MEDI0457 / Inovio, AstraZeneca - LARVOL DELTA (2024)

Table of Contents
INOVIO Reports First Quarter 2024 Financial Results and Recent Business Highlights (PRNewswire) - "The FDA provided feedback on the proposed Phase 3 trial design to evaluate the combination of INO-3112 and LOQTORZI as a potential treatment for patients with locoregionally advanced, high-risk, HPV-16/-18 positive throat cancer. INOVIO will discuss the proposed trial design with European regulatory authorities, as INOVIO plans to conduct the trial in both Europe and North America....The proposed multi-center Phase 3 trial will investigate whether LOQTORZI can help boost the tumor-infiltrating abilities of the antigen-specific T cells generated by INO-3112." European regulatory • FDA event • Oropharyngeal Cancer INOVIO Reports Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights (PRNewswire) - "INOVIO has submitted the proposed design of a Phase 3 trial to the FDA with the intent to evaluate the clinical benefit of INO-3112 in combination with a PD-1 inhibitor. Feedback on the clinical development plan is expected in the second quarter of 2024. If cleared to proceed by the FDA, the trial will investigate if LOQTORZI can help boost the tumor-infiltrating abilities of the antigen-specific T cells generated by INO-3112." Clinical protocol • FDA event • Oropharyngeal Cancer • Squamous Cell Carcinoma INOVIO and Coherus Announce Clinical Collaboration to Advance Development of INO-3112 in Combination with LOQTORZI (toripalimab-tpzi) (PRNewswire) - "INOVIO...today announced a clinical collaboration and supply agreement with Coherus BioSciences, Inc...to evaluate the combination of INO-3112 and LOQTORZI™ (toripalimab-tpzi) as a potential treatment for patients with locoregionally advanced, high-risk, HPV16/18 positive oropharyngeal squamous cell carcinoma (OPSCC), a type of head and neck cancer commonly known as throat cancer....Under the terms of the supply agreement, Coherus will provide LOQTORZI™ (toripalimab-tpzi), for a Phase 3 clinical trial to be conducted by INOVIO, pending alignment with the U.S. Food and Drug Administration (FDA) on study design." Licensing / partnership • Head and Neck Cancer • Oncology • Solid Tumor MEDI0457 Plus Durvalumab in HPV-associated HNSCC-Letter. (PubMed, Clin Cancer Res) - No abstract available Journal • Head and Neck Cancer • Squamous Cell Carcinoma of Head and Neck MEDI0457 Plus Durvalumab in HPV-associated HNSCC-Response. (PubMed, Clin Cancer Res) - No abstract available Journal • Head and Neck Cancer • Squamous Cell Carcinoma of Head and Neck Phase II Trial of MEDI0457 and Durvalumab for Patients With Recurrent/Metastatic Human Papillomavirus-Associated Cancers. (PubMed, Oncologist) - "The combination of MEDI0457 and durvalumab demonstrated acceptable safety and tolerability in patients with advanced HPV-16/18 cancers. The low ORR among patients with cervical cancer led to study discontinuation despite a clinically meaningful disease control rate." Journal • Metastases • P2 data • Cervical Cancer • Genito-urinary Cancer • Immune Modulation • Oncology • Penile Cancer • Solid Tumor • IL12A Survival benefit to immunotherapy according to site of organ involvement in metastatic anal cancer. (ASCO-GI 2023) - "58 (71%) received anti-PD-(L)1 immunotherapy, either alone (N=51) or in combination with bevacizumab or with MEDI-0457 on a clinical trial (N=7). In this single-institution retrospective study at a large academic referral center, both chemotherapy and immune checkpoint blockade were effective treatment options for patients with metastatic anal cancer. These data provide historical context in estimating median PFS necessary for future trial design in patients with metastatic anal cancer. Lymph node-only distribution of distant metastatic disease was predictive for improved survival with immunotherapy." IO biomarker • Metastases • Anal Carcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor Safety and Efficacy of MEDI0457 plus Durvalumab in Patients with Human Papillomavirus–Associated Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (Clin Cancer Res) - P1/2 | N=35 | NCT03162224 | Sponsor: MedImmune LLC | "We assessed whether...MEDI0457 combined with the PD-L1 inhibitor durvalumab could enhance HPV-specific T-cell response and improve outcomes in recurrent/metastatic HPV-16/18–associated HNSCC....Of 35 treated patients, 29 were response evaluable (confirmed HPV-associated disease; received both agents). ORR was 27.6% [95% confidence interval (CI), 12.7–47.2; four complete responses, four partial responses]; responses were independent of PD-L1 tumor-cell expression (≥25% vs. <25%). DCR-16 was 44.8% (95% CI, 26.5–64.3). Median PFS was 3.5 months (95% CI, 1.9–9.0); median OS was 29.2 months (15.2–not calculable)." P1/2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck Safety and Efficacy of MEDI0457 Plus Durvalumab in Patients With Human Papillomavirus-associated Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma. (PubMed, Clin Cancer Res) - "MEDI0457 plus durvalumab was well tolerated. While the primary efficacy endpoint was not reached, clinical benefit was encouraging." IO biomarker • Journal • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8 • IL12A Safety and Efficacy of MEDI0457 Plus Durvalumab in Patients With Human Papillomavirus-associated Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (Clin Cancer Res) - P1b/2a | N=35 | NCT03162224 | Sponsor: MedImmune LLC | "We assessed if a DNA vaccine targeting HPV-16/18 E6/E7 with interleukin-12 adjuvant (MEDI0457) combined with the PD-L1 inhibitor durvalumab could enhance HPV-specific T-cell response and improve outcomes in recurrent/metastatic HPV-16/18-associated HNSCC....Of 35 treated patients, 29 were response-evaluable (confirmed HPV-associated disease; received both agents). ORR was 27.6% (95% CI, 12.7-47.2; 4 complete responses, 4 partial responses); responses were independent of PD-L1 tumor-cell expression (≥25% vs <25%). DCR-16 was 44.8% (95% CI, 26.5-64.3). Median PFS was 3.5 months (95% CI, 1.9-9.0); median OS was 29.2 months (15.2-not calculable). Twenty-eight (80.0%) patients had treatment-related adverse events (grade 3: 5 [14.3%]; no grade 4/5), resulting in discontinuation in 2 (5.7%) patients." P1/2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers (clinicaltrials.gov) - P2 | N=77 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Recruiting ➔ Active, not recruiting | Trial primary completion date: Dec 2021 ➔ Dec 2022 Enrollment closed • Trial primary completion date • Anal Carcinoma • Cervical Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Oncology • Penile Cancer • Solid Tumor • vagin*l Cancer • Vulvar Cancer • CD4 The Efficacy of Therapeutic DNA Vaccines Expressing the Human Papillomavirus E6 and E7 Oncoproteins for Treatment of Cervical Cancer: Systematic Review. (PubMed, Vaccines (Basel)) - "Five different DNA therapeutic vaccines (GX-188E, VGX-3100, pNGVL4a-CRT/E7(detox), pNGVL4a-Sig/E7(detox)/HSP70, MEDI0457) were well-tolerated and clinically effective. Clinical implementation of DNA therapeutic vaccines into treatment regimen as a sole approach or in combination with conservative treatment holds great potential for effective cancer treatment." Journal • Review • Cervical Cancer • Gene Therapies • Gynecology • Oncology • Solid Tumor Inovio, AstraZeneca terminate cancer vaccine partnership (Biz Journal) - “MedImmune Ltd…arm of AstraZeneca…is terminating a cancer therapy partnership it has with Inovio Pharmaceuticals….Inovio disclosed MedImmune's decision to terminate the agreement in a document the Plymouth Meeting-based company filed last week with the Securities and Exchange Commission….Inovio (NASDAQ: INO)will reacquire the rights to INO-3112 and will no longer be entitled to receive potential future milestone payments or royalties from MedImmune. Inovio said it will also cease any development activities for which it would be entitled to seek reimbursem*nt from MedImmune. The two companies will continue to have rights to jointly publish work relating to the product candidate….MedImmune, according to Inovio's SEC filing, is conducting a phase 2 clinical trial of MED10457 in patients with head and neck squamous cell carcinomas. MedImmune has completed the final data cutoff for the trial and plans to complete the clinical study report by the end of 2022.” Licensing / partnership • Trial completion date • Oncology A phase 1/2A trial of synthetic DNA vaccine immunotherapy targeting HPV-16 and -18 after chemoradiation for cervical cancer. (ASCO 2018) - P1/2; "Adjuvant MEDI0457 is feasible after chemoradiation for locally advanced and/or recurrent cervical cancer. More than half of the patients developed detectable immune responses to HPV antigens after treatment. These results support further study into the efficacy of adding DNA therapy with CELLECTRA EP to chemoradiation for HPV-related cancers." P1/2 data • Cervical Cancer [VIRTUAL] Phase II trial of MEDI0457 and durvalumab for patients