Novus Finalizes Acquisition of Anelixis to Further Develop AT-1501

Novus Therapeutics announced on Monday that it had completed its acquisition of Anelixis Therapeutics, a privately held clinical stage biotechnology company. Anelixis Therapeutics is currently in the process of developing a next-gen anti-CD40 Ligand (CD40L) antibody as a potential treatment for organ and cellular transplantation, autoimmune diseases and neurodegenerative diseases.

Gross proceeds of approximately $108 million will go to Novus Therapeutics before deducting placement agent and additional offering expenses. The proceeds will be used to finance the advancement of a Phase II clinical trials of AT-1501, a humanized IgG1 anti-CD40L antibody with high affinity for CD40L.

“We are excited about AT-1501 and the potential to develop and commercialize the next generation anti-CD40L antibody, a well-validated target with broad therapeutic possibilities,” said Keith A. Katkin, Chairman of the Board of Directors of Novus. “After exploring a range of strategic options to maximize shareholder value, we believe this acquisition represents the greatest value creation opportunity for Novus stockholders, and we are confident that we have the management and scientific leadership team to fully realize this opportunity for patients in need of new treatment options.”

Anelixis announced the initiation of its Phase I study exploring AT-1501 back in November 2018. This came after the allowance of an Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA). At the time, the goal was to evaluate the safety and pharmacokinetics of AT-1501 in healthy volunteers, along with patients with amyotrophic lateral sclerosis (ALS).

ALS is a progressive neurodegenerative disease that has a median survival rate of three to five years after diagnosis. Patients are often diagnosed in their fourth of fifth decade of life. ALS is considered to be an orphan disease with approximately 5,000 newly diagnosed cases each year in the U.S.

Anelixis originally entered an exclusive licensing agreement with the ALS Therapy Development Institute back in 2015 to develop AT-1501 as a potential treatment for ALS and other diseases. The FDA granted orphan drug designation for AT-1501 in April 2018.

AT-1501 blocks costimulatory signaling between lymphocytes and antigen presenting cells. In preclinical models of autoimmunity, blocking CD40L signaling has been shown to slow disease progression. Since its founding back in 2015, Anelixis has optimized and validated a cGMP manufacturing process for AT-1501 as well.

"The advancement of AT-1501 into clinical development is a major milestone for Anelixis, but more importantly for people living with ALS and other devastating neurodegenerative or autoimmune diseases, including for example Type I Diabetes patients no longer able to monitor their glycemic index and requiring transplant surgery,” said Steven Perrin, PhD., President and Chief Executive Officer of Anelixis Therapeutics, at the time of the news. “The preclinical data for blocking CD40L is very compelling in preclinical models of ALS and in kidney transplantation and in pancreatic islet cell transplantation to treat Type 1 diabetes. This is an exciting opportunity for Anelixis to translate these preclinical studies into a potentially significant health benefit for many thousands of people with devastating diseases.”

Anelixis Therapeutics focuses on developing effective treatments for unmet medical needs. Specifically, the company focuses on autoimmune diseases, neurodegenerative diseases and people requiring an organ or cell-based transplant.

Novus Therapeutics specializes in targeting the CD40L pathway to develop treatments for people who require an organ or cell-based transplant, and for people with autoimmune and neurodegenerative disease.