Delving into the Latest Updates on Axalimogene filolisbac with Synapse

Overview

Basic Info

Drug Type

Shared antigen vaccine, Therapeutic vaccine

Synonyms

ADXS HPV, ADXS11-001-vaccine, Anal-cancer-vaccine-Advexis

+ [13]

Target

HPV E7

Mechanism

E7 inhibitors(Protein E7 inhibitors)

Therapeutic Areas

NeoplasmsUrogenital DiseasesDigestive System Disorders+ [4]

Active Indication-

Inactive Indication

Adenosquamous CarcinomaAnal Canal CarcinomaCarcinoma in situ of uterine cervix+ [18]

Originator Organization

Advaxis, Inc.

Active Organization-

Inactive Organization

Advaxis, Inc.

MedImmune LLC

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

RegulationOrphan Drug (US)

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Open label
Enrollment in the order of confirmation of eligibility and HPV+ tumor status
Prospective stratification based on 3 factors, epidermal growth factor receptor (EGFR) mutation status, performance status and first-line induction chemotherapy outcome;
Randomization (2:1 ratio): (82 patients receiving the combination of pemetrexed plus ADXS11-001 vs. 42 patients receiving pemetrexed alone)
Treatment Arm: Pemetrexed plus ADXS11-001 immunotherapy
Control Arm: Pemetrexed only
Positive control: pemetrexed chemotherapy

Start Date01 Dec 2018

Sponsor / Collaborator

Advaxis, Inc.

NCT02399813

/ CompletedPhase 2

Phase 2 Study of ADXS11-001 in Subjects With Persistent/Recurrent, Loco-Regional or Metastatic Squamous Cell Carcinoma of the Anorectal Canal

This is a single arm Phase 2 study. Stage 1 and 2 of the study are monotherapy evaluations of ADXS11-001 in 31 and 24 participants, respectively with persistent/recurrent, loco-regional or metastatic squamous cell carcinoma (SCCA) of the anorectal canal that have received at least 1 regimen for the treatment of advanced disease.

Start Date02 Jun 2016

Sponsor / Collaborator

Advaxis, Inc.

NCT02853604

/ TerminatedPhase 3

Phase 3 Study of ADXS11-001 Administered Following Chemoradiation as Adjuvant Treatment for High Risk Locally Advanced Cervical Cancer: AIM2CERV

Locally advanced cervical cancer at higher risk for recurrence (HRLACC) following concurrent chemotherapy and radiation therapy. This is a group of participants with a significant unmet need. The estimated probability of disease recurrence or death within 4 years of diagnosis is 50% and the prognosis is very grave for those who experience a recurrence.
The purpose of the study was to compare the disease free survival (DFS) of ADXS11-001 to placebo administered following cisplatin-based combination chemotherapy and radiation (CCRT) with curative intent in participants with HRLACC.

Start Date15 Dec 2015

Sponsor / Collaborator

Advaxis, Inc.

[+1]

100 Clinical Results associated with Axalimogene filolisbac

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100 Translational Medicine associated with Axalimogene filolisbac

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100 Patents (Medical) associated with Axalimogene filolisbac

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48

Literatures (Medical) associated with Axalimogene filolisbac

01 Jan 2023·Frontiers in immunology

Listeria monocytogenes: a promising vector for tumor immunotherapy.

Review

Author: Deng, Yan-Juan ; Shu, Lin-Zhen ; Deng, Huan ; He, Rui-Shan ; Xiong, Ying ; Chen, Kai-Yun ; Zhou, Zhi-Bin ; Ding, Yi-Dan

Cancer receives enduring international attention due to its extremely high morbidity and mortality. Immunotherapy, which is generally expected to overcome the limits of traditional treatments, serves as a promising direction for patients with recurrent or metastatic malignancies. Bacteria-based vectors such as Listeria monocytogenes take advantage of their unique characteristics, including preferential infection of host antigen presenting cells, intracellular growth within immune cells, and intercellular dissemination, to further improve the efficacy and minimize off-target effects of tailed immune treatments. Listeria monocytogenes can reshape the tumor microenvironment to bolster the anti-tumor effects both through the enhancement of T cells activity and a decrease in the frequency and population of immunosuppressive cells. Modified Listeria monocytogenes has been employed as a tool to elicit immune responses against different tumor cells. Currently, Listeria monocytogenes vaccine alone is insufficient to treat all patients effectively, which can be addressed if combined with other treatments, such as immune checkpoint inhibitors, reactivated adoptive cell therapy, and radiotherapy. This review summarizes the recent advances in the molecular mechanisms underlying the involvement of Listeria monocytogenes vaccine in anti-tumor immunity, and discusses the most concerned issues for future research.

