Pharmacology

Tectonic Therapeutic Initiates Phase 1B Study for TX45 in Group 2 Pulmonary Hypertension in Patients with Preserved Ejection Fraction Heart Failure

Retrieved on: 
Tuesday, March 26, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Other Health, GPCR, Disease, Harvard Medical School, Echocardiography, Cardiovascular disease, Pulmonary hypertension, Patient, Mortality, Tectonics, MD, Biology, Safety, Pharmacology, Relaxin, Heart failure, Pharmaceutical industry

The study will evaluate the safety and hemodynamic effects of single-dose TX45 in patients with Group 2 Pulmonary Hypertension secondary to Heart Failure with preserved Ejection Fraction (Group 2 PH with HFpEF).

Key Points: 
  • The study will evaluate the safety and hemodynamic effects of single-dose TX45 in patients with Group 2 Pulmonary Hypertension secondary to Heart Failure with preserved Ejection Fraction (Group 2 PH with HFpEF).
  • Group 2 PH with HFpEF impacts over 600,000 patients in the US and is associated with significant morbidity and mortality.
  • The Phase 1B study with TX45 in patients with Group 2 PH with HFpEF is a single dose, open-label study to evaluate safety, tolerability and acute hemodynamic effects of intravenous administration of TX45.
  • The study will evaluate the effect of TX45 on hemodynamic parameters, as determined by right heart catheterization and echocardiography.

Coya Therapeutics Provides a Corporate Update and Reports Fiscal 2023 Financial Results

Retrieved on: 
Tuesday, March 19, 2024
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Research, Pharmacology, LD, Survival, Serum, ALS, Science, PD, Houston Methodist Hospital, Patient, Regulatory affairs, Granulocyte-macrophage colony-stimulating factor, FD, GM-CSF, Nebraska Medicine, COYA, University, IPO, Senior, Society, IND, Commerce, Viral disease, Therapy, Frontotemporal dementia, FDA, FTD, Pharmaceutical industry

Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, provides a corporate update and announces its financial results for the year ended December 31, 2023.

Key Points: 
  • Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, provides a corporate update and announces its financial results for the year ended December 31, 2023.
  • COYA 302 is Coya’s combination of its proprietary LD IL-2 formulation with the immunomodulatory drug CTLA4-Ig.
  • “We believe that we have under-promised and over-delivered in executing on numerous deliverables in 2023 that have brought value to Coya,” commented Howard Berman, Ph.D., Chief Executive Officer of Coya.
  • Net loss was $8.0 million for the year ended December 31, 2023, compared to net loss of $12.2 million for the year ended December 31, 2022.

Dr. Vince Clinical Research Announces First Dosing in a Phase II Study in Patients With Depression

Retrieved on: 
Wednesday, March 13, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, Mental Health, Professional Services, Clinical Trials, Depression, Brain, Communication, MDD, Partnership, Patient, DSM-IV codes, Clinical trial, Safety, Pharmacology, Phase, Medical director, Dissociative, Pharmaceutical industry

Dr. Vince Clinical Research (DVCR) , a contract research organization (CRO) specializing in early phase trials, announced the first dosing in a Phase II multicenter trial of SPN-820 in adults with major depressive disorder (MDD).

Key Points: 
  • Dr. Vince Clinical Research (DVCR) , a contract research organization (CRO) specializing in early phase trials, announced the first dosing in a Phase II multicenter trial of SPN-820 in adults with major depressive disorder (MDD).
  • MDD is estimated to affect over 17 million adults in the United States, with approximately 30% of these patients being resistant to treatment.
  • Supernus Pharmaceuticals , in collaboration with Navitor Pharmaceuticals , is developing SPN-820 to provide a rapid-onset antidepressant response via oral administration for adult patients with treatment-resistant depression.
  • We are appreciative of the partnership with DVCR for our SPN-820 program.”
    The Phase II study is being conducted at six U.S. sites and is expected to enroll approximately 50 adult MDD patients.

