On October 20, 2020 Biodesix, Inc. a leading data-driven diagnostic solutions company with a focus in lung disease, reported recently published data from three clinical studies, which found important new information on diagnosis and management of lung nodules (Press release, Biodesix, OCT 20, 2020, View Source [SID1234568665]). Data from these studies, which are being presented at the American College of Chest Physicians (CHEST) annual meeting, demonstrate the value of the Nodify Lung testing strategy and confirm previously reported performance of the Nodify XL2 and Nodify CDT tests.

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Abstract #A1464/Poster #P1319: Identification of Likely Malignant Indeterminate Pulmonary Nodules by Analysis of Autoantibodies Against Lung Cancer-Associated Antigens
Authors: Kevin Doubleday, James Jett, Laura Peek, Trevor Pitcher
A retrospective analysis of the PANOPTIC study found that the blood-based Nodify CDT test accurately identified patients whose lung nodules were likely malignant, which confirms previously reported test performance. Patients identified as Nodify CDT positive may benefit from a more rapid evaluation and intervention for cancer.

Abstract #A1468/Poster #P1325: Lung Nodule Integrated Classifier Biomarker: First Data with Real-World Clinical Use
Authors: James Jett, Kerstin Pohl, Gerard Silvestri, Steven Springmeyer
A real-world clinical use study demonstrates the utility of the blood-based Nodify XL2 test for identifying patients with likely benign lung nodules by integrating the patients’ blood-based protein data with clinical risk factors, resulting in a large proportion of low to moderate risk nodules being reclassified as very low risk. Risk reclassification can reduce invasive procedures on benign nodules and ultimately lead to improved nodule management.

Abstract #A1476/Poster #P1324: Use of Two Blood-Based Biomarker Tests in Series to Reclassify Risk of Indeterminate Pulmonary Nodules Authors: Kevin Doubleday, James Jett, Laura Peek, Trevor Pitcher, Steven Springmeyer
Data suggest that while standard risk assessment for lung cancer is imprecise, it can be improved with the blood-based Nodify Lung testing strategy. By combining the Nodify CDT and Nodify XL2 tests, patients can be more appropriately assessed for risk of malignancy to help reduce unnecessary procedures on patients with benign nodules and delays in treatment for patients with cancer.

On October 20, 2020 NANOBIOTIX (Paris:NANO) (Euronext: NANO – ISIN: FR0011341205 – the "Company"), a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported four (4) clinical and/or pre-clinical presentations to be delivered at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting (Press release, Nanobiotix, OCT 20, 2020, View Source [SID1234568658]). Two presentations will be delivered by Nanobiotix and two will be delivered by the University of Texas MD Anderson Cancer Center.

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Details of presentations:

Phase I Study of Intratumoral NBTXR3 in Combination with anti-PD-1 in Patients with Advanced Cancers
Colette Shen, Jessica Frakes, Jiaxin Niu, Jared Weiss, Jimmy Caudell, Katherine Jameson, Patricia Said, Tanguy Seiwert

Abstract ID: 410

Date: Thursday, Nov. 12 from 4:50–5:20 p.m. EST and Saturday, Nov. 14 from 1–1:30 p.m. EST

Modulation of TCR Repertoire by Radiotherapy-activated NBTXR3 Nanoparticles
Audrey Darmon, Ping Zhang, Sébastien Paris

Abstract ID: 582

Date: Thursday, Nov. 12 from 4:50–5:20 p.m. EST and Saturday, Nov. 14 from 1–1:30 p.m. EST

Overcoming Resistance to anti-PD-1 with Tumor Agnostic NBTXR3: From Bench to Bedside
James W. Welsh, Colette Shen, Jessica Frakes, Jiaxin Niu, Jared Weiss, Jimmy Caudell, Hu Yun, Hampartsoum Barsoumian, Juliette Thariat, Sylvie Bonvalot, Zsusanna Papaï; Maria Angelica Cortez, Ping Zhang, Katherine L. Jameson, Patricia Said, Sébastien Paris, Tanguy Seiwert,

Abstract ID: 396

Date: Thursday, Nov. 12 from 4:50–5:20 p.m. EST and Saturday, Nov. 14 from 1–1:30 p.m. EST

