Eli Lilly will partner with ImmuNext to study and develop a preclinical novel potential target for autoimmune disease treatments, the companies said, through an up-to-$605 million-plus collaboration that is the phama giant’s second autoimmune-focused partnership launched in the past three months.
Jay Rothstein, CSO at ImmuNext, described the target in a statement as “a first-in-pathway antibody that specifically targets the metabolism of lymphocytes to reprogram rather than suppress the immune system.”
Validation studies—both ex vivo and in small animal studies—have shown the immunometabolic checkpoint target to operate independently and upstream of known immune checkpoint regulators. In addition, therapies targeting the novel transporter target have been shown to regulate immune cell metabolism, ImmuNext states on its website.
That creates an opportunity for treatment of indications with currently limited therapeutic avenues through potential new therapies for autoimmune diseases that are designed to regulate immune cell metabolism, Lilly and ImmuNext reason.
“Regulating the metabolism of immune cells is a promising approach to treating these diseases, and we look forward to working with ImmuNext to advance their immunometabolism target,” stated Ajay Nirula, MD, PhD, vice president of immunology at Lilly. “Immunology is an important area of research for Lilly, and we seek novel targets that could develop into new medicines for patients suffering with autoimmune diseases.”
Immunology is among Lilly’s areas of therapeutic interest, along with oncology, neuroscience, pain, and diabetes and diabetes-related complications.
Of Lilly’s $1.140 billion in immunology revenue last year, 82% came from the marketed drug Taltz® (ixekizumab), a treatment for moderate-to-severe plaque psoriasis and active psoriatic arthritis which generated $937.5 million—up 68% from $559.2 million in 2017.
Growing immunology portfolio
The remainder of Lilly’s immunology revenue came from other treatments that included Olumiant® (baricitinib), co-developed with Incyte. Olumiant’s 2 mg dose was approved last year for adults with moderate-to-severe rheumatoid arthritis.
Lilly is intent on growing its immunology portfolio. Olumiant is also in Phase III development in atopic dermatitis and systemic lupus erythematosus. Last year, Lilly launched Phase III trials for another immunology candidate, Mirikizumab (LY3074828), in psoriasis and ulcerative colitis.
Lilly bolstered its pipeline in autoimmune and other inflammatory diseases in December when it launched a partnership with Aduro Biotech to develop novel immunotherapies for autoimmune and other inflammatory diseases using Aduro’s cGAS-STING Pathway Inhibitor program. The companies inked a license agreement through which Lilly agreed to pay Aduro $12 million upfront and up to approximately $620 million per treatment developed.
In the latest collaboration, Lilly agreed to pay ImmuNext $40 million upfront, up to approximately $565 million in payments tied to achieving development and commercialization milestones, as well as tiered royalties ranging from the mid-single to low-double digits on product sales.
In return, ImmuNext agreed to grant Lilly an exclusive, worldwide license to develop and commercialize the novel immunometabolism target. The companies also established a three-year research collaboration designed to support the target’s development.
The companies have signed a global licensing and research collaboration agreement that is subject to customary closing conditions. Lilly said the agreement will not change its 2019 non-GAAP earnings per share (EPS) guidance, which ranges from $5.55 to $5.65. Lilly’s GAAP EPS guidance ranges from $4.57 to $4.67.
Privately-held ImmuNext is based within the Dartmouth-Hitchcock Medical Center in Lebanon, NH, which according to the company affords excellent access to both upstream academic research and downstream translational medicine.