CAR-T

Next Generation CAR-TCR Summit

The cell therapy field is showing no signs of slowing down, with huge investment and excitement around next generation products and their clinical validation in solid tumour indications. Formerly CAR-TCR Europe, the new and improved Next Generation CAR-TCR Therapies Summit is now the only industry-dedicated forum focused on the 2.0, next generation innovations in cell therapies. This year, we’ll be specifically focusing …

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FDA halts Allogene CAR-T trial after safety scare

A phase 1 trial of Allogene’s of-the-shelf CAR-T for lymphoma has been placed on hold by the FDA, after a “chromosomal abnormality” was seen in a patient receiving the cell therapy. Shares in the California biotech were hit hard after the news emerged, losing more than a third of their value as investors fretted that …

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Allogene set to disrupt CAR-T market with pivotal trial of ‘off the shelf’ therapy

In 2018, the former leadership of team from Kite Pharma founded Allogene, on a mission to outdo the CAR-T cancer cell therapies they had just sold to Gilead for $12 billion with an “off-the-shelf” rival that could be cheaper and easier to use. Data announced ahead of this year’s American Society of Clinical Oncology (ASCO) …

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Collaboration is key to advancing cell therapy research

Dr. Anne Kerber, VP, Head of Clinical Development, Europe at Kite, a Gilead Company, explains how the company works with researchers and physicians across Europe to expand patient access to cell therapy. This thought leadership series has been paid and developed by Kite, a Gilead Company. Cell therapy is a treatment involving the genetic modification …

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FDA approves BMS’ multiple myeloma CAR-T Abecma

The FDA has approved Bristol-Myers Squibb’s Abecma (idecabtagene vicleucel) for multiple myeloma, the first cell therapy to treat the disease. Abecma’s review was delayed after the FDA rejected a first filing in May last year, but it’s hoped that the drug could be a significant step forward in the treatment of this incurable condition. It …

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Lymphoma Action – championing the patient voice in cell therapy

Lymphoma Action is the only UK health charity dedicated to people affected by lymphoma. Chief Executive Ropinder Gill and Director of Operations and External Affairs Stephen Scowcroft believe it is essential to champion the patient voice in cell therapy. This thought leadership series has been paid for and developed with Kite, A Gilead Company. Lymphoma …

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NHS and Kite sign access deal for Kite’s cancer cell therapy Tecartus

NHS patients in England will be among the first in the world to receive Gilead’s Tecartus cancer cell therapy for certain types of lymphoma, after the company’s specialist Kite unit struck a deal with NICE.  Marketed as Tecartus (autologous anti-CD19-transduced CD3+) in Europe, the drug was approved in the EU in December for adults with …

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Why cell therapy manufacture is a team sport

Louis van de Wiel, Vice President, Site Head EU Manufacturing, Kite, a Gilead Company, reveals the complexity that sits behind the process of individualised cell therapy – and why team culture makes it work This thought leadership series has been paid and developed by Kite, a Gilead Company. In 2018, we were preparing to build …

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Welcome to the CAR-TCR Summit Europe 2021

Accelerate the Bench to Bedside Development of Novel CAR Immunotherapies for Safe, Effective & Affordable Advanced Therapies With CAR-TCR therapies on the cusp of achieving global approval, there are still many bottlenecks that are preventing this from becoming the ‘sell-out’ therapy that the field had hoped for. The CAR-TCR Summit Europe (16th-18th February 2021) will unravel …

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Triumvira Immunologics raises $55M in Series A funding round for new form of cancer cell therapy

The company hopes to use the money to bring its T-cell antigen coupler cell therapy technology – currently in preclinical development – into human clinical trials. German drugmaker Bayer’s venture capital arm led the round.

Preparing for an influx of cell and gene therapy approvals

Cell and gene therapies offer some of the most groundbreaking advancements in patient care the pharma industry has ever seen. However, to fully realise the potential of these innovative therapies, integration across the supply chain is critical – particularly with reimbursement and logistics. As of the end of 2019, there were 17 cell and gene …

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BMS, bluebird refile FDA approval application for CAR-T therapy in myeloma

The companies’ resubmission of their application Wednesday seeking approval for idecabtagene vicleucel was in line with the timeline they provided in May, when the FDA sent a refuse-to-file letter in response to their initial submission.

BMS ‘bet’ with Celgene shareholders in balance after CAR-T refile

Bristol-Myers Squibb and bluebird bio have refiled their CAR-T therapy for multiple myeloma, leaving the outcome of a three drug “bet” with former Celgene shareholders dependent on a fast review from the FDA. BMS gave Celgene’s shareholders a “Contingent Value Right” (CVR) to sweeten the $74 billion merger last November. Each shareholder got one CVR …

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Gilead’s Kite gains some height after second CAR-T approval in US

Gilead’s $11.9 billion purchase of Kite Pharma in 2017 didn’t follow the script, with two big write-downs in the value of the asset since then, but a fresh approval for a CAR-T therapy could claw back some value. Late last week, the FDA approved Kite’s Tecartus (brexucabtagene autoleucel; formerly KTE-X19) as a treatment for mantle …

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