Biotech Strategy Blog

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

Posts tagged ‘IPI-145’

After looking at one important poster yesterday on multiple myeloma, it’s time to explore other equally interesting targets in other tumour types.

Some years reflect the inertia that hit oncology R&D with a lot of old data rehashed or they can be flooded with many me-too compounds.  Not this year, there’s a lot to talk about and review… so much so that we may well have enough for three rounds of Gems from the Poster Halls, time permitting as ASCO is fast approaching!

Without much further ado, for round 1 we have explored eight posters spanning four companies with a variety of different targets including chemotherapy, targeted therapies and immunotherapies.  I will say though, that the lines are being blurred as all of these modalities can impact the immune system, sometimes in unexpected ways.

What’s in store for today?  A focus on biotech companies doing intriguing cancer research.

Companies mentioned: Infinity, Innate, Incyte, Agenus

One of the things I most enjoy in cancer research is hearing wonderful patient stories from oncologists who are at the coal face of clinical trials. They get to deal with death and dying every day and like those in Pharma R&D, also live for the successes, the drugs that make it through pipeline despite great odds against them and make a meaningful impact on the daily lives of ordinary people.

We’ve all heard topline data presented at medical conferences around the world, but what the summary data can’t tell you is how a drug can impact people in ways that are clinically meaningful yet are more obtuse to capture in the aggregate. This is why case studies at CME sessions are increasingly popular, because they add value and context to common issues in a way that a Kaplan-Meier curve can never do.

Zydelig_logoWith the flurry of recent US and EU approvals for obinutuzumab (Gazyva), ibrutinib (Imbruvica) and the newest kid on the block, idelalisib (Zydelig), in CLL and indolent lymphomas, I wanted to take a look at these drugs from a different perspective.

A reader wrote in asking which of these new agents would emerge the winner and why?

Today’s post therefore offers some thoughts on the emerging CLL landscape now that we are shifting from new product development to the marketplace.

Drugs mentioned: Gazyva, Imbruvica, Zydelig, ABT–199/GDC–0199, Arzerra, IPI–145, CTL–019
Companies: Roche/Genentech, J&J/Pharmacyclics, Gilead, GSK, Infinity, Novartis

To learn more, you can sign up or sign in below.

Chronic lymphocytic leukemia (CLL) and indolent non-Hodgkins Lymphoma (iNHL) have received significant attention over the last two years. More exciting new therapies than ever before – with multiple different mechanisms of action – have either recently come to market or are in development. There is an ongoing revolution in the CLL landscape and treatment of the disease, which above all else is good news for patients! As part of our ongoing longitudinal coverage, there’s a lot to discuss and catch up on in Chicago at the annual meeting of the American Society of Clinical Oncology (ASCO).

What’s different at ASCO this year?

Basically, a LOT more data – it’s almost a tsunami considering this is ASCO and not the American Society of Hematology (ASH) annual meeting!  I am excited to see that there is so much new data at ASCO. Yesterday, we highlighted 3 key sessions for multiple myeloma. For CLL/SLL and iNHL there are 9 – to put the sheer breadth of data and studies in context. This includes ongoing phase 1-3 trials, as well as new randomised controlled phase 3 studies that are now open and enrolling patients. If successful, some of these latter studies will play a crucial part in future registration packages to the Health Authorities. In the past, we have talked extensively about CD19 antibodies such as obinutuzumab (Gazyva) and BTK inhibitors such as ibrutinib (Imbruvica). Both of these drugs are now approved and available in the US.

Other therapies in development we have covered in the past have included PI3K inhibitors delta (idelalisib) and delta, gamma (IPI-145), as well as Bcl2 inhibitors (ABT-199 / GDC-0199), SYK inhibitors (fostamatinib and GS-9973), and CAR T cell therapies such as CTL019. To find out more about our insights on the ever-changing CLL landscape, you can sign in or sign up below.

Now that the last of the 2013 cancer conference season is finally over, we’re going to run a couple of post meeting summaries this week from ASH as a few subscribers have asked for the Cliff Notes version of what was hot – or not in the context of the market.

