Novartis announces an exclusive global licensing and research collaboration with Regenerex

NovartisNovartis today announced that it has entered into an exclusive global licensing and research collaboration agreement with Regenerex LLC, a biopharmaceutical company based in Louisville, Kentucky, for use of the company's novel Facilitating Cell Therapy (FCRx) platform. The hematopoietic stem cell-based FCRx platform has been investigated in kidney transplantation to induce stable immunological tolerance, resulting in graft survival without the need for lifelong immunosuppression. This collaboration reaffirms the Novartis commitment to transplant. Beyond transplant, Regenerex's novel platform potentially has curative potential for multiple underserved diseases and will be investigated in the rescue of serious genetic deficiencies such as inherited metabolic storage disorders and hemoglobinopathies.

"As the field of biomedicine sits on the cusp of a new transformation, we are excited to announce this agreement which supports the Novartis leadership position in cell therapy," said Dr. Timothy Wright, Global Head Development, Novartis Pharmaceuticals. "Thirty years ago, Novartis developed ciclosporin, which changed transplantation treatment paradigms and enabled countless lives to be saved. Now, this collaboration, along with our internal cell therapy assets, has the potential to transform medicine once again through innovation."

FCRx will broaden the current Novartis cell therapy portfolio, which includes two novel cell therapy platforms initially being investigated in hematological malignancies. HSC835 is a novel cell therapy approach that enables an expanded single umbilical cord blood derived hematopoietic stem cell transplant in patients with limited treatment options. HSC835 is currently in a Phase II trial in patients with high-risk hematological malignancies. A second cell therapy product, CTL019 is a chimeric antigen receptor T cell therapy currently in Phase II development in acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL).

About FCRx
FCRx is a novel allogeneic hematopoietic stem cell based therapy platform that also contains facilitating cells derived from a donor. The platform supports the development of tolerance, or "bone marrow chimerism," in transplant recipients, providing a better side effect profile than current human hematopoietic stem cell transplantation protocols. Chimerism may eventually render the recipient tolerant to cell, tissue or organ transplants from the same donor, thereby enabling transplant patients to discontinue immunosuppressive medications after building stable immunological tolerance. Results from a Phase II study in 15 kidney transplant recipients are extremely encouraging with six patients fully withdrawn from immunosuppression without loss of engraftment, and a further two with planned full withdrawal at 1 year[1]. Currently, solid organ transplant recipients must take immunosuppressive drugs for life to prevent rejection. This approach may also allow for treatment of inherited metabolic diseases like metachromatic leukodystrophy or sickle cell disease.

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 131,000 full-time-equivalent associates and operate in more than 140 countries around the world.

1. Leventhal J, Abecassis M, Miller J. Gallon L, Ravindra K, Tollerud DJ, King B, Herzig G, Herzig R, Ildstad ST. Chimerism and tolerance without GVHD or engraftment syndrome in HLA-mismatched combined kidney and hematopoietic stem cell transplantation. Science Translational Medicine 2012 Mar 7; 4(124): 124ra28.

Most Popular Now

Novartis rises to second place in 2018 Access to M…

Novartis ranked second in the 2018 Access to Medicine Index (ATMi), up from 3rd place in 2016, in recognition of its long-standing efforts to improve worldwide access to ...

Sanofi builds focus on rare blood disorders and ca…

Some of the most serious unmet patient needs today are in the field of hematology. Rare blood disorders and blood-related cancers continue to be a major focus of research...

MSD is looking for a digital health solution to em…

MSD Lebanon is looking for an external partner to co-create a digital solution that helps oncologists to stay updated with relevant clinical content about cancer. The sol...

FDA approves new treatment for patients with acute…

The U.S. Food and Drug Administration today approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for t...

Lilly submits New Drug Application to the FDA for …

Eli Lilly and Company (NYSE: LLY) has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lasmiditan for the acute...

New study reveals probiotics do not help children …

Probiotics are a multibillion-dollar industry with marketing claims of being an effective treatment for a multitude of ailments, including diarrhea. However, findings fro...

Merck and Pfizer provide update on avelumab in pla…

Merck and Pfizer Inc. (NYSE: PFE) today announced that the Phase III JAVELIN Ovarian 200 trial evaluating avelumab* alone or in combination with pegylated liposomal doxor...

U.S. FDA approves Larotrectinib, the first TRK inh…

The U.S. Food and Drug Administration (FDA) has approved larotrectinib, the first oral TRK inhibitor, under the brand name Vitrakvi®. The approval is for the treatment of...

FDA approves first treatment for Lambert-Eaton mya…

The U.S. Food and Drug Administration today approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a r...

Bristol-Myers Squibb awards "Golden Tickets…

Bristol-Myers Squibb Company (NYSE: BMY) and LabCentral, an innovative, shared laboratory space designed as a launchpad for life-sciences and biotech startups, today anno...

Alcon to highlight its vision, strategy and benefi…

Alcon, the eye care division of Novartis, will today hold its first Capital Markets Day for investors and analysts in relation to the previously-announced intention of No...

FDA grants breakthrough device designation to arti…

Bayer announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to the Artificial Intelligence Software for Chronic Thrombo...