Annual general meeting

IND approval from the US FDA for Phase II SAR-Bombesin imaging trial in prostate cancer

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Monday, June 6, 2022
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SYDNEY, June 6, 2022 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address growing medical needs in oncology, announces the approval of its Investigational New Drug (IND) application by the United States Food and Drug Administration (US FDA) to evaluate its SAR-Bombesin product as an imaging agent in prostate cancer patients that are Prostate-Specific Membrane Antigen (PSMA)-negative.

Key Points: 
  • Clarity's Executive Chairman, Dr Alan Taylor, commented,"Receiving clearance from the FDA on the imaging trial with SAR-Bombesin is yet another significant milestone for Clarity.
  • SABRE, which derives from "Copper-64 SAR-Bombesin in Biochemical REcurrence of Prostate Cancer trial", is a multi-center, single arm, non-randomised, open-label trial in up to 50 PSMA-negative patients with known or suspected prostate cancer.
  • The primary objectives of the trial are to investigate the safety and tolerability of 64Cu SAR-Bombesin, as well as its ability to correctly detect the recurrence of prostate cancer.
  • Given the prostate cancer indication is one of the largest in oncology, there is a significant unmet medical need in this segment.

ASTRUM-005: Henlius Released Phase 3 Study Results for the First-line Treatment of Small Cell Lung Cancer of Serplulimab at ASCO 2022

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Monday, June 6, 2022
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Serplulimab is the first China-developed anti-PD-1 mAb in first-line treatment of lung cancer that was presented orally at ASCO Annual Meeting.

Key Points: 
  • Serplulimab is the first China-developed anti-PD-1 mAb in first-line treatment of lung cancer that was presented orally at ASCO Annual Meeting.
  • Based on the large number of unmet clinical needs, the company has implemented a comprehensive first-line treatment strategy for lung cancer with multiple clinical trials.
  • ASTRUM-005 results are as follows:
    Serplulimab, a novel anti-PD-1 antibody, plus chemotherapy versus chemotherapy alone as first-line treatment for extensive-stage small-cell lung cancer: An international randomized phase 3 study (Abstract No.
  • The NDAs of the treatment for squamous non-small cell lung cancer (sqNSCLC) and the first-line treatment of extensive small-cell lung cancer (ES-SCLC) have been accepted by the NMPA.

Olaris, Inc. to present novel myOLARIS™-KTdx assay detecting graft status in kidney transplant recipients at American Transplant Congress 2022 Meeting

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Monday, June 6, 2022
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FRAMINGHAM, Mass., June 6, 2022 /PRNewswire-PRWeb/ -- Olaris, Inc., a precision medicine company leveraging metabolomics and machine learning for the discovery and development of its myOLARIS™ diagnostics products, which aim to optimize treatments and outcomes for individual patients, is pleased to announce that the company's study on the application of the myOLARIS-KTdx kidney transplant graft status score to transplant recipients has been selected for a poster presentation on June 6th at the upcoming American Transplant Congress (ATC) 2022 Annual Meeting, to be held June 4th-8th in Boston, Massachusetts.

Key Points: 
  • Olaris' researchers expanded the study to 115 kidney transplant recipients, with longitudinal samples including 371 urine samples.
  • They applied the urine metabolite-based score to patients with different clinical statuses at 90 days through 2 years post-transplant.
  • Further, myOLARIS-KTdx identified patients that retained stable graft function for 2 years with no infection or rejection events.
  • The results of the study establish a non-invasive signature for potential use in monitoring kidney transplant status and add novel insight to the appropriate balance of immunosuppressant treatment for kidney transplant patients.

Trialjectory Presents Poster Highlighting Platform's Effective Cancer Patient Clinical Trial Recruitment at 2022 ASCO Annual Meeting

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Monday, June 6, 2022
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NEW YORK, June 6, 2022 /PRNewswire/ -- Trialjectory, the AI-powered decision-support platform for patients, healthcare providers and pharmaceutical companies, announced today that the Company presented a poster on cancer patients' clinical trial participation at this year's American Society of Clinical Oncology (ASCO) Annual Meeting. The poster, titled, "Trialjectory: An Artificial Intelligence (AI)-Based Platform Empowering Patients and Oncologists by Accelerating Access to Participation in Cancer Clinical Trials," was presented by Limor Gortzak Uzan, M.D, Director of Oncology, Trialjectory.

