Biotech Strategy Blog

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

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.

To learn more insights on this intriguing topic and what Prof Qasim had to say, subscribers can log-in or you can click to gain access to BSB Premium Content.

Dr Bernie Fox (@BernardAFox) is a man on a mission to #FinishCancer, a Twitter hashtag he uses to reflect his vision.

A cancer immunotherapy rockstar, Bernard A Fox, PhD, is the Harder Family Endowed Chair for Cancer Research at Providence Center Center and Chief of the Laboratory of Molecular and Tumor Immunology at the Earle A. Chiles Research Institute in Portland, Oregon.

Fox is also a past president of the Society for Immunotherapy of Cancer (SITC) and CEO of UbiVac, a biotechnology company focused on therapeutic cancer vaccines.

Readers of the Blog and Novel Targets Podcast listeners will recall we had the privilege to interview Dr Fox back at the American Association for Cancer Research (AACR) annual meeting in New Orleans in 2016: “AACR Cancer Immunotherapy Insights from Dr Bernard Fox.”

Fast forward 18 months… it is now time for a detailed update on this issue, as a few interesting events have since come to light in this niche with Genentech/Roche abandoning development of their OX40 agonist, coupled with several new publications from different labs suggesting that concurrent administration of an anti-OX40 antibody with an anti-PD1 antibody attenuated the effect of anti-OX40 and resulted in poor treatment outcomes in mouse models.

Dr Fox kindly spoke to Biotech Strategy Blog about some of the key learnings from this research, where he sees the future potential for OX40, and what his vision for cancer immunotherapy is.

Here’s a short clip from the fireside chat…

 

He’s definitely a man on a mission to #FinishCancer!

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In our ESMO 2017 Preview series so far we covered our Top 5 immuno-oncology and targeted therapy abstracts to watch out for (the latter has been updated since it first posted so do check it out).

Now it’s time to turn to something completely different.

Castle Manzanares el Real, Madrid

Here we look at hepatocellular carcinoma (HCC), including Blueprint Medicines FGFR4 molecule, BLU–554.

We first covered Blueprint back in February this year with a particular focus on GIST.  Quite a bit has changed since then, so it’s a good time for an update, especially in HCC now that they have data in Madrid.

In the context of the HCC landscape, what’s changing in this niche, what should our expectations be, and how is this market evolving since our last update?

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Recently there has been a glut of encouraging new research published on the topic of breast cancer that is well worth perusing as a group, since new combination studies may emerge from these kind of data.

In this month’s Journal Club edition, we explore five such articles plus some related research in support of the main themes.

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While there continues to be an almost obsessive and fervant attention and focus on cancer immunotherapy, let’s not forget that chemotherapy and/or targeted therapy combinations are still the standard of care in many cases.

Plaza de Cibeles, Madrid

There are also numerous pipeline trials still ongoing and especially in the case of diseases with a low number of somatic mutations, other approaches may continue to have more utility and clinical benefit than say, monotherapy with checkpoint blockade.

So what’s in store in our second ESMO17 Preview series?

Following on from the Top 5 IO abstracts earlier this week, next up in the spotlight is the Targeted Therapy Top 5 Selections…

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There’s been another disturbance in the force – as luck would have it, after mentioning renal cell carcinoma (RCC) in yesterday’s post, BMS subsequently put out a press release on the CheckMate–214 study exploring the combination of nivolumab plus ipilimumab in the previously untreated metastatic setting.

The results to date were mixed, so what does this mean and what’s impacted by the findings?

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It’s that time of the year again – time to highlight key events and talks at the upcoming European Society of Medical Oncology (ESMO) meeting held in Madrid next month.

Over the next two days, we’re going to take a look at five key IO trials (today) and five targeted therapy studies (tomorrow) that are being presented at ESMO.

In short, what should readers know about these oral presentations for greater context, why are they important, and what should you be looking for?

We will cover the hidden gems from the poster halls to watch out for in a separate future post.

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Paris: If cancer immunotherapy is a revolution in how cancer is treated, then Dr Jérôme Galon is a revolutionary.

In addition to being a Research Director at INSERM in Paris, Dr Galon is one of the co-founders of Marseille based HalioDx, an immuno-oncology diagnostics company that is commercializing the research from his laboratory.

Last month, while in Paris, I had the great pleasure to talk with him in his office at the Centre de Recherche des Cordeliers (CRC) on the left bank of Paris.

At the time of the French revolution in 1789, it was the gathering place of the “Club des Cordeliers,” for famous revolutionaries such as Danton, Marat, and Camille Desmoulins. Dr Galon told me it was where the Declaration des droits de l’homme et du citoyen de 1789 (Declaration of the Rights of Man and Citizen) was signed.

As such, it’s a very appropriate place to find a cancer immunotherapy revolutionary…

To learn more insights on what he had to say about a variety of topics in cancer immunotherapy, subscribers can log-in or you can gain access to BSB Premium Content.

One of the intriguing themes that emerged recently at ASCO from several cancer immunotherapy trials centred around whether any elicited immune responses actually correlated with outcomes and if so, why and how?

Gems from the ASCO17 poster hall

It sounds easy in practice, yet in reality the topic has been quite a controversial one that has been hotly debated for a while.

With a wealth of new cancer immunotherapy trials now undwerway and initial results trickling out, how do we start to make sense of the information and what do we learn that might be useful going forward for future trials and the field as a whole?

With the help of a renowned cancer immunologist, we explored this concept in more detail to determine what can be gleaned from the data available.

Today, we look at part one of our latest mini-series, with the second part to follow later this week.

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Here we are with Part 2 of our latest mini-series on novel ways to jumpstart the immune system so that subsequent therapy can be more effective, leading to improved outcomes.

In Part 1, we looked at the preclinical and scientific evidence regarding a novel approach to modulate a cold or non-inflamed tumour type, thereby turning the phenotype into a hotter or inflamed one.

In principle, this concept sounds quite simple in theory, but in practice it’s actually much more technically challenging to do than many realise, especially when we consider not just the design of the antibody itself and perhaps even efficacy, but also the convenience of administration and tolerability, both as monotherapy and also in combination with other therapies.

What’s up on deck today is not one, but three interviews, offering readers a candid look through the keyhole at varied insights from different perspectives around a central R&D topic, namely…

What do you do when you have a new compound in clinical development and wish to explore how to integrate it – do you use it with an existing framework or try something new and different? What about other compounds that might be competing with it internally?

It’s a question every single oncology company faces when a new molecule moves out of preclinical development into phase 1 trials. What next?

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