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Clinical Trial News

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

NCT03929666Active, Not RecruitingPhase 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

Epsilogen Completes Series B Expansion to Advance IgE Antibody Therapy for Ovarian Cancer

  • Epsilogen secured additional funding of £12.5m in Series B expansion, bringing the total to £43.25m, to support clinical development of its IgE antibody pipeline.
  • The lead candidate, MOv18 IgE, will be evaluated in a Phase Ib trial for platinum-resistant ovarian cancer, showing promise as a first-in-class cancer IgE antibody.
  • MOv18 IgE targets folate receptor alpha, which is overexpressed in various cancers, and has demonstrated safety and initial clinical activity in a Phase I trial.
  • Epsilogen is also advancing its IgE-based pipeline, including IgE bispecifics and IgE/IgG combination antibody molecules, to enhance functionality in oncology.

Tarlatamab Shows Promise in Treating Extensive-Stage Small Cell Lung Cancer

  • Tarlatamab-dlle demonstrates a manageable safety profile and promising survival outcomes in first-line maintenance extensive-stage small cell lung cancer (ES-SCLC).
  • In a phase 2 study, patients with ES-SCLC previously treated with platinum-based chemotherapy showed continued anticancer activity with a median overall survival of 15.2 months.
  • Tarlatamab, a bispecific T cell engager, binds to DLL3 on cancer cells and CD3 on T cells, activating T cells to eliminate cancer cells.
  • The FDA granted accelerated approval to tarlatamab-dlle for ES-SCLC that has progressed during or after platinum-based chemotherapy.

A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)

NCT05060016Active, Not RecruitingPhase 2
Amgen
Posted 12/1/2021

First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

NCT05361395RecruitingPhase 1
Amgen
Posted 8/24/2022

Evaxion's Personalized Cancer Vaccine EVX-01 Shows Promise in Melanoma Phase 2 Trial

  • Evaxion Biotech reports a 69% Overall Response Rate (ORR) in its Phase 2 trial of EVX-01 combined with pembrolizumab for advanced melanoma.
  • The interim analysis showed that 11 out of 16 patients experienced objective clinical responses, with 15 patients exhibiting tumor reduction.
  • The complete one-year dataset will be presented at the ESMO Congress, followed by a webinar featuring key opinion leader Professor Georgina V. Long.
  • EVX-01, designed using Evaxion's AI-Immunology™ platform, is tailored to individual patient's tumor profiles, potentially enhancing treatment efficacy.

Personalized Neo-antigen Vaccine in Advanced Solid Tumors (NeoPepVac)

NCT03715985Unknown StatusPhase 1
Herlev Hospital
Posted 1/28/2019

A Single Arm Trial Evaluating the Efficacy and Safety of EVX-01 in Combination With Pembrolizumab in Adults With Unresectable or Metastatic Melanoma

NCT05309421RecruitingPhase 2
Evaxion Biotech A/S
Posted 8/30/2022

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