Agios Pharmaceuticals, Inc. (Agios): During 2010, we entered into a discovery and development collaboration and license agreement with Agios that focuses on cancer metabolism targets and the discovery, development and commercialization of associated therapeutics. We have an exclusive option through the end of phase I clinical trials to license any potential products that result from the Agios cancer metabolism research platform.
With respect to each product that we choose to license, Agios could receive up to approximately $120.0 million upon achievement of certain milestones and other payments plus royalties on sales, and Agios may also participate in the development and commercialization of certain products in the United States. Our option to license a product will terminate on April 14, 2015.
In June 2014, we exercised our option to license AG-221 from Agios on an exclusive worldwide basis, with Agios retaining the right to conduct a portion of commercialization activities for AG-221 in the United States. AG-221 is currently in a phase I study in patients that harbor an IDH2 mutation with advanced hematologic malignancies, including acute myeloid leukemia (AML).
You have been wrong over / over and over and you stated you are done here but you are back. WHY? Oh you nevr left you have other id as well
The terms of the non-tradable CVR include an additional payment of up to $2.00 if certain sales milestones are achieved. The CVR will entitle each Trius stockholder to receive $1.00 per share if net sales of tedizolid in the U.S., Canada and Europe are greater than or equal to $125 million in 2016 and up to an additional $1.00 per share, paid on a pro rata basis, for 2016 net sales between $125 million and $135 million.
RESULTS:Since study start in September 2013, 48 patients have been dosed and 27 are on study drug as of July 24, 2014. Parallel BID and QD cohort regimens are ongoing at doses up to 150 mg and 200 mg, respectively.
Therapy has been well tolerated and the MTD has not yet been reached. The majority of adverse events reported have been grade 1 and 2. There have been 9 deaths and 8 within the first 28 days of receiving AG-221. One death reported as possibly related to study drug in a subject with severe pneumonia. Eight subjects have had 11 SAEs reported as possibly related to study drug.
Preliminary PK analysis of the 30 mg through 75 mg BID and 100 mg QD doses demonstrated excellent exposure to AG-221, high accumulation after multiple doses, and a mean plasma half-life 40 hours. PD evaluation demonstrated sustained plasma 2-HG inhibition up to 97% in R140Q subjects and up to 50% in R172K subjects after multiple doses.
As of July 24, 2014, 48 subjects have been enrolled: 32 are evaluable for efficacy (having had a Day 28 bone marrow), 8 discontinued study prior to Day 28, and 8 are on study but prior to a Day 28 bone marrow assessment. Investigator-assessed objective responses have been observed in 20 subjects (8 CR, 1 CRp, 3 CRi and 8 PR). Five subjects had stable disease and remain on AG-221. Seven subjects have had progressive disease. Responses are durable, including complete remissions of up to 4.5 months and ongoing with subjects on study as long as 8 cycles (1 cycle = 28 days). Five subjects who achieved a CR went on to bone marrow transplantation. Additional and updated safety, PK/PD and efficacy data from the enrolled subjects will be presented.
CONCLUSION: AG-221, a potent, selective, oral inhibitor of mutated IDH2, is well tolerated in patients with advanced hematologic malignancies, and triggers the differentiation of leukemic blast cells that ultimately leads to objective durable responses, including complete remissions. These data provide continued validation of mutant IDH2 as a therapeutic cancer target.
The FDA's Oncologic Drugs Advisory Committee voted 5-2 against the drug, called panobinostat, noting its demonstrable benefits for patients with blood cancer but ultimately concluding that its side effects were too severe to warrant approval. In its pivotal trial, Novartis' treatment helped extend progression-free survival (PFS) by 3.9 months compared to placebo, but not without serious safety concerns. Seven percent of patients in the panobinostat arm died from non-cancer complications compared to just 3.5% in other group, alarming toxicity that outweighed the drug's benefit, panelists said.
He said GPRO going to 90 yesterday. Dropped 7 points and down 13 since he said it
go buy IBM knucklehead.... You have no clue about biotech investing. Name one co whose phase one trial saved lives. You need an education on Breakthrough Designation? I have been with PCYC since 7 and heard from posters like you to this day about PCYC. Hint. I gave you the answer.
Oh just to mention I'm averaged in at 49.45 and plan on selling above 15 billion mkt cap or higher
as long as drug is well tolerated there is no reason to sell. Since current and new patients will be on the drug for some time this will be easy to track.
all which need to be in combo therapy with what? Oh you may be clueless. ABT 199 has been coming into conversations for years and fails in comparison year after year
AGIOS is worth a lot more and CELG can pay it. Stock, cash and CVR. AGIOS could be bought for 6 billion and much higher depending on future data of solid tumors.