Mirror Biologics, Inc., specializing in development and manufacturing of immunotherapy products where the active ingredient is living, non-genetically altered, allogeneic (“off-the-shelf”) immune cells, announces that it has entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany. The parties will collaborate to conduct a Phase II clinical trial to evaluate the combination of an experimental immunotherapy drug, AlloStim® from Mirror, and an immune checkpoint inhibitor (ICI), avelumab (BAVENCIO®) from Merck KGaA, Darmstadt, Germany, in fourth-line metastatic colorectal cancer: NCT06557278.

Colorectal cancer (CRC) is the third most common cancer and the second most common cause of cancer deaths worldwide. In 2023, approximately 153,020 individuals were diagnosed with CRC and 52,550 died from the disease in the United States. There were more than 1.9 million new CRC cases and 0.9 million deaths reported worldwide in 2020. CRC incidence is increasing, and it is estimated that the number of CRC patients worldwide could reach 2.5 million by 2035. There is a high unmet medical need to provide additional treatment options that could potentially extend life with quality for advanced metastatic CRC patients.

ICI drugs have revolutionized the treatment and prognosis for several solid tumor types. The tumor types most susceptible to ICI are tumors characterized as immunologically ‘hot,’ meaning those that have high numbers of infiltrating anti-tumor immune cells. However, most solid tumors and almost all CRC tumors are immunologically ‘cold,’ having no infiltrating immune cells, making them refractory to ICI immunotherapy. This collaboration intends to use experimental AlloStim® to attempt to convert ICI-unresponsive CRC tumors into ICI-responsive tumors. If successful, this could provide a new treatment option for these patients.

The combination of experimental AlloStim® and ICI has previously resulted in a rare objective tumor response in a patient with metastatic CRC, which has provided the rationale for further exploration of this combination in this indication: see: Objective response after immune checkpoint inhibitors in a chemotherapy-refractory pMMR/MSS metastatic rectal cancer patient primed with experimental AlloStim® immunotherapy.

Dr. Michael Har-Noy, Founder and Chief Medical Officer of Mirror Biologics stated: “We are pleased to enter into this clinical collaboration with Merck KGaA, Darmstadt, Germany, evaluating the potential of investigational AlloStim® in combination with avelumab in patients who are suffering from advanced metastatic colorectal cancer. These patients have limited treatment options and are refractory to immunotherapy. The investigation of combination therapies may uncover additional possibilities for these patients. We look forward to working with Merck KGaA, Darmstadt, Germany to explore how we can bring the potential of immunotherapy to more patients.”

Under the terms of the agreement, Mirror Biologics will be the sponsor of the clinical study, and Merck KGaA, Darmstadt, Germany will supply avelumab for the study. The Phase II open-label study is expected to accrue up to 50 patients with metastatic CRC who are both chemotherapy- and immunotherapy-refractory and who have failed at least one third-line, non-chemotherapy treatment (e.g., regorafenib, TAS-102 with or without bevacizumab or fruquintinib). The clinical study will be conducted at approximately 10 sites in the USA.

 

Source: globenewswire.com

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