Idera’s troubled TLR program founders in PhII cancer study

Posted under autoimmune diseases, Blog, Clinical Trials, Companies, Diagnostics, Erbitux, Funding, head and neck cancer, Idera Pharmaceuticals, IMO-2055, Medical Devices, Medical Supply, Merck KgAA, Pharmaceuticals, Startups, TLR9, Universities, Videos by john

Cambridge, MA-based Idera Pharmaceuticals lost its big partner on toll-like receptor drugs when Merck KGaA backed out of its $421 million deal last year. This morning the biotech highlighted just how problematic the field is when it announced that the lead drug in that pact--IMO-2055--failed a mid-stage study in advanced head and neck cancer.

Investigators had been hunting signs of progression-free survival for patients in the study, which compared the results for patients taking the drug--a member of the toll-like receptor 9 (TLR9) family--in combination with Erbitux compared to Erbitux alone. Investigator patient assessments concluded the two arms achieved similar results, though an independent radiology review found that patients taking Erbitux alone experienced slightly longer PFS rates: 1.9 months compared to 1.5 months.

Merck KGaA wrote off its investment in the program last year after taking a close look at the depletion of white blood cells in patients as well as low electrolyte levels. But in handing back the rights, the pharma giant also agreed to see through the mid-stage study. Now Idera, which has seen its stock price ($IDRA) dwindle steadily since 2008, says it plans to hunt up new collaborators to pursue other cancer indications while it focuses on autoimmune diseases.

"Idera is focusing its development efforts on the drug candidates in our autoimmune disease program where we recently initiated a Phase II clinical trial of IMO-3100 in patients with psoriasis," says CEO Sudhir Agrawal. "Further, we are planning to submit an IND for IMO-8400 for the treatment of lupus in 2012." 

This isn't Idera's first taste of defeat on the TLR9 front. Novartis ($NVS) pulled out of a TLR9 pact with Idera for respiratory diseases back in 2009, two years after a program at Coley faltered in the clinic.  

- here's the press release

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Idera gets FDA green light for Phase II psoriasis drug test

UPDATED: Idera gets FDA green light for Phase II psoriasis drug test

Posted under Blog, Companies, Diagnostics, Funding, Idera Pharmaceuticals, IMO-3100, Medical Devices, Medical Supply, Merck KgAA, Pharmaceuticals, psoriasis, Startups, Universities, Videos by Mark Hollmer

Idera Pharmaceuticals ($IDRA) is ending the week with a second piece of positive news.

The Cambridge, MA-based drug developer disclosed Dec. 1 that the FDA has reversed a clinical hold on IMO-3100, which is designed to treat autoimmune diseases and inflammation. Based on a new study protocol, the FDA will allow it to proceed to a Phase II trial, now slated to begin during the first half of 2012.

Idera has been laying the groundwork for advancing IMO-3100 for months. The company sent the FDA an initial Phase II trial protocol back in July, which would test the novel dual-TLR antagonist in psoriasis patients over 12 weeks of treatment. The agency placed that plan on hold over various concerns. A new Phase II trial protocol submitted in October helped Idera gain the green light to proceed, with plans to test psoriasis patients over one month rather than three.

The drug is designed to block production of multiple cytokines induced through TLR7 and TLR9, genes that govern immune response.

The latest positive development--an early Christmas present of sorts for the company--comes after the developer said on Nov. 30 that it won back global rights to the oncology drug IMO-2055 from Merck KGaA, as part of the agreed-upon termination of its collaboration with the German company. The company's stock has been flat on today's news.

- here's the release

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Idera regains drug rights from Merck KGaA
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Merck KGaA nixes development of Idera Pharma cancer drug