HF158K1 / HighField Bio - LARVOL DELTA

HighField Biopharmaceuticals Files INDs for Two ADCplex Immunoliposomes with Different Cancer Killing Payloads to Overcome Limitations of Current ADCs (Businesswire) - "HighField Biopharmaceuticals...announced today it has filed two investigational new drug (IND) applications (HF158K1 and HFK2) with China’s National Medical Products Administration for immunoliposomes carrying different cancer killing payloads....HF158K1 (K1) and HFK2 (K2) are both fitted with HER2 antibodies for binding to cancer cell surface HER2 receptors in both HER2 high and low tumors. K1 is being evaluated as a monotherapy in an ongoing Phase 1 trial in the US (NCT05861895). The planned Phase 1 open label, dose escalation trial of K1 and K2 in China will evaluate the safety and pharmacokinetics of K1 as a monotherapy and preliminary efficacy in combination with K2."

New P1 trial • Trial status • Solid Tumor

HighField Biopharmaceuticals ASCO 2024 Poster Presentation Shows HFK1, a Unique Immunoliposome May Improve Clinical Outcomes over Antibody Drug Conjugates (Businesswire) - "HighField Biopharmaceuticals...will present positive clinical and preclinical data of HFK1, a drug encapsulated immunoliposome for treatment of solid tumors, at the American Society of Clinical Oncology annual meeting May 31 – June 4, in Chicago, IL. The poster presentation describes preliminary findings from the company’s Phase 1a study of HFK1 for HER2 low expression cancers....The clinical and preclinical data, which will be presented by HighField CEO and Scientific Founder Yuhong Xu, Ph.D., also includes study results comparing HFK1 to other antibody drug conjugates (ADCs) and PEGylated liposomal doxorubicin (PLD)."

P1 data • Preclinical • Oncology • Solid Tumor

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 Doses First Patient in Phase 1 Trial of HFK1, a Unique Immunoliposome, for Treatment of HER2 low and HER2+ Cancers (Businesswire) - "HighField Biopharmaceuticals, a clinical stage immuno-oncology company using lipid-based therapeutics to treat cancer, announced today the dosing of its first patient in its Phase 1 clinical trial of HFK1, a drug encapsulated immunoliposome containing doxorubicin for treatment of solid tumors. The multi-regional, open-label, clinical trial is enrolling patients who have advanced refractory solid tumors with HER2 low and HER2+ expression. HER2 expressing solid tumors include breast, bladder, pancreatic, ovarian, stomach, colon, prostate, lung, uterus and cervix cancers."

Trial status • Bladder Cancer • Breast Cancer • Cervical Cancer • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Uterine Cancer

A Clinical Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HF158K1 in Participants With HER-2 Positive or HER-2 Low Expression Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=84 | Recruiting | Sponsor: HighField Biopharmaceuticals Corporation | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor • HER-2

HighField Biopharmaceuticals Receives US FDA IND Clearance for Phase 1 Trial of Immunoliposome HF158K1 for Treatment of HER2 low and HER2+ Cancers (Businesswire) - "HighField Biopharmaceuticals...announced...the U.S. Food and Drug Administration has granted clearance of the company’s Investigational New Drug (IND) application for HF158K1, a drug encapsulated immunoliposome containing doxorubicin...The company will conduct a Phase 1 multi-regional, open-label, clinical trial in patients who have advanced refractory solid tumors with HER2 low and HER2+ expression....The trial, expected to begin this summer, will be conducted in the U.S., China and other countries. A Phase 1a dose escalation portion of the study will enroll 24 patients followed by Phase 1b dose expansion trial with up to 60 patients. Both the Phase 1a and 1b studies will assess the safety and preliminary efficacy of HF158K1."

IND • Trial status • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Tolerability and Safety of HF158K1 Injection in Participants With HER-2 Positive or Low Expression Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=84 | Not yet recruiting | Sponsor: HighField Biopharmaceuticals Corporation

Metastases • New P1 trial • Oncology • Solid Tumor • HER-2