IND

Sapience Therapeutics Presents Three Posters at the American Association for Cancer Research (AACR) Annual Meeting 2024

Retrieved on: 
Monday, April 8, 2024
Research, BCL9, MDSC, Survival, Patient, Wisdom, SVP, Neoplasm, The central science, Cancer, Macrophage, AP-1, IND, AACR, TAM, Phenotype, Therapy, Breast cancer, Poster, Cell, AP-1 transcription factor, TNBC, Metastasis, Vaccine

TARRYTOWN, N.Y., April 8, 2024 /PRNewswire/ -- Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, today announced the presentation of new data on its clinical and pipeline programs during three poster presentations at the 2024 American Association for Cancer Research (AACR) Annual Meeting, taking place April 5-10, 2024, in San Diego, CA.

Key Points: 
  • We look forward to ST316 and ST101 continuing to advance through clinical development and moving our AP-1 program into IND-enabling studies."
  • Sapience scientists will present non-clinical immune-oncology results from both of its clinical programs, ST316, a first-in-class antagonist of β-catenin, and ST101, a first-in-class antagonist of C/EBPβ.
  • In nonclinical studies, Sapience evaluated the ability of ST316 to enhance anti-tumor immune responses in combination with anti-PD-1 and anti-TIGIT therapies.
  • JunAP demonstrates potent anti-tumor activity in vivo in mouse triple negative breast cancer and melanoma tumor models.

Laekna Announces Two Poster Presentations on Internally Discovered Drug Candidates at AACR 2024

Retrieved on: 
Monday, April 8, 2024
PARP1, Chem, MDA, Drug, Patient, Cancer, IND, Abstract, AACR, Survivor, DRF, Clinical trial, PARP, MOA, Xenotransplantation, Safety, Biology, San Diego Convention Center, Drug discovery, Medicine, Annual general meeting, PCC, Pharmaceutical industry

"After advancing LAE102, our internally discovered antibody against ActRIIA, into IND stage, Laekna continues to strengthen our internal discovery efforts, with new drug candidates emerging", said Dr. Justin Gu, Chief Scientific Officer of Laekna.

Key Points: 
  • "After advancing LAE102, our internally discovered antibody against ActRIIA, into IND stage, Laekna continues to strengthen our internal discovery efforts, with new drug candidates emerging", said Dr. Justin Gu, Chief Scientific Officer of Laekna.
  • Laekna will continue our internal effort of discovery novel drug candidates to provide more options for patients."
  • The company has internally discovered 14 drug candidates, among which seven have been optimized and advanced to PCC (pre-clinical candidate) stage.
  • The Annual Meeting of AACR is set for April 05 to 10, 2024 at the San Diego Convention Center, California, USA.

Antengene Presents Four Preclinical Posters at AACR 2024

Retrieved on: 
Saturday, April 6, 2024
PRMT5, AML, CDX, Risk, Weight loss, LILRB4, MTAP, Acute myeloid leukemia, CRS, Cancer, IND, AACR, PDX, Antibody, DDI, TCE, Immunohistochemistry, San Diego Convention Center, Cytokine release syndrome, Vaccine

SHANGHAI and HONG KONG, April 5, 2024 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, today announced the presentation of four preclinical posters at the 2024 American Association for Cancer Research Annual Meeting (AACR 2024), taking place from April 5th to April 10th at the San Diego Convention Center in San Diego, California, the United States.

Key Points: 
  • SHANGHAI and HONG KONG, April 5, 2024 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, today announced the presentation of four preclinical posters at the 2024 American Association for Cancer Research Annual Meeting (AACR 2024), taking place from April 5th to April 10th at the San Diego Convention Center in San Diego, California, the United States.
  • Study results showed that ATG-042 has the potential to elegantly target tumor cells while sparing healthy cells, with an attractive developability profile.
  • 12:00 AM - 3:30 AM, April 10, 2024 (Beijing Time)
    This preclinical study was designed to test the in vitro/in vivo efficacy, and preclinical pharmacokinetic (PK) properties of ATG-042.
  • This poster presents the discovery and validation of a novel, highly sensitive immunohistochemistry (IHC) antibody that selectively identifies CLDN18.2.

