Latest news with #AlumeBiosciences
Yahoo
03-07-2025
- Health
- Yahoo
Alume Biosciences Announces Publication of Data Examining First-in-Human Use of Bevonescein to Illuminate Nerves in Nature Communications
SAN DIEGO, July 02, 2025--(BUSINESS WIRE)--Alume Biosciences, a late-clinical stage biotechnology company developing nerve-illuminating technology to enhance surgical safety, today announced the publication of first-in-human data from a Phase 1 clinical trial evaluating bevonescein (ALM-488) in head and neck surgeries. The original research article titled, "Intraoperative Nerve-Specific Fluorescence Imaging in Head and Neck Surgery: A Phase 1 Clinical Trial," authored by Lee, Y., Orosco, R., et al., was published in Nature Communications. Bevonescein is a novel fluorescent visualization drug designed to selectively illuminate nerves during surgery, helping to prevent inadvertent nerve injury and is currently being evaluated in ongoing Phase 3 clinical trials. "Currently, many head and neck surgeries result in nerve injuries, which can be catastrophic for the patients," said Eben L. Rosenthal, MD, Barry Baker Professor and Chair of the Department of Otolaryngology–Head and Neck Surgery at Vanderbilt University Medical Center and study senior author. "This first-in-human data demonstrate the safety of bevonescein and its potential to enhance nerve visualization in real time. It's especially promising to see improvements in nerve conspicuity at the optimal dose." Key Findings: Fluorescence Superiority: Bevonescein provided enhanced nerve visualization with higher nerve conspicuity scores in fluorescent compared to white light. All participants demonstrated improved visible nerve length; 57% showed more than 20% improvement. Optimal Dose Defined: The optimal treatment dose of bevonescein was 500mg. Favorable Safety Profile: No dose-limiting toxicities or infusion reactions occurred. No surgeries were delayed or canceled due to the study drug. "These data support our belief that bevonescein can help make surgery more precise by allowing surgeons to see nerves more clearly," said Quyen Nguyen, MD, PhD, Founder and CEO of Alume Biosciences. "When Roger Tsien and I started work on bevonescein, our vision was to translate his Nobel Prize-winning discoveries regarding fluorescence into tools that directly improve surgical outcomes. This milestone brings us closer to that goal." "With the growing adoption of fluorescence guidance in surgery, it's exciting to see this technology now applied to nerve identification," said Ryan Orosco, MD, Associate Professor, University of New Mexico and the study's co-lead author. "Bevonescein represents a paradigm shift in how we identify nerves during surgery, and ultimately how we improve patient outcomes." Study Overview The dose-defining and dose-timing clinical trial enrolled 27 adults undergoing elective head and neck surgery including parotidectomy, thyroidectomy and cervical neck dissections. Participants received intravenous bevonescein at varying doses to assess safety, pharmacokinetics, and optimal visualization timing. Surgical visualization of bevonescein-enabled nerve fluorescence was performed using the Zeiss Tivato surgical microscope with Yellow 560. Surgeons assessed nerve visualization using 4-point Likert scale that measured conspicuity, visible nerve length, and delineation of branching. About Bevonescein (ALM-488) Bevonescein is Alume's lead compound—a targeted fluorescent peptide-dye conjugate that binds to nerve tissue, enabling intraoperative nerve visualization. It is currently in Phase 3 clinical trials and is planned for New Drug Application (NDA) submission to the U.S. Food and Drug Administration in 2026. About Alume Biosciences Alume Biosciences is a biotechnology company pioneering nerve-targeted drugs to enhance surgical precision and preserve nerve function. Founded on a lead candidate co-invented by late Nobel Laureate Dr. Roger Tsien, Alume is committed to translating cutting-edge science into practical tools for surgeons and better outcomes for patients. Learn more at and LinkedIn. View source version on Contacts Media Contact Janine 201-245-6838 Error 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
Business Wire
02-07-2025
- Health
- Business Wire
Alume Biosciences Announces Publication of Data Examining First-in-Human Use of Bevonescein to Illuminate Nerves in Nature Communications
SAN DIEGO--(BUSINESS WIRE)--Alume Biosciences, a late-clinical stage biotechnology company developing nerve-illuminating technology to enhance surgical safety, today announced the publication of first-in-human data from a Phase 1 clinical trial evaluating bevonescein (ALM-488) in head and neck surgeries. The original research article titled, ' Intraoperative Nerve-Specific Fluorescence Imaging in Head and Neck Surgery: A Phase 1 Clinical Trial,' authored by Lee, Y., Orosco, R., et al., was published in Nature Communications. 'These data support our belief that bevonescein can help make surgery more precise by allowing surgeons to see nerves more clearly." Bevonescein is a novel fluorescent visualization drug designed to selectively illuminate nerves during surgery, helping to prevent inadvertent nerve injury and is currently being evaluated in ongoing Phase 3 clinical trials. 'Currently, many head and neck surgeries result in nerve injuries, which can be catastrophic for the patients,' said Eben L. Rosenthal, MD, Barry Baker Professor and Chair of the Department of Otolaryngology–Head and Neck Surgery at Vanderbilt University Medical Center and study senior author. 