Welcome to our dedicated page for Hemogenyx Pharma news (Ticker: HOPHF), a resource for investors and traders seeking the latest updates and insights on Hemogenyx Pharma stock.
Hemogenyx Pharma PLC (HOPHF), associated with Hemogenyx Pharmaceuticals plc (LSE: HEMO), generates news primarily around its clinical development, financing, and strategic collaboration activities in biotechnology. The company describes itself as a clinical stage biopharmaceutical group developing new medicines and treatments for blood and autoimmune diseases, with a particular focus on its HG-CT-1 CAR-T cell therapy for relapsed or refractory acute myeloid leukemia (R/R AML).
News updates frequently cover milestones in the Phase I clinical trial of HG-CT-1, including first-in-human dosing, safety evaluations, early signs of efficacy, and decisions by the independent Data Safety Monitoring Board on dose escalation. Additional coverage includes regulatory developments such as FDA interactions, Institutional Review Board approvals for pediatric enrollment, and broader trial design updates for both adult and pediatric patients.
Hemogenyx Pharmaceuticals also issues announcements on operational and strategic initiatives, such as its manufacturing partnership with Made Scientific to support HG-CT-1 production and its letter of intent with Cellin Technologies in Estonia to explore commercialization under the hospital exemption pathway. Capital markets news includes publication of a prospectus, share issuances arising from warrant exercises and restricted stock units, and updates on admission of new shares to the Official List and to trading on the London Stock Exchange.
Visitors to this news page can review a stream of company disclosures that document clinical progress, financing activities, manufacturing arrangements, and potential early revenue pathways. For investors and observers interested in CAR-T therapies, hematology-oncology, and early-stage biopharmaceutical development, Hemogenyx-related news provides insight into how the company is advancing its lead program and supporting infrastructure over time.
Hemogenyx Pharmaceuticals has announced a strategic partnership with WuXi Advanced Therapies to manufacture lentiviral vectors for its HEMO-CAR-T program targeting acute myeloid leukemia (AML). This collaboration aims to accelerate the product development towards phase I clinical trials. The partnership enhances Hemogenyx's ability to produce clinical materials necessary for regulatory submissions. The company anticipates filing an Investigational New Drug (IND) application in 2022. This program is expected to provide a more effective treatment for AML patients.
Hemogenyx Pharmaceuticals has announced progress on its lead product candidate, HEMO-CAR-T, for treating acute myeloid leukemia (AML). The company has requested a pre-Investigational New Drug (PIND) meeting with the FDA, aimed at refining its clinical trial plans and facilitating the IND application process. CEO Dr. Vladislav Sandler emphasized the importance of this step in enhancing the therapy's potential effectiveness, given AML's low survival rates. Successful development could greatly improve treatment outcomes for AML patients. Hemogenyx focuses on innovative therapies for blood diseases.
Hemogenyx Pharmaceuticals has successfully repaid convertible loans totaling $2,110,761 to Orgenesis, Inc., a step originally announced in October 2018. Both subsidiaries, Hemogenyx-Cell and Immugenyx, fulfilled the loan repayment terms. The company is poised for continued progress in developing its product candidates, backed by a substantial cash reserve that supports ongoing product development.
Hemogenyx Pharmaceuticals has secured a lease for a new 10,000 sq. ft. laboratory in New York's Mink Building, aimed at advancing its HEMO-CAR-T cell therapy for acute myeloid leukemia. The facility will feature two clean rooms designed for in-house cell manufacturing. CEO Dr. Vladislav Sandler expressed enthusiasm for the strategic location, citing collaboration opportunities with nearby Columbia University and City College. The move supports the company's anticipated growth and operational flexibility over the coming three years.
Hemogenyx Pharmaceuticals has signed a licence agreement with Eli Lilly, granting it exclusive rights to develop a CDX bispecific antibody for treating acute myeloid leukemia and other blood cancers. The agreement includes an upfront payment of US$250,000 and potential milestone payments up to US$1 million through clinical trials. This collaboration marks a significant advancement for Hemogenyx as it initiates IND-enabling studies, confirming the wider applicability of CDX beyond initial expectations. Successful therapy development could greatly impact patient survival rates for AML.
Hemogenyx Pharmaceuticals has announced its interim results for the six-month period ending June 30, 2021. Highlights include the completion of CDX antibody development with a global pharmaceutical partner and an agreement with the University of Pennsylvania for HEMO-CAR-T clinical trials. The company received two US patents for antibody technologies and made progress on its CBR/COVID-19 project. Additionally, Hemogenyx raised £12 million in development capital through convertible debt, later replaced by equity capital. The company remains focused on advancing its product candidates towards clinical trials.
Hemogenyx Pharmaceuticals has received a patent approval for monoclonal antibodies targeting the human FLT3/FLK2 receptor, significant for treating acute myeloid leukemia (AML). The patent, issued on August 31, 2021, adds to the company's intellectual property portfolio, which includes the CDX antibody and HEMO-CAR-T therapies. This development is crucial as it underpins ongoing collaboration with a leading pharmaceutical partner and aims to progress to clinical trials. Hemogenyx's advancements in AML therapies could affect survival rates, as current treatments yield low five-year survival rates.
Dr. Alan E. Walts has joined Hemogenyx Pharmaceuticals as a Board observer and business advisor, bringing over 25 years of biopharmaceutical experience. His background includes significant roles at Genzyme and various biotechnology firms. Dr. Walts' expertise is expected to accelerate Hemogenyx's development pipeline, particularly in new therapies for blood diseases. CEO Dr. Vladislav Sandler expressed optimism about Dr. Walts' addition, noting its potential to enhance the company’s strategic direction and R&D efforts.
Hemogenyx Pharmaceuticals has released a new corporate presentation detailing its work in developing innovative therapies for deadly blood diseases. The company, based in London with operations in New York City, focuses on advancing treatments for conditions like leukemia, lymphoma, and severe autoimmune diseases. With over 50 years of experience in bone marrow transplantation, Hemogenyx aims to improve patient outcomes and broaden access to these life-saving procedures. The presentation can be accessed here.
Hemogenyx Pharmaceuticals (OTC PINK:HOPHF) announced the successful passing of all resolutions at its Annual General Meeting (AGM) held on June 25, 2021. Key resolutions included the approval of the 2020 Annual Report and Accounts with 99.87% votes in favor, and the Directors' Remuneration Policy which received 99.07% approval. The total votes cast amounted to 126,796,363, representing 12.94% of the issued share capital. The AGM's outcomes reflect strong shareholder support for the management's proposals.