TKI

Summit Therapeutics Reports Financial Results and Operational Progress for the First Quarter Ended March 31, 2024

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Wednesday, May 1, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Doctor of Philosophy, PFS, Paranal Observatory, Table, License, Summit, Investment, ELCC, Progression-free survival, Research, Intraparenchymal hemorrhage, Immunotherapy, Trial of the century, Webcast, Cohort, Forecasting, PD-1, NGS, TKI, Patient, GRAIL, Brain, SMMT, Neoplasm, EGFR, VEGF, GAAP, Royal institute, Neuro, Lung cancer, Pharmaceutical industry

Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today reports its financial results and provides an update on its operational progress for the first quarter ended March 31, 2024.

Key Points: 
  • Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today reports its financial results and provides an update on its operational progress for the first quarter ended March 31, 2024.
  • In January 2024, followed by a presentation at ELCC 2024 in March 2024, Akeso announced updates from its Phase II AK112-201 trial data.
  • Also at ELCC 2024, Summit and Akeso highlighted promising ivonescimab Phase II data in NSCLC patients with brain metastases.
  • Operating cash outflow for the three months ended March 31, 2024 and 2023 was $30.1 million and $13.1 million, respectively.

Enliven Therapeutics Announces Positive Proof of Concept Data from Phase 1 Clinical Trial of ELVN-001 in Chronic Myeloid Leukemia

Retrieved on: 
Thursday, April 11, 2024
Patient, BCR, Safety, MMR, TKI, CML, Caregiver, Second generation, Therapy, Acute leukemia, Pharmaceutical industry

BOULDER, Colo., April 11, 2024 (GLOBE NEWSWIRE) -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage precision oncology company focused on the discovery and development of next-generation small molecule kinase inhibitors, today announced positive proof of concept data from the Phase 1 clinical trial evaluating ELVN-001 in patients with chronic myeloid leukemia (CML) who are relapsed, refractory, or intolerant to available tyrosine kinase inhibitors (TKIs) (NCT05304377).

Key Points: 
  • "Similar to our experience with previous successful Phase 1 trials in CML, ELVN-001 looks promising.
  • The preliminary data support that ELVN-001 is a potent and highly selective BCR::ABL1 inhibitor that has activity in heavily pre-treated patients, including post-asciminib patients."
  • “We are thrilled with ELVN-001’s initial Phase 1 data in heavily pre-treated patients with CML,” said Sam Kintz, Co-founder and Chief Executive Officer of Enliven.
  • The discussion will cover details of ELVN-001’s Phase 1 initial proof of concept data, the evolving treatment paradigm in CML, and how ELVN-001 could fit into the CML landscape.

Innovent to Present Clinical Data of Multiple Novel Molecules at the 2024 ASCO Annual Meeting

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Thursday, April 25, 2024
HKEX, Abstract, Spacecraft, ROS1, ASCO, TKI, Senior, ADC, Patient, Society, Ophthalmology, SAN, Pharmaceutical industry

SAN FRANCISCO and SUZHOU, China, April 24, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that about 20 accepted abstracts of clinical data from multiple trials in relation to multiple novel mono-/bi-specific antibodies and antibody-drug-conjugates (ADCs) as well as innovative drugs including TYVYT® (sintilimab injection), olverembatinib, taletrectinib (ROS1 TKI) from its oncology pipeline will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024 from May 31 to June 4, 2024, in Chicago, IL, U.S..

Key Points: 
  • SAN FRANCISCO and SUZHOU, China, April 24, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that about 20 accepted abstracts of clinical data from multiple trials in relation to multiple novel mono-/bi-specific antibodies and antibody-drug-conjugates (ADCs) as well as innovative drugs including TYVYT® (sintilimab injection), olverembatinib, taletrectinib (ROS1 TKI) from its oncology pipeline will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024 from May 31 to June 4, 2024, in Chicago, IL, U.S..
    Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are very pleased to present a robust set of clinical data for our next-generation innovative bispecific antibodies and ADC molecules for the first time at the 2024 ASCO Annual Meeting.
  • We observed the preliminary efficacy and safety signals for those innovative candidates, underscoring their potential for further development and clinical value.
  • As one of the few biopharmaceutical companies with both the technology platforms and robust pipeline in "IO+ADC" areas, Innovent will continue to make breakthroughs in the field of cancer treatment, and is committed to providing doctors and patients with more innovative, effective and safe treatment options."
  • Details on the abstracts are listed below:

