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

Action

modulators

Mechanism

MUC1 modulators(Mucin-1 modulators)

Therapeutic Areas

NeoplasmsInfectious DiseasesUrogenital Diseases

Active Indication

Human Papillomavirus InfectionSquamous Cell Carcinoma of Head and NeckProstatic Cancer

Inactive Indication

Advanced cancerBreast CancerChordoma+ [13]

Originator Organization

Etubics Corp.

Active Organization

National Cancer Institute

Etubics Corp.

Inactive Organization

ImmunityBio, Inc.

NantKwest, Inc.

License Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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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

NCT03563157

/ TerminatedPhase 1/2

NANT Colorectal Cancer (CRC) Vaccine: A Phase 1b/2 Trial of the NANT CRC Vaccine vs Regorafenib in Subjects With Metastatic CRC Who Have Been Previously Treated With Standard-of-Care Therapy

QUILT 3.071 NANT Colorectal Cancer (CRC) Vaccine: This is a Phase 1b/2 study investigating the effect of NANT CRC vaccine vs regorafenib in subjects with CRC who were previously treated with SOC.

Start Date28 Sep 2018

Sponsor / Collaborator

ImmunityBio, Inc.

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.

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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2

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

10 Mar 2025·ONCOLOGIST

Tri-Ad5 vaccine plus bintrafusp alfa for newly diagnosed, advanced-stage head and neck cancer not associated with human papillomavirus infection

Article

Author: Allen, Clint T ; Redman, Jason M ; Prins, Daniel ; Gulley, James L ; Turkbey, Evrim B ; Steinberg, Seth J ; Cordes, Lisa ; Schlom, Jeffrey ; Floudas, Charalampos S ; Donahue, Renee N ; Soon-Shiong, Patrick ; Marté, Jennifer L

Abstract:

Background:

Newly diagnosed, advanced-stage head and neck cancer (HNSCC) not associated with human papillomavirus (HPV) infection has poor survival and functional outcomes despite surgical management. Neoadjuvant immunotherapy is of interest to improve long-term outcomes.

Methods:

Individuals with untreated intermediate/high risk, p16-negative (if oropharyngeal) HNSCC were eligible and underwent pre- and post-treatment tumor biopsies. Primary endpoint was pathologic complete response or clinical-to-pathological downstaging (CPD). Treatment regimen: 5 × 1011 viral particles once, subcutaneously of each component of the Tri-Ad5 vaccine (ETBX-011, ETBX-061, and ETBX-051 targeting tumor-associated antigens (TAA): carcinoembryonic antigen [CEA], MUC-1, and brachyury, respectively) plus 1200 mg IV of bintrafusp alfa (anti-PD-L1 and anti-transforming growth factor-β) every 2 weeks for 2 doses. Participants returned to referring physicians for standard surgery ± adjuvant treatment if indicated.

Results:

Of 6 HNSCC patients, 2 (33.3%) had CPD. There were no pathologic complete responses. 2-year recurrence free survival (RFS) was 83.3% (95% CI, 27.3%-97.5%). Adverse events were consistent with known safety profiles of each agent. There were no surgical delays.

Conclusions:

In this small study, Tri-Ad5 vaccine plus bintrafusp alfa resulted in CPD in 2/6 patients. Participants also had favorable 2-year RFS compared to historical values. Ongoing tissue and peripheral immunome analyses may provide mechanistic insight. (ClincalTrials.gov Identifier: NCT04247282; IRB Approved.).

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 ; Gulley, James L. ; Strauss, Julius ; Cordes, Lisa M. ; 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
Human Papillomavirus Infection	Phase 2	United States	National Cancer Institute	09 Jun 2020
Metastatic Colorectal Carcinoma	Phase 2	United States	ImmunityBio, Inc.	28 Sep 2018
Triple Negative Breast Cancer	Phase 2	United States	ImmunityBio, Inc.	01 Sep 2018
Chordoma	Phase 2	United States	ImmunityBio, Inc.	31 Aug 2018
Unresectable Solid Neoplasm	Phase 2	United States	ImmunityBio, Inc.	31 Aug 2018
Metastatic Pancreatic Cancer	Phase 2	United States	ImmunityBio, Inc.	01 Aug 2018
Resectable Lung Non-Small Cell Carcinoma	Phase 2	United States	ImmunityBio, Inc.	01 Jun 2018
Unresectable Hepatocellular Carcinoma	Phase 2	United States	ImmunityBio, Inc.	25 May 2018
Squamous Cell Carcinoma	Phase 2	United States	NantKwest, Inc.	13 Jan 2018
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


NCT03563157 (CTgov)	Phase 1/2	Metastatic Colorectal Carcinoma	2	SBRT+Aldoxorubicin Hydrochloride+GI-6301+GI-4000+ETBX-061+Cetuximab+ETBX-051+ETBX-011+5-fluorouracil+ALT-803+ETBX-021+Nab-paclitaxel+Cyclophosphamide+Avelumab+haNK+Leucovorin+GI-6207+Regorafenib+oxaliplatin+Capecitabine (NANT Colorectal Cancer (CRC) Vaccine)	xrcfmzkbqa = ozhtrsrjjq osfejnpnby (pzrwcuojuz, iqzweywyvi - eghyffxmvr) View more	-	11 Dec 2024
				Regorafenib (Regorafenib)	ykucuqvjpe(qqpvpknbkn) = paetbdgbrv jswthitrcd (lzmgmpdgsi, niqzvbwjeg - sxidfahdpk) View more
NCT03384316 (CTgov)	Phase 1	Lung Cancer \| Colonic Cancer \| Breast 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))	dcvjmngjoy = pjywfyguca zgewdzfvhz (zvoixnxfur, yocgtalaai - ecelunjdtn) View more	-	23 Dec 2019
				adenoviral Carcinoembryonic antigen (CEA) vaccine+ETBX-061+ETBX-051+ETBX-011 (Expansion Cohort - 5 x 10^11 Viral Particles (VP))	dcvjmngjoy = qdeveraacg zgewdzfvhz (zvoixnxfur, mnvuixzglr - lqoilxixcm) View more
NCT03481816 (ESMO2019)	Phase 1	Metastatic castration-resistant prostate cancer	12	Ad5 PSA/MUC-1/Brachyury Vaccine	gpissgwlks(lbenilbizi) = aatmforgwo wxdvbalfoo (puxyyrgfql )	-	30 Sep 2019
AACR2018	Not Applicable	Adenoma	102	MUC1 vaccine	fedoqjrmet(wblnpyjfxs) = nrkbyspius onihsyrcrw (lxntkfpmqd )	-	01 Jul 2018
				Placebo	fedoqjrmet(wblnpyjfxs) = dorngeuwcr onihsyrcrw (lxntkfpmqd )