On January 4, 2023 Hadasit, the Innovation Engine of Hadassah Medical Organization and BIRAD, the Commercialization arm of Bar-Ilan University reported that they have entered into the research and license agreement with Immix BioPharma, for the development and commercialization of novel tissue specific therapeutics based on anti-BCMA CAR-T cells targeting plasma cell (Press release, , JAN 4, 2023, View Source [SID1234625842]). This technology has been developed as the result of a collaboration between Prof. Polina Stepensky, of Hadassah Medical Center, Jerusalem and Prof. Cyrille J. Cohen, of Bar-Ilan University, Ramat Gan. Dr. Shlomit Kfir-Erenfeld and Dr. Nathalie Asherie, of Hadassah Medical Center, and Ortal Harush, of Bar-Ilan University, also participated in the research.

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As of December 20, 2022, cutoff date, a total of 56 patients, including 50 multiple myeloma patients and 6 AL Amyloidosis patients, have received HBI0101, anti-BCMA CAR-T cells, as part of the ongoing Phase 1b clinical trial at Hadassah Medical Organization. At the current stage of the clinical study, when the patients received a target dose of 800M CAR-T positive cells, the overall response rate of the relapsed/refractory multiple myeloma patients reached 90%. The complete response rate of the AL amyloidosis patients reached 100%. In both patient populations, no significant unexpected side effects were observed.

Prof. Polina Stepensky, Head of Hadassah’s Department of Bone Marrow Transplantation and Cancer Immunotherapy and her team are responsible for the selection of B-cell maturation antigen (BCMA) as the optimal target for the treatment of multiple myeloma and are evaluating this novel CAR-T technology in the clinic.

Prof. Polina Stepensky, said, "We are very excited with the outstanding interim results of our ongoing Phase 1b study in multiple myeloma and amyloidosis AL patients. The licensing agreement will enable us to continue to advance the clinical studies. Our new adoptive cell transfer technology could become one of the first CAR-T treatments for these indications and other BCMA-positive malignancies and has the potential to improve the lives of so many patients globally."

Prof. Stepensky joined forces with Prof. Cyrille J. Cohen, Head of the Tumor Immunology and Immunotherapy Lab at Bar-Ilan University and a renowned scientist in the field of immune cells engineering, who designed the novel vector in this exciting collaboration. Prof. Cohen and his team built the optimal anti-BCMA CAR construct with proprietary design adaptations. They demonstrated the biological activity of CAR-T cells in the first preclinical studies, leading to establishment of the mutual invention of the researchers.

Prof. Cohen commented, "For the first time, we successfully reprogrammed a patient’s immune system with a proprietary receptor that we developed in our lab at Bar-Ilan University. Through this collaboration with Hadassah Medical Center, dozens of patients have the future promise of a better treatment option. This successful treatment encourages us to continue developing new approaches for the treatment of cancer and autoimmune diseases."

Further development of the technology was led by the Hadassah team, including extensive proof of concept preclinical studies, establishment of the GMP graded master cell bank, construction of a GMP manufacturing facility, implementation of SOPs and receiving the regulatory approval of the Israeli MOH to conduct clinical trial on humans.

"Hadassah Medical Organization, as one of the leading medical centers in Israel, is devoted to bringing to the Israeli population the most advanced healthcare technology in an affordable fashion," said Prof. Yoram Weiss, Director General of Hadassah Medical Organization. "Hadassah has invested millions of dollars of its donors’ money to support this technology during the first crucial stages of development, with the ultimate goal of bringing life-saving CAR-T therapy to cancer patients. I would also like to thank Israel’s Ministry of Health for its support of this project, in recognition of its innovation and importance for Israeli patients. We are delighted that we are able to share this technology at this point in time with the international community."

Zohar Yinon, CEO and SVP, Bar-Ilan University, commented, "I am proud of the scientific excellence of Prof. Cohen and the collaboration with Hadassah Medical Center. This is an example of the variety of research in the fields of health and medicine taking place in Bar-Ilan University’s labs, and of our eco-system that produces cutting-edge research and initiatives that are ready for commercialization by scientists at the faculties of medicine, life sciences, and engineering, the brain center, and the Institute of Nanotechnology and Advanced Materials (BINA)."