Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts from the ‘CAR-T’ category

Dr Michael Gilman, Obsidian

To get started in the New Year, we decided to roll out a new mini series on small cap and private biotechs, as seen through the lens of their dynamic CEOs.

This will run throughout January, with plenty of different products and perspectives to consider.

The honour for the very first CEO to be in the hot seat in 2018 went to Dr Nancy Simonian of Syros earlier this week during JPM18, who talks about their small molecule program and why they are excited about 2018.

When we first talked to Syros, they were a privately held start-up, now they’re listed on Nasdaq.

We now move on to the second one in the series, with a look at a new start-up called Obsidian Therapeutics in an interview with Dr Michael Gilman (right).

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For the last couple of years at every annual meeting of the American Society of Hematology (ASH) conference, I have posted an extensive Preview of the CAR T cell therapy landscape and looked at which abstracts piqued my interest.

The roaring 30s CAR

This year the review is the most extensive to date, with more companies, more research groups, more tumour types and way more preclinical research coming through. It’s like a kaleidoscope of ideas cascading through R&D.

The other thing to take note is how fast the field is moving – it’s warp speed now and so much comes through the literature every month on top of that.

So here we go – hold onto your hats as there is a LOT to contemplate this year!

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Dr Stephan Grupp at SITC17

National Harbor, MD – SITC 2017 wouldn’t be the same without an in-interview with Dr Stephan Grupp (CHOP) on the issues surrounding the Juno ROCKET trial and CAR T cell therapy safety.

This data has been eagerly awaited and anticipated by the field since the news of a cluster of lethal cerebral oedemas hit Juno in the summer 2016, seemingly out of the blue.

Yesterday, we reviewed the salient points from Dr Mark Gilbert (CMO) presentation highlighting their findings from the in-depth analyses performed to date.

In the second part we turn to a CAR T cell therapist with experience in treating children and young adults for his perspectives and candid reactions to the information presented.

We also talk about where the field is headed and some of the new developments we can look forward to hearing more about in the near to medium term future.

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Paris – amazingly it’s now 3 years since we interviewed Cellectis (NASDAQ: $CLLS) CEO André Choulika and CSO Philippe Duchateau (See post: Can Cellectis revolutionise CAR T cell therapy):

Cellectis CSO CEO

Cellectis Senior Management – Drs Duchateau and Choulika

Since then, we’ve followed the company over time, including an interview with one of their leading scientists, Dr Julianne Smith at ASH 2014, followed by the initial results of their first allogeneic CAR T cell therapy UCART19 presented at #ASH15 by Professor Qasim.

It’s hard to believe 3 years have gone by so quickly! As regular readers know what we often do on BSB is follow stories longitudinally, so while in Paris for an Immuno-Oncology Summit we thought it a rather timely opportunity to revisit Cellectis and take stock of where they’re at and ask what the future may hold for them?

With the recent news that Gilead have acquired Kite Pharma, there’s going to be a lot of interest in what companies such as Cellectis are doing to bring allogeneic “off the shelf” CAR T cell therapy to market.

This is the penultimate post in our summer mini-series on gene editing and allogeneic CAR T cell therapy and features a candid interview with Dr Philippe Duchateau, Chief Scientific Officer, at Paris based Cellectis.

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When we think of pioneers in the CAR T cell therapy space, one person who comes to mind is Waseem Qasim, Professor of Cell and Gene Therapy at the Institute of Child Health at University College London, and a Consultant Immunologist and Pediatrician at Great Ormond Street Hospital (GOSH).

Institute of Child Health

As readers may recall back in 2015, he gave the first allogeneic CAR T cell therapy under compassionate use to an infant with ALL, and in the process undoubtedly saved her life.

The subsequent case report published in Blood was the talk of 2015 annual meeting of the American Society of Hematology (ASH) in Orlando.

The poster focused on the first child that Prof Qasim treated and attracted a phenomenal amount of attention:

Prof Qasim UCART19 #ASH15 Poster

Where are we now with allogeneic CAR T cell therapy?

It’s been 18 months since we spoke to Prof Qasim, so while in London over the summer BSB caught up with him in his office at the Institute of Child Health.

This interview is the first in our latest 3-part mini-series on allogeneic CAR T cell therapy, which runs throughout this week. Here’s a teaser clip:

Kite’s first autologous product, Axi-Cel (in aggressive lymphomas), heads for regulatory approval in the US (PDUFA date November 29th), offering Gilead a hematology launch product with a high unmet need and, presumably, a relatively high price tag to match. Inevitably, some critical attention will subsequently be focused on the pipeline and whether they will move towards allogeneic CAR-T cell therapy (reduces cost of goods and increases profit margin) as well as how the TCR platform in solid tumours will fare.

It’s certainly a timely point to consider allogeneic CAR T cell therapies again given that things are rapidly heating up in the cell therapy niche following the Gilead announcement yesterday that they are acquiring Kite Pharma for $11.9 Billion.

