Stimulating Immune Response With Neoadjuvant Human Papilloma Virus (HPV)-16 Specific Vaccination in HPV-Oropharyngeal Squamous Cell Carcinoma (HPV-OPSCC)

This phase I/II trial studies how well PDS0101 alone or in combination with pembrolizumab works to shrink tumor in patients with human papillomavirus-associated oropharynx cancer that has spread to nearby tissue or lymph nodes (locally advanced). PDS0101 is a vaccine made from specific peptides that may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving PDS0101 with or without pembrolizumab may kill more tumor cells in patients with locally advanced human papillomavirus-associated oropharynx cancer before surgery so that it may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed.

开始日期2022-06-16

申办/合作机构

Mayo Clinic

NCT04260126 / Active, not recruiting临床2期

A Phase II, Open-Label, Multi-Center Study of PDS0101 and Pembrolizumab (KEYTRUDA®) Combination Immunotherapy in Subjects with Recurrent And/or Metastatic HNSCC and High-Risk HPV16 Infection

VERSATILE-002 is a Phase 2, open-label, multicenter study of the efficacy and safety of PDS0101 administered in combination with pembrolizumab in adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

开始日期2021-03-29

申办/合作机构

PDS Biotechnology Corp.

[+1]

NCT04580771 / Active, not recruiting临床2期IIT

IMMUNOCERV: Evaluating the Safety of Chemoradiation Combined With PDS0101 Immunotherapy in Treating Locally Advanced Cervical Cancer

This phase IIA trial studies the effect of a vaccine (PDS0101) when given together with chemotherapy and radiation therapy (chemoradiation) in treating patients with stage IB3-IVA cervical cancer. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. PDS0101 is a type of vaccine that is intended to help the immune system respond to human papillomavirus (HPV16)-infected cervical tumor cells. PDS0101 contains two active components: the first is called R-DOTAP (Versamune) and is included in the vaccine to boost the immune system's response against the HPV viral proteins and the second group of active components are selected small pieces of proteins (called peptides) taken from the HPV virus. Giving PDS0101 in combination with chemoradiation may work help to control cervical cancer.

开始日期2020-10-14

申办/合作机构

The University of Texas MD Anderson Cancer Center

[+1]

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100 项与 Pexipepimut-S 相关的转化医学

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100 项与 Pexipepimut-S 相关的专利（医药）

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项与 Pexipepimut-S 相关的文献（医药）

2023-10-01·International journal of radiation oncology, biology, physics

HPV Circulating Cell-Free DNA Kinetics in Cervical Cancer Patients Undergoing Definitive Chemoradiation.

Article

作者: Venkatesan, A ; Xiao, W ; Lynn, E J ; Sammouri, J ; Klopp, A H ; Court, K ; Napravnik, T Cisneros ; Seo, A ; Joyner, M M ; Jhingran, A ; Gjyshi, O ; Gillison, M ; Lin, L L ; Colbert, L

PURPOSE/OBJECTIVE(S):

The human papilloma virus (HPV) is a significant cause of cervical cancer and viral DNA can be detected in the blood of patients with cervical cancer (cfHPV-DNA). We hypothesized that detecting HPV cfDNA before, during and after chemoradiation (CRT) could provide insights into disease extent, clinical staging, and treatment response.

MATERIALS/METHODS:

Forty-seven patients with cervical cancer were enrolled on this study between 2017 and 2022, either as part of a standard-of-care (SOC) treatment banking protocol (33 patients) or as part of a clinical trial combining a therapeutic HPV vaccine (PDS0101; Immunocerv, 14 patients). Longitudinal plasma samples were collected from each patient as baseline, during week 1, 3 or 5 of CRT. cfHPV-DNA was quantified using droplet digital PCR targeting the HPV E6/E7 oncogenes of 13 high-risk types based on analysis of cervical tumor genotype (AmpFire). Clinical covariates, including FIGO stage, primary tumor size, and treatment response were studied using appropriate statistical tests.

