aldoxorubicin (INNO-206) News

|||||||||| aldoxorubicin (INNO-206) / ImmunityBio, Abraxane (albumin-bound paclitaxel) / BMS, Otsuka, Anktiva (inbakicept) / ImmunityBio
[VIRTUAL] Trial in progress: Open-label, randomized, comparative phase 2/3 study of combination immunotherapy plus standard-of-care chemotherapy and SBRT versus standard-of-care chemotherapy for the treatment of locally advanced or metastatic pancreatic cancer. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1586;
P2
The ongoing QUILT 88 phase II/III, multi-center, three-cohort, open-label, US study (NCT04390399) to evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus standard-of-care chemotherapy in combination with aldoxorubicin HCl, N-803, and PD-L1 t-haNK in subjects with locally advanced or metastatic pancreatic cancer...Subjects with locally advanced or metastatic pancreatic cancer who have received at least 16 weeks of treatment with gemcitabine plus nab-paclitaxel, and have had either a partial response (PR), CR, or stable disease (SD), will be enrolled into Cohort A to receive first-line maintenance therapy...Primary endpoints by cohort are: A) PFS per RECIST V1., B & C) OS . The secondary endpoints include overall response rate, DoR, DCR, OS(cohort A) and QoL by patient-reported outcomes.

|||||||||| aldoxorubicin (INNO-206) / NantWorks
Interview: NEWS FLASH: You're invited to interview Dr. Soon Shiong & ask him why his name is on a patent for chemo drug Aldoxorubicin! @CNBC @CNBCnow @FoxBusiness @RiggsReport @GMA @CBSNews @NBCNews @StockNewsNow @SquawkStreet @AACR @theNCI @Cancer_Cell @DanaFarber @davidfaber @business (Twitter) - Apr 22, 2021

|||||||||| aldoxorubicin (INNO-206) / NantWorks
Clinical: You should think of using Aldoxorubicin as a low dose chemo immunomodulator cohort - just contact Dr. Patrick Soon Shiong or $CYTR because Aldoxorubicin binds to Albumin and would result in more efficacy! https://t.co/FngxOURLpA (Twitter) - Mar 4, 2021

|||||||||| aldoxorubicin (INNO-206) / NantWorks
Orphan drug: @KermitCapital @ARKInvest @TomGardnerFool @mcuban value of $CYTR's Aldoxorubicin = (yearly doxorubicin sales) + (doxil, generic yearly sales) + (Orphan drug status USA 7 years) + (Orphan status Europe 10 yrs) + (Extended dosing over 550 mg/m2 up to 10,000 mg) @DrPaulyDeSantis (Twitter) - Feb 19, 2021

|||||||||| aldoxorubicin (INNO-206) / NantWorks
$CYTR's Aldoxorubicin!!!!! "Given the unique characteristics of aldoxorubicin, with the ability to cross the blood-brain" $NK Nantkwest filing page 221 @JohnCendpts @BioRunUp @BioStocks @mcuban @chamath $JNJ $PFE $MRNA $NVAX $GRTS $ACRS $SLS $CRMD $MVIS @spacex $SINO $CPSH $ZYNE (Twitter) - Feb 3, 2021

|||||||||| aldoxorubicin (INNO-206) / NantWorks, doxorubicin hydrochloride / Generic mfg.
I wonder if this has a chance since #aldoxorubicin was effectively shelved. #sarcoma (Twitter) - Sep 24, 2020

|||||||||| Trial primary completion date, Metastases: QUILT-3.071: QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine (clinicaltrials.gov) - Sep 17, 2020
P1b/2, N=332, Active, not recruiting, Sponsor: NantKwest, Inc.
The secondary endpoints include overall response rate, DoR, DCR, OS(cohort A) and QoL by patient-reported outcomes. Trial primary completion date: Dec 2019 --> Dec 2021

