NSCLC

Prelude Therapeutics Reports Full Year 2023 Financial Results and Outlines Key Objectives for 2024

Retrieved on: 
Thursday, February 15, 2024

WILMINGTON, Del., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today reported its financial results for the fiscal year ended December 31, 2023, and outlined key objectives for 2024.   

Key Points: 
  • “Our partnership with AbCellera represents a strategic step to expand our pipeline, based on our core competencies in medicinal chemistry, cancer biology and clinical development.
  • A second cohort of patients with AML is expected to initiate in the first half of 2024.
  • Under the terms of the agreement, Prelude and AbCellera will jointly discover, develop, and commercialize products emerging from the collaboration.
  • The decrease in general and administrative expenses was primarily due to our continued management of general and administrative expenses.

Results from First Patient in Kiromic BioPharma’s Deltacel-01 Clinical Trial Indicate Tumor Reduction at Two Months

Retrieved on: 
Wednesday, February 14, 2024

This patient, who was treated at the Beverly Hills Cancer Center (BHCC), continues to do well two months following treatment.

Key Points: 
  • This patient, who was treated at the Beverly Hills Cancer Center (BHCC), continues to do well two months following treatment.
  • “We are proud and excited to report these highly promising early results showing tumor reduction in a patient population that has few treatment options available.
  • Kiromic also reports that the second patient in the Deltacel-01 clinical trial has received the second and final infusion of Deltacel.
  • The Deltacel-01 clinical trial is expected to start enrolling patients at two additional clinical trial sites in the first half of the year.

Erasca Announces Two Clinical Trial Collaboration and Supply Agreements for Trametinib to Evaluate Naporafenib Combination in SEACRAFT-1 and SEACRAFT-2 Trials

Retrieved on: 
Wednesday, February 14, 2024

SAN DIEGO, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced two clinical trial collaboration and supply agreements (CTCSAs) with Novartis (NYSE: NVS) for the MEK inhibitor trametinib (MEKINIST®).

Key Points: 
  • Erasca is sponsoring the trials, and Novartis is supplying trametinib at no cost.
  • “Both trials are supported by compelling anti-tumor activity with a tolerable and manageable adverse event profile demonstrated in clinical data generated by Novartis.
  • Both RAS Q61X solid tumors and NRASm melanoma represent high unmet needs with no approved targeted therapies for these respective mutation types.
  • Erasca is exploring whether naporafenib in combination with trametinib can improve outcomes and help provide meaningful therapeutic benefit for these advanced solid tumor indications.

U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Augtyro™ (repotrectinib) for the Treatment of Patients with NTRK-Positive Locally Advanced or Metastatic Solid Tumors

Retrieved on: 
Wednesday, February 14, 2024

The filing acceptance is based on results from the registrational Phase 1/2 TRIDENT-1 trial (adult patients with NTRK-positive solid tumors) and CARE study (pediatric patients with NTRK-positive solid tumors).

Key Points: 
  • The filing acceptance is based on results from the registrational Phase 1/2 TRIDENT-1 trial (adult patients with NTRK-positive solid tumors) and CARE study (pediatric patients with NTRK-positive solid tumors).
  • The FDA granted the application Priority Review status and assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 15, 2024.
  • “While great advancements have been made over the last decade, patients with NTRK-positive locally advanced or metastatic solid tumors still experience significant unmet needs.
  • In the TRIDENT-1 study, Augtyro demonstrated clinically meaningful response rates in patients with NTRK-positive locally advanced or metastatic solid tumors.

Curasight announces acceleration of therapeutic strategy to strengthen position as a radiopharmaceutical theranostic company

Retrieved on: 
Tuesday, February 13, 2024

COPENHAGEN, Denmark, Feb. 13, 2024 /PRNewswire/ -- Curasight A/S ("Curasight" or the "Company" (XSAT: CURAS) announces today that it is accelerating and expanding its clinical therapeutic strategy with the addition of a new Phase I/IIa trial to include a total of five cancer indications in a so called basket trial design.

Key Points: 
  • COPENHAGEN, Denmark, Feb. 13, 2024 /PRNewswire/ -- Curasight A/S ("Curasight" or the "Company" (XSAT: CURAS) announces today that it is accelerating and expanding its clinical therapeutic strategy with the addition of a new Phase I/IIa trial to include a total of five cancer indications in a so called basket trial design.
  • To strengthen the Company's capital structure and secure funding for the acceleration of clinical activities, Curasight intends to launch a rights issue during the first quarter of 2024.
  • By launching this basket trial, we can accelerate development of both uTRACE and uTREAT (theranostic) in parallel and potentially have therapeutic efficacy data already during 2025.
  • Under the terms of the deal, Curasight is responsible for development until regulatory approval with Curium responsible for manufacturing and commercialisation.

