Phase 2 Clinical Trial Opportunity

yOU can see further info on this trial at: http://forum.melanomainternational.org/mif/viewtopic.php?f=54&t=36528&p=52312#p52312

Hey Edster, 

Yes, IMO-2125 is an intratumoral injection…and this study is combining that injection with either pembro or ipi given IV as usual.  Here is a really slick slide presentation from the company:

http://www.iderapharma.com/wp-content/uploads/2016/11/IMO-2125-An-Investigational-Intratumoral-Toll-Like-Receptor-9-Agonist-Modulates-the-Tumor-Microenvironment-to-Enhance-Anti-Tumor-Activity.pdf  

It is far easier to find out info from the company about their drug being fast tracked and the recruitment they are doing for the two arms of their upcoming trial….with ipi or with pembro….than it is to learn what was actually found in the phase 1 study.  Pretty much the only thing is the flashy poster presentation from MDAnderson/Idera linked above.

There is this link:

https://globenewswire.com/news-release/2017/06/22/1028282/0/en/Idera-Announces-FDA-Orphan-Drug-Designation-for-IMO-2125-for-the-Treatment-of-Melanoma.html

Which states in part:  "Idera is currently conducting the Phase 2 portion of the ipilimumab combination arm of a Phase 1/2 clinical trial of intratumoral IMO-2125 in patients with anti-PD-1 refractory metastatic melanoma.  The objectives of the current trial are to evaluate IMO-2125’s safety, tolerability and clinical activity. The company expects to complete enrollment of the Phase 2 multicenter trial in the second half of 2017 with overall response rate (ORR) data available in the first quarter of 2018.  The company has submitted an abstract to provide an update of clinical data from the ongoing trial at the European Society of Medical Oncology (ESMO) Congress being held in September, in Spain.

“The Orphan Drug Designation bestowed by the FDA today, represents another important step in the development of IMO-2125,” stated Joanna Horobin, M.B. Ch.B., Idera’s Chief Medical Officer.  “A substantial proportion of patients with metastatic melanoma do not benefit from anti-PD-1 therapy.  For these patients, with PD-1 refractory melanoma, ipilimumab offers a modest benefit with an overall response rate of 10-13%1,2.  Our goal is to significantly improve on this through the combination of IMO-2125 with ipilimumab.  We are increasingly encouraged with the data seen to date and look forward to providing our next clinical data update.”

Idera is also enrolling a second arm in the Phase 1/2 clinical trial in patients with PD-1 refractory melanoma to study the combination of IMO-2125 and pembrolizumab which is currently in the dose escalation phase.

In addition to the above mentioned clinical trial, the company recently initiated a trial of IMO-2125 monotherapy in refractory solid tumors, including PD-1 refractory melanoma.

Orphan Drug Designation is granted by the FDA Office of Orphan Products Development to drugs intended for the treatment of a rare disease or condition that affects fewer than 200,000 people in the United States. This designation provides certain incentives, including eligibility for federal grants, research and development tax credits, waiver of PDUFA filing fees and a seven-year marketing exclusivity period, once the product is approved and as long as orphan drug designation is maintained.

The approval of an orphan drug designation request does not alter the standard regulatory requirements and processes for obtaining marketing approval of an investigational drug. Sponsors must establish safety and efficacy of a compound in the treatment of a disease through adequate and well-controlled studies.

About the Phase 1/2 trial of IMO-2125 in PD-1 Refractory Melanoma
The Phase 1/2 trial of intratumoral IMO-2125 in combination with ipilimumab or pembrolizumab is being conducted in patients who are refractory to anti-PD-1 therapy.  The phase 1 portion of the trial was conducted at MD Anderson Cancer Center and the phase 2 portion of the trial is being conducted at multiple clinical sites.  In the Phase 1 arms of the trial, four dose levels of IMO-2125 (4, 8, 16 and 32 mg) have been administered intratumorally in one selected lesion at weeks 1, 2, 3, 5, 8 and 11, in combination with the standard dosing regimens of ipilimumab or pembrolizumab, beginning on week 2.  The Phase 2 expansion portion of the trial utilizes a Simon two-stage design. If at least 2 of the first 10 patients treated at the Phase 2 dose experience confirmed response the futility hurdle has been met and the trial may continue to enroll. Phase 2 will evaluate 21 patients at the phase 2 dose. Tumor biopsies have been collected pre- and post-24 hours of the first dose of IMO-2125, as well as at 8 and 13 weeks to evaluate multiple immune markers.  Clinical activity has been evaluated by the RECIST v1.1 criteria."  

Hope it works fabulously!!!  We certainly need additional treatment options for those who do not attain the relief they need from existing therapies.  However, thus far, I have seen nothing that indicates it will be better than the current intralesionals (like CAVATAK, T-VEC, PV10, etc) already being combined with immunotherapy.  But, hey!  I would love it if all these dogs will hunt!!

Wish I could share a Timmy with you today!!!  love, c

Hi Bubbles, they started putting the # of calories signs beside the Tim Bits and each one = 90 cals. They are trying to take all the fun out of my mornings, so I still buy the coffee but have cut out the Tim Bits!!!  Thank's Adam for the links, it looks like they are targeting people who fail Pd-1 drugs and are trying to give Ipi % a kick as a second line treatment. I hope the early data for the 9 patients holds up in the larger trial.