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]

100 项与 Pexipepimut-S 相关的临床结果

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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.

149

项与 Pexipepimut-S 相关的新闻（医药）

2025-01-01

·梅斯医学

超10款，有望“治愈”肿瘤的疫苗已在路上！或开创癌症治疗新时代

近年来，全球肿瘤疫苗的研发领域迎来了前所未有的发展浪潮。随着科技的飞速进步，特别是随着人工智能、mRNA疫苗技术的崛起，肿瘤疫苗作为癌症预防与治疗的新兴手段，正逐步从实验室走向临床应用，为全球癌症患者带来了新的希望。下面小编就结合全球肿瘤疫苗的研发管线，盘点一下研发进度相对靠前的部分肿瘤疫苗。值得注意的是，树突状细胞DC疫苗DCVax-L三期已经成功，mRNA疫苗mRNA-4157已经启动三期临床，有望在2025年上市。 DCVax-L：树突状细胞（DC）疫苗该候选疗法是一种个性化的免疫疗法，由患者自身肿瘤样本中的树突细胞和抗原(生物标记物)制成。适应症：胶质母细胞瘤临床进展：三期结果达到积极顶线结果三期结果显示：新诊断的GBM患者(n=232)随机化后的中位总生存期(mOS)为19.3个月(手术后22.4个月)，而对照组随机化后的mOS为16.5个月(HR=0.80, p=0.002)；48个月生存率为15.7% vs. 9.9%， 60个月生存率为13% vs. 5.7%。新诊断胶质母细胞瘤患者的总生存率复发性GBM (n=64)的mOS为复发后13.2个月vs. 7.8个月(HR = 0.58, p<0.001)；复发后24个月和30个月生存率分别为20.7% vs.9.6%，11.1% vs.5.1%。复发胶质母细胞瘤患者的总生存率在新诊断的伴有MGMT甲基化的GBM患者中，使用DCVax-L治疗的mOS为30.2个月(手术后33个月)，而对照组为21.3个月(n=199) (HR=0.74, p=0.027)。目前国内DC疫苗领域也取得了重大的突破，恒瑞源正研发的MASCT-I已经进入临床Ⅱ期，启辰生生物、康德赛医疗、立康生命、中生康元及恒赛生物等公司的DC候选药物也已经步入了一期临床，其中多款候选药物并展现出了良好的早期疗效。PDS0101：HPV阳性癌症疫苗简介：PDS0101是一种针对人乳头瘤病毒（HPV）的新型研究性免疫疗法，专为HPV阳性癌症设计。通过强烈刺激T细胞攻击，该疫苗展现出显著的抗癌潜力。可与其他免疫疗法和癌症治疗联合使用，以增强治疗效果。临床进展：2期临床在2024年欧洲肿瘤内科学会（ESMO）大会上发布的研究显示，癌症疫苗PDS0101联合PD-1免疫药物K药，显著提高了HPV16阳性的复发或转移性头颈鳞状细胞癌（HNSCC）患者的治疗效果。在53名PD-L1阳性（指标预示免疫治疗可能有效）的患者中，接受新型HPV疫苗PDS0101联合K药治疗的患者，平均生存时间为30个月。Bria-IMT：乳腺癌联合免疫治疗方案简介：Bria-IMT 方案是使用同种异体全肿瘤细胞疫苗联合检查点抑制剂 (checkpoint inhibitors, CPIs) 的联合免疫治疗。皮内给予经辐照的 SV-BR-1-GM 乳腺癌细胞能够分泌GM-CSF，并通过HLA-I和HLA-II分子提呈肿瘤相关抗原（TAAs），从而直接激活抗肿瘤免疫反应。作用机制：间接和直接刺激人体自身的抗癌细胞，包括激活CD4+和CD8+ T细胞，增强抗肿瘤免疫反应。