Background:
Prostate cancer may return after treatment in 30,000 to 50,000 people each year. There is no clear best way to treat these people. Better treatments are needed.
Objective:
To test a study drug (enzalutamide), both alone and combined with a second drug (M9241), in people with prostate cancer that returned after treatment.
Eligibility:
People aged 18 years and older with prostate cancer that returned after treatment.
Design:
Participants will be screened. They will have a physical exam, with blood tests. All their urine will be collected for 24 hours. They will have imaging scans of their chest, abdomen, pelvis, and bones. Their ability to perform everyday activities will be assessed. They may opt to give a stool sample.
Participants will be treated in 4-week cycles.
Enzalutamide is a pill taken by mouth once a day, every day. All participants will be given a supply of this drug to take at home.
M9241 is injected under the skin once a month, on the first day of each cycle. Half of the participants will receive both drugs.
All participants will visit the clinic once a month. Each visit should last no more than 8 hours. Blood and urine tests will be repeated.
All participants will receive the study treatment for 3 cycles. Some participants may need 3 more cycles of treatment with enzalutamide only. This re-treatment can be done only once.
Participants will have a follow-up visit 1 month after they finish treatment. After that, they will have visits every 6 weeks for up to 5 years. Imaging scans and blood tests will be repeated.
...

开始日期2024-04-22

申办/合作机构

National Cancer Institute

NCT05361798 / Recruiting临床2期IIT

A Phase II Study Evaluating T-Cell Clonality After Stereotactic Body Radiation Therapy Alone and in Combination With the Immunocytokine M9241 in Localized High and Intermediate Risk Prostate Cancer Treated With Androgen Deprivation Therapy

Background:
Prostate cancer is often treated with radiation and ADT (ADT is androgen deprivation therapy). Up to 30% of these cancers recur within 5 years of treatment. Researchers want to see if a new drug (M9241) can help the immune system to fight prostate cancer.
Objective:
To find what doses of M9241 are safe in people who are treated for prostate cancer. Also, to see what effects M9241 has on the immune system.
Eligibility:
People aged 18 and older with high- and intermediate-risk prostate cancer. Their cancer must not have spread to other parts of the body.
Design:
The study will last 7 months.
Participants will be screened. They will share their medical history. They will also have:
A physical exam
Routine blood and urine tests
Imaging scans of the chest, abdomen, and pelvis
A bone scan
A tumor biopsy
A specialized MRI. Participants will lie face down on the MRI scanner table. An antenna that receives a signal may be placed in the rectum.
All participants will be treated with radiation therapy and ADT.
Some participants will also receive M9241 as an injection under the skin. This treatment will start 4 weeks after the radiation has ended. Participants will receive a total of 3 doses. The injections will be 4 weeks apart. Some screening tests will be repeated at each visit.
Participants who do not receive M9241 will also have screening tests during the treatment period.
Participants will return for follow-up about 1 month after the last treatment or set of tests.

开始日期2023-06-12

申办/合作机构

National Cancer Institute

NCT05286814 / Recruiting临床2期IIT

Phase II Study Evaluating the Efficacy of M9241 in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer or Intrahepatic Cholangiocarcinoma

Background:
One way to treat liver cancer is to deliver chemotherapy drugs only to the liver (and not to the whole body). Researchers want to see if adding the drug M9241 can improve the treatment. The drug triggers the immune system to fight cancer.
Objective:
To see if treatment with HAIPs to deliver liver-directed chemotherapy in combination with M9241 is effective for certain cancers.
Eligibility:
People aged 18 and older who have cancer of the bile ducts that is only in the liver, or colorectal cancer that has spread to the liver.
Design:
Participants will be screened with:
Medical history
Physical exam
Blood tests
Pregnancy test (if needed)
Tumor biopsy (if needed)
Electrocardiogram
Computed tomography (CT) scans
Participants will have an abdominal operation. A catheter will be placed into an artery that feeds blood to the liver. The catheter will then be attached to the HAIP. The HAIP will lay under the skin on the left side of the abdomen.
Participants will have chemotherapy drugs or heparin with saline infused into the HAIP every 2 weeks. M9241 will be injected under the skin every 4 weeks. They will get systemic chemotherapy through an IV or mediport every 2 weeks. They will receive this treatment until their cancer gets worse or they have bad side effects.
Participants will have 2 study visits each month. They will have CT scans every 8 weeks. At visits, they will repeat some screening tests.
Participants will have a follow-up visit 1 month after treatment ends. Then they will be contacted every 6 months for 5 years.

