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AL 001

Drug Profile

AL 001

Alternative Names: AL-001

Latest Information Update: 02 Oct 2021

At a glance

  • Originator Alector
  • Class Antidementias; Immunotherapies; Monoclonal antibodies; Neuroprotectants; Recombinant proteins
  • Mechanism of Action Sortilin inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Dementia
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Dementia

Most Recent Events

  • 29 Jul 2021 Pharmacodynamic, efficacy and adverse events data from the phase II INFRONT-2 trial in Dementia released by Alector
  • 29 Jul 2021 Alector plans to begin testing AL 001 in C9orf72 amyotrophic lateral sclerosis (ALS) in the second half of 2021
  • 26 Jul 2021 Additional pharmacodynamics data from the phase II INFRONT-2 trial in Dementia presented at the Alzheimer's Association International Conference 2021 (AAIC-2021)

Development Overview

Introduction

AL 001 is a microglia activating recombinant human anti-human sortilin (SORT1) monoclonal antibody being developed by Alector for the treatment of frontotemporal dementia (FTD). FTD has been linked to a genetic mutation that hampers the production of progranulin (PGRN). AL 001 functions by shutting down the SORT1 degradation mechanism for PGRN and increasing the circulating half-life of the functional PGRN in the brain. The monoclonal antibody blocks the breakdown of PGRN and increases PGRN levels by binding to receptors on the surface of both microglia and neurons that facilitate PGRN degradation. Increased levels of PGRN sustains the survival of neurons and moderates the potentially harmful inflammatory responses of immune system cells including microglia. Clinical development is underway in the US, Canada, Germany, Italy, Netherlands, United Kingdom, Australia, Belgium, Portugal, Sweden, Switzerland, Spain and France.

Company Agreements

In July 2021, Alector and GlaxoSmithKline (GSK) entered in an gloabl collaboration agreement for AL 001 and AL 101. Under the terms of the agreement, both the companies will co-develop progranulin elevating monoclonal antibodies for a range of neurodegenerative disease which include frontotemporal dementia, amyotrophic lateral sclerosis, Parkinson’s disease and Alzheimer’s disease. The companies will share profits in the US and will co-commercialise. the exclusive commercialisation rights outside the US will be retained by GSK. In potential milestone payments, profit sharing and royalties, Alector will receive $US700 million in upfront payments and up to $1.5 billion. [1]

Key Development Milestones

In December 2019, the US FDA granted Fast Track designation for AL 001, for the treatment of patients with frontotemporal dementia (FTD) due to heterozygous mutations in the progranulin gene (FTD-GRN) [2] [3] .

In April 2020, Alector initiated a phase III INFRONT-3 trial to investigate the efficacy and safety of AL001 in participants at risk for or with frontotemporal dementia due to heterozygous mutations in the progranulin gene (NCT04374136; AL001-3; EudraCT-2019-004066-18). The double blind, placebo controlled trial intends to enrol 180 patients in the US, Canada, France, Germany, Italy, Netherlands, United Kingdom, Australia, Belgium, Portugal, Sweden, Spain, and Switzerland [4] .

In October 2019, Alector initiated an enrolment in INFRONT-2 phase II trial to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and effect on clinical outcome assessments (COAs) in patients with frontotemporal dementia with a granulin or C9orf72 mutation (NCT03987295; AL001-2). The multicenter, open-label trial was designed to enrol 32 patients in the UK, Netherlands, Italy, Germany, Canada and the US. In October 2019, the company released safety and efficacy data from the trial at the Alzheimer's Association International Conference (AAIC-2019). The effect of treatment on biomarkers associated with frontotemporal dementia was assessed using Quanterix's Simoa® assay. In July 2021, the company released results from the trial at the Alzheimer's Association International Conference (AAIC-2021) [5] [6] [7] [8] [9] .

In August 2018, Alector reported that the US FDA Office of Orphan Products Development granted orphan drug designation to AL 001 for the treatment of frontotemporal dementia [10] .

