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Clinical Trial News

HighField Biopharmaceuticals' HF1K16 Shows Promise in Phase 1 Trial for Refractory Metastatic Cancer

  • HighField Biopharmaceuticals presented positive Phase 1 data for HF1K16, an ATRA-encapsulated liposome, at the ESMO Congress, showing potential in refractory metastatic cancer patients.
  • The trial (NCT05388487) demonstrated encouraging immune modulation and efficacy signals, particularly in a R/R glioma cohort, with some patients surviving over two years.
  • HF1K16 targets myeloid-derived suppressor cells (MDSCs), converting them into active immune cells that stimulate T cells to attack cancer cells.
  • The company plans to advance HF1K16 into Phase 2 trials to determine the most beneficial indication, either as a monotherapy or in combination with standard treatments.

Tolerability and Safety of HF1K16 Injection in Patients With Refractory Solid Tumors

NCT05388487RecruitingPhase 1
HighField Biopharmaceuticals Corporation
Posted 2/16/2022

Bio-Path Holdings' BP1003 Demonstrates Therapeutic Potential in Diverse Cancers

  • Bio-Path Holdings announces a publication in Biomedicines highlighting BP1003's therapeutic potential across various cancer types.
  • BP1003, a STAT3 mRNA-targeting antisense drug, showed broad anti-tumor effects in preclinical models of breast, ovarian, and pancreatic cancer.
  • The study suggests BP1003 could enhance the efficacy of standard chemotherapies in treating difficult-to-treat cancers by targeting STAT3.
  • Bio-Path plans to file an IND application for BP1003, furthering its development as a specific STAT3 inhibitor.

Passage Bio's PBFT02 Shows Sustained Progranulin Increase in FTD-GRN Patients

• Passage Bio's PBFT02 gene therapy demonstrated robust and sustained increases in CSF progranulin levels in FTD-GRN patients in the upliFT-D trial. • Dose 1 of PBFT02 was well-tolerated in patients receiving an enhanced immunosuppression regimen, with no serious adverse events reported. • CSF progranulin levels remained elevated for up to 12 months post-treatment, exceeding levels found in healthy adult controls. • These findings support PBFT02's potential as a progranulin-raising therapy for neurodegenerative diseases, warranting further investigation.

A Study of PBFT02 in Participants With FTD and Mutations in the Granulin Precursor (GRN) or C9ORF72 Genes

NCT04747431RecruitingPhase 1
Passage Bio, Inc.
Posted 9/14/2021

GigaPath AI Model Shows Superior Accuracy in Predicting Cancer Mutations and Tumor Burden

  • GigaPath, a billion-parameter AI foundation model, demonstrates significant improvement in predicting cancer mutations, achieving an AUROC of 0.626 for lung adenocarcinoma, surpassing existing approaches.
  • The model, trained on over 1.3 billion image tiles from 171,189 H&E slides across 28 cancer centers, outperformed competing methods in pan-cancer gene prediction with 6.5% improvement in macro-AUROC.
  • Researchers have made GigaPath available as an open-source tool, enabling independent validation and potential integration with other imaging modalities and clinical data sources.

Nested Therapeutics' NST-628: A Novel Pan-RAF–MEK Molecular Glue for MAPK Pathway Inhibition

  • Nested Therapeutics is developing NST-628, an oral, brain-penetrant pan-RAF–MEK molecular glue designed to avoid paradoxical pathway activation.
  • NST-628 differentiates itself from other RAS/RAF/MAPK pathway inhibitors through its unique mechanism of action.
  • Preclinical data supports the clinical development of NST-628, suggesting its potential as an ideal combination therapy partner.
  • The novel mechanism and preclinical profile of NST-628 mark it as a significant advancement in targeting the MAPK pathway.

Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).

NCT04303780Active, Not RecruitingPhase 3
Amgen
Posted 6/4/2020

A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations

NCT05242822TerminatedPhase 1
Kinnate Biopharma
Posted 3/29/2022

FDA Approves Roche's Tecentriq Hybreza, a Subcutaneous PD-L1 Inhibitor, for Multiple Cancers

  • The FDA has approved Roche's Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), a subcutaneous formulation, for multiple cancer types previously approved for the IV form.
  • Tecentriq Hybreza, combining atezolizumab with Halozyme's Enhanze technology, offers a faster, approximately 7-minute injection compared to the 30-60 minute IV infusion.
  • Clinical trials demonstrated comparable drug levels, safety, and efficacy to IV Tecentriq, with 71% of patients preferring the subcutaneous formulation due to convenience.
  • This approval marks Tecentriq Hybreza as the first and only subcutaneous anti-PD-L1 cancer immunotherapy available in the US, enhancing treatment flexibility.

New Research Highlights Complexities of Central Centrifugal Cicatricial Alopecia in Diverse Populations

  • University of Pennsylvania study reveals that 72% of Central Centrifugal Cicatricial Alopecia (CCCA) cases show classic presentation, while 28% display atypical distributions, challenging current diagnostic approaches.
  • Research identifies significant comorbidities in CCCA patients, including high rates of hyperlipidemia (66%), hypertension (70%), and obesity (64%), suggesting potential links to cardiovascular disease and breast cancer.
  • Expert emphasizes the importance of culturally sensitive approaches to hair care modifications, particularly for African American patients, while calling for increased research in diverse populations.

Poseida Therapeutics' P-BCMA-ALLO1 Receives FDA RMAT Designation for Relapsed/Refractory Multiple Myeloma

• Poseida Therapeutics' P-BCMA-ALLO1, an allogeneic CAR-T cell therapy, has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA. • The RMAT designation is based on encouraging Phase 1 clinical data, highlighting P-BCMA-ALLO1's potential efficacy and safety in multiple myeloma patients. • This designation facilitates increased interaction with the FDA and may allow for accelerated approval based on surrogate endpoints. • New clinical data from the P-BCMA-ALLO1 Phase 1 study will be presented at the International Myeloma Society Annual Meeting in September 2024.

P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma

NCT04960579RecruitingPhase 1
Poseida Therapeutics, Inc.
Posted 5/5/2022

Infex Therapeutics Doses First Patient in Phase IIa RESP-X Trial for NCFB

  • Infex Therapeutics has dosed the first patient in its Phase IIa clinical trial of RESP-X for non-cystic fibrosis bronchiectasis (NCFB).
  • RESP-X is a first-in-class anti-virulence antibody targeting chronic Pseudomonas aeruginosa (Pa) infections in respiratory diseases.
  • The Phase IIa trial is a double-blinded, placebo-controlled study assessing the safety, efficacy, and optimal dosing of RESP-X in 12 NCFB patients.
  • RESP-X, in-licensed from Shionogi, aims to reduce the frequency of debilitating exacerbations in NCFB patients colonized with Pa.

PDS Biotech's Versamune HPV Plus Pembrolizumab Shows Promising Survival in Head and Neck Cancer

  • PDS Biotechnology's Versamune HPV, combined with pembrolizumab, demonstrates a median overall survival of 30 months in HPV16-positive recurrent/metastatic HNSCC patients.
  • The combination therapy achieved an objective response rate of 36% and a disease control rate of 77% in the VERSATILE-002 Phase 2 trial.
  • A significant portion of patients experienced deep tumor responses, with 21% showing 90-100% tumor shrinkage.
  • A Phase 3 trial is planned to compare Versamune HPV plus pembrolizumab against pembrolizumab alone in HPV16-positive R/M HNSCC patients.

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