Idera Pharmaceuticals Inc (NASDAQ: IDRA) is having an incredibly strong start to the trading session this morning after announcing strong Phase 1/2 clinical data. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (9:55), IDRA is trading at $2.22 per share after a gain of $0.27 per share or 13.85% thus far today.
IDRA Gains On Positive Clinical Data
As mentioned above, Idera Pharmaceuticals is having an overwhelmingly strong start to the week this morning after releasing strong data from a Phase 1/2 clinical trial. The results came from the dose-selection phase of the ongoing trial, designed to investigate IMO-2125.
The IMO-2125-ipilimumab dose-selection phase was conducted with 18 patients. According to the release, each of these patients progressed on nivolumab or pembrolizumab. These patients were treated with IMO-2125 at doses ranging from 4 mg to 32 mg in combination with standard dosing of ipilimumab. According to the press release offered by the company, there were no dose-limiting toxicities seen and the maximum tolerated dose was not reached. However, the 8 mg IMO-2125 dose has been chosen for further development upon acceptable safety, clinical activity, and evidence for target engagement on several biopsies of the injected tumor and a distant metastasis. Here are the key findings IDRA released with regard to the trial:
- Confirmed RECIST v1.1 response were observed in 4 of 9 subjects treated at the recommended dose of 8 mg.
- 6 out of the 9 patients treated at the 8 mg dose experienced disease control.
- IDRA said that a RECIST v1.1 PR of greater than 1 year duration is ongoing in patients treated with IMO-2125 4 mg.
- IMO-2125, when combined with ipilimumab, proved to be well tolerated at all dose levels studied.
- The treatment was also safely administered through the use of deep injection in patients lacking superficially accessible disease for injection.
In a statement, Adi Diab, M.D., lead trial investigator, assistant professor at the Department of Melanoma Medical Oncology, Division of Cancer Medicine at the University of Texas, MD Anderson Cancer Center, had the following to offer:
“The majority of patients with solid tumors do not respond to anti-PD-1 therapy and the published response rate to ipilumab alone in anti-PD-1 refractory melanoma is only 10-13%; to be seeing 6 out of 9 patients experiencing clear disease control is extremely exciting...”
This statement was followed up by Joanna Horbin, M.B., Ch.B., CMO at IDRA. Here's what she had to offer...
“Based on these positive and encouraging response data in anti-PD-1 refractory melanoma, where the greatest need exists, we have expanded the target number of patients in the ongoing Phase 2 expansion, including broadening eligibility to patients who have received prior ipilimumab, including ipilimumamb/PD-1 inhibitor combination... We plan to start a Phase 3 trial in patients with PD-1 refractory melanoma in the first quarter of 2018. Preparations are well-underway for this global initiative which is addressing a major unmet need in melanoma. We are very encouraged by the enthusiasm of investigators to participate in the Phase 3 study.”
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What We'll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on IDRA. In particular, we're interested in following the ongoing work surrounding IMO-2125 as the treatment seems to be overwhelmingly promising. Nonetheless, we'll continue to follow the story closely and bring the news to you as it breaks!
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