In December 2019, Alector completed the phase I/Ib INFRONT trial that evaluated safety, tolerability, pharmacokinetics and pharmacodynamic properties of AL 001 in healthy volunteers and in the patients with frontotemporal dementia with granulin mutation (AL001-1;NCT03636204). The completed phase I healthy volunteer single ascending portion of the AL 001 study successfully met its primary objective of safety with no drug-related serious adverse events and demonstrated proof-of-mechanism in the central nervous system (CNS). In April 2019, Alector announced dosing of the first patient in the multiple ascending dose phase Ib study that enrolled frontotemporal dementia (FTD) patients with a mutation in the progranulin gene to assess safety and pharmacodynamics monitor target specific biomarkers. The randomised trial, initiated in September 2018, enrolled 64 participants in the US, Canada and in the UK [11] [12] . In July 2019, the company presented safety and efficacy data of AL 001 at the Alzheimer's Association International Conference 2019 (AAIC-2019) [13] . In December 2019, Alector released pharmacodynamics data from the trial. In July 2020, Alector presented pharmacodynamics data from the trial at the Alzheimer's Association International Conference 2020 (AAIC-2020) [14] [2] .

In April 2021, Pharmacodynamic data were presented at the 73rd Annual Meeting of the American Academy of Neurology Session (AAN-2021) [15] .

Financing information

In July 2018, Alector secured $US133 million in Series E financing round. The company has previously raised $US282 million. The company expect to utilize the proceeding from the financing to advance Alector’s clinical programs and expand the company’s discovery platform [16] .

Patent Information

Alector 3 patent families directed to PGRN programs, which include 1 issued US patent, 4 pending U.S. non-provisional patent applications, 1 pending US provisional patent application, and multiple pending foreign patent applications covering the compositions and uses of our PGRN program product candidates and 1 US non-provisional patent application to methods of screening. 2 patent families are expected to expire in 2036 and the third patent family, assuming that the necessary non-provisional patent applications are timely filed and all other applicable requirements are satisfied for the US provisional patent application, in 2039, in both cases excluding any patent term adjustments and any patent term extensions.

Drug Properties & Chemical Synopsis

  • Route of administration IV, Parenteral
  • Formulation Infusion
  • Class Antidementias, Immunotherapies, Monoclonal antibodies, Neuroprotectants, Recombinant proteins
  • Target Sortilin
  • Mechanism of Action Sortilin inhibitors
  • WHO ATC code

    N06D-X (Other anti-dementia drugs)

  • EPhMRA code

    N7X (All other CNS drugs)

Biomarkers Sourced From Trials

Indication Biomarker Function Biomarker Name Number of Trials

amyotrophic lateral sclerosis

Outcome Measure

Neurofilament Light Chain (NF-L)

Granulocyte-macrophage colony-stimulating factor (GM-CSF)

Granulin (GEP)

1

1

1

amyotrophic lateral sclerosis

Brief Title

C9orf72

1

amyotrophic lateral sclerosis

Detailed Description

C9orf72

1

amyotrophic lateral sclerosis

Eligibility Criteria

SOD1

IGFALS

C9orf72

1

1

1

amyotrophic lateral sclerosis

Official Title

C9orf72

1

amyotrophic lateral sclerosis

Brief Summary

SOD1

IGFALS

C9orf72

1

1

1

dementia

Brief Summary

Granulin (GEP)

1

dementia

Brief Title

Granulin (GEP)

1

dementia

Official Title

Granulin (GEP)

1

frontotemporal dementia

Outcome Measure

Neurofilament Light Chain (NF-L)

Granulocyte-macrophage colony-stimulating factor (GM-CSF)

Granulin (GEP)

1

1

1

frontotemporal dementia

Detailed Description

Granulin (GEP)

C9orf72

2

1

frontotemporal dementia

Eligibility Criteria

Granulin (GEP)

C9orf72

2

1

frontotemporal dementia

Official Title

Granulin (GEP)

C9orf72

2

1

frontotemporal dementia

Brief Summary

Granulin (GEP)

