BrainChild Bio closes $116 million Series A financing. Funding will advance Phase 2 pivotal clinical trial for BCB-276 in an aggressive pediatric brain cancer, and support early pipeline programs for other CAR T cell therapies for pediatric and adult brain tumors. September 08, 2026 07:00 ET | Source: BrainChild Bio SEATTLE and CAMBRIDGE, Mass., Sept. 08, 2026 (GLOBE NEWSWIRE) - BrainChild Bio, Inc., a clinical-stage biotechnology company developing CAR T cell therapies to treat tumors in the central nervous system, today announced that the company has closed a $116 million Series A financing. An undisclosed private family fund and foundation, aligned with BrainChild Bio's mission, led the financing round, with participation from the company's initial investor, Seattle Children's, and new investor WRF Capital. Proceeds from the Series A financing will be used to support the ILLUMINATE Phase 2 study, a pivotal clinical trial (NCT07680439) to evaluate BCB-276, the company's investigational B7-H3-targeted autologous CAR T cell therapy, for the treatment of diffuse intrinsic pontine glioma (DIPG), a rare and aggressive pediatric brainstem tumor with limited treatment options. In addition, these funds will support the continued development of BCB-214, the company's triple-targeting CAR T cell therapy being advanced to initial clinical testing in glioblastoma. BrainChild Bio's pipeline programs leverage the company's CAR T cell therapy platform to treat tumors of the central nervous system (CNS), based on an exclusive license to technology developed at Seattle Children's, announced in December 2023. "Our path to building BrainChild Bio has led us to secure the support of a unique and committed syndicate of investors who share our mission to prioritize therapeutic innovation for children with cancer, while also rapidly advancing new science that can change the course of brain cancers for a wider population," said Steven Brugger, Chief Executive Office of BrainChild Bio. "We believe the time is right to show the breakthrough potential for our CAR T cell therapeutic approach with BCB-276 for DIPG which is a devastating pediatric brain cancer, as well as accelerate our efforts to advance other CAR T cell therapies for pediatric and adult brain tumors." Since the company's launch, BrainChild Bio has advanced BCB-276 into a registration-stage clinical development program for DIPG. Building on the foundational clinical experience generated at Seattle Children's, the company optimized the therapeutic product for late-stage clinical development, established the manufacturing, quality, and regulatory infrastructure required to support a registrational program. These efforts culminated in the initiation of the ILLUMINATE Phase 2 clinical trial, a pivotal registrational study designed to support a future Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for the treatment of DIPG. "This financing enables us to chart our path forward to serve the children and families afflicted with devastating brain tumors and represents a new paradigm for treating CNS brain tumors in children and adults," stated Michael Jensen, MD, Founder and Chief Scientific Officer of BrainChild Bio. "Our team at BrainChild Bio is steadfast in its commitment to harness CAR T cell technology in CNS tumors and we are uniquely positioned to do so." 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] BrainChild Bio's autologous CAR T cell therapy offers the potential to overcome barriers to effective therapies for DIPG, including 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. BrainChild Bio's CAR T cell therapies are engineered to be administered by locoregional delivery directly into the cerebrospinal fluid, permitting infused CAR T cells to directly access the tumor bed using an in-dwelling reservoir-catheter. This allows for extensive exposure of the pons to cerebrospinal fluid flow from the ventricular system, repetitive infusions of CAR T cells for more durable and sustained efficacy, and local therapeutic administration to minimize on-target, off-tumor toxicities. 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. BrainChild Bio is advancing a next-generation CAR T cell therapy platform for tumors of the CNS that integrates synthetic biology technologies, including multiplex targeting to address multiple tumor antigens, novel approaches to enhance CAR T cell functionality, delivery technologies intended to support 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 limited treatment options. More information is available at www.brainchildbio.com. [1] DIPG Registry.

