Biotech Strategy Blog

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

Posts tagged ‘macrogenics’

Continuing our ASCO20 coverage with another Preview in the pre-meeting series, we turn our attention to a particular modality of keen interest to many of our readers.

In this latest article, we highlight ten areas within the niche and include an array of companies, both big and small, across Pharma and Biotechs.

Some of them have some nice data to share, others will be footnotes to the meeting, but who fits into what category and what can we learn from the abstracts upfront?

To find out more, we looked very carefully at the hints and nuance which inevitably grace the writer’s pen – it’s time to hone in on where are the flourishes and the crossings out this year?

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

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Chicago – Having stayed until the last morning of the last day for a final expert interview and sessions on CAR-T therapy and metastatic breast cancer, there were certainly some interesting targets and findings to discuss in the post meeting analysis.

I particularly wanted to post some thoughts and commentary on the ongoing Macrogenics story around margetuximab, an anti-HER2 antibody that binds with elevated affinity to both the lower and higher affinity forms of CD16A, an Fc receptor.

In our last review in February, we noted that the company “could miss on PFS and have to wait for OS down the road,” which wasn’t far off given the rather weak PFS benefit of 0.9 months announced on May 15th.

We finally got to see the initial SOPHIA data presented at ASCO this morning by Dr Hope Rugo (UCSF), so what did we learn?

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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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File under: intriguing binary events coming up of interest this quarter…

Source: BBC

There are a couple of phase 3 readouts likely due soon on two quite different oncology drugs in late stage development, namely Mirv and Marge, (aka mirvetuximab soravtansine and margetuximab).

For British readers, they remind me of Howard and Hilda Hughes (right) in the highly popular 1980’s comedy sitcom, lead by Richard Briers, Ever Decreasing Circles.

Aside from the fact that it’s an amusing historical analogy with more than a bit of whimsy, there are some strange parallels and hidden messages to be found here. For the record, the two characters had a penchance for wearing matching yet rather garish and ghastly jumpers.

You could either make a similar negative case for the rush from limited phase 2 data to pivotal registration study as for terribly ugly sweaters, with the reduced return on efficacy being alluded to from the show’s title.

The ripple effect – which way will it go?

Or on the other hand… the matchy matchy look could also play out the other way, in terms of positive forthcoming readouts validating phase 2 findings, so which case looks stronger overall for each agent?

To find out, we take a look at the history, what we know, and share our thoughts on how things might pan out – either way, major positive or negative outcomes can have a major ripple effect.

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We tend to think of the Fall cancer conference season as full of hope for new molecules showcasing encouraging yet early new data.  Rarely does negative data or unexpected trial glitches immediately jump to mind, although it unfortunately happens with startling regularity!

We’ve received a few enquiries and questions about an update on the Macrogenics platform recently.

The company have what they call a Dual-Affinity Re-Targeting (DART) program that includes bispecifics, mostly with CD3 as a standard co-stimulatory domain, although some are dual inhibitory checkpoints instead.

After writing about rather modest clinical efficacy with enoblituzumab monotherapy (anti-B7-H3 antibody) at the SITC 2015 meeting, I suspect that few of the attendees were envisioning an unexpected side swipe after this year’s event with one of their bispecific molecules, but so it came to pass.

As always, there’s a lot more to the central issue of ‘raised liver enzymes’ than meets the eye, so by popular reader request we walked through the issues and evidence to take a look at what’s behind this phenomenon…

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September 1st… as the hot summer floats away from London town and cooler autumn days draw in, it’s time to think about the upcoming fall cancer conference season – it’s quite a busy one this year!

In the coming weeks, I will be rolling out our series on the ESMO 2016 Previews (Twitter #ESMO16) and taking a more in-depth look at various topics of interest. The Copenhagen meeting is later than usual and also more compressed, with numerous sessions now held simultaneously. It used to be that you could take a break between key sessions, but not any more – there’s a lot going on this year.

View of Thames BarrierOne of the things that jumped out to me from a preliminary review of this year’s hectic ESMO program is an interesting novel target that had some early preclinical data at AACR, but that sadly got lost in the tsunami of data there.

It is good to have that reminder and be able to return to it in the context of broader data because overcoming barriers to drug resistance with targeted therapies is still an important issue that is worth researching.

You likely won’t see it in many analyst reports or previews, however, although it’s a hidden gem of great interest and well worth exploring in terms of what we know so far. This means that readers will be both prepared and intrigued – don’t be surprised to hear about some BD&L deals in this niche in the future.

Curious? Subscribers can go here now to get all the details…

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Iwakuni Bridge

Cherry Blossoms and Iwakuni Bridge

We’re continuing our countdown to the 2016 AACR annual meeting in New Orleans with a look at anti TIM-3 and LAG-3 inhibitory checkpoints and highlighting some of the companies with noteworthy abstracts.

In case you missed it, yesterday AACR announced that Vice President Biden will be delivering remarks on the final day of the meeting, Wednesday, April 20th in the “Highlights 2016: Vision for the Future” Plenary Session. As conference diehards, we will be there in person, but AACR have announced they plan to livestream it to the world. It’s a fitting finale to what is set to be a “must attend” meeting for those with an interest in cancer new product development and in particular, cancer immunotherapy.

What can we learn from AACR abstracts on TIM–3 and LAG–3?

There is some early clinical data that we will be checking out (no pun intended) on TIM-3 and LAG-3.

Subscribers can read Day 2 of our “Road to AACR 2016” coverage by logging in, or you can purchase access.

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SITC Day 4 Highlights

It’s been an interesting annual meeting at the Society for Immunotherapy of Cancer (SITC) so far and not without controversy either, as the reaction to Incyte’s IDO1 data demonstrated on Friday when combined with Merck’s pembrolizumab (sse post).

Today, we heard the results from another early trial with a novel immune target. This time it was the turn of Macrogenics, a local biotech based up the road in Rockville, Maryland.

They are developing a number of monoclonal antibodies to a variety of targets, including B7-H3. After the controversial late breaker session on Friday, how did their drug fare in the hotseat here in National Harbor this morning?

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