Delving into the Latest Updates on Cancer vaccine(Therion Biologics Corp.) with Synapse

Overview

Basic Info

Drug Type

Recombinant vector vaccine, Therapeutic vaccine

Synonyms

CEA-MUC-1-TRICOM Vaccine, CEA-MUC-1/TRICOM, Falimarev-inalimarev

+ [11]

Target

CEACAM5 x MUC1

Action

antagonists, inhibitors, stimulants

Mechanism

CEACAM5 antagonists(Carcinoembryonic antigen related cell adhesion molecule 5 antagonists), MUC1 inhibitors(Mucin-1 inhibitors), Immunostimulants

Therapeutic Areas

NeoplasmsDigestive System DisordersRespiratory Diseases+ [2]

Active Indication

Small intestine carcinomaMetastatic colon cancerMetastatic Colorectal Carcinoma+ [8]

Inactive Indication

Adenocarcinoma of large intestineAdvanced cancerBladder Cancer+ [9]

Originator Organization

Therion Biologics Corp.

Active Organization

Bavarian Nordic A/S

National Cancer Institute

Therion Biologics Corp.

+ [1]

Inactive Organization

MedImmune LLC

Drug Highest PhasePhase 2

First Approval Date-

RegulationOrphan Drug (United States)

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Background:
Combination immunotherapy techniques are being explored to improve responses and enhance benefits in people with cancer. Researchers want to see if this type of treatment can help people with advanced solid tumors.
Objective:
To find a safe dose of SX-682 in combined treatment with Bintrafusp alfa and BN-CV301 vaccines and to see if this treatment will cause tumors to shrink.
Eligibility:
Adults age 18 and older with metastatic cancer may be eligible for the first part of the trial. Adults age 18 and older with metastatic triple negative breast cancer or p16 negative head and neck squamous cell cancer, and who are not candidates for curative surgery may be eligible for the second part of the trial.
Design:
Participants will be screened under a separate protocol.
Participants may have tumor biopsies. They will have physical exams. Their symptoms and medicines will be reviewed. They will have blood tests. They will have electrocardiograms to evaluate their heart.
Participants will have imaging scans of the chest, abdomen, and pelvis. They may have a procedure where a small tube with a tiny video camera is put into the nose to look at the throat if they have head and neck cancers.
Participants will get bintrafusp alfa through an intravenous catheter. For this, a small tube is put into an arm vein. They will get BN-CV301 vaccines as injections in the arm or thigh. They will take SX-682 by mouth twice a day. They will take the study drugs up to 2 years. They will keep a medicine diary.
Participants will have study visits every 2 weeks. They will have 1 or 2 follow-up visits within 30 days after they stop treatment. Then they will be monitored by phone or email for 2 years.

Start Date24 Nov 2020

Sponsor / Collaborator

National Cancer Institute

NCT04491955

/ CompletedPhase 2IIT

Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers

Background:
Metastatic or refractory/recurrent small bowel and colorectal cancers cannot be cured and are often not helped by standard treatments. Researchers want to find better treatments by testing a combination of drugs.
Objective:
To learn if a new combination of immunotherapy drugs can shrink tumors in people with advanced small bowel and colorectal cancers.
Eligibility:
People ages 18 and older who have advanced metastatic or refractory/recurrent small bowel and/or colorectal cancer.
Design:
Participants will be screened on a separate protocol. They will have a physical exam and medical history. They will have imaging scans. They will have blood and urine tests. Their heart function will be measured. They may have a tumor biopsy.
Participants will repeat some of the screening tests during the study.
Participants will be put into study groups. Each group will get a combination of the following drugs: CV301 vaccine (modified vaccinia Ankara (MVA)-BN-CV301 and Fowlpox (FPV)-CV301), M7824 (MSB0011359C), and N-803 (Anktiva). Some will also get NHS-IL12 (M9241).
Participants will get the CV301 vaccines by injection under the skin. They will get M7824 by intravenous infusion every 2 weeks. They will get N-803 by injection under the skin every 2 or 4 weeks. They may get NHS-IL12 by injection under the skin every 4 weeks. They will take the study drugs for up to 1 year. They will visit the National Institutes of Health (NIH) every 2 weeks.
After treatment ends, participants will go to the clinic for a 28-day follow-up visit or have a telephone call. They will be contacted every 3 months for 1 year, and then every 6 months after that for the rest of their life.

Start Date22 Sep 2020

Sponsor / Collaborator

National Cancer Institute

NCT03628716

/ CompletedPhase 2

A Phase 2, Multicenter, Single-Arm Trial of CV301 in Combination With PD-1/L1 Blockade in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

This is a Phase 2, single-arm, multi-institutional clinical trial designed to study the combination of CV301 with atezolizumab in the first-line treatment of UC not eligible for cisplatin-containing chemotherapy (Cohort 1) and in the second-line treatment of UC previously treated with standard first-line cisplatin-based chemotherapy (Cohort 2).

