MedPath

THE OHIO STATE UNIVERSITY

THE OHIO STATE UNIVERSITY logo
🇺🇸United States
Ownership
Private
Established
1958-01-01
Employees
10K
Market Cap
-
Website
http://www.osu.edu

Granite Bio Emerges with $100M Funding and Novel Immunology Pipeline for IBD and Allergies

• Versant Ventures has launched Granite Bio with $100 million in funding, advancing two novel antibody drugs targeting inflammatory conditions through its Ridgeline Therapeutics initiative. • Granite's lead candidate GRT-001 targets pro-inflammatory monocytes in IBD and is currently in Phase 1 trials, with ulcerative colitis studies planned for later this year. • The company's second candidate, GRT-002, targets IL-3 for treating itch and allergies, representing a different approach from established therapies like Dupixent and Cosentyx.

OncoHost's Plasma Proteomics Research Reveals Key Mechanisms of Immunotherapy Resistance in NSCLC

• OncoHost will present new research at AACR 2025 revealing five distinct proteomic expression patterns that explain resistance to immunotherapy in non-small cell lung cancer patients. • The study identified 388 resistance-associated proteins (RAPs) with 17.5% potentially targetable by existing or investigational drugs, opening new avenues for personalized treatment strategies. • This international collaborative research advances precision medicine by providing mechanistic insights into treatment resistance, potentially improving first-line immunotherapy decision-making for NSCLC patients.

Diabetes Drug Metformin Shows Promise in Preventing Acute Myeloid Leukemia

• Cambridge researchers discover that metformin, a widely prescribed diabetes medication, may help prevent acute myeloid leukemia (AML) in high-risk individuals by targeting mutations in the DNMT3A gene. • The drug appears to disrupt cancer development by interfering with pre-cancerous cell energy production and reversing damage caused by genetic mutations, offering a potential preventive strategy for this aggressive blood cancer. • With metformin's established safety profile and low cost (about 35p per pill), researchers are preparing clinical trials to confirm its efficacy as a repurposed cancer prevention therapy, potentially accelerating treatment availability.

Yale Researchers Launch Novel App-Based Intervention to Combat HIV Risk in Chemsex Communities

• Yale researchers have developed JomCare, an innovative mobile app designed to reduce HIV transmission risk by targeting sexualized drug use behaviors among gay and bisexual men. • The study employs a micro-randomized trial design to evaluate the effectiveness of just-in-time interventions in reducing high-risk behaviors associated with chemsex practices. • The research addresses a critical gap in HIV prevention, particularly in Southeast Asia where 90% of new HIV cases are sexually transmitted, with over half occurring among men who have sex with men.

AskBio's AB-1005 Gene Therapy for Parkinson's Disease Gains FDA RMAT Designation and Enrolls First Phase II Participants

• AskBio's AB-1005, a gene therapy for Parkinson's disease, has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, potentially expediting its development. • The RMAT designation was supported by positive 36-month Phase Ib data, demonstrating a favorable safety profile and encouraging trends in clinical outcome measures. • The Phase II REGENERATE-PD trial, evaluating AB-1005 in moderate-stage Parkinson's, has randomized its first participants across sites in the US, with plans to expand to Europe. • AB-1005 delivers glial cell line-derived neurotrophic factor (GDNF) to promote the survival of dopaminergic neurons, addressing a critical unmet need in Parkinson's treatment.

mHealth Intervention 'YES' Aims to Improve Quality of Life for Young Breast Cancer Survivors

• The 'Young, Empowered & Strong' (YES) study is a multicenter, randomized controlled trial evaluating a mobile app- and web-based intervention for young breast cancer survivors. • YES aims to improve quality of life and address specific concerns and symptoms experienced by adolescent and young adult (AYA) breast cancer patients. • The intervention utilizes electronic patient-reported outcome systems (ePROs) to provide tailored education and resources based on individual needs. • The study will assess the efficacy of YES at 6 months and sustainability at 9 months, with potential for broad application to AYA survivors of other cancers.

NSCLC Treatment Landscape: Biomarker Testing, Evolving Guidelines, and ADC Developments

• Biomarker testing is crucial for personalized NSCLC treatment, enabling tailored therapies for both early- and late-stage disease. • Updated lung cancer screening guidelines expand eligibility by removing quit time and reducing pack-year criteria, potentially benefiting more at-risk patients. • Sacituzumab govitecan monotherapy failed to improve overall survival in the EVOKE-01 trial, despite being well-tolerated. • A biologics license application for datopotamab deruxtecan was withdrawn, with a new application planned based on data from other trials.

