Biotech Strategy Blog

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

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…

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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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We have a two part mini-series this week exploring an approach on how to boost T cells in cold tumours. There are a number of different ways to do this, including adding them ex vivo such as via CAR T cell therapies, although this technique has yet to yield durable benefit in solid tumours.

So how else can it be done?

We’ve discussed immune agonists, oncolytic viruses and cancer vaccines in the past so now it’s time for something different…

In Part 1 of the series today, we explore the science behind the technology and some of the early clinical data that was recently presented at medical meetings.

In Part 2 tomorrow, we have not one but three, different voices exploring some researchers thoughts on where the approach might go.

It should make for interesting reading!

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There has been considerable focus on the impact of cancer immunotherapy and checkpoint blockade in particular in non-small cell lung cancer (NSCLC) of late, with approval of several agents in the 1L and 2L metastatic setting, as well as positive results reported in stage 3 unresectable disease earlier this year.

To date, the approvals have focused on monotherapies in second-line (nivolumab, pembrolizumab and atezolizumab) allcomers, as well as in 1L in two cases i.e. for people who are PD-L1 High expressers (≥ 50%) for pembrolizumab or allcomers in combination with chemotherapy (pembrolizumab).

Today as part of their 2Q earnings call details, AstraZeneca ($AZN) announced that the MYSTIC trial exploring the combination of the anti-PD-L1 antibody, durvalumab (Imfinzi), plus anti-CTLA–4 antibody, tremelimumab, unfortunately missed the interim endpoint of progression-free survival (PFS).

This is the first dual IO-IO combo readout in this setting and while disappointing, the results aren’t entirely surprising, as regular readers will no doubt realise.

We are now awaiting several other trial readouts in 1L NSCLC, including Merck’s phase 3 confirmatory trial for pembrolizumab plus chemo and Genentech/Roche’s IMpower150 trial, which explores atezolizumab in combination with chemotherapy, with and without the anti-VEGF inhibitor, bevacizumab (Avastin).

For historical reference, we originally wrote up our perspectives on the 1L NSCLC landscape in January this year then followed that up with a provocative post outlining out predictions on what to expect earlier this month, including the projected miss in PFS for AstraZeneca’s IO combo.

So what does this latest data mean for AZN?

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Berlin: Checkpoint Charlie

With a series of inconsistent results involving phase 3 trials involving checkpoint antibody therapy, even in similar indications, it’s time to get down and dirty and look at some of the factors that might be influencing the outcomes since three of the five approved anti-PD(L)1 products have now been similarly affected.

It’s an interesting and intriguing conundrum, to be sure…

Instead of obeying traffic rules, with immune checkpoints maybe we need to consider following immunology rules instead 🙂

The potential hidden answers, however, might be surprising to some readers.

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The latest company immunotherapy announcement is from Lilly and Nektar Therapeutics, for a strategic collaboration to co-develop NKTR–358, which targets the IL–2 receptor complex, thereby impacting regulatory T cells (Tregs). It is thought that this target may have particular relevance to autoimmune disorders and other chronic inflammatory conditions. This agreement involves an initial payment of $150 million, with the potential for up to $250 million in additional development and regulatory milestones.

Source: Nektar Therapeutics

Preclinical data on this novel compound was recently presented on July 10th at the World Congress of Inflammation.

We first spoke to Nektar at SITC in November, including an interview with one of their leading scientists (Dr Jonathan Zalevsky) together with the academic PI (Dr Adi Diab), and I’m delighted to say that the dynamic duo graciously agreed to a follow-up discussion at ASCO last month on the emerging IO pipeline.

In our current analysis and commentary on the IO pipeline, we also look briefly at the Lilly deal with NKTR–358 in autoimmune disease.

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