开始日期2022-10-24

申办/合作机构

National Cancer Institute

100 项与 NHS-IL-12 相关的临床结果

登录后查看更多信息

100 项与 NHS-IL-12 相关的转化医学

登录后查看更多信息

100 项与 NHS-IL-12 相关的专利（医药）

登录后查看更多信息

项与 NHS-IL-12 相关的文献（医药）

2024-06-01·Journal of Gastrointestinal Oncology

Hepatic artery infusion pump (HAIP) therapy in combination with targeted delivery of IL-12 for patients with metastatic colorectal cancer or intrahepatic cholangiocarcinoma: a phase II trial protocol

Article

作者: Rainey, Ashley J ; Hannah, Cathleen E ; Eade, Alyssa V ; Smith, Kathleen M ; Pu, Tracey ; Hernandez, Jonathan M ; Blakely, Andrew M ; Smith, Emily C ; Davis, Jeremy L ; Luberice, Kenneth ; Xie, Changqing ; Friedman, Lindsay R ; Gulley, James L ; Monge, Cecilia ; Greten, Tim F ; Ramamoorthy, Bhavishya ; Victory, Jack H ; Lambdin, Jacob ; Larrain, Carolina ; Mabry, Donna ; Schlom, Jeffrey ; Sarvestani, Amber Leila ; Ryan, Carrie E

Background:

Treatment of advanced liver tumors remains challenging. Although immune checkpoint inhibition has revolutionized treatment for many cancers, responses in colorectal liver metastases and biliary tract cancers remain suboptimal. Investigation into additional immunomodulatory therapies for these cancers is needed. Interleukin-12 (IL-12) is a pro-inflammatory cytokine with robust anti-tumor activity, but systemic adverse effects largely terminated therapeutic development of recombinant human IL-12 (rhIL-12). PDS01ADC is a novel human monoclonal antibody (NHS76) conjugated to two IL-12 heterodimers with established safety in phase I trials. The NHS76 antibody specifically targets histone/DNA complexes which are accessible only in regions of cell death and this antibody has been shown to accumulate locally in tumors.

Methods:

Patients with unresectable metastatic colorectal cancer (mCRC) or unresectable intrahepatic cholangiocarcinoma (ICC) will receive synchronization of subcutaneous PDS01ADC with floxuridine delivered via a hepatic artery infusion pump (HAIP). The primary outcome measured in this study will be overall response rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Secondary outcomes measured in this study will include hepatic and non-hepatic progression-free survival (PFS), overall survival, and safety of PDS01ADC combination therapy with HAIP.

Discussion:

Poor clinical response of these liver tumors to immunotherapy is likely due to various factors, including poor immune infiltrate into the tumor and immunosuppression by the tumor microenvironment. By exploiting the tumor cell death induced by HAIP locoregional therapy in combination with systemic chemotherapy, PDS01ADC is poised to modulate the tumor immune microenvironment to improve outcomes for patients undergoing HAIP therapy.

Trial Registration:

ClinicalTrials.gov (ID NCT05286814 version 2023-10-18); https://clinicaltrials.gov/study/NCT05286814?term=NCT05286814&rank=1.

2023-08-01·Cancer immunology, immunotherapy : CII

Exploiting docetaxel-induced tumor cell necrosis with tumor targeted delivery of IL-12.

Article

作者: Chariou, Paul L. ; Gameiro, Sofia R. ; Santiago-Sanchez, Ginette S. ; Hamilton, Duane H. ; Padget, Michelle R. ; Fabian, Kellsye P. ; Solocinski, Kristen ; Schlom, Jeffrey ; Hodge, James W. ; Kowalczyk, Joshua T. ; Franks, S. Elizabeth

There is strong evidence that chemotherapy can induce tumor necrosis which can be exploited for the targeted delivery of immuno-oncology agents into the tumor microenvironment (TME). We hypothesized that docetaxel, a chemotherapeutic agent that induces necrosis, in combination with the bifunctional molecule NHS-IL-12 (M9241), which delivers recombinant IL-12 through specific targeting of necrotic regions in the tumor, would provide a significant antitumor benefit in the poorly inflamed murine tumor model, EMT6 (breast), and in the moderately immune-infiltrated tumor model, MC38 (colorectal). Docetaxel, as monotherapy or in combination with NHS-IL-12, promoted tumor necrosis, leading to the improved accumulation and retention of NHS-IL-12 in the TME. Significant antitumor activity and prolonged survival were observed in cohorts receiving docetaxel and NHS-IL-12 combination therapy in both the MC38 and EMT6 murine models. The therapeutic effects were associated with increased tumor infiltrating lymphocytes and were dependent on CD8⁺ T cells. Transcriptomics of the TME of mice receiving the combination therapy revealed the upregulation of genes involving crosstalk between innate and adaptive immunity factors, as well as the downregulation of signatures of myeloid cells. In addition, docetaxel and NHS-IL-12 combination therapy effectively controlled tumor growth of PD-L1 wild-type and PD-L1 knockout MC38 in vivo, implying this combination could be applied in immune checkpoint refractory tumors, and/or tumors regardless of PD-L1 status. The data presented herein provide the rationale for the design of clinical studies employing this combination or similar combinations of agents.

2023-05-01·Journal for immunotherapy of cancer

First-in-human phase Ib trial of M9241 (NHS-IL12) plus avelumab in patients with advanced solid tumors, including dose expansion in patients with advanced urothelial carcinoma

Article

作者: Deville, Jean-Laurent ; Wang, XiaoZhe ; Seebeck, Joerg ; Sznol, Mario ; Chennoufi, Sarah ; Gulley, James L ; Maruzzo, Marco ; Donahue, Renee N ; Beier, Frank ; Gourdin, Theodore S ; Dirix, Luc ; Schroeder, Andreas ; Maio, Michele ; Vugmeyster, Yulia ; Strauss, Julius ; Schlom, Jeffrey ; Tsai, Yo-Ting ; Ravaud, Alain ; Pachynski, Russell K

Background:

In preclinical studies, combining M9241 (a novel immunocytokine containing interleukin (IL)-12 heterodimers) with avelumab (anti-programmed death ligand 1 antibody) resulted in additive or synergistic antitumor effects. We report dose-escalation and dose-expansion results from the phase Ib JAVELIN IL-12 trial investigating M9241 plus avelumab.

Methods:

In the dose-escalation part of JAVELIN IL-12 (NCT02994953), eligible patients had locally advanced or metastatic solid tumors; in the dose-expansion part, eligible patients had locally advanced or metastatic urothelial carcinoma (UC) that had progressed with first-line therapy. Patients received M9241 at 4, 8, 12, or 16.8 µg/kg every 4 weeks (Q4W) plus avelumab 10 mg/kg every 2 weeks (Q2W, dose levels (DLs) 1–4) or M9241 16.8 µg/kg Q4W plus avelumab 800 mg once a week for 12 weeks followed by Q2W (DL5/dose expansion). Primary endpoints for the dose-escalation part were adverse events (AEs) and dose-limiting toxicities (DLTs), and those for the dose-expansion part were confirmed best overall response (BOR) per investigator (Response Evaluation Criteria in Solid Tumors V.1.1) and safety. The dose-expansion part followed a two-stage design; 16 patients were enrolled and treated in stage 1 (single-arm part). A futility analysis based on BOR was planned to determine whether stage 2 (randomized controlled part) would be initiated.