Real-World Data Reinforces Cilta-Cel Efficacy in Relapsed Multiple Myeloma, While Ide-Cel Shows Promise in CNS Involvement

• Real-world evidence confirms cilta-cel's effectiveness in relapsed/refractory multiple myeloma, mirroring clinical trial outcomes with high response rates and durable remission. • A significant portion of patients in the real-world study wouldn't have met clinical trial eligibility, highlighting cilta-cel's potential in a broader patient population. • Ide-cel demonstrates promising results in patients with CNS involvement of multiple myeloma, showing favorable responses and manageable safety profiles in a retrospective analysis. • Renal impairment does not significantly impact the efficacy of BCMA-targeting CAR T-cell therapies in relapsed/refractory multiple myeloma, though increased monitoring for ICANS and infections may be warranted.

Breyanzi Plus Ibrutinib Shows Promise in High-Risk CLL Patients

• Data from the TRANSCEND CLL 004 study reveals an 86% objective response rate in relapsed/refractory CLL/SLL patients treated with Breyanzi and Ibrutinib. • The combination therapy demonstrated a median duration of response of 41.4 months and a 45% complete remission rate in treated patients. • Breyanzi, already approved for CLL/SLL after BTK and BCL2 inhibitor failure, may see improved efficacy when combined with Ibrutinib. • BMS's Breyanzi, projected to reach $2.6 billion in sales by 2030, is also being evaluated with AbbVie's Venclexta for enhanced outcomes.

Telehealth-Delivered Cognitive Behavioral Therapy Effectively Reduces Suicidal Ideation and Attempts

• A randomized clinical trial demonstrated that telehealth-delivered brief cognitive behavioral therapy (CBT) is a safe and effective intervention for adults with suicidal ideation or behavior. • The study compared brief CBT to present-centered therapy, finding that CBT led to significant reductions in suicide attempts, highlighting its potential for high-risk patients. • Researchers emphasize that telehealth can increase access to evidence-based treatments, especially for individuals in rural or underserved areas, expanding the reach of suicide prevention efforts. • The findings support the use of virtual mental health care to deliver critical interventions, ensuring that individuals receive timely and effective support during and after public health crises.

PE-CGS Network Advances Patient-Partnered Cancer Research Despite Implementation Challenges

• The Participant Engagement and Cancer Genome Sequencing (PE-CGS) Network, launched under the Cancer Moonshot Initiative, is working to enhance patient involvement in cancer research through five NCI-funded centers. • Key priorities include tailoring educational materials, measuring engagement effectiveness, and developing strategies to return genomic data to participants, with special focus on rare and understudied cancers. • Despite progress, significant challenges remain in streamlining consent processes, facilitating health data sharing, and improving electronic health record interoperability across institutions.

Aquestive's Anaphylm Sublingual Film Shows Rapid Symptom Resolution in Allergy Challenge Study

• Aquestive Therapeutics' Anaphylm sublingual film demonstrated rapid resolution of allergen-related symptoms, beginning within 2 minutes of administration in an Oral Allergy Syndrome (OAS) challenge study. • The study met its primary and secondary endpoints, showing comparable pharmacokinetic profiles of Anaphylm in subjects with and without allergen exposure, indicating consistent drug absorption. • Complete symptom resolution was achieved in an average of 12 minutes, significantly faster than the 74 minutes observed during screening, with swelling resolved within 5 minutes in all instances. • Aquestive plans to request a pre-New Drug Application (NDA) meeting with the FDA in Q4 2024 and anticipates a full product launch of Anaphylm in Q1 2026, pending regulatory approval.

City Therapeutics Launches with $135M to Advance RNAi-Based Medicines

• City Therapeutics launched with $135 million in Series A funding to innovate RNA interference (RNAi) therapeutics, led by Alnylam's former CEO, John Maraganore. • The company aims to develop smaller, more potent RNAi triggers and enhance delivery to various tissues beyond the liver, expanding therapeutic applications. • City Therapeutics plans to advance one to two new drugs into clinical trials each year, starting around the end of 2025, targeting multiple disease indications. • The startup's siRNA-engineering platform focuses on designing and optimizing RNAi-based medicines with improved potency, specificity, and delivery methods.