'This first-in-human data demonstrate the safety of bevonescein and its potential to enhance nerve visualization in real time. It's especially promising to see improvements in nerve conspicuity at the optimal dose.' Key Findings: Fluorescence Superiority: Bevonescein provided enhanced nerve visualization with higher nerve conspicuity scores in fluorescent compared to white light. All participants demonstrated improved visible nerve length; 57% showed more than 20% improvement. Optimal Dose Defined: The optimal treatment dose of bevonescein was 500mg. Favorable Safety Profile: No dose-limiting toxicities or infusion reactions occurred. No surgeries were delayed or canceled due to the study drug. 'These data support our belief that bevonescein can help make surgery more precise by allowing surgeons to see nerves more clearly,' said Quyen Nguyen, MD, PhD, Founder and CEO of Alume Biosciences. 'When Roger Tsien and I started work on bevonescein, our vision was to translate his Nobel Prize-winning discoveries regarding fluorescence into tools that directly improve surgical outcomes. This milestone brings us closer to that goal.' 'With the growing adoption of fluorescence guidance in surgery, it's exciting to see this technology now applied to nerve identification,' said Ryan Orosco, MD, Associate Professor, University of New Mexico and the study's co-lead author. 'Bevonescein represents a paradigm shift in how we identify nerves during surgery, and ultimately how we improve patient outcomes.' Study Overview The dose-defining and dose-timing clinical trial enrolled 27 adults undergoing elective head and neck surgery including parotidectomy, thyroidectomy and cervical neck dissections. Participants received intravenous bevonescein at varying doses to assess safety, pharmacokinetics, and optimal visualization timing. Surgical visualization of bevonescein-enabled nerve fluorescence was performed using the Zeiss Tivato surgical microscope with Yellow 560. Surgeons assessed nerve visualization using 4-point Likert scale that measured conspicuity, visible nerve length, and delineation of branching. About Bevonescein (ALM-488) Bevonescein is Alume's lead compound—a targeted fluorescent peptide-dye conjugate that binds to nerve tissue, enabling intraoperative nerve visualization. It is currently in Phase 3 clinical trials and is planned for New Drug Application (NDA) submission to the U.S. Food and Drug Administration in 2026. About Alume Biosciences Alume Biosciences is a biotechnology company pioneering nerve-targeted drugs to enhance surgical precision and preserve nerve function. Founded on a lead candidate co-invented by late Nobel Laureate Dr. Roger Tsien, Alume is committed to translating cutting-edge science into practical tools for surgeons and better outcomes for patients. Learn more at and LinkedIn.
Yahoo
18-02-2025
- Business
- Yahoo
Alume Biosciences Appoints Kaveri Parker as Chief Business Officer
SAN DIEGO, Feb. 18, 2025 /PRNewswire/ -- Alume Biosciences, a late-clinical stage biotechnology company developing nerve illuminating technology to potentially make surgery safer, today announced the appointment of Kaveri Parker, Ph.D. as Chief Business Officer. Dr. Parker is a forward-thinking biopharma leader and joins Alume Biosciences with deep experience in strategy and operations leadership roles. "We are pleased to welcome Kaveri to our growing team and are confident her vision will help us advance the field of fluorescent-guided surgery for the benefit of patients and surgeons," said Quyen Nguyen, M.D., Ph.D., Alume Biosciences Chief Executive Officer. "Kaveri brings a track-record of success across licensing agreements, partnership development, financing and more. Her deep expertise and insights providing strategic guidance in biopharma will be critical as we approach potential FDA approval for our lead candidate, bevonescein, and as we grow as a company." "I am thrilled to join Alume at this key stage in the Company's development as we are poised to advance an important product candidate at the forefront of fluorescent-guided surgery," said Dr. Parker. "Surgical safety is a key area with room for improvement across the industry and Alume's approach has the potential for tangible impact in patients' lives. I am eager to work with the full team to identify key pathways for growth and commercialization opportunities." Prior to joining Alume Biosciences, Dr. Parker was the Chief Business Officer of Synedgen, Inc. where she oversaw commercial, strategic and business development activities for the Company's drug and medical device assets. While at Synedgen, Dr. Parker secured both dilutive and non-dilutive funding for complex and high-risk programs and was the co-architect of the Company's $110M contract with the Biomedical Advanced Research and Development Authority (BARDA). She also secured high-value partnerships with public and private stakeholders. She additionally serves as the strategic and commercialization lead for a national pandemic preparedness team at the Mayo Clinic. She has ongoing Strategy and Transaction Advisory roles with multiple private companies. She was previously the President and CEO of ID Genomics, a company focused on antibiotic susceptibility testing. Dr. Parker has a Ph.D. from Washington University School of Medicine in Saint Louis. About Alume Biosciences Alume Biosciences is on a mission to make our proprietary nerve illumination technology available for surgeons so that patients everywhere can benefit. Alume was born out of a collaboration between head and neck surgeon Dr. Quyen Nguyen and Nobel Laureate Dr. Roger Tsien working to advance nerve illuminating technology to protect and preserve nerve function in surgery. Learn more at and LinkedIn. Media Contact Janine Bogris 201-245-6838 View original content to download multimedia: SOURCE Alume Biosciences Sign in to access your portfolio