C9orf72

2

1

Biomarker

Drug Name Biomarker Name Biomarker Function
AL 001 C9orf72 Brief Summary, Brief Title, Detailed Description, Eligibility Criteria, Official Title
Granulin (GEP) Brief Summary, Brief Title, Detailed Description, Eligibility Criteria, Official Title, Outcome Measure
Granulocyte-macrophage colony-stimulating factor (GM-CSF) Outcome Measure
IGFALS Brief Summary, Eligibility Criteria
Neurofilament Light Chain (NF-L) Outcome Measure
SOD1 Brief Summary, Eligibility Criteria
For more detail, check out BiomarkerBase: the leading source of information about biomarkers used in drug development and diagnostic tests, tracking a comprehensive list of biomarker uses worldwide by over 800 companies

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Dementia Frontotemporal Dementia; heterozygous mutations in the progranulin gene - Phase III Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Portugal, Spain, Sweden, Switzerland, USA (fast track), United Kingdom IV / Infusion Alector 23 Jul 2020

Priority Development Status

Type Region Indication
Fast Track USA Dementia

Orphan Status

Indication Patient Segment Country Organisation Event Date
Dementia - USA Alector 08 Aug 2018

Commercial Information

Involved Organisations

Organisation Involvement Countries
Alector Originator USA
Alector Owner USA
GlaxoSmithKline Market Licensee United-Kingdom

Scientific Summary

Adverse Events

Results from phase I INFRONT study showed that AL 001 was well tolerated and was safe in patients with frontotemporal dementia with a granulin mutation [7] [12] .

In a phase I trial, AL 001 was generally safe and well tolerated through the highest dose assessed, healthy volunteers and in patients with frontotemporal dementia [13] [12] .

Results from the phase II INFRONT-2 trial showed that AL 001 exhibited favourable safety profile. Mild treatment-related adverse events (AEs) were reported in Six of the 27 patients. The most common AEs observed in the trial in more than two patients were falls (5/27, 18.5%) and rash (3/27, 11.1%). Three patients in the FTD-GRN cohort experienced serious AEs, but none of these were attributed to treatment with the drug [6] [9] .

Pharmacodynamics

Summary

Results from the phase II INFRONT-2 trial showed that treatment with AL 001 resulted in a time-dependent and durable decreases over twelve months to levels seen in age-matched controls, indicating that AL001 restores normal lysosome and complement function in these patients. Cathepsin (CTSD) levels at baseline (n = 9), at 6 months (n = 8), at 12 months (n = 8) and for age-matched procured control group (n = 44) were 5.2(1.16) fmol/L, 3.8(0.57) fmol/L, 3.1(0.21) fmol/L and 3.4(0.08) fmol/L, respectively. Lysosomal-associated membrane protein 1(LAMP1) levels at baseline (n = 9), at 6 months (n = 8), at 12 months (n = 8) and for age-matched procured control group (n = 44) were 0.6(0.12) fmol/L, 0.4(0.06) fmol/L, 0.4(0.043) fmol/L and 0.4(0.01) fmol/L, respectively. Complement C1q B chain (C1QB), levels at baseline (n = 9), at 6 months (n = 8), at 12 months (n = 8) and for age-matched procured control group (n = 44) were 0.7(0.12) fmol/L, 0.6(0.07) fmol/L, 0.5(0.02) fmol/L and 0.5(0.02) fmol/L, respectively. Chronic dosing led to a sustained increase in PGRN levels to the normal range in FTD-GRN carriers [5] [6] [9] .

In a phase I/Ib trial, multiple ascending dose of AL 001 in frontotemporal dementia patients with a mutation in the progranulin (PGRN) gene showed a statistically significant normalisation in a number of disease-associated proteins, including inflammatory and lysosomal biomarkers (n=8; R=-0.36; P<0.0005). Five patients from symptomatic FTD-GRN cohort showed no significant increases in plasma neurofilament light chain (NfL) levels, after 12 weeks. Moreover, an initial trend showed a 14% reduction in plasma NfL levels compared to baseline levels (n=5; mean=14%; range=-4% to 41%). Compared to healthy volunteers, AL 001 treatment rescued cathepsin B (CTSB), a marker of lysosomal function, by 58%. AL 001 treatment also partially normalized markers of inflammation and gliosis, osteopontin (SPP1) and chitotriosidase (CHIT1) by 52% and 22%, respectively. There was a 14% reduction in plasma neurofilament light chain (NfL), a marker of neuron injury and stress observed after 8 weeks after the last dose [14] [2] [12] .

