Delving into the Latest Updates on TG-01(Targovax) with Synapse

Overview

Basic Info

Drug Type

Therapeutic vaccine

Synonyms

Target-

Mechanism

Immunostimulants

Therapeutic Areas

NeoplasmsImmune System DiseasesCardiovascular Diseases+ [1]

Active Indication

Multiple MyelomaSmoldering Multiple Myeloma

Inactive Indication

Pancreatic adenocarcinoma

Originator Organization

Circio Holding ASA

Active Organization

Circio Holding ASA

Inactive Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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Gene Sequence

Sequence Code 1200587266

Sequence Code 1200587268

Sequence Code 9906473

Sequence Code 1200587269

Sequence Code 1200587267

Sequence Code 1200587270

Sequence Code 9906477

Phase 1b study evaluating the efficacy and immune response to a synthetic long peptide mutant KRAS vaccine (SPL mKRASvax) combined with Balstilimab and Botensilimab for unresectable or metastatic mismatch repair-proficient (MMR-p) colorectal cancer (mCRC) or unresectable or metastatic MMR-p pancreatic ductal adenocarcinoma (PDAC) patients with measurable disease following first-line FOLFIRINOX/FOLFOXIRI (FFX).

Start Date04 Nov 2024

Sponsor / Collaborator

The Sidney Kimmel Comprehensive Cancer Center

[+2]

NCT06015724 / RecruitingPhase 2IIT

A Phase 2 Study Evaluating the Efficacy of Anti-CD38 Antibody in Combination With KRAS Vaccine and Anti-PD-1 Antibody in Subjects With Pancreatic Ductal Adenocarcinoma and Refractory Non-Small Cell Lung Cancer

The goal of this clinical trial is to test the safety and tolerability of anti-CD38 monoclonal antibody (mAb), daratumumab, in combination with KRAS vaccine (Targovax TG-01/Stimulon QS-21) when given with anti-PD-1 (programmed cell death protein 1) mAb (nivolumab) in patients with advanced non-small cell lung cancer (NSCLC) or pancreatic ductal adenocarcinoma (PDAC). The main questions it aims to answer are:
How well does daratumumab and nivolumab, when given with a vaccine, control or stop these types of cancer?
How well does participants bodies handle these study drugs?
Does this combination of study drugs help participants live longer? Participants will receive daratumumab, nivolumab with KRAS vaccine and have regular tests and procedures to follow how the participants are doing on these study drugs.

Start Date31 Jan 2024

Sponsor / Collaborator

Georgetown University

[+3]

NCT05841550 / RecruitingPhase 1/2IIT

A Phase 1/Phase 2 Study to Investigate Safety, Tolerability and Efficacy With TG01/QS-21 Vaccine Administration in Patients With Confirmed KRAS or NRAS Codon 12/13 Mutation and High-risk Smoldering Multiple Myeloma or Multiple Myeloma and Evidence of Measurable Disease ≥ 1 Line of Treatment

The goal of this clinical trial is to test the safety, tolerability, and efficacy of TG01 vaccination in patients with KRAS or NRAS mutation on codon 12/13 mutation who has multiple myeloma or high-risk smoldering multiple myeloma. The main question it aims to answer are:
Is TG01/QS-21 vaccination safe and tolerable for this patient group? Is TG01/QS-21 vaccination treatment efficient in this group in terms of increased overall response rate, overall survival rate, progression-free survival, and time til next treatment? Is there an immunological response to the vaccine? Participants will be given TG01/QS-21 vaccination treatment. Treatment consists of 12 doses of TG01/QS-21 vaccine given every two weeks in the first 12 weeks, followed by every eight weeks until week 52.

Start Date19 May 2023

Sponsor / Collaborator

Oslo universitetssykehus HF

[+1]

100 Clinical Results associated with TG-01(Targovax)

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100 Translational Medicine associated with TG-01(Targovax)

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100 Patents (Medical) associated with TG-01(Targovax)

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3

Literatures (Medical) associated with TG-01(Targovax)

31 Mar 2020·British Journal of CancerQ1 · MEDICINE

TG01/GM-CSF and adjuvant gemcitabine in patients with resected RAS-mutant adenocarcinoma of the pancreas (CT TG01-01): a single-arm, phase 1/2 trial

Q1 · MEDICINE

Article

Author: Palmer, Daniel H ; Miller, Robert ; Faluyi, Olusola ; Aksnes, Anne-Kirsti ; Amund Eriksen, Jon ; Jensen Gjertsen, Trine ; Ma, Yuk Ting ; Neoptolemos, John P ; Møller, Anne-Sophie ; Valle, Juan W ; Iversen, Berit ; Dueland, Svein

AbstractBackgroundTG01 is the first cancer immunotherapy targeting KRAS oncogenic mutations. This study assessed the safety and efficacy of TG01/GM-CSF in patients with resected pancreatic adenocarcinoma.MethodsPatients with stage I or II pancreatic adenocarcinoma who had undergone surgical resection (R0 or R1) received adjuvant gemcitabine with TG01/GM-CSF using two schedules of vaccination. Immune response was defined as a positive delayed-type hypersensitivity (DTH) response and/or positive T-cell proliferation assay.ResultsThirty-two patients were enrolled between February 2013 and May 2016. Nineteen were treated with the high antigen burden, with four serious adverse reactions considered possibly related to TG01 treatment, including three allergic reactions. On this basis, a further 13 patients received a modified vaccination schedule with reduced antigen burden, with no serious adverse events related to TG01. Ninety-five percent patients in the main cohort and 92% in the modified cohort had a positive immune response. Median overall survival (OS) was 33.1 months, and median disease-free survival (DFS) was 13.9 months for the main cohort. For the modified cohort, the median OS was 34.3 months and median DFS was 19.5 months.ConclusionsTG01/GM-CSF with gemcitabine was well tolerated, with high levels of immune activation. OS and DFS compare favourably with published data for adjuvant gemcitabine.Clinical trial registrationThis clinical trial was registered at ClinicalTrials.gov (NCT02261714).

