Firm will continue a Phase II SCCHN study with partial reimbursement from Idera.
Merck KGaA has terminated its oncology deal with Idera Pharmaceuticals that covered toll-like receptor 9 (TLR9) agonists including clinical-stage IMO-2055. The decision was made in July, and Idera has now regained global rights to the program.
During their collaboration, Merck conducted Phase I trials in several cancers, including a study evaluating IMO-2055 in combination with Erbitux®, cisplatin, and 5-fluorouracil for the first-line treatment of squamous cell cancer of the head and neck (SCCHN). The trial was terminated after data showed that treatment with IMO-2055 plus cisplatin/5-fluorouracil and Erbitux was associated with increased neutropenia and electrolyte imbalances as compared to a clinical trial of cisplatin/5-fluorouracil and Erbitux.
Merck KGaA has an ongoing randomized Phase II trial evaluating IMO-2055 in combination with only Erbitux in patients with SCCHN. “Under our termination agreement with Merck KGaA, Merck KGaA will continue to conduct the ongoing Phase II trial in patients with SCCHN, and Idera will have rights to the data as well as to the data from Phase I trials conducted in other cancer indications,” explains Sudhir Agrawal, chairman and CEO of Idera.
Idera has agreed to reimburse approximately €1.8 million of Merck’s expenses during the course of the ongoing Phase II trial. The company expects to make the payment over the course of approximately 12 months starting March 2012.
Idera will also pay Merck milestone fees of €1 million each upon entering into any future partnership for IMO-2055, initiating the next Phase II or Phase III trial with this compound, and submitting marketing applications in any country.
Idera and Merck initiated their partnership for IMO-2055 and follow-on TLR9 agonists in December 2007. Merck paid an up-front license fee of €28 million and agreed to milestones totaling €264 million as well as royalties.
In February 2009, Idera earned its initial milestone fee of €3.0 million upon the dosing of the first patient in a clinical study of IMO-2055 in combination with Erbitux and Camptosar® in patients with colorectal cancer. In January 2010, the firm obtained €3 million, triggered by Merck’s initiation of the Phase II trial in SCCHN.
Commenting on the return of rights to the TLR9 agonist program, Dr. Agrawal notes, “We believe that regaining our rights to IMO-2055 as well as the rights to the clinical data will provide us greater flexibility and control in the clinical development of IMO-2055 and the opportunity to pursue new business collaborations.”
Currently, IMO-2055 is in a Phase Ib trial in combination with Tarceva® and Avastin® in patients with advanced non-small-cell lung cancer (NSCLC). Thirty-six patients have been recruited in this trial, and data analysis is ongoing.
IMO-2055 is also in a Phase Ib trial in combination with Erbitux and FOLFIRI in patients with metastatic colorectal cancer. Twenty-two patients have been recruited, and data analysis is ongoing.
The ongoing SCCHN Phase II trial is being conducted in combination with Erbitux as a second-line treatment in patients with recurrent and/or metastatic SCCHN. Idera says that the study is fully enrolled, and patient treatment and follow-up are ongoing.
Merck has conducted a Phase I trial to evaluate safety and dose-dependent pharmacokinetics and pharmacodynamics of IMO-2055 after three weekly doses by subcutaneous or intravenous administration.