临床进展：3期 1/2期临床试验显示，BRIA-IMT 治疗显示出较好的安全性，同时使得多药治疗无效的进展/转移性乳腺癌患者获益。研究者在接受3期制剂患者中观察到更好的疗效和生存率。该制剂已应用于正在进行中的3期临床试验， BNT116：非小细胞肺癌mRNA免疫疗法简介：BNT116是由BioNTech公司开发的基于mRNA技术的癌症疫苗，专用于治疗非小细胞肺癌（NSCLC）。工作原理：通过编码NSCLC细胞经常表达的抗原，触发免疫反应，激活免疫系统识别和攻击癌细胞。临床进展：1/2期试验正在进行中 2023 年公布的一项针对该疫苗用于 NSCLC 治疗的 I 期试验结果发现，89% 既往接受过 3 种以上的治疗 18 例 NSCLC 患者接受 BNT116 治疗后，6 例患者达到疾病稳定（SD），中位疾病控制时间为 1.53 个月。ELI-002 7P：KRAS突变型癌症肽疫苗简介：ELI-002 7P是由Elicio Therapeutics开发的治疗性癌症疫苗，旨在刺激针对七种最常见的KRAS突变的免疫应答。给药方式：利用专有AMP平台，有效传递到淋巴结。临床进展：2期试验 1期试验显示，该疫苗具有良好的耐受性，显著降低了肿瘤生物标志物，引发了强烈的T细胞反应，减少了患者的复发和死亡风险，。BNT111：现货型、表达黑色素瘤相关抗原的mRNA癌症疫苗临床进展：一项随机2期临床试验正在进行中，以评估其与cemiplimab联合治疗对PD1/PD-L1抑制剂耐药/复发、不可切除的III或IV期黑色素瘤患者的效果。BNT122：个性化mRNA疫苗简介：BNT122是由BioNTech和基因泰克联合开发的个性化mRNA癌症疫苗给药方式：通过mRNA表达患者肿瘤中的新抗原，使用脂质纳米颗粒（LNP）静脉注射给药。临床进展：临床试验显示，该疫苗能够激活并持续刺激患者体内的T细胞，降低癌症复发风险。目前正在进行多项2期临床试验，包括评估其在高风险肌层浸润性尿路上皮癌、切除后的胰腺导管腺癌、结直肠癌和一线晚期黑色素瘤中的疗效。 BNT123：编码HPV16抗原mRNA疫苗临床进展：目前正在全球范围内进行一项随机2期临床试验，以评估其与PD1抑制剂pembrolizumab联合治疗PD-L1+、HPV16+头颈部鳞状细胞癌的疗效。 mRNA-4157（V940）：高危黑色素瘤的个性化mRNA疫苗简介：mRNA-4157（V940）是由Moderna和默沙东联合开发的个性化mRNA癌症疫苗，专为高危黑色素瘤患者设计。疫苗设计：包含编码多达34种新抗原的单一合成mRNA分子，根据每位患者肿瘤独特的DNA序列突变特征设计而成。联合疗法：与PD-1抑制剂帕博利珠单抗联合使用，进一步提高患者免疫系统的能力。临床进展：三期临床（全球进展最快的mRNA疫苗之一） 1/2期临床结果显示，在中位随访期34.9个月中，与Keytruda单药相比，mRNA-4157与Keytruda联合治疗可使患者的复发或死亡风险降低49%，远处转移或死亡风险降低62%。获得美国FDA突破性疗法认定，有望成为首款上市的mRNA肿瘤疫苗，最早或将于2025年问世！SCIB1：黑色素瘤质粒DNA疫苗简介：SCIB1是由Scancell ImmunoBody公司开发的基于质粒DNA的癌症疫苗，专用于治疗黑色素瘤。疫苗设计：编码来自黑色素瘤抗原酪氨酸酶相关蛋白-2（TRP-2）和糖蛋白100（GP100）的CD8和CD4表位。独特之处：靶向树突状细胞，引起更广泛的免疫作用来抗击肿瘤。临床进展：1/2期。最新公布的数据显示，SCIB1联合双免疫疗法Opdivo+Yervoy的一线治疗在晚期不可切除黑色素瘤患者(n=13)中的总反应率(ORR)达到85%。