Delving into the Latest Updates on Adenoviral MUC1 vaccine(Etubics Corp.) with Synapse

Overview

Basic Info

Drug Type

Recombinant vector vaccine, Therapeutic vaccine

Synonyms

Adenoviral MUC1 vaccine, AD5 MUC1, AD5-MUC1

+ [2]

Target

MUC1

Mechanism

MUC1 modulators(Mucin-1 modulators)

Therapeutic Areas

NeoplasmsDigestive System DisordersSkin and Musculoskeletal Diseases+ [1]

Active Indication

Breast CancerLiver CancerProstatic Cancer

Inactive Indication

ChordomaColorectal CancerHepatocellular Carcinoma+ [10]

Originator Organization

Etubics Corp.

Active Organization

Etubics Corp.

Inactive Organization

ImmunityBio, Inc.

NantKwest, Inc.

National Cancer Institute

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

Background:
Some people who get head and neck cancer will need surgery to treat their cancer. Research suggests that immunotherapy drugs may help fight head and neck cancer if given before surgery. In most cases, there is enough time between cancer diagnosis and surgery to test immunotherapy drugs. In this study, researchers are testing the safety and anti-cancer abilities of 3 drugs given before surgery for head and neck cancer.
Objective:
To learn if giving M7824 alone, or with the TriAd Vaccine (ETBX-011, ETBX-051 & ETBX-061), or with TriAd vaccine plus Anktiva (N-803) can shrink previously untreated head and neck tumors before surgery or stop the tumors from coming back after all treatment.
Eligibility:
People age 18 and older who have a head and neck cancer that has not been treated before, and the tumor must be removed with surgery.
Design:
Participants will be screened in a separate protocol.
Participants will have the following tests:
medical history and physical exams
computed tomography or magnetic resonance imaging scans
tumor, mucosa, and skin biopsies
electrocardiograms to monitor heart activity
endoscopies (a tube is inserted through the nose to see the upper airway)
blood and urine tests.
All participants will get bintrafusp alfa (M7824) through an intravenous infusion. For this, a small plastic tube is put into an arm vein. Some may also get the TriAd vaccine. It is injected under the skin on the arms or legs. Some may also get N-803. It is injected under the skin on the stomach.
Participants will have clinic visits while they are getting treatment and after treatment ends.
After treatment ends, participants will have their scheduled surgery. There will be two follow up visits at the National Institutes of Health (NIH) after your surgery. They will be contacted by phone or email every 2 weeks for 3 months. Then they will be contacted every 3 months for 2 years.
...

Start Date09 Jun 2020

Sponsor / Collaborator

National Cancer Institute

NCT03554109 / WithdrawnPhase 2

An Open-Label Randomized Phase 2 Trial Of The NANT NEOADJUVANT Triple-Negative Breast Cancer (TNBC) VACCINE VS Standard-Of-Care For The Neoadjuvant Treatment Of Subjects With TNBC

This is a randomized open-label phase 2 study to evaluate the efficacy and safety (as assessed by pCR) of the NANT Neoadjuvant TNBC Vaccine regimen (experimental arm) compared to the SoC dose-dense regimen of doxorubicin/cyclophosphamide followed by paclitaxel (control arm).

Start Date01 Sep 2018

Sponsor / Collaborator

ImmunityBio, Inc.

NCT03574649 / WithdrawnPhase 2

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

This is a randomized phase 2 study to compare the efficacy of neoadjuvant, consolidation, and adjuvant immunotherapy (NANT NSCLC Combination Immunotherapy; experimental arm) to standard of care (surgery and adjuvant chemotherapy; control arm) in subjects with stage II-IIIa resectable NSCLC.

Start Date01 Sep 2018

Sponsor / Collaborator

ImmunityBio, Inc.

100 Clinical Results associated with Adenoviral MUC1 vaccine(Etubics Corp.)

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100 Translational Medicine associated with Adenoviral MUC1 vaccine(Etubics Corp.)

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100 Patents (Medical) associated with Adenoviral MUC1 vaccine(Etubics Corp.)

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28

Literatures (Medical) associated with Adenoviral MUC1 vaccine(Etubics Corp.)

01 May 2023·Clinical cancer research : an official journal of the American Association for Cancer Research

Randomized, Double-Blind, Placebo-Controlled Trial of MUC1 Peptide Vaccine for Prevention of Recurrent Colorectal Adenoma

Article

Author: Singhi, Aatur D. ; Rodriguez, Luz M. ; Bansal, Ajay ; Kaufman, Sharon F. ; McMurray, Ryan P. ; Boardman, Lisa A. ; Hur, Chin ; Limburg, Paul J. ; Bao, Riyue ; Strand, Carrie ; Foster, Nathan R. ; Diergaarde, Brenda ; Szabo, Eva ; Schoen, Robert E. ; Dzubinski, Lynda ; Cruz-Correa, Marcia ; Richmond, Ellen ; Jacqueline, Camille M. ; Umar, Asad ; Beatty, Pamela ; Pai, Reetesh K. ; Salazar, Andres ; Kastenberg, David ; Zahrieh, David M. ; McKolanis, John ; Finn, Olivera J.

