Kiromic BioPharma Reports Favorable Early Safety and Tolerability Data from First Patient Enrolled in the Phase 1 Deltacel-01 Clinical Trial

HOUSTON--(BUSINESS WIRE)-- Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”), a clinical-stage, fully-integrated biotherapeutics company using its proprietary DIAMOND^® artificial intelligence and data mining platform to develop cell therapies with a focus on immuno-oncology, reports favorable safety and tolerability from the first patient 23 days after Deltacel™ infusion in the Phase 1 clinical trial for treatment of stage 4 metastatic non-small cell lung cancer (NSCLC) at Beverly Hills Cancer Center, located in Beverly Hills, California, USA. Specifically, laboratory test results and observations by clinical staff identified no adverse events and confirmed that Deltacel is being well tolerated with initial safety profile. Continued monitoring of safety and tolerability will provide more insights as the trial enrolls additional patients.

Kiromic expects to report preliminary efficacy results from this patient by the end of January 2024. Two more patients are expected to be enrolled between January and February 2024.

“Our first-in-human clinical trial of Deltacel is proceeding very well and on plan,” said Pietro Bersani, Chief Executive Officer of Kiromic. “With no adverse events observed during the first 23 days post-treatment, we have strong indication that Deltacel is well tolerated. We look forward to discussing updates with members of the investment community during our meetings next week in San Francisco, concurrent with the 42^nd Annual J.P. Morgan Healthcare Conference.”

Investment professionals interested in meeting with Mr. Bersani, Chief Financial Officer Brian Hungerford and Chief Scientific Officer Dr. Leonardo Mirandola at LHA’s offsite event being held January 8-10 should contact Tirth Patel at tpatel@lhai.com.

“We are very pleased to see favorable initial safety and tolerability data from the first patient treated in our Deltacel-01 study,” said Dr. Afshin Eli Gabayan, Medical Oncologist, Medical Director, and Principal Investigator at Beverly Hills Cancer Center. “Seeing no adverse events reported 23 days after Deltacel infusion provides early validation that this novel cell therapy is well tolerated when combined with low dose radiation for lung cancer patients. We look forward to further evaluating optimal dose level, efficacy, and long-term safety outcomes as additional patients are enrolled and treated. If this promising initial data is replicated in more patients, Deltacel could become a new alternative treatment option for NSCLC patients.”

About Deltacel-01

In Kiromic’s open-label Phase 1 clinical trial, titled “Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer” (NCT06069570), patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the study is to evaluate safety, while secondary ones include objective response, progression-free survival, overall survival, time to progression, time to treatment response and disease control rates.

About Deltacel^™

Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is the leading candidate in Kiromic’s GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial focus on NSCLC, the most prevalent type of lung cancer and representing about 80% to 85% of lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.

About Kiromic BioPharma

Kiromic BioPharma, Inc. is a clinical-stage, fully integrated biotherapeutics company using its proprietary DIAMOND^® artificial intelligence (AI) 2.0 target discovery engine to develop and commercialize cell therapies focusing on immuno-oncology. Kiromic is developing a multi-indication allogeneic cell therapy platform that exploits the natural potency of Gamma Delta T-cells to target solid tumors. Kiromic’s DIAMOND^® AI is where data science meets target identification to dramatically compress the years and hundreds of millions of dollars required to develop a live drug. The Company maintains offices in Houston, Texas. To learn more, visit www.kiromic.com and connect with us on Twitter and LinkedIn.

About Beverly Hills Cancer Center

As a private, academic, community-based cancer center, Beverly Hills Cancer Center not only provides the latest state-of-the-art cancer treatments all under one roof, but also provides leading clinical trials and research, attracting patients globally. By providing access to groundbreaking clinical trials, the Beverly Hills Cancer Center offers patients the opportunity to participate in the most advanced cancer treatments currently in development in the world. Beverly Hills Cancer Center is composed of an internationally recognized multidisciplinary medical team consisting of Medical Oncologists, Radiation Oncologists, Radiologists, Hematologists and Internists who provide exceptional patient care and support services including a robust and highly efficient team of clinical research professionals. More information is available on: www.BHCancerCenter.com.

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Kiromic makes such forward-looking statements pursuant to the safe harbor provisions of the United States Private Securities Litigation Reform Act, Section 21E of the Securities Exchange Act of 1934, as amended, and other federal securities laws. All statements other than statements of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as: “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements regarding: Kiromic’s ability to achieve its objectives and Kiromic’s financing strategy and availability of funds. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in our Annual Report on Form 10-K for the year ended December 31, 2022, and as detailed from time to time in our other SEC filings. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. Such forward-looking statements relate only to events as of the date of this press release. We undertake no obligation to update any forward-looking statements except to the extent required by law.

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