Prior to the open of U.S. markets for trading today, Alector Inc. (ALEC:NASDAQ) and GlaxoSmithKline (GSK:NYSE) announced "a strategic global collaboration for the development and commercialization of two clinical-stage, potential first-in-class monoclonal antibodies (AL001 and AL101) designed to elevate progranulin (PGRN) levels."
The firms advised that "PGRN is a key regulator of immune activity in the brain with genetic links to multiple neurodegenerative disorders, making it one of the most attractive genetically validated targets for the development of new immuno-neurology treatments."
GlaxoSmithKline's Chief Scientific Officer and President of Research and Development Dr Hal Barron remarked, "Our focus on human genetics and the science of the immune system gives us unique insights into the potential of targets such as progranulin to help patients with a number of neurodegenerative diseases. Working with Alector's world class scientists will allow us to investigate the potential of these immuno-neurology therapies to help patients with frontotemporal dementia, a devastating disease without any currently approved treatments, as well as explore the ability to help patients with other neurodegenerative diseases, such as ALS, Parkinson's and Alzheimer's."
Alector's CEO Arnon Rosenthal, Ph.D., commented, "This transformative collaboration brings together Alector's leading immuno-neurology expertise with GSK's commitment to immunology and human genetics, proven drug development capabilities and global footprint, to help expand and accelerate the development of our progranulin franchise into large indications, while bolstering the build out of our own late-stage development and commercial capabilities."
"Importantly, this collaboration is designed to fully support AL001 and AL101's development and to enable Alector to continue building a fully integrated company as we strive to address the high unmet medical need in patients suffering from neurodegenerative diseases," CEO Rosenthal added.
The companies stated that under the terms of the agreement, Alector is to receive $700 million in upfront payments and will also be eligible to receive up $1.5 billion in additional payments from GSK upon achieving certain specific clinical development, regulatory and commercial launch-related milestones.
The report noted that the agreement stipulates that Alector will be tasked with leading the global clinical development of AL001 and AL101 through Phase 2 proof-of-concept. After that, the two firms will both equally split the responsibilities and costs of all further late-stage AL001 and AL101 clinical studies and related global development costs.
The firms stated they will share the responsibility for commercialization efforts in the U.S. and will share in any profits and losses. Alector is to lead efforts associated with AL001 in orphan indications and GSK will head up commercialization of AL101 for use in both Alzheimer's and Parkinson's diseases. GSK will oversee global marketing and commercialization effort for both AL001 and AL101, and Alector will be entitled to receive tiered royalties from these sales.
The company explained that "the progranulin-elevating monoclonal antibodies AL001 and AL101 are novel human monoclonal antibodies that elevate levels of progranulin by blocking the sortilin receptor responsible for progranulin degradation." The firm mentioned that AL001 is presently being evaluated in a pivotal Phase 3 clinical trial in individuals who are at risk for frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). The company added that it plans to initiate a new Phase 2 study of AL001 in patients with ALS in H2/21.
Alector advised that its AL101 is formulated for those suffering from more prevalent neurodegenerative diseases. The company stated that a Phase 1a study of AL101 is now underway in healthy volunteers though it is ultimately intended for treatment of Alzheimer's and Parkinson's.
Frontotemporal dementia (FTD) was described as a rapidly progressing and severe form of dementia with on currently FDA-approved treatment options that affects 50,000-60,000 people in the U.S. and approximately 110,000 in EU countries.
GSK is a leading London-based global healthcare company that has a market cap of over US$100 billion. The firm develops and markets an extensive array of pharmaceuticals and vaccines for numerous conditions including human immunodeficiency virus (HIV), immuno-inflammation, infectious diseases, respiratory diseases, oncology, vaccines and rare diseases.
Alector is a clinical stage biotech company headquartered in South San Francisco, Calif. The firm stated that its work is centered around immuno-neurology as a novel therapeutic approach for addressing neurodegenerative disease treatments. The firm indicated that it is creating a portfolio of innate immune system programs that are capable of repairing and rejuvenating immune cells genetic mutations that cause dysfunction in the brain's immune system. The company advised that "its immuno-neurology product candidates are supported by biomarkers and target genetically defined patient populations in frontotemporal dementia and Alzheimer's disease," and that it also applies the same approach in its immuno-oncology programs.
Alector started the day with a market cap of around $1.8 billion with approximately 79.8 million shares outstanding and a short interest of about 8.3%. ALEC shares opened more than 40% higher today at $31.79 (+$9.38, +41.86+%) over yesterday's $22.41 closing price and reached a new 52-week high this morning of $43.32. The stock has traded today between $30.83 and $43.32 per share and is currently trading at $35.63 (+$12.23, +59.03%).[NLINSERT]
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