Latest news with #MichaelJensen
Business Wire
15-05-2025
- Health
- Business Wire
FDA Grants Regenerative Medicine Advanced Therapy Designation for BrainChild Bio's B7-H3 CAR T-cell Therapy for Incurable Pediatric Brain Tumors
SEATTLE & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BrainChild Bio, Inc., a clinical-stage biotechnology company developing CAR T-cell therapies to treat tumors in the central nervous system (CNS), today announced that the investigational B7-H3 targeting autologous CAR T-cell therapy has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S Food and Drug Administration (FDA) for the treatment of diffuse intrinsic pontine glioma (DIPG), an incurable pediatric brain tumor. The use of a regenerative medicine, specifically a CAR T-cell therapy, offers the potential to overcome barriers for other drug modalities to be effective in addressing DIPG, including the precarious location of the DIPG tumor in the brainstem, the infiltrative growth of the tumor throughout normal brainstem functional anatomy, and the blood brain barrier that remains intact during tumor progression. BrainChild Bio has designed BCB-276 to be administered by locoregional delivery of targeted CAR T-cells directly into the cerebrospinal fluid, permitting infused CAR T-cells to directly access the tumor bed, using an indwelling reservoir-catheter device. This approach to administering an autologous B7-H3 CAR T-cell therapy has been successfully implemented and resulted in the promising overall survival benefit in patients with brain tumors observed in the BrainChild-03 Phase 1 trial (NCT04185038), conducted by BrainChild Bio's academic partner, Seattle Children's Research Institute, and recently published in Nature Medicine. 'We are very pleased to now also receive RMAT designation, less than one month after being granted Breakthrough Therapy designation from FDA for our lead CAR T therapy, BCB-276, for the treatment of DIPG. Receiving designations from two independent reviews within FDA further validates the positive CAR-T clinical results achieved by our team to date and the urgent need for a treatment for DIPG,' stated Michael Jensen, MD, Founder and Chief Scientific Officer of BrainChild Bio. 'Our team is keenly focused on initiating the pivotal Phase 2 trial by the end of this year and look forward to continuing to work with the FDA on an accelerated path forward to bring potential new CAR-T treatments for CNS brain tumors in children and adults.' FDA grants RMAT designation to investigational regenerative medicine therapies, including cell therapies, that are aimed at treating serious or life-threatening diseases have shown preliminary clinical evidence that the drug has the potential to address unmet medical needs for the disease. Investigational medicines with RMAT are provided intensive interactions with the FDA during the product candidate's development process in addition to being eligible for rolling submission and priority review of the marketing application. 'It's gratifying to see another important benchmark reached in our work to combat pediatric brain cancer,' said Dr. Jeff Sperring, Chief Executive Officer at Seattle Children's. 'Our research is the foundation of progress to bring potential therapies to kids as fast as we can – and we're excited about the possibilities afforded by this designation.' BrainChild Bio is preparing to advance BCB-276 in a Phase 2 multi-center, pivotal registration trial to support a potential Biologics License Application (BLA) to the FDA for the treatment of children and young adults with DIPG. This clinical plan is based on alignment between BrainChild Bio and FDA at a Type B meeting in late 2024. About Diffuse Intrinsic Pontine Glioma (DIPG) and Application of CAR T-cell Therapies Diffuse intrinsic pontine glioma (DIPG) is a primary high-grade brain tumor that arises in the pons and is uniformly fatal. DIPG affects approximately 300 children per year in the U.S. with the majority of diagnoses made in children between 5 and 10 years of age. Current standard-of-care treatment remains limited to palliative focal radiation therapy which results in a median overall survival of only about 11 months from diagnosis. 