Pharmacokinetics

Landos Biopharma Provides Business Update and Reports Fourth Quarter and Full Year 2023 Results

Retrieved on: 
Thursday, March 21, 2024
Research, Ulcerative colitis, ECCO, LTE, ACG, Patient, UC, Journal, Biomarker, NEXUS, Wind, Insurance, Abstract, American College, Clinical trial, Safety, Pharmacokinetics, Poster, NLRX1, European, PLXDC2, Pharmaceutical industry

NEW YORK, March 21, 2024 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ: LABP) (“Landos” or “the Company”), a clinical-stage biopharmaceutical company developing novel, oral medicines for patients with autoimmune diseases, today provided a business update and reported financial results for the fourth quarter and the full year ended December 31, 2023.

Key Points: 
  • NEW YORK, March 21, 2024 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ: LABP) (“Landos” or “the Company”), a clinical-stage biopharmaceutical company developing novel, oral medicines for patients with autoimmune diseases, today provided a business update and reported financial results for the fourth quarter and the full year ended December 31, 2023.
  • Top-line results are planned for the fourth quarter of 2024.
  • Research and development expenses were $3.1 million for the fourth quarter of 2023, compared to $3.4 million for the fourth quarter of 2022.
  • General and administrative expenses were $3.5 million for the fourth quarter of 2023, compared to $3.1 million for the fourth quarter of 2022.

CAMP4 Therapeutics Announces Dosing of First Participant in Phase 1 Clinical Study of CMP-CPS-001, a Potential First-in-Class Therapeutic for Urea Cycle Disorders

Retrieved on: 
Thursday, March 21, 2024
Disability, Gene, Enzyme, Seizure, Patient, DSM-IV codes, RNA, Messenger, Protein, Trial of the century, CPS1, UCD, Clinical trial, Therapy, Safety, Pharmacokinetics, Ammonia, Brain damage, Disorder, Blood, Pharmaceutical industry

“Most importantly, the clinical development of CMP-CPS-001 is a step toward potentially bringing a new, disease-modifying treatment to individuals living with UCDs.

Key Points: 
  • “Most importantly, the clinical development of CMP-CPS-001 is a step toward potentially bringing a new, disease-modifying treatment to individuals living with UCDs.
  • People with urea cycle disorders accumulate excessive ammonia in their blood, which may cause irreversible brain damage, disability, and seizures, and may be fatal.
  • CMP-CPS-001 targets carbamoyl phosphate synthetase 1 (CPS1), a key enzyme that catalyzes the first step of the urea cycle.
  • For more information about the Phase 1 clinical study of CMP-CPS-001, please visit clinicaltrials.gov ( NCT06247670 ).

Sosei Heptares Doses First Subject in Phase 1 Trial with HTL0033744, an EP4 Agonist for Inflammatory Bowel Disease

Retrieved on: 
Thursday, March 21, 2024
EP4, Inflammation, Biomarker, IBD, Inflammatory bowel disease, Therapy, Safety, Pharmacokinetics, Pharmaceutical industry

This approach is widely recognized to promote deeper remission and offer better long-term clinical outcomes1,2.

Key Points: 
  • This approach is widely recognized to promote deeper remission and offer better long-term clinical outcomes1,2.
  • HTL’744 aims to address the significant unmet need of people with IBD that do not achieve satisfactory disease control.
  • The trial will be conducted in the UK and initial data read-outs are anticipated from 2025.
  • EP4 agonists are a recognized and exciting class of drugs with a dual mechanism of action that can resolve inflammation and promote mucosal healing.

Immatics Announces Full Year 2023 Financial Results and Corporate Update

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Thursday, March 21, 2024
Ovarian cancer, Head, Uterine cancer, GSK, Patient, Dendreon, Commercial, Cancer, Bristol Myers Squibb, Neoplasm, Melanoma, TCR, Therapy, Research, MAGEA4, Sarcoma, GMP, Safety, Pharmacokinetics, Amgen, QC, CDMO, Development, Prevalence, Half-life, RECIST, Senior, FDA, Lung cancer, Administration, Conference, Entrepreneurship, Bank, Corr, Messenger, Protein, Pharmacology, Uveal melanoma, Pharmaceutical industry

“Immatics kicked off 2024 with a successful capital raise, providing significant financial runway and additional momentum to advance our ongoing clinical cell therapy and bispecific trials,” said Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics.