Start Date18 Sep 2018

Sponsor / Collaborator

Bavarian Nordic A/S

100 Clinical Results associated with Cancer vaccine(Therion Biologics Corp.)

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100 Translational Medicine associated with Cancer vaccine(Therion Biologics Corp.)

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100 Patents (Medical) associated with Cancer vaccine(Therion Biologics Corp.)

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19

Literatures (Medical) associated with Cancer vaccine(Therion Biologics Corp.)

01 Mar 2023·Cancer Immunology, Immunotherapy

Phase II trial of CV301 vaccine combined with atezolizumab in advanced urothelial carcinoma

Article

Author: Hsieh, Andrew Caleb ; Grivas, Petros ; Maughan, Benjamin Louis ; Lee, Richard J ; Pico-Navarro, Cesar ; Gafoor, Zarina ; Sonpavde, Guru P ; Montgomery, Robert B ; Wei, Xiao X ; Grewal, Jaspreet S ; Yu, Evan Y ; McGregor, Bradley Alexander ; Perschy, Teresa ; Cheng, Heather H ; Kilbridge, Kerry L ; Jain, Rohit ; Schweizer, Michael Thomas

CV301 comprises recombinant poxviruses, Modified Vaccinia Ankara (MVA) and Fowlpox (FPV), encoding CEA, MUC-1, and co-stimulatory Molecules (TRICOM) ICAM-1, LFA-3, and B7-1. MVA-BN-CV301 is used for priming and FPV-CV301 is used for boosting. A Phase 2, single-arm trial was designed to evaluate CV301 plus atezolizumab as first-line treatment for cisplatin-ineligible advanced urothelial carcinoma (aUC) (Cohort 1) or progressing after platinum chemotherapy (Cohort 2). MVA-CV301 was given subcutaneously (SC) on Days 1 and 22 and FPV-CV301 SC from day 43 every 21 days for 4 doses, then tapered gradually over up to 2 years. Atezolizumab 1200 mg IV was given every 21 days. The primary endpoint was objective response rate (ORR). Overall, 43 evaluable patients received therapy: 19 in Cohort 1; 24 in Cohort 2; nine experienced ≥ Grade 3 therapy-related adverse events. In Cohort 1, one had partial response (PR) (ORR 5.3%, 90% CI 0.3, 22.6). In Cohort 2, 1 complete response and 1 PR were noted (ORR 8.3%, 90% CI 1.5, 24.0). The trial was halted for futility. Patients exhibiting benefit demonstrated T-cell response to CEA and MUC-1. The trial illustrates the challenges in the development of vaccines, which should be guided by robust preclinical data.

01 Feb 2023·International Journal of Cancer

Phase 1 trial of CV301 in combination with anti‐PD‐1 therapy in nonsquamous non‐small cell lung cancer

Article

Author: Gulley, James L. ; Donahue, Renee N. ; Korchin, Borys ; Devarakonda, Siddhartha ; Gray, Jhanelle E. ; Birhiray, Ruemu ; Schlom, Jeffrey ; Rajan, Arun ; Menius, Erika

AbstractCV301, a poxviral‐based vaccine, has been evaluated in a phase 1 clinical trial (NCT02840994) and shown to be safe and immunologically active (phase 1a). Preclinical data support a combination of CV301 with programmed death‐1 inhibitors, which has been evaluated in the phase 1b part of this trial and is reported here. Patients with advanced nonsquamous non‐small cell lung cancer (NSCLC) without actionable genomic alterations received two priming doses of modified vaccinia Ankara‐BN‐CV301 (MVA) 4 weeks apart, followed by boosting doses of fowlpox‐CV301 (FPV) at increasing time intervals for a maximum of 17 doses in combination with nivolumab for cohort 1 (C1) and 15 doses in combination with pembrolizumab for cohort 2 (C2). The primary objective was evaluation of safety and tolerability. Between October 2017 and September 14, 2018, patients were enrolled (C1: 4; median age: 64 years). Mean treatment duration was 332 days in C1 and 289 days in C2. CTCAE ≥grade 3 adverse events (AEs) were observed in four (100%) patients in C1 and three (37.5%) patients in C2. There was one death on trial. Immune‐related AEs (irAEs) fulfilling criteria for a dose‐limiting toxicity included 1 case of pneumonitis. Among 11 evaluable patients, 1 (9%) had a complete response, 1 (9%) had a partial response and 9 (82%) had stable disease. We conclude that CV301 administered with PD‐1 inhibitors is safe and clinically active in patients with advanced NSCLC. The frequency or severity of AEs is not increased, including irAEs for each component of the combination.