1 Barriers to effective therapies for DIPG include the precarious location of the tumor in the brainstem, the infiltrative growth of the tumor throughout normal brainstem functional anatomy, and the blood brain barrier that remains relatively intact during tumor progression preventing therapies from gaining access to the cancer. The barriers to effective therapies for DIPG can be effectively overcome by the locoregional delivery of appropriately targeted CAR T-cells directly into the cerebrospinal fluid via intracerebroventricular (ICV) dosing with an indwelling reservoir-catheter device. This enables the potential for extensive exposure of the pons to cerebrospinal fluid flow from the ventricular system, thus permitting infused CAR T-cells to directly access the tumor bed. This also allows for repetitive infusions of CAR T-cells to replenish the tumor bed, offering the potential for more durable and sustained efficacy. Additionally, with the blood brain barrier intact, this therapeutic approach can also minimize any on-target, off-tumor toxicities resulting from systemic exposure of CAR T-cells. About BrainChild Bio BrainChild Bio, Inc., is a kids-first, clinical-stage biotechnology company harnessing the power of CAR T-cell technology to treat tumors in the central nervous system, prioritizing pediatric indications with plans to expand into adult CNS tumors, specifically Glioblastoma and brain metastasis. BrainChild Bio was launched out of Seattle Children's Therapeutics program and founded on the work of Dr. Michael Jensen, a pioneer in the cancer immunotherapy field and previous Chief Therapeutics Officer at Seattle Children's. BrainChild Bio is advancing a next-generation CAR T-cell therapy platform for tumors of the CNS that weaves together synthetic technologies, including multiplex targeting and enhanced potency controls, to enable multiple targets in a single CAR T-cell therapy, novel transgenes to increase potency, delivery technology for durable efficacy, and streamlined CAR T-cell design and manufacturing. BrainChild Bio's lead drug candidate is BCB-276, an autologous CAR T-cell therapy that targets the immune checkpoint B7-H3, that is advancing in clinical trials for the treatment of diffuse intrinsic pontine glioma (DIPG), a pediatric cancer that forms in the brainstem which currently has no approved treatments. BrainChild Bio's cell therapy approach using autologous B7-H3 CAR T-cell therapy has received Breakthrough Therapy designation and Regenerative Medicine Advanced Therapy designation from the U.S. Food and Drug Administration (FDA). More information is available at _____________________________________________________________ 1 DIPG Registry.
Yahoo
14-05-2025
- Yahoo
Hoosock, Jensen families, friends and fellow officers attend vigil for fallen heroes on National Mall in Washington, DC
WASHINGTON, D.C. (WSYR-TV) — The names of five fallen officers from Central New York were read aloud before a crowd of thousands Tuesday night at the Annual Candlelight Vigil on the National Mall outside the U.S. Capitol Building. Despite the persistent rain, each officer was well-represented with family members or fellow officers. For the reading of Officer Michael Jensen's name, his mom and dad traveled to Washington, DC from Oneida County. Jensen's police family, including Syracuse Police Chief Joe Cecile, were part of the detail that made the trip. Lt. Michael Hoosock's widow, Cait, and their three children were in attendance for the reading of his name. Onondaga County Sheriff Toby Shelley and Hoosock's fellow deputies were also there. A detail from Oswego County, including Sheriff Don Hilton, attended the vigil for Deputy Cailee Campbell who was killed in a crash last year. Kathy Owen, the widow of Oneida Indian Nation Police Sgt. Ronald Owen, attended the vigil with her family. They were seated in front of a detail from the Nation, led by Chief David Verne. The annual reading of the roll call included 345 names newly recognized this year, either because of a death in the line of duty last year or a special circumstance that finally allowed past deaths to be recognized this year. Lt. David McShane, of the State's Department of Environmental Conservation, who died from a 9/11-related illness last year was also included in the roll call. His fellow officers attended in his memory. In addition to the reading, the names of each officer were newly added to the National Law Enforcement Officers Memorial wall. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Yahoo
05-05-2025
- Yahoo
Overnight lane closures planned for I-81 N