RESULTS:

All 47 patients had detectable HPV cfDNA during CRT with 38 out of 47 having HPV type 16 detected. The median cfDNA at baseline was 24.5 copies/mL, with a range of 0 to 157,638 copies/mL. Of the 35 patients with at least three measurements, 20 (57%) had peak cfDNA counts at week 3, and 30 out of 35 showed a decline in cfDNA counts at week 5 compared to week 3. The proportion of patients who cleared cfDNA (<16 copies/mL) increased with each week of CRT, reaching 75% at week 5. Baseline cfDNA counts were associated with para-aortic nodal involvement (p<0.0001) but not with FIGO stage or gross tumor volume. A greater proportion of patients treated with therapeutic HPV-directed vaccine had clearance of cfDNA counts as compared to those treated with SOC (at week 3, 38% vs 5%, P = 0.02 and week 5, 79% vs 22%, P = 0.0054) CONCLUSION: HPV cfDNA levels change dynamically throughout definitive CRT and peak during the first 3 weeks for the majority of patients. Treatment with a therapeutic HPV vaccine was associated with a more rapid decline in cfHPV DNA. Further analysis of cfDNA kinetics could provide valuable information on the relationship between cfDNA levels, treatment response, and clinical outcomes.

2020-06-01·Journal for immunotherapy of cancer2区 · 医学

Immunomodulation to enhance the efficacy of an HPV therapeutic vaccine

2区 · 医学

ArticleOA

作者: Jochems, Caroline ; Morillon Ii, Y Maurice ; Schlom, Jeffrey ; Smalley Rumfield, Claire ; Pellom, Samuel T

Background:

While prophylactic human papillomavirus (HPV) vaccines will certainly reduce the incidence of HPV-associated cancers, these malignancies remain a major health issue. PDS0101 is a liposomal-based HPV therapeutic vaccine consisting of the immune activating cationic lipid R-DOTAP and HLA-unrestricted HPV16 peptides that has shown in vivo CD8+ T cell induction and safety in a phase I study. In this report, we have employed the PDS0101 vaccine with two immune modulators previously characterized in preclinical studies and which are currently in phase II clinical trials. Bintrafusp alfa (M7824) is a first-in-class bifunctional fusion protein composed of the extracellular domains of the transforming growth factor-β receptor type II (TGFβRII) fused to a human IgG1monoclonal antibody blocking programmed cell death protein-1 ligand (PDL1), designed both as a checkpoint inhibitor and to bring the TGFβRII ‘trap’ to the tumor microenvironment (TME). NHS-interleukin-12 (NHS-IL12) is a tumor targeting immunocytokine designed to bring IL-12 to the TME and thus enhance the inflammatory Th1 response.

Methods:

We employed TC-1 carcinoma (expressing HPV16 E6 and E7 and devoid of PDL1 expression) in a syngeneic mouse model in monotherapy and combination therapy studies to analyze antitumor effects and changes in immune cell types in the spleen and the TME.

Results:

As a monotherapy, the PDS0101 vaccine generated HPV-specific T cells and antitumor activity in mice bearing HPV-expressing mEER oropharyngeal and TC-1 lung carcinomas. When used as a monotherapy in the TC-1 model, NHS-IL12 elicited antitumor effects as well as an increase in CD8+ T cells in the TME. When used as a monotherapy, bintrafusp alfa did not elicit antitumor effects or any increase in T cells in the TME. When all three agents were used in combination, maximum antitumor effects were observed, which correlated with increases in T cells and T-cell clonality in the TME.

Conclusion:

These studies provide the rationale for the potential clinical use of combinations of agents that can (1) induce tumor-associated T-cell responses, (2) potentiate immune responses in the TME and (3) reduce immunosuppressive entities in the TME.