ZyVersa Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, March 25, 2024
Research, Diabetic nephropathy, Cholesterol, Obesity, Institutional review board, Patient, Protocol, MJFF, University, IND, IRB, Investigational New Drug, Therapy, Atherosclerosis, Metabolic syndrome, Government, Inflammasome, Pharmaceutical industry

WESTON, Fla., March 25, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical-stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of renal and inflammatory diseases with high unmet medical needs, reports financial results for full year ending December 31, 2023, and provides business update.

Key Points: 
  • Scientific collaboration to assess Inflammasome ASC Inhibitor IC 100 as a potential treatment for atherosclerosis expected to conclude H1-2024.
  • WESTON, Fla., March 25, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical-stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of renal and inflammatory diseases with high unmet medical needs, reports financial results for full year ending December 31, 2023, and provides business update.
  • “Throughout 2023 and early 2024, ZyVersa achieved considerable progress in advancing development of our two lead candidates.
  • The impairment is a result of the decline in stock value and the resulting market capitalization of ZyVersa during the 2023 Period.

Artelo Biosciences Reports Fiscal 2023 Year-End Financial Results and Provides Business Update

Retrieved on: 
Monday, March 25, 2024
ART, Research, Depression, Neuropathic pain, Argyreia nervosa, Weight gain, Cachexia, Anxiety, Cancer, IND, Investment, Safety, Pain, FDA, Cannabidiol, Pharmaceutical industry

SOLANA BEACH, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatologic and neurological conditions, today reported financial and operating results for the fiscal year ended December 31, 2023 and provided a business update.

Key Points: 
  • SOLANA BEACH, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatologic and neurological conditions, today reported financial and operating results for the fiscal year ended December 31, 2023 and provided a business update.
  • “We made substantial progress on multiple programs last year,” commented Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences.
  • Cash and Investments: Cash and investments totalled $10.4 million as of December 31, 2023.
  • R&D Expenses: Research and development expenses were $5.7 million for the year ended December 31, 2023, compared to $4.3 million for the same period in 2022.

Tonix Pharmaceuticals Receives Rare Pediatric Disease Designation from the FDA for TNX-2900 for the Treatment of Prader-Willi Syndrome

Retrieved on: 
Monday, March 25, 2024
Eating, Prader–Willi syndrome, Obesity, Orphan drug, Appetite, Ageing, Tonix Pharmaceuticals, IND, Polyphagia, Priority review, Oxytocin, Marketing, FDA, Genetic disorder, PWS, Food, Pharmaceutical industry

CHATHAM, N.J., March 25, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to TNX-2900* (intranasal potentiated oxytocin), a proprietary magnesium (Mg2+)-potentiated formulation of intranasal oxytocin, to treat Prader-Willi syndrome (PWS) in children and adolescents. TNX-2900 was previously granted Orphan Drug designation by the FDA in 2022 for the treatment of PWS and the investigational new drug (IND) application was cleared by the FDA in 2023. The Company may be eligible to receive a transferable Priority Review Voucher if TNX-2900 for PWS is approved for marketing. Recently, vouchers have sold for approximately $100 million.

Key Points: 
  • TNX-2900 was previously granted Orphan Drug designation by the FDA in 2022 for the treatment of PWS and the investigational new drug (IND) application was cleared by the FDA in 2023.
  • The Company may be eligible to receive a transferable Priority Review Voucher if TNX-2900 for PWS is approved for marketing.
  • Recently, vouchers have sold for approximately $100 million.
  • “The Rare Pediatric Disease Designation is an important regulatory milestone in the development of TNX-2900.

Sagimet Biosciences Reports Full Year 2023 Financial Results and Provides Corporate Updates

Retrieved on: 
Monday, March 25, 2024
Research, FASN, Fatty liver disease, Congress, Exercise, Progression-free survival, F2, Patient, SAN, Food and Drug Administration, F3, G&A, IPO, Obesity, IND, Acne, Bevacizumab, Glioblastoma, Fibrosis, Clinical trial, NASH, FDA, Drug development, Pharmaceutical industry

SAN MATEO, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today reported financial results for the full year ended December 31, 2023, and provided corporate updates.

