Pharmacodynamics

Molecular Templates, Inc. Provides Interim Update

Retrieved on: 
måndag, juni 3, 2024
Therapy, IC50, ETB, B cell, Patient, Neck, Cancer, HNSCC, NSCLC, Pharmacodynamics, Tumor microenvironment, CPS, Hematology, COVID, FC, Head, Lung cancer, Plasma cell, PET, CD38, DSM-IV codes, Immunosuppression, Neoplasm, Vaccine

AUSTIN, Texas, June 03, 2024 (GLOBE NEWSWIRE) -- Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates,” or “MTEM”), a clinical-stage company focused on the discovery and development of targeted biologic therapeutics with unique mechanisms of action (engineered toxin bodies or “ETBs”) for cancer and immune-mediated disease, today provided an update on its clinical-stage programs.

Key Points: 
  • AUSTIN, Texas, June 03, 2024 (GLOBE NEWSWIRE) -- Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates,” or “MTEM”), a clinical-stage company focused on the discovery and development of targeted biologic therapeutics with unique mechanisms of action (engineered toxin bodies or “ETBs”) for cancer and immune-mediated disease, today provided an update on its clinical-stage programs.
  • Two heavily pre-treated patients with low PD-L1 expressing squamous cell carcinoma of the head and neck (HNSCC) had achieved partial responses with MT-6402 monotherapy.
  • These patients remain in response and in good clinical condition, continuing treatment in cycles 21 and 12 (one cycle = 4 weeks), respectively.
  • In addition, four of the HNSCC patients treated with MT-6402 had stable disease with two showing tumor reduction.

Kymera Therapeutics to Present New Clinical Data from Ongoing Phase 1 Trial of MDM2 Degrader KT-253 at ASCO Annual Meeting

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torsdag, maj 23, 2024
Uveal melanoma, Patient, Headache, DL2, Carcinoma, Plasma, Acute myeloid leukemia, PD, Thrombocytopenia, Toxicity, ACC, Nausea, Black Majesty, Messenger, Pharmacodynamics, Therapy, Grade 3, Safety, Acute lymphoblastic leukemia, Arm, CDKN1A, MD, Blood, AML, Efficacy, MPN, ALL, Biomarker, ASCO, Șaeș, MDM2, Fatigue, Poster, Society, TPD, Adenoid cystic carcinoma, Aes, Merkel-cell carcinoma, Resource, Vomiting, MCC, DLT, Annual general meeting, Pharmaceutical industry

WATERTOWN, Mass., May 23, 2024 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today announced new clinical data for KT-253, a first-in-class MDM2 degrader, from its ongoing Phase 1 dose escalation trial will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 31 – June 4, 2024, in Chicago, Illinois. Results released in an ASCO abstract today include a data cut-off of January 26, 2024.

Key Points: 
  • Results released in an ASCO abstract today include a data cut-off of January 26, 2024.
  • “We continue to see encouraging data from the trial’s dose escalation phase demonstrating potent upregulation of p53 biomarkers and signs of antitumor activity in patients.
  • The Company expects to complete the study and share additional clinical data to inform the program’s next development steps in 2024 at an upcoming medical meeting.
  • Kymera is also developing a biomarker-based patient selection strategy for subsequent development beyond Phase 1a and is expected to present data at a medical meeting this year.

Purple Biotech Reports First Quarter 2024 Financial Results

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tisdag, maj 21, 2024
Net, Risk, Tumor microenvironment, SCCHN, FDA, Pancreatic cancer, CA19-9, Oncology, Randomness, NK, Escape Room, Recurrence, AACR, Cancer, STAT3, Table, B cell, Administration, Phase II, PDAC, Average cost, Neoplasm, Safety, Jefferies Group, NSCLC, ADS, Interim, ASCO, Poster, International, Society, Drug resistance, SAB, IGF1R, Nivolumab, Cetuximab, DCR, Patient, Quarter, Pharmacodynamics, Death, Efficacy, CM24, Biomarker, SOC, Annual general meeting, Pharmaceutical industry

REHOVOT, Israel, May 21, 2024 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, today announced financial results for the three months ended March 31, 2024.

