相关临床试验
5
0 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
2001
已完成
2
40.0%
招募中
2
40.0%
Temporarily Not Available
1
20.0%
暂无批准数据
- A platinum-relapsed small cell lung cancer patient achieved 16.7 months of progression-free survival after systemic Olvi-Vec plus platinum rechallenge, exceeding her prior first-line PFS of 14.3 months. - The case report, published in Frontiers in Oncology, describes an 84.6% reduction in target lesion size, surpassing the reduction seen after first-line platinum and etoposide therapy. - Findings come from the Phase 1b/2 OLVI-VEC-202-SCLC trial (NCT07136285), an open-label study run in China by licensing partner Newsoara HYK Biopharmaceuticals. - Genelux continues dose-escalation enrollment in systemic Olvi-Vec lung cancer programs, with additional dose-finding updates expected in 2026 alongside Phase 3 ovarian cancer topline data.
- Olvi-Vec demonstrated a 33% overall response rate in platinum-relapsed small cell lung cancer patients, with two of three partial responses occurring in the highest dose cohort showing tumor shrinkage of approximately 55% and 85%. - In non-small cell lung cancer patients, the therapy achieved a 60% disease control rate with tumor reductions up to 22.7% compared to baseline measurements. - The oncolytic immunotherapy was generally well tolerated across both trials and showed potential for durable responses, with one patient achieving 12.1 months of progression-free survival. - Additional interim data from both lung cancer trials is expected throughout 2026, alongside topline results from a Phase 3 ovarian cancer trial in the second half of the year.
- Genelux Corporation has appointed Dr. Jason Litten as Chief Medical Officer effective January 2, 2026, to oversee clinical development and medical strategy for the company's oncolytic immunotherapy pipeline. - Dr. Litten brings over 20 years of biopharmaceutical experience, including leadership roles at Chimeric Therapeutics, Artiva Biotherapeutics, and Amgen, with expertise in Phase 1-4 clinical trials across multiple cancer types. - The appointment comes as Genelux advances Olvi-Vec through pivotal milestones, including ongoing Phase 3 trials in platinum-resistant ovarian cancer and Phase 2 trials in non-small-cell lung cancer. - Dr. Litten received a stock option grant for 275,000 shares as part of his compensation package, reflecting the company's confidence in his ability to advance their oncolytic vaccinia virus platform.
- Genelux reported Q3 2025 financial results with $21.0 million in cash and investments, providing runway into Q3 2026 as the company advances its oncolytic immunotherapy Olvi-Vec across multiple solid tumor indications. - The company's Phase 3 OnPrime ovarian cancer registrational trial continues enrolling patients across U.S. sites, with topline data now expected in the second half of 2026 rather than earlier projections. - Interim data from two systemic lung cancer studies are anticipated in Q4 2025, potentially validating Olvi-Vec's broader therapeutic utility beyond intraperitoneal delivery. - Early data from the small cell lung cancer trial showed a 71% disease control rate with no dose-limiting toxicities, suggesting favorable safety and potential clinical activity in this difficult-to-treat population.
- 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.
- FDA indicates that Genelux's ongoing Phase 3 OnPrime/GOG-3076 trial could potentially support traditional approval for Olvi-Vec in platinum-resistant/refractory ovarian cancer without requiring a separate confirmatory study. - The regulatory guidance represents a significant milestone for Genelux, potentially accelerating the approval timeline if the trial demonstrates clinically meaningful progression-free survival advantage without compromising overall survival. - Topline safety and efficacy data from the registrational trial are expected in the first half of 2026, addressing an urgent unmet need for innovative treatments in this difficult-to-treat patient population.
