Precision Therapy. Personalized

Second generation CD 19 CAR T with a 4-1BB co-stimulatory domain and A3B1 binder, a nin-FMC63 murine scfv.

The selection of CD4 & CD8 T-cells leads to high specificity.

The use of IL-7 & IL-15 during manufacturing leads to higher persistence of CAR T-cells.

  • Lower Relapse Rates and Higher Progression Free Survival (PFS).
CART T-cell: Chimeric antigen receptor T-cell | IL: Interleukin

Global evidence
you can trust

Global data of ~140 patients, over four years.

First fractioned does globally, designed to improve safety.

1-year OS, ORR and PFS of varnim-cel are comparable to USFDA approved CAR T products.

  • Robust Efficacy & safety
  • Large patient pool globally
  • Designed to be safer
  • Improves patient outcomes and quality of life
CART T-cell: Chimeric antigen receptor T-cell | OS: Overall survival | ORR: Objective response rate | PFS: Progression free survival | USFDA: United States Food and Drug Administration

Consistent, high quality, every time

Manufactured using the fully integrated Miltenyi CliniMACS Prodigy system, a USFDA and EMA approved platform – an automated closed GMP system.

GMP grade raw materials used in the manufacturing process and multi-step QC testing across the product manufacturing process, overcoming variability and ensuring global safety parameters.

LV is imported from Europe (Spain).

  • 100% manufacturing success*.
  • Global quality product, manufacturing standards and processes.
USFDA: United States Food and Drugs Administration | EMA: European Medicines Agency | GMP: Good Manufacturing Practices | QC: Quality Control | *during the IMAGINE clinical trial in India

Uncompromised, state-of-the-art product handling

Qartemi is transported in a LN2 vapour phase at -150°C.

Data loggers continuously monitor the temperature of the dry shipper.

Ensuring chain of custody and chain of identity by collaborating with leading international logistics partners.

  • Cryogenic transportation of a Cell & Gene Therapy Product as per Global CGT standards to ensure cell viability, maintain therapeutic potency & preserve immunogenicity.
CGT: Cell and Gene Therapy | LN: Liquid Nitrogen

Adherence to 
global benchmark

Robust technical feasibility assessment process of treatment sites.

Customized medical & product handling training program to equip doctors and all stakeholders with the necessary guidance to appropriately screen patients and manage adverse events.

Expert Advisory Panel: A value added service provided to the prescriber in the form of an advisory panel consisting of Principal Investigators and Spanish KOLs to evaluate the patient’s profile and provides expert advice.

KOLs: Key Opinion Leaders
Image is for illustration purpose only
Image is for illustration purpose only
Image is for illustration purpose only
Image is for illustration purpose only
Image is for illustration purpose only

About Qartemi

Qartemi (varnimcabtagene autoleucel) is a groundbreaking immunotherapy for Relapsed / Refractory B Cell Non-Hodgkin Lymphoma. It is an autologous second-generation CAR T-cell product.

Qartemi consists of 4-1BB co-stimulatory domain and a non-FMC63 based murine single chain variable fragment targeting CD19 (A3B1 binder), manufactured in India by Immuneel Therapeutics.

Mechanism of Action

CAR T-cell therapy is a novel treatment to fight some cancers. It involves using body’s own immune system to treat your cancer.

The body has different types of blood cells, such as white blood cells. Lymphocytes are a part of white blood cells, which are an important part of your immune system that fights infections and cancers. These are broadly of two types – B-cells and T-cells.

T-cell lymphocytes are an integral part of your immune system and play an important role in fighting cancer. T-cells recognize abnormal cells, such as cancer cells, using proteins on their surface called receptors. They bind to proteins found on cancer cells and destroy them. Sometimes, cancer cells can survive by disguising themselves from being recognized by T-cells. 

For CAR T-cell production, T-cells from your blood are collected through a process called Apheresis. Scientists in the laboratory then change the DNA of T-cells to make them produce a new type of receptor, called a Chimeric Antigen Receptor (CAR), they become CAR T-cells. These CAR T-cells are more efficient at binding to and removing cancer cells. They also send out signals that attract other immune cells and cause them to rapidly reproduce near the cancer cells. This increases the chance of eliminating cancer cells from the body. Thus, CAR T-cells can find and destroy cancer cells more effectively than ordinary T-cells.

CD-19 CAR T-cell therapy has been a standard of care for Relapsed/Refractory B-cell Malignancies in the West since 2017. Based on the recently published evidence, CD-19 targeted CAR T-cell therapy is now the preferred second line therapy for some sub types of B-cell Malignancies.

Indications and Dosage

Indication
Relapsed / Refractory B Cell Non-Hodgkin lymphoma(B-NHL) in patients aged greater than 18 years of age. Reference: QARTEMI Prescribing Information.
Dosage
One dose of QARTEMI contains 0.1 x 106 to 5 x 106 CAR-positive viable T cells per kg of body weight and is dispensed in three fractions – 10%, 30%, 60%, dispersed in three infusion bags of approximately 30 ml each.

Efficacy

Safety

cytokine release syndrome (CRS)

G3 + 0%

Overall 75% (n = 9/12)

Frequently asked questions

Before reaching out for support, we recommend checking our comprehensive Frequently Asked Questions (FAQ) section. In case your queries are not answered, please contact us.

check faq’s