|Over a month ago|
Nanobiotix sets recommended dose for planned NBTXR3 plus Anti-PD-1 study » 16:1709/2109/21/22
Nanobiotix announced determination of the recommended phase 2 dose (RP2D) of NBTXR3 in combination with pembrolizumab or nivolumab for the treatment of patients suffering from inoperable locoregional recurrent (LRR) or recurrent and metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) that is resistant to prior immunotherapy. RP2Ds were determined for NBTXR3 plus pembrolizumab or nivolumab for patients with LRR or R/M HNSCC that has not received prior immunotherapy, lung metastases (mets) from any primary tumor, or liver mets from any primary tumor as well. The combined dose escalation and dose expansion parts of Study 1100 are expected to enroll up to 141 patients. The complete dose escalation part enrolled 29 patients in three cohorts: (i) head and neck lesions from LRR or R/M HNSCC eligible for anti-PD-1 therapy; (ii) lung mets from any primary cancer eligible for anti-PD-1 therapy; and (iii) liver mets from any primary cancer eligible for anti-PD-1 therapy. Study participants received a one-time intratumoral injection of NBTXR3 prior to their first radiotherapy session. They then received radiotherapy, followed by anti-PD-1. Based on the study's results, the RP2D for all three cohorts was determined to be 33% of gross tumor volume. Nanobiotix aims to deliver an industry-leading head and neck cancer treatment franchise powered by NBTXR3, and to replicate that approach across other solid tumor indications. Pursuant to this strategy, the Company has amended the ongoing expansion phase of Study 1100 to further strengthen the rationale behind a registrational protocol evaluating NBTXR3 plus anti-PD-1 for patients with R/M HNSCC that is resistant to prior immunotherapy.
NanoBiotix, LianBio announce first patient enrolled in Asia in NANORAY-312 trial » 16:2509/0709/07/22
NanoBiotix (NBTX) and…
NanoBiotix (NBTX) and LianBio (LIAN) announced randomization of the first patient in Asia in NANORAY-312, a global Phase 3 registrational trial evaluating NBTXR3 for the treatment of elderly patients with locally advanced head and neck squamous cell carcinoma ("LA-HNSCC") who are ineligible for platinum-based chemotherapy. "We believe NBTXR3 has demonstrated the potential to improve treatment outcomes in multiple solid tumor indications, including in Study 102, the Nanobiotix Phase 1 trial evaluating the product candidate for the treatment of elderly patients with locally advanced head and neck squamous cell carcinoma," said Yizhe Wang, Ph.D., Chief Executive Officer, LianBio. "We look forward to working with our clinical partners at sites across Greater China and South Korea to evaluate NBTXR3 in this difficult-to-treat patient population. With radiotherapy usage on the rise in Asia, we believe NBTXR3 may become an important part of the treatment landscape for patients with cancer in the region."
