The ALS Therapy Development Institute (ALS TDI) is excited to share that Anelixis Therapeutics, the for-profit clinical-stage development company that advanced the drug AT-1501 to clinical trial, announced on Monday, September 14, that they have been acquired by Novus Therapeutics.
Through this acquisition, AT-1501 is expected to advance to the next stage of clinical development, a phase 2 trial in ALS.
“We are pleased to see that Novus Therapeutics has expressed a strong commitment to advance AT-1501 through further clinical development for ALS. People with ALS expect and need more and better treatment options. We are hopeful that AT-1501, a drug invented at ALS TDI, can emerge as one.” said Fernando G. Vieira, M.D., ALS TDI’s Chief Scientific Officer.
AT-1501 is an investigational antibody that targets the CD40 ligand (CD40L), a protein present at the surface of some white blood cells that is involved in inflammation. In ALS, blocking CD40L activation decreases inflammatory responses implicating CD40L in neurodegeneration.
AT-1501 was invented by the ALS Therapy Development Institute, and in 2019, Anelixis Therapeutics successfully completed phase 1 clinical trials for AT-1501 as a treatment for ALS. The study, involving both healthy volunteers and participants with ALS, showed that AT-1501 was well tolerated at all doses tested and that the pharmacokinetic properties of AT-1501 were typical for an IgG1 antibody therapeutic.
AT-1501 is being developed by Novus Therapeutics as a potential treatment in renal transplantation, islet cell transplantation, autoimmune nephritis, and ALS. ALS will be the first of these indications to begin enrolling for Phase 2 trials, and enrollment is expected to begin by the end of 2020.
ALS TDI’s CEO, Steve Perrin, PhD stated, “The partnership between ALS TDI and Anelixis to move AT-1501 from preclinical to clinical development has been very exciting. This unique business relationship truly demonstrates the ability of a nonprofit to leverage philanthropic support to move a promising treatment into clinical trials. As we discover more potential treatments for ALS, we will lean into these experiences as we look to advance new leads into human clinical testing.”
AT-1501 is the first potential treatment to be invented at ALS TDI and successfully advanced through a Phase 1 clinical study. However, scientists at ALS TDI are continuing to work to find more potential treatments for people with ALS. With continued funding, ALS TDI hopes to develop more promising treatments that can be brought through trial and eventually become available for people with ALS.
AT-1501 is a humanized IgG1 anti-CD40L antibody with high affinity for CD40L, a well-validated target with broad therapeutic potential. The CD40/CD40L pathway plays a central role in generating pro-inflammatory responses in autoimmune disease, allograft transplant rejection, and neuroinflammation. In a Phase 1 safety study of healthy volunteers and patients with ALS, AT-1501 was well tolerated at all doses tested.
About Anelixis Therapeutics
Anelixis Therapeutics, Inc. was a clinical stage, privately held biotechnology company developing treatments for patients with neurodegenerative disease, people requiring an organ or cell based transplant, as well as people with an autoimmune disease. Since its founding in 2015, Anelixis Therapeutics has optimized and validated a cGMP manufacturing process for AT-1501, confirmed exceptional activity in preclinical disease models, demonstrated safety and tolerability in humans
The development of AT-1501 has been funded with support from The ALS Therapy Development Institute, Augie’s Quest to Cure ALS, The ALS Association, ALS One, ALS Finding a Cure, and The Congressionally Directed Medical Research Program. Anelixis also conducted several private placement rounds including a round led by Noble Capital Markets, Inc. (Noble), an investment bank headquartered in Boca Raton Florida, who acted as the exclusive placement agent in a private placement financing round, and a financing round was also led by the Biotechnology Value Fund, L.P. and other affiliates of BVF Partners L.P. (“BVF”).
For more information, please visit the company’s website at www.AnelixisTherapeutics.com.