Investigator's brochure

PreveCeutical Awards ICON Analgesic Program (Painkiller) Clinical Development

Retrieved on: 
Tuesday, February 7, 2023
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Vancouver, British Columbia--(Newsfile Corp. - February 7, 2023) - PreveCeutical Medical Inc. (CSE: PREV) (OTCQB: PRVCF) (FSE: 18H) (the "Company" or "PreveCeutical"), is pleased to announce that on February 1, 2023, PreveCeutical has appointed ICON as the clinical research organization (CRO) to complete the following.

Key Points: 
  • Vancouver, British Columbia--(Newsfile Corp. - February 7, 2023) - PreveCeutical Medical Inc. (CSE: PREV) (OTCQB: PRVCF) (FSE: 18H) (the "Company" or "PreveCeutical"), is pleased to announce that on February 1, 2023, PreveCeutical has appointed ICON as the clinical research organization (CRO) to complete the following.
  • Construction of a clinical development plan for Phase 1 through pivotal Phase 3 studies.
  • PreveCeutical shall commence the clinical development with ICON in Q1 2023 and work with regulators to seek any potential fast track provisions as we believe that a non-addictive pain analgesic will meet the requirements due to the global abuse of painkillers currently available.
  • PreveCeutical's Chief Executive Officer, Mr. Stephen Van Deventer, commented, "Moving forward as PreveCeutical transitions from an R&D company into clinical development, it is our priority to select the best partner for this development.

Autolus Therapeutics to Present Three Clinical Data Updates at the American Society of Hematology (ASH) Annual Meeting 2022

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Thursday, November 3, 2022
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Were looking forward to presenting follow up data from three of our clinical trials at ASH this year.

Key Points: 
  • Were looking forward to presenting follow up data from three of our clinical trials at ASH this year.
  • For both AUTO1/22 in pediatric ALL patients and for AUTO4 in peripheral T Cell Lymphoma we will present longer follow up data.
  • Overall, obe-cel has a tolerable safety profile in patients with r/r B-cell cancers despite high disease burden.
  • In collaboration with Autolus academic partner, UCL, obe-cel is currently being evaluated in a Phase 1 clinical trials for B-NHL.

IN8bio to Present Positive Early Data from Ongoing Phase 1 Study of INB-100 at the 64th American Society of Hematology Annual Meeting

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Thursday, November 3, 2022
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These early signs of long-term durability and progression-free survival demonstrate the potential of INB-100 as a new treatment option in this patient population.

Key Points: 
  • These early signs of long-term durability and progression-free survival demonstrate the potential of INB-100 as a new treatment option in this patient population.
  • These data suggest that treatment with a one-time allogeneic gamma-delta T cell therapy has the potential to disrupt the treatment paradigm for AML.
  • We look forward to sharing updated data at ASH and additional data at future peer-reviewed conferences.
  • The abstract highlights data from Cohort 1 of the ongoing Phase 1 clinical trial of INB-100 in patients with high-risk AML undergoing HSCT.

Allogene Therapeutics Announces Poster Presentation of Its Phase 1 UNIVERSAL Trial in Multiple Myeloma at the 64th Annual Meeting of the American Society of Hematology

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Thursday, November 3, 2022
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UNIVERSAL is the first trial to demonstrate significant responses can be achieved with an allogeneic CAR T product candidate.

Key Points: 
  • UNIVERSAL is the first trial to demonstrate significant responses can be achieved with an allogeneic CAR T product candidate.
  • The Company will host an in-person and virtual Research & Development Showcase on Tuesday, November 29, 2022 in New York City.
  • This event will include a discussion of updated data from the UNIVERSAL trial with single dose ALLO-715 and next steps for the program.
  • AlloCAR T is a trademark ofAllogene Therapeutics, Inc.
    ALLO-715 (BCMA) utilizes TALEN gene-editing technology pioneered and owned by Cellectis.

Affimed Announces Presentation of Phase 1/2 Data from AFM13 in Combination with Allogeneic NK Cells and Preclinical AFM28 Data at ASH 2022 Annual Meeting

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Thursday, November 3, 2022
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Each cycle of treatment consists of a lymphodepletion, followed by single dose of AFM13 precomplexed with cbNK cells and three subsequent infusions of AFM13 monotherapy.

Key Points: 
  • Each cycle of treatment consists of a lymphodepletion, followed by single dose of AFM13 precomplexed with cbNK cells and three subsequent infusions of AFM13 monotherapy.
  • In a panel of AML cell lines, AFM28 successfully engaged allogeneic NK cells to destroy CD123-positive tumor cells through antibody-dependent cytotoxicity (ADCC).
  • AFM28 is currently being prepared for a first-in-human clinical investigation as monotherapy and in combination with allogeneic NK cells.
  • Clinical development is planned as both monotherapy and in combination with allogeneic NK cells in patients with relapsed/refractory CD123-positive leukemias.

