相关临床试验
8
2 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2010
进行中（未招募）
2
25.0%
Available
1
12.5%
已完成
1
12.5%
招募中
1
12.5%
终止
1
12.5%
Unknown
1
12.5%
撤回
1
12.5%
暂无试验数据
暂无批准数据
- The global oncolytic virus therapy market is projected to grow from USD 21.54 million in 2025 to USD 223.5 million by 2035, at a CAGR of 26.36% during 2026–2035. - Oncolytic viruses selectively infect and destroy cancer cells while stimulating systemic anti-tumor immune responses, transforming "cold" tumors into "hot" ones. - A robust clinical pipeline, including cretostimogene grenadenorepvec, CAN-2409, RP1, and Olvi-Vec, is advancing across melanoma, bladder, lung, and other solid tumors. - Recent regulatory milestones, including FDA accelerated approval of TUDRIQEV (RP1) for advanced melanoma, underscore growing momentum in the field.
- The oncolytic virus therapy landscape has expanded steadily over the past decade, with over 100 companies worldwide pursuing clinical or preclinical programs developing 110+ oncolytic virus drugs. - Key market drivers include growing cancer incidence in hard-to-treat solid tumors, increasing understanding of cancer biology, advancements in viral engineering, and rising adoption of personalized medicine approaches. - Leading companies such as Candel Therapeutics, Oncolytics Biotech, and CG Oncology are advancing promising therapies like CAN-2409, Pelareorep, and CG0070 through Phase III clinical trials. - Recent developments include innovative combination approaches, with Imugene and JW Therapeutics collaborating on CF33-CD19 with CAR-T therapy, and multiple FDA designations granted including Fast Track and RMAT status.
- CG Oncology announced accelerated Phase 3 PIVOT-006 topline results now expected in the first half of 2026, ahead of the original schedule due to faster-than-expected enrollment completion. - The 364-patient randomized trial is evaluating intravesical cretostimogene against surveillance for intermediate-risk non-muscle invasive bladder cancer, a condition with no current FDA-approved treatment options. - Morgan Stanley raised its price target to $93 and increased the probability of success for the intermediate-risk program to 70%, citing strong execution and physician engagement. - CG Oncology stock surged 29.26% to $54.20 following the announcement, with the company planning to present updated data at the J.P. Morgan Healthcare Conference on January 15.
- Iovance Biotherapeutics appointed Corleen Roche as Chief Financial Officer effective August 6, 2025, during the commercial launch of its groundbreaking TIL therapy. - Roche brings 30 years of biotech experience including CFO roles at CG Oncology, Immunome, and Biogen, with expertise in multiple product launches. - The appointment comes as Iovance commercializes Amtagvi, the first FDA-approved T cell therapy for solid tumors, marking a significant milestone in cancer treatment. - Roche will focus on revenue growth and pipeline investments as the company advances its tumor infiltrating lymphocyte platform across multiple solid tumor indications.
- The oncolytic virus cancer therapy market is experiencing robust growth with over 120 companies actively developing 125+ pipeline therapies, representing a significant expansion in this therapeutic segment. - The global market for oncolytic virus immunotherapy was valued at $156.8 million in 2024 and is projected to reach $429.1 million by 2030, growing at a CAGR of 18.3%. - Several promising candidates are advancing through late-stage clinical trials, including Olvi-Vec in Phase III for platinum-resistant ovarian cancer and CG0070 in Phase III for non-muscle invasive bladder cancer. - Recent breakthroughs in synthetic biology and vector engineering are enhancing the safety, selectivity, and immune-stimulatory capabilities of oncolytic viruses through genetic modifications and combination protocols.
- CG Oncology's cretostimogene grenadenorepvec demonstrated a 75.5% complete response rate in high-risk BCG-unresponsive non-muscle invasive bladder cancer patients, with 34% maintaining complete response at 24 months. - The FDA has granted Fast Track and Breakthrough Therapy designations to cretostimogene, potentially expediting its regulatory pathway for a disease with limited treatment options. - The drug's 27.9-month median duration of response may provide a competitive edge over Johnson & Johnson's TAR-200, positioning CG Oncology as a significant player in the bladder cancer treatment landscape.
- CG Oncology's cretostimogene demonstrated a positive outcome in its Phase 3 BONDER-002 trial for non-muscle invasive bladder cancer (NMIBC). - The trial results could pave the way for a Biologics License Application (BLA) submission to regulatory authorities for potential approval. - Cretostimogene is an oncolytic immunotherapy designed to selectively replicate in tumor cells, leading to their destruction and triggering an immune response. - The BONDER-002 trial evaluated cretostimogene in patients with high-risk NMIBC who are unresponsive to Bacillus Calmette-Guérin (BCG) therapy.
• Protara Therapeutics' TARA-002 demonstrated a 72% complete response rate in non-muscle invasive bladder cancer patients, regardless of prior BCG exposure. • In BCG-unresponsive patients, TARA-002 achieved a 100% complete response rate at six months, highlighting its potential in a registrational cohort. • CG Oncology's cretostimogene grenadenorepvec showed a 74.5% complete response rate in BCG-unresponsive patients, with a median duration of response exceeding 27 months. • Both TARA-002 and cretostimogene grenadenorepvec exhibited favorable tolerability profiles, with minimal treatment-related adverse events.
- The PIVOT-006 trial is a phase 3 study assessing cretostimogene, an oncolytic immunotherapy, against surveillance in intermediate-risk non-muscle invasive bladder cancer (NMIBC). - Cretostimogene, designed to selectively replicate in bladder cancer cells, has shown promising response rates and tolerability in BCG-unresponsive NMIBC. - The trial randomizes patients to intravesical cretostimogene or surveillance, with the option for crossover upon recurrence, aiming to improve recurrence-free survival. - Strong enrollment progress is noted, with support from organizations like SUO-CTC and BCAN, highlighting the importance of patient-centered research in this area.
• CG Oncology will host a conference call on December 5, 2024, to discuss Phase 3 BOND-003 trial results for cretostimogene in high-risk BCG-unresponsive NMIBC. • The BOND-003 trial evaluates cretostimogene monotherapy as a potential bladder-sparing treatment for non-muscle invasive bladder cancer (NMIBC). • Dr. Mark Tyson, II from Mayo Clinic, the lead investigator, will present the findings at the Society of Urologic Oncology (SUO) annual meeting. • Cretostimogene is an investigational oncolytic immunotherapy being studied across multiple clinical trials for NMIBC, including ongoing Phase 3 studies.
