Exclusive: Carl June’s Tmunity encounters a lethal roadblock as 2 patient deaths derail lead trial, raise red flag forcing a rethink of CAR-T for solid tumors

Oz Azam and Carl June

June 2, 2021 11:00 AM EDTUpdated June 3, 05:22 AM

Exclusive: Carl June’s Tmunity encounters a lethal roadblock as 2 patient deaths derail lead trial, raise red flag forcing a rethink of CAR-T for solid tumors

John Carroll

Editor & Founder

The multifaceted campaign to create a CAR-T for solid tumors has run into a lethal problem.

In exclusive interviews, Tmunity founders Carl June and Oz Azam tell me that they have had to scrap their lead program for prostate cancer following the deaths of 2 patients earlier in the year — the last a little more than a month ago — after they experienced lethal bouts of neurotoxicity. What started as a voluntary halt by Tmunity in the face of these deaths flipped to an FDA-enforced red light for the clinical trial, while the biotech scrambled to rework its CAR-T design with a plan to get “version two” back into the clinic as soon as possible, with a new IND planned for the second half of the year.

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ZS Perspective: 3 Predictions on the Future of Cell & Gene Therapies

Ben Hohn

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

January 19, 2022 02:06 AM ESTUpdated 01:34 PM

Deals

Cell/Gene Tx

What kind of biotech startup wins a $3B syndicate, woos a gallery of marquee scientists and recruits GSK's Hal Barron as CEO in a stunner? Let Rick Klausner explain

John Carroll

Editor & Founder

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

January 20, 2022 08:31 AM ESTUpdated 10:30 AM

Bioregnum

Cell/Gene Tx

'Altos was really a once-in-a-lifetime opportunity': Hal Barron reflects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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ENDPOINTS CAREERS

Associate Director, Program Management - Cell & Gene Therapy Manufacturing

Lonza

Portsmouth, NH, USA

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

January 20, 2022 07:21 AM EST

Pharma

FDA+

European Parliament signs off on strengthening drug regulator's ability to tackle shortages

Zachary Brennan

Senior Editor

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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January 19, 2022 01:29 PM ESTUpdated 04:21 PM

FDA+

FDA+ roundup: FDA's neuroscience deputy departs amid ongoing Aduhelm investigations; Califf on the ropes?

Zachary Brennan

Senior Editor

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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January 19, 2022 07:16 AM EST

Pharma

Secondary patents prove to be key in biosimilar blocking strategies, researchers find

Zachary Brennan

Senior Editor

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

January 19, 2022 02:43 AM ESTUpdated 11:12 AM

People

GSK R&D chief Hal Barron jumps ship to run a $3B biotech startup, Tony Wood tapped to replace him

John Carroll

Editor & Founder

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Director, Business Development, Cell & Gene Therapies

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Remote

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Kenneth Galbraith, incoming Zymeworks CEO

January 20, 2022 07:20 AM EST

R&D

Pharma

Zymeworks replaces half its C-suite, aims to lay off 25% of total workforce as new CEO takes over

Max Gelman

Editor

New Zymeworks CEO Kenneth Galbraith is aiming to hit the ground running when his tenure officially begins next month, but he’ll be doing so with a much different looking team.

In a lengthy press release outlining the biotech’s 2022 goals, Galbraith said Zymeworks will be laying off at least 25% of its staff over the course of the year. Half of its C-suite will also be replaced immediately as Galbraith looks to remake the company in his image after Ali Tehrani, Zymeworks’ founder and CEO since 2003, stepped down two weeks ago.

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January 18, 2022 09:51 AM EST

R&D

FDA+

CBO: Medicare negotiations will hamper drug development more than previously thought

Zachary Brennan

Senior Editor

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.