pegylated all-trans retinoic acid (HF1K16) / HighField Bio - LARVOL DELTA

Targeting MDSCs with HF1K16 Unlocks Long-Term Survival in Refractory Recurrent Glioma: an update of NCT05388487 (SITC 2025) - P1 | "These findings support continued clinical investigation of HF1K16.Trial Registration NCT05388487Ethics Approval This study is approved by the Ethics Committee of Huashan Hospital Affiliated to Fudan University at Mar 11, 2022Consent Written informed consent was obtained from the patient for publication of this abstract and any accompanying images. A copy of the written consent is available for review by the Editor of this journal."

Late-breaking abstract • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor

Myeloid cell targeted immune modulation in solid tumor and brain tumor patients: An analysis of nct05388487 phase 1 study data (AACR 2025) - P1 | "HF1K16 treatments were shown to be safe and well tolerated with limited side effects. Significantly reducing the proportion of MDSC was achieved. This myeloid-targeting immunotherapy approach may offer a novel therapeutic strategy for the treatment of brain tumors."

Clinical • Late-breaking abstract • P1 data • Brain Cancer • Glioma • Oncology • Solid Tumor • CD8

A phase Ia study of the myeloid-derived suppressor cell modulator HF1K16 in refractory and metastatic cancer patients: Preliminary efficacy and safety (ESMO 2024) - P1 | "While the interpretation of our data is limited by the small sample size, the results provide an encouraging signal and warrants further assessment. We are currently conducting an advanced glioma-specific expansion arm and patient recruitment continues with anticipated completion in 2024."

Clinical • Metastases • Myeloid-derived suppressor cells • P1 data • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor

Data from a Phase 1 Trial of HighField Biopharmaceuticals’ HF1K16 Show the New Immuno-Oncology Drug is Safe and Signals Efficacy in Treating Refractory Metastatic Cancers (Businesswire) - P1 | N=54 | NCT05388487 | Sponsor: HighField Biopharmaceuticals Corporation | "HighField Biopharmaceuticals...announced today its CEO and Scientific Founder Yuhong Xu, Ph.D, presented positive safety and efficacy findings from an ongoing Phase 1 clinical trial of HF1K16 (K16) in refractory metastatic cancer patients at the European Society of Medical Oncology (ESMO) Congress in Barcelona, Spain, September 13 – 17, 2024....As of Sept 1, 2024, 19 patients having Grade II, III and IV tumors have been enrolled. Among the 10 patients with Grade II and III gliomas, median overall survival (mOS) is 629 days. For the 9 patients with Grade IV or glioblastoma, the most aggressive brain tumors, mOS is 315 days."

P1 data • Oncology • Solid Tumor

Exploratory phase I study of HF1K16 for the treatment of patients with refractory/recurrent advanced glioma. (ASCOBT 2024) - P1 | "Prior to and during treatment, peripheral blood mononuclear cells were collected and analyzed with flow cytometry to monitor the changes in myeloid cell phenotype and T cell composition. The recruitment of patients is anticipated completed in 2024."

Clinical • IO biomarker • Metastases • P1 data • Tumor mutational burden • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor • TMB

Exploratory phase I study of HF1K16 for the treatment of patients with refractory/recurrent advanced glioma: Preliminary efficacy and mechanism as a monotherapy. (ASCO 2024) - P1 | "While the interpretation of our data is limited by the small sample size, the results provide an encouraging signal and warrants further assessment. Patient recruitment continues with anticipated completion in 2024. Clinical trial information: NCT05388487."

Clinical • Metastases • Monotherapy • P1 data • Brain Cancer • CNS Tumor • Dyslipidemia • Glioblastoma • Glioma • Hypertriglyceridemia • Metabolic Disorders • Oncology • Pain • Solid Tumor • CD8

Evaluate the Safety, Tolerability and PK of HF1K16 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: HighField Biopharmaceuticals Corporation | Terminated ➔ Completed

Trial completion

HighField Biopharmaceuticals Announces Two Abstracts Accepted for the 2024 ASCO Annual Meeting (Businesswire) - "The abstracts reflect Phase 1 clinical trials of two kinds of lipid-based therapeutics. HFK1 is a drug encapsulated immunoliposome containing doxorubicin for patients with advanced refractory solid tumors having HER2 low and HER2+ expression. HER2 expressing solid tumors include breast, bladder, pancreatic, ovarian, stomach, colon, prostate, lung, uterus and cervix cancers. HF1K16 is a drug encapsulated immune modulating liposome containing all-trans retinoic acid (ATRA) for patients with recurrent and refractory glioma."

