SHEBA MEDICAL CENTER

BRCA2 Mechanism Reveals Why PARP Inhibitors Work in Only Some Cancer Patients

2 months ago

• NYU Langone researchers have discovered that BRCA2 acts as a molecular shield preventing PARP1 from binding to DNA damage sites, explaining why PARP inhibitors are effective only in certain cancer patients. • The study, published in Nature, used advanced single-molecule imaging to reveal how BRCA2 ensures RAD51 protein can access DNA repair sites instead of PARP1, preventing treatment-generated DNA breaks in resistant cancer cells. • This breakthrough explains variable patient responses to PARP inhibitors like olaparib, which have shown effectiveness in pancreatic, prostate, breast, and ovarian cancers with BRCA mutations, pointing to the need for patient-specific tumor profiling.

Cell and Gene Therapy Sector Overcomes Manufacturing and Investment Hurdles Amid 30% Funding Growth

2 months ago

• Despite market challenges, the cell and gene therapy (CGT) sector saw investments reach $15.2 billion in 2024, marking a 30% increase from the previous year, with approximately 3,000 developers and 2,000 clinical trials currently active. • Manufacturing and distribution remain significant obstacles for CGT advancement, with industry leaders highlighting issues including limited treatment center capacity, single-supplier dependencies for critical materials, and patient cell variability that complicates standardization. • Experts predict the FDA will approve 10-20 cell and gene therapies in 2025, with automation, robotic systems, and in vivo approaches identified as key technological innovations that could help overcome current sector challenges.

ExoPTEN Shows Promising Results for Spinal Cord Injury Recovery in Preclinical Study

2 months ago

• NurExone Biologic's ExoPTEN demonstrated significant motor function recovery and improved blood flow at spinal cord injury sites in a recent preclinical study, supporting its upcoming IND submission. • The study compared two dosing regimens - a single high dose versus a lower dose over five days - with both approaches showing marked improvements in motor function compared to controls. • Histological analysis revealed that ExoPTEN treatment significantly increased blood vessel size, suggesting improved circulation crucial for tissue healing and functional restoration in spinal cord injuries.

Tethis and Sheba Medical Center Partner on AI-Powered Liquid Biopsy for Early Rectal Cancer Detection

2 months ago

• Tethis S.p.A. and Sheba Medical Center have launched a research collaboration to evaluate circulating tumor cells in rectal cancer patients using Tethis' proprietary See.d® technology. • The study will monitor CTCs and ctDNA before and after neoadjuvant therapy, aiming to predict cancer relapse earlier than conventional imaging methods through standardized sample preparation. • Researchers expect the technology to enhance detection of circulating tumor cells even in early-stage patients and provide insights into inflammatory cell profiles that could guide immunotherapy decisions.

Inspira Technologies Enhances HYLA Blood Sensor with AI-Powered Oxygenation Monitoring

4 months ago

• Inspira Technologies has integrated a next-generation oxygenation indicator into its HYLA blood sensor, enabling continuous monitoring of tissue oxygenation without blood draws. • Clinical validation of the enhanced HYLA system is currently underway at Sheba Medical Center, with FDA submission planned for the second half of 2025. • The technology aims to revolutionize the $2.5 billion point-of-care testing market by providing real-time monitoring of blood parameters and early detection of respiratory complications.

Third-Generation CAR T-Cell Therapy Shows Promise in Relapsed/Refractory CLL

5 months ago

• A phase 1/2 study of HD-CAR-1, a third-generation CAR T-cell therapy, demonstrates encouraging response rates in heavily pretreated CLL patients. • Six of nine patients (67%) achieved complete remission (CR) three months post-treatment, with 83% showing undetectable minimal residual disease. • With a median follow-up of 27 months, the progression-free survival rate was 30%, and achieving CR correlated with significantly longer PFS (P = .024). • The therapy showed a favorable safety profile, with only one case of grade 3 cytokine release syndrome and no neurotoxicity observed.

Clearmind Medicine's CMND-100 Receives IRB Approval for AUD Clinical Trial at Yale

5 months ago

• Clearmind Medicine received IRB approval for its Phase I/IIa clinical trial of CMND-100, a novel therapeutic targeting alcohol use disorder (AUD). • The trial, to be conducted at Yale School of Medicine, will assess the safety, tolerability, and efficacy of CMND-100 in reducing alcohol cravings. • CMND-100 aims to address the critical gap in AUD treatment, where current options have limited efficacy (less than 30%) and patient compliance. • Alcohol consumption causes 2.6 million deaths annually worldwide, highlighting the urgent need for effective AUD treatments.

New PPAR Agonists Expand Treatment Landscape for Primary Biliary Cholangitis

6 months ago

• Ursodeoxycholic acid (UDCA), while groundbreaking, leaves up to 40% of Primary Biliary Cholangitis patients with inadequate response, highlighting the need for additional treatment options. • Recent accelerated approvals of PPAR agonists seladelpar and elafibranor offer new hope, with seladelpar showing the first clinically meaningful improvements in pruritus symptoms. • Real-world effectiveness and safety profiles of these new treatments remain to be established, as rare but serious side effects typically only emerge with broader clinical use.

Enlivex Therapeutics Initiates Phase I Trial of Allocetra™ for Psoriatic Arthritis

6 months ago

• Enlivex Therapeutics has dosed the first patient in a Phase I clinical trial evaluating Allocetra™ for psoriatic arthritis, with no initial safety concerns. • The trial aims to enroll six patients unresponsive to conventional treatments, assessing safety and changes in pain and disease activity over 12 months. • Allocetra™, an off-the-shelf cell therapy, seeks to reprogram macrophages to their homeostatic state, potentially offering a novel approach for inflammatory conditions. • The psoriatic arthritis treatment market is projected to reach $20.5 billion by 2032, highlighting the need for more effective and safer therapies.

