TKI

Clearside Biomedical’s Versatile Suprachoroidal Injection Platform Highlighted in Four Ophthalmic Indications in Clinical Data Presentations at AAO 2023 Annual Meeting

Retrieved on: 
Tuesday, November 7, 2023

“The AAO meeting held over the past week was exceptionally positive for Clearside and our clinical development partners,” said, George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer.

Key Points: 
  • “The AAO meeting held over the past week was exceptionally positive for Clearside and our clinical development partners,” said, George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer.
  • Two of our partners, REGENXBIO and Aura Biosciences, presented new, positive Phase 2 safety and clinical efficacy data from their respective programs utilizing our SCS Microinjector.
  • The findings from the survey indicated that physicians found the XIPERE injection easy to learn, with patient outcomes consistent with clinical trial data.
  • Clearside’s medical meeting presentations can be accessed on the Company’s Publications and Presentations page.

Black Diamond Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, November 6, 2023

and NEW YORK, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with genetically defined cancers, today reported financial results for the third quarter ended September 30, 2023, and provided a corporate update.

Key Points: 
  • and NEW YORK, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with genetically defined cancers, today reported financial results for the third quarter ended September 30, 2023, and provided a corporate update.
  • In October 2023, Black Diamond presented a poster at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics detailing preclinical data for BDTX-4933.
  • In September 2023, Black Diamond announced a CEO transition, appointing Chairman of the Board Mark Velleca, M.D., Ph.D. to President and Chief Executive Officer.
  • Net cash used in operations was $18.4 million for the third quarter of 2023 compared to $16.5 million for the third quarter of 2022.

IDRx Presents Preliminary Clinical Data from Ongoing Phase 1 StrateGIST Study at CTOS 2023 Supporting Best-in-Class Potential of IDRX-42 in Patients with GIST

Retrieved on: 
Thursday, November 2, 2023

“Importantly, these preliminary data will help guide our discussions with physicians regarding development strategies for IDRX-42 in patients with GIST in early lines of therapy to prevent the emergence of genomically-driven resistance mutations.

Key Points: 
  • “Importantly, these preliminary data will help guide our discussions with physicians regarding development strategies for IDRX-42 in patients with GIST in early lines of therapy to prevent the emergence of genomically-driven resistance mutations.
  • Median duration on treatment was 16 weeks and continuing, with 70% (23/33) of patients remaining on treatment at time of data cutoff.
  • 4/28 patients are on study for
  • Title: Phase 1 Study of IDRX-42 in Patients with Advanced Gastrointestinal Stromal Tumors Resistant to Prior Systemic Therapy: Early Results
    Session: CTOS Poster Reception 5:30-6:30 p.m. GMT, Thursday, November 2nd

Ivonescimab’s Novel Mechanism of Action Highlighting Cooperative Binding to be Featured in Poster Presentation at SITC 2023

Retrieved on: 
Tuesday, October 31, 2023

The poster with updated data describing ivonescimab’s mechanism of action will be displayed on Saturday November 4, 2023, from 11:55am to 1:25pm Pacific Time.

Key Points: 
  • The poster with updated data describing ivonescimab’s mechanism of action will be displayed on Saturday November 4, 2023, from 11:55am to 1:25pm Pacific Time.
  • The poster is a collaborative effort between Summit and our collaboration and licensing partner, Akeso, Inc. (HKEX Code: 9926.HK), who generated and analyzed the data.
  • The poster describes how ivonescimab displays unique cooperative binding to each of its intended targets with higher affinity when in the presence of both PD-1 and VEGF.
  • Lung cancer is believed to impact approximately 238,0004 people in the United States each year and approximately 477,0005 in Europe.

AnHeart Therapeutics Announces Exclusive License Agreement With Nippon Kayaku for Taletrectinib in Japan

Retrieved on: 
Monday, October 30, 2023

AnHeart Therapeutics (“AnHeart”), a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer, today announced it has entered into an exclusive license agreement with Nippon Kayaku Co., Ltd (“Nippon Kayaku”) to market and distribute AnHeart’s lead investigational therapy, taletrectinib, in Japan.

Key Points: 
  • AnHeart Therapeutics (“AnHeart”), a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer, today announced it has entered into an exclusive license agreement with Nippon Kayaku Co., Ltd (“Nippon Kayaku”) to market and distribute AnHeart’s lead investigational therapy, taletrectinib, in Japan.
  • Taletrectinib is a next-generation ROS1 tyrosine kinase inhibitor (TKI) being developed for the treatment of ROS1-positive non-small cell lung cancer (NSCLC).
  • Nippon Kayaku will be responsible for regulatory approvals and commercialization of taletrectinib for ROS1-positive NSCLC in Japan, and will have rights to further develop taletrectinib for new indications in the region.
  • AnHeart will be responsible for the clinical development of taletrectinib for ROS1-positive NSCLC and for supplying taletrectinib to Nippon Kayaku for future commercialization purposes in Japan.

