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Clinical Trial News

Ruxolitinib Shows Promise in Refractory Sclerotic Chronic Graft-versus-Host Disease

  • A phase 2 trial reveals ruxolitinib's effectiveness in treating refractory sclerotic chronic graft-versus-host disease (cGVHD), particularly affecting the skin and joints.
  • At 6 months, 49% of patients showed a partial response in skin and/or joints, with 77% maintaining this response at 12 months, indicating sustained benefit.
  • The study reported a low nonrelapse mortality rate of 2.2% and a high failure-free survival rate of 77.1% at 12 months, suggesting improved overall outcomes.
  • Ruxolitinib was generally well-tolerated, with no new safety signals, offering a valuable treatment option for this challenging condition.

Study of Ruxolitinib in Sclerotic Chronic Graft-Versus-Host Disease After Failure of Systemic Glucocorticoids

NCT03616184CompletedPhase 2
University of Nebraska
Posted 9/5/2018

Bambusa Therapeutics Secures $15 Million Seed Funding for Bispecific Antibody Development

  • Bambusa Therapeutics has successfully closed a Series Seed financing round, raising approximately $15 million to advance its bispecific antibody programs.
  • The funding will support the development of Bambusa's pipeline of bispecific antibodies, aimed at treating immunological and inflammatory disorders, towards Phase I clinical studies.
  • Bambusa Therapeutics is focused on creating best-in-disease bispecific antibody therapeutics by leveraging validated targets and innovative antibody engineering.
  • The financing was co-led by BVF Partners L.P. and Dawn Biopharma, with participation from Salvia GmbH and INCE Capital, bolstering Bambusa's efforts in the I&I therapeutic landscape.

Actuate Therapeutics' Elraglusib Shows Promise in Relapsed/Refractory Ewing Sarcoma Trial

  • Actuate Therapeutics' elraglusib demonstrates anti-tumor activity in relapsed/refractory Ewing sarcoma (r/r EWS) patients, with two ongoing complete responses.
  • The Phase 1/2 trial of elraglusib combined with cyclophosphamide/topotecan shows a disease control rate of approximately 62% in the first eight patients.
  • Enrollment is ongoing for the study, with topline data expected in the first half of 2025, potentially paving the way for a Phase 2 trial.
  • Elraglusib, a GSK-3β inhibitor, offers a novel targeted approach for r/r EWS, addressing a significant unmet need due to limited treatment options.

9-ING-41 in Pediatric Patients With Refractory Malignancies.

NCT04239092TerminatedPhase 1
Actuate Therapeutics Inc.
Posted 6/5/2020

Zanidatamab Shows Promise in HER2-Positive Gastroesophageal and Colorectal Cancers

  • Jazz Pharmaceuticals presented updated Phase 2 data at ESMO 2024 for zanidatamab plus chemotherapy in HER2-positive metastatic gastroesophageal adenocarcinoma (mGEA).
  • Zanidatamab combined with chemotherapy and bevacizumab showed encouraging anti-tumor activity in HER2-positive metastatic colorectal cancer (mCRC).
  • Data from a Phase 2 trial of lurbinectedin and irinotecan in relapsed small cell lung cancer (SCLC) supports the ongoing LAGOON confirmatory trial.
  • The FDA has granted priority review for zanidatamab in previously treated HER2-positive biliary tract cancer, with a PDUFA target action date of November 29, 2024.

A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer

NCT03929666CompletedPhase 2
Jazz Pharmaceuticals
Posted 8/29/2019

A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers

NCT05152147Active, Not RecruitingPhase 3
Jazz Pharmaceuticals
Posted 12/2/2021

Philippines Expedites Approval Process for ASF Vaccines Amidst Outbreak

  • The Philippines is fast-tracking the approval of African Swine Fever (ASF) vaccines, aiming for potential approval within six months.
  • Clinical trials are ongoing for ASF vaccines from manufacturers in Thailand, the US, and Vietnam, with one vaccine already approved for limited use.
  • The Department of Agriculture (DA) has allocated P350 million to procure 600,000 doses, expanding the vaccine rollout to additional regions.
  • The country seeks to control the spread of ASF, which has affected numerous provinces since 2019, to stabilize pork supply and prices.