2019-06-15·Journal of immunology (Baltimore, Md. : 1950)2区 · 医学

Antigen Priming with Enantiospecific Cationic Lipid Nanoparticles Induces Potent Antitumor CTL Responses through Novel Induction of a Type I IFN Response

2区 · 医学

Article

作者: Woodward, Jerold G. ; Gandhapudi, Siva K. ; Bush, John Peyton C. ; Ward, Martin ; Conn, Greg ; Bedu-Addo, Frank

Abstract:

Certain types of cationic lipids have shown promise in cancer immunotherapy, but their mechanism of action is poorly understood. In this study, we describe the properties of an immunotherapeutic consisting of the pure cationic lipid enantiomer R-1,2-dioleoyl-3-trimethyl-ammonium-propane (R-DOTAP) formulated with modified viral or self-peptide Ags. R-DOTAP formulations with peptide Ags stimulate strong cross-presentation and potent CD8 T cell responses associated with a high frequency of polyfunctional CD8 T cells. In a human papillomavirus tumor model system, a single s.c. injection of tumor-bearing mice with R-DOTAP plus human papillomavirus Ags induces complete regression of large tumors associated with an influx of Ag-specific CD8 T cells and a reduction of the ratio of regulatory/Ag-specific CD8 T cells. R-DOTAP also synergizes with an anti-PD1 checkpoint inhibitor, resulting in a significant inhibition of B16 melanoma tumor growth. We found that R-DOTAP stimulates type I IFN production by dendritic cells in vivo and in vitro. s.c. injection of R-DOTAP results in an IFN-dependent increase in draining lymph node size and a concomitant increase in CD69 expression. Using knockout mice, we show that type I IFN is required for the induction of CD8 T cell activity following administration of R-DOTAP plus Ag. This response requires Myd88 but not TRIF or STING. We also show that R-DOTAP stimulates both TLR7 and 9. Collectively, these studies reveal that R-DOTAP stimulates endosomal TLRs, resulting in a Myd88-dependent production of type I IFN. When administered with Ag, this results in potent Ag-specific CD8 T cell responses and antitumor activity.

148

项与 Pexipepimut-S 相关的新闻（医药）

2024-12-06

·GlobeNewswire-Health Care

PDS Biotechnology Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

PRINCETON, N.J., Dec. 06, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced that on December 3, 2024, PDS Biotech granted nonstatutory stock options to purchase 7,000 shares of common stock to an employee in the clinical department as a material inducement to employment with PDS Biotech and in accordance with Nasdaq Listing Rule 5635(c)(4) and PDS Biotech’s 2019 Inducement Plan, as amended, which was adopted on June 17, 2019, and provides for the granting of equity awards to new employees of PDS Biotech. Each stock option has an exercise price of $2.25, the closing price of PDS Biotech’s common stock on December 3, 2024. Each stock option vests over a four-year period, with one-quarter of the shares vesting on the first anniversary of the grant date and the remaining shares vesting monthly over the 36-month period thereafter, subject to continued employment with the company through the applicable vesting dates. About PDS Biotechnology PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor. For more information, please visit www.pdsbiotech.com Forward Looking Statements This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for Versamune® HPV, PDS01ADC and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning Versamune® HPV, PDS01ADC and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.   Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation. Investor Contact:Mike MoyerLifeSci AdvisorsPhone +1 (617) 308-4306 Email: mmoyer@lifesciadvisors.com Media Contact:Janine McCargo6 DegreesPhone +1 (646) 528-4034Email: jmccargo@6degreespr.com

