INDIANAPOLIS & LA JOLLA, Calif.—In a collaboration deal that will pursue therapeutic targets focused on immunology and other select indications, global pharma giant Eli Lilly and Co. connected with small/medium-sized company (SMC) Avidity Biosciences Inc. to discover, develop and commercialize potential new medicines.
In this alliance—which comes with an upfront payment of $20 million from Lilly as well as an investment of $15 million—the companies will utilize Avidity's technology platform to progress new therapeutic approaches toward clinical development and then commercialization. Avidity is eligible to receive up to approximately $405 million per target in development and commercialization milestones, plus royalties ranging from the mid-single to low-double digits on product sales.
“We are excited to expand our oligonucleotide research and development efforts through this strategic collaboration with Avidity,” said Dr. Andrew C. Adams, chief scientific officer for RNA therapeutics at Lilly. “Their expertise in studying the combination of monoclonal antibodies and oligonucleotide-based therapies represent a promising avenue of research toward development of new RNA-based medicines.”
Avidity’s Antibody Oligonucleotide Conjugates (AOC) platform is designed to combine the tissue selectivity of monoclonal antibodies and the precision of oligonucleotide-based therapeutics to potentially overcome barriers to the delivery of oligonucleotides and target genetic drivers of disease.
“This collaboration with Lilly provides an exceptional opportunity to leverage Avidity's proprietary AOC platform in order to generate new therapeutic targets in disease areas that have been challenging to pursue using oligonucleotide-based approaches,” Kent Hawryluk, Avidity’s chief business officer, commented in a statement. “Lilly's extensive research, development, regulatory and commercial capabilities make them an ideal partner, and we look forward to a long and productive relationship.”
In other key news this month from Lilly, the company—along with partner Pfizer Inc.—announced rather mixed top-line results from a Phase 3 study evaluating tanezumab 2.5 mg and 5 mg, with the objective of comparing the long-term joint safety and 16-week efficacy of tanezumab relative to nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with moderate-to-severe osteoarthritis (OA) of the hip or knee.
The tanezumab 5 mg treatment arm met two of the three co-primary efficacy endpoints, demonstrating a statistically significant improvement in pain and physical function compared to NSAIDs at the 16-week analysis, while patients’ overall assessment of their OA was not statistically different than NSAIDs. Patients who received tanezumab 2.5 mg did not experience a statistically significant improvement in pain, physical function or patients’ overall assessment of their OA at 16 weeks compared to NSAIDs. In the safety analysis, there was a higher rate of joint safety events in the tanezumab arms compared to NSAIDs at 80 weeks, and the difference was statistically significant.
Joint safety was a composite measure consisting of adjudicated outcomes of rapidly progressive osteoarthritis (RPOA) type 1 or type 2, subchondral insufficiency fracture, osteonecrosis or pathological fracture. Tanezumab is a monoclonal antibody that is part of an investigational class of non-opioid chronic pain medications known as nerve growth factor (NGF) inhibitors.
“We are analyzing these findings in the context of the recent Phase 3 results as we assess potential next steps for tanezumab,” noted Ken Verburg, tanezumab development team leader, Pfizer Global Product Development. “We plan to review the totality of data from our clinical development program for tanezumab with regulatory authorities.”
“Lilly and Pfizer recognize the significant unmet needs for patients living with osteoarthritis,” added Christi Shaw, president, Lilly Bio-Medicines. “We are committed to understanding these results for people who suffer from chronic pain.”