03 Aug 2021·Human vaccines & immunotherapeuticsQ3 · MEDICINE

ADXS11-001 LM-LLO as specific immunotherapy in cervical cancer

Q3 · MEDICINE

Article

Author: Cruz-Esquivel, Ivan ; Morán-Mendoza, Andrés ; Arango-Bravo, Eder ; Cetina-Pérez, Lucely ; Castro-Eguiluz, Denisse ; Serrano-Olvera, Juan a ; Galicia-Carmona, Tatiana ; Flores-de La Torre, Celia ; Villalobos-Valencia, Ricardo

Human papillomavirus (HPV) infection is a well-known cause of cervical cancer. Therapeutic cancer vaccines are part of the current therapeutic options for HPV-associated cancers. Axalimogen filolisbac (ADXS11-001) is an immunotherapy based on live attenuated Listeria monocytogenes-listeriolysin O (Lm-LLO), designed by biological engineering to secrete an antigen-adjuvant fusion protein, composed of a truncated fragment of LLO fused to HPV. The proposed mechanism of action is that Lm-based vectors infect antigen-presenting cells (APC) and secrete HPV-LLO fusion proteins within the APC cytoplasm, these proteins are processed and presented to cytotoxic T lymphocytes (CTL), thus generating a new population of CTLs specific to HPV antigens. These HPV-specific CTLs destroy HPV infected cells. ADXS11-001 has demonstrated safety results in phase I-II studies in women with cervical cancer and is being assessed in clinical trials in patients with HPV-positive anal canal and head and neck cancers.

03 Jun 2021·Human vaccines & immunotherapeuticsQ3 · MEDICINE

Enhanced therapeutic efficacy of Listeria-based cancer vaccine with codon-optimized HPV16 E7

Q3 · MEDICINE

Article

Author: Yao, Hao ; Jiao, Xin’An ; Chen, Jiaqi ; Jia, Yanyan ; Wang, Yuting ; Ling, Zhiting ; Pan, Zhiming ; Yin, Yuelan ; Duan, Feifei ; Feng, Youwei

Cervical cancer is a leading cause of high mortality in women in developing countries and has a serious impact on women's health. Human papilloma virus (HPV) prophylactic vaccines have been produced and may hold promise for reducing the incidence of cervical cancer. However, the limitations of current HPV vaccine strategies make the development of HPV therapeutic vaccines particularly important for the treatment of HPV related lesions. Our previous work has demonstrated that LM4Δhly::E7 was safe and effective in inducing antitumor effect by antigen-specific cellular immune responses and direct killing of tumor cell on a cervical cancer model. In this study, the codon usage effect of a novel Listeria-based cervical cancer vaccine LM4Δhly::E7-1, was evaluated for effects of codon-optimized E7 expression, cellular immune response and therapeutic efficacy in a tumor-bearing murine model. Our data demonstrated that up-regulated expression of E7 was strikingly elevated by codon usage optimization, and thus induced significantly higher Th1-biased immunity, lymphocyte proliferation, and strong specific CTL activity ex-vivo compared with LM4Δhly::E7-treated mice. Furthermore, LM4Δhly::E7-1 enhanced a remarkable therapeutic effect in establishing tumors. Taken together, our results suggest that codon usage optimization is an important consideration in constructing live bacterial-vectored vaccines and is required for promoting effective T cell responses.

