MASSACHUSETTS GENERAL HOSPITAL

Targeted therapies for metastatic colorectal cancer (mCRC) are moving to earlier treatment lines, emphasizing the importance of molecular testing. Key options include anti-EGFR therapy for RAS wild-type patients, BRAF V600E inhibitors like encorafenib, and HER2-directed therapies such as trastuzumab plus tucatinib. Ongoing trials aim to integrate these therapies into first-line settings, including MOUNTAINEER-03 for HER2-positive patients and studies on new RAS-targeted therapies.

Brain-computer interfaces (BCIs) can significantly aid disabled individuals but raise privacy concerns. A government report highlights the need to protect neural data, provide post-implant support, and address coding, coverage, and payment issues. Despite challenges like recruitment and data measurement, the industry is progressing. Consumer neurotech devices often lack neural data protections, and the BCI field lacks patient safeguards. A collaborative community aims to develop outcome measures for clinical trials and improve communication with CMS for reimbursement. The report emphasizes the potential of BCIs to enhance quality of life for people with disabilities.

NeuroSense Therapeutics reports completion of 18-month Phase 2b PARADIGM study, highlighting PrimeC's potential to slow ALS progression. Positive FDA feedback supports Phase 3 study commencement in mid-2025. The company plans early commercialization in Canada with a potential 2026 launch. NeuroSense secured a $5 million private placement in December 2024, and Phase 2b results were presented at the 2024 ALS/MND Symposium. The company expects to submit a dossier to Health Canada in Q2 2025.

Alzamend Neuro to present non-clinical data on AL001, a lithium-based treatment, at the Society of Toxicology 2025 Annual Meeting, showing enhanced brain-specific lithium delivery with minimized systemic exposure and no adverse effects. The company plans five Phase II trials in 2025 targeting Alzheimer's disease, bipolar disorder, major depressive disorder, and PTSD, aiming for FDA 505(b)(2) approval.

Neurizon Therapeutics submitted an IND application to the FDA for NUZ-001, targeting TDP-43 protein aggregation in ALS, to initiate a Phase 2/3 clinical trial within the HEALEY ALS Platform Trial framework. The FDA has 30 days to review the application.

NeuroKaire, a biotech company, secured $10M to develop a clinical test identifying drug efficacy for depression. The test, based on a blood draw, provides insights into brain function and drug response, aiding in personalized antidepressant selection. Funding led by GreyBird Ventures, with participation from Meron Capital and Jumpspeed Ventures, will support scaling operations and expanding pharmaceutical partnerships.

NYU Langone Health transplanted a genetically modified pig kidney into a 53-year-old woman, Towana Looney, for the third time. Looney, who had been on dialysis for over eight years, was discharged from the hospital and is recovering well. The kidney came from a pig with 10 DNA alterations, including removal of immune-triggering genes. This follows two previous pig kidney transplants, one of which failed due to inadequate blood flow. Xenotransplantation remains experimental and is only available to critically ill patients under the FDA's compassionate use program.

Taletrectinib, a next-gen ROS1 TKI, shows superior efficacy, CNS penetration, and safety in ROS1+ NSCLC, with TRUST-I trial data revealing 90.6% ORR in TKI-naive patients and 51.5% in crizotinib-pretreated. TRUST-II global trial supports consistent activity and safety, with pooled analysis confirming taletrectinib's benefit as a first-line option.