Tyrosine kinase receptors

HUTCHMED announces savolitinib approved in China for patients with lung cancer with MET exon 14 skipping alterations

Retrieved on: 
Tuesday, June 22, 2021

Approximately 2-3% of newly diagnosed NSCLC patients have MET exon skipping 14 alterations, a specific genetic mutation.

Key Points: 
  • Approximately 2-3% of newly diagnosed NSCLC patients have MET exon skipping 14 alterations, a specific genetic mutation.
  • Savolitinib is an oral, potent and selective MET TKI that has demonstrated clinical activity in advanced solid tumors.
  • It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations).
  • HUTCHMED is responsible for the manufacturing and supply of savolitinib, and AstraZeneca is responsible for its commercialization in China and worldwide.

First Patient Dosed in Phase II Basket Trial of Taletrectinib for Solid Tumors with NTRK Fusion

Retrieved on: 
Friday, June 18, 2021

(AnHeart), a clinical stage oncology company focused on underserved patients in global markets, today announced that the first patient has been dosed in a Phase II basket trial of taletrectinib for solid tumors containing NTRK fusions ( NCT04617054 ).

Key Points: 
  • (AnHeart), a clinical stage oncology company focused on underserved patients in global markets, today announced that the first patient has been dosed in a Phase II basket trial of taletrectinib for solid tumors containing NTRK fusions ( NCT04617054 ).
  • Building upon the promising preliminary results in the Phase II trial for non-small cell lung cancer (NSCLC) with ROS1 fusions, we are moving forward with the Phase II trial of taletrectinib for NTRK fusion-driven solid tumors, said Bing Yan, MD, Co-founder and Chief Medical Officer of AnHeart.
  • We are very pleased to see that our partner AnHeart is advancing the Phase II trial of taletrectinib in NTRK fusion-driven solid tumors.
  • More information about the ongoing TRUST (Taletrectinib ROS1 LUng STudy) trial in ROS1 fusion positive NSCLC and the ongoing basket trial in NTRK fusion positive solid tumors of taletrectinib may be found by searching clinical trial identifiers NCT04395677 and NCT04617054, respectively at https://clinicaltrials.gov .

BerGenBio (BGBIO): FDA grants fast track designation

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Wednesday, June 16, 2021

FDA has granted bemcentinib fast track designation in combination with an anti-PD-L1 agent for the treatment of AXL-positive advanced/metastatic NSCLC patients (without driver mutations) who have progressed following first-line treatment.

Key Points: 
  • FDA has granted bemcentinib fast track designation in combination with an anti-PD-L1 agent for the treatment of AXL-positive advanced/metastatic NSCLC patients (without driver mutations) who have progressed following first-line treatment.
  • Notably durable responses were observed in the relapsed AML setting (ORR of 31%; 5/16) and median overall survival of 13.3 months (data still immature).
  • About Edison: Edison is a leading research and investor relations consultancy, connecting listed companies to the widest pool of global investors.
  • Having been the first in-market 17 years ago, Edison now has more than 100 analysts covering every economic sector.

Ryvu Therapeutics Presents Positive Phase I Data for RVU120 at the Virtual 26th Annual Congress of the European Hematology Association. Phase I/II Data for SEL24 (MEN1703) presented by development partner Menarini

Retrieved on: 
Friday, June 11, 2021

The data presented at EHA 2021 covers the first four dose cohorts, in which RVU120 demonstrated favorable safety and PK profile.

Key Points: 
  • The data presented at EHA 2021 covers the first four dose cohorts, in which RVU120 demonstrated favorable safety and PK profile.
  • In vitro data demonstrate that RVU120 can induce erythroid cells to differentiate and therefore rescue anemia inpreclinical models.
  • SEL24 (MEN1703), a first-in-class, orally available, dual PIM/FLT3 kinase inhibitor discovered and initially developed by Ryvu Therapeutics and licensed to the Menarini Group.
  • Ryvu is listed on the main market of the Warsaw Stock Exchange, and is a component of sWIG80 index.

Bergenbio Presents Encouraging Updated Preliminary Data From Phase Ii Study In Relapsed Aml Patients At Eha Virtual Meeting

Retrieved on: 
Friday, June 11, 2021

An update will be provided from an expansion cohort of 27 relapsed/refractory AML patients, who were assessed to explore safety and efficacy together with translational analysis.

Key Points: 
  • An update will be provided from an expansion cohort of 27 relapsed/refractory AML patients, who were assessed to explore safety and efficacy together with translational analysis.
  • The data indicate that the combination of bemcentinib, a once-daily oral AXL-inhibitor and LDAC is efficacious and well tolerated in the elderly and unfit relapsed AML population.
  • Ongoing dialogue continues with the FDA and EMA regulatory agenciesto align on a pathway for apivotalregistration trial for the combination ofbemcentinibandLDAC in relapsed elderly AML patients unfit for intensive chemotherapy.
  • Data from a Phase II in human clinical trial has shown that treatment with AXL inhibitor bemcentinib increased the rate ventilator free survival in hospitalised COVID-19 patients.

