Change the tumor from "cold" to "hot"! Intra-tumor immunotherapy Tavo unlocks PD-1 checkpoint potential, combined With K drug treatment of drug-resistant melanoma efficacy is strong!

May 08 , 2020 /PRNewswire
BIOON/ -- Oncoec Medical Medicaled is a biotech company focused on developing immunotherapy for tumors tumors in the tumor Recently, the company announced that it had achieved strong efficacy data in the Phase II
clinical trial of the pilot drug Tavo (interleukin-12, IL-12, plasmids) and Keytruda (Creeda, Pabolizumab, Pabloli-Zumab) in combination with the treatment of anti-PD-1 checkpoint drug-resistant metastatic metastatic melanoma clinical trials in recent years, immunocheckpoint inhibitors have become a common first-line treatment for melanoma However, about 40 percent of melanoma are considered "cold" tumors, which means that there is not enough immune cell immersion in tumor , and therefore poor lying to immunocheckpoint inhibitor treatment It is estimated that only 12%-15% of "cold" melanomas respond to immunocheckpoint inhibitors A major challenge in this area is how to transform these 'cold' melanomas into 'hot' melanoma to respond to immunocheckpoint inhibitor treatment Tavo is a of intra-tumor DNA tumor immunotherapy, a DNA plasmid that encodes interleukin 12 (IL-12), which is directly imported into the tumor lesions through intra-tumor electroporation technology, local expression of IL-12 (a cytokine with immunostimulation) in the tumor microenvironment, triggering the recruitment of recruiting cells into the tumor, to transform "cold"
tumors into "
tumors, and thus overcome the resistance to immune Tavo's treatment process and mechanism of action (see: http://oncoec.com/tavo/
) this announcement is a key, global, one-arm phase II trial conducted by OncoSec and Mersadon to assess the efficacy and safety of Tavo's combination with the anti-PD-1 therapy Keytruda (Korida, generic name: pembrolizumab, Pabloli Zumab) The study enrolled a total of 23 adult patients with non-reprecision or metastatic melanoma, who had melanoma lesions that can be fed with intra-tumor electroporoma, and were predicted to have a therapeutic response against PD-1 therapy by using baseline biomarker data (the proportion of checkpoint-positive immune cells in tumor ) In the study, patients received Tavo electroporations on the first, 5, and 8 days of each cycle (one cycle of 6 weeks) and received a 200 mg dose of Keytruda intravenous infusion every 3 weeks The patient continues to receive treatment until the progression of the disease is confirmed, or the treatment is not up to 2 years results showed that of the 22 assessable patients, 9 were in remission, 8 of which were completely remission, and the objective remission rate (ORR) of (ORR) was 41% and the total remission rate (CR) was 36% The median non-progressive lifetime (PFS) was 5.6 months , and after 19.6 months of median follow-up, the median total survival (OS) was still not reached important, in addition to the degenerative electroporation lesions, 29.2% of the untreated lesions also appear to , which may be caused by the proliferation of tumors specific immune cells and systemic circulation in this trial, level 3 or higher adverse reactions limited, including pain, chills, sweating and cellular itisis, and certain toxic effects usually observed using immunocheckpoint inhibitors such as Keytruda by examining tissue samples before and after treatment, the researchers found that combination therapy increased the number of immune cells in the tumor microenvironment compared to baseline levels gene expression analysis showed that combination therapy led to the tumor cell immune activation gene upward, increased the number of proliferative immune cells in peripheral blood, indicating that the system immune response was activated the findings were recently presented in a press release on the official website of the American Association for Cancer Research (AACR) and published in the official journal Clinical Cancer
research( Clinical Cancer Research) at the Phae II Of IL-12 Plamid Tranfec and PD-1 Immune "For patients who are predicted to have a poor response to immunocheckpoint inhibitor monotherapy, the combination of Keytruavo and Telectrovia can improve treatment response," said Adil Daud, author of the paper on the efficacy of injections in Tavo tumors, clinical professor at the University of California, San Francisco (UCSF) and director of clinical research on melanoma at UCSF's Helen Diller Family Comprehensive Cancer Center By using electroperforated local delivery of Tavo, we were able to avoid many of the toxic effects associated with systemic IL-12 administration, while still receive clinical responses in treated and untreated melanoma lesions and induced immune cell immersion " Daniel J O'Connor, President and CEO of OncoSec, said: "AACR's choice to publish these data in its publication Clinical Oncology Research highlights its importance and relevance The study provides evidence of how Tavo converted "cold" melanoma serotonin from immunology to "hot" melanoma, and made checkpoint therapy( such as Keytruda) more effective while minimizing side effects These findings provide a clinical basis for the ongoing Tavi and Keytruda joint treatment of key KEYNOTE-695 studies of anti-PD-1 checkpoint drug-resistant metastatic melanoma Because KEYNOTE-695 is treating patients with advanced metastatic melanoma who have not
been approved by the FDA , almost all clinical trials are open and actively recruit patients during the current COVID-19 pandemic We aim to complete the patient entry group this year and look forward to providing mid-term data updates for this critical study at the appropriate scientific meeting or other appropriate time "KEYNOTE-695 is a critical, global, open label Phase II trial that is evaluating the progression of or after treatment of of melanoma in the combination of Tavo and Keytruda for anti-PD-1 point resistance, non-resectionability or metastatic (PHASE III/IV) melanoma, who received Keytruda or Opdivo (Odivo, Navuliu monoantigen) treatment after completing the KEYNOTE-695 trial, OncoSec plans to submit an accelerated approval application to the FDA Previously, Tavo has been granted fast-track eligibility (FTD) and orphan drug eligibility (ODD) for the treatment of melanoma by the U.S FDA
, as well as FTD for the treatment of triple-negative breast cancer (TNBC) OncoSec is also conducting a Phase II clinical trial with Mercadon to evaluate Tavo and Keytruda's joint treatment tNBC (BioValleyBioon.com) original origin: OncoSec' TAVO in Combination with KEYTRUDa Demontrated 41% Overall Repone Rate and 36% Complete Repone in a-Late Stage Metatatic Study Study in 'Clinical Cancer Clinical Feature'