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Clinical Trial News

Hengrui Pharmaceutical Secures NMPA Approval for JAK1 Inhibitor Ivarmacitinib in Severe Alopecia Areata

Drug Approval
  • Hengrui Pharmaceutical received NMPA approval for Ivarmacitinib Sulfate Tablets, a second-generation JAK1 inhibitor, for treating severe alopecia areata in China.
  • Phase III clinical trials demonstrated a 40% response rate at 24 weeks compared to 9% for placebo, representing a significant therapeutic advancement for patients with this autoimmune condition.
  • The drug is already approved in China for multiple autoimmune conditions and has secured a $223 million licensing deal with Arcutis for North American and European markets.
  • Hengrui reported 21.78% year-over-year revenue growth to ¥13.6 billion in 2024, with innovative drug sales surging 33.25%.

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of SHR-2173 in Patients With Systemic Lupus Erythematosus

NCT06955598Active, Not RecruitingPhase 1
Guangdong Hengrui Pharmaceutical Co., Ltd
Posted 11/24/2024

Phase I Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Injection of SHR-2173 in Healthy Subjects

NCT06995001CompletedPhase 1
Guangdong Hengrui Pharmaceutical Co., Ltd
Posted 4/28/2024

EmpNia Receives FDA Clearance for eMotus Respiratory Motion Management System in Radiation Therapy

  • EmpNia announced FDA clearance for its eMotus system, a disposable sensor pad and software solution designed to manage respiratory motion during image-guided radiation therapy.
  • The system addresses critical challenges in radiation therapy by offering universal compatibility with existing equipment and setup times measured in minutes rather than hours.
  • Pre-market evaluations demonstrated significant improvements in workflow efficiency, setup simplicity, and motion tracking accuracy across all clinical presentations.
  • The cost-effective disposable model eliminates the need for capital-intensive installations and maintenance contracts, making precision radiation therapy more accessible.

Genenta Reports 3-Year Survival in Glioblastoma Patients with Temferon Cell Therapy

Orphan Drug
  • Two patients with newly diagnosed glioblastoma multiforme have survived three years from initial surgery in Genenta's TEM-GBM trial, with one showing no disease progression and the other achieving disease stabilization without additional therapy.
  • The phase 1/2a trial demonstrated a 29% two-year survival rate and 17-month median overall survival in unmethylated MGMT patients, compared to historical rates of 14% and 13-15 months respectively.
  • Temferon represents a first-in-class hematopoietic stem cell therapy that reprograms the tumor microenvironment by delivering interferon-alpha directly to tumors through engineered myeloid cells.
  • Genenta has initiated the TEM-GU phase 1 study to evaluate Temferon in genitourinary cancers, with plans to demonstrate safety in metastatic renal cell carcinoma by year-end.

A Clinical Gene Therapy Study with Hematopoietic Stem Cells for the Treatment, with Single Dose of Temferon, of Patients Suffering from Metastatic Renal Cell Carcinoma

NCT06716853RecruitingPhase 1
Genenta Science
Posted 10/22/2024

A Study Evaluating Temferon in Patients with Glioblastoma & Unmethylated MGMT

NCT03866109RecruitingPhase 1
Genenta Science
Posted 3/5/2019

Sigvotatug Vedotin Shows Promise in NSCLC as Novel Integrin Beta-6 Targeted ADC Advances to Phase 3

Oncology
  • The novel integrin beta-6 directed antibody-drug conjugate sigvotatug vedotin demonstrated a confirmed overall response rate of 19.0% as monotherapy in NSCLC patients, with higher efficacy in nonsquamous, taxane-naive patients at 31.0%.
  • Combination therapy with pembrolizumab showed enhanced activity with a confirmed overall response rate of 42.9% in frontline NSCLC treatment, supporting the agent's potential for immune checkpoint inhibitor synergy.
  • The drug has advanced to the phase 3 Be6A Lung-01 trial comparing sigvotatug vedotin to docetaxel in previously treated NSCLC patients, bypassing phase 2 development due to encouraging early results.
  • Integrin beta-6 represents an attractive therapeutic target as it is minimally expressed in healthy tissues but upregulated in carcinogenesis and associated with poor prognosis in multiple cancer types.

A Study of Sigvotatug Vedotin in Advanced Solid Tumors

NCT04389632RecruitingPhase 1
Seagen, a wholly owned subsidiary of Pfizer
Posted 6/8/2020

A Study of SGN-B6A Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer

NCT06012435Active, Not RecruitingNot Applicable
Seagen, a wholly owned subsidiary of Pfizer
Posted 2/21/2024

This is a Study to Learn About How the Combination of the Study Medicines Sigvotatug Vedotin Plus Pembrolizumab Works in People With Non-small Cell Lung Cancer With High Levels of PD-L1.