NBTXR3 Nanoparticle with Immunoradiation Improves Survival and Generates Long-term Anti-tumor Memory in an anti-PD1 Resistant Murine Lung Cancer Model
Yun Hu, Sébastien Paris, Hampartsoum Barsoumian, Chike Osita Abana, Saumil Gandhi, Quynh-Nhu Nguyen, Maria Angelica Cortez, James W. Welsh

Abstract ID: 200

Date: Wednesday, Nov. 11 from 12:15 pm – 12:25 pm EST

About NBTXR3

NBTXR3 is a novel radioenhancer composed of functionalized hafnium oxide nanoparticles that is administered via one-time intra-tumoral injection and activated by radiation therapy. The physical and universal mode of action (MoA) of NBTXR3 is designed to trigger cellular destruction death and adaptive immune response.

NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) of the oral cavity or oropharynx in elderly patients unable to receive chemotherapy or cetuximab with limited therapeutic options. Promising results have been observed in the phase I trial regarding local control. In the United States, the Company has started the regulatory process to commence a phase III clinical trial in locally advanced head and neck cancers. In February 2020, the United States Food and Drug Administration granted the regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced head and neck squamous cell cancer who are not eligible for platinum-based chemotherapy.

Nanobiotix is also running an Immuno-Oncology development program. The Company has launched a Phase I clinical trial of NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors in locoregional recurrent (LRR) or recurrent and metastatic (R/M) HNSCC amenable to re-irradiation of the HN and lung or liver metastases (mets) from any primary cancer eligible for anti-PD-1 therapy.

Other ongoing NBTXR3 trials are treating patients with hepatocellular carcinoma (HCC) or liver metastases, locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and pancreatic cancer. The Company is also engaged in a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to further expand the NBTXR3 development program.

On October 20, 2020 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported the collaboration with three additional clinical sites to increase recruitment capacity for the Phase 1/2 brain cancer study of NOX-A12 plus radiotherapy, as a measure to ensure the timely completion of the study under the current challenging conditions posed by the COVID-19 pandemic (Press release, NOXXON, OCT 20, 2020, View Source [SID1234568657]).

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Along with the hospitals in Mannheim, Essen and Bonn, which have been participating in the recruitment of patients for the study since mid-2019, NOXXON will also collaborate with investigators at three additional hospitals in Leipzig, Münster and Tübingen, Germany.

The clinical Phase 1/2 trial investigates three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external-beam radiotherapy in newly diagnosed brain cancer patients. Having completed patient recruitment in the first and second dose cohort, all six centers will continue enrolling patients into the highest dose cohort. Top-line data from the study is expected in mid-2021.

"Timely completion of recruitment remains our main focus for this trial. Adding these new clinical sites enables us to increase recruitment capacity and to diversify the geographical distribution of the study in light of the COVID-19 pandemic. We are very pleased to receive the support of three prominent clinical sites in Tübingen, Leipzig and Münster to contribute to this important study," commented Aram Mangasarian, CEO of NOXXON.

On October 19, 2020 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, reported three poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 35th Anniversary Annual Meeting (SITC 2020) (Press release, Cue Biopharma, OCT 19, 2020, View Source [SID1234608294]).

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Presentation Details:
Title: Immuno-STATs: Leveraging protein engineering to expand and track antigen-specific T cells in vivo
Poster #: 623
Presenter: Steven Almo, Ph.D., ‎co-founder
Date: Wednesday, November 11, 2020 from 5:15–5:45 p.m. EST and Friday, November 13, 2020 from 4:40–5:10 p.m. EST

Title: CUE-100 series Immuno-STATs from concept to the clinic: Leveraging protein engineering to stimulate and selectively deliver affinity-attenuated IL-2 to antigen-specific T cells
Poster #: 553
Presenter: Saso Cemerski, Ph.D., ‎vice president and head, discovery and translational immunology
Date: Wednesday, November 11, 2020 from 5:15–5:45 p.m. EST and Friday, November 13, 2020 from 4:40–5:10 p.m. EST