Key Points: 
  • REHOVOT, Israel, May 21, 2024 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, today announced financial results for the three months ended March 31, 2024.
  • Financial Results for the Quarter Ended March 31, 2024
    Research and Development Expenses were $3.4 million for the three months ended March 31, 2024, a decrease of $0.1 million, or 2.8%, compared to $3.5 million in the same period of 2023.
  • As of March 31, 2024, Purple Biotech had cash and cash equivalents and short-term deposits of $10.8 million.
  • A reconciliation of certain IFRS to non-IFRS financial measures has been provided in the tables included in this press release.

At278 Ultra-Concentrated Ultra-Rapid Acting Insulin Demonstrates Superiority in Phase i Clinical Trial in Overweight and Obese People With Type 2 Diabetes

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måndag, maj 20, 2024
Randomness, Patient, Diabetes, PD, Insulin aspart, Type 1, US3, BST, AIM, Clinical trial, Trial of the century, Pharmacodynamics, Absorption, Medical school, Type 2 diabetes, Pharmacokinetics, Insulin, Type 1 diabetes, Division, Injection, Blood, Internal medicine, Metabolism, BMI, Physician, AREC, Pharmaceutical industry

With no concentrated (>200 U/mL), rapid acting insulins on the market, AT278 has potential to be the first, and only, insulin available to the growing number of patients with high daily insulin requirements.

Key Points: 
  • With no concentrated (>200 U/mL), rapid acting insulins on the market, AT278 has potential to be the first, and only, insulin available to the growing number of patients with high daily insulin requirements.
  • They further add to the positive results from our previous clinical study in Type 1 diabetic patients, where superiority was also demonstrated.
  • AT278 has the potential to be the only highly concentrated, ultra-rapid acting insulin to enable the next generation of miniaturised, longer wear insulin pumps.
  • Pharmacokinetics and Pharmacodynamics of a Novel U500 Insulin Aspart Formulation: A Randomized, Double-Blind, Crossover Study in People With Type 1 Diabetes Care 2023;46(4):757–764: https://doi.org/10.2337/dc22-1054

Immutep Presents Data from Safety Lead-in Phase of AIPAC-003 at ESMO Breast 2024

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onsdag, maj 15, 2024
ASX, Patient, CD4, Plasma, MBC, Pharmacodynamics, Safety, Autoimmune disease, RECIST, IMM, Poster, Congress, Blood, CDK, Cancer, Eftilagimod alpha, MHC, Paclitaxel, ESMO, Oncology, CD8, TNBC, Gamma ray, MHC class II, Pharmaceutical industry

SYDNEY, AUSTRALIA, May 15, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces encouraging efficacy, safety, and pharmacodynamic data from the safety lead-in of the AIPAC-003 Phase II/III trial presented at the European Society for Medical Oncology (ESMO) Breast Cancer 2024 Congress. This lead-in represents the first ever 90mg dosing of eftilagimod alpha (“efti”), a soluble LAG-3 protein and MHC Class II agonist, given in combination with weekly paclitaxel.

Key Points: 
  • During the immuno-oncology (IO)-chemotherapy treatment of efti and paclitaxel, this patient achieved a partial response (PR) that subsequently turned into a CR.
  • As of the data cut-off (April 3), no dose-limiting toxicities and no treatment-emergent adverse events of grade 3 or higher severity were recorded.
  • Further data updates in terms of safety and efficacy from AIPAC-003 are expected in CY2024.
  • The ESMO Breast 2024 poster will be available on the Posters & Publications section of Immutep’s website.

Arrowhead Pharmaceuticals Presents New Clinical Data Showing ARO-RAGE Achieves High Level of Gene Knockdown in Patients with Asthma

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måndag, maj 20, 2024
Research, Infectious Diseases, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Science, Molecule, Lung, Patient, Arrowhead, Asthma, FVC, Pharmacodynamics, NHV, Safety, RAGE, Conference, Serum, American Thoracic Society, H5N1, TSLP, BALF, Interim, RNA interference, ATS, ARO, Gastric lavage, DLCO, FEV1, Pharmaceutical industry

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that new interim clinical data on ARO-RAGE, an investigational RNAi-based medicine for the treatment of inflammatory lung diseases, such as asthma, were presented at the American Thoracic Society (ATS) 2024 International Conference.