ONONDAGA COUNTY, N.Y. (WSYR-TV) — Overnight traffic might affect your evening commute. At least for drivers heading north on Interstate 81 as the NYSDOT has announced overnight lane closures planned for I-81 north in the Towns of Salina and Cicero. Beginning Tuesday May 6, the NYSDOT said I-81 north will be shut down to one lane between Exits 27-28 (Syracuse Airport/Taft Rd/N Syracuse) and Exit 98 (NY 31/Cicero/Bridgeport) and that the closure is to facilitate setting steel on the South Bay Road bridge over I-81 as part of the I-81 Viaduct Project. The closure will run from 6 p.m. to 6 a.m., beginning Tuesday, May 6, through Friday, May 9. Construction is weather-dependent. Fallen Officer Michael Jensen honored at SPD memorial Fugitive caught: Terrence Hill apprehended Auburn man arrested after threatening 'disrespectful' trash collectors with a knife DA: Westhill lacrosse players had failed abduction day before hazing incident Your Stories Q&A: When will the new Chick-fil-A open in DeWitt? Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Yahoo
30-04-2025
- Yahoo
LDS Church files appeal after court sides with opposition in sex abuse settlement lawsuit
EDITOR'S NOTE: A lawsuit only represents one side of a story. SALT LAKE CITY (ABC4) — The Utah-based Church of Jesus Christ of Latter-day Saints filed an appeal in federal court Thursday after a judge ruled against the organization earlier this month, according to documents. The 2021 lawsuit is between the church and its insurance companies, National Union Insurance and ACE Property & Casualty Co., and pertains to a dispute over whether the insurance companies are required to pay the organization's settlement payments. PREVIOUS STORY: LDS Church loses lawsuit over payment of sexual abuse settlements The dispute began after the church settled a high-profile sex abuse lawsuit in West Virginia and the insurance companies refused to pay the settlement costs. The church claimed the insurance companies were required under contract to make the payments and sued them in Salt Lake City's federal court. On April 6, the court ruled against the church, saying the companies did not breach their contract as they 'did not owe the church a duty to defend or indemnify under any implicated policy.' Court documents show the church is now appealing the ruling through the U.S. Court of Appeals for the Tenth Circuit in Colorado. The original West Virginia sex abuse lawsuit was filed by several members of the church who accused the organization of not protecting children from sexual abuse. The suit claims the church was negligent for failing to report a reasonable suspicion that church member Michael Jensen was abusing children. The suit also claimed the church failed to consider his history of child sexual abuse allegations when 'holding out Mr. Jensen's babysitting services for Church families,' according to documents and the Associated Press. Jensen was convicted of abusing two of the children and was sentenced to 35 to 75 years in prison, and in 2018, both sides of the civil lawsuit reached a settlement agreement. At the time, lawyers for the church allegedly said it was the largest settlement ever paid by the organization to sexual abuse victims. In the latest suit, the church claims the insurance companies are 'obligated to defend and indemnify the Church against the Underlying Lawsuit and must pay the Church the entire amount of its settlement and defense costs,' the complaint reads. Attorneys on both sides argued over the contract, presenting different interpretations of the agreement. Ultimately, the court sided with the insurance companies, leading to the appeal. ABC4 reached out to the church for a statement and a spokesperson said they would not be commenting outside of what lawyers have already written in documents. Ryan Bittan, Matthew Drachman, and the Associated Press contributed to this reporting. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Business Wire
22-04-2025
- Business
- Business Wire
FDA Grants Breakthrough Therapy Designation for BrainChild Bio's B7-H3 CAR T-Cell Therapy for Incurable Pediatric Brain Tumors
SEATTLE & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BrainChild Bio, Inc., a clinical-stage biotechnology company developing CAR T-cell therapies to treat tumors in the central nervous system (CNS), today announced that the investigational B7-H3 targeting autologous CAR T-cell therapy has been granted Breakthrough Therapy designation (BTD) by the U.S Food and Drug Administration (FDA) for the treatment of diffuse intrinsic pontine glioma (DIPG), an incurable pediatric brain tumor. This FDA designation was based on the promising overall survival benefit in patients with brain tumors treated with an autologous B7-H3 CAR T-cell therapy observed in the BrainChild-03 Phase 1 trial (NCT04185038), conducted by BrainChild Bio's academic partner, Seattle Children's, and recently published in Nature Medicine. 