Black Diamond Therapeutics Presents Novel Real-World Evidence of the Evolving EGFR Mutation Landscape in NSCLC and the Opportunity for BDTX-1535 in an Oral Presentation at the 2024 American Association of Cancer Research Annual Meeting

Retrieved on: 
Sunday, April 7, 2024
Diamond, EGFR, Helmy Eltoukhy, Mutation, Prevalence, NSCLC, Survival, Foundation Medicine, Patient, Cancer, Lung cancer, AACR, PACC, TKI, Drug resistance, MD Anderson Cancer Center, Associate professor

CAMBRIDGE, Mass., April 07, 2024 (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 cancer, presented real-world evidence of the evolving epidermal growth factor receptor (EGFR) mutation landscape in non-small cell lung cancer (NSCLC), and the potential of BDTX-1535 to address a broader range of mutations compared to existing therapies. The results were disclosed in an oral presentation on April 7, 2024, at the 2024 American Association of Cancer Research (AACR) Annual Meeting held in San Diego, California.

Key Points: 
  • The results were disclosed in an oral presentation on April 7, 2024, at the 2024 American Association of Cancer Research (AACR) Annual Meeting held in San Diego, California.
  • The analyses reveal a broad spectrum of non-classical mutations, as well as an increased prevalence of the acquired resistance mutation, C797S.
  • The compound also potently inhibits the drug resistance C797S mutation, which emerges following treatment with third-generation EGFR inhibitors, including osimertinib.
  • Black Diamond is currently advancing BDTX-1535 in a Phase 2 trial for patients with EGFRm NSCLC across multiple lines of therapy.

Clearside Biomedical Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

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Tuesday, March 12, 2024
Patient, G&A, BioCryst Pharmaceuticals, Eye, Drug delivery, Clinical trial, AAO, Extension, Webcast, Pharming, CPT, Safety, Disease, SPA, American Academy of Ophthalmology, Compass, Insurance, Diabetic retinopathy, Conference call, Aura, AMD, TKI, CLS, FDA, Administration, Conference, SCS, DME, American Academy, OASIS, Injection, Research and development, Axitinib, Pharmaceutical industry

ALPHARETTA, Ga., March 12, 2024 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), today reported financial results for the fourth quarter and year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • License Revenue: License and other revenue for the fourth quarter of 2023 was $6.3 million, compared to $0.3 million for the fourth quarter of 2022.
  • Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2023 were $6.3 million, compared to $5.0 million for the fourth quarter of 2022.
  • General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2023 were $2.9 million, compared to $3.2 million for the fourth quarter of 2022.
  • Other Expense: Non-cash interest expense for the fourth quarter of 2023 was $2.3 million, compared to $2.0 million for the fourth quarter of 2022.

Promising Intracranial Anti-Tumor Activity and Safety Data for Ivonescimab in NSCLC Patients with Brain Metastases Featured at ELCC 2024

Retrieved on: 
Friday, March 22, 2024
Research, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Oncology, SMMT, Intraparenchymal hemorrhage, Sun, EGFR, Central European Time, Metastasis, ELCC, Progression-free survival, Anaplastic lymphoma kinase, Constipation, Brain, Drug, HKEX, Safety, Anemia, Phase, Summit, TKI, Time in Europe, PFS, ALK, Pharmaceutical industry

The first poster, “Intracranial Activity of Ivonescimab Alone or in Combination with Platinum Doublet Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases” includes data from patients with asymptomatic brain metastases at baseline.

Key Points: 
  • The first poster, “Intracranial Activity of Ivonescimab Alone or in Combination with Platinum Doublet Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases” includes data from patients with asymptomatic brain metastases at baseline.
  • This analysis consisted of the 35 patients with advanced or metastatic NSCLC who had asymptomatic brain metastases at baseline; 28 patients were treated with ivonescimab plus chemotherapy in AK112-201, and seven patients were treated with monotherapy ivonescimab in AK112-202.
  • Patients across both cohorts experienced an intracranial response rate of 34%, and eight patients (23%) experienced a complete response by RANO criteria.
  • The most frequent TEAEs were anemia and decreased neutrophil counts in squamous patients and anemia and constipation in non-squamous patients.

