Clinical trial

ROSEN, SKILLED INVESTOR COUNSEL, Encourages BioVie Inc. Investors to Secure Counsel Before Important Deadline in Securities Class Action – BIVI

Retrieved on: 
Saturday, February 17, 2024

WHAT TO DO NEXT: To join the BioVie class action, go to https://rosenlegal.com/submit-form/?case_id=21342 or call Phillip Kim, Esq.

Key Points: 
  • WHAT TO DO NEXT: To join the BioVie class action, go to https://rosenlegal.com/submit-form/?case_id=21342 or call Phillip Kim, Esq.
  • WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles.
  • The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation.
  • 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017.

Iovance’s AMTAGVI™ (lifileucel) Receives U.S. FDA Accelerated Approval for Advanced Melanoma

Retrieved on: 
Friday, February 16, 2024

SAN CARLOS, Calif., Feb. 16, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) cell therapies for patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved AMTAGVI™ (lifileucel) suspension for intravenous infusion. AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication is approved under an accelerated approval based on overall response rate (ORR) and duration of response. Iovance is also conducting TILVANCE-301, a Phase 3 trial to confirm clinical benefit.

Key Points: 
  • This indication is approved under an accelerated approval based on overall response rate (ORR) and duration of response.
  • AMTAGVI is the first and the only one-time, individualized T cell therapy to receive FDA approval for a solid tumor cancer.
  • “Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients.
  • Iovance will host a conference call and live audio webcast today to discuss the FDA approval of AMTAGVI.

BostonGene Announces Publication in Nature

Retrieved on: 
Friday, February 16, 2024

BostonGene , a leading provider of AI-based molecular and immune profiling solutions, today announced the online publication of the manuscript “ Clinical trial links oncolytic immunoactivation to survival in glioblastoma ,” in Nature, an international journal publishing peer-reviewed research in all fields of science and technology prioritizing originality, significance, interdisciplinary relevance, timeliness, accessibility, sophistication, and groundbreaking findings.

Key Points: 
  • BostonGene , a leading provider of AI-based molecular and immune profiling solutions, today announced the online publication of the manuscript “ Clinical trial links oncolytic immunoactivation to survival in glioblastoma ,” in Nature, an international journal publishing peer-reviewed research in all fields of science and technology prioritizing originality, significance, interdisciplinary relevance, timeliness, accessibility, sophistication, and groundbreaking findings.
  • Utilization of immunotherapy for GBM has been challenging due to the scarcity of infiltrating antitumor lymphocytes caused by a highly immunosuppressive or “lymphocyte-depleted” tumor microenvironment (TME).
  • "BostonGene's innovative RNA-seq analytics lent novel insights into the dynamic changes associated with CAN-3110 therapy within the glioblastoma microenvironment," said Nathan Fowler, MD, Chief Medical Officer at BostonGene.
  • “Looking to the future, we are excited at the possibilities of harnessing oncolytic viruses to transform immunosuppressive microenvironments across a range of solid cancer types.”

Avidity Biosciences to Present New AOC 1001 Long-term Efficacy and Safety Data from MARINA-OLE™ Trial in People Living with Myotonic Dystrophy Type 1 (DM1) at 2024 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference

Retrieved on: 
Thursday, February 15, 2024

SAN DIEGO, Feb. 15, 2024 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™), today announced that the company will be presenting multiple posters from all three clinical development programs in rare muscle diseases, including new AOC 1001 long-term efficacy and safety data from the MARINA open-label extension (MARINA-OLE™) trial in people living with myotonic dystrophy type 1 (DM1) at the 2024 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference being held March 3-6, 2024, in Orlando, Florida.

Key Points: 
  • ET for a live video webcast event, which will be available on the company's website.
  • The company is hosting Volume 8 of its investor and analyst event series on March 4, 2024, beginning at 8:00 a.m.
  • ET to discuss new AOC 1001 long-term efficacy and safety data from the MARINA-OLE™ trial in people living with DM1.
  • A replay of the webcast will be archived on Avidity's website following the event.

Inventiva reports preliminary 2023 fiscal year financial Information¹ and provides an update on its clinical trial NATiV3

Retrieved on: 
Thursday, February 15, 2024

Frédéric Cren, Chairman, Chief Executive Officer and cofounder of Inventiva, stated: “2023 has been an eventful year for the company.

Key Points: 
  • Frédéric Cren, Chairman, Chief Executive Officer and cofounder of Inventiva, stated: “2023 has been an eventful year for the company.
  • This allowed us to draw down the second tranche of €25 million of the €50 million EIB loan in January 2024.
  • We have advanced our pivotal NATiV3 Phase III clinical trial with lanifibranor in NASH after the implementation of the revised study design in early 2023, with 913 patients randomized to date.
  • An adverse event of elevated aminotransferases has been reported in a patient enrolled in the trial following a scheduled visit.