with recurrent/metastatic HPV-associated cancers. (ASCO 2021) - P2 | "The combination of MEDI0457 and durvalumab demonstrated acceptable safety/tolerability in pts with advanced HPV-16/18 cancers . Despite a clinically meaningful DCR, the low ORR among pts with cervical cancer led to study discontinuation for futility . Correlative studies are ongoing to characterize pts with prolonged disease control with study treatment." Clinical • P2 data • Anal Carcinoma • Cardiovascular • Cervical Cancer • Genito-urinary Cancer • Heart Failure • Hematological Disorders • Infectious Disease • Neutropenia • Oncology • Penile Cancer • Solid Tumor • Squamous Cell Carcinoma • IL12A A phase 1b/2a, multi-center, open-label study to evaluate the safety and efficacy of combination treatment with MEDI0457 (INO-3112) and durvalumab (MEDI4736) in patients with recurrent/metastatic human papilloma virusassociated head and neck squamous cell cancer. (ASCO 2018) - P1b/2a; "Primary objectives are safety and objective response rate. Secondary objectives are disease control rate at 16 weeks, overall survival, progression-free survival, and pharmaco*kinetics and immunogenicity of durvalumab." Clinical • Head and Neck Cancer [VIRTUAL] Safety and efficacy of MEDI0457 plus durvalumab in patients (pts) with human papillomavirus-associated recurrent/metastatic head and neck squamous cell carcinoma (HPV+ R/M HNSCC) (ESMO 2020) - P1b/2a | "Funding: AstraZeneca. Clinical trial identification: NCT03162224." Clinical • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8 • IL12A • PD-1 Safety and Efficacy of MEDI0457 and Durvalumab in Patients With HPV Associated Recurrent/Metastatic Head and Neck Cancer (clinicaltrials.gov) - P1b/2a; N=35; Completed; Sponsor: MedImmune LLC; Active, not recruiting ➔ Completed Clinical • Trial completion • Head and Neck Cancer • Immune Modulation • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck Therapy for High-Risk HPV 16-Positive Oropharynx Cancer Patients (clinicaltrials.gov) - P2; N=0; Withdrawn; Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; N=66 ➔ 0; Trial completion date: Sep 2027 ➔ Mar 2021; Recruiting ➔ Withdrawn; Trial primary completion date: Sep 2024 ➔ Mar 2021 Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Head and Neck Cancer • Immune Modulation • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PCR DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers (clinicaltrials.gov) - P2; N=77; Not yet recruiting; Sponsor: M.D. Anderson Cancer Center; Initiation date: Mar 2018 ➔ Jun 2018 Clinical • Trial initiation date • Anal Carcinoma • Cervical Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Oncology • Penile Cancer • Solid Tumor • vagin*l Cancer • Vulvar Cancer • CD4 Therapy for High-Risk HPV 16-Positive Oropharynx Cancer Patients (clinicaltrials.gov) - P2; N=66; Recruiting; Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Not yet recruiting ➔ Recruiting Clinical • Enrollment open • Head and Neck Cancer • Immune Modulation • Oncology • Oropharyngeal Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PCR DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers (clinicaltrials.gov) - P2; N=77; Not yet recruiting; Sponsor: M.D. Anderson Cancer Center; Initiation date: Jun 2018 ➔ Sep 2018 Clinical • Trial initiation date • Anal Carcinoma • Cervical Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Oncology • Penile Cancer • Solid Tumor • vagin*l Cancer • Vulvar Cancer • CD4 DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers (clinicaltrials.gov) - P2; N=77; Not yet recruiting; Sponsor: M.D. Anderson Cancer Center; Trial completion date: Jan 2021 ➔ Jan 2020 Clinical • Trial completion date • Anal Carcinoma • Cervical Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Penile Cancer • Solid Tumor • vagin*l Cancer • Vulvar Cancer • CD4 DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers (clinicaltrials.gov) - P2; N=77; Recruiting; Sponsor: M.D. Anderson Cancer Center; Not yet recruiting ➔ Recruiting Clinical • Enrollment open • Anal Carcinoma • Cervical Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Oncology • Penile Cancer • Solid Tumor • vagin*l Cancer • Vulvar Cancer • CD4 Therapy for High-Risk HPV 16-Positive Oropharynx Cancer Patients (clinicaltrials.gov) - P2; N=66; Not yet recruiting; Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Clinical • New P2 trial • Head and Neck Cancer • Immune Modulation • Oncology • Oropharyngeal Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PCR References