FDA nod of Astrazeneca's Etcamah brings new breast cancer option. Sep. 8, 2026 A little more than four months after an FDA advisory committee voted against Astrazeneca plc's Etcamah (camizestrant) to treat first-line breast cancer, the U.S. agency granted accelerated approval of the next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist. The drug, cleared by the EU in July, was approved alongside Guardant Health's Guardant360 companion diagnostic assay that helps identify patients with estrogen receptor-1 mutations, bringing them a potentially effective treatment sooner than previous standard-of-care protocols, which have required radiographic progression before a treatment switch. In April, the FDA's Oncologic Drugs Advisory Committee voted against the drug, 6-3, saying it did not demonstrate a clinically meaningful benefit in treating those with HR+/HER2- breast cancer. Although the Serena-6 phase III trial met its progression-free survival primary endpoint (16 months camizestrant vs. 9.2 months control), the no votes reflected concerns over the randomized treatment switch to Etcamah based solely on detection of the ESR1 mutation, an acquired resistance to an aromatase inhibitor, which is typically used together with a cyclin-dependent kinase 4/6 inhibitor as first-line treatment. Damages from med-tech cyberattacks adding up. The breadth and depth of the recent cyberattacks on medical device companies continues to expand as more companies report that they too were hit and others more fully assess the impact an attack had on them. Novocure Ltd., of Jersey, U.K., is the most recent to disclose a cyber event. In an SEC 8-K filing last week, the company reported a cybersecurity incident that occurred in mid-August, about the same time other med-tech companies were being attacked. While it's still assessing the damage caused, Novocure said it doesn't believe the incident is "reasonably likely" to have a material impact on its financial condition or operations. Meanwhile, Boston Scientific Corp. is reporting just the opposite. In an 8-K filed today, Boston Scientific disclosed that the Aug. 25 cyber intrusion it experienced is likely to materially impact both its third quarter and fiscal 2026 results. Xenotransplantation: Pig kidneys function as bridge to human donor. Xenotransplantation has finally delivered true medical benefit, with pig kidneys functioning for long enough to provide a bridge to a matching human donor organ. Two of five recipients of pig kidneys genetically engineered by Egenesis Bio Inc. have successfully transitioned to receiving human donor transplants, in the first reported cases of a xenotransplant leading on to an allotransplantation. Phase IIIs in DM1, CV outcomes blow up for Novartis. Novartis AG suffered two phase III trial failures, as delpacibart etedesiran (del-desiran) fell short in the Harbor trial testing the antibody oligonucleotide conjugate in myotonic dystrophy type 1 (DM1) and pelacarsen fizzled in the cardiovascular (CV) outcomes Horizon study trying the antisense oligonucleotide (ASO) in patients with elevated lipoprotein (a), or Lp(a). In Harbor, del-desiran did not turn up statistically significant improvement vs. placebo on the primary endpoint of video hand opening time. In Horizon, pelacarsen as compared to placebo missed the primary endpoint of reducing the risk of CV events, a composite of CV death, non-fatal myocardial infarction, non-fatal stroke, and urgent coronary revascularization requiring hospitalization. Shares of Novartis (NYSE:NVS) were trading at $138.91, down $21.08, or 13%. Another DM1 player, Dyne Therapeutics Inc., saw its shares (NASDAQ:DYN) drop $5.19, or 21%, to sell for $19.09. Dyne is developing zeleciment basivarsen (DYNE-101), which consists of an ASO conjugated to an antigen-binding fragment that binds to the transferrin receptor 1. Brainchild secures $116M for its CAR T for childhood brain cancer. Brainchild Bio Inc. decided to take on two challenges simultaneously: it's developing CAR T therapeutics for brain cancer and it's doing it initially in a pediatric indication. The Seattle Children's spinout secured $116 million in series A financing for its lead product, BCB-276, for treating diffuse intrinsic pontine glioma, a relatively rare brain cancer that affects approximately 300 children per