We are Now Enrolling a Phase II Study of the SV-BR-1-GM Regimen for Metastatic or Locally Recurrent Breast Cancer Patients in Combination with Retifanlimab

What is the purpose of this study?

The purpose of this study is to help patients with advanced breast cancer with a clinical trial involving SV-BR-1-GM in combination with other anti-cancer drugs.

SV-BR-1-GM was created with a human breast cancer cell line that has been genetically engineered to produce a substance called GM-CSF, which occurs naturally in the body and is used to stimulate production of white blood cells by your bone marrow. The goal of this clinical trial is to help develop targeted killer T-cells/antibodies in the treatment of cancer.

In this clinical study, you will receive injections of SV-BR-1-GM in combination with two FDA approved drugs and one experimental immunotherapy drug, Retifanlimab.

Biomarkers: HER2+, HER2-, ER+, ER-, PR+, PR-

This research study is being conducted for the therapy of advanced breast cancer in combination with a targeted immunotherapy drug (retifanlimab).

The goal of this therapy is to boost your immune system and/or help to control or shrink your cancer.

There is no charge for the experimental therapy injections. There may be some costs for the study procedures. BriaCell, the study sponsor, and your doctors at Manhattan Hematology Oncology Associates are committed to minimizing costs. Travel costs, parking, and other expenses associated with participation in the study may be covered for you.

The BRI-ROL-001 clinical trial is enrolling potential patients regardless of their HLA matching status and tumor grade. Patients with Hemoglobin ≤ 8g/L will also be eligible.

We are Now Enrolling Patients for a Phase II Study of IGM-8444 as a Single Agent and In Treatment Combination for Relapsed, Refractory, or Newly Diagnosed Colorectal Cancers

What is the purpose of this study?

The purpose of this study is to help patients with advanced or newly diagnosed colorectal cancer challenges.

About IGM-8444

IGM-8444 is an Immunoglobulin M (IgM) antibody, a protein normally produced by the body’s immune system to detect harmful substances, made to target DR5.

DR5 is a protein on the surface of certain cells that when activated, may kill cancer cells. R5 is seen at higher levels on tumor cells than normal human cells, which allows drugs targeting DR5 to induce cell death and eliminate the cancer cells.

Unlike traditional IgG antibodies, IGM-8444 has 10 binding units, enabling it to bind to DR5 more tightly due to its IgM structure, and cross-link multiple DR5 receptors at the same time, sending a stronger signal to cause cancer cell death.

The IGM Colon Cancer Study at Manhattan Hematology Oncology Associates, NYC

This clinical study will test IGM-8444 (as an IV treatment) in combination with the FOLFIRI treatment plan, or another FDA approved similar treatment.

“We continue to be very pleased with the indications of clinical activity that we are observing with IGM-8444,” said Chris Takimoto, M.D., Chief Medical Officer of IGM Biosciences. “We are also very pleased with the excellent safety profile that we have seen to date. The long progression-free survival that we have seen in some patients, especially those who have progressed on prior chemotherapy, is quite encouraging as we proceed to further clinical development with FOLFIRI and other combination therapies such as bevacizumab."

All study-related care, including laboratory tests and clinic procedures performed solely for research purposes, will be provided at no charge to the patient.

This clinical trial at Manhattan Hematology Oncology Associates with Dr. Alec Goldenberg is now open and actively enrolling at Manhattan Hematology Oncology Associates,157 East 32nd Street, NYC.

We are Currently Enrolling 1st- and 2nd-Line CML Patients for a Clinical Trial of ASCiminib Monotherapy with Dose Escalation.

This clinical trial in New York City could offer a new opportunity to CML patients.

CML Chronic Myeloid Leukemia is a malignancy that affects the bone marrow where blood cells are made. Some patients fo not respond to Tyrosine Kinase Inhibitors (TKIs), or may develop a refractory disease.

This clinical trial at Manhattan Hematology Oncology Associates with Dr. Alec Goldenberg offers a monotherapy for patients with chronic myeloid leukemia in chronic phase (CML-CP) without the T315I mutation, previously treated with 1 tyrosine kinase inhibitor (TKI) and also for newly diagnosed patients with CML-CP. Asciminib inhibits the ABL1 kinase activity of the BCR::ABL1 fusion protein by binding to the ABL myristoyl pocket.

Asciminib and all study-related care, including laboratory tests and clinic procedures performed solely for research purposes, will be provided at no charge to the patient. The study is now open and actively enrolling at Manhattan Hematology Oncology Associates, 157 East 32nd Street, NYC.