|||||||||| aldoxorubicin (INNO-206) / NantWorks, racemetyrosine (SM-88) / Tyme, doxorubicin hydrochloride / Generic mfg.
A lot of exciting trials going on— @DrShubhamPant has a pan KRAS inhibitor, @NantWorks has an IL15, aldoxorubicin, NK cell, metronomic chemo trial, @PennMedicine has CAR-T targeting mesothelin & MUC1, & many sites have @Tyme SM-88 open including @PanCAN #PancChat (Twitter) - Sep 15, 2020

|||||||||| aldoxorubicin (INNO-206) / NantWorks, doxorubicin hydrochloride / Generic mfg.
Journal: Conjugate of Doxorubicin to Albumin-Binding Peptide Outperforms Aldoxorubicin. (Pubmed Central) - Aug 15, 2020
Free Dox clears quickly from the tumor, while ABD-Dox maintains a steady concentration in the tumor for at least 72 h, so that its relative accumulation at 72 h is ≈120-fold greater than that of free Dox. The improved pharmacokinetics and biodistribution of ABD-Dox result in enhanced therapeutic efficacy in syngeneic C26 colon carcinoma and MIA PaCa-2 pancreatic tumor xenografts, compared with free Dox and aldoxorubicin, an albumin-reactive Dox prodrug currently in clinical development.

|||||||||| Trial completion date, Trial primary completion date: QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Subjects With SCC Who Have Progressed (clinicaltrials.gov) - Aug 11, 2020
P1/2, N=65, Active, not recruiting, Sponsor: NantKwest, Inc.
The improved pharmacokinetics and biodistribution of ABD-Dox result in enhanced therapeutic efficacy in syngeneic C26 colon carcinoma and MIA PaCa-2 pancreatic tumor xenografts, compared with free Dox and aldoxorubicin, an albumin-reactive Dox prodrug currently in clinical development. Trial completion date: Dec 2019 --> Apr 2021 | Trial primary completion date: Dec 2019 --> Jan 2021

||||||||||  PD-L1.t-haNK / ImmunityBio, aldoxorubicin (INNO-206) / LadRx, Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Enrollment open, Trial completion date, Trial primary completion date, Metastases:  QUILT-88: Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer (clinicaltrials.gov) -  Jun 22, 2020
P2, N=268, Recruiting,  Sponsor: ImmunityBio, Inc.
Trial completion date: Dec 2019 --> Apr 2021 | Trial primary completion date: Dec 2019 --> Jan 2021 Not yet recruiting --> Recruiting | Trial completion date: May 2023 --> Jun 2022 | Trial primary completion date: May 2023 --> Jun 2021

|||||||||| When there is no good answer- use Pat S Shiong cocktail FTW -metronomic chemotherapy (combinations of aldoxorubicin, gemcitabine, abraxane, oxaliplatin, 5FU, and cyclophosphamide) SBRT, Avelumab, N803 (IgG1 Fc-engineered IL-15-fusion protein), 5. Allogeneic haNK cells. (Twitter) - Jun 16, 2020

|||||||||| It is the kitchen sink -Reduced dose metronomic chemotherapy (combinations of aldoxorubicin, gemcitabine, abraxane, oxaliplatin, 5FU, and cyclophosphamide) 2. SBRT, 3. Avelumab, 4. N803 (IgG1 Fc-engineered IL-15-fusion protein), 5. Allogeneic haNK cells. (Twitter) - Jun 11, 2020

||||||||||  PD-L1.t-haNK / ImmunityBio, aldoxorubicin (INNO-206) / LadRx, Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
New P2 trial, Metastases:  QUILT-88: Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer (clinicaltrials.gov) -  May 14, 2020
P2, N=268, Not yet recruiting,  Sponsor: ImmunityBio, Inc.