Abstract:

Purpose::

To assess whether MUC1 peptide vaccine produces an immune response and prevents subsequent colon adenoma formation.

Patients and Methods::

Multicenter, double-blind, placebo-controlled randomized trial in individuals age 40 to 70 with diagnosis of an advanced adenoma ≤1 year from randomization. Vaccine was administered at 0, 2, and 10 weeks with a booster injection at week 53. Adenoma recurrence was assessed ≥1 year from randomization. The primary endpoint was vaccine immunogenicity at 12 weeks defined by anti-MUC1 ratio ≥2.0.

Results::

Fifty-three participants received the MUC1 vaccine and 50 placebo. Thirteen of 52 (25%) MUC1 vaccine recipients had a ≥2-fold increase in MUC1 IgG (range, 2.9–17.3) at week 12 versus 0/50 placebo recipients (one-sided Fisher exact P < 0.0001). Of 13 responders at week 12, 11 (84.6%) responded to a booster injection at week 52 with a ≥2-fold increase in MUC1 IgG measured at week 55. Recurrent adenoma was observed in 31 of 47 (66.0%) in the placebo group versus 27 of 48 (56.3%) in the MUC1 group [adjusted relative risk (aRR), 0.83; 95% confidence interval (CI), 0.60–1.14; P = 0.25]. Adenoma recurrence occurred in 3/11 (27.3%) immune responders at week 12 and week 55 (aRR, 0.41; 95% CI, 0.15–1.11; P = 0.08 compared with placebo). There was no difference in serious adverse events.

Conclusions::

An immune response was observed only in vaccine recipients. Adenoma recurrence was not different than placebo, but a 38% absolute reduction in adenoma recurrence compared with placebo was observed in participants who had an immune response at week 12 and with the booster injection.

25 May 2021·British journal of cancerQ1 · MEDICINE

Conventional versus reverse sequence of neoadjuvant epirubicin/cyclophosphamide and docetaxel: sequencing results from ABCSG-34

Q1 · MEDICINE

Article

Author: Egle, Daniel ; Exner, Ruth ; Balic, Marija ; Dubsky, Peter C ; Bjelic-Radisic, Vesna ; Gnant, Michael ; Filipits, Martin ; Petzer, Andreas L ; Petru, Edgar ; Rudas, Margaretha ; Pichler, Angelika ; Frantal, Sophie ; Sevelda, Paul ; Singer, Christian F ; Bago-Horvath, Zsuzsanna ; Tinchon, Christoph ; Stoeger, Herbert ; Greil, Richard ; Jakesz, Raimund ; Bartsch, Rupert ; Fitzal, Florian ; Wette, Viktor ; Pfeiler, Georg ; Muy-Kheng, Tea Maria ; Hubalek, Michael

BACKGROUND:

Preoperative chemotherapy containing anthracyclines and taxanes is well established in early-stage breast cancer. Previous studies have suggested that the chemotherapy sequence may matter but definitive evidence is missing. ABCSG trial 34 evaluated the activity of the MUC1 vaccine tecemotide when added to neoadjuvant treatment; the study provided the opportunity for the second randomisation to compare two different anthracycline/taxane sequences.

METHODS:

HER2-negative early-stage breast cancer patients were recruited to this randomised multicentre Phase 2 study. Patients in the chemotherapy cohort (n = 311) were additionally randomised to a conventional or reversed sequence of epirubicin/cyclophosphamide and docetaxel. Residual cancer burden (RCB) with/without tecemotide was defined as primary study endpoint; RCB in the two chemotherapy groups was a key secondary endpoint.

RESULTS:

No significant differences in terms of RCB 0/I (40.1% vs. 37.2%; P = 0.61) or pathologic complete response (pCR) rates (24.3% vs. 25%, P = 0.89) were observed between conventional or reverse chemotherapy sequence. No new safety signals were reported, and upfront docetaxel did not result in decreased rates of treatment delay or discontinuation.

CONCLUSION:

Upfront docetaxel did not improve chemotherapy activity or tolerability; these results suggest that upfront neoadjuvant treatment with anthracyclines remains a valid option.

01 Jun 2020·The oncologistQ2 · MEDICINE

A Phase I Trial Using a Multitargeted Recombinant Adenovirus 5 (CEA/MUC1/Brachyury)-Based Immunotherapy Vaccine Regimen in Patients with Advanced Cancer

Q2 · MEDICINE

Article

Author: Orpia, Alanvin ; Bilusic, Marijo ; Marté, Jennifer L. ; Karzai, Fatima ; Donahue, Renee N. ; Redman, Jason M. ; Burmeister, Andrea ; Madan, Ravi A. ; McMahon, Sheri ; Schlom, Jeffrey ; Cordes, Lisa M. ; Gulley, James L. ; Strauss, Julius ; Sater, Houssein Abdul ; Steinberg, Seth M. ; Palena, Claudia ; Gatti-Mays, Margaret E.

