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.
About Hemogenyx Pharmaceuticals
Hemogenyx Pharmaceuticals (LSE: HEMO, OTC: HOPHF) is a clinical-stage biopharmaceutical company headquartered in London, UK, with operational subsidiaries based in New York City. The company is dedicated to the development of transformative therapies for blood and autoimmune diseases, leveraging cutting-edge biotechnology to address unmet medical needs. With a focus on innovation, Hemogenyx is pioneering treatments that aim to improve outcomes for patients suffering from life-threatening conditions such as Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL).
Core Business and Mission
At its core, Hemogenyx Pharmaceuticals is committed to revolutionizing the treatment landscape for hematological diseases. The company’s mission is to extend the curative potential of bone marrow transplantation and develop novel therapies that offer hope to patients with limited treatment options. By targeting diseases with poor survival rates and high unmet needs, Hemogenyx is carving a niche in the competitive biopharmaceutical industry.
Product Pipeline
Hemogenyx is advancing a robust pipeline of innovative therapies, including:
- HEMO-CAR-T: A proprietary CAR-T cell therapy designed to treat relapsed or refractory AML. This therapy modifies a patient’s T-cells to recognize and destroy cancer cells, offering a potentially safer and more effective alternative to traditional chemotherapy.
- CDX Bi-Specific Antibody: A next-generation antibody engineered to target AML and ALL, as well as to facilitate conditioning for bone marrow transplantations. Utilizing advanced bi-specific pairing technology, this candidate has demonstrated enhanced efficacy in preclinical studies.
- Platform Technologies: The company employs proprietary platform technologies to accelerate the development of novel therapies, serving as an engine for continuous innovation.
Market Position and Differentiation
Hemogenyx operates in the highly specialized field of oncology and immunotherapy, positioning itself as a key player in the development of therapies for rare and challenging blood cancers. The company differentiates itself through its focus on subsets of leukemia that are particularly difficult to treat, such as relapsed/refractory AML and pediatric ALL. By addressing these niches, Hemogenyx is filling critical gaps in the treatment landscape and offering new hope to patients.
Industry Context and Challenges
The biopharmaceutical industry is characterized by rapid innovation, high R&D costs, and stringent regulatory requirements. Hemogenyx faces competition from established players in CAR-T therapy and antibody development but stands out due to its specialized focus and proprietary technologies. The company’s ability to navigate clinical trials and secure regulatory approvals will be pivotal to its success.
Commitment to Innovation
Hemogenyx Pharmaceuticals exemplifies a commitment to scientific excellence and innovation. Its state-of-the-art research facilities in New York City and partnerships with leading institutions like MD Anderson Cancer Center underscore its dedication to advancing medical science. By focusing on therapies with transformative potential, the company is making significant strides in the fight against life-threatening diseases.
Hemogenyx Pharmaceuticals has announced the schedule for opening its first clinical site for the Phase I trial of HEMO-CAR-T (HG-CT-1), targeting relapsed/refractory acute myeloid leukemia in adults. The company expects Institutional Review Board approval by mid-November, followed by a Site Initiation Visit in the third week. The trial will evaluate HG-CT-1's safety profile and assess secondary objectives including efficacy, overall survival rates, progression-free survival, and duration of response in patients with R/R AML who have therapeutic options.
Hemogenyx Pharmaceuticals announces a strategic investment from Prevail Partners, , totaling $350,000 (£269,000) through a subscription for ordinary shares at $0.075 per share, a 275% premium to the closing price on October 1, 2024. The subscription will take effect in March 2025, supporting the planned HEMO-CAR-T pediatric study.
Additionally, Hemogenyx's subsidiary has signed an amendment with Prevail InfoWorks, Inc. to provide clinical services for the upcoming Phase I study of anti-FLT3 CAR-T cells in pediatric patients with relapsed/refractory acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). The study is expected to commence in the first half of 2025.
The investment from Prevail Partners will largely cover the initial payment to InfoWorks for the pediatric study services.
Hemogenyx Pharmaceuticals plc (LSE: HEMO) has released its unaudited interim results for the six months ended 30 June 2024. Key highlights include:
- FDA lifted the clinical hold on the IND application for HEMO-CAR-T
- Raised £3.325 million to advance HEMO-CAR-T towards Phase I clinical trials
- Phase I trials expected to begin shortly at M.D. Anderson Cancer Center in Texas
- Advancements in Chimeric Bait Receptor (CBR) and bispecific antibody (CDX) programmes
The company has focused on getting HEMO-CAR-T into clinical trials while progressing other product candidates. They have evaluated its potential for pediatric AML and a subset of ALL. A clinical-grade assay for HEMO-CAR-T trials has been developed. The CBR platform is being tested against rare cancers and viral infections. CDX studies for IND application are advancing, with a new improved version showing enhanced effectiveness in lab tests.
Financial results show a loss before taxation of £2,815,604 for H1 2024, with cash and cash equivalents of £1,642,762 as of 30 June 2024.