Results:

At data cut-off, 36 patients had received M9241 plus avelumab in the dose-escalation part. All DLs were well tolerated; one DLT occurred at DL3 (grade 3 autoimmune hepatitis). The maximum-tolerated dose was not reached, and DL5 was declared the recommended phase II dose, considering an observed drug–drug interaction at DL4. Two patients with advanced bladder cancer (DL2 and DL4) had prolonged complete responses. In the dose-expansion part, no objective responses were recorded in the 16 patients with advanced UC; the study failed to meet the criterion (≥3 confirmed objective responses) to initiate stage 2. Any-grade treatment-related AEs occurred in 15 patients (93.8%), including grade ≥3 in 8 (50.0%); no treatment-related deaths occurred. Exposures for avelumab and M9241 concentrations were within expected ranges.

Conclusions:

M9241 plus avelumab was well tolerated at all DLs, including the dose-expansion part, with no new safety signals. However, the dose-expansion part did not meet the predefined efficacy criterion to proceed to stage 2.

项与 NHS-IL-12 相关的新闻（医药）

2024-11-06

·GlobeNewswire-Health Care

PDS Biotech to Announce Third Quarter Financial Results on November 14, 2024 at 8:30 a.m. Eastern Time

PRINCETON, N.J., Nov. 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 the Company will host a conference call to report financial results for the quarter ended September 30, 2024, and provide a clinical program update on Thursday, November 14, 2024, at 8:30 a.m. Eastern Time. Conference Call Details Date: November 14, 2024Time: 8:30 a.m. Eastern TimeDial-in: 1-877-704-4453 or 1-201-389-0920Webcast Registration: Click HereCall MeTM Registration: Click Here (Available 15 minutes prior to call) About PDS BiotechnologyPDS 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 in 2024 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. We believe that proof-of-concept long-term data have shown positive survival results and tumor shrinkage with these combinations and indicate favorable tolerability. We believe that the novel investigational mechanisms of action of Versamune® HPV and the combination of Versamune® HPV and PDS01ADC have resulted in compelling results with potential to successfully disrupt a tumor’s internal defenses, while also generating potent, targeted killer T-cells to attack the tumor. We also believe that data from more than 350 patients, as well as ongoing clinical trials across multiple tumor types and standard treatment regimens, have validated the potential for both platforms and point to potential broad utility. For more information, please visit www.pdsbiotech.com. Forward Looking StatementsThis 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

免疫疗法财报

2024-10-22

·GlobeNewswire-Health Care

PDS Biotech Announces Presentation of Rationale and Design of First Recurrent Prostate Cancer Trial to Combine an Androgen Receptor Pathway Inhibitor with an Immunocytokine

Study to evaluate PDS01ADC + Xtandi® (Enzalutamide) versus Xtandi® alone to be presented by Dr. Ravi Madan, National Cancer Institute at Cytokines 2024PRINCETON, N.J., Oct. 22, 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 the rationale and trial design for a study evaluating PDS01ADC for the treatment of recurrent prostate cancer will be discussed during an oral presentation at the 12th Annual Meeting of the International Cytokine & Interferon Society (Cytokines 2024) in Seoul, South Korea. Details of the presentation are as follows: Date: Wednesday, October 23, 2024Session time: 08:30-10:10 Korean Standard Time (KST)Session title: Symposium 20 - Cytokine-mediated Translational Approaches of Human DiseasesPresentation time: 09:20-09:32 KSTPresentation title: A Clinical Trial Combining a Tumor Targeting Immunocytokine (PDS01ADC) and Enzalutamide without Testosterone Lowering Therapy in Biochemically Recurrent Prostate CancerPresenter: Ravi A. Madan, M.D., Head, Prostate Cancer Clinical Research Section, Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, part of the U.S. National Institutes of Health 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 in 2024 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 StatementsThis 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 PDS01ADC, Versamune® HPV (formerly PDS0101), PDS0203 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 PDS01ADC, Versamune® HPV, PDS0203 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. Xtandi® is a registered trademark of Astellas Pharma, Inc. 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