免疫疗法

2024-12-03

·GlobeNewswire-Health Care

PDS Biotech to Host Key Opinion Leader Event on December 17 at 12 p.m. ET

Discussion topics to include pathology and prevalence of HPV16-positive head and neck cancer, VERSATILE-003 Phase 3 clinical trial design and initiationPRINCETON, N.J., Dec. 03, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced a Key Opinion Leader (“KOL”) event to discuss the pathology and growing prevalence of HPV16-positive head and neck squamous cell carcinoma (“HNSCC") as well as the Company’s upcoming VERSATILE-003 Phase 3 clinical trial of Versamune® HPV + pembrolizumab for first-line treatment of recurrent and/or metastatic HPV16-positive HNSCC. The KOL event will take place on Tuesday, December 17, 2024, at 12 p.m. ET and panel participants include: Francis “Frank” Worden, M.D., Rogel Cancer Center, University of MichiganKevin Harrington, MBBS, Ph.D., The Institute of Cancer Research, United Kingdom The event will be moderated by Kirk Shepard, M.D., PDS Biotech’s Chief Medical Officer. Webcast and Registration Details Date: Tuesday, December 17, 2024Time: 12 p.m. - 1:30 p.m. ETRegistration: Click here About Our Speakers Francis Worden, M.D., is a clinical professor awarded the Nancy Wigginton Oncology Research Professor of Thyroid Cancer endowed chair at the Rogel Cancer Center at the University of Michigan. He is a clinical investigator with the multidisciplinary head and neck cancer and lung cancer teams. Dr. Worden is a leading expert in the treatment of HPV-positive oropharyngeal cancer. He has co-authored over 190 peer-reviewed articles and participated in approximately 20 clinical trials with three ongoing trials in HNSCC, including the VERSATILE-002 trial. Dr. Worden received his medical degree from the Indiana University School of Medicine. He completed a combined internal medicine and pediatrics residency at the Detroit Medical Center and finished a medical oncology/hematology fellowship at the University of Michigan. In 2000, Dr. Worden joined the University of Michigan Rogel Cancer Center faculty. Kevin Harrington, MBBS, Ph.D., is Head of the Division of Radiotherapy and Imaging at The Institute of Cancer Research in the United Kingdom. Dr. Harrington is a Professor of Biological Cancer Therapies at The Institute of Cancer Research. He was the principal investigator for KEYNOTE-048, the pivotal clinical trial that supported the U.S. Food and Drug Administration approval for the use of pembrolizumab and pembrolizumab + chemotherapy in the first-line treatment of recurrent and/or metastatic HNSCC. Earlier this year, Dr. Harrington presented the results of the VERSATILE-002 clinical trial during the European Society of Medical Oncology Congress. He studied medicine at St. Bartholomew's Hospital in London and began focusing on head and neck cancer as a Ph.D. student at Hammersmith Hospital. Dr. Harrington completed post-doctoral research in molecular medicine at the Mayo Clinic, before being appointed as a Consultant Oncologist at The Royal Marsden National Health Service Foundation in 2001. He has published more than 600 articles on cancer treatment. About PDS Biotechnology PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor. For more information, please visit www.pdsbiotech.com Forward Looking Statements This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for Versamune® HPV, PDS01ADC and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning Versamune® HPV, PDS01ADC and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation. Investor Contact:Mike MoyerLifeSci AdvisorsPhone +1 (617) 308-4306 Email: mmoyer@lifesciadvisors.com Media Contact:Janine McCargo6 DegreesPhone +1 (646) 528-4034Email: jmccargo@6degreespr.com

免疫疗法临床3期高管变更ASCO会议

2024-11-21

·癌度

《癌度早报2024年11月21日》

一、新药快讯 1、一线治疗非小细胞肺癌脑转移新药佐利替尼获批上市 2024年11月20日，一款名为佐利替尼的靶向药获批上市，用于治疗具有EGFR基因19号外显子缺失或外显子21置换突变，并伴有中枢神经系统转移的局部晚期或转移性非小细胞肺癌患者的一线治疗。与其他的靶向药不同，佐利替尼具有完全透过血脑屏障的能力，可以维持在脑组织和脑脊液中高度的药物暴露，具有高达100%的血脑屏障透过率。相关的临床试验数据表明，这款药的治疗应答率为68.6%，中位无进展生存期9.6个月。 2、皮下注射PD-1的K药治疗非小细胞肺癌三期临床成功据官方媒体信息，免疫治疗药物帕博利珠单抗的一项关键性三期临床试验取得积极结果，化疗联合皮下注射剂型帕博利珠单抗治疗转移性非小细胞肺癌的一线治疗，与化疗联合静脉注射剂型的帕博利珠单抗相比，达到了非劣效性标准，这一研究结果将会提交给全球监管机构进行讨论。这款皮下注射剂型获批将会有助于更加利于治疗和使用！ 3、41%的患者肿瘤大幅度缩小，HPV治疗性疫苗来了最近HPV病毒引发的头颈鳞癌发病率增加，一种新的免疫联合疗法，名为Versamune的HPV治疗性疫苗联合帕博利珠单抗正在研究，初步的临床研究结果表明：在从未使用过PD-1等免疫药物的患者中，41%的患者肿瘤大幅缩小，其中部分患者肿瘤全消失。87%的患者生存期超过1年，很多患者的肿瘤控制时间超过了传统疗法。该疗法即将进入大规模三期临床试验，预计将会招募350名患者。图片来源：摄图网二、抗癌前沿 1、早期肺癌术后的复发风险，与特定基因突变有关系一期非小细胞肺癌术后有30%的概率会出现复发，在最近的一项临床研究中，570名一期非小细胞肺癌有12.5%的患者复发，其中KRAS基因的G12V突变的患者复发率为37.5%，KRAS基因G12V突变和TP53基因突变可以预测患者有较短的生存期。KRAS基因G13D、MET基因的E168D、PTEN和TP53基因突变都影响了肺癌的生存期。扫描下图二维码，加入癌度病友群（癌痛知识分享群、基因检测群、临床试验招募群），每天第一时间获知：🍀癌度快报🍀、🍀癌度夜话🍀；

