Latest news with #BiologicalLicenseApplication
Yahoo
26-05-2025
- Business
- Yahoo
Huonslab Achieves Last-Patient-In (LPI) in Phase 1 Pivotal Study for Recombinant Human Natural Hyaluronidase PH20
Phase 1 Pivotal Study in Korea for HLB3-002 Plans to apply for marketing approval with the MFDS by the 2H 2025 PANGYO, South Korea, May 26, 2025--(BUSINESS WIRE)--Huonslab Co., Ltd. ("Huonslab"), a subsidiary of Huons Global (KOSDAQ:084110) has announced the successful completion of patient enrollment in its pivotal phase 1 clinical trial of Hydizyme™ (recombinant human natural hyaluronidase PH20; rHuPH20; HLB3-002), marking a significant milestone in the ongoing HLB3-002 development program. HLB3-002 Phase 1 Study (NCT06713317) was designed to evaluate the safety and allergenicity of HLB3-002 in 243 healthy volunteers. The study is being conducted as a two-part, randomized, double-blind, placebo-controlled study. The first part focuses on evaluating allergenicity of HLB3-002 upon single intradermal administration of HLB3-002, while the second part focuses on evaluating safety of HLB3-002 upon single subcutaneous administration. The study is ongoing at four leading medical institutions in South Korea, known for their excellence in clinical research: Seoul National University Hospital, Asan Medical Center, Konkuk University Medical Center, and Chung-Ang University Hospital. The participating sites were selected to support consistent trial conduct and participant recruitment. Huonslab expects to submit a Biological License Application (BLA) for marketing approval with the MFDS by the second half of this year, pending trial outcomes. Huonslab's official said, "This milestone represents an important step in advancing the HLB3-002 development program. The results of this phase 1 will provide Huonslab with important insights into the safety and allergenicity profile of HLB3-002, laying a solid foundation for future clinical trials and regulatory submission." In April, Huonslab attracted much attention at the 2025 Annual Meeting of the American Association for Cancer Research (AACR 2025), held in Chicago, when the company announced the result of formulation conversion using recombinant human hyaluronidase HLB3-002 in a poster presentation. About Huonslab Huonslab, a South Korean biologics R&D leader and subsidiary of Huons Global (KOSDAQ:084110), is a fast-paced Bio, Pharmaceuticals & Healthcare business holding company with more than 2,200 employees, worldwide. Huonslab was established in 2018 to innovate human hyaluronidase-based biologics for subcutaneous (SC) delivery. Its proprietary HyDIFFUZE™ platform, manufactured with a recombinant CHO cell line and patented process, offers a patient-friendly and economical alternative to traditional intravenous (IV) delivery by streamlining SC administration of various therapeutic modalities. View source version on Contacts Media Contact Dr. Byung Ha LeeChief Business Officerblee@
Business Wire
26-05-2025
- Business
- Business Wire
Huonslab Achieves Last-Patient-In (LPI) in Phase 1 Pivotal Study for Recombinant Human Natural Hyaluronidase PH20
PANGYO, South Korea--(BUSINESS WIRE)-- Huonslab Co., Ltd. ('Huonslab'), a subsidiary of Huons Global (KOSDAQ:084110) has announced the successful completion of patient enrollment in its pivotal phase 1 clinical trial of Hydizyme™ (recombinant human natural hyaluronidase PH20; rHuPH20; HLB3-002), marking a significant milestone in the ongoing HLB3-002 development program. HLB3-002 Phase 1 Study (NCT06713317) was designed to evaluate the safety and allergenicity of HLB3-002 in 243 healthy volunteers. 'This milestone represents an important step in advancing the HLB3-002 development program. The results of this phase 1 will provide Huonslab with important insights into the safety and allergenicity profile of HLB3-002." The study is being conducted as a two-part, randomized, double-blind, placebo-controlled study. The first part focuses on evaluating allergenicity of HLB3-002 upon single intradermal administration of HLB3-002, while the second part focuses on evaluating safety of HLB3-002 upon single subcutaneous administration. The study is ongoing at four leading medical institutions in South Korea, known for their excellence in clinical research: Seoul National University Hospital, Asan Medical Center, Konkuk University Medical Center, and Chung-Ang University Hospital. The participating sites were selected to support consistent trial conduct and participant recruitment. Huonslab expects to submit a Biological License Application (BLA) for marketing approval with the MFDS by the second half of this year, pending trial outcomes. Huonslab's official said, 'This milestone represents an important step in advancing the HLB3-002 development program. The results of this phase 1 will provide Huonslab with important insights into the safety and allergenicity profile of HLB3-002, laying a solid foundation for future clinical trials and regulatory submission.' In April, Huonslab attracted much attention at the 2025 Annual Meeting of the American Association for Cancer Research (AACR 2025), held in Chicago, when the company announced the result of formulation conversion using recombinant human hyaluronidase HLB3-002 in a poster presentation. About Huonslab Huonslab, a South Korean biologics R&D leader and subsidiary of Huons Global (KOSDAQ:084110), is a fast-paced Bio, Pharmaceuticals & Healthcare business holding company with more than 2,200 employees, worldwide. Huonslab was established in 2018 to innovate human hyaluronidase-based biologics for subcutaneous (SC) delivery. Its proprietary HyDIFFUZE™ platform, manufactured with a recombinant CHO cell line and patented process, offers a patient-friendly and economical alternative to traditional intravenous (IV) delivery by streamlining SC administration of various therapeutic modalities.