|||||||||| doxorubicin hydrochloride / Generic mfg.
Journal: Engineered collagen-binding serum albumin as a drug conjugate carrier for cancer therapy. (Pubmed Central) - May 13, 2020
Dox-CBD-SA decreased adverse events compared to aldoxorubicin. Thus, engineered CBD-SA could be a versatile and clinically relevant drug conjugate carrier protein for treatment of solid tumors.

|||||||||| [VIRTUAL] Immunotherapy combining NK and T cell activation with IL-15 super agonist (N-803), off-the-shelf high-affinity CD16 NK (haNK) or PDL1 targeted haNK and checkpoint inhibitor in relapsed/refractory advanced pancreatic cancer. () - Apr 29, 2020 - Abstract #ASCO2020ASCO_3390;
Orchestrated immunomodulatory outpatient combination treatment is feasible and results in clinical benefit and CR in selected patients with acceptable toxicity. Research Funding: NantKwest

|||||||||| aldoxorubicin (INNO-206) / NantWorks, doxorubicin hydrochloride / Generic mfg.
Preclinical, Journal: Aldoxorubicin-loaded nanofibers are cytotoxic for canine mammary carcinoma and osteosarcoma cell lines in vitro: A short communication. (Pubmed Central) - Apr 3, 2020
There were differences in IC50 between the osteosarcoma lines, with lower and higher IC50 for HMPOS and D-17 cells, respectively, with all drugs (aldoxorubicin-loaded NFP, free aldoxorubicin or free doxorubicin). Our results indicate that drug-loaded NFPs are cytotoxic for various canine mammary carcinoma and osteosarcoma cell lines in vitro and hold promise as a mechanism for enhancing delivery of chemotherapeutic agents to canine tumors.

|||||||||| netupitant (Ro 67-3189) / Helsinn, Otsuka, doxorubicin hydrochloride / Generic mfg., Sovaldi (sofosbuvir) / Gilead
Clinical, Journal: Successes, failures, and future prospects of prodrugs and their clinical impact. (Pubmed Central) - Mar 4, 2020
For example, newer platelet aggregation inhibitors could signal the end of the warfarin era with their demanding treatment follow-up...This strategy employs the design of artificial enzymes to activate prodrugs at specific sites. Agents designed for use in DEPT medicine can be directed at antibodies, genes, viruses, and clostridia.

|||||||||| aldoxorubicin (INNO-206) / NantWorks, doxorubicin hydrochloride / Generic mfg.
#CytRxCorporation Highlights Significant Positive Events From its Licensed Drug #Aldoxorubicin $CYTR https://t.co/QwrJ0POJx0 (Twitter) - Feb 1, 2020

|||||||||| aldoxorubicin (INNO-206) / NantWorks
Journal: Aldoxorubicin in soft tissue sarcomas. (Pubmed Central) - Sep 11, 2019
The current clinical and pharmacological data available for aldoxorubicin are extremely promising for its use in the treatment of advanced and metastatic soft tissue sarcomas compared with equivalent doses of doxorubicin although Phase III data are lacking. We review aldoxorubicin for the treatment of advanced and metastatic soft tissue sarcomas and discuss the impact it may have in the future.

|||||||||| Enrollment change, Trial withdrawal: QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer (clinicaltrials.gov) - Aug 28, 2019
P2, N=0, Withdrawn, Sponsor: NantKwest, Inc.
We review aldoxorubicin for the treatment of advanced and metastatic soft tissue sarcomas and discuss the impact it may have in the future. N=558 --> 0 | Not yet recruiting --> Withdrawn

|||||||||| Enrollment change, Trial withdrawal, Metastases: QUILT-3.088: NANT Pancreatic Cancer Vaccine (clinicaltrials.gov) - Aug 28, 2019
P2, N=0, Withdrawn, Sponsor: NantKwest, Inc.
N=558 --> 0 | Not yet recruiting --> Withdrawn N=1064 --> 0 | Not yet recruiting --> Withdrawn