免疫疗法临床研究

2024-10-02

·GlobeNewswire-Health Care

PDS Biotech Announces 36-Month Overall Survival Rate of 84.4% in Locally Advanced Cervical Cancer Patients Treated with Versamune® HPV and Chemoradiation

100% 36-month overall survival (OS) and progression-free survival (PFS) rates in patients fully treated with Versamune® HPV combined with chemoradiation (N=8)88% (15/17) of patients had a complete metabolic responseIMMUNOCERV Phase 2 clinical trial results presented at ASTRO Annual Meeting 2024 PRINCETON, N.J., Oct. 02, 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 updated data from the IMMUNOCERV Phase 2 clinical trial evaluating Versamune® HPV (formerly PDS0101) with chemoradiation to treat locally advanced cervical cancer were presented at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2024 in an oral presentation by Adam Grippin, M.D., Ph.D., of The University of Texas MD Anderson Cancer Center. The abstract was granted Basic/Translational Science Award from the ASTRO Annual Meeting Steering Committee. “HPV is responsible for virtually all cervical cancers and presents an opportunity for immunologic targeting1. However, there are currently no FDA-approved HPV-targeted immunotherapies to treat cervical cancer,” said Ann Klopp, M.D., Ph.D., Professor of Radiation Oncology and Head of the Gynecologic Section at MD Anderson. “These data suggest that further investigation is warranted into the safety and efficacy of Versamune® HPV in combination with standard of care in the treatment of locally advanced cervical cancer.” The IMMUNOCERV Phase 2 clinical trial (NCT04580771) evaluated the efficacy, safety and tolerability of Versamune® HPV in combination with standard-of-care chemoradiotherapy for the treatment of locally advanced cervical cancer. The investigator-initiated study enrolled 17 newly diagnosed high-risk patients with large tumors of at least 5 cm in size. Highlights from the presentation include: All patients received at least 2 doses of Versamune® HPV.Median follow-up was 19 months.36-month overall survival (OS) rate was 84.4%, and 100% for the eight patients who received all five doses of Versamune® HPV. Historical published data show 36-month OS rate with chemoradiation in this population of approximately 64%.236-month progression free survival (PFS) rate was 74.9%, among all patients and 100% for the eight patients who received all five doses of Versamune® HPV. Historical published data show 36-month PFS rate with chemoradiation in this population of approximately 61%.2Complete metabolic response (CMR) was achieved in 15/17 (88%) patients.Versamune® HPV appeared to be safe and well-tolerated. The most common treatment-related toxicities were injection site reactions in twelve patients (71%). “We are pleased that data from the Phase 2 IMMUNOCERV trial demonstrate compelling clinical activity and a promising safety profile,” said Frank Bedu-Addo, Ph.D., President and Chief Executive Officer of PDS Biotech. “Based on our continued research in various HPV-positive cancers, Versamune® HPV appears to work in combination with a variety of therapeutic agents to generate clinical responses and promote improved survival in patients with minimal toxicity. We look forward to the next steps in the development of Versamune® HPV for locally advanced cervical cancer.” National Cancer Institute, Cervical Cancer Causes, Risk Factors and Prevention. https://www.cancer.gov/types/cervical/causes-risk-preventionRose PG, et al. Concurrent Cisplatin-Based Radiotherapy and Chemotherapy for Locally Advanced Cervical Cancer. N Engl J Med. 1999;340:1144-53. 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 in 2024 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 StatementsThis 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 PDS01ADC, Versamune® HPV (formerly PDS0101), PDS0203 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 PDS01ADC, Versamune® HPV, PDS0203 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