Yahoo
26-05-2025
- Business
- Yahoo
Huonslab Achieves Last-Patient-In (LPI) in Phase 1 Pivotal Study for Recombinant Human Natural Hyaluronidase PH20
Phase 1 Pivotal Study in Korea for HLB3-002 Plans to apply for marketing approval with the MFDS by the 2H 2025 PANGYO, South Korea, May 26, 2025--(BUSINESS WIRE)--Huonslab Co., Ltd. ("Huonslab"), a subsidiary of Huons Global (KOSDAQ:084110) has announced the successful completion of patient enrollment in its pivotal phase 1 clinical trial of Hydizyme™ (recombinant human natural hyaluronidase PH20; rHuPH20; HLB3-002), marking a significant milestone in the ongoing HLB3-002 development program. HLB3-002 Phase 1 Study (NCT06713317) was designed to evaluate the safety and allergenicity of HLB3-002 in 243 healthy volunteers. The study is being conducted as a two-part, randomized, double-blind, placebo-controlled study. The first part focuses on evaluating allergenicity of HLB3-002 upon single intradermal administration of HLB3-002, while the second part focuses on evaluating safety of HLB3-002 upon single subcutaneous administration. The study is ongoing at four leading medical institutions in South Korea, known for their excellence in clinical research: Seoul National University Hospital, Asan Medical Center, Konkuk University Medical Center, and Chung-Ang University Hospital. The participating sites were selected to support consistent trial conduct and participant recruitment. Huonslab expects to submit a Biological License Application (BLA) for marketing approval with the MFDS by the second half of this year, pending trial outcomes. Huonslab's official said, "This milestone represents an important step in advancing the HLB3-002 development program. The results of this phase 1 will provide Huonslab with important insights into the safety and allergenicity profile of HLB3-002, laying a solid foundation for future clinical trials and regulatory submission." In April, Huonslab attracted much attention at the 2025 Annual Meeting of the American Association for Cancer Research (AACR 2025), held in Chicago, when the company announced the result of formulation conversion using recombinant human hyaluronidase HLB3-002 in a poster presentation. About Huonslab Huonslab, a South Korean biologics R&D leader and subsidiary of Huons Global (KOSDAQ:084110), is a fast-paced Bio, Pharmaceuticals & Healthcare business holding company with more than 2,200 employees, worldwide. Huonslab was established in 2018 to innovate human hyaluronidase-based biologics for subcutaneous (SC) delivery. Its proprietary HyDIFFUZE™ platform, manufactured with a recombinant CHO cell line and patented process, offers a patient-friendly and economical alternative to traditional intravenous (IV) delivery by streamlining SC administration of various therapeutic modalities. View source version on Contacts Media Contact Dr. Byung Ha LeeChief Business Officerblee@ Sign in to access your portfolio
Yahoo
20-05-2025
- Business
- Yahoo
Longeveron® to Attend BIO International Convention 2025
Focus on potential partnership and strategic opportunities for the Company's stem cell therapy program for Alzheimer's disease Recent Type B meeting with FDA provided alignment on a planned single, pivotal Phase 2/3 clinical trial, which if positive, would be acceptable for Biological License Application (BLA) submission for Alzheimer's disease Initiation of planned single, pivotal Phase 2/3 clinical trial in mild Alzheimer's disease anticipated in 2H 2026, contingent upon obtaining non-dilutive funding and/or partnering support Results from the Phase 2a clinical trial (CLEAR MIND) evaluating laromestrocel as a potential treatment for Alzheimer's disease were published in the peer reviewed journal Nature Medicine Laromestrocel is, to Company's knowledge, the first cellular therapeutic candidate to receive FDA Regenerative Medicine Advanced Therapy (RMAT) designation for Alzheimer's disease MIAMI, May 20, 2025 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that the Company will participate in the BIO International Convention taking place June 16-19, 2025 at the Boston Convention & Exhibition Center. At the conference, members of the Longeveron management team will host meetings with global pharmaceutical company executives to explore potential partnership and strategic opportunities for the Company's Alzheimer's disease program, which has generated positive data in successful Phase 1 and Phase 2 clinical trials. Results from the Phase 2a clinical trial (CLEAR MIND), which support the therapeutic potential of laromestrocel in the treatment of mild Alzheimer's disease, were published in the peer reviewed journal Nature Medicine in March 2025. Longeveron's lead investigational therapeutic candidate is laromestrocel, a proprietary, scalable, allogenic cellular therapy. In the completed