Cell Therapy Cancer Vaccine Shows Promise for Progression-Free Survival in Metastatic Pancreatic Cancer


The vaccination therapy improved progression-free survival by 3.1 months over standard care in 1 patient treated.

KiroVax (BSK01; Kiromic BioPharma) was efficacious in treating metastatic pancreatic cancer in 1 patient dosed in a phase 1 clinical trial of the cell therapy cancer vaccine candidate.1

The patient experienced a progression-free survival (PFS) of 7 months after treatment with KiroVax and chemotherapy compared with a PFS of 3.9 months with standard of care.

“We are very proud of the results we achieved with KiroVax/BSK01 in addressing advanced metastatic pancreatic cancer. We believe that this is an exciting study, as we believe it demonstrates Kiromic’s early clinical success in the cellular therapy arena,” Maurizio Chiriva Internati, DBSc, PhD, president, chief executive officer, chairman, and founder, Kiromic BioPharma, said in a statement.1

KiroVax consists of matured antigen presenting cells that express tumor specific antigens. It is designed to target and treat multiple types of solid tumors. The next-generation cell therapy vaccine was developed using Kiromic BioPharma’s proprietary DIAMOND® artificial intelligence platform used for target selection. The DIAMOND platform is being used to identify targets for both cell and gene immuno-oncologic therapies. With this platform, Kiromic is currently developing multi-indication allogeneic chimeric antigen receptor (CAR) T-cell therapies that utilizes γ Δ T-cells to target solid tumors.

Based on these data, Kiromic plans to further evaluate KiroVax in subsequent clinical trials and to also evaluate the cell therapy vaccine as an adjuvant with other cell therapies. 

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“By reaffirming this published clinical study, we intend to illustrate Kiromic’s robust cellular therapy platform, and accordingly, we believe that KiroVAX/BSK01 may have a powerful and synergistic impact as an adjuvant to our novel and innate immunity cellular therapy pipeline,” Internati added.1 “As we did with KiroVax/BSK01, we expect to be able to also progress Kiromic’s CAR-T therapies to the clinical arena.”

Kiromic has 2 γ Δ CAR T-cell therapies also in development. These are Alexis PRO-1 (procel), which targets PD-L1 in solid tumors, and Alexis ISO-1 (isocel), which targets an isoform of mesothelin in solid tumors. Both are in preclinical studies, with phase 1 studies expected to initiate in 2022 and 2023, respectively.

Kiromic recently announced a strategic collaboration with Gemelli Teaching Hospital IRCCS, in Rome, Italy, to help develop isocel.2 Specifically, the hospital will help to accelerate analyses of the investigational γ Δ CAR T-cell therapy.

“Gemelli is the very best possible European partner for Kiromic, as it has the ability to accelerate the analysis of our immune cell therapy candidate and shares our vision for improving cancer targeting through the use of bioinformatics and artificial intelligence,” Internati said in a previous statement.2 “Gemelli is one of the leading immuno-oncology centers in Europe, and is led by Professor Scambia, who has more than 30 years in the immuno-oncology field, having written or contributed to more than 1,300 publications on this topic. We look forward to advancing this clinical partnership.”

“We are pleased to have been selected to analyze Kiromic's off-the-shelf allogeneic CAR-T candidate. Our database of cancer tissue is one of the best in Europe for the types of cancer Kiromic is trying to treat, and our comprehensive cancer center foundation is extremely strong, built on significant research and development in the field of immunotherapy and live cell therapy,” Giovani Scambia, MD, PhD, director, Gemelli Teaching Hospital IRCCS, added to the statement.2

1. Kiromic Biopharma, now clinical stage, reports significant progression free survival benefit in metastatic pancreatic cancer patient treated with Kirovax/Bsk01, company’s phase 1 cell therapy cancer vaccine candidate for solid tumors - discovered by, and validation of, Kiromic’s proprietary Diamond® artificial intelligence platform. News release. Kiromic BioPharma. October 25, 2021. https://www.businesswire.com/news/home/20211025005273/en/
2. Kiromic Biopharma announces strategic collaboration with Gemelli Teaching Hospital to accelerate the analysis of allogeneic CAR-T clinical trial candidate Alexis Iso-1 in solid cancers. News release. Kiromic BioPharma. October 11, 2021. https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-announces-strategic-collaboration-gemelli
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