P1 data • Bladder Cancer • Breast Cancer • Cervical Cancer • Colon Cancer • Gastric Cancer • Glioma • Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Urothelial Cancer • Uterine Cancer

HighField Biopharmaceuticals HF1K16 Phase 1a Data Suggests the New Immuno-Oncology Drug is Safe, Well-Tolerated and Efficacious in Solid Tumors (Businesswire) - P1a | N=54 | NCT05388487 | Sponsor: HighField Biopharmaceuticals Corporation | "HighField Biopharmaceuticals...announced today it has completed its Phase 1a study of HF1K16. Treating patients having multiple tumor types, the data demonstrated that the drug, administered as a single agent, is well-tolerated with only one dose-limiting toxicity (DLT) at the highest dose level. HF1K16 is a drug encapsulated immune modulating liposome containing all-trans retinoic acid....Overall, the disease control rate for the patients is about 35% with a median overall survival of 8.5 months. The maximum survival period has exceeded 24 months and five patients have survived more than 10 months."

P1 data • Oncology • Solid Tumor

HighField Biopharmaceuticals Announces Positive Phase 1a Data of HF1K16, a new Immuno-Oncology Drug, For Patients with Recurrent and Refractory Glioma (Businesswire) - P1b/2 | N=54 | NCT05388487 | Sponsor: HighField Biopharmaceuticals Corporation | "HighField Biopharmaceuticals...announced results of its Phase 1a study of HF1K16 showing three of five patients with recurrent and refractory glioma had maintained disease control for more than 8 months with one patient experiencing complete response....'We are currently enrolling additional glioma patients in our Phase 1b/2 extension trial to confirm these outcomes and expect to have the results in the first quarter of 2024.'...Of the three patients who had experienced disease control, one patient achieved complete remission after 12 months of treatment and has been cancer free afterwards for 7 months. One of the other two patients, with grade IV glioblastoma, maintained stable disease for more than 4 months."

P1 data • P1/2 data • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor

HighField Biopharmaceuticals Announces First Patient Dosed in Phase 1b/2 Trial of HF1K16 for Recurrent and Refractory Glioma (Businesswire) - "HighField Biopharmaceuticals...announced today the first patient has been dosed in a Phase 1b/2 trial of HF1K16 for recurrent and refractory glioma. HF1K16 is a drug encapsulated immune modulating liposome containing all-trans retinoic acid....The Phase 1b/2 trial will be conducted in China and will assess safety and efficacy as well as evaluate changes in MDSC numbers and phenotypes."

Trial status • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor

Tolerability and Safety of HF1K16 Injection in Patients With Refractory Solid Tumors (clinicaltrials.gov) - P1 | N=54 | Recruiting | Sponsor: HighField Biopharmaceuticals Corporation | N=24 ➔ 54 | Trial completion date: Dec 2023 ➔ Nov 2025 | Trial primary completion date: May 2023 ➔ Apr 2025

Enrollment change • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Modulating MDSCs by HF1K16: A mono-therapy phase Ia study examining safety and preliminary efficacy in patients with refractory and metastatic cancer. (ASCO 2023) - P1 | "HF1K16 is well tolerated at the 45 mg/m2 and 90 mg/m2 dose levels when given as monotherapy. Using the RECIST 1.1 criteria, one patient achieved an objective response with a progressive reduction of the target lesion from 70mm to 23.7mm. Four patients had PFS longer than 3 months."

Clinical • Metastases • P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

HighField Biopharmaceuticals’ HF1K16, a New Immuno-Oncology Drug, Shows Promise in Patients with Refractory Glioblastoma (Businesswire) - "HighField Biopharmaceuticals...announced today the publication of an abstract including preliminary data from a Phase 1a clinical trial of HF1K16 in refractory metastatic cancer patients. It was published online at the American Society of Clinical Oncology (ASCO) Annual Meeting....The preliminary data reported at ASCO is from an ongoing Phase 1a trial in China with patients suffering from a variety of refractory metastatic cancers. Based on the positive findings related to glioma, HighField Bio expects to begin a Phase 1b/2 trial in China for patients with refractory glioma in the next few weeks."

New P1/2 trial • P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Tolerability and Safety of HF1K16 Injection in Patients With Refractory Solid Tumors (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: HighField Biopharmaceuticals Corporation | Trial completion date: Jun 2023 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ May 2023

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

The Expression of ARMCX1 in Gastric Cancer Contributes to Prognosis and Influences Chemotherapy. (PubMed, J Immunol Res) - "Among which, ARMCX1 exhibited great potential to serve as a prognostic biomarker for gastric patients; furthermore, patients with low expression of ARMCX1 could be more sensitive to these 9 chemotherapeutic agents: A-770041, AMG-706, ATRA, BEZ235, bortezomib, CGP60474, dasatinib, HG-64-1, and pazopanib, rather than the other chemotherapeutic agents. This study helps the improvement of evaluating the prognosis of gastric cancer patients, and would help optimize chemotherapeutic strategies in consideration of the expression of ARMCX1."

Biomarker • Journal • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Tolerability and Safety of HF1K16 Injection in Patients With Refractory Solid Tumors (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: HighField Biopharmaceuticals Corporation

New P1 trial • Oncology • Solid Tumor

Evaluate the Safety, Tolerability and PK of HF1K16 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=16 | Terminated | Sponsor: HighField Biopharmaceuticals Corporation

New P1 trial