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Yesterday Novartis announced the initial data from the JULIET trial in relapsed/refractory aggressive lymphomas such as diffuse large cell lymphomas (DLBCL) that were presented at the upcoming International Conference on Malignant Lymphoma (iCML) meeting in Lugano.

Here at BSB, we’ve been following CAR T cell therapy developments in earnest since 2012 when Penn and Novartis first announced their collaboration to develop what is now known as CTL019.

Five years on, we now have two such cell therapy products already filed with the Health Authorities and the JULIET trial will likely be the third indication submitted by the end of the year. This niche is now well established for regular readers and not something that has been a flash in the pan over a year or so.

There are a few interesting points of note on the CAR T cell front that are also worth exploring in conjunction with this news.

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Long time attendees at the annual meeting of the American Association for Cancer Research (AACR) know that there are usually interesting posters and sessions buried on the last day of the meeting.

This year was no exception, with a major symposium on CAR T Cell Cancer Immunotherapy chaired by Michael Jensen MD (pictured right).

BSB readers will recall we interviewed him at the 2016 BMT Tandem meeting in Honolulu (See post: Optimizing CD19 CAR T cell therapy).  Excerpts from this interview also featured in Episode 14 – Cell Therapy Pioneers of the Novel Targets Podcast.

The CAR T symposium on the last day of AACR was one of my highlights of the meeting. The three speakers were:

  • Michael Jensen, MD (Seattle Children’s) Engineering Next Generation CAR T cells using Synthetic Biology-Inspired Technologies
  • Terry J. Fry, MD (National Cancer Institute) Defining and overcoming limitations of CD19 CAR immunotherapy in pediatric ALL
  • Christine E. Brown, PhD (City of Hope) Progress and Challenge in CAR T Cell Therapy for Brain Tumors

Each of these presentations would merit a full blog post in their own right, but in this particular post we’re focusing on CAR T cell therapy targeting glioblastoma multiforme (GBM).

GBM is the most common primary malignant brain tumor, and one with a dismal prognosis – the 5-year survival rate is only around 5%, so there is also a high unmet medical need for new effective treatment options. This devastating disease has proven to be a miserable graveyard for Pharma over the last decade, with many agents unfortunately ending up in dog drug heaven.

After her AACR17 presentation, Dr Brown kindly spoke to BSB.

This post is part of our series of thouight leader interviews from AACR17. It also continues our ongoing posts on the adoptive cellular therapy landscape, and in particular, CAR modified T cells.

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It’s finally time…

US Capitol Building, DC

By popular request from BSB readers, we have a CAR T cell therapy preview of the main abstracts to watch out for, including talks and posters, and what emerging themes to expect are likely to be.

If you are registered on the AACR site and signed in, then clicking on any of the abstracts highlighted in this review will enable you to add any interesting ones you fancy to your conference itinerary.

There’s a surprising amount to cover this year, especially when we consider the incredible work that’s ongoing to address a number of suboptimal aspects in the construct developments.  It’s continuing to progress at warp speed, so hold onto your hats and buckle down for our latest rock around the AACR clock.

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Hans Bishop, Juno

After a rocky 2016 for Juno with JCAR015 and the trial that imploded unexpectedly and badly, the CEO Hans Bishop quietly announced that announced that ROCKET has been abandoned:

“2016 was a year of progress and learning for Juno and the cancer immunotherapy field. We continue to experience encouraging signs of clinical benefit in our trial addressing NHL, but we also recognize the unfortunate and unexpected toxicity we saw in our trial addressing ALL with JCAR015. We have decided not to move forward with the ROCKET trial or JCAR015 at this time.”

A strange year of hubris attracting nemesis might be another way of describing the events for some observers.

We covered the Juno roller coaster and events in July and December 2016 for those who want to catch up on the full history of this unfortunate and ongoing debacle:

Where does the latest Juno news leave things and what can we expect going forward?

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One of the pioneers of CAR T cell therapy in children is Dr Stephan Grupp, who is Director of the Cancer Immunotherapy Program at The Children’s Hospital of Philadelphia (CHOP).

Dr Stephan Grupp ASH16

He led the way in developing ways of treating cytokine release (CRS) syndrome through the use of tocilizumab. At the recent American Society of Hematology annual meeting, Dr Grupp presented the results of the ELIANA study, the first global, multi-center clinical trial with CTL019 (Novartis) in pediatric acute lymphoblastic leukemia (p-ALL).

What was surprising to many at ASH was that despite the fact that CAR T cell therapy is one of the hottest topics in hematology (if not the hottest), many presentations were in small (tiny) meeting rooms, which many people could not get into. Several overflow rooms were rapidly opened up, but still people were left out. Someone clearly did not get the memo!

If you didn’t make into the meeting room at ASH to hear Dr Grupp, he kindly spoke to BSB about the data he presented and also shared his perspective of what the future may hold for CAR T cell therapy in pediatric ALL.

There’s also additional commentary on some of the other key CAR T cell presentations that caught our attention at ASH.

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