INmune Bio Inc. (NASDAQ:INMB) saw its stock jump 28% on Monday after announcing that its Phase I/II trial evaluating INKmune™ in patients with metastatic castration-resistant prostate cancer (mCRPC) successfully met both its primary and secondary endpoints. With enrollment now closed, the company is preparing for the next phase of development.
The CaRe PC trial, conducted by the clinical-stage biotech focused on immunology and inflammation, tested three different dose levels of INKmune™. The treatment demonstrated a strong safety profile across all dose groups, fulfilling the trial’s primary endpoint. Additionally, the company noted that patients with initially low levels of natural killer (NK) cell activation showed the most significant gains in NK activation biomarkers, helping pinpoint the ideal patient group for future studies.
“INKmune was safe and effective at activating NK cells in a subset of more than half of these patients with advanced disease,” said Dr. Mark Lowdell, Chief Scientific Officer at INmune Bio. “Excitingly we did see, in some patients, individual tumor lesions either reducing in size or completely disappearing during treatment, so we believe this could be evidence of a direct effect on tumor cell killing.”
Building on these encouraging findings, the company now plans to design a randomized Phase 2b trial, focusing on patients with less advanced forms of the disease. The goal is to better assess the therapeutic impact and potential clinical outcomes in a population where effects may be more easily measurable.
Following the announcement, investors responded positively, sending shares sharply higher as optimism grew around the future of the INKmune™ program and its potential role in prostate cancer treatment.
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