Bayer Pharma AG

MONDAY, Dec. 30, 2024 -- Men with negative multiparametric magnetic resonance imaging (mpMRI) results avoiding biopsy do not have an increased risk for clinically significant prostate cancer (PCa), according to a study published online Dec. 12 in JAMA Oncology . Charlie A. Hamm, M.D., Ph.D., from Charité-Universitätsmedizin Berlin, and colleagues examined the feasibility and safety of a community-based MRI diagnostic strategy in men aged 18 to 75 years with suspected PCa. Participants underwent 3-Tesla mpMRI; those with findings suspected to be PCa were recommended for targeted prostate biopsy (PB). Men with negative mpMRI results or positive mpMRI results and benign findings on PB were monitored systematically for three years. Overall, 593 men underwent mpMRI and 48 percent had negative MRI results; 44 and 41 percent avoided PB initially and over three years, respectively. The researchers found that clinically significant PCa was detected in 27 and 29 percent of men after immediate PB and after three years, respectively. Seven men with negative MRI results had PCa diagnosed by immediate PB and 279 entered the monitoring phase. A total of 233 completed three-year monitoring, with seven PCa diagnoses. Nineteen percent of the 307 men with positive MRI results showed no PCa after immediate PB; of these, 71 and 7 percent completed monitoring and were diagnosed with clinically significant PCa, respectively. "By providing programmatic three-year monitoring data for both patients with negative and positive MRI results, findings from this study address the gap of knowledge highlighted in current guidelines on the use of MRI in the diagnosis and management of PCa," the authors write. Several authors disclosed ties to pharmaceutical and medical technology companies, including Bayer Pharma AG and Siemens Healthineers, both of which contributed funding for the study. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

SEATTLE--( BUSINESS WIRE )--Bonum Therapeutics, a biotechnology company that is using innovative technology for conditional activation of biologics to create highly active and less toxic medicines, today announced that Samuel C. Blackman, MD, PhD, has joined its board of directors as an independent director. Blackman, a pediatric neuro-oncologist by training, is the co-founder and head of research and development at Day One Biopharmaceuticals, which is dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases. Blackman led Day One’s acquisition and development of OJEMDA™, which the FDA approved earlier this year for treatment of the most common form of childhood brain tumors, low-grade glioma. “We are delighted to welcome Sam Blackman to the Bonum Therapeutics team. His judgment and his deep experience in the clinical development of novel immune-oncology agents will benefit Bonum and the patients Bonum is seeking to serve,” said John Mulligan, PhD, Bonum’s founder and CEO. “Sam has overseen the successful development of novel therapies for pediatric and adult cancers across a range of indications and mechanisms of action. His help will make our board and our team better—we are honored that he chose to work with Bonum.” “I’m thrilled to have the opportunity to join the Bonum Therapeutics board of directors as Bonum advances its programs into the clinic,” said Blackman. “The development of innovative therapeutics that have the potential to address ongoing gaps in both activity and safety for patients with a variety of life-threatening diseases has been core to my career as both a physician and drug developer. Bonum’s science, mission, team, and culture have made a significant impression on me, and I am excited to be a part of the company’s bright future.” Prior to founding Day One in 2018, Blackman held positions of increasing responsibility at large pharmaceutical companies, including Merck and GlaxoSmithKline, and biotechnology companies such as Seattle Genetics, Juno Therapeutics, and Silverback Therapeutics. Most recently, he was head of clinical development at Mavupharma, a drug discovery company focused on leveraging the immune system to treat cancer and infectious diseases. He is also a member of the board of directors of Presage Biosciences. Sam is a graduate of the pediatric hematology-oncology fellowship program at the Dana Farber Cancer Institute and Children’s Hospital Boston and the pediatric residency program at Cincinnati Children’s Hospital Medical Center. He received his BA in philosophy from the University of Chicago and his MD and PhD degrees from the University of Illinois at Chicago. About Bonum Therapeutics Bonum Therapeutics is a privately held biotechnology company that uses a novel, antibody-based mechanism to create regulated and targeted, highly active, and less toxic medicines. Bonum’s most advanced program is in preclinical development. The company was founded in 2022 as a spinout of Good Therapeutics, following the sale of Good to Roche in September 2022 for $250 million, plus milestones. Bonum’s molecules combine a sensor component directed against a specific biological marker and a therapeutic component. When the sensor binds its target, the tethered effector becomes available to deliver potent activity only where it is needed. The technology is applicable to a wide range of therapeutic areas, including oncology, autoimmunity, metabolic disorders, and pain management. Bonum’s initial efforts focus on regulated immunocytokines, including conditionally active IL-2, IFN-alpha, IL-12, and TGF-beta, while it pursues additional applications in partnership with others. The company is backed by a group of leading venture investors including Rivervest Venture Partners, Roche Venture Fund, Digitalis Ventures, American Century Investments, Codon Capital, and Vivo Capital. For more information, please visit our website at www.bonumtx.com and connect with us on LinkedIn .