Coya Therapeutics Presents ALS Biomarker Data at Society of Neuroimmune Pharmacology Conference

Retrieved on: 
Tuesday, March 12, 2024
Health, General Health, Research, Pharmaceutical, Science, Biotechnology, Diagnosis, Pharmacology, LD, Conference, Survival, Serum, Coya, Disease, ALS, Associate, Patient, Biomarker, COYA, ROS, Death, Reactive oxygen species, Society, Therapy, Patent, FDA, Oxidative stress

The data presented highlights the strong predictive value of levels of an oxidative stress biomarker (4-HNE) with the rate of disease progression and survival in 50 ALS patients from a longitudinal patient registry cohort.

Key Points: 
  • The data presented highlights the strong predictive value of levels of an oxidative stress biomarker (4-HNE) with the rate of disease progression and survival in 50 ALS patients from a longitudinal patient registry cohort.
  • In a proof-of-concept study in patients with ALS, the combination of low dose interleukin-2 (LD IL-2) and CTLA-4 Ig appeared to lower 4-HNE and other proinflammatory biomarker levels.
  • Furthermore, Coya has filed patent applications relating to the use of the biomarker in ALS.
  • Data was collected from a previously established biobank at Houston Methodist to monitor and track ALS patient outcomes with biomarkers.

KalVista Pharmaceuticals Reports Third Fiscal Quarter Results and Provides Operational Update

Retrieved on: 
Monday, March 11, 2024
Health, Pharmaceutical, Research, CFO, Patient, HAE, Health care, CBO, NDA, American Academy, KALV, Factor, MHRA, Clinical trial, Hereditary angioedema, Safety, Pharmacology, AAAAI, Fiscal year, Food, Pharmaceutical industry

(NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today provided an operational update and released financial results for the third fiscal quarter ended January 31, 2024.

Key Points: 
  • (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today provided an operational update and released financial results for the third fiscal quarter ended January 31, 2024.
  • Third Fiscal Quarter Financial Results:
    Revenue: No revenue was recognized for the three months ended January 31, 2024, or January 31, 2023.
  • The increase in R&D expenses during the quarter primarily reflects the ongoing Phase 3 KONFIDENT and KONFIDENT-S trials.
  • The decrease in the net cash and marketable securities position was due to cash consumption from operating expenses.

Synnovation Therapeutics Announces First Patient Dosed in Phase I Trial with SNV1521, a PARP1 Selective Inhibitor for the Treatment of Solid Tumors

Retrieved on: 
Monday, March 11, 2024
Oncology, Health, Other Health, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Pharmacology, PARP1, Senior, HRD, Medicine, University, CNS, Patient, MD Anderson Cancer Center, PARP, Therapy, Cancer, Safety, Pharmaceutical industry

Synnovation Therapeutics, a precision medicine company developing small molecule therapies optimized to achieve best-in-class pharmacology against highly validated disease targets, today announced that the first patient has been dosed in a Phase I trial evaluating SNV1521 in patients with solid tumors.

Key Points: 
  • Synnovation Therapeutics, a precision medicine company developing small molecule therapies optimized to achieve best-in-class pharmacology against highly validated disease targets, today announced that the first patient has been dosed in a Phase I trial evaluating SNV1521 in patients with solid tumors.
  • SNV1521 is a potentially best-in-class, potent, highly selective and CNS penetrant PARP1 inhibitor.
  • In preclinical models, selective PARP1 targeting has been shown to improve both the efficacy and safety of the class.
  • “Dosing of the first patient in the SNV1521 Phase I trial is a key milestone as Synnovation transitions from a preclinical to clinical stage biotech company.

NeoImmuneTech Appoints Dr. Luke Oh, Ph.D. as New Chief Executive Officer

Retrieved on: 
Tuesday, April 2, 2024
Mallinckrodt, Inflammation, Pharmacology, McGill University, Organization, Acute radiation syndrome, ARS, KOSDAQ, Research, EDT, Senior, Doctor of Philosophy, IL-7, Human Genome Sciences, Drug development, Division, NIT, Vertex Pharmaceuticals

ROCKVILLE, Md., April 2, 2024 /PRNewswire/ -- NeoImmuneTech, Inc. (KOSDAQ: 950220), announced that Luke Oh, Ph.D. has been appointed as President and Chief Executive Officer (CEO) of NeoImmuneTech, Inc. (NIT or "NeoImmuneTech"), effective from March 29, 2024 (EDT).