In non-human primate models, healthy volunteers, and heterozygous carriers of GRN mutations AL 001 showed that it effectively binds sortilin with a high affinity and blocks the interaction between PGRN and sortilin receptor. Blocking sortilin with the AL 001 antibody increases PGRN levels in plasma and cerebrospinal fluid (CSF) [15] .

Therapeutic Trials

Results from the phase I INFRONT study showed that AL 001 was able to restore the level of progranulin in patients with frontotemporal dementia with a granulin mutation back to the normal range [7] [12] .

Results from the single ascending dose part of the phase I trial of AL 001, demonstrated dose dependent increase in PGRN levels in plasma and in cerebrospinal fluid in healthy volunteers and in patients with frontotemporal dementia [13] [12] .

Results from the phase II INFRONT-2 trial showed that treatment with AL 001 in the symptomatic FTD-GRN cohort exhibited a rapid and sustained 2-2.5-fold elevations of progranulin comparable to normal levels from an age-matched procured control group of healthy volunteer. Progranulin levels for AL 001 in plasma at baseline (n = 12), 25 weeks (n = 9) and 49 weeks (n = 7) were 40.3(2.64) ng/ml, 99.0(4.94) ng/ml and 86.8(3.72) ng.//ml respectively. Progranulin levels for AL 001 in cerebrospinal fluid (CSF) at baseline (n = 10), 25 weeks (n = 9) and 49 weeks (n = 7) were 2.3(0.22) ng/ml, 4.4(0.43) ng/ml and 4.2(0.54) ng/ml, respectively. Progranulin levels for the controlled group in plasma (n = 46) and CSF (n = 44) were 64.6-196.0 and 3.48-7.06 respectively. Treatment with AL 001 resulted in a greater than 10% difference in the atrophy rates in favour of AL 001 for the whole brain and frontotemporal cortex measures, and an approximately 50% reduction in ventricular enlargement. Neurofilament light chain (NfL) levels for AL 001 in plasma at baseline (n = 12), 25 weeks (n = 9) and 49 weeks (n = 7) were 62.8(13.57) pg/ml, 67.5(24.51) pg/ml and 46.3 (12.93) pg/ml, respectively. Neurofilament light chain (NfL) levels for AL 001 in CSF at baseline (n = 11), 25 weeks (n = 9) and 49 weeks (n = 9) were 7.3(1.51) ng/ml, 7.7(1.63) ng/ml and 6.5(1.29) ng/ml, respectively. Percent volume changes observed in the brain over 12 months using volumetric MRI in for AL 001 (n = 7) and GENFI2 control cohort (n = 8), in whole brain [-4.1(0.93); -4.6(0.93); difference in relative atrophy rate 10.9%], frontotemporal cortex [-1.5(0.54); -1.8(0.51); difference in relative atrophy rate 16.7%] and ventricles [12.9(4.99); 25.6(14.6); difference in relative atrophy rate 49.6%].Treatment with the monoclonal antibody showed a 47% slowing of clinical progression among the INFRONT-2 patients relative to matched GENFI2 controls. The CDR® plus NACC FTLD-SB scores in the GENFI2 matched control group (N = 10), showed an annual increase of 6.4 points from baseline over one year, indicating rapid disease progression. In contrast, the annual increase in the AL 001 cohort (N = 12) was only 3.4 points over one year, a 3.0-point difference in annual change [6] [9] .

Future Events

Expected Date Event Type Description Updated
31 Dec 2021 Trial Update Alector plans to begin testing AL 001 in C9orf72 amyotrophic lateral sclerosis (ALS) in the second half of 2021 [6] 04 Aug 2021
30 Jul 2020 Trial Update Alector plans a phase III trial for Dementia (IV) in July 2020 (NCT04374136) (700313431) 21 May 2020
30 Jun 2020 Trial Update Alector plans a phase II trial for Dementia in the first half of 2020 [17] 18 Jun 2021
31 Jul 2019 Trial Update Alector plans a phase-II trial for Dementia in Canada, Germany, Italy, Netherlands, United Kingdom and USA in July 2019 (IV, Infusion) (NCT03987295) 14 Oct 2019
30 Jun 2019 Trial Update Alector plans a phase I trial for Dementia in the first half of 2019 [17] 14 Oct 2019
15 Sep 2018 Trial Update Alector plans a phase I trial for Dementia in USA in September 2018 (NCT03636204) (700298951) 03 Oct 2018

