LOS ANGELES—Seeing an opportunity to reduce risk in thedevelopment of therapeutics by better integrating such efforts with diagnostictools, ImaginAb Inc., a clinical-stage company developing in-vivo molecular imaging agents based on antibody fragmenttechnology, entered into a collaboration and commercialization agreement withCopenhagen, Denmark-based H. Lundbeck AS in early October.
Although the companies did not release any financialdetails, they did note that the deal calls for ImaginAb and Lundbeck tocollaborate around a novel central nervous system (CNS) target, exploring theuse of re-engineered antibodies to accelerate the blood-brain barrier (BBB)transport of biologics.
According to Dr. Christian Behrenbruch, CEO of ImaginAb,"this collaboration represents a great opportunity for both companies toexplore an increasingly important intersection between therapeutic anddiagnostic medicine. Given the worrying number of recent failures of late-stagebiologics programs, including for neurodegenerative applications, there is acritical need to explore new ways of integrating diagnostic and therapeuticstrategies to de-risk development."
This sentiment echoes what Behrenbruch said earlier in thefall regarding a recent collaboration and commercialization deal for thedevelopment of in-vivo imaging agentsfor autoimmune diseases and cancer with MacroGenics Inc.
"I think this idea that diagnostic and therapeutic medicinetogether are going to play a much more entwined role—I think we're there,"Behrenbruch said at the time. "We see far more engagements than we did fiveyears ago from pharma looking at novel ways of doing patient selection, novelways of profiling a target in patients. And I think this idea—that diagnosticmedicine can lower the cost of therapeutic development—I think is now startingto become something that people really believe and are committed to."
Under the terms of the more recent agreement with Lundbeck,the two companies will collaborate to "concurrently develop biologics withimproved BBB transport and imaging agents that are capable of quantitatingkinetics and targeting efficacy." The agreement also includes an option forLundbeck to commercialize the results of the collaboration for both diagnosticand therapeutic uses.
"Molecular imaging has become a prevalent aspect ofdeveloping new CNS products, both during product development and for clinicalmanagement of disease, and we are pleased to be working with ImaginAb toexplore this exciting opportunity," said Dr. Jeffrey Stavenhagen, head ofbiologics at Lundbeck, in the news release about the deal.
Behrenbruch describes ImaginAb's approach as takingtherapeutic drugs and then re-engineering imaging agents directly from them.This means the imaging agents "have the same front-end targeting business asthe therapeutic antibody does," he says, but are inert and are able to clearfrom the bloodstream rapidly. This makes "developing the imaging protocols andthe relevancy of the imaging … very, very high in relation to the antibodydrug," he says, adding that imaging such as this offers a significant advantageover biopsies in terms of patient selection.
Lundbeck, Takeda submit NDA for depression drug
COPENHANGEN, Denmark—H. Lundbeck AS and TakedaPharmaceutical Co. Ltd. recently announced their submission of a New DrugApplication (NDA) to the U.S. Food and Drug Administration (FDA) for theinvestigational agent vortioxetine (formerly known as Lu AA21004) for thetreatment of major depressive disorder in adult patients.
Vortioxetine is under investigation as an antidepressantwith multimodal activity that is thought to work through a combination of twomechanisms of actions: receptor activity modulation and reuptake inhibition.The NDA includes data from six short-term placebo-controlled studies, includingone dedicated study in the elderly. The studies have been conducted in regionsthroughout the world and support statistically significant efficacy ofvortioxetine in a dose range of 5 to 20 mg per day. Efficacy of vortioxetinewas also demonstrated in a long-term relapse-prevention study in majordepression. The vortioxetine global clinical development program included morethan 7,500 individuals exposed to the drug.
"The prevalence and complexity of major depressive disorderremains a growing concern for physicians and those living with the condition.This NDA submission is a critical milestone for Takeda and our partnerLundbeck, demonstrating our commitment to those living with and treating thiscondition," said Dr. Azmi Nabulsi, president of Takeda Global Research &Development Center Inc. "Together, we are focused on patients' needs andbelieve that the multimodal activity profile of vortioxetine may translate intotherapeutic benefits that help advance the treatment of depression."
Within 75 days of submission, the FDA is expected todetermine whether the NDA filing will be accepted for review. Acceptance of thefiling will trigger a milestone payment from Takeda to Lundbeck.