Industry Funding Linked to Increased Efficacy in Psychiatric Drug Trials

• A new study reveals that psychiatric drugs appear approximately 50% more effective in manufacturer-funded clinical trials compared to independently sponsored trials. • The "sponsorship effect" highlights potential bias, where manufacturer-funded trials are more likely to report favorable outcomes for their drugs. • Publication bias, where positive results are more likely to be published, significantly contributes to the observed sponsorship effect in drug trials. • Preregistration of clinical trials has helped reduce this bias since 2005, but challenges remain in addressing previously approved drugs based on potentially biased evidence.

Naveris Showcases NavDx Test Advances for HPV-Associated Oropharyngeal Cancer Surveillance at ASTRO 2024

• Naveris will present new data at the ASTRO Annual Meeting demonstrating the NavDx test's role in managing HPV-driven oropharyngeal cancers. • A study analyzing over 1,000 blood samples showed NavDx can identify patients at risk of treatment failure earlier than imaging. • Research indicates NavDx can predict outcomes based on HPV DNA clearance during treatment, potentially guiding radiation therapy intensity. • Data suggests NavDx outperforms imaging in post-radiotherapy surveillance for oropharyngeal cancer, exhibiting fewer false positives.

Strategic Collaborations and Novel Therapies Advance Cancer and Brain Injury Treatment

• AstraZeneca and Moffitt Cancer Center are collaborating to accelerate cell therapy development, focusing on CAR T and TCR T therapies for solid tumors. • SWOG Cancer Research Network developed a risk prediction model to identify cancer patients at high risk for emergency room visits during clinical trials. • A national clinical trial is launched by UC San Francisco to repurpose existing drugs for treating traumatic brain injury (TBI), addressing a critical unmet need. • The Ohio State University initiates clinical trials for HOSU-53, a novel DHODH inhibitor, in partnership with Jabez Biosciences, targeting cancer metabolism.

ZKR Orthopedics Initiates FDA Trial for Patella LIFT Procedure in Patellofemoral Arthritis

• ZKR Orthopedics has commenced its FDA PELICAN trial with the first U.S. patella LIFT procedure for patellofemoral arthritis. • The minimally invasive Patella LIFT aims to alleviate pain by unloading the patella, offering a less complex alternative to traditional surgeries. • The PELICAN study will compare the Patella LIFT Implant to tibial tubercle osteotomy, assessing patient-reported outcomes and safety. • The trial, involving multiple sites in the U.S. and Europe, follows promising results from a European pilot study showing improved function.

AVMA Veterinary Clinical Trials Registry Highlights New Studies in Canine and Feline Oncology and Neurological Disorders

• The AVMA Veterinary Clinical Trials Registry lists studies for animal health, connecting researchers with veterinarians and owners. • North Carolina State University is exploring a novel treatment approach for oral cancer in cats. • Several studies are investigating canine cancers, including hemangiosarcoma, osteosarcoma, and mast cell tumors, with innovative therapies. • Research is underway to assess treatments for canine cognitive dysfunction and degenerative myelopathy, mirroring human neurological conditions.

First-in-Human Trial Launched for Novel DHODH Inhibitor HOSU-53 in Solid Tumors and Lymphomas

• A Phase I/II clinical trial is set to begin at Ohio State University, evaluating the novel DHODH inhibitor HOSU-53 in patients with advanced solid tumors and Non-Hodgkin's lymphoma. • HOSU-53, developed at Ohio State, targets dihydroorotate dehydrogenase (DHODH), a key enzyme in cancer cell metabolism, aiming to disrupt DNA and RNA synthesis. • Preclinical studies suggest HOSU-53 can selectively starve cancer cells by depriving them of pyrimidines, potentially enhancing the efficacy of other cancer therapies. • The trial, led by the OSUCCC – James, represents the first human testing of this best-in-class DHODH inhibitor, with Jabez Biosciences as the industrial development partner.

DeepWell DTx Gains FDA Clearance for Digital Therapeutic SDK Targeting Stress and Hypertension

• DeepWell Digital Therapeutics (DTx) received FDA 510(k) clearance for its biofeedback software development kit (SDK) designed for stress reduction and hypertension management. • The SDK integrates into video games and other media to stimulate the vagus nerve, reduce sympathetic nervous system activation, and enhance patient engagement. • DeepWell's technology may qualify for reimbursement under proposed Digital Mental Health Treatment (DMHT) device codes by CMS, effective potentially in 2025. • The clearance enables media developers to efficiently create FDA-cleared digital therapeutics, potentially expanding access to mental and physical health support.
© Copyright 2025. All Rights Reserved by MedPath