- Available Translational Data Continue to Demonstrate Correlation between Proliferation and Clonal Expansion of T-Cells to Clinical Responses -
- An additional 5th Unconfirmed RECIST v1.1 Response Observed in 10th Evaluable Patient from Ongoing IMO-2125 8mg Phase 2 Dose Expansion Cohort -
In the oral presentation entitled, “TLR9 agonist harnesses innate immunity to drive tumor-infiltrating T-cell expansion in distant lesions in a Phase 1/2 study of intratumoral IMO-2125 plus ipilimumab in anti-PD-1 refractory melanoma patients,”
Key Highlights to be Presented Include:
- IMO-2125 induces a strong Type 1 interferon gene signature, macrophage influx and robust dendritic cell (DC) maturation post-injection;
- Combination therapy induces CD8+ T-cell proliferation and activation that is preferential to the tumor;
- The hallmark of observed tumor shrinkage appears to be the presence of Ki67+ CD8+ T-cell effector cells in the distant/un-injected tumor;
- Major T-cell clones expanding on therapy in responding patients are shared between local/injected and distant/un-injected lesions, indicating that priming/reactivation is to a shared antigen;
- Additionally, the company announced that since the last clinical data update provided at the
European Society of Medical Oncology Conferencein September, an additional (5th) unconfirmed RECIST v.1.1 response has been observed in the 10th evaluable patient to date.
“These important translational findings continue to strengthen our understanding of the critical role of intratumoral IMO-2125 therapy in the priming of T-cells and activation of the tumor microenvironment to produce durable tumor shrinkage when administered with ipilimumab in patients with anti PD-1 refractory metastatic melanoma,” stated
A copy of the oral presentation as well as a related poster will be available
About the Phase 1/2 trial of IMO-2125 in combination with ipilimumab (NCT02644967)
Study 2125-204 is a Phase 1/2 open-label study of intratumoral IMO-2125 given in combination with either ipilimumab or pembrolizumab to patients with PD-(L)1 refractory melanoma with a planned enrollment of approximately 90 patients. IMO-2125 is given in escalating dosages from 4 to 32 mg combined with either ipilimumab (3 mg/kg i.v. every 3 weeks for 4 doses) or pembrolizumab (2 mg/kg i.v. every 3 weeks). Study endpoints are safety, tumor response, pharmacodynamics, and pharmacokinetics. Serial biopsies of both the injected and a distant tumor are being performed for translational immunologic studies. Preliminary data, presented at
IMO-2125 is a toll-like receptor (TLR) 9 agonist that received orphan drug designation from the
About Metastatic Melanoma
Melanoma is a type of skin cancer that begins in a type of skin cell called melanocytes. As is the case in many forms of cancer, melanoma becomes more difficult to treat once the disease has spread beyond the skin to other parts of the body such as the lymphatic system (metastatic disease). Because melanoma occurs in younger individuals, the years of life lost to melanoma are also disproportionately high when compared with other cancers. Although melanoma is a rare form of skin cancer, it comprises over 75% of skin cancer deaths.
Harnessing the approach of the earliest researchers in immunotherapy and the company’s vast experience in developing proprietary immunology platforms, Idera’s lead development program is focused on priming the immune system to play a more powerful role in fighting cancer, ultimately increasing the number of people who can benefit from immunotherapy. Idera continues to invest in research and development, and is committed to working with investigators and partners who share the common goal of addressing the unmet needs of patients suffering from rare, life-threatening diseases. To learn more about Idera, visit www.iderapharma.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding the Company's strategy, future operations, collaborations, intellectual property, cash resources, financial position, future revenues, projected costs, prospects, plans, and objectives of management, are forward-looking statements. The words "believes," "anticipates," "estimates," "plans," "expects," "intends," "may," "could," "should," "potential," "likely," "projects," "continue," "will," and "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Idera cannot guarantee that it will actually achieve the plans, intentions or expectations disclosed in its forward-looking statements and you should not place undue reliance on the Company's forward-looking statements. There are a number of important factors that could cause Idera's actual results to differ materially from those indicated or implied by its forward-looking statements. Factors that may cause such a difference include: whether interim results from a clinical trial, such as preliminary results reported in this release, will be predictive of the final results of the trial, whether results obtained in preclinical studies and clinical trials will be indicative of the results that will be generated in future clinical trials, including in clinical trials in different disease indications; whether products based on Idera's IMO-2125 will successfully advance through the clinical trial process on a timely basis or at all and receive approval from the
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Source: Idera Pharmaceuticals, Inc.