Prothena Reports Fourth Quarter and Full Year 2023 Financial Results, and Provides Financial Guidance and Business Highlights

Retrieved on: 
Thursday, February 15, 2024

In addition, the Company provided 2024 financial guidance and business highlights.

Key Points: 
  • In addition, the Company provided 2024 financial guidance and business highlights.
  • “2023 was a year of strong progress for Prothena as we advanced our protein dysregulation portfolio and moved closer to becoming a fully integrated commercial company.
  • Total revenue for the fourth quarter and full year of 2023 included BMS collaboration revenue of $0.3 million and $91.3 million, respectively.
  • As of December 31, 2023, Prothena had $621.0 million in cash, cash equivalents and restricted cash, and no debt.

Travere Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, February 15, 2024

Net product sales for the fourth quarter of 2023 were $39.9 million, compared to $25.8 million for the same period in 2022.

Key Points: 
  • Net product sales for the fourth quarter of 2023 were $39.9 million, compared to $25.8 million for the same period in 2022.
  • Research and development (R&D) expenses for the fourth quarter of 2023 were $59.7 million, compared to $58.1 million for the same period in 2022.
  • Total other income, net, for the fourth quarter of 2023 was $5.7 million, compared to $1.1 million for the same period in 2022.
  • ET to discuss company updates as well as fourth quarter and full year 2023 financial results.

Nurix Therapeutics Reports Fourth Quarter and Fiscal Year 2023 Financial Results and Provides a Corporate Update

Retrieved on: 
Thursday, February 15, 2024

NX-2127 exhibited dose-dependent PK, leading to robust and sustained degradation of BTK and biologically relevant degradation of IKZF1 (Ikaros).

Key Points: 
  • NX-2127 exhibited dose-dependent PK, leading to robust and sustained degradation of BTK and biologically relevant degradation of IKZF1 (Ikaros).
  • NX-2127 had a manageable safety profile that was consistent with previous reports for BTK-targeted and immunomodulatory therapies.
  • During the year ended November 30, 2023, Nurix achieved research milestones under its collaborations with Gilead and Sanofi totaling $12.5 million and $7.0 million, respectively.
  • Cash, cash equivalents and marketable securities was $295.3 million as of November 30, 2023, compared to $268.7 million as of August 31, 2023.

Kurome Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for KME-0584 for the Treatment of Acute Myeloid Lymphoma (AML) and High-Risk Myelodysplastic Syndromes (MDS)

Retrieved on: 
Thursday, February 15, 2024

Kurome Therapeutics Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared the IND for KME-0584, allowing the company to proceed with a Ph1 clinical trial in relapsed/refractory (R/R) AML and high-risk (HR) MDS patients.

Key Points: 
  • Kurome Therapeutics Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared the IND for KME-0584, allowing the company to proceed with a Ph1 clinical trial in relapsed/refractory (R/R) AML and high-risk (HR) MDS patients.
  • Kurome plans to initiate the clinical trial in the latter half of 2024.
  • “This is a major milestone for the Kurome team and our collaborators and validates our unique approach to AML and MDS as well as the suitability of KME-0584 for initial clinical testing,” said Jan Rosenbaum, Ph.D., CEO and CSO at Kurome.
  • “We look forward to getting our clinical trial underway and testing our approach of targeting dysregulated immune signalling in the setting of AML and HR-MDS by targeting both IRAK1 and IRAK4 together to improve efficacy in this difficult to treat R/R patient population.”

Global Healthcare Executive Jill DeSimone Joins Swim Across America Board of Directors

Retrieved on: 
Thursday, February 15, 2024

CHARLOTTE, N.C., Feb. 15, 2024 /PRNewswire-PRWeb/ -- Swim Across America, a national nonprofit dedicated to providing grants for cancer research and patient programs and raising funds through swimming events, is pleased to announce that Jill DeSimone, a global pharmaceutical executive, has been appointed to the Swim Across America Board of Directors. Jill's career included championing excellence in patient care for serious diseases, while igniting scalable growth and agility in the healthcare marketplace. She held positions of executive leadership for more than 30 years, culminating in eight years as president of Oncology for Merck.

Key Points: 
  • After a Successful Career with Oncology Pharmaceutical Companies, Jill DeSimone is Making Waves in the Fight Against Cancer
    CHARLOTTE, N.C., Feb. 15, 2024 /PRNewswire-PRWeb/ -- Swim Across America , a national nonprofit dedicated to providing grants for cancer research and patient programs and raising funds through swimming events, is pleased to announce that Jill DeSimone, a global pharmaceutical executive, has been appointed to the Swim Across America Board of Directors.
  • "One of my greatest joys has been volunteering and encouraging many of my colleagues and friends to volunteer with Swim Across America," says Jill DeSimone.
  • "Jill has been supporting Swim Across America for many years," commented Pam Ryan, Swim Across America board chair.
  • Swim Across America was founded in 1987 with its first open water charity swim in Long Island Sound.