New treatments for Chronic Lymphocytic Leukemia (CLL) was one of the hot topics at the recent annual meeting of the American Society of Hematology in New Orleans.

Hot on the heels of Roche’s recent FDA approval for Gazyva (obinutuzumab/GA101) in CLL, other companies in the race to market including:

  • Pharmacyclics and Johnson & Johnson (ibrutinib)
  • Gilead (idelalisib, GS-9973)
  • Infinity (IPI-145)
  • AbbVie and Roche (ABT-199/GDC-0199)
  • Novartis (CTL019).

Here’s my subjective and personal assessment of the winners and losers based on the data presented:

ASH for me always starts on a Saturday, as Friday is taken up with travel and a Super Friday corporate symposium, if any manage to catch our interest.

The start this year was somewhat disrupted by an ice storm that hit many southern states, causing considerable chaos for many ASH attendees – flights, hotels, bags, meetings, interviews, Ad Boards, investigator meetings, poster sessions and presentations etc.

I did enjoy the B cell malignancies CME session yesterday afternoon. Although it was sponsored by Gilead, it was well balanced and included discussion on FCR, ibrutinib, idelalisib, IPI-145, TGR-1202, ABT-199 and several earlier investigational compounds.

The highlight for me was Susan O’Brien’s thoughtful and philosophical talk on where are we going with CLL?

It’s an important question for physicians to start asking themselves with Gazyva approved in CLL, Imbruvica (ibrutinib) is pending in CLL and idelalisib expected to gain approval in 2014.

Originally, I was thinking of doing an in-depth review of lymphomas i.e. non-Hodgkin’s lymphoma (NHL), which involve 85% of lymphomas and Hodgkin’s lymphoma (HL), which take up the remaining 15%. This topic, however, has been largely done to death already.

There are are some very useful sources of carefully curated content that I enjoy following every year and in this post I’m going to direct you to some of those and highlight where I think the critical topics are in lymphomas.

Companies mentioned: Roche, GSK, AbbVie, Pharmacyclics, Gilead, Infinity, Seattle Genetics

Drugs mentioned: Rituxan, Arzerra, Gazyva, ABT-199, ibrutinib, idelalisib, IPI-145, Adcetris 

The chronic lymphocytic leukemia (CLL) landscape has been one of the most dynamic and exciting over the last 12 months, with many new therapies emerging against different targets from CD20 to BCR signaling, Bcl2 to the PI3K pathway. Other new targets may also soon emerge.

The annual meeting of the American Society of Hematology (ASH) in New Orleans sets the scene for the rollout of more mature data and affords an early evaluation of where the various companies competing in this space may shake out.  Given that we are moving beyond traditional chemoimmunotherapy to evaluate several newer classes of therapy including B cell receptor (BCR) and PI3K signaling, anti-CD20 antibodies, anti-CD19 chimeric antigen receptor T cell technology (CART) it looks to be shaking out to an exciting conference.

Companies mentioned: Roche/Genentech, Gilead, Pharmacyclics, Abbott, Celgene, Infinity, Incyte, ONO, Amgen, TG Therapeutics, Novartis

Products discussed: rituximab, bendamustine, obinutuzumab, idelalisib, ibrutinib, ABT-199, CC-292, GS-9973, IPI-145, ONO-4059, INCB40093, AMG 319, TGR-1202, CTL-019

In her annual preview video of what’s hot at ASCO 2013, Sally Church (@Maverickny) discusses several therapeutic areas with new data at the meeting including:

  • Immunotherapy (PD-1, PD-L1, CTLA-4)
  • CLL (GA-101, idelalisib, IPI-145)
  • Breast Cancer (palbociclib, PF-05280014)
  • Lung Cancer (LDK-378, AP26113)
  • Pancreatic Cancer (Abraxane, TH-302)

This video was originally published on Pharma Strategy Blog and includes an edited mechanism of action (MOA) for PD-L1 (courtesy of Roche/Genentech). Several people have since remarked it’s the first time they fully understood what “upregulation” meant.

If you missed the video, it’s well worth watching again in the run up to ASCO 2014.

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