临床3期疫苗免疫疗法

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适应症	最高研发状态	国家/地区	公司	日期
阴茎肿瘤	临床2期	美国	National Cancer Institute	2021-10-19
阴道肿瘤	临床2期	美国	National Cancer Institute	2021-10-17
肛门肿瘤	临床2期	美国	National Cancer Institute	2021-10-13
直肠癌	临床2期	美国	National Cancer Institute	2021-10-05
头颈癌转移	临床2期	美国	PDS Biotechnology Corp.	2021-03-29
头颈癌转移	临床2期	爱尔兰	PDS Biotechnology Corp.	2021-03-29
头颈癌转移	临床2期	波多黎各	PDS Biotechnology Corp.	2021-03-29
头颈癌转移	临床2期	英国	PDS Biotechnology Corp.	2021-03-29
HPV阳性的口咽鳞状细胞癌	临床2期	美国	PDS Biotechnology Corp.	2021-03-29
HPV阳性的口咽鳞状细胞癌	临床2期	爱尔兰	PDS Biotechnology Corp.	2021-03-29

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04580771 (IMMUNOCERV, GlobeNewswire) 人工标引	临床2期	局部晚期宫颈癌 HPV16-positive	17	Versamune® HPV + Chemoradiation (at least 2 doses)	範選鬱築廠觸願積糧淵(齋構選觸顧蓋壓壓衊衊) = 願鑰選淵鑰願醖淵鏇壓選憲夢簾願獵願網廠鬱 (鑰願遞積鏇顧製遞齋築 ) 更多	积极	2024-10-02
				Versamune® HPV + Chemoradiation (five doses)	範選鬱築廠觸願積糧淵(齋構選觸顧蓋壓壓衊衊) = 構鹽壓糧遞淵簾鏇構積選憲夢簾願獵願網廠鬱 (鑰願遞積鏇顧製遞齋築 ) 更多
NCT04260126 (VERSATILE-002, ESMO2024) 人工标引	临床2期	头颈部鳞状细胞癌一线	-	PDS0101 and pembrolizumab	選窪範觸願鹹鹹範餘繭(夢餘淵積窪壓獵壓繭鏇) = 艱鑰鬱夢醖遞遞衊遞選夢蓋窪鑰憲鏇憲網艱襯 (鏇鹹積淵襯壓襯觸鑰鬱, 18.4 ~ NE) 更多	积极	2024-09-14
NCI-Led (GlobeNewswire) 人工标引	临床2期	人乳头瘤病毒 16 阳性	-	PDS0101+PDS0301+Bintrafusp-alfa (ICI naïve group)	襯範鹽鹽壓窪繭鬱窪淵(簾淵糧願顧壓網蓋鑰簾) = 窪衊壓鑰齋窪簾艱觸鏇醖衊窪齋獵膚鹽獵艱範 (壓製鬱繭構壓窪築淵願 ) 更多	积极	2023-11-09
				PDS0101+PDS0301+Bintrafusp-alfa (ICI resistant group)	襯範鹽鹽壓窪繭鬱窪淵(壓顧鏇壓築積艱網鏇獵) = 艱蓋餘襯鹽製繭簾憲醖構構衊選醖夢壓觸構網 (齋餘醖觸鏇獵鹹積築餘 ) 更多