Key Points: 
  • Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that new interim clinical data on ARO-RAGE, an investigational RNAi-based medicine for the treatment of inflammatory lung diseases, such as asthma, were presented at the American Thoracic Society (ATS) 2024 International Conference.
  • “These results underscore the potential of our proprietary TRiMTM platform to enable us to develop impactful new therapies to potentially treat multiple pulmonary diseases with significant unmet needs.
  • Arrowhead also presented preclinical data on two additional lung targeted programs that utilize the company’s proprietary Targeted RNAi Molecule (TRiMTM) platform.
  • ARO-IAV is designed to silence expression of highly conserved influenza A viruses, including the highly pathogenic avian influenza virus (H5N1).

Amolyt Pharma Announces Abstracts Accepted for Presentation at the GRS Congress, ECE and ENDO

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tisdag, maj 7, 2024
ENDO, Cortex, Congress, European Society of Endocrinology, Patient, Hypoparathyroidism, Abstract, Rat, Novel, Acromegaly, Pharmacokinetics, Cohort, Combined, GRS, ECE, Trial of the century, Female, Pharmacodynamics, Fragility, Pharmaceutical industry

LYON, France and CAMBRIDGE, Mass., May 07, 2024 (GLOBE NEWSWIRE) -- Amolyt Pharma, a global company specialized in developing therapeutic peptides for rare endocrine and related diseases, today announced that the company has had multiple abstracts accepted for presentation at the 10th International Congress of the Growth Hormone Research Society (GRS), which is being held May 10-11 in Stockholm, Sweden, the 26th European Congress of Endocrinology (ECE), which is being held May 11-14 in Stockholm, Sweden, and at the 2024 Endocrine Society Meeting (ENDO), which is being held June 1-4 in Boston, Massachusetts.

Key Points: 
  • LYON, France and CAMBRIDGE, Mass., May 07, 2024 (GLOBE NEWSWIRE) -- Amolyt Pharma, a global company specialized in developing therapeutic peptides for rare endocrine and related diseases, today announced that the company has had multiple abstracts accepted for presentation at the 10th International Congress of the Growth Hormone Research Society (GRS), which is being held May 10-11 in Stockholm, Sweden, the 26th European Congress of Endocrinology (ECE), which is being held May 11-14 in Stockholm, Sweden, and at the 2024 Endocrine Society Meeting (ENDO), which is being held June 1-4 in Boston, Massachusetts.
  • These presentations cover both of Amolyt’s development programs, eneboparatide in Phase 3 for the treatment of hypoparathyroidism and AZP-3813 in Phase 1 for the treatment of acromegaly.
  • Details of the presentations are as follows:
    10th International Congress of the Growth Hormone Research Society (GRS) – May 10-11, Stockholm, Sweden
    Title: Additive Effect of Combined Treatment with the Small Peptide GH Receptor Antagonist, AZP-3813, and the Somatostatin Analog, Octreotide, in Decreasing IGF1 Levels in the Rat
    26th European Congress of Endocrinology (ECE) – May 11-14, Stockholm, Sweden
    Title: Increased Urinary Excretion of Calcium and Nephrolithiasis: Real-Life Data from the Epi-Hypo Cohort of Hypoparathyroidism Patients
    Title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZP-3813, a Novel, Small Peptide Growth Hormone Receptor Antagonist, in Healthy Subjects
    Poster Display: 9:40am CEST on Sunday, May 12 to 3:30pm CEST on Tuesday, May 14, 2024
    Title: Additive Effect of Combined Treatment with the Small Peptide GH Receptor Antagonist, AZP-3813, and the Somatostatin Analog, Octreotide, in Decreasing IGF1 Levels in the Rat
    Title: Increased Bone Fragility Over Time in Women with Chronic Hypoparathyroidism: Real-world Data from the HypoparaNet Italian Cohort
    Poster Display: 9:40am CEST on Sunday, May 12 to 3:30pm CEST on Tuesday, May 14, 2024
    2024 Endocrine Society Meeting (ENDO) – June 1-4, Boston, Mass.
  • Title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZP-3813, a Novel Small Peptide Growth Hormone Receptor Antagonist, in Healthy Subjects
    Title: Increased Fragility of Bone Over Time in Female Patients with Chronic Hypoparathyroidism: Real-world Data from the Italian Cohort
    Title: Enhanced Ability of the Small Peptide GH Receptor Antagonist, AZP-3813, to Decrease IGF1 When Combined with the Somatostatin Analog, Octreotide
    Title: Eneboparatide, a Potent Stimulator of Urinary Calcium Reabsorption, Induces Prolonged Renal Cortex Retention and PTH1 Receptor Signalling