Hemogenyx Pharmaceuticals plc (LSE:HEMO) has announced the successful development of a clinical-grade assay to assess FLT3 protein expression in acute myeloid leukemia (AML) cells. This assay is important for identifying and recruiting patients for the upcoming Phase I clinical trials of the company's HEMO-CAR-T product candidate. The trials are set to begin shortly at MD Anderson Cancer Center, with plans to expand to the University of Pennsylvania Medical Center.
The development of this assay marks a significant milestone in advancing HEMO-CAR-T towards clinical trials, potentially offering a life-saving treatment for AML patients. Dr. Vladislav Sandler, CEO and Co-Founder of Hemogenyx, expressed excitement about the imminent start of Phase I trials at MD Anderson, a leading institution in cancer care.
Hemogenyx Pharmaceuticals plc (LSE:HEMO) has announced a significant advancement in its CDX bi-specific antibody development for treating relapsed/refractory acute myeloid leukaemia (AML), a subset of acute lymphoblastic leukaemia (ALL), and potentially for conditioning in bone marrow transplantations. The company's scientists have created an improved version of CDX using Lonza's bYlok bispecific pairing technology, which has shown enhanced efficacy in in vitro testing. Additional in vivo studies are currently underway.
CEO Dr. Vladislav Sandler highlighted the potential of this development to improve treatment outcomes for patients with often incurable blood cancers. The advancement could accelerate the product candidate's progress towards clinical trials and potentially attract new industry partners interested in co-developing CDX.
Hemogenyx Pharmaceuticals plc (LSE:HEMO), a clinical-stage biopharmaceutical company, has been invited to present at the 2024 Chemical and Biological Defense Science & Technology (CBD S&T) Conference in Fort Lauderdale, FL, from December 2-5, 2024. The company will showcase its Chimeric Bait Receptor (CBR) platform, an advanced immunotherapy designed to reprogram innate immune cells to combat viral infections and specific types of cancer.
The presentation, titled 'Chimeric Bait Receptor (CBR) for Reprogramming of Myeloid Cells to Target and Eliminate Emerging Viral Infections', will focus on the platform's application in fighting viral threats. Dr. Vladislav Sandler, CEO & Co-Founder, emphasized the opportunity to establish Hemogenyx's position in the biodefense field and engage with experts, potential collaborators, and investors.
Hemogenyx Pharmaceuticals (LSE:HEMO) has announced its participation in the 6th Macrophage-Directed Therapies Summit in Boston, MA, from October 1-3, 2024. The company will present its work on the proprietary Chimeric Bait Receptor (CBR) platform, an advanced immunotherapy designed to program innate immune cells to combat specific cancers and viral threats.
The presentation will focus on using the CBR platform for treating rare cancers. Dr. Vladislav Sandler, CEO & Co-Founder, emphasized the opportunity to establish Hemogenyx's position in myeloid cell therapies and engage with potential collaborators and investors. This event highlights Hemogenyx's commitment to developing innovative treatments for life-threatening diseases, showcasing its state-of-the-art research capabilities in New York City.
Hemogenyx Pharmaceuticals announced the successful passing of all resolutions at its Annual General Meeting held on June 27, 2024. Key resolutions included the adoption of the company's annual accounts, approval of the Directors' Remuneration Report, re-appointment of Sir Marc Feldmann as Director, and re-appointment of PKF Littlejohn LLP as auditors. The voting results showed strong approval from shareholders, with most resolutions receiving over 90% votes in favor. Highlights include a 99.89% approval for the annual accounts and a 99.10% approval for the re-appointment of auditors. The resolutions enable the company to continue its strategic objectives and operational plans effectively.
Hemogenyx Pharmaceuticals has provided an update on its ongoing activities and progress as of June 17, 2024. The company has added a new US medical center to its HEMO-CAR-T clinical trial sites, enhancing its scope and expediting timelines. It is also expanding the HEMO-CAR-T indication to include pediatric AML and ALL. On the Chimeric Bait Receptor (CBR) platform, Hemogenyx is developing multiple CBR constructs for rare cancers and mRNA-based delivery for viral infections. IND-enabling studies for its CDX bispecific antibody are progressing for treating AML and ALL and conditioning in bone marrow transplants. The company is pursuing non-dilutive financing to support these initiatives.
Hemogenyx Pharmaceuticals has announced the posting of its Annual Report and Accounts for the year ending 31 December 2023. The report, along with the Notice of the Annual General Meeting (AGM) and a Form of Proxy, is now available on the company's website. The AGM will take place on 27 June 2024 at 2:00 pm BST at SP Angel Corporate Finance LLP's offices in London. Hemogenyx Pharmaceuticals focuses on developing new medicines and treatments for blood and autoimmune diseases, aiming to expand the curative power of bone marrow transplants.
Shareholders can find more details on the company's investor relations page. The company has its headquarters in London and operates subsidiaries in New York City. The announcement is distributed by RNS, a news service of the London Stock Exchange, and is compliant with regulations established by the Financial Conduct Authority.
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