Drs. Susumu Kobayashi and Alexandre Reuben Announced as Recipients of EGFR Resisters/LUNGevity Research Award

Retrieved on: 
Wednesday, November 1, 2023

WASHINGTON, Nov. 1, 2023 /PRNewswire/ -- LUNGevity Foundation, the nation's leading lung cancer-focused nonprofit organization, is thrilled to announce the recipients of the EGFR Resisters/LUNGevity Research Award for EGFR-Positive Lung Cancer.

Key Points: 
  • WASHINGTON, Nov. 1, 2023 /PRNewswire/ -- LUNGevity Foundation, the nation's leading lung cancer-focused nonprofit organization, is thrilled to announce the recipients of the EGFR Resisters/LUNGevity Research Award for EGFR-Positive Lung Cancer.
  • "We are pleased to partner with LUNGevity again on patient-directed research to address the unmet needs of the EGFR-positive lung cancer community," said Kristen Kimball, patient advocate with the EGFR Resisters.
  • "This research focuses on a dreaded challenge that many patients will face during their treatment journey—drug resistance."
  • The recipients of the 2023 EGFR Resisters/LUNGevity Research Award for EGFR-Positive Lung Cancer are:
    Dr. Kobayashi and his team recently identified CD74, a novel gene that plays a critical role in the development of DPTCs.

AI-Powered Tumor Microenvironment Analysis Predicts Treatment Outcomes in NSCLC Patients with EGFR Mutation: Groundbreaking Studies to be Presented by Lunit at SITC 2023

Retrieved on: 
Wednesday, November 1, 2023

The study found that EGFR-TKI affects the immune landscape of EGFR-mutated NSCLC as higher PD-L1 expression and differential immune phenotypes.

Key Points: 
  • The study found that EGFR-TKI affects the immune landscape of EGFR-mutated NSCLC as higher PD-L1 expression and differential immune phenotypes.
  • Patients with an inflamed immune phenotype after EGFR-TKI treatment showed a more favorable response to subsequent immune checkpoint inhibitors (ICI) treatment.
  • Another study investigated the effect of tumor fragmentation index (TFI), the number of tumor fragments per total tumor area, in TME.
  • Visit Lunit's booth at SITC 2023 at Booth #227 to learn more about these pioneering studies.

First Immunotherapy Success in TKI-Resistant Lung Cancer Setting Demonstrates Power of AI-driven Immune Phenotyping by Lunit SCOPE IO - newly published in JCO

Retrieved on: 
Tuesday, October 24, 2023

Against the backdrop of growing interest and need for an AI biomarker in medical practices, this marks the second time a study utilizing Lunit SCOPE IO has been published in the prestigious JCO.

Key Points: 
  • Against the backdrop of growing interest and need for an AI biomarker in medical practices, this marks the second time a study utilizing Lunit SCOPE IO has been published in the prestigious JCO.
  • Lunit SCOPE IO, an AI-powered TIL analyzer for assessing immune phenotype from H&E, played a pivotal role in this research.
  • Immune phenotype as assessed by Lunit SCOPE IO showed predictive power in stratifying patients more likely to respond to ABCP treatment.
  • "We aim for Lunit SCOPE IO to continue to make immune phenotyping a quantitative biomarker readily accessible for research, clinical use, and companion diagnostics (CDx) business."

Avistone Announces Phase II Results for Vebreltinib, a c-Met Tyrosine Kinase Inhibitor (TKI) at the European Society for Clinical Oncology (ESMO) Congress

Retrieved on: 
Monday, October 23, 2023

METex14 is an independent prognostic factor associated with poorer survival rates in patients with NSCLC.

Key Points: 
  • METex14 is an independent prognostic factor associated with poorer survival rates in patients with NSCLC.
  • As of August 9, 2022, 113 patients were enrolled in the China study, among whom 52 patients had METex14 skipping mutations (Cohort 1).
  • Avistone is an oncology company focused on developing innovative therapies for patients with significant unmet medical needs globally.
  • Avistone has an extensive pipeline of targeted therapies including two clinical-stage drug candidates and several ongoing programs in the pre-clinical development stage.

AnHeart Therapeutics’ Investigational Medicine Taletrectinib Shrank Tumors in More Than 90 Percent of People With ROS1-Positive Non-Small Cell Lung Cancer Who Were ROS1 TKI Naïve in Global Pivotal TRUST-II Trial

Retrieved on: 
Saturday, October 21, 2023

Taletrectinib shrank tumors in 57% of patients who had previously been treated with a ROS1 TKI (TKI pre-treated).

Key Points: 
  • Taletrectinib shrank tumors in 57% of patients who had previously been treated with a ROS1 TKI (TKI pre-treated).
  • Taletrectinib also showed robust intracranial activity in the subgroup of patients with disease that had spread to the brain.
  • Median progression-free survival (IRC-assessed) was not reached for TKI naïve patients and was 11.7 months for TKI pre-treated patients, respectively.
  • In both trials, taletrectinib shrank tumors in almost every ROS1 TKI naïve person and more than half of people previously treated with a ROS1 TKI, and the responses were durable.