Development History

Event Date Update Type Comment
22 Sep 2021 Biomarker Update Biomarkers information updated Updated 02 Oct 2021
29 Jul 2021 Scientific Update Pharmacodynamic, efficacy and adverse events data from the phase II INFRONT-2 trial in Dementia released by Alector [6] Updated 04 Aug 2021
29 Jul 2021 Trial Update Alector plans to begin testing AL 001 in C9orf72 amyotrophic lateral sclerosis (ALS) in the second half of 2021 [6] Updated 04 Aug 2021
26 Jul 2021 Scientific Update Additional pharmacodynamics data from the phase II INFRONT-2 trial in Dementia presented at the Alzheimer's Association International Conference 2021 (AAIC-2021) [5] Updated 15 Sep 2021
02 Jul 2021 Licensing Status GlaxoSmithkline in licenses AL 001 from Alector outside USA [1] Updated 12 Jul 2021
17 Apr 2021 Scientific Update Pharmacodynamic data presented at the 73rd Annual Meeting of the American Academy of Neurology Session (AAN-2021) [15] Updated 29 Jun 2021
27 Jul 2020 Scientific Update Pharmacodynamics data from the phase I/Ib INFRONT trial in Dementia presented at the Alzheimer's Association International Conference 2020 (AAIC-2020) [14] Updated 31 Aug 2020
23 Jul 2020 Phase Change - III Phase-III clinical trials in Dementia in USA, Canada, Germany, Italy, Netherlands, United Kingdom, Australia, Belgium, Portugal, Sweden, Switzerland, France (IV) (NCT04374136) (EudraCT2019-004066-18) Updated 18 Jun 2021
22 Apr 2020 Phase Change - III Phase-III clinical trials in Dementia in Spain (IV) (EudraCT-2019-004066-18) Updated 21 May 2020
31 Dec 2019 Trial Update Alector completes a phase I trial in Dementia in USA (IV) (NCT03636204) Updated 06 Aug 2020
31 Dec 2019 Scientific Update Pharmacodynamics data from a phase I trial in Dementia released by Alector [2] Updated 05 Jun 2020
05 Dec 2019 Regulatory Status AL 001 receives Fast Track designation for Dementia [IV,Infusion] in USA [2] [3] Updated 05 Jun 2020
09 Oct 2019 Scientific Update Efficacy and safety data from a phase I trial in Dementia presented at the (Alzheimer's Association International Conference (AAIC-2019) [7] Updated 14 Oct 2019
09 Sep 2019 Phase Change - II Phase-II clinical trials in Dementia in United Kingdom, USA, Netherlands, Italy, Germany, Canada (IV) (NCT03987295) Updated 14 Oct 2019
09 Sep 2019 Trial Update Alector initiates enrolment in a INFRONT phase II trial for Dementia in the UK, the USA, Germany, Italy, Netherland, Canada [8] (NCT03987295) Updated 14 Oct 2019
14 Jul 2019 Scientific Update Efficacy and adverse events data from a phase I trial in Dementia presented at the Alzheimer's Association International Conference 2019 (AAIC-2019) [13] Updated 24 Oct 2019
17 Jun 2019 Trial Update Alector plans a phase-II trial for Dementia in Canada, Germany, Italy, Netherlands, United Kingdom and USA in July 2019 (IV, Infusion) (NCT03987295) Updated 14 Oct 2019
06 May 2019 Trial Update Alector plans a phase III trial for Dementia (IV) in July 2020 (NCT04374136) Updated 21 May 2020
04 Apr 2019 Trial Update Alector plans a phase II trial for Dementia in the first half of 2020 [17] Updated 18 Jun 2021
04 Apr 2019 Trial Update Alector plans a phase I trial for Dementia in the first half of 2019 [17] Updated 14 Oct 2019
28 Mar 2019 Patent Information Alector has patents pending for PGRN program in USA [17] Updated 04 Apr 2019
14 Sep 2018 Phase Change - I Phase-I clinical trials in Dementia in USA (IV)(NCT03636204) Updated 03 Oct 2018
17 Aug 2018 Trial Update Alector plans a phase I trial for Dementia in USA in September 2018 (NCT03636204) Updated 03 Oct 2018
08 Aug 2018 Regulatory Status AL 001 receives Orphan Drug status for Dementia in USA [10] Updated 17 Aug 2018
25 Jul 2018 Phase Change Early research in Dementia in USA (Parenteral) [16] Updated 30 Jul 2018