01 Dec 2019·Journal for ImmunoTherapy of CancerQ2 · MEDICINE

Vaccinia virus-mediated cancer immunotherapy: cancer vaccines and oncolytics

Q2 · MEDICINE

ReviewOA

Author: Dai, Enyong ; Lu, Binfeng ; Guo, Zongbi ; Feist, Mathilde ; Liu, Weilin ; Bartlett, David L ; He, Yukai ; Guo, Zong Sheng ; Giehl, Esther ; Storkus, Walter J ; Liu, Zuqiang

Cancer vaccines and oncolytic immunotherapy are promising treatment strategies with potential to provide greater clinical benefit to patients with advanced-stage cancer. In particular, recombinant vaccinia viruses (VV) hold great promise as interventional agents. In this article, we first summarize the current understanding of virus biology and viral genes involved in host-virus interactions to further improve the utility of these agents in therapeutic applications. We then discuss recent findings from basic and clinical studies using VV as cancer vaccines and oncolytic immunotherapies. Despite encouraging results gleaned from translational studies in animal models, clinical trials implementing VV vectors alone as cancer vaccines have yielded largely disappointing results. However, the combination of VV vaccines with alternate forms of standard therapies has resulted in superior clinical efficacy. For instance, combination regimens using TG4010 (MVA-MUC1-IL2) with first-line chemotherapy in advanced-stage non-small cell lung cancer or combining PANVAC with docetaxel in the setting of metastatic breast cancer have clearly provided enhanced clinical benefits to patients. Another novel cancer vaccine approach is to stimulate anti-tumor immunity via STING activation in Batf3-dependent dendritic cells (DC) through the use of replication-attenuated VV vectors. Oncolytic VVs have now been engineered for improved safety and superior therapeutic efficacy by arming them with immune-stimulatory genes or pro-apoptotic molecules to facilitate tumor immunogenic cell death, leading to enhanced DC-mediated cross-priming of T cells recognizing tumor antigens, including neoantigens. Encouraging translational and early phase clinical results with Pexa-Vec have matured into an ongoing global phase III trial for patients with hepatocellular carcinoma. Combinatorial approaches, most notably those using immune checkpoint blockade, have produced exciting pre-clinical results and warrant the development of innovative clinical studies. Finally, we discuss major hurdles that remain in the field and offer some perspectives regarding the development of next generation VV vectors for use as cancer therapeutics.