Improved supply capabilities of Neuraceq® to provide better patient access to beta-amyloid PET BOSTON, Jan. 9, 2024 /PRNewswire/ -- Life Molecular Imaging (LMI) and SOFIE Biosciences (SOFIE), a national US manufacturer and developer of PET radiopharmaceuticals, announce that the companies have expanded their strategic partnership and licensing agreement to provide and distribute Neuraceq® out of SOFIE's radiopharmaceutical manufacturing site located in Houston, Texas. The first doses will be available on January 9th, 2023. Continue Reading Life Molecular Imaging (PRNewsfoto/Life Molecular Imaging) Neuraceq® is an FDA-approved imaging agent for the detection of beta-amyloid plaques in the brain of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline. It is used in clinical routine and is also a powerful imaging biomarker for the appropriate characterisation of subjects enrolled in clinical trials to support drug development in neurodegenerative diseases. "With the addition of Houston, TX to our distribution network, Life Molecular Imaging continues to expand the availability of Neuraceq®, an important diagnostic imaging tool for the detection of beta-amyloid plaques in the brain. We are truly excited about our continued collaboration with SOFIE to provide greater availability of our approved beta-amyloid tracer Neuraceq® to physicians and their patients, and to our pharma partners for routine clinical and research use," said Ludger Dinkelborg, Ph.D., Managing Director at LMI. Patrick Phelps, SOFIE president & CEO states, "After many years of hard work from numerous scientists and clinicians, the recent news in the treatment of Alzheimer's disease seems extremely promising. SOFIE is committed to the further expansion and availability of LMI's Neuraceq® PET diagnostic tracer throughout our national PET manufacturing and dispensing network." About Neuraceq® (florbetaben 18F) Indication Neuraceq® is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive decline. A negative Neuraceq® scan indicates sparse to no amyloid neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive Neuraceq® scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq® is an adjunct to other diagnostic evaluations. Limitations of Use A positive Neuraceq® scan does not establish the diagnosis of AD or any other cognitive disorder. Safety and effectiveness of Neuraceq® have not been established for (i) predicting development of dementia or other neurologic conditions and (ii) monitoring responses to therapies. Important Safety Information Risk for Image Interpretation and Other Errors Neuraceq® images should be interpreted independent of a patient's clinical information. Physicians should receive training prior to interpretation of Neuraceq® images. Following training, image reading errors (especially false positives) may still occur. Additional interpretation errors may occur due to, but not limited to, motion artifacts or extensive brain atrophy. Radiation Risk Administration of Neuraceq®, like other radiopharmaceuticals, contributes to a patient´s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. It is important to ensure safe handling to protect patients and health care workers from unintentional radiation exposure. Most Common Adverse Reactions In clinical trials, the most frequently observed adverse drug reactions in 872 subjects with 1090 Neuraceq® administrations were injection site reactions, consisting of erythema (1.7%), injection site irritation (1.1%), and pain (3.4%). About Life Molecular Imaging (LMI) Life Molecular Imaging (LMI, formerly Piramal Imaging) was formed in 2012 with the acquisition of the molecular imaging research and development portfolio of Bayer Pharma AG. It is now part of the Alliance Medical Group (a member of the Life Healthcare Group) offering an integrated business including research and development laboratories, a network of cyclotrons, radiopharmacies and imaging facilities. By developing novel PET tracers for molecular imaging, LMI is focusing on a key field of modern medicine. The organization strives to be a leader in the Molecular Imaging field by developing innovative products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. Please visit . About Life Healthcare Group Life Healthcare is a global people-centered, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 38 years' experience in the South African private healthcare sector, and currently operates 66 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, and wellness, occupational health, primary health and emergency medical services. The Group owns Alliance Medical Group, the leading independent provider of medical imaging services (MRI, CT, and PET scans) within Europe, operating internationally across 10 countries. Life Molecular Imaging, a division of Alliance is an integrated pharmaceutical business that includes research and development laboratories, access to a network of cyclotrons and radio-pharmacies and imaging facilities, with Life Radiopharma being Alliance's distributor of radiopharmaceuticals to diagnose many types of diseases. Visit: About SOFIE SOFIE's vision is to improve patient outcomes by developing and delivering molecular diagnostics and therapeutics (theranostics). With its robust radiopharmaceutical production and distribution network, mature contract manufacturing services, and high value theragnostic intellectual property, SOFIE is poised to deliver on the promise of radiopharmaceuticals. For more information visit SOFIE's website or contact by email at [email protected] For media queries contact: Brittany Hahn Marketing Communications Manager, Life Molecular Imaging [email protected] Dawn Allen Customer Connections Manager, SOFIE [email protected] SOURCE Life Molecular Imaging