|Over a quarter ago|
Nanobiotix reports new data featuring NBTXR3 plus chemoradiation » 15:5806/0506/05/22
Nanobiotix announced the…
Nanobiotix announced the reporting of new data at the 2022 Annual Meeting of the American Society for Clinical Oncology featuring potential first-in-class radioenhancer NBTXR3 in combination with concurrent chemoradiation for the treatment of head and neck cancer and rectal cancer. Nanobiotix also presented a trial-in-progress poster on the study design of the Company's ongoing pivotal phase 3 study, NANORAY-312, evaluating NBTXR3 as a single agent activated by radiotherapy for the treatment of elderly and frail patients with locally advanced head and neck squamous cell carcinoma who are ineligible for platinum-based chemotherapy. In view of the company's strategy for development of NBTXR3 as a product candidate that can integrate across solid tumor indications along with major treatment modalities within each indication, starting with head and neck cancer, the company believes these new data add support for the radioenhancer in combination with chemoradiation and as a neoadjuvant therapy with the potential to improve surgical outcomes. A Phase 1b/2 Study Evaluating NBTXR3 in Combination with Concurrent Chemoradiation for Patients with Locally Advanced or Recurrent Head and Neck Squamous Cell Carcinoma: This study, sponsored, executed, and reported by former Nanobiotix collaborator in Asia, PharmaEngine, sought to evaluate the safety and feasibility of NBTXR3 intratumoral injection when added to low-dose weekly cisplatin-containing CCRT for patients with locally advanced or recurrent head and neck squamous cell carcinoma. The study also aimed to establish the recommended phase 2 dose, however the RP2D was not determined due to stoppage of the phase 1b part of the trial resulting from the conclusion of the collaboration between PEI and Nanobiotix in 2021. Adult patients with T3-4 LA-HNSCC suitable for cisplatin were eligible for the study and 12 such patients were enrolled. These patients received a single intratumoral injection of NBTXR3, followed by a low-dose weekly regimen of CCRT. All 12 patients were deemed evaluable and all had stage 4 locally advanced disease. Of these evaluable patients, 3, 6, and 3 patients received NBTXR3 at the 5%, 10%, and 15% dose levels, respectively. No serious adverse events inconsistent with what would normally be expected from a low-dose CCRT regimen were observed. Dose-limiting toxicities of grade 3 increased ALT and grade 3 increased AST were observed in one patient at the 10% dose level. Common Grade 3 adverse events observed across dose levels were stomatitis, decreased WBC, decreased appetite, decreased neutrophil count, and leukopenia. One patient experienced grade 4 hyponatremia. Preliminary efficacy results showed a disease control rate of 100%, with an overall response rate of 58.3% according to RECIST 1.1. The study concluded that adding a single intratumoral injection of NBTXR3 to weekly low dose cisplatin-containing CCRT was feasible and had a favorable safety profile for patients with LA-HNSCC. A Phase 1b/2 Study Evaluating NBTXR3 in Combination with Concurrent Chemoradiation in the Neoadjuvant Setting for Patients with Locally Advanced or Unresectable Rectal Cancer: This study, sponsored, executed, and presented by PEI, sought to evaluate safety, feasibility, and early signs of efficacy for neoadjuvant NBTXR3 combined with CCRT followed by surgery for patients with locally advanced or unresectable rectal cancer. The study established the recommended phase 2 dose of NBTXR3 at 22% of gross tumor volume, however the phase 2 part of the trial was stopped as a result of the conclusion of the collaboration between PEI and Nanobiotix in 2021. Adult and older patients with T3-T4 locally advanced or unresectable rectal cancer suitable for chemoradiation were eligible for the study and 32 such patients were enrolled. These patients received a single intratumoral injection of NBTXR3, followed by a weekly regimen of CCRT. 31 of 32 patients were deemed evaluable and none of the evaluable patients had tumors eligible for surgery at the time of diagnosis. Of the 31 evaluable patients, 6, 4, 3, and 18 patients received NBTXR3 at the 5%, 10%, 15%, and 22% dose levels, respectively. No NBTXR3-related SAEs or grade greater than or equal to 3 AEs were observed. The most frequently reported AEs were grade 1 or 2 decreased WBC, diarrhea, increased CRP, UTI, and decreased lymphocyte count which were all consistent with what would normally be expected from CCRT. Preliminary efficacy results showed a disease control rate of 100%, with an overall response rate of 35.5% according to RECIST 1.1. Pathological tumor downstaging was observed in 14 of 31 patients after therapy, 25 patients underwent surgery, and 96% of those patients achieved R0 surgical margins. Pathological complete response was observed in 20% of the patients who received surgery. The study concluded that a single intratumoral injection of NBTXR3 in combination with CCRT is feasible and has a favorable safety profile in the neoadjuvant setting for patients with locally advanced or unresectable rectal adenocarcinoma.