Key Points: 
  • In January 2024, Sagimet sold 9,000,000 shares of its Series A common stock in an underwritten public offering and received $104.7 million in net proceeds.
  • In November 2023, Sagimet presented preclinical data evaluating denifanstat alone or in combination with semaglutide in mouse models of MASH at the 7th Obesity and NASH Drug Development Summit.
  • In October 2023, Sagimet’s license partner for China, Ascletis Bioscience Co. Ltd. (Ascletis), presented Phase 2 topline results at the European Academy of Dermatology and Venereology (EADV) Congress 2023 in Berlin, Germany.
  • In July 2023, Sagimet closed an upsized IPO of Series A common stock, at a public offering price of $16.00 per share.

Apogee Therapeutics Announces First Participants Dosed in Phase 1 Trial of APG808, its Novel Half-life Extended IL-4Rα Antibody for the Treatment of Chronic Obstructive Pulmonary Disease (COPD) and Other Inflammatory Diseases

Retrieved on: 
Monday, March 25, 2024
I&I, TARC, Atopic dermatitis, Disease, Half-life, Patient, SAN, Heel, IND, Respiratory disease, Asthma, SQ, Clinical trial, Therapy, Safety, Pharmacokinetics, Engineering, Pharmaceutical industry

SAN FRANCISCO and WALTHAM, Mass., March 25, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis (AD), COPD, asthma and other inflammatory and immunology (I&I) indications, today announced that it has initiated dosing of healthy volunteers in its first clinical trial for APG808, a novel subcutaneous (SQ) extended half-life monoclonal antibody (mAb) targeting IL-4Rα, which is being developed as a treatment for people living with moderate-to-severe COPD, asthma and other I&I diseases.

Key Points: 
  • COPD is a progressive respiratory disease that is estimated to affect approximately 10 percent of the global population 40 years of age and older.
  • Despite recent advancements in COPD treatment, a significant number of people continue to suffer and die from the disease.
  • The APG808 Phase 1 trial is designed as a double-blind, placebo-controlled, first-in-human, single-ascending dose trial in healthy volunteers.
  • Importantly, this points to potentially less frequent dosing for patients with COPD, which could significantly improve quality of life.”

BlueRock Therapeutics and Foundation Fighting Blindness announce collaboration to expand the Uni-Rare natural history study of patients living with inherited retinal diseases

Retrieved on: 
Monday, March 25, 2024
Retina, Research, Gene, Development, IRD, Leber congenital amaurosis, Retinitis pigmentosa, Paratriathlon, Patient, Bayer, Foundation Fighting Blindness, Visual impairment, University, Wilfrid Sellars, Senior, IND, Therapy, IPSC, Usher syndrome, B cell, Pharmaceutical industry

The new cohort will include patients living with IRDs caused by mutations in multiple genes.

Key Points: 
  • The new cohort will include patients living with IRDs caused by mutations in multiple genes.
  • “BlueRock is developing a pipeline of cell therapies that we believe has great potential for restoring vision in people living with blindness caused by retinal disease,” said Ahmed Enayetallah, Senior Vice President and Head of Development for BlueRock Therapeutics.
  • Primary photoreceptor diseases are a subgroup of inherited retinal diseases that includes retinitis pigmentosa and cone- rod dystrophies.
  • OpCT-001 aims to restore vision loss caused by these diseases by replacing degenerated tissue in the retina with functional cells.

In Preparation for Expected Human Clinical Trials, NurExone Signs Agreement for Large Scale Preclinical Testing for Its Spinal Cord Injury Therapy, ExoPTEN

Retrieved on: 
Friday, March 22, 2024
Drug discovery, Rat, NRX, PTEN, Patient, Contract research organization, IND, Regenerative medicine, Behavior, Spinal cord, Spinal cord injury, SCI, Pharmaceutical industry

This large-scale animal testing represents a significant step towards filing an Investigational New Drug (IND) application in the US for NurExone’s ExoPTEN therapy for spinal cord injury (SCI).

Key Points: 
  • This large-scale animal testing represents a significant step towards filing an Investigational New Drug (IND) application in the US for NurExone’s ExoPTEN therapy for spinal cord injury (SCI).
  • Under the terms of the agreement, Vivox will provide Contract Research Organization (CRO) services to NurExone, as a prerequisite to commencing Human Trials under the planned IND.
  • The testing will encompass mobility, behavior, motor and sensory recovery of rats following Spinal Cord Injury and treatment with ExoPTEN," said Dr. Lior Shaltiel, CEO of NurExone.
  • By collaborating with Vivox, NurExone aims to accelerate the development and regulatory path of ExoPTEN, to bring this potentially transformative treatment to patients in need.