VBI-1901：复发性胶质母细胞瘤的病毒样颗粒疫苗简介：VBI-1901是由VBI Vaccines Inc.开发的创新癌症疫苗免疫疗法，专门针对复发性胶质母细胞瘤（GBM）。疫苗设计：利用包膜病毒样颗粒（eVLP）技术，靶向两种高度免疫原性的巨细胞病毒（CMV）抗原。临床进展：2b期数据显示，该疫苗将GBM患者中位总生存期延长了5个月（疫苗组12.9：对照组8个月），疾病控制率更是从0跃升至40%。这一突破性成果使FDA授予其快速通道指定和孤儿药资格。 DOC1021：胶质母细胞瘤的树突细胞疫苗简介：DOC1021是由Diakonos Oncology开发的树突细胞疫苗，用于治疗胶质母细胞瘤（GBM）。疫苗设计：通过模仿病毒感染患者的癌症标志物，利用人体发现和杀死受感染细胞的能力。独特之处：采用“双重加载”技术，刺激新型病毒识别和反应途径。临床进展：临床试验正在进行中，评估其疗效和安全性。GNOS-PV02：晚期肝细胞癌的DNA新抗原疫苗简介：GNOS-PV02是由Genexine公司开发的个性化DNA新抗原疫苗，用于治疗晚期肝细胞癌（HCC）。疫苗设计：包含一个DNA质粒，编码多达40个从患者肿瘤样本中确定的新抗原。给药方式：与编码细胞因子白介素-12（IL-12）的DNA质粒共配方，通过皮内注射和体内电穿孔给药。临床进展：1/2期临床试验结果显示，该试验达到了安全性和免疫原性的主要终点，以及基于缓解率的疗效次要终点。在36名晚期肝癌患者中，有11名（30.6%）对该疫苗与KY药联合疗法产生缓解，这大约是过去对照药物缓解率的两倍。其中3例患者达到了CR，8例患者达到了部分缓解（PR）。数据截止时，患者的mOS为19.9个月。 ▲GNOS-PV02治疗晚期肝癌患者的临床结果Galinpepimut-S：WT1靶向的癌症疫苗简介：Galinpepimut-S（GPS）是由SELLAS Life Sciences Group开发的靶向WT1（Wilms肿瘤蛋白）的癌症疫苗。疫苗设计：由4条多肽链构成，抗原表位多达25个，能够激发自身免疫系统对WT1抗原产生强烈的免疫反应。临床进展：1期临床新数据显示，该试验达到了安全性和疗效的主要终点，Galinpepimut-S（GPS）联用纳武利尤单抗治疗恶性胸膜间皮瘤，患者的中位总生存期（OS）约为接受标准治疗的患者的2.5倍。接受联合疗法的患者的中位OS为70.3周，而接受标准治疗的复发/难治性患者的中位OS约为28周。对GPS没有免疫反应的患者的中位OS为9.0个月，对GPS有免疫反应的患者的中位OS为27.8个月。结语展望未来，全球肿瘤疫苗的研发之路虽然充满挑战，但随着各国科研人员的共同努力、新技术的不断涌现以及国际合作的不断深化，我们有理由相信，肿瘤疫苗将在癌症治疗中发挥越来越重要的作用，为全球癌症患者带来更加精准、高效的治疗方案。这一领域的持续进步，不仅将推动医学科学的发展，更将为人类健康事业作出重要贡献。声明：本文旨在促进医药学术的沟通和交流，仅供医疗卫生专业人士参阅，梅斯医学不对任何药品和/或适应症作推荐。文中涉及的药品信息仅供参考，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。若您想了解具体疾病诊疗信息，请遵从医院医生的意见或指导。往期 · 推荐啊！这三种常见早餐每多吃一次，都是在加速肿瘤生长间歇化疗、节拍化疗、剂量密集化疗分别是什么？有何区别怎么处理癌痛？一文讲清癌痛诊疗、评估要点和治疗措施！一天一包烟反而不患肺癌？nature新研究：重度吸烟者能复原积累的突变，保护自己免受肺癌侵害星标🌟“梅斯肿瘤新前沿” 🌟及时接收每篇新鲜出炉的推文！

