Alector, Inc. operates as a clinical-stage biopharmaceutical company, which engages in pioneering of immuno-neurology. It develops portfolio of innate immune system programs, designed to functionally repair genetic mutations and enable the rejuvenated immune cells to counteract emerging brain pathologies. Its treatment targets immune dysfunction as a root cause of multiple pathologies that are drivers of degenerative brain disorders. The company was founded by Asa Abeliovich, Errik B. Anderson, Tillman U. Gerngross, and Arnon Rosenthal in May 2013 and is headquartered in South San Francisco, CA.
Clinical Trials
3
3 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2013
Active, not recruiting
3
100.0%
No approval data available
- Novartis discontinued development of VHB937 (lifonebart) after the Phase 2 ASTRALS trial in early-stage ALS missed both primary and secondary endpoints. - The 251-patient trial tested the TREM2-stabilizing monoclonal antibody or placebo for 40 weeks, with no numerical data released by the company. - The setback adds to a difficult pipeline stretch for Novartis, following Phase 3 misses for pelacarsen and del-desiran and halted rap-cel studies. - Detailed ASTRALS findings are scheduled for presentation at the 37th International Symposium on ALS/MND in Amsterdam on December 9-11, 2026.
- Rani Therapeutics appointed Dr. Sara Kenkare-Mitra as Strategic Advisor, bringing nearly three decades of biologics development experience and a track record of global regulatory approvals across multiple therapeutic areas. - The company also named Jesper Høiland as Head of Strategy, leveraging his 30+ years of pharmaceutical leadership experience and expertise in obesity and metabolic diseases. - Both appointments aim to advance the RaniPill® platform strategy and prioritize clinical programs with the greatest potential for meaningful impact, particularly following encouraging preclinical data with oral semaglutide. - The strategic hires position Rani to capitalize on the potential of oral biologic delivery across multiple therapeutic areas and support future partnering opportunities.
- Alector's latozinemab (AL001) failed to meet its primary clinical endpoint in the 96-week phase III INFRONT-3 study for frontotemporal dementia due to progranulin gene mutation (FTD-GRN). - The drug showed statistically significant effects on biomarker endpoints but no treatment-related improvements across secondary and exploratory endpoints including fluid biomarkers and brain imaging. - Following the trial failure, Alector discontinued the study's extension and cut its workforce by 49% to focus resources on its remaining clinical candidate nivisnebart for Alzheimer's disease. - The company's stock plummeted 62.5% in the past month following the disappointing trial results, highlighting the significant impact of late-stage clinical failures on biotech valuations.
- Alector's investigational antibody latozinemab failed to slow disease progression in a 96-week Phase III trial for frontotemporal dementia caused by progranulin gene mutations. - Despite significantly increasing progranulin biomarker levels, the GSK-partnered drug showed no clinical benefit versus placebo and missed all secondary endpoints. - The failure prompted Alector to discontinue the drug program, lay off 49% of its workforce, and led to a 51% stock price drop. - The results raise questions about the clinical translatability of targeting plasma progranulin concentrations for neurodegenerative diseases.
- Alector's 96-week Phase 3 INFRONT-3 trial evaluating latozinemab for frontotemporal dementia due to progranulin gene mutation failed to meet its clinical co-primary endpoint. - The company recently amended the trial's statistical analysis plan to include plasma progranulin as a co-primary endpoint, receiving FDA endorsement for this modification. - Despite the setback, analysts maintain optimistic outlook with Buy ratings, citing the ongoing Phase 2 PROGRESS-AD trial for Alzheimer's disease and potential regulatory submissions in 2026. - Alector maintains a strong cash position of $307.3 million as of June 2025, providing runway into the second half of 2027.
- Dispatch Bio, a new biotech company formed through collaboration between Arch Venture Partners and the Parker Institute for Cancer Immunotherapy, has raised $216 million to develop a universal solid tumor treatment approach. - The company's lead therapy combines gene therapy, immunotherapy, and cell therapy by using engineered viruses to tag cancer cells with a synthetic "flare" antigen that CAR-T cells can then target and destroy. - Founded by renowned researchers including University of Pennsylvania's Carl June and Stanford's Chris Garcia, the approach aims to overcome current limitations of checkpoint inhibitors and CAR-T therapies in treating solid tumors. - The therapy is expected to enter clinical testing next year and could potentially address the challenge that many "cold" tumors pose to existing immunotherapies.
- Alector's Latozinemab (AL001) leads the frontotemporal dementia pipeline as a monoclonal antibody targeting progranulin deficiency, currently in pivotal Phase III trials with potential approval by 2026-2027. - Gene therapy companies AviadoBio and Passage Bio are developing AAV-based treatments AVB-101 and PBFT02 to restore progranulin expression through one-time administration, with readouts expected in late 2027 or early 2028. - The FTD therapeutic landscape is shifting from symptom management to disease modification, with multiple approaches including monoclonal antibodies, gene therapies, and oral small molecules targeting genetic biomarkers. - By 2028, the FTD market may include personalized therapies aligned with genetic profiles, potentially transforming clinical outcomes for patients aged 45-64 who currently lack disease-modifying treatment options.
• Alector anticipates topline data from the Phase 3 INFRONT-3 trial of latozinemab for frontotemporal dementia with a granulin gene mutation (FTD-GRN) by Q4 2025. • Enrollment in the Phase 2 PROGRESS-AD trial of AL101/GSK4527226 for early Alzheimer's disease is expected to complete in mid-2025, with 75% of participants enrolled. • Alector is advancing its preclinical pipeline, utilizing the Alector Brain Carrier (ABC) technology to enhance therapeutic delivery for neurodegenerative diseases. • The company's cash reserves of $457.2 million as of September 30, 2024, are projected to sustain operations through 2026, supporting ongoing clinical and research programs.
• Over 120 Alzheimer's Disease treatment therapies are under development by 110+ companies globally, ranging from preclinical to marketed phases. • Emerging therapies like NRDN-201, ST-501, and KarXT are in various clinical trial phases, showing potential for significant market impact. • MapLight Therapeutics initiated a Phase 1 trial for ML-007/PAC, targeting schizophrenia and Alzheimer's disease psychosis, with Phase 2 trials planned. • The FDA granted conventional approval to Leqembi (lecanemab-irmb), marking the first amyloid beta-directed antibody to transition from accelerated approval.
• Cassava Sciences' simufilam failed to reduce cognitive decline in a Phase III Alzheimer's trial, leading to the termination of a second study. • Alector's AL002 did not slow clinical progression in early Alzheimer's disease patients in the INVOKE-2 Phase II trial. • A plasma ptau-217 test reliably predicted regional tau accumulation in early Alzheimer's, potentially reducing the need for tau PET scans.