Key Points: 
  • “Immatics kicked off 2024 with a successful capital raise, providing significant financial runway and additional momentum to advance our ongoing clinical cell therapy and bispecific trials,” said Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics.
  • For IMA203CD8 GEN2, Immatics cleared dose level 4a (DL4a, up to ~1.6x109 TCR-T cells) in December 2023, which is currently intended to be the target dose for further development.
  • A next data update for both Phase 1b cohorts with IMA203 GEN1 and IMA203CD8 GEN2 is planned for 2H 2024.
  • On September 11, 2023, Immatics announced a strategic multi-platform collaboration with Moderna, combining Immatics’ target and TCR platforms with Moderna’s cutting-edge mRNA technology.

Enliven Therapeutics Announces $90 Million Private Placement Financing and Provides Pipeline Updates

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Tuesday, March 19, 2024
HER2, Acute leukemia, Exercise, Index, Exchange, Colorectal cancer, MMR, Memorial, Headache, Patient, Research, Diarrhea, Brain, CML, KOL, Aes, Sale, Cancer, Security (finance), IND, MBA, Prospectus, MBC, Nausea, Therapy, CRC, PIPE, Pharmacokinetics, MTD, Food, Pharmaceutical industry

BOULDER, Colo., March 19, 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 that it has entered into a securities purchase agreement for a private investment in public equity (PIPE) financing that is expected to result in gross proceeds of approximately $90 million, before deducting offering expenses. The financing includes participation from new and existing investors, including Commodore Capital, Fairmount, Venrock Healthcare Capital Partners, a biotech investor, a large mutual fund, Rock Springs Capital, Logos Capital, Woodline Partners LP and Acuta Capital Partners.

Key Points: 
  • “The additional funding further strengthens our balance sheet and enables us to achieve critical, longer-term clinical milestones as we advance our parallel lead programs, ELVN-001 and ELVN-002.
  • Enliven anticipates the gross proceeds from the private placement to be approximately $90 million, before deducting offering expenses.
  • The PIPE financing is expected to close on or about March 21, 2024, subject to satisfaction of customary closing conditions.
  • Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

Jasper Therapeutics Announces First Patient Dosed in Phase 1b/2a SPOTLIGHT Clinical Study of Briquilimab in Chronic Inducible Urticaria

Retrieved on: 
Tuesday, March 19, 2024
Patient, Cold urticaria, CSU, Trial of the century, B cell, Therapy, Safety, Pharmacokinetics, CD117, Pharmaceutical industry

REDWOOD CITY, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) in mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), today announced that the first patient has been dosed in Jasper’s Phase 1b/2a (SPOTLIGHT) clinical study of subcutaneous briquilimab for the treatment of CIndU.

Key Points: 
  • REDWOOD CITY, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) in mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), today announced that the first patient has been dosed in Jasper’s Phase 1b/2a (SPOTLIGHT) clinical study of subcutaneous briquilimab for the treatment of CIndU.
  • The SPOTLIGHT study is evaluating a single administration, at two different dose levels, of subcutaneous briquilimab in adult patients with cold urticaria (ColdU) or symptomatic dermographism (SD).
  • “We are excited to announce dosing of the first patient in the SPOTLIGHT study in patients with CIndU, our second clinical program evaluating briquilimab in a mast cell-mediated disease,” said Edwin Tucker, Chief Medical Officer of Jasper.
  • Jasper anticipates reporting preliminary data from the SPOTLIGHT study in the second half of 2024.

Aligos Therapeutics Announces the Initiation of the Phase 2a HERALD Study of ALG-055009 in MASH Subjects

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Monday, March 18, 2024
Proton, Magnetic resonance imaging, Patient, Biomarker, MASH, Trial of the century, MBA, Doctor of Philosophy, Principal investigator, Therapy, Safety, Pharmacokinetics, Liver, Magnetic resonance, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., March 18, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced the initiation of the Phase 2a HERALD study of ALG-055009 in subjects with metabolic dysfunction-associated steatohepatitis (MASH). Screening of subjects has begun at clinical study sites across the U.S.