Bergenbio Presents Encouraging Updated Preliminary Data From Phase Ii Study In Relapsed Aml Patients At Eha Virtual Meeting

Retrieved on: 
Friday, June 11, 2021

An update will be provided from an expansion cohort of 27 relapsed/refractory AML patients, who were assessed to explore safety and efficacy together with translational analysis.

Key Points: 
  • An update will be provided from an expansion cohort of 27 relapsed/refractory AML patients, who were assessed to explore safety and efficacy together with translational analysis.
  • The data indicate that the combination of bemcentinib, a once-daily oral AXL-inhibitor and LDAC is efficacious and well tolerated in the elderly and unfit relapsed AML population.
  • Ongoing dialogue continues with the FDA and EMA regulatory agenciesto align on a pathway for apivotalregistration trial for the combination ofbemcentinibandLDAC in relapsed elderly AML patients unfit for intensive chemotherapy.
  • Data from a Phase II in human clinical trial has shown that treatment with AXL inhibitor bemcentinib increased the rate ventilator free survival in hospitalised COVID-19 patients.

Cullinan Oncology Receives Investigational New Drug (IND) Clearance from the FDA for CLN-049, a FLT3 x CD3 Bispecific Antibody for the Treatment of Relapsed/Refractory AML

Retrieved on: 
Monday, June 7, 2021

IND clearance by the FDA paves the way to test a differentiated treatment approach by targeting extracellular FLT3, an oncogenic driver in AML, stated Patrick Baeuerle, Cullinans Chief Scientific Officer, Biologics.

Key Points: 
  • IND clearance by the FDA paves the way to test a differentiated treatment approach by targeting extracellular FLT3, an oncogenic driver in AML, stated Patrick Baeuerle, Cullinans Chief Scientific Officer, Biologics.
  • We are excited to initiate human dosing of CLN-049, a T cell-engaging, IgG-like antibody in patients with relapsed/refractory AML.
  • CLN-049is a humanized bispecific antibody being developed for relapsed/refractory AML.
  • In preclinical studies, CLN-049led to potent FLT3-dependent killing of leukemic cellsin vitroat a wide range of FLT3 expression levels on AML cells.

C4 Therapeutics Presents Pre-clinical Data on CFT8919, A Selective Degrader of EGFR L858R, at Keystone Symposium on Targeted Protein Degradation

Retrieved on: 
Monday, June 7, 2021

We are excited to share strong preclinical data that establishes CFT8919 as a potent and selective degrader of EGFR L858R, a mutation responsible for more than a third of mutant EGFR lung cancer diagnoses.

Key Points: 
  • We are excited to share strong preclinical data that establishes CFT8919 as a potent and selective degrader of EGFR L858R, a mutation responsible for more than a third of mutant EGFR lung cancer diagnoses.
  • Across our portfolio, we see the potential for targeted protein degradation to transform patient care.
  • CFT8919 does not induce degradation of known cereblon neo-substrates SALL4 or GSPT1, indicating that the potential associated toxicities will not be liabilities.
  • Additionally, in vivo data demonstrates the following:
    CFT8919 degrades and inhibits mutant EGFR in tumors upon oral administration.

AnHeart and Innovent Releases Preliminary Results from the Phase II TRUST Trial of Taletrectinib in ROS1 Fusion Positive NSCLC at the ASCO 2021 Annual Meeting

Retrieved on: 
Monday, June 7, 2021

The results were as follows:

Key Points: 
  • The results were as follows:
    In the crizotinib pre-treated patients (n=5), the ORR was 60% (3/5); and the DCR was 100% (5/5).
  • Our team is highly focused on completing patient enrollment for this phase II TRUST trial in Q3 2021, said Bing Yan, MD, Co-founder and Chief Medical Officer of AnHeart.
  • We sincerely thank the patients, their families and investigators in the TRUST trial and look forward to bringing taletrectinib to all ROS1 fusion positive patients in the near future upon approval.
  • Taletrectinib has shown good efficacy and safety results, which offers hope to patients with ROS1 fusion positive non-small cell lung cancer."

InnoCare Presents Latest Clinical Data of pan-FGFR Inhibitor Gunagratinib at the 2021 ASCO Annual Meeting

Retrieved on: 
Friday, June 4, 2021

InnoCare (HKEX: 09969), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, presented the latest clinical data for the pan-FGFR inhibitor gunagratinib today at the 2021 American Society of Clinical Oncology (ASCO) annual meeting.

Key Points: 
  • InnoCare (HKEX: 09969), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, presented the latest clinical data for the pan-FGFR inhibitor gunagratinib today at the 2021 American Society of Clinical Oncology (ASCO) annual meeting.
  • This is the first time InnoCare has presented gunagratinibs clinical data at an international academic conference, showing good safety and tolerability.
  • ICP-192 (gunagratinib), developed by InnoCare Pharma, is a novel pan-FGFR (fibroblast growth factor receptors) inhibitor that potently and selectively inhibits FGFR activities irreversibly by covalent binding.
  • The 2021 ASCO Annual Meeting will be held online from June 4th to 8th, 2021.