Alto Neuroscience Announces Data Presentations Highlighting Late-Stage Clinical Pipeline and Robust Platform at Upcoming Scientific Conferences

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torsdag, maj 9, 2024
Neurology, Mental Health, Health, Pharmaceutical, Clinical Trials, Schizophrenia, CMO, Neuroscience, University of Toronto, University of California, Cognition, Vortioxetine, Biological Psychiatry (journal), Biomarker, Prevalence, Into, Diagnosis, Deficit spending, Drug development, Area studies, Remind, Depression, Data, Pharmacodynamics, EEG, Bipolar, Trial, Chair, Volunteering, Lab, Cognitive deficit, Doctor of Philosophy, Society, University, Cyclothymia, Randomness, ASCP, Pharmaceutical industry

“Alto’s precision psychiatry platform continues to get stronger with each new dataset we analyze.

Key Points: 
  • “Alto’s precision psychiatry platform continues to get stronger with each new dataset we analyze.
  • Importantly, we have systematically identified and prospectively replicated neurobiological markers linked to cognitive impairment associated with schizophrenia in a comprehensive analysis inclusive of all major candidate biomarkers.
  • New analysis of vortioxetine Phase 3 data demonstrates that baseline cognitive performance is not a moderator of response to vortioxetine.
  • A notable relationship between theta response and processing speed, which is thought to underpin cognitive impairment in schizophrenia, was observed.

Purple Biotech's Randomized Phase 2 CM24 Pancreatic Cancer Study Selected as Late-Breaking Abstract Poster Presentation at ASCO 2024 Annual Meeting

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torsdag, april 25, 2024
PFS, Efficacy, Safety, DCR, Risk, Nivolumab, Randomness, SOC, Drug resistance, Death, CM24, Tumor microenvironment, OS, PD-1, PDAC, ASCO, Cancer, Patient, Society, CA19-9, Interim, BMS, Neoplasm, Bristol Myers Squibb, Annual general meeting, Pharmacodynamics, Escape Room, Pharmaceutical industry

REHOVOT, Israel, April 25, 2024 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, today announced that interim results from its randomized, controlled, open label, multicenter Phase 2 study of CM24, a first in class immune checkpoint inhibitor, for the treatment of pancreatic ductal adenocarcinoma (PDAC), have been selected as late-breaking abstract poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting which will take place on May 31 – June 4, 2024 in Chicago, Illinois.

Key Points: 
  • The primary endpoint of the study is overall survival (OS), with progression free survival (PFS) and objective response rate (ORR) as secondary endpoints.
  • The study was designed as Bayesian to evaluate the potential benefit of the experimental arm vs SoC and is not powered for hypothesis testing.
  • Approximately 60 patients have been enrolled in the randomized study in 18 centers in the U.S., Spain and Israel.
  • “We are honored to be selected by the ASCO committee with our late breaking abstract poster presentation and are looking forward to presenting our interim results from our randomized Phase 2 CM24 study at the ASCO 2024 annual meeting.” stated Gil Efron, Chief Executive Officer of Purple Biotech.

Kynos Therapeutics announces positive top-line results from the first-in-human Phase I study of its KMO inhibitor, KNS366, demonstrating safety, tolerability and target engagement

Retrieved on: 
måndag, april 22, 2024
Inflammation, Safety, Innovation, Pharmacokinetics, Human, Patient, Kynurenine, Innovate UK, Pharmacodynamics, Immune system, Therapy, Cynus, KMO, Pharmaceutical industry

KMO is an enzyme that acts at a key point in the kynurenine pathway of tryptophan metabolism, converting kynurenine into 3-hydroxykynurenine (3-HK).

Key Points: 
  • KMO is an enzyme that acts at a key point in the kynurenine pathway of tryptophan metabolism, converting kynurenine into 3-hydroxykynurenine (3-HK).
  • By inhibiting KMO activity, KNS366 is designed to reduce elevated 3-HK in order to prevent excess tissue damage and dysregulation of the immune system occurring during inflammation.
  • The Phase I study of KNS366 was a randomized, double-blind, placebo-controlled dose escalation study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of KNS366 in healthy adult participants.
  • To our knowledge, this is the first time a KMO inhibitor has been administered across multiple days resulting in sustained KMO inhibition in humans.