01 Mar 2004·Medical and Veterinary EntomologyQ2 · AGRICULTURAL & FORESTRY SCIENCE

Abundance of stable flies on heifers treated for control of horn flies with organophosphate impregnated ear tags

Q2 · AGRICULTURAL & FORESTRY SCIENCE

Article

Author: O. R. Quaino ; A. A. Guglielmone ; A. J. Mangold ; M. M. Volpogni ; O. S. Anziani

Abstract. Ear tags containing 40% organophosphate insecticides (diazinon or diazinon plus chlorpyrifos‐ethyl) were applied to control Haematobia irritans (L.) (Diptera: Muscidae) in treated (TG01 and TG02) and untreated (UG01 and UG02) groups of Holstein heifers born in 2001 and 2002, respectively. Control and treated groups were assessed for the abundance of Stomoxys calcitrans (L.) (Diptera: Muscidae) from August 2001 to April 2002 and again from August 2002 to April 2003. The treatment had a high efficacy for control of horn flies (maximum median number per heifer of TG01 and TG02 = 5) but a low effect on the abundance of stable flies. The total numbers of S. calcitrans were 1251 (42.9% of the total) and 1668 (57.1%) for TG01 and UG01, and 1423 (48.8%) and 1494 (51.2%) in TG02 and UG02, respectively. No significant difference in stable fly burden was found in 55 of the 76 weeks evaluated. A unimodal peak of abundance in the spring was found during the first fly season, and a bimodal abundance, with peaks in the spring and autumn, during the second season. No strong associations between horn fly and stable fly burdens was found in individuals of the CG01 (correlation coefficient = 0.13, P > 0.05) or CG02 (correlation coefficient = 0.538, P < 0.05, determination coefficient = 0.289).

15 Feb 1988·International Journal of CancerQ1 · MEDICINE

Conjugates of elliptinium acetate with mouse monoclonal anti‐α‐fetoprotein antibodies or fab fragments: In vitro cytotoxic effects upon human hepatoma cell lines

Q1 · MEDICINE

Article

Author: Gilles F. Alberici ; Marc Pallardy ; Jean-Marc Mondesir ; Claude Bohuon ; Luc Manil ; Jean-Jacques Dessaux ; Jacqueline Fournier ; Pierre Gros

AbstractElliptinium acetate (EA) is a new anti‐cancer compound displaying cytostatic activity against various malignancies including hepatoma. Using 3 hepatoma cell lines, we compared the in vitro activity of doxorubicin (reference drug), of EA and of conjugates made up with this latter drug and monoclonal antibodies (MAbs). The linkage was performed by a direct oxidation method. Specific immunoconjugates were prepared with an anti‐alphafetoprotein (AFP) MAb (AF01) or its Fab fragment (Fab AF01). Non‐specific conjugates were obtained with an anti‐thyroglobulin MAb (TG01) or its Fab (Fab TG01). Direct membrane injury (51Cr‐release), DNA and protein synthesis as well as AFP release were investigated for all compounds. Free EA displayed only weak activity on DNA and protein synthesis, at 10‐fold higher molar concentration than doxorubicin. Conjugation of EA with whole AF01 allowed significant potentiation of protein synthesis inhibition without affecting the 3 other tests. In contrast, Fab AF01 × EA conjugates displayed a marked effect in the 4 tests; in particular, this conjugate was at least 100 times more efficient than any other compound when tested in the 51Cr‐release test. Neither Fab AF01 nor free EA alone or in combination exhibited such an effect. Fab TG01 × EA conjugate was not directly cytotoxic but potentiated inhibition of DNA and protein synthesis between 2‐ and 10‐fold. The mechanism of the direct cytotoxic effect of anti‐AFP Fab × EA conjugate, which has never been described in any other immunodrug model, was investigated.

100 Deals associated with TG-01(Targovax)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Multiple Myeloma	Phase 2	NO	Circio Holding ASA	19 May 2023
Smoldering Multiple Myeloma	Phase 2	NO	Circio Holding ASA	19 May 2023
Pancreatic adenocarcinoma	Discovery	NO	Circio Holding ASA	01 Dec 2012
Pancreatic adenocarcinoma	Discovery	ES	Circio Holding ASA	01 Dec 2012
Pancreatic adenocarcinoma	Discovery	GB	Circio Holding ASA	01 Dec 2012

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02261714 (CTgov)	Phase 1/2	Pancreatic adenocarcinoma	32	TG01	togqwrnqgp(wxflwtsihq) = dseayrwhzj lznhypdteg (kdlsqilrxs, vbuckfnxhf - hrcupumuma) View more	-	14 May 2020
NCT02261714 (Pubmed \| Med J Aust) Manual	Phase 1/2	RAS mutation Pancreatic Adenocarcinoma Adjuvant RAS Mutation	32	GM-CSF+gemcitabine+TG01	(xuktujphkj) = four serious adverse reactions considered possibly related to TG01 treatment, including three allergic reactions hyrvkfpodv (ttucwpxrmt ) View more	Positive	01 Mar 2020