Nanobiotix SA (ADS) trading resumes 14:2805/1705/17/22
Nanobiotix SA (ADS) trading halted, volatility trading pause 14:2305/1705/17/22
Nanobiotix reports FY21 ($1.35) vs. ($1.38) in FY20 » 16:2203/3003/30/22
Based on the current…
Based on the current operating plan and financial projections, Nanobiotix anticipates that the cash and cash equivalents of EUR 83.9 million as of December 31, 2021, will fund its operations into the second quarter of 2023. CEO Laurent Levy says: "Our clinical program evaluating first-in-class radioenhancer, NBTXR3, yielded compelling new data suggesting that our lead therapeutic candidate may improve treatment outcomes for patients both as a single-agent activated by radiotherapy for local diseases and as a combination therapy with anti-PD-1 for systemic disease. We also achieved the launch of our pivotal phase III study, NANORAY-312-a critical milestone as we advance toward global registration in head and neck cancer. 2022 has already seen the enrollment of our first European patients in NANORAY-312, and we expect the first patients in the U.S. and Asia this year. In parallel, we continue to make consistent progress in our Company-led immunotherapy pathway, along with the additional studies evaluating NBTXR3 across tumor indications and therapeutic combinations led by strategic collaborators. We are steadfast in our commitment to bring the potential benefits of NBTXR3 to millions of patients around the world, and in 2022 we will focus on executing our ongoing studies, defining our registration strategy in immunotherapy, and generating more evidence to support the broad applicability of our technology."
Nanobiotix's new preclinical immunotherapy data showcasing potential of NBTXR3 » 16:2001/2601/26/22
The company states:…
The company states: "NANOBIOTIX announced the publication of new preclinical immunotherapy data for novel, potentially solid tumor- and therapeutic combination-agnostic radioenhancer NBTXR3 in the Journal of Nanobiotechnology. The Nanobiotix preclinical program aims both to provide a deeper understanding of the NBTXR3 mechanism of action and to discover new pathways for the radioenhancer to potentially improve treatment outcomes for patients. Given preclinical and early clinical data suggesting a potential immune priming effect triggered by radiotherapy (RT)-activated NBTXR3 and the medical unmet need for patients with primary or secondary resistance to immune checkpoint inhibitors, Nanobiotix and The University of Texas MD Anderson Cancer Center are exploring several therapeutic combinations involving checkpoint inhibitors, radiotherapy, and NBTXR3. Following previously reported positive preclinical data on the addition of NBTXR3 to a combination of radiotherapy and anti-PD-1 in anti-PD-1 sensitive and resistant lung cancer models, this evaluation investigated the addition of NBTXR3 to a combination of radiotherapy, anti-PD-1, and anti-CTLA-4 in an anti-PD-1 resistant model. Mice were inoculated with metastatic lung cancer cells in their right (primary tumor) and left (secondary tumor) legs. They were then treated with various combinations of anti-PD-1, anti-CTLA-4, NBTXR3, and radiotherapy in an effort to isolate the effect of adding NBTXR3, modifying the RT protocol, or both. Mice surviving after 178 days were rechallenged with tumor cells and monitored for tumor growth. The evaluation showed that both modifications to RT protocol and the addition of NBTXR3 improved outcomes of combination therapy, and that the cohorts in which NBTXR3 was included in the regimen outperformed all others."
Fly Intel: After-Hours Movers » 18:4801/0501/05/22
RGP, SLGC, NBTX, BLI, HEAR, LNDC, STRO, TOST
Nanobiotix enrolls first patient in NANORAY-312 trial » 16:1901/0501/05/22
Nanobiotix announced that…
Nanobiotix announced that the first patient has been enrolled in NANORAY-312, a global, open-label, two-arm, randomized, Investigator's Choice phase III registration study that is designed to investigate the efficacy and safety of radiotherapy-activated NBTXR3 with or without cetuximab versus radiotherapy with or without cetuximab in high-risk, chemotherapy-ineligible elderly patients with locally-advanced head and neck squamous cell carcinoma.
Nanobiotix downgraded to Neutral from Buy at Kempen » 08:1512/2212/22/21
Kempen analyst Ingrid…
Kempen analyst Ingrid Gafanhao downgraded Nanobiotix to Neutral from Buy with a EUR 7.50 price target.