Phase 2a clinical trial (CLEAR MIND), laromestrocel treated patients showed an overall slowing/prevention of disease worsening compared to placebo. The trial achieved the primary safety and secondary efficacy endpoints and showed statistically significant improvements in pre-specified clinical and biomarker endpoints in specific laromestrocel groups compared to placebo. Longeveron previously announced top-line results for the CLEAR MIND Phase 2a clinical trial on October 5, 2023, and reported additional clinical data and imaging biomarker results from CLEAR MIND on December 20, 2023. Full results from the CLEAR MIND study were presented in a featured research oral presentation at the 2024 Alzheimer's Association International Conference (AAIC). The FDA has granted laromestrocel both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for the treatment of mild Alzheimer's disease, which allow greater access to FDA interaction during laromestrocel's development for Alzheimer's disease. Laromestrocel is, to Company's knowledge, the first cellular therapeutic candidate to receive FDA RMAT designation for Alzheimer's disease. To connect with Longeveron during the conference, please request a meeting via the BIO International Conference meeting portal or contact info@ About Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company's lead investigational product is laromestorcel, an allogeneic mesenchymal stem cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Laromestrocel has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease, and Aging-related Frailty. Laromestrocel development programs have received five distinct and important FDA designations: for the HLHS program - Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program - Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation. For more information, visit or follow Longeveron on LinkedIn, X, and Instagram. Forward-Looking StatementsCertain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management's current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve known and unknown risks, uncertainties, and other important factors that could cause actual results, performance, or achievements to differ materially from those anticipated, expressed, or implied by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as 'anticipate,' 'believe,' 'contemplate,' 'continue,' 'could,' 'estimate,' 'expects,' 'intend,' 'looks to,' 'may,' 'on condition,' 'plan,' 'potential,' 'predict,' 'preliminary,' 'project,' 'see,' 'should,' 'target,' 'will,' 'would,' or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects and include, but are not limited to, statements about the various below-listed factors. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, our cash position and need to raise additional capital, the difficulties we may face in obtaining access to capital, and the dilutive impact it may have on our investors; our financial performance, and ability to continue as a going concern; the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials, and the reporting of data from those studies and trials; the size of the market opportunity for certain of our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting; our ability to scale production and commercialize the product candidate for certain indications; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates in the U.S. and other jurisdictions; our plans relating to the further development of our product candidates, including additional disease states or indications we may pursue; our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and our ability to attract and retain such personnel; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing. Further information relating to factors that may impact the Company's results and forward-looking statements are disclosed in the Company's filings with the Securities and Exchange Commission, including Longeveron's Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on February 28, 2025, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The Company operates in highly competitive and rapidly changing environment; therefore, new factors may arise, and it is not possible for the Company's management to predict all such factors that may arise nor assess the impact of such factors or the extent to which any individual factor or combination thereof, may cause results to differ materially from those contained in any forward-looking statements. The forward-looking statements contained in this press release are made as of the date of this press release based on information available as of the date of this press release, are inherently uncertain, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Investor and Media Contact:Derek ColeInvestor Relations Advisory in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
