US 12,263,219 B2
Therapeutic composition and method combining multiplex immunotherapy with cancer vaccine for the treatment of cancer
David Granger Bostwick, Orlando, FL (US); Brian Rafferty Bostwick, Orlando, FL (US); and Peter John Littrup, Bloomfield Hills, MI (US)
Assigned to Rampart Health, L.L.C., Orlando, FL (US)
Filed by Rampart Health, L.L.C., Orlando, FL (US)
Filed on Feb. 11, 2022, as Appl. No. 17/670,146.
Claims priority of provisional application 63/148,922, filed on Feb. 12, 2021.
Prior Publication US 2022/0257761 A1, Aug. 18, 2022
Int. Cl. A61K 39/395 (2006.01); A61B 18/02 (2006.01); A61K 9/00 (2006.01); A61K 31/675 (2006.01); A61K 38/19 (2006.01); A61K 38/20 (2006.01); A61K 38/21 (2006.01); A61K 39/00 (2006.01); A61K 45/06 (2006.01); A61P 35/04 (2006.01)
CPC A61K 39/39558 (2013.01) [A61B 18/02 (2013.01); A61K 9/0019 (2013.01); A61K 31/675 (2013.01); A61K 38/191 (2013.01); A61K 38/193 (2013.01); A61K 38/2026 (2013.01); A61K 38/204 (2013.01); A61K 38/208 (2013.01); A61K 38/212 (2013.01); A61K 38/217 (2013.01); A61K 39/0011 (2013.01); A61K 45/06 (2013.01); A61P 35/04 (2018.01); A61K 2039/507 (2013.01); A61K 2039/5152 (2013.01)] 18 Claims
 
1. A method of treating a tumor or a cancer in a subject in need consisting of:
intradermally administering to the subject a therapeutic composition consisting of:
i) two immune checkpoint inhibitors comprising a CTLA-4 inhibitor, and a PD-1 inhibitor or PD-L1 inhibitor,
ii) cyclophosphamide, and
iii) a cancer vaccine prepared from cancer cell lysates that have been prepared through an ex vivo treatment consisting of irradiation, cryofreezing, and suspension in a low-dose solution of cyclophosphamide, that creates necroptotic cancer cells while minimizing destruction of cancer antigens, in an amount effective to treat the tumor or cancer,
wherein the cancer cell lysates are prepared by one or more treatments selected from the group consisting of dissociation or dissection, fixation, centrifugation, resuspension, enrichment, and combinations thereof; and
post intradermal administration of the therapeutic composition, further administering a drug selected from a cytokine drug, a cytotoxic or cytostatic chemotherapeutic drug, and combinations thereof, to the subject daily.