100 Deals associated with Cancer vaccine(Therion Biologics Corp.)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Prostatic Cancer	Phase 2	-	Therion Biologics Corp.	-
Prostatic Cancer	Phase 2	-	Bavarian Nordic, Inc.	-
Metastatic Pancreatic Cancer	Discovery	United States	Therion Biologics Corp.	01 Jun 2004
Metastatic Pancreatic Cancer	Discovery	United States	Therion Biologics Corp.	01 Jun 2004
Ovarian Cancer	Discovery	-	Bavarian Nordic, Inc.	-
Ovarian Cancer	Discovery	-	Therion Biologics Corp.	-
Ovarian Cancer	Discovery	-	Therion Biologics Corp.	-
Ovarian Cancer	Discovery	-	Bavarian Nordic, Inc.	-
Ovarian Cancer	Discovery	-	National Cancer Institute	-
Ovarian Cancer	Discovery	-	National Cancer Institute	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04491955 (CTgov)	Phase 2	Colorectal Cancer \| Small intestine carcinoma	32	NHS-IL12 (M9241) (Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241))	(yustjtnzyr) = gnmcwiecdy hjsvnlzehg (ezgnelftar, nuhdmcbbtj - lqvdnrhlph) View more	-	14 Nov 2023
				Fowlpox (FPV)-CV301+N-803+modified vaccinia Ankara (MVA)-BN-CV301+M7824+NHS-IL12 (M9241) (Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation)	(wvjouxbxsv) = ahehkpwkdp hcxsqhdiyx (wlcyqevvzi, ffqenzcjkx - oeuqcilysn) View more
NCT03547999 (HCRN GI16-288, ASCO_GI2023) Manual	Phase 2	Metastatic Colorectal Carcinoma First line MSS	17	mFOLFOX + nivolumab	(wewvcbvmwv) = jjgoxbhmvv tblfwbyhnw (frdtjsxanb ) View more	Positive	24 Jan 2023
				mFOLFOX + nivolumab + CV301	(wewvcbvmwv) = wapwuiadcp tblfwbyhnw (frdtjsxanb ) View more
NCT04491955 (ASCO_GI2023) Manual	Phase 2	Advanced Colorectal Adenocarcinoma \| Small intestine carcinoma Second line	30	overall	(agkdptffoq) = yhvrmqicre tgoxzawlhd (kqsifzsivj )	Positive	24 Jan 2023
				CV301+N-803+bintrafusp alfa (triple therapy)	(kvvpytnxxw) = xhaxspzpnl wdfvxqzapu (vbjpyhhnor, 33.7 - 86.0) View more
NCT03376659 (CTgov)	Phase 1/2	Adenocarcinoma of large intestine \| Pancreatic adenocarcinoma metastatic \| Metastatic Pancreatic Cancer \| Metastatic Colorectal Carcinoma	8	CV301+Bevacizumab+Durvalumab+Capecitabine	fitvnyodss(fntqqlbyeo) = zcguxvhiew vmjiowkmvq (pddkkephtu, bbhpimocyl - fmzzfmqizl) View more	-	10 Jan 2023
NCT03628716 (CTgov)	Phase 2	Bladder Cancer	43	Atezolizumab+CV301 (CV301 + Atezolizumab (Cohort 1))	(wshdynpvqc) = vrfjqgxiwv uromvuistt (ltahkxzjrv, jdrkzrnayq - pkaliobfyb) View more	-	27 Apr 2022
				Atezolizumab+CV301 (CV301 + Atezolizumab (Cohort 2))	(wshdynpvqc) = crzgxvowqe uromvuistt (ltahkxzjrv, snuqfuxfcn - bmwkwqqgry) View more
MP16-14 (AUA2021)	Phase 2	Non-Muscle Invasive Bladder Neoplasms	30	BCG alone	(ufyadysyya) = okkqzodovs eflhvbsrkv (gxlkdyigtg, 56.9 - 100) View more	Negative	01 Sep 2021
				BCG+PANVAC	(ufyadysyya) = dkozfwtgam eflhvbsrkv (gxlkdyigtg, 59.8 - 100) View more
NCT02015104 (CTgov)	Phase 2	Carcinoma of urinary bladder, invasive \| Non-Muscle Invasive Bladder Neoplasms	32	BCG intravesical live (TICE Bacillus Calmette-Guerin (BCG))+PANVAC (Bacillus Calmette-Guerin (BCG) + PANVAC)	sagehqfafo(efruthuiso) = brmpxlvvmr haxhvlcqzp (vkmwrqrrvk, dzigjwfagl - sdxiansfcr) View more	-	22 Jan 2020
				BCG intravesical live (TICE Bacillus Calmette-Guerin (BCG)) (Bacillus Calmette-Guerin (BCG) Alone)	sagehqfafo(efruthuiso) = xdbpnlzpia haxhvlcqzp (vkmwrqrrvk, qravpwtukk - cbomlwkqic) View more
NCT02840994 (ESMO2019) Manual	Phase 1	Squamous non-small cell lung cancer	12	nivolumab+CV301 (patients pre-treated with platinum-containing chemotherapy)	(liwfdkuwzk) = 3/4 C1 and 3/8 C2 pts with 1 fatal juvgvqejfp (bdwasotssh ) View more	Positive	30 Sep 2019
				pembrolizumab+CV301 (patients receiving frontline treatment with pembrolizumab after a minimum of 11 weeks of SD per RECIST)
NCT00103142 (CTgov)	Phase 2	Secondary malignant neoplasm of lung \| Neoplasm Metastasis \| Colorectal Cancer	74	therapeutic autologous dendritic cells+falimarev (PANVAC-V + PANVAC-F + DC)	yhfcftvncd(viludognlr) = xnyvtpzctq uuxblysrzr (yyuxivviwb, ftypnsiqzl - yozdyukpfp) View more	-	07 Apr 2014
				falimarev+sargramostim (PANVAC-V + PANVAC-F + GM-CSF)	yhfcftvncd(viludognlr) = mnhgpshaza uuxblysrzr (yyuxivviwb, wmjaaovwxl - cqbzvpagoc) View more
NCT00179309 (CTgov)	Phase 2	Metastatic breast cancer	48	PANVAC-V+PANVAC-F+Docetaxel+Sargramostim (Arm I - PANVAC + Docetaxel)	(vwcwytavhx) = bavrldxtaa tjjrjngxll (hqxmqzrqtw, nciadkszvo - pfqxdacohg) View more	-	27 Jun 2013
				Docetaxel (Arm II - Docetaxel Alone)	(vwcwytavhx) = xlupblgnew tjjrjngxll (hqxmqzrqtw, fbkwxjygei - lrjvzdyddq) View more