Key Points: 
  • ROCKVILLE, Md., April 2, 2024 /PRNewswire/ -- NeoImmuneTech, Inc. (KOSDAQ: 950220), announced that Luke Oh, Ph.D. has been appointed as President and Chief Executive Officer (CEO) of NeoImmuneTech, Inc. (NIT or "NeoImmuneTech"), effective from March 29, 2024 (EDT).
  • Se Hwan Yang, Ph.D., as Chief Executive Officer of NeoImmuneTech, Inc.
  • In his new role, Dr. Oh will lead NeoImmuneTech from its Rockville headquarters and overview all the operations in Korea.
  • Se Hwan Yang initiated, aligning the company on our business priorities, and stepping up this new phase of NeoImmuneTech."

Promising New Data Published on Potential Therapy to Boost Effectiveness of Pancreatic Cancer Treatments

Retrieved on: 
Tuesday, March 26, 2024
Toxicity, Cell, Development, Survival, BLR, Disease, American Cancer Society, PNAC, Research, University, Quality of life, Cancer, IND, Pharmacology, Pancreatic cancer, Mario, Potential, RFU, Therapy, Helix, Person, Pharmaceutical industry

The data points to a promising strategy to boost the effectiveness of existing drugs in pancreatic cancer and other solid-tumor cancers.

Key Points: 
  • The data points to a promising strategy to boost the effectiveness of existing drugs in pancreatic cancer and other solid-tumor cancers.
  • According to the American Cancer Society , some 66,000 persons in the U.S. are diagnosed annually with pancreatic cancer, a disease with a very low survival rate that is projected to take 51,000 lives in 2024.
  • "Finding an approach to use lower doses while maintaining efficacy has been a constant search for cancer treatments."
  • "BLR-100 targets the formation of the protective tumor stroma, a fibrotic-like element that is thought to retard the entry of chemo-therapeutic agents."

Shasqi Appoints Travis Biechele, Ph.D. as VP of Research to Lead Pipeline Development

Retrieved on: 
Monday, March 11, 2024
Pharmacology, Therapeutic index, Seagen, SAN, Patient, University, Spacecraft, MD, Neoplasm, CAPAC, ADC, Shasqi, Click chemistry, Pharmaceutical industry

SAN FRANCISCO, March 11, 2024 /PRNewswire/ -- Shasqi, Inc. ("Shasqi") a biotech company whose mission is to make cancer drugs more effective with click chemistry, today announced that it has appointed Travis Biechele, Ph.D. as VP of Research.

Key Points: 
  • SAN FRANCISCO, March 11, 2024 /PRNewswire/ -- Shasqi, Inc. ("Shasqi") a biotech company whose mission is to make cancer drugs more effective with click chemistry, today announced that it has appointed Travis Biechele, Ph.D. as VP of Research.
  • Biechele has over two decades of experience in oncology research, with a focus on developing antibody-drug conjugates (ADCs), with both Seagen (now Pfizer) and Merck.
  • Shasqi's pipeline is composed of a range of tumor-targeted activators against validated antigen targets that are combined with protodrugs based on a range of validated payloads.
  • Prior to Merck, Biechele spent 10 years at Seagen (now Pfizer), where he played a pivotal role in the development of ADC technology.

Larimar Therapeutics Announces the Dosing of the First Patient in Long-term Open Label Extension Study for Nomlabofusp in Patients with Friedreich’s Ataxia

Retrieved on: 
Monday, March 11, 2024
Pharmacology, Friedreich's ataxia, FDA, BLA, Ataxia, Mitochondrion, Safety, Therapy, Pharmacokinetics, Patient, OLE, FA, Gene expression, Pharmaceutical industry

Nomlabofusp (CTI-1601) is a novel protein replacement therapy designed to address the root cause of Friedreich's ataxia (FA) by delivering frataxin to mitochondria.

Key Points: 
  • Nomlabofusp (CTI-1601) is a novel protein replacement therapy designed to address the root cause of Friedreich's ataxia (FA) by delivering frataxin to mitochondria.
  • “We are pleased to dose the first patient in our OLE study, further advancing the nomlabofusp clinical program and building on the successful completion of our Phase 2 dose escalation study.
  • Based on our Phase 1 and Phase 2 findings, we expect to continue daily dosing throughout the study,” said Carole Ben-Maimon, MD, President, and Chief Executive Officer of Larimar.
  • Initial data from the OLE study is expected in Q4 2024.