Key Points: 
  • The Phase 2a study is being led by Principal Investigator, Dr. Stephen Harrison
    SOUTH SAN FRANCISCO, Calif., March 18, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced the initiation of the Phase 2a HERALD study of ALG-055009 in subjects with metabolic dysfunction-associated steatohepatitis (MASH).
  • Screening of subjects has begun at clinical study sites across the U.S.
    “ALG-055009 has enhanced potency, greater beta selectivity, and a favorable PK profile.
  • We believe that these optimized pharmacologic properties may result in improved therapeutic outcomes for patients living with MASH.
  • The initiation of the HERALD study is an important next step in achieving our goal to create a best-in-class thyroid hormone receptor beta agonist,” stated Lawrence Blatt, Ph.D., MBA, Chairman, President, and CEO of Aligos Therapeutics.

Larimar Therapeutics Reports Fourth Quarter and Full Year 2023 Operating and Financial Results and Provides Update on Nomlabofusp Development

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Thursday, March 14, 2024
Research, Database, Gene expression, Disease, Patient, Accounting, OLE, Insurance, Ataxia, Clinical trial, Skin, Therapy, Safety, Pharmacokinetics, Interim, FA, FDA, BLA, Pharmaceutical industry

BALA CYNWYD, Pa., March 14, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today reported its fourth quarter and full year 2023 operating and financial results.

Key Points: 
  • BALA CYNWYD, Pa., March 14, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today reported its fourth quarter and full year 2023 operating and financial results.
  • Nomlabofusp was generally well-tolerated and demonstrated dose-dependent increases in skin and buccal cell frataxin levels.
  • Research and development expenses for the fourth quarter of 2023 were $10.6 million compared to $7.2 million for the fourth quarter of 2022.
  • General and administrative expenses for the fourth quarter of 2023 were $3.5 million compared to $3.2 million for the fourth quarter of 2022.

Terns Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Updates

Retrieved on: 
Thursday, March 14, 2024
Pharmacokinetics, Patient, Administration, Research and development, Weight loss, Obesity, BCR-ABL, CML, GIPR, Safety, Pharmaceutical industry

FOSTER CITY, Calif., March 14, 2024 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity, today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided corporate updates.

Key Points: 
  • Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2026.
  • Research and Development (R&D) Expenses: R&D expenses were $17.5 million and $63.5 million for the quarter and year ended December 31, 2023, respectively, as compared with $10.7 million and $39.6 million for the quarter and year ended December 31, 2022, respectively.
  • General and Administrative (G&A) Expenses: G&A expenses were $6.6 million and $39.1 million for the quarter and year ended December 31, 2023, respectively, as compared with $6.2 million and $22.4 million for the quarter and year ended December 31, 2022, respectively.
  • Net Loss: Net loss was $21.0 million and $90.2 million for the quarter and year ended December 31, 2023, respectively, as compared with $15.8 million and $60.3 million for the quarter and year ended December 31, 2022, respectively.

Immuneering Announces Positive Topline Results from Phase 1 Portion of its Phase 1/2a Clinical Trial of IMM-1-104 in RAS-Mutant Solid Tumors

Retrieved on: 
Thursday, March 14, 2024
Toxicity, Concept, Plasma, Candidate, RECIST, Oncology, RAS, Patient, FACP, City, Cancer, Pancreatic cancer, Neoplasm, Therapy, Safety, Pharmacokinetics, SLD, Pharmaceutical industry

“Today’s results are an important step towards that goal, as we share positive topline data from the Phase 1 portion of our Phase 1/2a clinical trial of IMM-1-104 in advanced RAS-mutant solid tumors.

Key Points: 
  • “Today’s results are an important step towards that goal, as we share positive topline data from the Phase 1 portion of our Phase 1/2a clinical trial of IMM-1-104 in advanced RAS-mutant solid tumors.
  • Immuneering evaluated both 240mg and 320mg QD as prospective doses for the Phase 2a portion of its Phase 1/2a study.
  • The Phase 2a portion is expected to include up to twenty clinical sites and has already dosed its first patient.
  • Initial data from multiple arms of the Phase 2a portion of Immuneering’s Phase 1/2a study of IMM-1-104 expected in 2024.