1

News (Medical) associated with Axalimogene filolisbac

15 Jul 2023

·www.prnewswire.com

Anal Cancer Pipeline Insight Research 2023: Focus on 6+ Companies and 8+ Pipeline Drugs Featuring Incyte, Merck, Novartis, & Advaxis

DUBLIN, July 14, 2023 /PRNewswire/ -- The "Anal Cancer - Pipeline Insight, 2023" clinical trials has been added to ResearchAndMarkets.com's offering. With a focus on 6+ companies and 8+ pipeline drugs, this report provides a detailed analysis of the current scenario and growth prospects across the indication. The report covers an extensive range of pipeline drug profiles, encompassing both clinical and nonclinical stage products. It also provides a comprehensive assessment of therapeutics, including product type, stage, route of administration, and molecule type. Additionally, the report highlights inactive pipeline products in this space, providing a complete overview of the Anal Cancer pipeline landscape. To provide a holistic understanding, the report outlines the present scenario and growth prospects in the field of Anal Cancer. It offers a detailed picture of the Anal Cancer pipeline landscape, including an overview of the disease and treatment guidelines. Furthermore, the report conducts an in-depth assessment of the commercial and clinical aspects of Anal Cancer, evaluating the pipeline products under development. Detailed descriptions of each drug are provided, including their mechanisms of action, clinical studies, NDA approvals (if any), and comprehensive product development activities. This includes technology, Anal Cancer collaborations, licensing, mergers and acquisitions, funding, designations, and other relevant product-related details. Stay ahead of the curve and gain a comprehensive understanding of the latest advancements in Anal Cancer treatment with our in-depth report on the Anal Cancer pipeline landscape. Discover novel approaches and potential breakthroughs that are shaping the future of Anal Cancer therapeutics. Anal Cancer Emerging Drugs Chapters This segment of the Anal Cancer report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Anal Cancer Emerging Drugs PDS0101: Merck & Co PDS0101 is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by a simple subcutaneous injection in combination with other immunotherapies and cancer treatments. Interim data suggests PDS0101 generates clinically effective immune responses, and the combination of PDS0101 with other treatments demonstrates significant disease control by shrinking tumors, delaying disease progression, and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents. Currently, the drug is being evaluated in the Phase II stage of its development for the treatment of patients with anal cancer. Avelumab: Merck KGaA Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody. Avelumab has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, avelumab has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models. The drug is in phase II of clinical trials for the treatment of anal cancer. Anal Cancer: Therapeutic Assessment Phases Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Molecule Type Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Product Type Anal Cancer Report Insights Anal Cancer Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Anal Cancer Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Players Incyte Corporation Merck & Co Novartis Pharmaceuticals Advaxis Merck KGaA Key Products Retifanlimab PDS0101 KFA-115 ADXS11-001 Avelumab For more information about this clinical trials report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

Phase 2ImmunotherapyGene TherapyASCO

100 Deals associated with Axalimogene filolisbac

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Cervical Carcinoma	Phase 3	US	Advaxis, Inc.	15 Dec 2015
Locally Advanced Cervical Carcinoma	Phase 3	AR	Advaxis, Inc.	15 Dec 2015
Locally Advanced Cervical Carcinoma	Phase 3	BR	Advaxis, Inc.	15 Dec 2015
Locally Advanced Cervical Carcinoma	Phase 3	CA	Advaxis, Inc.	15 Dec 2015
Locally Advanced Cervical Carcinoma	Phase 3	CL	Advaxis, Inc.	15 Dec 2015
Locally Advanced Cervical Carcinoma	Phase 3	MY	Advaxis, Inc.	15 Dec 2015
Locally Advanced Cervical Carcinoma	Phase 3	MX	Advaxis, Inc.	15 Dec 2015
Locally Advanced Cervical Carcinoma	Phase 3	PL	Advaxis, Inc.	15 Dec 2015
Locally Advanced Cervical Carcinoma	Phase 3	RU	Advaxis, Inc.	15 Dec 2015
Locally Advanced Cervical Carcinoma	Phase 3	RS	Advaxis, Inc.	15 Dec 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02164461 (Phase I, CTgov)	Phase 1	Recurrent Cervical Cancer \| Small Cell Carcinoma \| Adenosquamous Carcinoma ... View more	12	Axalimogene filolisbac (Axalimogene Filolisbac 1x10^9 Cfu)	nrhcqqkdqm(wbhvrpakvw) = blaahgqmto efzmbfejdr (ruokvuknqw, lbmsgkguua - rpmmqfufka) View more	-	20 May 2024
NCT02164461 (Phase I, CTgov)	Phase 1		12	Axalimogene filolisbac (Axalimogene Filolisbac 5x10^9 Cfu)	nrhcqqkdqm(wbhvrpakvw) = lgqkpnxjhp efzmbfejdr (ruokvuknqw, qooipkuups - wzfdvneneb) View more	-	20 May 2024
NCT02291055 (P241, CTgov)	Phase 1/2	Squamous cell carcinoma of head and neck metastatic \| Recurrent Cervical Cancer \| Squamous Cell Carcinoma of Head and Neck ... View more	75	MEDI4736+ADXS11-001 (Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736)	nkcyefwnaw(pksdngvxuo) = iszyfhcvbt uiszrwhnkj (bpsggkiqcf, enwqbtrahf - nczxttqfzi) View more	-	20 Mar 2023
NCT02291055 (P241, CTgov)	Phase 1/2		75	MEDI4736+ADXS11-001 (Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736)	nkcyefwnaw(pksdngvxuo) = nyvcvmwlgh uiszrwhnkj (bpsggkiqcf, hpsohhdxgg - ouabmrtljv) View more	-	20 Mar 2023
NCT02399813 (CTgov)	Phase 2	Anal Canal Carcinoma \| Squamous cell carcinoma, metastatic	36	Axalimogene filolisbac	hiorugemcg(qosecdvuhr) = afcecmtmxs sweefvosxc (dqtoyctsms, hxibzyhlpe - lujfcytdcw) View more	-	20 Mar 2023
NCT02853604 (AIM2CERV, CTgov)	Phase 3	Locally Advanced Cervical Carcinoma	110	Placebo (Placebo)	nitqhuzbxv(npbzgjyjso) = ctesdyhzga csmekwnxhn (cipleithcy, iqjtlsvkaz - ejskqoandd) View more	-	14 Mar 2023
NCT02853604 (AIM2CERV, CTgov)	Phase 3	Locally Advanced Cervical Carcinoma	110	ADXS11-001 (ADXS11-001)	nitqhuzbxv(npbzgjyjso) = srsljzsznf csmekwnxhn (cipleithcy, vruhwcwqyo - clmozzmxib) View more	-	14 Mar 2023
NCT01266460 (Gynecologic Oncology Group protocol 265 \| GOG/NRG0265, CTgov)	Phase 2	Recurrent Cervical Cancer \| Adenosquamous Carcinoma \| Cervical Squamous Cell Carcinoma ... View more	54	Laboratory Biomarker Analysis+Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001	ddjkoxnoui(qaxfzyziuq) = lxlvpwpfjt gqwxegoqei (mlmbriyuts, svamlfutla - phjugitlkg) View more	-	11 Sep 2020
NCT02399813 (Pubmed) Manual	Phase 2	Anus Neoplasms	29	axalimogene filolisbac	otqwgmejoa(qjzsnmafnk) = uwrljbvrtb qggwgadwrg (sydbjrkrqa ) View more	Negative	14 Apr 2020
AACR2018	Not Applicable	HPV16 positive Oropharyngeal Cancer	8	ADXS11-001	zsslbsnwmn(dzlixscbpj) = wuslqbeekp smidznurtf (myraglbcie ) View more	-	01 Jul 2018
NCT01266460 (GOG/NRG0265, ASCO2016)	Phase 2	Uterine Cervical Cancer Maintenance	29	ADXS11-001	mcwtntbeso(blojxxvnxp) = gsovsxpuwj wepewiyatc (brbrqcagec ) View more	Positive	20 May 2016
NCT02164461 (Phase I, SITC2015)	Phase 1	Uterine Cervical Cancer HPV-E7 tumor antigen	6	ADXS11-001 5x10^9 CFU	pseovwwyoh(kuyvccfugy) = hhgreyuidn czirueuuxl (szrtflfkth ) View more	Positive	04 Nov 2015
AACR2015	Phase 1	Osteosarcoma	10	Lm-LLO-HER2/neu	twijfsmsbo(ktybvlvihc) = xbtrdaealq osihakoqxe (emethrymhi ) View more	-	01 Aug 2015