Kiromic BioPharma Announces FDA Authorization of IND to Initiate Phase 1 Clinical Trial Evaluating Deltacel in Non-Small Cell Lung Cancer
Company Expects Beginning of First in Human Trial Activation in Second Quarter of 2023
Deltacel is Being Developed to Treat Solid Malignancies, Which Comprise 90% of All Cancers
Deltacel is the Company’s allogeneic, non-engineered, off-the-shelf Gamma Delta T-cell (GDT) therapy. Notably, Deltacel does not require the use of any viral vector as many other cell therapies do, which, among other advantages, allows for reduced manufacturing costs. Kiromic is seeking to address a significant unmet need by applying cell therapy to treat solid malignancies, which comprise 90% of all cancers, including NSCLC. Lung cancer is by far the leading cause of cancer death in the US, accounting for about 1 in 5 of all cancer deaths. Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined.
“Receiving the authorization from the FDA to administer Deltacel to patients enables us to advance our GDT therapy candidate into the clinic. As a potentially well tolerated and effective treatment, we look forward to the opportunity for Deltacel to have a meaningful impact on the hundreds of thousands of patients with non-small cell lung cancer and with other solid cancers,” stated
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
Global Head, Corporate Communications
LHA Investor Relations