Biotech Strategy Blog

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

Posts tagged ‘AG-221’

The 2016 annual meeting of the American Society of Hematology with over 27, 000 attendees, a record high, was the venue for the announcement of a major new initiative by the Leukemia Lymphoma Society (LLS), called Beat AML.

It is lead by three well respected researchers in the Hematology/Oncology field:

  • Dr John Byrd (Ohio State)
  • Dr Brian Druker (OHSU)
  • Dr Ross Levine (MSK)

Beat AML is a special project at LLS, who have developed a broad collaboration with academic researchers, pharmaceutical companies, a genomic provider, and a clinical research organization:

 

Source: LLS

Initially, there will be five trial sites, which will each offer all arms of the trial. The centers are:

  • Memorial Sloan Kettering Cancer Center in New York
  • The Ohio State University Comprehensive Cancer Center in Ohio
  • OHSU Knight Cancer Institute in Oregon
  • Dana-Farber Cancer Institute and
  • Massachusetts General Hospital Cancer Center, both in Massachusetts.

Further sites and (hopefully) also other drugs from pharma companies will be added in due course, so if you’re interested in joining this project, do contact them after checking out more details here!

For our industry readers, this would be a great opportunity to get involved in an exciting and landmark study for AML, whether you are a researcher or a company with a promising drug in early development. These types of trials can help speed up drug development if a therapy graduates in a particular subset.

Here, we offer an in-depth analysis of the scientific and clinical rationale behind this important landmark study and the targets/drugs selected to date.

BSB also spoke with Dr Brian Druker, Director of the Oregon Health and Science University (OHSU) Knight Cancer Institute in Portland, Oregon, who offers additional insights on the special project.

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Acute Myeloid Leukemia (AML) is usually a disease of the elderly and an area of high unmet medical need, especially in those who unfortunately relapse post stem cell transplantation (SCT) or are considered ineligible for a transplant. In some ways, it has languished in the graveyard of R&D with very few new therapies approved by the FDA or EMA over the last decade. In fact, it has been quite the opposite with Pfizer’s gemtuzumab ozogamicin (Mylotarg), an anti-CD33 antibody drug conjugate (ADC) approved and subsequently withdrawn from the US marketplace following lack of confirmatory phase III data.

The list of agents, targeted and and cytotoxics, that have been evaluated and found wanting in the elderly AML setting is very long. These patients are usually considered ineligible for transplant and rather challenging to treat given the concomittant co-morbidities and often frail performance status often exclude them from drug clinical trials also. A number of phase II trials have also generated promising efficacy data, only to fall short in larger randomised studies.

There are now a new raft of compounds in development, quite a few with data at ASCO or EHA, making it a suitable time for an update of the AML landscape.

Companies mentioned: Karyopharm, Astellas, Ambit, Arog, Sunesis, Celgene, Novartis, Genentech, Agios
Compounds mentioned: selinexor, ASP2215, crenolanib, quizartinib, trebananib, vosaroxin, Vidaza, midostaurin, ABT-199, GDC-0199, AG–221, TIM3.

To read more about our insights and review of the AML data at ASCO, you can log-in to read the full article.

To round off our series of post AACR reviews this week (there will be more coming next week as well, don’t worry), I wanted to look at some interesting non-immunotherapeutic agents that I found compelling and worth watching out for in the future.

A couple of things to remember or understand is that AACR is a very different conference from ASH and ASCO, aside from the presence of noticeably more science:

a) Much of the data presented at this meeting is either preclinical or phase I-II cinical data
b) Most of these studies are usually exploratory or preliminary in nature

Phase I trials are usually designed to evaluate dose finding in either a single agent or with an untested and untried combination. Investigators are interested in a number of key things here, which might include:

  • Maximum tolerated dose (MTD)
  • Dose limiting toxicities (DLT)
  • A recomemmended phase II dose (RP2D)
  • PK and PD
  • General tolerability assessment.

Sometimes a different formulation is tested, in which case bioavailabity is also important. To be expressly clear though – any efficacy signals seen are a bonus. That’s the main purpose of phase II trials.

That said, one of the things I most like about AACR is the early phase I data in new targets or data that explains why resistance develops as an adaptive response to therapy.  With these in mind, here are three excellent examples from well put together research from the meeting that we can learn a lot from.

To read more about our analysis of up and coming compounds including:

DEDN6526A, a novel ADC in melanoma; AG–221 in IDH2 mutant AML and MDS; a PI3K-α isomer-specific inhitor, BYL719, and the impact of PTEN alterations

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