临床结果临床2期免疫疗法ASCO会议

100 项与 NHS-IL-12 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
复发性前列腺癌	临床2期	美国	National Cancer Institute	2024-04-22
HPV相关癌症	临床2期	北美洲	PDS Biotechnology Corp.	2023-01-03
肝内胆管癌	临床2期	美国	National Cancer Institute	2022-10-24
转移性结直肠癌	临床2期	美国	National Cancer Institute	2022-10-24
不能切除性胰腺癌	临床2期	美国	National Cancer Institute	2021-06-15
胰腺继发性恶性肿瘤	临床2期	美国	National Cancer Institute	2021-06-15
去势敏感前列腺癌	临床2期	美国	National Cancer Institute	2021-02-23
转移性去势抵抗性前列腺癌	临床2期	美国	National Cancer Institute	2021-02-23
卡波西肉瘤	临床2期	美国	National Cancer Institute	2020-07-13
膀胱癌	临床1期	美国	National Cancer Institute	2020-07-13

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02994953 (COMBO \| JAVELIN IL-12, CTgov)	临床1期	局部晚期恶性实体瘤	52	Avelumab+M9241 (Part A Cohort 1: M9241 4 mcg/kg + Avelumab 10 mg/kg)	衊窪艱網築築繭築鬱遞(醖鏇醖鹽構壓壓夢襯構) = 鏇鏇廠蓋憲衊襯簾窪製窪觸獵淵鑰醖膚衊衊鑰 (憲憲淵廠鹽蓋醖顧鹹繭, 獵艱廠餘蓋遞繭顧獵餘 ~ 顧廠鹽壓願鬱製鑰觸艱) 更多	-	2024-09-20
				Avelumab+M9241 (Part A Cohort 2: M9241 8 mcg/kg + Avelumab 10 mg/kg)	衊窪艱網築築繭築鬱遞(醖鏇醖鹽構壓壓夢襯構) = 醖糧齋鏇糧選壓壓窪醖窪觸獵淵鑰醖膚衊衊鑰 (憲憲淵廠鹽蓋醖顧鹹繭, 願構簾餘鹹選醖鏇積膚 ~ 範繭鬱遞鏇衊夢構觸繭) 更多
NCT04491955 (CTgov)	临床2期	结直肠癌 \| 小肠癌	32	NHS-IL12 (M9241) (Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241))	選餘憲觸醖醖廠餘範築(餘壓衊衊遞齋淵製鬱衊) = 壓餘齋鹹觸廠艱製遞夢夢齋壓遞觸艱鑰蓋獵窪 (網糧襯繭壓製網蓋膚築, 糧齋鏇願築構製觸製鑰 ~ 蓋鹹艱鏇遞餘艱願構醖) 更多	-	2023-11-14
				FPV-CV301+N-803+modified vaccinia Ankara (MVA)-BN-CV301+M7824+NHS-IL12 (M9241) (Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation)	選餘憲觸醖醖廠餘範築(繭糧繭願窪築遞膚鹽鑰) = 齋醖選糧鬱醖襯選鏇網遞淵顧網願觸鬱齋糧觸 (艱築鏇糧鏇夢繭獵顧餘, 顧積膚鹽鹹簾衊遞獵製 ~ 願廠鏇鏇製簾築膚顧壓) 更多
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)	鹽構遞襯齋淵遞淵鹽窪(窪顧窪鹹襯鬱襯艱夢壓) = 簾網鏇願糧餘遞築憲衊構製廠遞範製獵艱鹽鹽 (鑰鹽糧窪築選壓餘艱顧 ) 更多	积极	2023-11-09
				PDS0101+PDS0301+Bintrafusp-alfa (ICI resistant group)	艱築醖築齋齋膚廠獵壓(繭憲鹽淵餘範遞齋淵網) = 鹹艱糧獵構網顧鏇網選醖遞觸觸憲遞糧糧鬱齋 (淵築廠選鏇網艱積艱衊 ) 更多
