DEVELOPMENT HISTORY
Industry & Cell Source Development Milestones
Year
Industry Developments
Cell Source Developments
2013
First CAR-T complete response in Leukemia; Science deems cancer immunotherapy “breakthrough of the year”; “turning point in cancer”
2014
First PD-1 inhibitor approved by the FDA; First BiTE approved by FDA; First CAR-T receives breakthrough therapy designation from FDA
First patient treated with Megadose Drug Combination (patient is still cancer free through the end of 2021)
2015
First oncolytic virus therapy approved by FDA; CAR-T Phase 1/2 study shows 71% response rate with 57% complete remission; however, 86% suffered from cytokine release syndrome
Proof-of-concept completed / patent filed for genetically modified T cells combined with Veto Cells – improved persistence/ efficacy for allogeneic treatment
2016
First clinical trial for CRISPR gene editing tool; Over 200 CAR-T cell trials documented; Molmed granted marketing approval in Europe for HSCT treatment reducing GvHD based on Phase 1/2 data; then reimbursed at EUR 164K per dose
Proof-of-concept completed and patent filed for Anti-viral Veto Cells show haploidentical HSCT under RIC with successful engraftment, with no GvHD and pronounced anti-viral effect
2017
First CAR-T cell therapy approved by FDA – Kymriah from Novartis – price $475k per dose; KITE acquired for $11.9B by Gilead Sciences (with no product sales and no FDA approved products at that time)
GMP Veto Cell production validated in Germany. State of Texas (CPRIT) / MD Anderson Cancer Center (MDACC) $10M grant funding to recruit Prof. Reisner
2018
Second CAR-T cell therapy approved by FDA – Yescarta from Gilead Sciences – price $373k per dose; JUNO acquired for $9B by Celgene; Allogene reaches $3B market CAP; Journal of Clinical Oncology names CAR-T “2018 Advance of the Year”; James Allison (MD Anderson Chair of Immunology) wins Nobel Prize in Medicine
Prof. Reisner Heads Stem Cell Research at MDACC; Production protocol completed for Veto Cell human trials in the US; CLCS commences collaboration with CAR-T inventor Zelig Eshhar on allogeneic CAR-T + Veto Cell combined therapy. CLCS commences sponsored research at MDACC
2019
FDA approves Keytruda from Merck, first PD-1 inhibitor approved for lung cancer. BMS acquires Celgene for $74B. Vertex acquires Semma (preclinical stage stem cell therapy for type 1 diabetes) for $950M in cash.
Cell Source sponsors cell production and human clinical trials at MDACC. First patient successfully treated with Anti-viral Veto Cell. Preclinical data confirm Veto effectiveness for SCD and type 1 diabetes.
2020
FDA approves Tecartus from Gilead, first CAR-T cell immunotherapy for mantle cell lymphoma, Allogene market CAP reaches $6B. Gilead acquires Immunomedics (cancer and autoimmune disease immunotherapy) for $21B.
First patient cohort shows successful engraftment under RIC with absolutely no GvHD. Optimal dose level attained. Collaboration with Zelig Eshhar confirms Veto CAR-T proof-of-concept.
2021
FDA approves Abecma, first CAR T cell immunotherapy for multiple myeloma and Brezyani for large B cell lymphoma, both from BMS. Legend market CAP reaches $8B, Fate market cap reaches $10B.
CLCS completes 2nd patient cohort, adds SCD to clinical trial, and prepares IRB for Veto Kidney transplant with mismatched donor and eliminating need for post-transplant immune suppression.
2022
BMS acquires preclinical cancer immunotherapy focused Century for up to $3B
FDA approves revised irradiation protocol for Veto trial. Veto Kidney IRB submitted.