year in the U.S. The B7-H3-targeted autologous CAR T-cell therapy is dosed directly into the lateral ventricles of the central nervous system via an indwelling reservoir-catheter device, which allows for repeat dosing of the treatment. Based on promising phase I results in 21 patients, Brainchild recently launched a phase II study testing the cell therapy following treatment with ionizing radiation. Moonwalk snags $70M to advance its obesity drug into phase I development. Moonwalk Biosciences Inc. used its human genetics, epigenomics and multi-omics discovery platform to discover multiple gene targets involved in adipose tissue biology. With preclinical data in hand, the company secured a $70 million series B financing to develop its lead candidate MW-101, an siRNA targeting the expression of an undisclosed gene with the potential to decrease lipids stored in adipose tissue. The company expects to start first-in-human clinical studies in late 2027 following completion of ongoing IND-enabling studies. Ciliatech nabs FDA IDE for implant to treat glaucoma. Ciliatech SAS received U.S. FDA investigational device exemption (IDE) for a feasibility study of Intercil Uveal Spacer, its implant to treat glaucoma. The trial which will evaluate the safety and performance of the device, will focus on patients who fall into the "middle segment" treatment gap, between the conventional minimally invasive glaucoma surgery and more invasive filtering procedures. "We are addressing a population that has no solution," Olivier Benoit, CEO of Ciliatech, told BioWorld. Sky Labs shares extend rally after $15M Kosdaq IPO. Shares of Sky Labs Inc. (KOSDAQ:386380) have nearly tripled since its Sept. 4 debut, as the company seeks to turn data generated by its wearable rings into a clinical data platform for the industry and medical institutions. Despite weak IPO demand, Sky Labs' shares on the tech-heavy Kosdaq closed at ₩29,750 (US$22.10) Sept. 8, down 2.62% from the previous day but 197.5% higher than the offering price. The Seongnam-based company had pegged the offering of about 2 million shares to ₩10,000 per share, well below the target range of ₩13,000 to ₩16,000 per share. Korea Investment & Securities was the lead underwriter. Asia Bio Partnering: APAC biotechs rethink partnering playbook. Asia-Pacific biotechs that want to compete globally need to make decisions about corporate structure, intellectual property, financing and clinical development from the outset, panelists said during the recent Asia Bio Partnering Forum in Singapore. The region's partnering strategies are also moving beyond the familiar model of licensing Asian-developed assets to Western drugmakers. Companies and investors are experimenting with co-development agreements, territorial licenses and "reverse newcos" that bring assets originating outside China into locally established companies to capitalize on China's drug development infrastructure. A&As: new ceos for arletta, samsara, sense neuro, typewriter. New hires and promotions in the biopharma and med-tech industries. Financings: Typewriter's $56M series A; Superluminal adds $60M in series B. Biopharma and med-tech companies raising money in public or private financings. Holiday notice. BioWorld's offices were closed in observance of Labor Day in the U.S. No issue was published Monday, Sept. 7. To read more on related topics, click on one of the words below.

ST. PAUL, Minn., Jan. 21, 2025 /PRNewswire/ -- ScaleReady, in collaboration with Wilson Wolf Manufacturing, Bio-Techne Corporation and CellReady, today announced that BrainChild Bio has been awarded a $300,000 G-Rex® Grant. The G-Rex® Grant will support expeditious process development and commercial readiness of BCB-276, BrainChild Bio's lead autologous CAR-T therapy for the treatment of diffuse intrinsic pontine glioma (DIPG), an incurable type of pediatric brain tumor. BrainChild Bio plans to advance BCB-276 into a multi-center Phase 2 pivotal clinical trial in 2025 for the treatment of children and young adults with DIPG."G-Rex has been an essential element of our clinical CAR-T manufacturing program at Seattle Children's dating back to 2012. We greatly appreciate the support of ScaleReady's G-Rex Grant Program as well as the technical expertise offered to us by ScaleReady related to new advancements," said Dr