Delving into the Latest Updates on CEA-targeted vaccine(Etubics Corp.) with Synapse

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.
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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 CEA-targeted vaccine(Etubics Corp.)

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100 Translational Medicine associated with CEA-targeted vaccine(Etubics Corp.)

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100 Patents (Medical) associated with CEA-targeted vaccine(Etubics Corp.)

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7

Literatures (Medical) associated with CEA-targeted 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 ; Steinberg, Seth J ; Cordes, Lisa ; Turkbey, Evrim B ; Gulley, James L ; 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.).

11 Mar 2022·The oncologistQ2 · MEDICINE

A Randomized Phase II Trial of mFOLFOX6 + Bevacizumab Alone or with AdCEA Vaccine + Avelumab Immunotherapy for Untreated Metastatic Colorectal Cancer

Q2 · MEDICINE

Article

Author: Marshall, John L ; Bilusic, Marijo ; Gandhy, Shruti ; Redmond, Erica ; Abdul Sater, Houssein ; Tsai, Yo-Ting ; Gulley, James L ; Weinberg, Benjamin A ; Kim, Sunnie S ; Jochems, Caroline ; Redman, Jason M ; Marte, Jennifer L ; Donahue, Renee N ; Schlom, Jeffrey ; Steinberg, Seth M ; Gatti-Mays, Margaret E ; McMahon, Sheri ; Strauss, Julius ; Cordes, Lisa M

Abstract:

Background:

FOLFOX plus bevacizumab is a standard of care (SOC) for first-line treatment of microsatellite-stable metastatic colorectal cancer (MSS mCRC). This study randomized patients to SOC or SOC plus avelumab (anti-PD-L1) plus CEA-targeted vaccine.

Methods:

Patients with untreated MSS mCRC enrolled to a lead-in arm assessing safety of SOC + immuno-oncology agents (IO). Next, patients were randomized to SOC or SOC + IO. The primary endpoint was progression-free survival (PFS). Multiple immune parameters were analyzed.

Results:

Six patients enrolled to safety lead-in, 10 randomized to SOC, and 10 to SOC + IO. There was no difference in median PFS comparing SOC versus SOC + IO (8.8 months (95% CI: 3.3-17.0 months) versus 10.1 months (95% CI: 3.6-16.1 months), respectively; hazard ratio 1.061 [P = .91; 95% CI: 0.380-2.966]). The objective response rate was 50% in both arms. Of patients analyzed, most (8/11) who received SOC + IO developed multifunctional CD4+/CD8+ T-cell responses to cascade antigens MUC1 and/or brachyury, compared to 1/8 who received SOC alone (P = .020). We detected post-treatment changes in immune parameters that were distinct to the SOC and SOC + IO treatment arms. Accrual closed after an unplanned analysis predicted a low likelihood of meeting the primary endpoint.

Conclusions:

SOC + IO generated multifunctional MUC1- and brachyury-specific CD4+/CD8+ T cells despite concurrent chemotherapy. Although a tumor-directed immune response is necessary for T-cell–mediated antitumor activity, it was not sufficient to improve PFS. Adding agents that increase the number and function of effector cells may be required for clinical benefit.

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. ; Strauss, Julius ; Gulley, James L. ; 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 CEA-targeted 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
Squamous Cell Carcinoma of Head and Neck	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
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
Unresectable Melanoma	Phase 2	-	ImmunityBio, Inc.	01 Dec 2017
Colonic Cancer	Phase 2	United States	ImmunityBio, Inc.	26 Jun 2017
Ovarian Cancer	Phase 2	United States	ImmunityBio, Inc.	26 Jun 2017
Thyroid Cancer	Phase 2	United States	ImmunityBio, Inc.	26 Jun 2017

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01147965 (QUILT-3.038, CTgov)	Phase 1/2	Lung Cancer \| Breast Cancer \| Prostatic Cancer ... View more	43	Ad5 CEA Vaccine (Cohort 1)	ltnelwzhge = jwcnimring kedciyiygd (htvsmbdxpa, xvrdymjmml - sxgftsejzk) View more	-	25 Nov 2025
NCT01147965 (QUILT-3.038, CTgov)	Phase 1/2		43	Ad5 CEA Vaccine (Cohort 2)	ltnelwzhge = uvvxejqncb kedciyiygd (htvsmbdxpa, oafspwgepr - ecmapybbjc) View more	-	25 Nov 2025
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)	uqueyjvzvz = nlhivbmbwo usujsozqlt (xkgmvvyccm, xymxvremjb - tpaxjlrcwh) View more	-	11 Dec 2024
NCT03563157 (CTgov)	Phase 1/2	Metastatic Colorectal Carcinoma	2	Regorafenib (Regorafenib)	dtsegpbnxc(dkyuxssefv) = jxrtxgkjis cxkzvtwaod (ltduuqigaf, nygkheogjh - fobzilnqpe) View more	-	11 Dec 2024
NCT03127098 (CTgov)	Phase 1/2	Lung Cancer \| Ovarian Cancer \| Colonic Cancer ... View more	3	ALT-803+ETBX-011	fdqltylvxl = cloearkrun oajxfvplao (pnazzrdmoq, raocyvxrpr - dilskvsmmc) View more	-	06 Aug 2024
NCT03136406 (QUILT-3.039, CTgov)	Phase 1/2	Pancreatic Cancer	3	aNK for Infusion+ALT-803+GI-4000+Nab-paclitaxel+Cyclophosphamide+avelumab+Leucovorin+Bevacizumab+ETBX-011+Oxaliplatin+5-fluorouracil+Capecitabine	buloxmkknd = lfkfzikpoi euphdazzxx (qtayiuixvr, glspfbgxtv - emnaujfzcw) View more	-	11 Jun 2024
NCT04247282 (SITC2023)	Phase 1/2	Squamous Cell Carcinoma of Head and Neck Neoadjuvant	20	Bintrafusp alfa (BA) alone	jvljtyheoh(gsawemlboe) = gzgxdugsfb kaziitmbyo (ttzwcrgtev )	Positive	02 Nov 2023
NCT04247282 (SITC2023)	Phase 1/2	Squamous Cell Carcinoma of Head and Neck Neoadjuvant	20	Bintrafusp alfa (BA) + TriAdeno vaccine	jvljtyheoh(gsawemlboe) = tzjuktuhlk kaziitmbyo (ttzwcrgtev )	Positive	02 Nov 2023
NCT04247282 (Tri-Ad5 vaccine plus bintrafusp alfa, CTgov)	Phase 1/2	Squamous Cell Carcinoma of Head and Neck	21	M7824	zteagntxdi = msswxsfjma zxwozdkegk (slatnpeyyd, tjcwmwnqiz - dxkkgdgavd) View more	-	08 Aug 2023
NCT03586869 (ASCO2019)	Phase 1	Metastatic Pancreatic Cancer Third line	12	Low-dose chemotherapy (aldoxorubicin, cyclophosphamide, oxaliplatin, nab-paclitaxel, 5-FU/L)	cunrrybivk(iquohvndnc) = weokppysej znylzfhvnk (ljxldwadzb ) View more	Positive	26 May 2019
NCT01147965 (ASCO2014)	Phase 1/2	Metastatic Colorectal Carcinoma	35	ETBX-011	tbdrtqhszq(loqmomuhsn) = jyqqrqldsg zrtmboagiw (lwskdqbhyx ) View more	-	20 May 2014
AACR2013	Phase 1/2	Advanced Colorectal Adenocarcinoma	32	ETBX-011	mxwnpjagby(zzdhpkcthb) = igaschloxo xlscziojuu (rldoitmypj )	-	15 Apr 2013