References

  1. GSK and Alector announce global collaboration in immuno-neurology for two clinical stage first-in-class monoclonal antibodies for neurodegenerative diseases.

    Media Release
  2. 10-K 1 alec-10k_20191231.htm 10-K - Alector, Inc. Internet-Doc 2020;.

    Available from: URL: https://www.sec.gov/Archives/edgar/data/1653087/000156459020012520/alec-10k_20191231.htm
  3. Alector Announces FDA Fast Track Designation Granted to AL001 for the Treatment of Patients with Frontotemporal Dementia.

    Media Release
  4. A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene

    ctiprofile
  5. Jackson S, Yeh FL, Ward M, Rhinn H, Huang JY, Pappalardo JL, et al. Six Months Interim Analysis of the Phase 2 Study of Al001 in Frontotemporal Dementia Patients Carrying a Granulin Mutation. AAIC-2021 2021; abstr. N/A.

    Available from: URL: https://alz.confex.com/alz/2021/meetingapp.cgi/Paper/54593
  6. Alector Presents 12-Month Results from the INFRONT-2 Phase 2 Open-label Clinical Study of AL001 for the Treatment of Symptomatic Frontotemporal Dementia Patients with a Progranulin Mutation.

    Media Release
  7. Alector Announces Data from On-going Phase 1b Trial Demonstrating that AL001 Reverses Progranulin Deficiency in Frontotemporal Dementia Patients.

    Media Release
  8. Alector Initiates Phase 2 Trial of AL001 in Patients with Frontotemporal Dementia.

    Media Release
  9. A Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9orf72 Mutations Causative of Frontotemporal Dementia

    ctiprofile
  10. Alector Receives Orphan Drug Designation from the U.S. FDA for AL001 for the Treatment of Frontotemporal Dementia.

    Media Release
  11. Alector Announces First Frontotemporal Dementia Patient Dosed in Phase 1b Study of AL001.

    Media Release
  12. A First in Human Phase 1 Study in Healthy Volunteers and in Participants With Frontotemporal Dementia (FTD) With Granulin Mutation

    ctiprofile
  13. Paul R, Ward M, Siddiqui O, Hagey M, Long H, King R, et al. A phase 1 study of AL001 in healthy volunteers and frontotemporal dementia patients carrying a granulin mutation. AAIC-2019 2019; abstr. 35586.

    Available from: URL: https://eventpilotadmin.com/web/page.php?page=IntHtml&project=AAIC19&id=35586
  14. Haynes BA, Rhinn H, Yeh FL, Long H, Ward M, Hagey M, et al. AL001 restores CSF PGRN levels and normalizes disease-associated biomarkers in individuals with frontotemporal dementia due to heterozygous mutations in the progranulin gene. AAIC-2020 2020; abstr. ODO3-06-03.

    Available from: URL: https://alz.confex.com/alz/20amsterdam/meetingapp.cgi/Paper/46114
  15. Paul R, Long H, Tu G, Haynes BA, Ward M, McCaughey S, et al. AL001 Blocks the Sortilin/PGRN Interaction and is a Potential Therapy for FTD-GRN. AAN-2021 2021; abstr. P1.018.

    Available from: URL: https://index.mirasmart.com/AAN2021/PDFfiles/AAN2021-004422.html
  16. Alector Announces $133 Million in Series E Financing to Advance Broad Portfolio of Immuno-Neurology and Immuno-Oncology Programs.

    Media Release
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