Abstract:

Lessons Learned:

Concurrent ETBX-011, ETBX-051, and ETBX-061 can be safely administered to patients with advanced cancer. All patients developed CD4+ and/or CD8+ T-cell responses after vaccination to at least one tumor-associated antigen (TAA) encoded by the vaccine; 5/6 patients (83%) developed MUC1-specific T cells, 4/6 (67%) developed CEA-specific T cells, and 3/6 (50%) developed brachyury-specific T cells. The presence of adenovirus 5-neutralizing antibodies did not prevent the generation of TAA-specific T cells.

Background:

A novel adenovirus-based vaccine targeting three human tumor-associated antigens—CEA, MUC1, and brachyury—has demonstrated antitumor cytolytic T-cell responses in preclinical animal models of cancer.

Methods:

This open-label, phase I trial evaluated concurrent administration of three therapeutic vaccines (ETBX-011 = CEA, ETBX-061 = MUC1 and ETBX-051 = brachyury). All three vaccines used the same modified adenovirus 5 (Ad5) vector backbone and were administered at a single dose level (DL) of 5 × 1011 viral particles (VP) per vector. The vaccine regimen consisting of all three vaccines was given every 3 weeks for three doses then every 8 weeks for up to 1 year. Clinical and immune responses were evaluated.

Results:

Ten patients enrolled on trial (DL1 = 6 with 4 in the DL1 expansion cohort). All treatment-related adverse events were temporary, self-limiting, grade 1/2 and included injection site reactions and flu-like symptoms. Antigen-specific T cells to MUC1, CEA, and/or brachyury were generated in all patients. There was no evidence of antigenic competition. The administration of the vaccine regimen produced stable disease as the best clinical response.

Conclusion:

Concurrent ETBX-011, ETBX-051, and ETBX-061 can be safely administered to patients with advanced cancer. Further studies of the vaccine regimen in combination with other agents, including immune checkpoint blockade, are planned.

100 Deals associated with Adenoviral MUC1 vaccine(Etubics Corp.)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chordoma	Phase 2	US	ImmunityBio, Inc.	31 Aug 2018
Pancreatic Cancer	Phase 2	US	NantKwest, Inc.	28 Jul 2018
Colorectal Cancer	Phase 2	US	NantKwest, Inc.	25 May 2018
Hepatocellular Carcinoma	Phase 2	US	ImmunityBio, Inc.	25 May 2018
Liver Cancer	Phase 2	US	-	17 May 2018
Breast Cancer	Phase 2	US	-	11 Mar 2018
Non-Small Cell Lung Cancer	Phase 2	-	ImmunityBio, Inc.	01 Feb 2018
Squamous Cell Carcinoma	Phase 2	US	NantKwest, Inc.	13 Jan 2018
Melanoma	Phase 2	-	ImmunityBio, Inc.	01 Dec 2017
Merkel Cell Carcinoma	Phase 2	-	ImmunityBio, Inc.	01 Dec 2017

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04247282 (CTgov)	Phase 1/2	Head and Neck Neoplasms \| Squamous Cell Carcinoma of Head and Neck \| Human Papillomavirus Infection	21	M7824	sgixcaqmjf(vvixuhmhcy) = mpcgutdupp bfdwgnpxif (pzhbppekkl, gprfsrfeuw - ouqmpjsidw) View more	-	08 Aug 2023
NCT03384316 (CTgov)	Phase 1	Colonic Cancer \| Prostatic Cancer \| Lung Cancer ... View more	11	adenoviral Carcinoembryonic antigen (CEA) vaccine+ETBX-061+ETBX-051+ETBX-011 (Dose Level 1 Cohort - 5 x 10^11 Viral Particles (VP))	esrtmioukb(cdsvzziuac) = klihexhkav dllvtohlmh (swvmineuuk, zptubjczmq - ytripxblla) View more	-	23 Dec 2019
NCT03384316 (CTgov)	Phase 1		11	adenoviral Carcinoembryonic antigen (CEA) vaccine+ETBX-061+ETBX-051+ETBX-011 (Expansion Cohort - 5 x 10^11 Viral Particles (VP))	esrtmioukb(cdsvzziuac) = qvtjlwunwj dllvtohlmh (swvmineuuk, npjkioqfez - imrpnakayt) View more	-	23 Dec 2019
NCT03481816 (ESMO2019)	Phase 1	Metastatic castration-resistant prostate cancer	12	Ad5 PSA/MUC-1/Brachyury Vaccine	qdlaioncxs(goclakrrae) = wblegkigvm jlxtxowtfw (kvrxdxjmnw )	-	30 Sep 2019
AACR2018	Not Applicable	Adenoma	102	MUC1 vaccine	czbopjhoen(ckdskrcxrr) = oiridwxrrf giveprptte (udvsdmyerl )	-	01 Jul 2018
AACR2018	Not Applicable	Adenoma	102	Placebo	czbopjhoen(ckdskrcxrr) = tmvoiztrqd giveprptte (udvsdmyerl )	-	01 Jul 2018