'Breakthrough Therapy designation gives us the possibility to accelerate the development path for BCB-276 as a CAR T-cell therapy that can potentially transform the treatment of DIPG,' stated Michael Jensen, MD, Founder and Chief Scientific Officer of BrainChild Bio. 'This designation is a major milestone for the children and families afflicted with these devastating brain tumors and represents a new paradigm for treating CNS brain tumors in children and adults, including a large number of patients suffering with glioblastomas and brain metastases.' FDA grants Breakthrough Therapy designation to investigational medicines that demonstrate the potential to treat a serious or life-threatening condition and show preliminary clinical evidence that the drug may show substantial clinical improvement over available therapies. Investigational medicines with BTD are provided early and more frequent interactions with the FDA to discuss the product candidate's development plan in addition to being eligible for rolling submission and priority review of the marketing application. 'This designation is an important milestone for Seattle Children's and demonstrates our continued momentum in pediatric brain cancer research,' said Dr. Jeff Sperring, Chief Executive Officer of Seattle Children's. 'We harness the power of research to bring potential cures to kids faster, and we're excited by the early promise shown by our work with BrainChild Bio to advance a potential CAR T therapy.' BrainChild Bio is preparing to advance BCB-276 in a Phase 2 multi-center, pivotal registration trial to support a potential Biologics License Application (BLA) to the FDA for the treatment of children and young adults with DIPG. This clinical plan is based on alignment between BrainChild Bio and FDA at a Type B meeting in late 2024. About Diffuse Intrinsic Pontine Glioma (DIPG) and Application of CAR T-cell Therapies Diffuse intrinsic pontine glioma (DIPG) is a primary high-grade brain tumor that arises in the pons and is uniformly fatal. DIPG affects approximately 300 children per year in the U.S. with the majority of diagnoses made in children between 5 and 10 years of age. Current standard-of-care treatment remains limited to palliative focal radiation therapy which results in a median overall survival of only about 11 months from diagnosis. 1 Barriers to effective therapies for DIPG include the precarious location of the tumor in the brainstem, the infiltrative growth of the tumor throughout normal brainstem functional anatomy, and the blood brain barrier that remains relatively intact during tumor progression preventing therapies from gaining access to the cancer. The barriers to effective therapies for DIPG can be effectively overcome by the locoregional delivery of appropriately targeted CAR T-cells directly into the cerebrospinal fluid via intracerebroventricular (ICV) dosing with an indwelling reservoir-catheter device. This enables the potential for extensive exposure of the pons to cerebrospinal fluid flow from the ventricular system, thus permitting infused CAR T-cells to directly access the tumor bed. This also allows for repetitive infusions of CAR T-cells to replenish the tumor bed, offering the potential for more durable and sustained efficacy. Additionally, with the blood brain barrier intact, this therapeutic approach can also minimize any on-target, off-tumor toxicities resulting from systemic exposure of CAR T cells. About BrainChild Bio BrainChild Bio, Inc., is a kids-first, clinical-stage biotechnology company harnessing the power of CAR T-cell technology to treat tumors in the central nervous system, prioritizing pediatric indications with plans to expand into adult CNS tumors, specifically Glioblastoma and brain metastasis. BrainChild Bio was launched out of Seattle Children's Therapeutics program and founded on the work of Dr. Michael Jensen, a pioneer in the cancer immunotherapy field and previous Chief Therapeutics Officer at Seattle Children's. BrainChild Bio is advancing a next-generation CAR T-cell therapy platform for tumors of the CNS that weaves together synthetic technologies, including multiplex targeting and enhanced potency controls, to enable multiple targets in a single CAR T-cell therapy, novel transgenes to increase potency, delivery technology for durable efficacy, and streamlined CAR T-cell design and manufacturing. BrainChild Bio's lead drug candidate is BCB-276, an autologous CAR T-cell therapy that targets the immune checkpoint B7-H3, that is advancing in clinical trials for the treatment of diffuse intrinsic pontine glioma (DIPG), a pediatric cancer that forms in the brainstem which currently has no approved treatments. More information is available at