|||||||||| Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date, Metastases: QUILT-3.072: NANT Hepatocellular Carcinoma (HCC) Vaccine (clinicaltrials.gov) - Aug 28, 2019
P1/2, N=0, Withdrawn, Sponsor: NantKwest, Inc.
N=1064 --> 0 | Not yet recruiting --> Withdrawn N=382 --> 0 | Trial completion date: Dec 2022 --> Aug 2019 | Active, not recruiting --> Withdrawn | Trial primary completion date: Jul 2020 --> Aug 2019

|||||||||| Trial primary completion date: QUILT-3.070:Pancreatic Cancer Vaccine: Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy (clinicaltrials.gov) - Jul 15, 2019
P1/2, N=173, Active, not recruiting, Sponsor: NantKwest, Inc.
N=382 --> 0 | Trial completion date: Dec 2022 --> Aug 2019 | Active, not recruiting --> Withdrawn | Trial primary completion date: Jul 2020 --> Aug 2019 Trial primary completion date: Dec 2018 --> Dec 2019

|||||||||| Trial primary completion date: QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Subjects With SCC Who Have Progressed (clinicaltrials.gov) - Jul 15, 2019
P1/2, N=65, Active, not recruiting, Sponsor: NantKwest, Inc.
Trial primary completion date: Dec 2018 --> Dec 2019 Trial primary completion date: May 2019 --> Dec 2019

|||||||||| Trial completion date, Trial primary completion date: QUILT-3.080: NANT Pancreatic Cancer Vaccine (clinicaltrials.gov) - Jul 15, 2019
P1b/2, N=173, Active, not recruiting, Sponsor: NantKwest, Inc.
Trial primary completion date: May 2019 --> Dec 2019 Trial completion date: May 2020 --> Dec 2019 | Trial primary completion date: May 2019 --> Dec 2019

|||||||||| Enrollment closed, Metastases: QUILT-3.071: QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine (clinicaltrials.gov) - May 17, 2019
P1b/2, N=332, Active, not recruiting, Sponsor: NantKwest, Inc.
Trial completion date: May 2020 --> Dec 2019 | Trial primary completion date: May 2019 --> Dec 2019 Recruiting --> Active, not recruiting

|||||||||| Enrollment closed: QUILT-3.067: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy. (clinicaltrials.gov) - May 17, 2019
P1/2, N=79, Active, not recruiting, Sponsor: NantKwest, Inc.
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting

|||||||||| Enrollment change, Trial withdrawal: QUILT-3.057: NANT Neoadjuvant Triple- Negative Breast Cancer (TNBC) Vaccine (clinicaltrials.gov) - May 14, 2019
P2, N=0, Withdrawn, Sponsor: NantKwest, Inc.
Recruiting --> Active, not recruiting N=376 --> 0 | Not yet recruiting --> Withdrawn

|||||||||| Enrollment change, Trial withdrawal: QUILT-3.091 NANT Chordoma Vaccine vs Radiation in Subjects With Unresectable Chordoma. (clinicaltrials.gov) - May 13, 2019
P1b/2, N=0, Withdrawn, Sponsor: NantKwest, Inc.
N=376 --> 0 | Not yet recruiting --> Withdrawn N=427 --> 0 | Not yet recruiting --> Withdrawn

|||||||||| Enrollment closed, Trial primary completion date: QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Subjects With SCC Who Have Progressed (clinicaltrials.gov) - May 13, 2019
P1/2, N=65, Active, not recruiting, Sponsor: NantKwest, Inc.
N=427 --> 0 | Not yet recruiting --> Withdrawn Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2018 --> May 2019

|||||||||| Enrollment closed: QUILT-3.080: NANT Pancreatic Cancer Vaccine (clinicaltrials.gov) - May 13, 2019
P1b/2, N=173, Active, not recruiting, Sponsor: NantKwest, Inc.
Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2018 --> May 2019 Recruiting --> Active, not recruiting



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