On October 25, 2021 Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and gaseous NO (gNO) for the treatment of solid tumors, reported that it will report financial results for its second fiscal quarter ended September 30, 2021 on Thursday, November 11, 2021 (Press release, Beyond Air, OCT 25, 2021, View Source [SID1234591905]). The Company’s management team is scheduled to host a conference call and webcast at 4:30 pm Eastern Time the same day.

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On October 25, 2021 GE Healthcare reported that it will showcase over 15 innovative multi-modality radiation therapy solutions, offering medical practitioners imaging tools and support they need to improve patient-centered care and advance the practice of precision medicine (Press release, GE Healthcare, OCT 25, 2021, View Source [SID1234591921]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"GE Healthcare aims to drive improved patient outcomes through cutting-edge multi-modality radiation therapy planning and guidance solutions. Our expertise in clinical workflows, deep learning image reconstruction and image segmentation, and precision analytics can help support the delivery of more efficient, precise and personalized care," said Jan Makela, President & CEO, Imaging at GE Healthcare.

GE Healthcare’s precision radiation oncology technologies, including those listed below, provide clinicians with images and information for precise tailoring of treatments.

Below are highlights that GE Healthcare will be showcasing at ASTRO 2021 from October 24th to 27th:

Vysioneer VBrain: GE Healthcare is proud to announce its collaboration with Vysioneer. Vysioneer’s VBrain solution applies auto-contouring to the three most common types of brain tumors: brain metastasis, meningioma and acoustic neuroma. VBrain demonstrates 12.2 percent higher sensitivity for lesion detection while decreasing treatment planning time at a median of 30.8 percent. VBrain is vendor-neutral, integrating with different treatment planning systems by supporting data routing to and from DICOM nodes within a hospital network.[1]
Spectronic Medical Synthetic CT, MR[2] auto-segmentation: GE Healthcare will integrate Spectronic Medical AB’s AI-based software for more precise cancer treatment planning. This AI solution, in combination with GE Healthcare’s advanced AIR Recon DL technology, offers a deep learning solution and radiation therapy treatment planning alternative to standard CT images. The combined solution begins with GE Healthcare’s AIR Recon DL, a deep learning image reconstruction technology that leverages raw data from the MR scanner to reduce image noise, maximize image quality and resolution, and shorten scan times. The high-quality MR images generated by the GE scanner are then converted into synthetic CT images by Spectronic Medical’s AI-based solution, providing clinicians with the CT images they have come to expect with MR soft tissue details to more accurately target lesions and help improve patient outcomes.[3]
Mirada RTx[4]: As a part of their strategic collaboration to improve outcomes for patients, GE Healthcare and Mirada Medical are focusing on advancing automation and Artificial Intelligence (AI) technologies to enable faster, more consistent and more precise cancer radiotherapy treatment. To do so, the Mirada Medical RTx product has been integrated into the GE Healthcare AW Workstation and AW Server to enable enhanced cancer visualization and diagnostic capabilities. These integrations result in increased automation to deliver improvements in care workflows and help drive efficiency and time savings.
Discovery MI Gen 2: GE Healthcare’s Discovery MI Gen 2 brings together the high sensitivity[5] of digital detection with the company’s industry-first CT image reconstruction technology: Deep Learning Image Reconstruction for TrueFidelity CT Images. Generated using a dedicated deep neural network, TrueFidelity CT Images have the potential to improve reading confidence in a wide range of clinical applications such as head, whole body and cardiovascular, for patients across age groups.. The system also offers Q.Clear for up to 2x improvement in image quality (SNR) as well as MotionFree for up to 67 percent improvement in lesion volume measurements[6].
Revolution Platform: GE Healthcare’s family of intelligent CT scanners helps clinicians plan treatments to deliver more precise and efficient RT imaging solutions. The powerful Revolution platform is built on the wide-coverage Gemstone Clarity detector, Deep Learning Image Reconstruction and Gemstone Spectral Imaging to deliver superb clarity for optimizing treatment planning and diagnostic images. It empowers clinicians to stay ahead of the curve in an increasingly competitive market with scalable solutions that broaden healthcare system capabilities today and tomorrow.
Discovery RT Gen 3: Discovery RT is a wide-bore scanner providing a thorough approach to radiation therapy planning. In addition to providing a streamlined workflow and sub-millimetric images that are effectively free of motion and metal artifacts, the system also allows for simulation across an 80 cm wide bore with 80 cm field of view reconstruction. Discovery RT expands capabilities to also meet specific needs in diagnostic, interventional and bariatric imaging.
Through these and a variety of additional solutions, GE Healthcare aims to further reinforce its role as a core partner in multidisciplinary cancer care and provide increasingly accessible, more precise, and high-value radiation therapy.

GE Healthcare will be exhibiting at booth 1337 from October 24th to 27th.

On October 24, 2021 Orion reported that it will be presenting a video at the LSX’s Inv€$tival Showcase which is being held as a hybrid event with both online and in-person meetings (Press release, Orion Biotechnology, OCT 24, 2021, View Source [SID1234591886]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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We are looking forward to the forum that directly connects life science companies to global capital and partners. It takes place in London and is held in partnership with global investment bank Jefferies, running the days before the Jefferies London Healthcare Conference.