Takeda Announces U.S. FDA Approval of Supplemental New Drug Application (sNDA) for ICLUSIG® (ponatinib) in Adult Patients with Newly Diagnosed Ph+ ALL

Retrieved on: 
Tuesday, March 19, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, AP, Mutation, BP, Disease, New Drug Application, Patient, ALL, Shanda, CML, MD, University, MD Anderson Cancer Center, Priority review, MRD, CP, TKI, Glomus tumor, Food, Pharmaceutical industry

Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ICLUSIG® (ponatinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ICLUSIG® (ponatinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.
  • This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
  • ICLUSIG is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML.

Bristol Myers Squibb Announces CheckMate -9DW Trial Evaluating Opdivo (nivolumab) Plus Yervoy (ipilimumab) Meets Primary Endpoint of Overall Survival for the First-Line Treatment of Advanced Hepatocellular Carcinoma

Retrieved on: 
Wednesday, March 20, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, HCC, Bristol Myers Squibb, OS, BMY, TKI, Ipilimumab, Patient, Checkmate, Sorafenib, Immunotherapy, Survival, Nivolumab, Pharmaceutical industry

The dual immunotherapy combination of Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in OS compared to investigator’s choice of sorafenib or lenvatinib.

Key Points: 
  • The dual immunotherapy combination of Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in OS compared to investigator’s choice of sorafenib or lenvatinib.
  • The safety profile for the combination of Opdivo plus Yervoy remained consistent with previously reported data and was manageable with established protocols, with no new safety signals identified.
  • “Advanced stage liver cancer patients remain in need of additional treatment options that may help improve survival,” said Dana Walker, M.D., M.S.C.E., vice president, global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb.
  • Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -9DW clinical trial.

Intracranial Anti-Tumor Activity and Safety of Ivonescimab in NSCLC Patients with Brain Metastases to be Featured at ELCC 2024

Retrieved on: 
Thursday, March 14, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, SMMT, Sun, EGFR, Central European Time, ELCC, NSCLC, Anaplastic lymphoma kinase, Drug, HKEX, Safety, Phase, Summit, TKI, Time in Europe, ALK, Pharmaceutical industry

Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, will be presented at the 2024 European Lung Cancer Congress (ELCC 2024) in Prague, Czech Republic.

Key Points: 
  • Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, will be presented at the 2024 European Lung Cancer Congress (ELCC 2024) in Prague, Czech Republic.
  • Two posters featuring updated ivonescimab data will be displayed on Friday, March 22 from 12:00 to 12:45pm Central European Time.
  • The first poster, “Intracranial Activity of Ivonescimab Alone or in Combination with Platinum Doublet Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases” includes data from patients with asymptomatic brain metastases at baseline.
  • These patients were enrolled in either AK112-202 (NCT04900363), in which ivonescimab is delivered as monotherapy, or AK112-201 (NCT04736823), in which ivonescimab is delivered in combination with platinum doublet chemotherapy, both of which are Phase II clinical trials for patients with advanced or metastatic NSCLC.

BIO-TECHNE RECEIVES EUROPEAN IVDR CERTIFICATION FOR DIAGNOSTIC TEST TO MONITOR CHRONIC MYELOID LEUKEMIA

Retrieved on: 
Friday, March 22, 2024
Certification, Acute leukemia, Kit, BCR-ABL, Patient, CML, Class, Bio-Techne, Sale, Cancer, IVDR, Diagnosis, Workflow, ABL1, Safety, Liquid biopsy, TKI, Physician, IVDD, Medical device

MINNEAPOLIS, March 22, 2024 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced that Asuragen, part of Bio-Techne's Molecular Diagnostics Division, has completed the Class C Certification under the new European Union In Vitro Diagnostic Regulation (IVDR) for its QuantideX® qPCR BCR-ABL IS Kit. Previously, the kit was CE-IVD marked for sale in the EU in compliance with the In Vitro Diagnostic Directive (IVDD), which has now been replaced by the IVDR.

Key Points: 
  • Previously, the kit was CE-IVD marked for sale in the EU in compliance with the In Vitro Diagnostic Directive (IVDD), which has now been replaced by the IVDR.
  • The QuantideX qPCR BCR-ABL IS Kit gives labs a robust and reliable tool for monitoring chronic myeloid leukemia (CML) patients.
  • The highly sensitive qPCR-based in vitro diagnostic test quantifies BCR-ABL1 and ABL1 transcripts in blood samples from patients with CML to determine their response to tyrosine kinase inhibitor (TKI) therapy.
  • CML patients must undergo regular monitoring to ensure that they continue to receive the most appropriate treatment for their cancer.