Keck School of Medicine of USC

ScaleReady Awards G-Rex Grants to Advance Novel CAR-T Cell Therapy Manufacturing

a month ago

• ScaleReady has awarded a $200,000 G-Rex Grant to March Biosciences to advance manufacturing of MB-105, a novel CAR-T therapy targeting CD5 for T-cell lymphomas that received FDA orphan drug designation in January 2025. • A2 Biotherapeutics received a $300,000 G-Rex Grant to evaluate the G-CART process, a standardized workflow designed for high-throughput CAR-T manufacturing that can be adapted for commercial scale production. • The G-Rex platform, currently used by over 800 organizations in approximately 50% of CGT clinical trials, aims to reduce complexity, time, and costs in cell therapy manufacturing through a modular and flexible approach.

USC Study Confirms Safety Profile of COVID-19 Treatments: Paxlovid and Other Antivirals Show Minimal Serious Side Effects

a month ago

• A comprehensive review by USC's Keck School of Medicine found that most FDA-approved COVID-19 treatments, particularly oral antivirals like Paxlovid, cause few serious side effects. • Monoclonal antibodies targeting the coronavirus spike protein showed no significant adverse events, while tocilizumab (Actemra) was associated with infection and low white blood cell counts in some studies. • Convalescent plasma transfusions were linked to higher risks of internal bleeding, infection, and blood clots, but all identified serious adverse events aligned with current product labeling.

NeOnc Technologies Secures Nasdaq Listing, Expands Brain Cancer Clinical Trials to India

2 months ago

• USC-licensed biotech NeOnc Technologies has successfully listed on Nasdaq, marking a significant milestone for the company developing novel intranasal drug delivery systems for brain tumors. • NeOnc has partnered with CBCC Global Research to expand clinical trials across 30 FDA-compliant sites in India, accelerating development of its neuro-oncology treatments including NEO100 and NEO212. • The company's proprietary technology bypasses the blood-brain barrier through intranasal delivery, potentially revolutionizing treatment for glioblastoma and other CNS diseases with limited current therapeutic options.

FDA Sets PDUFA Date for Lower-Dose Neffy Nasal Spray in Young Pediatric Patients with Anaphylaxis

4 months ago

• The FDA has set a PDUFA target action date of March 6, 2025, for ARS Pharmaceuticals' sNDA for a 1 mg dose of Neffy (epinephrine nasal spray). • This lower dose is intended for pediatric patients weighing 33 to 66 lbs (15 to 30 kg), expanding treatment options for this vulnerable population. • Neffy was initially approved in August 2024 for anaphylaxis in adults and children over 66 lbs, offering a needle-free alternative to epinephrine injections. • Pending approval, Neffy 1 mg could be available in the second quarter of 2025, providing a more accessible and less intimidating treatment option for young children.

Semaglutide Shows Promise in Reducing Alcohol Consumption and Cravings

6 months ago

• A new study reveals that semaglutide, known as Ozempic and Wegovy, significantly reduces alcohol cravings and consumption in individuals with alcohol use disorder. • Participants on semaglutide experienced fewer heavy drinking days and decreased alcohol intake during lab tests compared to those on a placebo, indicating potential therapeutic benefits. • The research suggests semaglutide's effects on alcohol cravings may surpass existing treatments, offering a promising avenue for addressing the unmet needs in alcohol use disorder. • Further studies are warranted to explore semaglutide's long-term efficacy, optimal dosages, and safety, particularly for individuals without obesity or diabetes.

Cancer Care Evolution: Industry Leaders Address Quadruple Aim Challenges and Opportunities

7 months ago

• Healthcare leaders highlight the evolution from Triple Aim to Quadruple Aim in cancer care, emphasizing the critical addition of provider well-being alongside patient experience, population health, and cost savings. • Despite advancements in precision medicine and patient care, physician burnout remains prevalent, with experts expressing concern over increasing demands on healthcare providers and the need for better support systems. • Industry experts discuss innovative solutions including dose rounding, care setting shifts, and community engagement initiatives, while acknowledging persistent challenges in healthcare costs and accessibility.

FDA Approves Pivotal Trial of Aquablation Therapy vs. Prostatectomy for Localized Prostate Cancer

8 months ago

• The FDA has approved an IDE trial comparing Aquablation therapy to radical prostatectomy for localized prostate cancer. • The WATER IV PCa trial will enroll 280 patients with Grade Group 1-3 localized prostate cancer across 50 sites. • The study's primary endpoint is morbidity at 6 months, with long-term follow-up on treatment-related harm and oncologic events. • Aquablation, already approved for BPH, aims to improve safety and quality of life outcomes compared to prostatectomy.

Blood Test Predicts Survival in Men Newly Diagnosed With Metastatic Prostate Cancer

8 months ago

• A new blood test can predict treatment response and survival in men newly diagnosed with metastatic hormone-sensitive prostate cancer (mHSPC). • The test measures circulating tumor cells (CTCs); higher counts indicate poorer outcomes, including shorter survival and faster disease progression. • The CellSearch test, already FDA-cleared, can identify patients who may benefit from more aggressive therapies or clinical trial participation. • Measuring CTC levels at the start of therapy can predict long-term survival, aiding in personalized treatment strategies for advanced prostate cancer.

NIH-Funded Study to Investigate Type 1 Diabetes' Impact on Children's Brain Development

8 months ago

• A nationwide longitudinal study, funded by a $2.7 million NIH grant, will explore the effects of type 1 diabetes on brain development in children. • The multi-site study will involve 12 research centers across the U.S. and recruit over 1,000 children newly diagnosed with type 1 diabetes. • Researchers aim to identify factors that may accelerate or mitigate the risk of brain-related complications in children with type 1 diabetes. • The study will use fMRI and collect data on academic performance, memory, attention, and neurobehavioral health to refine clinical guidelines.

Phase 3 Trial of Crinecerfont Shows Promise in Treating Pediatric Congenital Adrenal Hyperplasia

a year ago

A phase 3 clinical trial has demonstrated that crinecerfont, an oral corticotropin-releasing factor type 1 receptor antagonist, effectively reduces elevated androstenedione levels in children with congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency, while also allowing for a decrease in glucocorticoid doses.