EGFR

Equillium Announces Positive Topline Data from the Type B Portion of the Phase 1b EQUALISE Study of Itolizumab in Lupus Nephritis

Retrieved on: 
Monday, April 1, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, EOS, Itolizumab, Week, S1P, Dialysis, Type, AMP, Exercise, Ono Pharmaceutical, Infection, Lymphocytopenia, Patient, Serum albumin, Peripheral edema, CD6, Lupus, EULAR, EGFR, Therapy, Proteinuria, ALC, Lupus nephritis, Nursing

Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced positive topline data from the Type B portion of the Phase 1b EQUALISE study evaluating itolizumab in lupus nephritis patients.

Key Points: 
  • Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced positive topline data from the Type B portion of the Phase 1b EQUALISE study evaluating itolizumab in lupus nephritis patients.
  • Key topline data from the Type B portion of the EQUALISE study in lupus nephritis:
    Subjects were highly proteinuric: baseline mean UPCR of 4.9 g/g.
  • Itolizumab treatment (over 6 months) was also associated with reductions in absolute lymphocyte counts (ALC), another known pharmacodynamic effect.
  • Two subjects had at least one serious adverse event, none of which were related to study treatment.

InnoCare Announces Dosing of First Patient in Clinical Study of the Combination of SHP2 Inhibitor ICP-189 and EGFR Inhibitor Furmonertinib

Retrieved on: 
Friday, March 29, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Lung cancer, EGFR, SRC, NSCLC, Patient, Breakthrough therapy, Trial of the century, DLT, Clinical trial, PACC, HKEX, FDA, SHP2, Food, Pharmaceutical industry

In July 2023, InnoCare and ArriVent BioPharma, Inc. (Nasdaq: AVBP) announced a clinical development collaboration, accelerating the clinical trial of ICP-189 in combination with furmonertinib in patients with advanced or metastatic NSCLC in China.

Key Points: 
  • In July 2023, InnoCare and ArriVent BioPharma, Inc. (Nasdaq: AVBP) announced a clinical development collaboration, accelerating the clinical trial of ICP-189 in combination with furmonertinib in patients with advanced or metastatic NSCLC in China.
  • Furmonertinib is being advanced by ArriVent in global studies in patients with advanced or metastatic NSCLC with EGFR mutations, including exon 20 insertion mutations.
  • Furmonertinib is also being evaluated for the treatment of NSCLC patients with EGFR P-loop alpha-c helix compressing (PACC) mutations.
  • We will accelerate the clinical study and expect this innovative therapy to benefit more NSCLC patients early.”

Iambic Therapeutics to Present New Pre-Clinical Data for IAM1363, a Selective and Brain-Penetrant Inhibitor of Both HER2 Wild-Type and Oncogenic Mutants, at the 2024 AACR Annual Meeting

Retrieved on: 
Thursday, March 28, 2024
Science, Research, Pharmaceutical, Oncology, Health, Artificial Intelligence, Technology, Clinical Trials, HER2, Trial of the century, EGFR, AACR, Neoplasm, Therapy, Safety

Iambic Therapeutics today announced it will highlight new preclinical data for IAM1363, a selective and brain-penetrant inhibitor of HER2 signaling for the treatment of HER2-driven cancers, in a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 5-10 in San Diego.

Key Points: 
  • Iambic Therapeutics today announced it will highlight new preclinical data for IAM1363, a selective and brain-penetrant inhibitor of HER2 signaling for the treatment of HER2-driven cancers, in a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 5-10 in San Diego.
  • The poster presentation will showcase preclinical data illustrating how the unique binding mechanism and potent HER2 activity of IAM1363 overcomes multiple resistance mechanisms and how its strong EGFR avoidance widens the safety margin.
  • IAM1363 potently inhibits both the wild type and mutant forms of HER2, showing over 1000-fold selectivity against EGFR due to a unique binding mode and tumor enhancement not seen with other HER2 inhibitors, leading to exceptional in vivo efficacy and tolerability in various HER2-driven cancer models, including those resistant to existing HER2-targeting agents.
  • IAM1363 is now in a Phase 1 clinical study .

Iambic Therapeutics Announces First Patient Dosed in Phase 1 Clinical Study of IAM1363, a Highly Selective HER2 Inhibitor for the Treatment of Solid Tumors

Retrieved on: 
Wednesday, March 27, 2024
Oncology, Health, Technology, Health Technology, Clinical Trials, Artificial Intelligence, Biotechnology, Penetrance, HER2, Toxicity, Automation, EGFR, Trastuzumab, Therapeutic index, Brain, Disease, Central nervous system, Patient, CNS, Trial of the century, Therapy, Cancer, Pharmacokinetics, Machine learning, Pharmaceutical industry

Iambic Therapeutics, a biotechnology company developing novel therapeutics using its unique AI-driven discovery platform, today announced that the first patient has been dosed in its Phase 1 clinical study evaluating IAM1363, a selective and brain-penetrant inhibitor of HER2 signaling for the treatment of HER2-driven cancers.

Key Points: 
  • Iambic Therapeutics, a biotechnology company developing novel therapeutics using its unique AI-driven discovery platform, today announced that the first patient has been dosed in its Phase 1 clinical study evaluating IAM1363, a selective and brain-penetrant inhibitor of HER2 signaling for the treatment of HER2-driven cancers.
  • In HER2 tumor models, including intracranial tumor models, IAM1363 has demonstrated favorable efficacy and tolerability compared to benchmark tyrosine kinase inhibitors and HER2-targeted antibody-drug conjugates.
  • “For the patients I see in clinic there remains a significant need to improve therapies for HER2-driven cancers.
  • IAM1363 is a promising agent because of its potency and selectivity for HER2, and its ability to readily cross the blood brain barrier.