Key Points: 
  • The poster, titled, "Trialjectory: An Artificial Intelligence (AI)-Based Platform Empowering Patients and Oncologists by Accelerating Access to Participation in Cancer Clinical Trials," was presented by Limor Gortzak Uzan, M.D, Director of Oncology, Trialjectory.
  • The poster highlighted clinical trial registration and participation for patients using Trialjectory, showing significantly higher engagement and enrollment rates compared to reported national averages.
  • "Most cancer patients are open to participating in clinical trials, as they often achieve better outcomes with advanced new treatment options, compared with the standard of care.
  • "Democratizing access to clinical trials not only increases patient participation but also accelerates the drug development process for pharmaceutical companies as a result.

Nouscom Announces Positive Full Phase 1 Data of NOUS-209, an 'off-the-shelf' Neoantigen Cancer Immunotherapy for the Treatment of dMMR/MSI-H Solid Tumors, at ASCO 2022

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Monday, June 6, 2022
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BASEL, Switzerland, June 6, 2022 /PRNewswire/ -- Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized viral vectored immunotherapies, today announced first data from the completed Phase 1 trial evaluating NOUS-209 in combination with anti-PD-1 checkpoint inhibitor (pembrolizumab). The data, presented yesterday in a poster discussion session at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrated NOUS-209 to be safe, highly immunogenic and with promising signs of clinical efficacy.

Key Points: 
  • NOUS-209, Nouscom's leadproduct, is an off-the-shelf cancer vaccine targeting 209 shared neoantigens.
  • Dr. Marina Udier, Chief Executive Officer of Nouscom, said: "These new data with all patients enrolled continues to reinforce our compelling and differentiating data for NOUS-209.
  • Nouscom, which was founded in 2015 and is headquartered in Basel, Switzerland with operations in Rome, Italy, is backed by international life sciences investors.
  • For more information on Nouscom, please visit the company's website at www.nouscom.com or follow us on LinkedIn at www.linkedin.com/company/nouscom-ag/

Nouscom Announces Positive Full Phase 1 Data of NOUS-209, an 'off-the-shelf' Neoantigen Cancer Immunotherapy for the Treatment of dMMR/MSI-H Solid Tumors, at ASCO 2022

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Monday, June 6, 2022
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BASEL, Switzerland, June 6, 2022 /PRNewswire/ -- Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized viral vectored immunotherapies, today announced first data from the completed Phase 1 trial evaluating NOUS-209 in combination with anti-PD-1 checkpoint inhibitor (pembrolizumab). The data, presented yesterday in a poster discussion session at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrated NOUS-209 to be safe, highly immunogenic and with promising signs of clinical efficacy.

Key Points: 
  • NOUS-209, Nouscom's leadproduct, is an off-the-shelf cancer vaccine targeting 209 shared neoantigens.
  • Dr. Marina Udier, Chief Executive Officer of Nouscom, said: "These new data with all patients enrolled continues to reinforce our compelling and differentiating data for NOUS-209.
  • Nouscom, which was founded in 2015 and is headquartered in Basel, Switzerland with operations in Rome, Italy, is backed by international life sciences investors.
  • For more information on Nouscom, please visit the company's website at www.nouscom.com or follow us on LinkedIn at www.linkedin.com/company/nouscom-ag/

Eisai Presents New Findings for Antibody Drug Conjugate Farletuzumab Ecteribulin at 2022 ASCO Annual Meeting

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Sunday, June 5, 2022
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NUTLEY, N.J., June 5, 2022 /PRNewswire/ -- Eisai announced today new investigational data from the platinum-resistant ovarian cancer (PROC) cohort expansion of a Phase 1 study (Study 101) evaluating the antibody drug conjugate (ADC) co-developed by Eisai and Bristol Myers Squibb, farletuzumab ecteribulin (MORAb-202). The safety and efficacy findings are being featured in a poster discussion at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (#ASCO22), a hybrid meeting in Chicago from June 3 to 7 (NCT03386942; Abstract: #5513). Farletuzumab ecteribulin is composed of Eisai's in-house developed farletuzumab, a humanized IgG1 monoclonal antibody that binds to the folate receptor alpha (FRα), and Eisai's anticancer agent eribulin, a microtubule dynamics inhibitor, using an enzymatically cleavable linker.