Curasight announces acceleration of therapeutic strategy to strengthen position as a radiopharmaceutical theranostic company

Retrieved on: 
Tuesday, February 13, 2024

COPENHAGEN, Denmark, Feb. 13, 2024 /PRNewswire/ -- Curasight A/S ("Curasight" or the "Company" (XSAT: CURAS) announces today that it is accelerating and expanding its clinical therapeutic strategy with the addition of a new Phase I/IIa trial to include a total of five cancer indications in a so called basket trial design.

Key Points: 
  • COPENHAGEN, Denmark, Feb. 13, 2024 /PRNewswire/ -- Curasight A/S ("Curasight" or the "Company" (XSAT: CURAS) announces today that it is accelerating and expanding its clinical therapeutic strategy with the addition of a new Phase I/IIa trial to include a total of five cancer indications in a so called basket trial design.
  • To strengthen the Company's capital structure and secure funding for the acceleration of clinical activities, Curasight intends to launch a rights issue during the first quarter of 2024.
  • By launching this basket trial, we can accelerate development of both uTRACE and uTREAT (theranostic) in parallel and potentially have therapeutic efficacy data already during 2025.
  • Under the terms of the deal, Curasight is responsible for development until regulatory approval with Curium responsible for manufacturing and commercialisation.

HEALWELL AI’s Pentavere Referenced by Several Leading Global Organizations for its Strength in Artificial Intelligence for Preventative Care

Retrieved on: 
Thursday, February 8, 2024

Pentavere continues to publish ground-breaking AI work accepted at prestigious global medical conferences and leading oncology organizations.

Key Points: 
  • Pentavere continues to publish ground-breaking AI work accepted at prestigious global medical conferences and leading oncology organizations.
  • In the past quarter Pentavere presented its AI work, in partnership with leading academic centers and global pharmaceutical companies at a number of prestigious conferences.
  • TORONTO, Feb. 08, 2024 (GLOBE NEWSWIRE) -- HEALWELL AI Inc. (“HEALWELL” or the “Company”) (TSX: AIDX) (OTCQX: HWAIF), an AI and data science company focused on preventative care, is pleased to announce that its subsidiary Pentavere Research Group Inc. (“Pentavere”), continues to publish ground-breaking AI work accepted at prestigious global medical conferences and leading oncology organizations.
  • Using Artificial Intelligence to automate the extraction of staging criteria from the electronic health records of oropharyngeal cancer patient.

Foghorn Provides Pipeline Update on FHD-909 BRM Selective Inhibitor

Retrieved on: 
Thursday, February 8, 2024

Selective BRM inhibition has been a sought-after objective in cancer research for many years.

Key Points: 
  • Selective BRM inhibition has been a sought-after objective in cancer research for many years.
  • A variety of tumor types, including NSCLC, are known to have mutations in BRG1, which we believe make them dependent on BRM activity for their survival.
  • Selective blocking of BRM activity is considered a promising strategy for causing tumor cell death while sparing healthy cells.
  • The collaboration includes a US 50/50 co-development and co-commercialization agreement for Foghorn’s Selective BRM oncology program and an additional undisclosed oncology target.

Genprex Expands Nonclinical Programs into New Therapeutic Indications with Research Collaborators

Retrieved on: 
Wednesday, February 7, 2024

AUSTIN, Texas, Feb. 7, 2024 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced the expansion of its nonclinical programs into new indications through Sponsored Research Agreements and Material Transfer Agreements with multiple academic research collaborators to study TUSC2, the tumor suppressor gene used in Genprex's lead drug candidate, REQORSA (quaratusugene ozeplasmid), and NPRL2, another tumor suppressor gene. The new indications being evaluated include ALK-positive lung cancer and other additional programs that are not disclosed at this time.

Key Points: 
  • The new indications being evaluated include ALK-positive lung cancer and other additional programs that are not disclosed at this time.
  • "Research indicates that the TUSC2 gene used in REQORSA may benefit many types of cancers and potentially the treatment of other diseases.
  • Research collaborators at the Rogel Cancer Center's Judith Tam ALK Lung Cancer Research Initiative are studying the combination of Genprex's REQORSA, which uses the TUSC2 tumor suppressor gene, with various ALK inhibitors.
  • Genprex believes this system allows for delivery of a number of cancer-fighting genes, alone or in combination with other cancer therapies, to combat multiple types of cancer.

Bristol Myers Squibb Announces Acceptance of U.S. and EU Regulatory Filings for Neoadjuvant Opdivo (nivolumab) and Chemotherapy Followed by Surgery and Adjuvant Opdivo in Resectable Non-Small Cell Lung Cancer

Retrieved on: 
Wednesday, February 7, 2024

Bristol Myers Squibb (NYSE: BMY) today announced two regulatory acceptances for applications for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC).

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced two regulatory acceptances for applications for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC).
  • "Between 30% to 55% of non-small cell lung cancer patients who undergo surgery will experience disease recurrence.
  • The study also showed benefits in key secondary endpoints including pathologic complete response (pCR) and major pathologic response (MPR).
  • Opdivo and Opdivo-based combinations have shown efficacy benefits in the neoadjuvant, adjuvant or perioperative settings across four cancers to date, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.