Preclinical toxicology and pharmacology evaluation of a newTNFR2 antagonistic monoclonal antibody for CTCL therapy
新型TNFR2拮抗单克隆抗体用于CTCL治疗的临床前毒理学和药理学评价
基本信息
- 批准号:10772580
- 负责人:
- 金额:$ 122.17万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2021
- 资助国家:美国
- 起止时间:2021-09-01 至 2024-11-30
- 项目状态:已结题
- 来源:
- 关键词:AntibodiesAntibody TherapyAutoimmunityBenchmarkingBindingBostonCancer PatientCancerousCapitalCellsClinicalClinical TrialsColon CarcinomaCutaneous T-cell lymphomaCyclic GMPDataDevelopmentDoseDrug KineticsEffector CellEvaluationFormulationFrequenciesFundingFutureGrowthGuidelinesHealthHealth Care CostsHealth ExpendituresHumanImmuneImmune checkpoint inhibitorImmune systemImmunooncologyImmunotherapyIn VitroInfiltrationInternationalInvestigational DrugsInvestigational New Drug ApplicationMacaca fascicularisMalignant NeoplasmsMalignant neoplasm of ovaryMarketingMediatingMolecular TargetMonoclonal AntibodiesMusNew Drug ApprovalsOncogenesOncogenicPatientsPersonsPharmacologic SubstancePharmacology and ToxicologyPhaseProcessProductionProductivityReceptors, Tumor Necrosis Factor, Type IIRegulatory AffairsRegulatory T-LymphocyteReportingResistanceSafetySamplingSecureSignal TransductionSmall Business Innovation Research GrantSocietiesSurfaceTNFRSF1A geneTechnologyTestingTherapeuticTimeTissuesToxic effectToxicologyValidationantagonistanti-tumor immune responseantitumor effectcGMP productioncancer cellcancer infiltrating T cellscancer therapydesigndimerin vitro activityin vivoinnovationinterestlarge scale productionmanufacturing runnovel strategiesnovel therapeutic interventionnovel therapeuticsoverexpressionpharmacologicpre-clinicalpreventprogrammed cell death protein 1programsreceptorresearch clinical testingselective expressiontargeted cancer therapytargeted treatmenttherapeutic targettherapy outcometooltumortumor microenvironmenttumor necrosis factor receptor bindingvalidation studies
项目摘要
PROJECT SUMMARY
Cancer has killed over 600,000 people in US in 2020. The cost for healthcare and society is unbearable: because
of cancer, $180B healthcare expenditure and $134B lost productivity are recorded every year. This is happening
despite recent advancements in therapy and the emergence of an ever expanding array of new therapeutics for
the over 1.8M new cancer patients every year. Indeed, because of the multitude and redundancy of mechanisms
contributing to cancer growth, therapies are often ineffective. Several components should be targeted at the
same time in order to maximize therapy outcome. However, this is particular hard to attain because of 1) the
striking variability among cancers and the limited number of cancer specific targets 2) the ability of cancer cells
to orchestrate a microenvironment of healthy tissue and cells around them, that promote cancer growth and
therapy resistance. Boston Immune Technologies and Therapeutics (BITT) is developing BITT-1492, able to
target both cancer cells and their microenvironment. BITT-1492 is an antagonist antibody against TNFR2 – a
receptor highly expressed in cancer tissue and immune suppressive cells in the microenvironment, where it
mediates pro-survival signaling. Thanks to BITT’s proprietary antibody design platform, BITT-1492 is the first
and only antibody able to dominantly shut down TNFR2 signaling. Due to selective expression and key role of
TNFR2 for a variety of cancers and tumor microenvironment cells, BITT-1492 will find application in the therapy
of several cancers, starting with Cutaneous T cell Lymphoma (CTCL), where TNFR2 is known to act as an
extremely potent oncogene. BITT has already completed extensive pre-clinical validation for BITT-1492,
demonstrating potent activity in CTCL, colon and ovarian cancers. In the proposed Fast-Track project, BITT will
complete a pre-clinical toxicology and pharmacology assessment of BITT-1492 to obtain relevant data for an
Investigational New Drug (IND) application. This will be accomplished by performing, in line with ICH guidelines,
an exploratory small-scale toxicology study to be carried out in Phase I, that will demonstrate the safety of use
of BITT-1492 for a wider IND-enabling toxicology and pharmacokinetic studies in Phase II. As part of the PhaseII
BITT will also test the suitability of BITT-1492 production process for cGMP standard compliance. At the end of
the SBIR project, BITT will be ready to advance BITT-1492 to clinical testing for which a combination of Venture
Capital seed funds and SBIR PhaseIIb are expected to be leveraged. The successful completion of this project
and initial clinical testing evidence will help to secure the already expressed interest of pharmaceutical
companies with whom BITT will engage to complete late-stage clinical testing and launch BITT-1492 into
international markets.
项目总结
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Kenneth Olivier其他文献
Kenneth Olivier的其他文献
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{{ truncateString('Kenneth Olivier', 18)}}的其他基金
Advancing BITT-101 a novel dominant CD40 antagonist for use in treatment of Sjogren Syndrome.
推进 BITT-101 成为一种新型 CD40 拮抗剂,用于治疗干燥综合征。
- 批准号:
10760568 - 财政年份:2023
- 资助金额:
$ 122.17万 - 项目类别:
Preclinical toxicology and pharmacology evaluation of a newTNFR2 antagonistic monoclonal antibody for CTCL therapy
新型TNFR2拮抗单克隆抗体用于CTCL治疗的临床前毒理学和药理学评价
- 批准号:
10323802 - 财政年份:2021
- 资助金额:
$ 122.17万 - 项目类别:
Pulmonary clinical medicine: PFT lab, bronchoscopy, consultation services, and education
肺部临床医学:PFT实验室、支气管镜检查、咨询服务和教育
- 批准号:
9788012 - 财政年份:
- 资助金额:
$ 122.17万 - 项目类别:
Pulmonary clinical medicine: PFT lab, bronchoscopy, consultation services, and education
肺部临床医学:PFT实验室、支气管镜检查、咨询服务和教育
- 批准号:
9157603 - 财政年份:
- 资助金额:
$ 122.17万 - 项目类别:
Pulmonary clinical medicine: PFT lab, bronchoscopy, consultation services, and education
肺部临床医学:PFT实验室、支气管镜检查、咨询服务和教育
- 批准号:
10253954 - 财政年份:
- 资助金额:
$ 122.17万 - 项目类别:
Pulmonary clinical medicine: PFT lab, bronchoscopy, consultation services, and education
肺部临床医学:PFT实验室、支气管镜检查、咨询服务和教育
- 批准号:
10008883 - 财政年份:
- 资助金额:
$ 122.17万 - 项目类别:
Inflammatory and immune dysregulation associated lung disease
炎症和免疫失调相关的肺部疾病
- 批准号:
9572321 - 财政年份:
- 资助金额:
$ 122.17万 - 项目类别:
Pulmonary clinical medicine: PFT lab, bronchoscopy, consultation services, and education
肺部临床医学:PFT实验室、支气管镜检查、咨询服务和教育
- 批准号:
9357331 - 财政年份:
- 资助金额:
$ 122.17万 - 项目类别:
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