MEDI0457 / Inovio, AstraZeneca - LARVOL DELTA (1)

Home

May 13, 2024

March 06, 2024

January 04, 2024

July 15, 2023

July 15, 2023

April 27, 2023

See Also
Inovio Pharmaceuticals (NASDAQ:INO) Now Covered by StephensReviewing Delcath Systems (NASDAQ:DCTH) & Inovio Pharmaceuticals (NASDAQ:INO)

December 13, 2022

December 20, 2022

December 02, 2022

December 01, 2022

February 14, 2022

January 26, 2022

November 04, 2021

May 22, 2018

April 28, 2021

May 22, 2018

July 24, 2020

April 27, 2021

April 23, 2021

April 12, 2018

December 03, 2019

July 16, 2018

October 05, 2018

November 15, 2018

June 28, 2019

Copyright ©2024 - LARVOL. All Rights Reserved. | Privacy Policy | Contact Us | Login

LARVOL 548 Market St, Suite 44120, San Francisco, CA 94104

MEDI0457 / Inovio, AstraZeneca - LARVOL DELTA (2024)

References

Top Articles
Mary Schmich is world famous - but you may not know her - Medill Reports Chicago
Column: Not so long ago — 29 years — I started writing a column. This will be the last. Thank you.
RS: The Beach Event is Back and More AFK-Friendly!
The Beach Is Here! - This Week In RuneScape - Lunagang
Craigslist In Staten Island
William P. Clements Jr. University Hospital | Dallas, Texas | UT Southwestern Medical Center
Kreis sucht dringend Fachkräfte
Das Team | Batten & Company
Enthalpy Analytical hiring Field Technician - Lab Service Center in Los Angeles, California, United States | LinkedIn
Citrix System Engineer (M/F/X) - CTG Luxembourg P.S.F. - jobs.lu
Tim Steele Taylorsville Nc
Learning Hub Inspire Brands
Latest Posts
Foe Tools Kraken
A legendary Chicago newspaper columnist bids farewell — and wonders who will be left to tell her city’s tale
Article information

Author: Edwin Metz

Last Updated:

Views: 5520

Rating: 4.8 / 5 (58 voted)

Reviews: 89% of readers found this page helpful

Author information

Name: Edwin Metz

Birthday: 1997-04-16

Address: 51593 Leanne Light, Kuphalmouth, DE 50012-5183

Phone: +639107620957

Job: Corporate Banking Technician

Hobby: Reading, scrapbook, role-playing games, Fishing, Fishing, Scuba diving, Beekeeping

Introduction: My name is Edwin Metz, I am a fair, energetic, helpful, brave, outstanding, nice, helpful person who loves writing and wants to share my knowledge and understanding with you.