Israeli Healthtech Innovation Drives Global Healthcare Solutions

6 months ago

• Israel's healthtech sector is thriving, ranking third globally in tech company density and driving innovation in AI-driven healthcare and precision medicine. • Sheba Medical Center's ARC Innovation Center is fostering global healthtech solutions by merging technology with human-centered design to address healthcare challenges. • EmbARC Ventures, in collaboration with Ilex Medical, is launching a healthtech startup accelerator, offering funding, mentorship, and clinical trial access to early-stage companies. • Sheba and Paradigm Health Inc. are partnering to revolutionize clinical trials using AI, aiming to enhance patient recruitment, data management, and cost-effectiveness.

Enlivex's Allocetra Shows Promise in Phase I/II Knee Osteoarthritis Trial

6 months ago

• Enlivex Therapeutics reports positive interim efficacy data from its Phase I/II trial of Allocetra in patients with moderate to severe knee osteoarthritis. • The data showed statistically significant improvements in key endpoints, including pain reduction and improved joint functionality, compared to baseline. • Enlivex has initiated the Phase II stage of the trial, a double-blind, randomized, placebo-controlled study to further assess Allocetra's efficacy and safety. • Allocetra aims to address the unmet need for treatments that can arrest or reverse the progression of osteoarthritis, which affects over 32.5 million Americans.

Starget Pharma Secures $5.1M to Advance AI-Powered Targeted Radiotherapy

7 months ago

• Starget Pharma has secured $5.1 million in funding from Cancer Focus to advance its AI-powered targeted radiotherapy platform. • The funding will support a clinical trial evaluating the safety and efficacy of Starget Pharma’s therapy for advanced metastatic cancers. • Starget Pharma's platform combines diagnostic imaging and targeted radiotherapy for personalized cancer treatment plans. • The AI-driven technology aims to deliver precise radiation to tumor cells, minimizing damage to healthy tissue and improving outcomes.

NAYA Biosciences Initiates Phase 1/2a Trial of NY-303 for Hepatocellular Carcinoma

7 months ago

• NAYA Biosciences has commenced a Phase 1/2a clinical trial for NY-303, a GPC3-targeted NK Engager bispecific antibody, in patients with hepatocellular carcinoma (HCC). • The trial will evaluate the safety and efficacy of NY-303 as a monotherapy in HCC patients who have not responded to first-line immunotherapy, starting in Israel. • The Phase 1 portion will focus on dose escalation, while Phase 2a aims to assess objective response rate and progression-free survival, potentially expanding to the U.S. and Europe. • NY-303's novel mechanism targets both NK cells and GPC3, offering a new approach for patients with limited treatment options and poor survival rates.

NAYA Biosciences Initiates Phase 1/2a Trial of NY-303 for Hepatocellular Carcinoma

7 months ago

• NAYA Biosciences has commenced a Phase 1/2a clinical trial for NY-303, a GPC3-targeting NK Engager bispecific antibody, in patients with hepatocellular carcinoma (HCC). • The trial will assess the safety and efficacy of NY-303 as a monotherapy in patients who have not responded to first-line immunotherapy. • Phase 1 will focus on dose escalation, while Phase 2a will expand to the US and Europe to evaluate objective response rate and progression-free survival. • NY-303's novel mechanism targets both NK cells and GPC3, potentially overcoming resistance to checkpoint inhibitors in HCC.

NAYA Biosciences Initiates Phase 1/2a Trial of NY-303 for Hepatocellular Carcinoma

7 months ago

• NAYA Biosciences has commenced a Phase 1/2a clinical trial for NY-303, a GPC3-targeted NK Engager bispecific antibody, in patients with hepatocellular carcinoma (HCC). • The trial will evaluate the safety and efficacy of NY-303 as a monotherapy in patients who have not responded to first-line immunotherapy. • The Phase 1 portion will focus on dose escalation, while Phase 2a will assess objective response rate and progression-free survival in the US and Europe. • NY-303's unique mechanism targets both NK cells and GPC3, potentially overcoming resistance to checkpoint inhibitors in HCC patients.

FDA Approves Cobenfy, a Novel Schizophrenia Treatment Targeting Cholinergic Receptors

8 months ago

• The FDA has approved Cobenfy (xanomeline and trospium chloride) as the first new class of drug for schizophrenia in over 30 years, offering a novel approach to treatment. • Cobenfy targets muscarinic receptors, unlike traditional antipsychotics that focus on dopamine, potentially reducing side effects like weight gain and movement disorders. • Clinical trials demonstrated Cobenfy significantly reduced schizophrenia symptoms compared to placebo, marking a transformative moment in managing this challenging condition. • Expected to launch in late October, Cobenfy offers a new option for adults with schizophrenia, with ongoing studies exploring its potential in Alzheimer's psychosis and other conditions.

CBD Shows Promise in Curbing SARS-CoV-2 Replication, Clinical Trials Needed

3 years ago

• Early research suggests CBD may help curb SARS-CoV-2 replication in infected cells, warranting further investigation through rigorous clinical trials. • Studies indicate CBD acts post-infection, blocking virus replication, while THC and other cannabinoids do not show the same antiviral effects. • Researchers emphasize that current evidence does not support self-medication with CBD and highlight the importance of vaccines and antibody drugs. • Clinical trials are underway to assess CBD's efficacy in treating COVID-19, with challenges in enrolling patients due to milder Omicron cases.