HOUSTON - Kiromic BioPharma, Inc. (OTCQB: KRBP) has reported stable disease and favorable safety outcomes in the first cohort of its phase 1 clinical trial for Deltacel, an investigational cancer treatment. The therapy, aimed at stage 4 metastatic non-small cell lung cancer (NSCLC), has shown consistent results in follow-up visits, with one patient experiencing a 6.6% tumor size reduction two months post-treatment.
Two patients from the initial group continued to demonstrate stable disease two months after completing treatment, with one patient's imaging scans indicating no brain metastases. The four-month follow-up for these patients is expected in June 2024.
Based on these preliminary results, Kiromic plans to apply for FDA Fast Track Designation (FTD) by the end of the second quarter, which could expedite the drug's review process. FTD allows for more frequent FDA communication and may qualify the drug for Accelerated Approval and Priority Review.
The first patient cohort received two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. The trial's primary objective is to evaluate safety, with secondary measures including response and survival rates.
Deltacel (KB-GDT-01) is an allogeneic Gamma Delta T-cell therapy, part of Kiromic's platform targeting solid tumors, with a focus on NSCLC. Preclinical studies have supported its safety and efficacy profile.
The Beverly Hills Cancer Center (BHCC), where the trial is being conducted, has expressed optimism regarding the initial safety and efficacy observed. Medical Director Dr. Afshin Eli Gabayan highlighted the importance of these early signs of response and tolerability.
Kiromic, a clinical-stage biotherapeutics company, leverages its proprietary artificial intelligence engine in developing cell therapies focusing on immuno-oncology.
This news is based on a press release statement from Kiromic BioPharma. The company cautions that the press release contains forward-looking statements subject to risks and uncertainties, and actual results may differ materially.
InvestingPro Insights
Kiromic BioPharma's recent announcement on the progress of its Deltacel treatment in clinical trials has drawn attention to the company's potential in the field of immuno-oncology. Amidst this development, InvestingPro data highlights a market capitalization of $3.4 million USD for KRBP, indicative of its small-cap status in the biopharmaceutical sector. Despite the promising clinical outcomes, the company's financial metrics paint a challenging picture, with an adjusted P/E ratio for the last twelve months as of Q4 2023 standing at -0.16, suggesting that the company has yet to reach profitability.
InvestingPro Tips reveal that Kiromic BioPharma operates with a significant debt burden and is quickly burning through cash, which are crucial considerations for investors. Furthermore, the company's stock generally trades with high price volatility, a factor that could influence investment decisions amid the latest clinical updates. With a total of 15 additional tips listed on InvestingPro, investors can gain more in-depth insights into the company's financial health and market performance.
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