Non–Small Cell Lung Cancer Cell Therapy Receives FDA IND Clearance

Kiromic BioPharma’s KB-GDT-01 (Deltacel), an investigational allogeneic gamma delta T-cell (GDT) therapy intended to treat non–small cell lung cancer (NSCLC), has received clearance of its investigational new drug (IND) application by the FDA.¹

Deltacel is non-engineered and based on a platform that aims to utilize the natural characteristics of Gamma Delta T-cells in the targeting of solid cancers; as such, viral vectors are not required in the manufacturing process. Kiromic Biopharma expects that this will reduce manufacturing costs for the cell therapy. The company stated that it expects to initiate a phase 1 clinical trial for Deltacel, which will evaluate the cell therapy in combination with another anti-tumor therapy, within the second quarter of 2023.^1,2

“Receiving the authorization from the FDA to administer Deltacel to patients enables us to advance our GDT therapy candidate into the clinic,” Pietro Bersani, the CEO of Kiromic BioPharma, said in a statement.¹ “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 NSCLC and with other solid cancers. We are in the process of activating clinical trial sites, and we look forward to providing updates on our progress.”

The IND application, which was originally submitted on March 31, 2023, is supported by positive preclinical safety data reported by the company in February 2023.³ The data includes results from a histopathology evaluation which showed no adverse microscopic findings related to Deltacel in mice that received the cell therapy in combination with a non-biological anti-tumor therapy.

“We’re pleased to receive a clean pharmacology profile with no adverse findings and are encouraged by the preclinical results to-date in support of our planned IND submission,” Leonardo Mirandola, PhD, chief scientific officer, Kiromic BioPharma, said in a February 2023 statement.³ “This histopathology report includes results from more than 500 histological sections from multiple organs of mice treated with Deltacel, with the combination treatment of Deltacel and a non-biological anti-tumor therapy, or mice left untreated. This study completes the necessary dataset for authoring the Pharmacology Report of the Efficacy Study, which is an essential component of the nonclinical module of our IND application... These findings are in line with what we observed in a study evaluating Deltacel monotherapy at a dose more than 7 times higher than the maximum dose planned for the Deltacel clinical trial, and they confirm that Deltacel was well tolerated in mice, even when given as part of a combination therapy that further boosted its potency.”

Kiromic BioPharma’s IND for Deltacel was also supported by written feedback provided by the FDA based on a Type B Pre-IND meeting regarding the company’s development strategy for the cell therapy.⁴ The feedback related to chemistry, manufacturing, and controls; nonclinical studies; and the company’s clinical study plan. At the time the feedback was announced in October 2022, Kiromic BioPharma also stated that it had undertaken measures to streamline operations related to Deltacel’s continued development, which included the elimination of 20 employee positions. The company intends to simultaneously pursue the continued development of Procel and Isocel, 2 other cell therapy candidates.

Kiromic BioPharma intends to carry out the manufacturing for Deltacel with an expanded current good manufacturing practice (cGMP) manufacturing facility which is located in Houston, Texas.⁵ The completion of the 34,000-square-foot facility’s construction was announced in July 2022. The company noted that the construction fulfilled a requirement set forth by the FDA in a clinical hold communication that the agency put forward in June 2021. According to the company, the facility “includes flexible cellular therapy and viral vector suites, a dedicated cGMP microbiology lab, a dedicated cGMP quality control lab, a research and development laboratory, and an FDA Code of Federal Regulations (CFR-9) compliant vivarium.”

REFERENCES

1. Kiromic Biopharma announces FDA authorization of IND to initiate phase 1 clinical trial evaluating Deltacel in non-small cell lung cancer. News release. Kiromic BioPharma, Inc. May 1, 2023. Accessed May 1, 2023. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-announces-fda-authorization-ind-initiate-phase

2. Kiromic Biopharma submits investigational new drug application for phase 1 trial with Deltacel for non-small cell lung cancer. News release. Kiromic BioPharma, Inc. April 3, 2023. Accessed May 1, 2023. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-submits-investigational-new-drug-application

3. Kiromic Biopharma reports favorable Deltacel preclinical pharmacology results. News release. Kiromic BioPharma, Inc. February 28, 2023. Accessed May 1, 2023. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-reports-favorable-deltaceltm-preclinical

4. Kiromic Biopharma announces FDA feedback from type B pre-IND meeting confirms Deltacel development strategy. News release. Kiromic BioPharma, Inc. October 6, 2022. Accessed May 1, 2023. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-announces-fda-feedback-type-b-pre-ind-meeting

5. Kiromic Biopharma achieves milestone with timely completion of expanded cGMP manufacturing facility to support cell therapy oncology pipeline. News release. Kiromic BioPharma, Inc. July 7, 2022. Accessed May 1, 2023. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-achieves-milestone-timely-completion-expanded