Key Points: 
  • The safety and efficacy findings are being featured in a poster discussion at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (#ASCO22), a hybrid meeting in Chicago from June 3 to 7 ( NCT03386942 ; Abstract: #5513).
  • As the field of targeted therapy continues to evolve, antibody drug conjugates are anticipated to become a key modality in the treatment of recurrent, platinum-resistant disease."
  • We look forward to sharing further results assessing farletuzumab ecteribulin as a potential treatment for patients with platinum-resistant ovarian cancer."
  • In the case of ILD/pneumonitis, dosing of farletuzumab ecteribulin could be modified, interrupted or permanently discontinued depending on the severity.

Gracell Biotechnologies Schedules Clinical Update Call After EHA2022

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Friday, June 3, 2022
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SAN DIEGO, Calif. and SUZHOU and SHANGHAI, China, June.

Key Points: 
  • SAN DIEGO, Calif. and SUZHOU and SHANGHAI, China, June.
  • 3, 2022 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced that the Company plans to hold a clinical update call on June 13 after the European Hematology Association 2022 Hybrid Congress (EHA 2022) as the data is subject to meeting's embargo policy until June 12.
  • Gracell Biotechnologies Inc.("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies.
  • For more information on Gracell, please visit www.gracellbio.com .Follow @GracellBio on LinkedIn .

Caris Life Sciences Introduces the Caris Assure™ Liquid Biopsy Assay at ASCO 2022

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Friday, June 3, 2022
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CHICAGO, June 3, 2022 /PRNewswire/ -- Caris Life Sciences®(Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, today introduced its Caris Assure™ liquid biopsy assay at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Booth #22081).

Key Points: 
  • Caris Assure is the most powerful liquid biopsy assay ever developed, providing whole exome and whole transcriptome sequencing (WES/WTS) assessing somatic tumor, somatic CHIP and germline alterations
    CHICAGO, June 3, 2022 /PRNewswire/ -- Caris Life Sciences (Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, today introduced its Caris Assure liquid biopsy assay at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Booth #22081).
  • "Caris Assure establishes a new standard for liquid biopsy testing," said David D. Halbert , Chairman, Founder and CEO of Caris Life Sciences.
  • With Caris Assure, we have created the most extensive sequencing assay available to ensure we leave no stone unturned in properly guiding treatment selection and ongoing cancer care management."
  • This unique assay includes characterization of somatic tumor alterations, somatic Clonal Hematopoiesis of Indeterminate Potential (CHIP) alterations and identification of incidental germline findings.

Atento Announces Cooperation Agreement with Investors

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Thursday, June 2, 2022
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NEW YORK, June 2, 2022 /PRNewswire/ -- Atento S.A. (NYSE: ATTO) ("Atento" or the "Company"), one of the largest providers worldwide and the leading company in customer relationship services and business process outsourcing (CRM / BPO) in Latin America, today announced the execution of a cooperation agreement (the "Agreement") with Kyma Capital, Charles Frischer and Asheef Lalani (the "Investors"), who beneficially own in the aggregate approximately 8.5% of the Company's outstanding ordinary shares. Pursuant to the Agreement, the Board of Directors of Atento (the "Board") will nominate Akshay Shah to stand for election as a new independent director at the Company's 2022 Annual Meeting of Shareholders scheduled to be held on 29 June, 2022.

Key Points: 
  • (NYSE: ATTO) ("Atento" or the "Company"), one of the largest providers worldwide and the leading company in customer relationship services and business process outsourcing (CRM / BPO) in Latin America, today announced the execution of a cooperation agreement (the "Agreement") with Kyma Capital, Charles Frischer and Asheef Lalani (the "Investors"), who beneficially own in the aggregate approximately 8.5% of the Company's outstanding ordinary shares.
  • "We look forward to welcoming Akshay to the Board," said Carlos Lpez-Abada, CEO of Atento.
  • Atento has over 400 clients to whom it offers a wide range of CRM BPO services through multiple channels.
  • Atento undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.