An Open-label, Phase I/II Multicenter Clinical Trial of NECVAX-NEO1 as add-on to First-line Neoadjuvant Anti-PD-1 Monoclonal Antibody Therapy in Patients With Triple-negative Breast Cancer

Phase I/II, multicenter, open-label, single-arm trial in triple-negative breast cancer patients under first-line neoadjuvant therapy with approved standard of care anti-PD-1 monoclonal antibody (PD-1 inhibitor), epirubicin/cyclophosphamide chemotherapy, and nab-paclitaxel therapy. NECVAX-NEO1 treatment in addition to standard of care anti-PD1 monoclonal antibody therapy can be prolonged after breast cancer surgery for another 24 weeks, according to the investigator's decision taking into consideration the study patient's health status.

开始日期2024-10-15

申办/合作机构

NEC Corp.

[+1]

NCT06631079 / Recruiting临床1/2期

An Open-label, Phase I/II Multicenter Clinical Trial of NECVAX-NEO1 in Addition to Anti-PD-1 or Anti-PD-L1 Monoclonal Antibody Therapy in Patients With Solid Tumors

Phase I/II multicenter, open-label, single-arm trial in patients to evaluate the safety and effect of NECVAX-NEO1 administered in combination with PD-1/PD-L1 mABs in patients with solid tumors. Patients with solid tumors who will be treated with approved standard of care (SoC) PD-1 or PD-L1 monoclonal antibody inhibitor therapy, and who after starting treatment with PD-1/PD-L1 inhibitor reached either Stable Disease (SD) or Partial Response (PR) (Cohort 1) or PD (Cohort 2) according to RECIST 1.1 and iRECIST assessed at the Baseline visit may be enrolled in the study

开始日期2024-10-07

申办/合作机构

NEC Corp.

[+1]

CTIS2024-513716-95-00 / Recruiting

- NECVAX-NEO1-LT

开始日期2022-05-16

申办/合作机构

NEC OncoImmunity AS

100 项与 NECVAXNEO1 相关的临床结果

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100 项与 NECVAXNEO1 相关的转化医学

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100 项与 NECVAXNEO1 相关的专利（医药）

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项与 NECVAXNEO1 相关的新闻（医药）

2023-07-12

·FierceBiotech

South Korean biotech group spies US SPAC as route to Nasdaq

The plan is to take the holding company onto the Nasdaq under the new name OSR Biosciences in the fourth quarter. OSR Holdings is the latest biotech business to choose a merger with a special purpose acquisition company (SPAC) as a way to hop onto the public markets. Seoul, South Korea-headquartered OSR is a global healthcare holding company with operations including a pair of subsidiaries in South Korea and Switzerland focused on developing drugs for oncology and osteoarthritis. The company also owns a distributor of medical devices for neurovascular and other diseases and last week announced plans to acquire Landmark BioVentures, another Swiss company that operates four oncology- and immunology-focused biotech ventures in France. The latest announcement will see OSR merge with U.S.-based Bellevue Life Sciences Acquisition. The SPAC went public in February with a $60 million IPO and the goal of finding a suitable healthcare-focused company to join forces with. In OSR, it appears to have found the desired target, and the plan is to take the holding company onto the Nasdaq under the new name OSR Biosciences in the fourth quarter of the year. The only clinical-stage candidate in OSR’s portfolio is VXM01, an immunotherapy in phase 1/2 development by the Swiss-German biotech Vaximm for glioblastoma in combination with Merck KGaA’s Bavencio. Vaximm also has therapies targeting the proteins mesothelin, WT1 and PD-L1 in preclinical development. "We are delighted to identify OSR Holdings as our candidate,” Bellevue Life Sciences Acquisition's CEO Kuk Hyoun Hwang said in a postmarket release yesterday. “OSR Holdings represents a timely investment opportunity working on the development of breakthrough therapies for unmet medical needs." While SPAC deals were a hot ticket for biotechs to go public a couple of years ago, the rush cooled in 2022 as the industry hit tough times. Since then, their use has been more sporadic, with some companies testing the SPAC waters again near the year’s end. This spring also saw a trickle of merger announcements, with Anew Medical, enGene and NKGen Biotech all opting for the blank check route to market.