GBR 1342 to be devel­oped by Glenmark Pharma­ceu­ticals' spinoff inno­va­tion com­pany

{{image}}Mahwah, NJ (Press Release) – Glenmark Pharma­ceu­ticals (Glenmark), a research-led, integrated global pharma­ceu­tical com­pany, today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has granted Orphan Drug Desig­na­tion to its bispecific anti­body can­di­date GBR 1342 for the treat­ment of patients with multiple myeloma who have received prior ther­a­pies. Derived from the com­pany's pro­pri­e­tary BEAT® (Bispecific Engagement by Antibodies based on the T cell re­cep­tor) tech­nology, GBR 1342 is being in­ves­ti­gated for the treat­ment of multiple myeloma. The can­di­date is one of five clin­i­cal-stage assets in the pipe­line of Glenmark's new inno­va­tion com­pany.

GBR 1342 is designed to bind to both CD3 on T cells and CD38, an an­ti­gen known to be implicated in hema­to­logical malig­nan­cies, on target cells. This activates T cells and redirects them to­ward CD38+ tumor cells found in multiple myeloma. Once directed at the right target, the T cells help destroy the tumor cells.

A first-in-human, open-label, Phase 1 trial of GBR 1342 in multiple myeloma, is ongoing to assess the safety and tolerability of in­creas­ing doses of GBR 1342, and will also eval­u­ate bio­markers, immuno­gen­icity, and addi­tional measures of dis­ease activity.

"Patients who are struggling with dis­eases like multiple myeloma are seeking new treat­ment options and inno­va­tive ap­proaches. We believe the focus of our new com­pany is essential to these patients and to the health­care sys­tem," said Alessandro Riva, MD, CEO of the new com­pany. "As one of our first im­por­tant pipe­line mile­stones, we are excited that the FDA has recog­nized the poten­tial for GBR 1342 to offer a sig­nif­i­cant ad­vancement for patients with multiple myeloma."

Multiple myeloma is a rare blood disorder in which plasma cells in the bone marrow be­come malignant and replicate unchecked.1 The malignant plasma cells can displace nor­mal blood cells in the body, leading to anemia and uncontrolled bleeding.¹ It can also cause issues with bone density and strength, as well as lead to an in­creased risk of in­fec­tion by lowering the body's immune response.¹

More than 32,000 new cases of multiple myeloma are ex­pec­ted to be diag­nosed in 2019 in the U.S.2 During that same time, about 13,000 people are ex­pec­ted to die from the dis­ease.²

The FDA Office of Orphan Products Development grants orphan drug desig­na­tion to novel drugs and biologics that are in­tended for the safe and effective treat­ment, diag­nosis or prevention of rare dis­eases or disorders that affect fewer than 200,000 people in the United States. The desig­na­tion allows manu­fac­turers to qualify for various incentives, in­clud­ing tax credits for qualified clin­i­cal trials and – upon regu­la­tory approval – 7 years of mar­ket exclusivity.

About Glenmark Pharma­ceu­ticals

Glenmark Pharma­ceu­ticals is a research-driven, global, integrated pharma­ceu­tical or­ga­ni­za­tion with operations in more than 80 countries. It is ranked among the top 75 Pharma & Biotech com­pa­nies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2018). Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). Glenmark has several molecules in various stages of clin­i­cal devel­op­ment and is focused in the areas of on­col­ogy, auto­immune dis­ease and pain. For more in­for­ma­tion, please visit www.glenmarkpharma-us.com.

References

1. American Cancer Society 2019, What is Multiple Myeloma, accessed 3 September 2019 https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html
2. American Cancer Society 2019, Key Statistics About Multiple Myeloma, accessed 28 August 2019 https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html

Source: Glenmark Pharma­ceu­ticals.