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.

Alpine Immune Sciences Provides Corporate Update and Full Year 2023 Financial Results

Retrieved on: 
Monday, March 18, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Research program, Administration, Congress, Development, WT, Lupus, Patient, Immunoglobulin A, Glomerular filtration rate, SLE, Inflammation, MD, UPCR, Neonatal Fc receptor, American College, Investment, Clinical trial, Society, EGFR, Nephrology, BAFF, Proteinuria, Immunoglobulin G, Autoimmunity, ALPN, Pharmaceutical industry

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today reported full year 2023 financial results and company highlights for the fourth quarter ended December 31, 2023.

Key Points: 
  • Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today reported full year 2023 financial results and company highlights for the fourth quarter ended December 31, 2023.
  • “2023 was a transformational year for Alpine, with initial IgA nephropathy (IgAN) data presented at the American Society of Nephrology Kidney Week 2023 suggesting a best-in-class profile for povetacicept, our next-generation dual BAFF/APRIL inhibitor.
  • In addition, povetacicept was well tolerated during subcutaneous administration, with no instances of IgG
  • Net Loss: Net loss for the year ended December 31, 2023, was $32.2 million compared to $57.8 million for the same period in 2022.

Azitra, Inc. Announces Full Year 2023 Financial Results and Provides Business Updates

Retrieved on: 
Friday, March 15, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, Genetics, Clinical Trials, Other Health, Prevalence, Administration, EGFR, Ichthyosis, Joint, Patient, Netherton syndrome, G&A, Cancer, IND, Rash, Bayer, Clinical trial, Research and development, Skin, BTK, Patent, FDA, Chemotherapy, Pharmaceutical industry

Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the full year ended December 31, 2023, and provided a business update.

Key Points: 
  • Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the full year ended December 31, 2023, and provided a business update.
  • Completed and filed post-IND, FDA commitments for characterization of drug substance and drug product for ATR-12.
  • Selected and hired clinical research organization for ATR-12 clinical trial and selected initial clinical sites for activation.
  • Net Loss was $11.3 million for the year ended December 31, 2023, compared to $10.7 million for the comparable period in 2022.

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.

Aethon Therapeutics Announces Collaboration with Revolution Medicines to Discover and Develop Novel Aethon Antibody Programs

Retrieved on: 
Thursday, April 4, 2024
Partner, EGFR, Oncogene, Partnership, RAS, Patient, Research, Aethon, Publication, Neoplasm, Therapy, BTK, Immune system, Apple tree, Pharmaceutical industry

NEW YORK, April 4, 2024 /PRNewswire/ -- Aethon Therapeutics, Inc., a biotechnology company discovering and developing novel antibody therapeutics designed to attack cancer cells in tandem with targeted covalent inhibitor cancer therapies, today announced that it has entered into a collaboration agreement with Revolution Medicines, Inc., a clinical-stage oncology company developing targeted therapies for patients with RAS-addicted cancers. Under the terms of the agreement, Aethon will use its HapImmune™ platform to discover novel bispecific antibodies to mount an immune attack directed towards cancer cells hit by Revolution Medicines' RAS(ON) inhibitors, with the goal of fueling tumor clearance and helping to establish immune memory.

Key Points: 
  • The terms of the agreement provide for a multi-year collaboration under which Aethon is responsible for conducting preclinical work, with full reimbursement by Revolution Medicines.
  • Revolution Medicines has an option to conduct any clinical development of products that may arise from the collaboration.
  • The arrangement provides for both upfront and potential downstream payments covering future development and commercialization activities should Revolution Medicines exercise its option.
  • Beyond the programs being advanced in partnership with Revolution Medicines, Aethon has additional programs targeting validated covalent small molecules that inhibit RAS, EGFR, and BTK.

Lutris Pharma Appoints Life Sciences and Pharmaceutical Entrepreneur Moshe "Mori" Arkin to Its Board of Directors

Retrieved on: 
Monday, April 1, 2024
Culture, EGFR, Organization, Philosophy, Education, History, Patient, Orphan, Left–right political spectrum, Growth factor, Acquisition, Perrigo, Quality of life, Psychology, Drug development, TEL, Food, Pharmaceutical industry

TEL AVIV, Israel, April 1, 2024 /PRNewswire/ -- Lutris Pharma , a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing dose limiting side effects, today announced the appointment Moshe "Mori" Arkin, a life sciences and pharmaceutical entrepreneur, and Founder and Chairman of Arkin Holdings, to its Board of Directors.

Key Points: 
  • TEL AVIV, Israel, April 1, 2024 /PRNewswire/ -- Lutris Pharma , a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing dose limiting side effects, today announced the appointment Moshe "Mori" Arkin, a life sciences and pharmaceutical entrepreneur, and Founder and Chairman of Arkin Holdings, to its Board of Directors.
  • "Mori is one of Israel's most successful life sciences and pharmaceutical entrepreneurs with an extraordinary background spanning decades in the industry," stated Antoni Ribas, M.D., Ph.D., Chairman and Founder of Lutris Pharma.
  • "Arkin Bio Ventures has been an investor in Lutris Pharma since its inception and has been a steadfast supporter of the Company, ever since.
  • In 2011, they formed the Arkin Family Foundation, which supports organizations and projects in education, arts and culture, welfare, healthcare, civil rights, and Jewish-Arab coexistence.