar el actual ensayo cl铆nico de Fase I de HG-CT-1 y podr铆a ampliarse para incluir pacientes pedi谩tricos con r/r AML. Los primeros datos cl铆nicos muestran resultados prometedores en seguridad y posible eficacia. Made Scientific aportar谩 experiencia especializada en la transferencia tecnol贸gica y la fabricaci贸n de c茅lulas CAR-T.
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鞚措矆 韺岉姼雱堨嫮鞚� HG-CT-1鞚� 歆勴枆 欷戩澑 1靸� 鞛勳儊鞁滍棙鞚� 臧�靻嶍檾頃橁碃, 頃勳殧 鞁� 靻岇晞 r/r AML 頇橃瀽旯岇 鞝侅毄 氩旍渼毳� 頇曤寑頃橂姅 瓴冹潉 氇╉憸搿� 頃╇媹雼�. 齑堦赴 鞛勳儊 雿办澊韯半姅 鞎堨爠靹标臣 鞛犾灛鞝� 鞙犿毃靹� 旄‰┐鞐愳劀 鞙犽頃� 瓴瓣臣毳� 氤挫榾鞀惦媹雼�. Made Scientific電� CAR-T 靹疙彫旃橂鞚� 旮办垹 鞚挫爠 氚� 鞝滌“ 歆�鞗愳棎 鞝勲 鞐焿鞚� 鞝滉车頃╇媹雼�.
Hemogenyx Pharmaceuticals (HOPHF) a annonc茅 un partenariat strat茅gique de fabrication avec Made Scientific afin de faire progresser sa th茅rapie CAR-T HG-CT-1 pour les adultes atteints de leuc茅mie my茅lo茂de aigu毛 r茅fractaire ou en rechute (r/r AML). La collaboration utilisera les installations GMP de Made Scientific 脿 Newark et Princeton, NJ, pour l'approvisionnement clinique et commercial des th茅rapies cellulaires.
Ce partenariat vise 脿 acc茅l茅rer l'essai clinique en cours de Phase I sur HG-CT-1 et pourrait 茅ventuellement 锚tre 茅tendu aux patients p茅diatriques atteints de r/r AML. Les premi猫res donn茅es cliniques montrent des r茅sultats prometteurs en termes de s茅curit茅 et d'efficacit茅 potentielle. Made Scientific apportera une expertise sp茅cialis茅e en transfert technologique et en fabrication de cellules CAR-T.
Hemogenyx Pharmaceuticals (HOPHF) hat eine strategische Produktionspartnerschaft mit Made Scientific angek眉ndigt, um die CAR-T-Therapie HG-CT-1 f眉r erwachsene Patienten mit rezidivierender/refrakt盲rer akuter myeloischer Leuk盲mie (r/r AML) voranzubringen. Die Zusammenarbeit nutzt die GMP-Einrichtungen von Made Scientific in Newark und Princeton, NJ, f眉r die klinische und kommerzielle Versorgung mit Zelltherapien.
Die Partnerschaft zielt darauf ab, die laufende Phase-I-Studie zu HG-CT-1 zu beschleunigen und gegebenenfalls auf p盲diatrische r/r AML-Patienten auszuweiten. Fr眉he klinische Daten zeigen vielversprechende Ergebnisse hinsichtlich Sicherheit und potenzieller Wirksamkeit. Made Scientific bringt spezialisierte Expertise im Technologietransfer und in der Herstellung von CAR-T-Zelltherapien ein.
- Early clinical data shows promising safety and efficacy results for HG-CT-1 therapy
- Partnership provides access to GMP-certified manufacturing facilities for both clinical and commercial supply
- Potential expansion of trial to include pediatric patients indicates broader market opportunity
- Manufacturing collaboration could accelerate ongoing Phase I clinical trial progress
- Manufacturing partnership suggests significant capital requirements for therapy development
- Early-stage Phase I status indicates long pathway to potential commercialization
Hemogenyx Pharmaceuticals Announces Manufacturing Partnership with Made Scientific to Advance HG-CT-1 CAR-T Therapy
CITY OF LONDON, GB / / September 8, 2025 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), is pleased to announce a manufacturing partnership with Made Scientific, a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO), 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.
Under the agreement, Hemogenyx Pharmaceuticals will leverage Made Scientific's specialized expertise in CAR-T cell therapy technology transfer and manufacturing at its GMP facilities in Newark and Princeton, NJ, which are equipped for both clinical and commercial supply of cell therapies. 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.
The Company has already made significant progress in the trial, with early clinical data supporting growing confidence in both safety and potential efficacy.
Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented:
"Partnering with a trusted CDMO like Made Scientific is essential to the success of HG-CT-1, our lead CAR-T therapy. Made's expertise in cell therapy manufacturing will be instrumental in driving the continued progress of this potentially breakthrough therapy for patients with relapsed or refractory AML, fully in line with our identity as a life saving company."
Syed T. Husain, Chairman & CEO of Made Scientific, said:
"Our collaboration with Hemogenyx Pharmaceuticals reflects Made Scientific's commitment to advancing next-generation cell therapies that address urgent, unmet medical needs. Through our integrated development and manufacturing solutions and highly experienced team, we are proud to support Hemogenyx Pharmaceuticals as they advance HG-CT-1 in their Phase I clinical trial."
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.
About Made Scientific
Made Scientific is a leading US-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical and commercial supply. Operating from two U.S.-based manufacturing facilities, Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.
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SOURCE: Hemogenyx Pharmaceuticals PLC
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FAQ
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