Biotech Strategy Blog

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

Posts tagged ‘Bispecific antibodies’

AACR20 – Ten New Directions in Early Cancer Drug Development

It is becoming increasing obvious in these challenging times as the pandemic spreads globally that no corner of the earth (except perhaps the Antartica) is being left untouched.  As lockdowns begin or continue depending the phase the spread is at, this also has numerous implications for clinical trials, both academic and company funded studies alike.

Which direction should we be considering for early anti-cancer therapeutics?

One of the broader effects of the coronavirus pandemic likely means we won’t see much new data on many of the clinical trials after the currently scheduled presentations for AACR, ASCO, ESMO and ASH for a while yet, perhaps well in to 2021, which in turn is a strong reminder if we want to see how much progress is being made then we need to look at what data is available now.

I can well imagine many folks are already completely Zoomed or WebExed out from constant online meetings dealing with the implications of the pandemic on research and clinical development, as well as what happens to new and existing trials, so the idea of listening to two days of a virtual meeting on top is probably a bit daunting for the time-challenged observers amongst you.

AACR’s virtual meeting is a wonderful opportunity for smart folks to take some careful snapshots of where we are now, and how some of the early pipeline agents are shaping up.

The good news is we while your online internal meetings continue apace, we will be posting many reviews, summaries, discussion and analysis of the data here on BSB, hopefully sparing many of the additional stress in busy times. We plan to make the process of analysis and commentary relatively easy so you can follow along with us.

For reference, you can access all of our ongoing AACR20 conference coverage here. Future posts will also be added to this magazine page as they are posted.

In our fourth AACR Preview series, we take a keen look at some additional early products in development of interest, as we continue our updates on the never ending oncology R&D journey.

We highlight 10 emerging agents in early stage development to watch out for…some are new and others we previously reviewed preclinically and have moved along in their R&D journey into the clinic, with good and bad results to think about.

To learn more from our oncology analysis and get a heads up on insights and commentary emerging from the first annual AACR virtual meeting subscribers can log-in or you can click to gain access to BSB Premium Content.

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SITC19 Preview: Which new IO data that grabbed our interest?

National Harbor, MD

With the abstract drop from the 2019 Society for the Immunotherapy of Cancer (SITC) meeting now available, what can we learn from some of the research slated for formal oral presentation this year?

Here in part one (posters will be reviewed tomorrow) we take a look at a mix of preclinical and early clinical studies that grabbed our initial interest from the oral presentations – they include the good, bad, and intriguing – to see exactly what can be learned from this year’s mix of abstracts?

The short answer is quite a lot.

Every year the what to watch out for preview is a popular one.  This year there are some surprises in store as well as some particularly important findings that BSB readers may well be keen to find out more about ahead of the conference later this week in order to maximise their thinking and avoid the inevitable brain-fry and fatigue that sets in on Saturday afternoon…

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How F-star are optimising bispecific antibodies for cancer treatment

Mononclonal and bispecific antibodies in the immuno-oncology space have certainly had a bit of a roller coaster ride over the last couple of years with various safety concerns including cytokine release syndrome (CRS) and even fatalities coming to the fore following clinical holds on various compounds across several quite different compounds.

Barbara Hepworth sculpture at Downing College, Cambridge

As companies work their way through those issues with FDA and other Health Authorities, can we also learn from our previous experiences with checkpoint blockade, immune agonists and other IO targets in order to develop safer products?

One thing has become clear and that’s how important particular aspects of the engineered molecules can make an impact in terms of both safety and efficacy. There are, after all, quite a few factors that can be manipulated or changed to impact performance, much as the design arrangement and composition of various components into a unified whole is crucial to Formula Once racing cars.

In our second part of the bispecific mini-series, we head over to Europe and interview the CSO of a leading company in the IO bispecific space to learn more about these design features and the potential benefits they might induce.

It makes for rather interesting reading when we consider the next wave of IO clinical trials…

To learn more and get a heads up on our latest oncology insights and thought leader interview, subscribers can log-in or you can click to gain access to BSB Premium Content.

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The Next Wave of IO with Dr Dan Chen

It’s time to launch a new mini-series where we explore some of the issues and concepts surronding a given topic and then look at how they are being tackled through the lens of different biotech companies.

Storm clouds gathering over immune agonists and bispecific antibodies?

The latest topic is bispecific antibodies, a development we have often covered since 2014/2015 here on BSB. Much has happened in that time and many compounds have fallen by the wayside. In my view, this is a normal part of oncology R&D attrition – it’s not that we encounter problems, it’s how companies handle the road blocks along the way that matters.

What can we learn from the first two waves of immuno-oncology that can be applied to bispecific developments?  There is no doubt that while some have been successful in making it to market, quite a few have encountered various challenges along the journey.  Why is that and how to we address the emerging or thorny issues?

Change is inevitable in the cancer immunotherapy revolution, we can hardly expect to get things right first time, every time. Some approaches will work well, some won’t, others will need tweaking and turn out to be useful tools down the road in future iterations. Learning from past experience to make the next wave better and more effective is an important part of this process rather than putting everything in one basket and then abandoning it if it doesn’t work first time.

One man who has experienced the first and second waves and is ideally placed to candidly discuss the learnings and future changes needed is Dr Dan Chen. He was global head of cancer immunotherapy while at Genentech/Roche and is now spearheading clinical development at IGM Biosciences, a biotech focused on next generation antibodies and bispecifics.