NCT04260126 (VERSATILE002, ASCO 12023 \| ASCO 22023) 人工标引	临床2期	人乳头瘤病毒相关的头颈部鳞状细胞癌 HPV16 Positive	48	PDS0101+pembrolizumab	醖簾鏇憲窪選夢壓積獵(獵鏇獵餘選廠選顧鑰窪) = 鏇鹽鏇鬱壓衊獵簾範鹽醖齋製糧淵繭範鏇壓繭 (廠積夢齋觸廠範願範衊 ) 更多	积极	2023-05-31
NCT04580771 (IMMUNOCERV, GlobeNewswire) 人工标引	临床2期	宫颈癌	9	chemoradiotherapy+PDS-0101	夢廠構鹽觸廠網餘製簾(繭壓糧憲廠鏇繭製構鑰) = low-grade local injection site reactions 鹹憲廠範鹹遞鹹獵鑰蓋 (鑰構遞繭艱醖夢觸艱顧 )	积极	2022-11-14
NCT04580771 (IMMUNOCERV, SITC2022)	临床2期	局部晚期宫颈癌 HPV16	17	PDS0101	蓋構構憲糧襯遞選憲淵(簾廠壓網遞膚獵衊簾觸) = 襯網顧遞顧範襯選鑰選遞鹹膚齋廠鏇艱獵獵選 (構衊糧淵繭簾襯憲製網 ) 更多	积极	2022-11-07
NCT04287868 (Biospace) 人工标引	临床2期	肿瘤 HPV Positive	37	NHS-IL-12+bintrafusp alfa+PDS 0101 (CPI refractory)	獵窪簾選淵獵鑰鑰壓壓(觸遞糧醖鏇觸獵窪網憲) = 鏇廠顧鑰襯築製獵網憲醖鑰繭製壓艱網廠鏇窪 (簾築範獵遞糧鏇選膚遞 )	积极	2022-10-11
				NHS-IL-12+bintrafusp alfa+PDS 0101 (CPI naïve)	齋鹹廠膚鹽選憲製衊鏇(鏇窪壓顧鏇顧憲膚襯醖) = 鹹壓襯簾積窪齋膚構積鹽遞簾選簾憲窪襯餘顧 (淵選範壓範醖醖齋衊餘 ) 更多
NCT04287868 (ASCO2022) 人工标引	临床2期	HPV相关癌症 HPV Positive	30	M9241+bintrafusp alfa+PDS0101 (with checkpoint naïve disease)	築網築製鏇膚積夢遞襯(醖艱膚廠範襯鏇鏇衊餘) = 窪鬱積廠艱簾齋鬱遞齋獵糧鹽廠廠鏇願築蓋網 (蓋餘鏇衊鹽鹹襯夢築膚 ) 更多	积极	2022-06-02
				M9241+bintrafusp alfa+PDS0101 (with checkpoint refractory disease)	築網築製鏇膚積夢遞襯(醖艱膚廠範襯鏇鏇衊餘) = 繭遞網餘製鹹築獵鬱壓獵糧鹽廠廠鏇願築蓋網 (蓋餘鏇衊鹽鹹襯夢築膚 ) 更多
NCT04287868 (ASCO 12021 \| ASCO 22021) 人工标引	临床2期	HPV相关癌症 HPV Positive	14	M9241+bintrafusp alfa+PDS0101	構簾網鬱網製艱鬱鏇鏇(觸齋淵鏇簾壓襯憲觸廠) = 觸願憲醖築鬱願範襯選蓋網繭蓋淵鹽繭糧糧窪 (構憲鹹蓋範窪襯壓糧繭 )	积极	2021-05-20
				M9241+bintrafusp alfa+PDS0101 (checkpoint naïve disease)	構簾網鬱網製艱鬱鏇鏇(觸齋淵鏇簾壓襯憲觸廠) = 夢獵窪觸鬱鹹觸獵鏇鬱蓋網繭蓋淵鹽繭糧糧窪 (構憲鹹蓋範窪襯壓糧繭 )