Candid Therapeutics Launches with $370M to Advance Bispecific T-Cell Engagers for Autoimmune Diseases

• Candid Therapeutics launched with $370 million in funding to develop bispecific T-cell engagers for autoimmune diseases, acquiring two private biotechs, Vignette Bio and TRC 2004. • The company's pipeline includes two T-cell engagers, targeting BCMA and CD20, which have completed Phase 1 testing in cancer and are slated for autoimmune clinical trials next year. • Candid aims to offer a more commercially viable and convenient alternative to cell therapies for autoimmune diseases, leveraging the potential of bispecific antibodies. • CEO Ken Song believes T-cell engagers represent a transformative approach, citing encouraging case reports and growing industry interest in the field.

A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001)

NCT04471727RecruitingPhase 1
Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Posted 12/14/2020

FDA Approves RYTELO™ (imetelstat) for Transfusion-Dependent Anemia in Low-Risk MDS

  • The FDA has approved RYTELO™ (imetelstat) for adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia.
  • RYTELO is a first-in-class telomerase inhibitor that binds to the RNA component of human telomerase, inhibiting its activity.
  • The drug is indicated for patients who have not responded to, lost response to, or are ineligible for erythropoiesis-stimulating agents (ESA).
  • Biologics by McKesson has been selected as a limited specialty pharmacy provider for RYTELO, ensuring access to this vital therapy.

T2 Biosystems Advances Diagnostic Pipeline for AMR, Pediatric Infections, Lyme Disease, and Candida auris

  • T2 Biosystems is finalizing its 510(k) application for the T2Resistance Panel, aiming for FDA submission in Q4 2024 to combat antimicrobial resistance.
  • The company seeks FDA clearance to expand the T2Candida Panel for pediatric Candida infections and the T2Bacteria Panel for pediatric bacterial infections.
  • T2 Biosystems will establish its own lab to launch the T2Lyme Panel as a Laboratory Developed Test, ensuring greater control and potential profit.
  • Non-dilutive funding is being pursued to advance the development of a diagnostic test for Candida auris, addressing a critical public health threat.

Akeso's Ivonescimab Demonstrates Superiority Over Pembrolizumab in Lung Cancer Trial

• Akeso's Ivonescimab showed a notable increase in progression-free survival compared to Merck's Keytruda (pembrolizumab) in a Phase III clinical trial for lung cancer. • The Ivonescimab group demonstrated better outcomes regardless of patient age, gender, or the presence of liver and brain metastasis. • Akeso has already submitted an application to China’s National Medical Products Administration for Ivonescimab's approval as a treatment for advanced PD-L1 positive non-small cell lung cancer. • Akeso reported its first net profit since going public, driven by a more than five-fold increase in revenue, partly attributed to Ivonescimab's potential.

Femasys Receives FDA Clearance for FemChec Fallopian Tube Diagnostic

  • Femasys Inc. has received FDA 510(k) clearance for FemChec, a diagnostic solution designed for checking the fallopian tubes using controlled contrast delivery.
  • FemChec is intended for use with an intrauterine catheter, delivering a consistent stream of saline and air for ultrasound evaluation of the fallopian tubes.
  • The device is a key component of Femasys' FemBloc non-surgical permanent birth control solution, confirming procedure success with natural contrast and ultrasound.
  • FemChec offers a safer alternative to traditional methods, reducing the need for radiology referrals, X-ray dye, and radiation exposure for women.

Prospective Multi-Center Trial for FemBloc Permanent Birth Control

NCT05977751RecruitingNot Applicable
Femasys Inc.
Posted 10/31/2023

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