In order to think about what’s needed in the future rather than rush headlong into a different modality, we first have to take stock and then reflect on the learnings of the past clinical trial experiences in order to figure out how to fix them…

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What to watch out for in Bispecifics at ASCO19

Bispecifics in the garden? Who knows!

We’re continuing our preview of the ASCO 2019 annual meeting (Twitter #ASCO19) with a look at a fast-paced area of drug development that is attracting a lot of interest, namely the potential of bispecifics as novel cancer treatments.

On BSB we’ve been following this emerging field for the past five years or so, but at this year’s ASCO we expect to hear clinical data that may offer new insights.

If you’ve been in London this past week, then you may have been at the annual Royal Horticultural Society (RHS) Chelsea Flower Show, which features impressively designed show gardens built around a theme or location. They’re built with great attention to detail just for Chelsea, then at a few days they’re dismantled.

Large cancer meetings like ASCO19 are a bit like that too. We all come together for a few days to mix and mingle then go our separate ways again.

In the spirt of Chelsea, in this post we’re taking a look at what to watch for in the “ASCO19 bispecific garden,” if one were to be made.  There’s certainly a surfeit of choice to consider and like flowers, some may flourish under certain conditions, but not others.

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ASH18 Highlights from Day 3

What latest ASH18 data jumps to our attention?

San Diego – It’s time to put another dozen studies in the spotlight and review what we can learn from the existing data with a view on where we’re headed in the future.

Today’s list covers a whole gamut of targeted therapies, bispecific antibodies, CAR-T cell therapies and other immunotherapies, what’s more we have a range of targets in the list too, and not the obvious ones either.

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A different take on targeting cancer

While many observers attentions have recently been focused on immuno-oncology of late, particularly with respect to checkpoint blockade and CAR T cell therapies, these are not the only class of drugs that are being investigated in the clinic.

Field of dreams or crowded marketplace?

We saw a lot of early preclinical data and especially got to see quite a few new targets at AACR, while next month ASCO offers a new opportunity to see inital phase 1 data presented in several developmental therapeutic sessions and in the poster halls.

There is no doubt that the oncology R&D niche is becoming increasingly competitive and crowded, which means that companies need to think carefully about how they can clearly differentiate themselves and position their platform much more assertively than before.

For small biotechs, this also means going beyond offering great preclinical packages to demonstrating proof of concept in the clinic, hence phase 1/2 trials are receiving a lot more attention these days, as potential collaborators and acquirers flock to the poster halls.

Today we have a CEO from one of these emerging biotech companies in the BSB hotseat with a candid discussion about their approach, why they are different, and importantly, where they are heading…

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Update on CD123 and other viable targets in AML

Coney Island Roller Coaster

In the roller coaster of life that is oncology R&D, molecules come and molecules go… a rare few reach blockbuster heights while many others are quietly packed off to dog drug heaven, never to be seen or heard of again.

This is also very true of targets as well…

What about the in-between space?

Unfortunately, that’s where most molecules and cancer targets end up – into a deep black nothingness where we seek the high affinity targets with low grade side effects – and fall short in some way. It’s a frustrating place to be, to be sure.

One of these conundrums is compounds against CD123 (IL3Rα), which have been in the spotlight on and off this year and are turning out to be a rather mixed bag.

After our recent update on Cellectis and their CD123 direct CAR T cell therapy (UCART123), I wasn’t expecting to write any more on this until ASH in mid December. How wrong that prediction turned out to be!

Today we have quite a few things to discuss on this topic, so if interested in CD123 in hematologic malignancies and going beyond that to find better targets in AML then this is the poster for you…

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Xencor and Novartis storm the hematologic bispecific market

This morning, like many folks, I woke up to the latest immuno-oncology news on the bispecific front that Xencor, a Los Angeles based biotech, announced their latest collaboration, this time with Novartis.

Over the last few years, we have seen a surfeit of bispecifics emerge that are focused on stimulating the immune system, particularly with regard to T cells and natural killer (NK) cells, as well as antigen targets on the surface of tumours. The first one approved was Amgen’s blinatumomab (Blincyto), a CD19 targeted bispecific for the treatment of acute lymphoblastic leukemia (ALL), which we have written extensively about.

Xencor logoThe Xencor/Novartis deal has a number of interesting implications that are well worth exploring in more depth that go far beyond the information provided in the press release.

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Is TIM–3 the next important checkpoint target?

One of the most important challenges in cancer immunotherapy is overcoming immune resistance. For example, even with the high response rates seen in acute lymphoblastic leukemia (ALL) with CAR – T cell therapy, a significant number of patients relapse after an initial response.

Chinatown Honolulu

Chinatown, Honolulu 2016

Could immune resistance be reversed or prevented by the addition of appropriate checkpoint blockade? Which ones matter though, that is the critical question?  Rather than randomly picking ones to try, we need scientific evidence regarding these choices.

This post explores some of the latest data presented at the BMT Tandem meeting on the role of T cell immunoglobulin mucin–3 (TIM–3) and PD–1 upregulation in causing resistance.

If you’re not already a sub and want to read our coverage of ASH, BMT Tandem and the forthcoming AACR 2016 annual meeting, you can purchase individual access below. This week only – inspired by the story of Eddie Aikau in Hawaii – we have a special offer that we’ve never done before (and may never do again) of $75 off a quarterly subscription. The deal ends tomorrow Friday March 4th at 12 noon HST. Check it out!

Subscribers can login to read more about the latest data on how alternative checkpoint inhibitors may have a role to play in cancer treatment.  Welcome to the new folks who signed up this week, good to see y’all!

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