GSK GSK plc

Alector, Inc. (Nasdaq: ALEC) and GSK plc (LSE/NYSE: GSK) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to latozinemab, an investigational human monoclonal antibody designed to block sortilin to elevate progranulin (PGRN) levels for the potential treatment of frontotemporal dementia with a progranulin gene mutation (FTD-GRN).

“In partnership with GSK, we are encouraged and excited by this FDA Breakthrough Designation. FTD-GRN is a rare and rapidly progressing neurodegenerative disease and one of the most common causes of early onset dementia," said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. “With this designation, we look forward to continued productive conversations with the FDA, recognizing the unmet need for people living with FTD-GRN, a serious condition for which there are no FDA-approved treatment options available. Latozinemab, the most advanced progranulin-elevating candidate in clinical development for FTD-GRN, is currently being studied in the pivotal INFRONT-3 Phase 3 study, which achieved target enrollment in October 2023.”

The FDA granted latozinemab Breakthrough Therapy Designation for FTD-GRN based upon data from the INVOKE-2 Phase 2 clinical trial of latozinemab in FTD-GRN participants. The FDA's Breakthrough Therapy Designation is granted to expedite the development and review of drugs in the United States that are intended to treat a serious condition, when preliminary clinical evidence indicates the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).1

About Latozinemab Latozinemab (AL001) is an investigational human monoclonal antibody designed to modulate progranulin (PGRN), a key regulator of immune activity in the brain with genetic links to multiple neurodegenerative disorders, including frontotemporal dementia (FTD), Alzheimer’s disease, and Parkinson’s disease. Latozinemab aims to increase the level of PGRN in humans by inhibiting sortilin, a degradation receptor for PGRN. Latozinemab has received Orphan Drug Designation for the treatment of FTD as well as both Breakthrough Therapy and Fast Track designations for the treatment of FTD due to a progranulin gene mutation (FTD-GRN) from the U.S. Food and Drug Administration.

About Frontotemporal Dementia (FTD) Frontotemporal dementia (FTD) is a rare neurodegenerative disease, but it is one of the most common causes of early onset dementia..2 It affects an estimated 50,000 to 60,000 people in the United States and roughly 110,000 in the European Union, with potentially higher prevalence in Asia and Latin America.3,4 There are multiple heritable forms of FTD, and FTD patients with a progranulin gene mutation (FTD-GRN) represent 5% to 10% of all people with FTD.5 Patients with FTD frequently develop symptoms such as behavioral changes, lapses in judgment, and diminished language skills when they are in their 40’s and 50’s with the disease running its course in 7-10 years.6 There are no U.S. Food and Drug Administration-approved treatment options available for any form of FTD.2

Collaboration with GSKIn July 2021, Alector entered into a collaboration and license agreement with GSK (NYSE: GSK) to collaborate on the global development and commercialization of progranulin-elevating monoclonal antibodies, including latozinemab and AL101 (GSK4527226). Under the terms of the GSK agreement, Alector received $700 million in upfront payments. In addition, Alector may be eligible to receive up to an additional $1.5 billion in clinical development, regulatory, and commercial launch-related milestone payments. In the United States, the companies will equally share profits and losses from commercialization of latozinemab and AL101. Outside of the United States, Alector will be eligible for double-digit tiered royalties.

About AlectorAlector is a clinical-stage biotechnology company pioneering immuno-neurology, a novel therapeutic approach for the treatment of neurodegenerative diseases. Immuno-neurology targets immune dysfunction as a root cause of multiple pathologies that are drivers of degenerative brain disorders. Alector has discovered and is developing a broad portfolio of innate immune system programs, designed to functionally repair genetic mutations that cause dysfunction of the brain’s immune system and enable rejuvenated immune cells to counteract emerging brain pathologies. Alector’s immuno-neurology product candidates are supported by biomarkers and seek to treat indications, including Alzheimer’s disease and genetically defined frontotemporal dementia patient populations. Alector is headquartered in South San Francisco, California. For additional information, please visit www.alector.com.

About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements regarding our product candidates, the expectation regarding the implications of Breakthrough Therapy Designation, planned and ongoing preclinical studies and clinical trials, expected milestones, including the timing of data from our INFRONT-3 trial, and expectations of our collaborations. Such statements are subject to numerous risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to risks and uncertainties as set forth in Alector’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q, as well as the other documents Alector files from time to time with the Securities and Exchange Commission. These documents contain and identify important factors that could cause the actual results for Alector to differ materially from those contained in Alector’s forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and Alector specifically disclaims any obligation to update any forward-looking statement, except as required by law.

REFERENCES

1. U.S. Food and Drug Administration (FDA). Breakthrough Therapy.
2. The Association for Frontotemporal Degeneration (AFTD).
3. Patient estimates based on internal forecasting analysis using published literature sources.
4. E.U. estimates include EU5 countries only (Spain, Italy, France, U.K. and Germany).
5. FTD Disorders Registry.
6. Moore KM, Nicholas J, Grossman M, et al. Lancet Neurol. 2020 Feb; 19 (2).

Alector Contacts:

Alector Katie Hogan 202-549-0557katie.hogan@alector.com

1AB (media)Dan Budwick973-271-6085 dan@1abmedia.com

Argot Partners (investors)Laura Perry Argot Partners212-600-1902alector@argotpartners.com