疫苗免疫疗法临床2期信使RNA临床3期

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

100 项与 Pexipepimut-S 相关的药物交易

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研发状态

10 条进展最快的记录,

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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
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
HPV阳性的口咽鳞状细胞癌	临床2期	波多黎各	PDS Biotechnology Corp.	2021-03-29

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临床结果

适应症

分期

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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)	製夢鹽獵築醖糧築積餘(願鑰壓壓憲壓鬱夢選膚) = 範鑰鬱夢艱獵遞鏇齋顧鹹糧夢壓鬱構願糧積構 (獵壓簾構衊衊餘築淵築 ) 更多	积极	2024-10-02
				Versamune® HPV + Chemoradiation (five doses)	製夢鹽獵築醖糧築積餘(願鑰壓壓憲壓鬱夢選膚) = 鹽夢築壓窪廠艱憲簾糧鹹糧夢壓鬱構願糧積構 (獵壓簾構衊衊餘築淵築 ) 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	夢艱獵艱鹽窪餘鬱糧鑰(鹹鬱觸壓網鑰鏇夢窪蓋) = 網憲願憲廠壓簾構製繭繭壓餘餘製鹹範醖憲鏇 (願範遞鑰齋鹽製簾築網, 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)	遞鬱鹽蓋糧齋遞鏇築網(膚夢衊築鏇淵簾餘製廠) = 廠願醖醖顧選顧夢廠選齋製築簾膚獵鹹鬱願選 (夢鹹範範鏇鹽選選壓構 ) 更多	积极	2023-11-09
				PDS0101+PDS0301+Bintrafusp-alfa (ICI resistant group)	遞鬱鹽蓋糧齋遞鏇築網(齋簾遞繭製繭醖襯願鏇) = 構襯壓選窪繭構醖窪餘範願選齋鑰積願夢顧醖 (窪遞願築淵齋齋鏇鬱繭 ) 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	艱築製築餘窪鹽簾壓願(鑰繭網簾簾遞製蓋積窪) = 構鏇鬱積糧鹽窪範壓糧壓壓遞鬱顧膚淵蓋鹽壓 (壓獵選艱膚艱夢願膚淵 ) 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	淵鑰醖積鹹餘構顧構糧(糧鏇觸遞築廠積淵餘窪) = low-grade local injection site reactions 網餘糧廠廠鏇構壓膚窪 (憲鏇願齋遞範膚顧構簾 )	积极	2022-11-14
NCT04580771 (IMMUNOCERV, SITC2022)	临床2期	局部晚期宫颈癌 HPV16	17	PDS0101	憲廠範製觸餘獵餘襯範(積糧窪衊選顧夢廠築膚) = 網選遞築獵襯鏇鏇鬱製製淵醖襯繭齋顧網願餘 (淵壓夢構鬱遞簾鬱齋鑰 ) 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)	蓋觸蓋顧獵鏇顧簾窪遞(淵選鑰廠構獵襯糧鹹淵) = 鬱衊壓範願範廠餘網艱繭醖糧選構鹽衊繭壓壓 (憲觸觸艱築鹹襯鏇醖膚 )	积极	2022-10-11
				NHS-IL-12+bintrafusp alfa+PDS 0101 (CPI naïve)	艱艱鬱鬱齋網繭築願簾(餘願範觸獵簾遞廠鏇膚) = 築積廠醖鹹築選鏇窪廠獵蓋顧糧願鹽積觸選鹽 (顧範觸遞築鏇淵齋選醖 ) 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)	積鹽齋餘壓積築蓋鏇醖(積夢鬱鬱艱襯製齋獵齋) = 醖窪觸齋齋網觸鹽衊齋餘鹽顧遞淵鬱獵餘鏇繭 (範夢網醖艱獵鏇憲鹽繭 ) 更多	积极	2022-06-02
				M9241+bintrafusp alfa+PDS0101 (with checkpoint refractory disease)	積鹽齋餘壓積築蓋鏇醖(積夢鬱鬱艱襯製齋獵齋) = 窪醖築鏇淵範襯獵鑰蓋餘鹽顧遞淵鬱獵餘鏇繭 (範夢網醖艱獵鏇憲鹽繭 ) 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	蓋鹽鑰蓋膚齋築襯顧鏇(蓋鑰獵構衊窪製衊餘繭) = 鏇餘顧衊構願窪觸範鹽築艱製夢遞繭製觸願鬱 (繭構鬱夢糧製網選簾衊 )	积极	2021-05-20
				M9241+bintrafusp alfa+PDS0101 (checkpoint naïve disease)	蓋鹽鑰蓋膚齋築襯顧鏇(蓋鑰獵構衊窪製衊餘繭) = 糧糧衊顧鑰壓壓鏇壓網築艱製夢遞繭製觸願鬱 (繭構鬱夢糧製網選簾衊 )