NCT06758401RecruitingPhase 3
Pfizer
Posted 7/23/2025

Avacta Strengthens Leadership Team with Appointment of Chief Medical Officer and Business Development Advisor

OncologyTargeted Therapy
  • Avacta Group plc has appointed David Liebowitz, M.D., Ph.D. as Chief Medical Officer to lead clinical strategy and execution for its targeted cancer therapy pipeline.
  • Liebowitz brings over 30 years of experience in oncology drug development and has contributed to more than 25 Investigational New Drug applications throughout his career.
  • The company also appointed Yulii Bogatyrenko as business development advisor to strengthen corporate growth strategy and pipeline advancement.
  • These appointments come at a pivotal time as Avacta continues to advance its pre|CISION platform for targeted oncology drug delivery.

Healx Partners with SCI Ventures in $2M AI-Driven Initiative to Develop Spinal Cord Injury Treatments

AIDrug DiscoveryRare Disease
  • Healx has partnered with SCI Ventures in a $2 million collaboration to apply AI-powered drug discovery to spinal cord injury, which affects over 20 million people globally with limited treatment options.
  • The partnership combines Healx's machine learning expertise with SCI Ventures' neuroregeneration domain knowledge and unique dataset access to target chronic spinal cord injury treatments.
  • The collaboration aims to dramatically shorten the path from discovery to clinical application by prioritizing AI-driven target discovery and drug repurposing strategies.
  • Success in spinal cord injury could open doors to AI-powered therapies for other neurological conditions including traumatic brain injury, stroke, ALS, multiple sclerosis, Parkinson's, and Alzheimer's disease.

DRC Medicine Announces $422 Million SPAC Merger to Advance Therapeutic Mask Technology and Parkinson's Drug Pipeline

AI
  • DRC Medicine, a Japanese biotechnology company, announced a business combination agreement with Ribbon Acquisition Corp that values the combined company at approximately $422.15 million and will provide $50.42 million in cash proceeds.
  • The company is developing the world's first therapeutic masks for seasonal allergic rhinitis using proprietary Hydro Silver Titanium® technology and advancing a pipeline of AI-powered diagnostic kits for infectious diseases.
  • DRC Medicine is in final negotiations to acquire an innovative ATP-enhancing drug for Parkinson's disease that is currently in clinical trials, expanding its therapeutic portfolio.
  • Current DRC Medicine shareholders will retain 100% of their equity and own approximately 82.91% of the combined company, which is expected to be listed on NASDAQ Global Market.

Capsule Sponge Test Combined with Biomarkers Shows Promise for Barrett Esophagus Risk Stratification

  • A new capsule-sponge test combined with biomarkers successfully stratified 910 Barrett esophagus patients into risk groups, with high-risk patients showing 37.7% positive predictive value for dysplasia or cancer.
  • Patients with both atypia and aberrant p53 biomarkers demonstrated the highest risk of high-grade dysplasia or cancer, with a relative risk of 135.8 compared to low-risk patients.
  • The low-risk group showed only 0.4% prevalence of high-grade dysplasia or cancer, with 97.8% negative predictive value, potentially reducing unnecessary endoscopic surveillance.
  • The test can be administered by nurses with minimal training and does not require endoscopy resources, offering a more accessible screening approach for Barrett esophagus patients.

Tempus AI Raises $650 Million Through Convertible Notes to Advance AI-Driven Precision Medicine Platform

AIPrecision Medicine
  • Tempus AI successfully priced a $650 million convertible senior notes offering, increasing from the initially announced $400 million, to fund its AI-enabled precision medicine platform development.
  • The company plans to use approximately $274.7 million of proceeds to repay existing debt and $36.2 million for capped call transactions, with remaining funds allocated to general corporate purposes including potential acquisitions.
  • The notes carry a 0.75% annual interest rate and mature in 2030, with conversion features that allow holders to convert to Tempus Class A common stock at approximately $84.19 per share.
  • Tempus operates one of the world's largest multimodal healthcare data libraries and provides AI-powered precision medicine solutions to physicians for personalized patient care and therapeutic development.

FDA Clears IND for IKS014 HER2-Targeted ADC, Enabling US Clinical Trial Expansion

Oncology
  • The FDA has approved Iksuda Therapeutics' IND application for IKS014, a HER2-targeted antibody drug conjugate, allowing expansion of ongoing Phase 1 clinical trials to include US sites alongside existing locations in Australia, New Zealand, and Singapore.
  • Preliminary clinical data from the dose-escalation study demonstrates promising activity across multiple solid tumor types including breast, ovarian, gallbladder, and esophageal cancers, with notable efficacy in patients who relapsed after prior Enhertu treatment.
  • The Phase 1 trial is nearing completion of its dose-escalation phase and will proceed to expansion cohorts targeting HER2-positive breast cancer patients refractory to Enhertu, HER2-low breast cancer patients, and HER2-positive gastric cancer patients.
  • IKS014 utilizes a tumor-selective payload release mechanism with monomethyl auristatin F (MMAF) and showed impressive preclinical activity in both high- and low-HER2 expressing tumors with a favorable therapeutic index.

IKS014 in Advanced Solid Tumors That Express HER2

NCT05872295RecruitingPhase 1
Iksuda Therapeutics Ltd.
Posted 9/14/2023

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