NCT04235777 (ASCO2023) 人工标引	临床1期	泌尿生殖系统肿瘤	16	Bintrafusp alfa+M9241	衊壓襯憲艱淵範顧窪繭(遞積夢積網鹽鹹糧淵鑰) = The most frequent TRAEs were fatigue (grade 2, 38%), lipase increase (grade 2+3, 31%), and anemia (grade 2+3, 31%). Grade 3 hematuria occurred in 2 patients (13%); a grade 4 creatinine increase occurred in one (8%). 鹹夢鑰襯糧齋鹹築願鑰 (鑰繭積餘壓鹽鬱壓鹽顧 )	积极	2023-05-26
				SBRT+Bintrafusp alfa+M9241 (bintrafusp alfa and M9241 with either sequential SBRT)
NCT04491955 (ASCO_GI2023) 人工标引	临床2期	晚期结直肠腺癌 \| 小肠癌二线	30	overall	壓鹹淵鏇獵築鹹願簾鏇(願鹽網衊艱鹹膚壓鏇衊) = 醖選淵蓋廠齋襯鹹醖衊築鹹顧鏇網構憲襯鹹艱 (範範積獵餘膚鬱鹹艱襯 )	积极	2023-01-24
				CV301+N-803+bintrafusp alfa (triple therapy)	製襯鏇繭醖鹹襯繭壓夢(糧觸築夢糧觸構糧鏇鹹) = 齋淵願餘廠築餘鹽範艱鏇構艱遞願蓋願網網製 (願膚願鑰鹽蓋淵鏇膚繭, 33.7 ~ 86.0) 更多
NCT01417546 (Pubmed)	临床1期	转移性实体瘤	13	NHS-IL12 12 µg/kg SC q2w	醖遞積艱選艱窪壓獵遞(憲築窪淵鹹艱構願餘齋) = 夢夢蓋願糧鬱繭廠膚積觸蓋艱膚鹹製壓壓壓廠 (餘選廠壓觸選艱壓淵壓 )	-	2023-01-14
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)	憲製憲襯鬱襯鏇鹽蓋鬱(鏇蓋窪願窪顧築積鏇製) = 窪鹹觸醖簾構遞膚鹹憲窪網夢鹹簾夢積醖構繭 (遞膚築夢齋遞鬱衊願簾 ) 更多	积极	2022-06-02
				M9241+bintrafusp alfa+PDS0101 (with checkpoint refractory disease)	憲製憲襯鬱襯鏇鹽蓋鬱(鏇蓋窪願窪顧築積鏇製) = 遞製衊鹹觸衊鹹鹽顧餘窪網夢鹹簾夢積醖構繭 (遞膚築夢齋遞鬱衊願簾 ) 更多
SITC2019	N/A	-	-	Entinostat	構範餘憲獵鑰廠艱獵鬱(憲膚簾餘鬱鑰獵夢積淵) = areas of tumor necrosis identified via H&E staining also displayed DNA fragmentation measured by the TUNEL assay 簾鬱範齋繭築醖齋遞廠 (遞範夢壓構網襯繭願鹹 ) 更多	积极	2019-11-01
NCT02994953 (JAVELIN IL-12, ESMO2019) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	-	Avelumab+M9241	蓋壓鏇遞製顧觸製簾鏇(膚膚鬱醖夢簾簾膚廠壓) = 1 pt (DL3, grade 3 autoimmune hepatitis) 製構衊鑰窪衊鹹鹹蓋鏇 (齋選鑰艱鑰積蓋餘壓壓 ) 更多	不佳	2019-09-30
NCT01417546 (Pubmed \| Clin Cancer Res) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	-	NHS-IL-12	膚餘憲鹽餘衊願衊範築(願齋廠蓋餘選築築簾襯) = No observed 鹽積壓窪廠餘網淵膚製 (壓網壓齋糧廠網艱壓衊 ) 更多	积极	2019-06-15