Immutep receives FDA and IRB approval in the US for Phase IIb TACTI-003 trial in HNSCC

Immutep was granted Fast Track designation for efti to treat 1st line HNSCC patients by the US FDA in early April 2021.

Immutep Limited, a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, announces it has completed all the necessary competent authority steps with the US Food and Drug Administration (FDA) and has received IRB approval to commence its phase IIb TACTI-003 trial in the United States. Patient recruitment for the TACTI-003 trial is expected to begin within this quarter.

TACTI-003 will evaluate the Company’s lead product candidate, eftilagimod alpha (“efti” or “IMP321”), in combination with MSD’s KEYTRUDA(R) (pembrolizumab) as a first line therapy in approximately 154 patients with Head and Neck Squamous Cell Carcinoma (HNSCC). It is a randomized, controlled clinical study that will take place across Australia, Europe and the United States of America in up to 35 clinical sites.

Immutep was granted Fast Track designation for efti to treat 1st line HNSCC patients by the US FDA in early April 2021.

Pending approval by the European and Australian competent authorities and ethics committees, Immutep expects to broaden its recruitment sites into these regions.

Commenting on the start of the TACTI-003 trial, Immutep CSO and CMO Frédéric Triebel said: “We are delighted to start our new TACTI-003 trial in first line HNSCC patients to evaluate efti in combination with pembrolizumab vs pembrolizumab monotherapy. Results we reported from this therapeutic combination earlier in June at ASCO in the second line setting were robust, with sustained and durable responses. We look forward to deepening these results with a larger group of 1 st line HNSCC patients in TACTI-003.”

Tags : #Immutep #FdaApproval #IrbApproval #AutoimmuneDiseases #CancerTreatment

About the Author


Team Medicircle

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

Deworming in Children: A Crucial Step Towards Healthy GrowthFebruary 07, 2025
AI-powered blue-collar hiring platform Vahan.ai secures investment from APAC HR services leader Persol Group amid booming gig economy in India; plans to develop AI recruitment technology to support 8 major Indian languages February 07, 2025
Scars That Never Heal: The Painful Reality of Female Genital MutilationFebruary 06, 2025
Maharashtra’s Healthcare Betrayal: Why Are Crucial Funds Going Unused?February 06, 2025
1vision, 1 mission: Avaada Foundation’s CSR initiatives are powering communities and delivering sustainable progress across 5 key focus areasFebruary 06, 2025
Top 5 Technology Brands that are Transforming the Cancer Care Journeys for Hospitals and PatientsFebruary 06, 2025
Women's Wellness brand NUA Raises Rs 35 Crore in Pre-Series C led by Mirabilis Investment TrustFebruary 06, 2025
8 Effective Ways to Minimize Postpartum ComplicationsFebruary 06, 2025
Does Where You Live Decide Your Fate? The Urban-Rural Breast Cancer Divide in IndiaFebruary 06, 2025
Nepal leads the world with largest pictorial health warnings on all tobacco productsFebruary 05, 2025
Fleetguard Filters Private Limited Recognized for Excellence in CSR at Navabharat’s 4th CSR ConclaveFebruary 05, 2025
Six new regions of the Russian Federation are set to connect to Moscow's AI medical services platform, MosMedAIFebruary 04, 2025
Six new regions of the Russian Federation are set to connect to Moscow's AI medical services platform, MosMedAIFebruary 04, 2025
Ashok Leyland Reinforces ESG Commitment, Ranked No. 1 Globally in Sustainalytics’ RatingsFebruary 04, 2025
Calcium Supplements: Do You Really Need Them?February 04, 2025
Digital Diagnostics Doubles Its Foreign Publication Count in 2024February 04, 2025
World Cancer Day quotesFebruary 04, 2025
India can take a big leap in Cancer Care with Improved access to treatment and People-centered Approach: ExpertsFebruary 04, 2025
Lilly India appoints Winselow Tucker as the President and General ManagerFebruary 04, 2025
Driving Excellence in Clinical Research: ISCR's 18th Annual Conference Highlights Innovation, Technology, and Patient-CentricityFebruary 04, 2025