Financing provides strong base to complete Phase 3 clinical trial and commercialization of lead product candidate NiCord® for blood cancers
Jerusalem, Israel, June 19, 2017 — Gamida Cell Ltd., a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, today announced the signing of a $40 million financing to support the ongoing Phase 3 trial of the Company’s FDA Breakthrough Designated clinical-stage product, NiCord, to facilitate bone marrow transplantation. The financing is being led by new investor Shavit Capital. Additional primary participants include new investors VMS Investment Group and Israel Biotech Fund, as well as existing investor and major shareholder, Novartis. Current shareholders Clal Biotechnology Industries (CBI) and Israel HealthCare Ventures (IHCV) also participated in the financing.
“We are very pleased to have the strong support from both new and current investors as we continue to advance our lead product NiCord through late stage development and toward commercialization,” said Gamida Cell President and CEO Yael Margolin, Ph.D. “With this financing, we are well-positioned to complete the Phase 3 clinical trial of NiCord with the goal of bringing this lead product candidate to market and filling an important unmet need in bone marrow transplantation for blood cancer patients who cannot rapidly find a fully matched donor.”
Gamida Cell plans to use the proceeds to complete NiCord’s Phase 3 clinical trial and prepare for product commercialization by expanding its in-house manufacturing capacity, and the Company’s presence in the US, as well as continuing to develop additional pipeline products such as CordIn® for rare genetic diseases and NK cells as a treatment for cancer.
“The financing announced today provides important support for Gamida Cell’s innovative product pipeline, which has the potential to change the clinical application of cell based therapies. We are excited to take Gamida Cell to the next step towards becoming a commercial global company based on innovative oncology therapy,” said Gamida Cell’s Chairman of the Board, Julian Adams, Ph.D.
Gary Leibler, Founder and Managing Partner of Shavit Capital, stated, “Gamida Cell has a highly impressive management team, shareholder base and board of directors. These, combined with the strong clinical data of the Company’s pipeline products, attracted the attention of first tier international financial investors and pharmaceutical companies. Gamida Cell is now on course to complete its primary goal of developing its flagship product, NiCord, to address a multi-billion dollar market and help the many patients in need of better therapies.”
Andrew Ng, Head of Healthcare of VMS Investment Group, added, “We are pleased to join this distinguished group of investors and support this promising company. As a Hong Kong-based investment group with a strong healthcare presence and network in Asia, we are committed to supporting Gamida Cell with its Asia development and ultimately enabling more patients with high-risk blood cancers to benefit from this life-saving technology.”
NiCord is a stand-alone graft derived from a single umbilical cord blood unit which has been expanded in culture and enriched with stem and progenitor cells using Gamida Cell’s proprietary NAM technology. NiCord leverages the advantages of umbilical cord blood which does not need full tissue matching to the patient, and can therefore be available to practically all patients in need. It also aims to address the major barrier of umbilical cord blood transplantation – delayed hematopoietic recovery – by demonstrating an advantage with a primary endpoint that is clinically meaningful.
Results from the Phase 1 and Phase 2 studies of NiCord were published in the April 2017 edition of the Journal of Biology of Blood and Marrow Transplantation entitled “Transplantation of Ex Vivo Expanded Umbilical Cord Blood (NiCord) Decreases Early Infection and Hospitalization”.
Gamida Cell is currently enrolling patients in an international, multi-center, Phase 3 registration study of NiCord as a graft for bone marrow transplantation for patients with blood cancer who do not have a rapidly available fully matched donor. The Company announced in February 2017 that the first patient in the study had been transplanted. NiCord has an FDA Breakthrough Therapy Designation as well as FDA and EMA orphan drug designations, the most recent granted in March 2017. For more information on enrolling transplantation centers and study inclusion and exclusion criteria please click here.
About Gamida Cell
Gamida Cell is a world leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases. The company’s pipeline of products are in development to treat a wide range of conditions including cancer, genetic hematological diseases such as sickle cell disease and thalassemia, bone marrow failure syndromes such as aplastic anemia, genetic metabolic diseases and refractory autoimmune diseases. Gamida Cell’s current shareholders include Novartis, Clal Biotechnology Industries, Elbit Imaging (part of the Elbit Imaging Group), Israel Healthcare Ventures, Denali Ventures and Auriga Ventures. For more information please visit www.gamida-cell.com.
Jun 19, 2017