Title: A phase 1 trial of CUE-101 a novel HPV16 E7-pHLA-IL2-Fc fusion protein in patients with recurrent/metastatic HPV16+ head and neck cancer
Poster #: 354
Presenter: Sara I. Pai, M.D., Ph.D., associate professor, Massachusetts General Hospital and Harvard Medical School, Boston
Date: Thursday, November 12, 2020 from 4:50–5:20 p.m. EST and Saturday, November 14, 2020 from 1–1:30 p.m. EST

"Data presented from these posters further demonstrate the therapeutic potential of our Immuno-STAT platform," said Anish Suri, Ph.D., president and chief scientific officer of Cue Biopharma. "We look forward to presenting preclinical data highlighting the IL-2 based CUE-100 series Immuno-STATs, as well as results from our ongoing open-label, dose escalation Phase 1 monotherapy trial with CUE-101 in patients with HPV16+ head and neck cancer."

About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules. This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

About Immuno-STAT
Immuno-STAT biologics are designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of our biologic drugs is designed using our proprietary scaffold comprising: 1) a peptide-MHC complex (pMHC) to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells.

The simultaneous engagement of co-regulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in highly targeted T cell modulation. Because our drugs are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, modified outside the body (ex vivo), and reinfused.

On October 19, 2020 Betta Pharmaceutical Co., Ltd. reported that the first subject of the Phase I clinical study of the new drug BPI-27336 was successfully enrolled (Press release, Betta Pharmaceuticals, OCT 19, 2020, View Source [SID1234574036]). On October 20, the patient’s first administration was completed. The study is called "Phase I clinical study of BPI-27336 tablets in patients with advanced solid tumors", and the main investigator is Professor Shen Lin from Beijing Cancer Hospital. The study includes two parts: dose escalation and enrollment expansion. The main goal is to evaluate the safety and tolerability of BPI-27336 as a selective ERK1/2 small molecule inhibitor for patients with advanced solid tumors, explore the maximum tolerated dose (MTD) and Dose-limiting toxicities (DLTs), as well as determining the recommended dose for later clinical studies, and evaluating the initial efficacy.

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Mechanism of action of BPI-27336

ERK1/2 is an important member of the mitogen-activated protein kinases (MAPK) family, located downstream of the RAS/RAF/MEK/ERK (RAS-MAPK) pathway. The RAS-MAPK signaling pathway is involved in a series of cell physiological activities such as cell growth, development, differentiation, and apoptosis, and is the hardest hit area that induces tumors. Domestic and foreign literature reports that MAPK is obviously related to the occurrence and development of lung cancer, breast cancer, ovarian cancer, esophageal cancer, colon cancer, stomach cancer, liver cancer and other tumors. As the "final manager" downstream of the RAS-MAPK pathway, targeted inhibition of ERK1/2 is expected to be used to treat cancer caused by abnormal activation of the RAS-MAPK pathway, and may also be resistant to RAF or MEK inhibitors due to the reactivation of ERK1/2 The medicine is effective for patients.

Up to now, there is no drug marketed for ERK target in the world. As a new type of potent and selective ERK1/2 small molecule oral inhibitor, BPI-27336 has shown excellent anti-tumor effects in a variety of preclinical disease models, especially KRAS mutant tumor models, and has good safety. Sex, tolerability and pharmacokinetic characteristics. BPI-27336 is expected to improve the drug resistance of the RAS-MAPK pathway and enhance the efficacy, and it is expected to bring a breakthrough in the drugless global problem of KRAS mutant tumors. We look forward to accelerating the progress of clinical research with the help of the cooperation center and experts, providing patients with new treatment plans and meeting urgent clinical needs.

According to the announcement of the work plan for the registration and classification of chemical drugs, BPI-27336 is an "innovative drug that has not been marketed at home or abroad", and its registration is classified as category 1 chemical drugs. In February 2020, Betta Pharmaceuticals received the "Clinical Trial Notice" issued by the National Medical Products Administration (NMPA). BPI-27336 tablets meet the requirements of relevant drug registration regulations and agreed to carry out clinical research on solid tumors in accordance with the submitted plan (Acceptance number CXHL1900397, CXHL1900398).