On October 23, 2021 Applied DNA Sciences, Inc. (ADNAS). a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, reported that it has signed a mutual collaboration agreement with Ganesha Ecosphere Ltd. (GESL), the largest recycled polyester (rPET) fibre producer in India, to tag an initial pilot production of rPET at GESL’s facilities (Press release, Applied DNA Sciences, OCT 23, 2021, View Source [SID1234591893]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Having 3 production facilities in north India, GESL has over 300-plus customers, 250-plus suppliers, and 500-plus product variants. The company produces a wide range of RPSF in white, black and dope dyed colours in solid and hollow conjugated suitable for yarn spinning, nonwovens and fibre fill applications.

On October 23, 2021 OncXerna Therapeutics, Inc. ("OncXerna"), a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its targeted oncology therapeutic candidates, reported new biomarker data from a retrospective analysis of results from its Phase 1b clinical trial of navicixizumab in an electronic poster at the European Society of Gynaecological Oncology (ESGO) Congress 2021 (Press release, OncXerna Therapeutics, OCT 23, 2021, View Source [SID1234591826]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Data presented in the poster are from a retrospective analysis of results from an open-label Phase 1b trial evaluating navicixizumab, a potentially first-in-class anti-DLL4/VEGF bispecific antibody targeting tumor vasculature, in combination with paclitaxel in patients with platinum-resistant ovarian cancer (PROC). Pre-treatment biopsies were analyzed using the investigational Xerna TME Panel to retrospectively compare the biomarker classification of patients against clinical outcomes.

"There is a pressing unmet need for new treatments for patients with platinum-resistant ovarian cancer who have progressed on Avastin or failed more than two lines of prior therapy," said Dr. Kathleen Moore, Stephenson Cancer Center, Oklahoma. "I believe the data presented at ESGO demonstrated the potential of navicixizumab together with the Xerna TME Panel to help address this need. The response rate and treatment durability of navicixizumab in this heavily pretreated patient population are very exciting and results showed improved outcomes in patients classified as having a high angiogenesis score by the Xerna TME Panel’s novel, RNA-expression based algorithm. We have been searching for a predictive biomarker for anti-angiogenic therapies and the Xerna TME panel results presented at ESGO are very promising."

Key data and conclusions from the ESGO poster include:

Clinical outcomes were greater in biomarker positive (B+) vs. biomarker negative (B-) patients
Overall response rate (ORR) in B+ patients: 62% (8/13)
ORR in B- patients: 25% (5/20)
ORR across all patients: 43% (19/44)
Disease control rate (DCR) in B+ patients: 100% (13/13)
DCR in B- patients: 65% (13/20)
DCR across all patients: 77% (34/44)

A consistent correlation was seen between B+ subtype and improved progression-free survival (PFS)
Median PFS in B+ patients: 2 months (95% confidence interval: 5.5 – not estimable)
Median PFS in B- patients: 9 months (95% confidence interval: 1.8 – 8.9)

Laura Benjamin, Ph.D., President and Chief Executive Officer of OncXerna, commented, "The retrospective biomarker analyses presented at ESGO provide an important point of validation for the development of the Xerna TME Panel. Our next step is to further explore these findings through a prospective Phase 3 trial of navicixizumab plus paclitaxel that is also designed to quantify the Xerna TME Panel’s predictive value. We look forward to the initiation of this trial and the evaluation of our Xerna TME Panel as a potential companion diagnostic for immuno-oncology and anti-angiogenic agents."

A copy of the ESGO poster (Abstract 918), entitled: "Correlative analyses of a Phase 1b study of navicixizumab plus paclitaxel in patients with platinum-resistant ovarian cancer using the Xerna TME Panel," can be found here.

About the Phase 1b Trial

The Phase 1b trial was an open-label, non-randomized, dose-escalation and expansion study of the safety, tolerability, and efficacy of navicixizumab plus paclitaxel in patients with platinum-resistant ovarian cancer. The trial enrolled patients who previously received Avastin (bevacizumab) and/or more than 2 prior lines of therapy. Patients were treated with navicixizumab once every two weeks together with weekly paclitaxel. The primary endpoint of the trial was incidence of dose limiting toxicities. Secondary endpoints included response rate assessed by RECIST criteria 1.1 and progression-free survival. For more information, see ClinicalTrials.gov Identifier: NCT03030287.

About Navicixizumab

Navicixizumab is an anti-DLL4/VEGF bispecific antibody product candidate that demonstrated antitumor activity in patients who were previously treated with Avastin (bevacizumab) in a Phase 1b clinical trial. The U.S. Food and Drug Administration granted Fast Track designation to navicixizumab for the treatment of high-grade ovarian, primary peritoneal, or fallopian tube cancer in patients who have previously received Avastin and/or more than 2 prior lines of therapy. Navicixizumab is an investigational agent that has not been approved, and it has not been demonstrated to be safe or effective for any use, including for the treatment of advanced ovarian cancer.

About the Xerna TME Panel

The Xerna TME Panel uses proprietary RNA-based gene expression data and a machine learning-based algorithm to classify patients based on the interplay between angiogenic and immunogenic dominant biologies of the tumor microenvironment (TME). The Xerna TME Panel is an investigational assay that has not been approved and has not been demonstrated to be safe or effective for any use.