Precision BioSciences Announces Data Presentation on Effective Cell Dose and Functional Attributes of CD19 Allogeneic CAR T, Azer-Cel, at the Upcoming 2022 American Society of Hematology (ASH) Annual Meeting

Retrieved on: 
Thursday, November 3, 2022
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Title: Effective Cell Dose and Functional Attributes of Azercabtagene Zapreleucel (azer-cel; PBCAR0191) Associate with Allogeneic CAR T-Cell Safety and Efficacy in Patients with Relapsed/Refractory B-Cell Lymphoma

Key Points: 
  • Title: Effective Cell Dose and Functional Attributes of Azercabtagene Zapreleucel (azer-cel; PBCAR0191) Associate with Allogeneic CAR T-Cell Safety and Efficacy in Patients with Relapsed/Refractory B-Cell Lymphoma
    Poster Session: 704.
  • ARCUS is a highly precise and versatile genome editing platform that was designed with therapeutic safety, delivery, and control in mind.
  • This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
  • Forward-looking statements are based on managements current expectations, beliefs and assumptions and on information currently available to us.

Adicet Bio Reports ASH Abstract Data from Ongoing ADI-001 Phase 1 Trial in Relapsed or Refractory Aggressive B-Cell Non-Hodgkin’s Lymphoma (NHL)

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Thursday, November 3, 2022
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The abstract outlines a summary of clinical data as of a July 15, 2022 data-cut date.

Key Points: 
  • The abstract outlines a summary of clinical data as of a July 15, 2022 data-cut date.
  • We look forward to providing additional clinical data from a later data-cut date during the ASH Annual Meeting, said Francesco Galimi, M.D., Ph.D., Chief Medical Officer of Adicet Bio.
  • There were eight patients with large B-cell lymphoma (LBCL) and one with mantle cell lymphoma.
  • ET to discuss recent data from its ongoing Phase 1 clinical study of ADI-001 in relapsed or refractory aggressive B-cell NHL.

Arcellx Announces Presentation of New Clinical Data from Its CART-ddBCMA Phase 1 Trial in Patients with Relapsed or Refractory Multiple Myeloma at the 64th ASH Annual Meeting and Exposition

Retrieved on: 
Thursday, November 3, 2022
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REDWOOD CITY, Calif., Nov. 3, 2022 /PRNewswire/ -- Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, today announced that new clinical data from its Phase 1 study of CART-ddBCMA in patients with relapsed or refractory multiple myeloma will be presented at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition taking place December 10-13, 2022, in New Orleans, Louisiana. The data in the ASH abstract contains previously presented data from a May 3, 2022, data cut. The presentation at ASH will include new data with longer follow-up period and additional patients from a recent data cut.

Key Points: 
  • The data in the ASH abstract contains previously presented data from a May 3, 2022, data cut.
  • The presentation at ASH will include new data with longer follow-up period and additional patients from a recent data cut.
  • Arcellx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases.
  • Arcellx's lead product candidate, CART-ddBCMA, is being developed for the treatment of relapsed or refractory multiple myeloma (r/r MM) in an ongoing Phase 1 study.

Odyssey Health, Inc. Provides Recap on Concussion Drug Development

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Thursday, October 6, 2022
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Las Vegas, Nevada, Oct. 06, 2022 (GLOBE NEWSWIRE) -- Odyssey Health, Inc. (OTC: ODYY), f/k/a Odyssey Group International, Inc., a company focused on developing unique, life-enhancing medical products, today presents a recap of their concussion drug development program.

Key Points: 
  • Las Vegas, Nevada, Oct. 06, 2022 (GLOBE NEWSWIRE) -- Odyssey Health, Inc. (OTC: ODYY), f/k/a Odyssey Group International, Inc., a company focused on developing unique, life-enhancing medical products, today presents a recap of their concussion drug development program.
  • Odyssey acquired the intellectual property and all rights to the drug on March 1, 2021.
  • Since the acquisition Odyssey has made significant progress in the development program.
  • Created a Scientific Advisory Board of renowned medical doctors who evaluated our drug technology, pre-clinical studies and are overseeing the clinical trials.

Alpha Tau Announces FDA Approval of IDE to Initiate Multi-Center Pivotal Study of Alpha DaRT™ in Recurrent Cutaneous SCC

Retrieved on: 
Wednesday, June 8, 2022
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"We are very excited about the upcoming commencement of our U.S. pivotal study, undoubtedly our most significant clinical trial to date," commented Alpha Tau CEOUzi Sofer.

Key Points: 
  • "We are very excited about the upcoming commencement of our U.S. pivotal study, undoubtedly our most significant clinical trial to date," commented Alpha Tau CEOUzi Sofer.
  • Yaniv Sagie, Alpha Tau VP Quality and Regulatory Affairs, noted, "This amazing milestone represents the culmination of Alpha Tau's rigorous teamwork and unwavering commitment to quality and regulatory excellence."
  • Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral insertion of radium-224 impregnated seeds.
  • Alpha Tau believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain.