Generate Biomedicines, Inc. · NASDAQ:GENB
Generate Biomedicines — IDWeek 2024
12 slides from Generate Biomedicines's conference presentation, October 2024
Slide 1: First-in-human study of a novel half life extended monoclonal antibody (GB-0669) against SARS-CoV-2
First-in-human study of a novel half life extended monoclonal antibody (GB-0669) against SARS-CoV-2 and related sarbecoviruses Dinesh de Alwis, Francesco Borriello, Eric Carlin, Rounak Nassirpour, Stephanie Straley , Akber Safder Andrew Robertson, Anna Allen, Inaki Troconiz, Daria Hazuda, Lovely Goy
Slide 2: Disclosures
Disclosures • Dr. De Alwis has stock in Merck Inc. • Dr. De Alwis is a current employee of Generate Biomedicines
Slide 3: GB-0669: potent half-life extended antibody effective against diverse sarbecoviruses and variants
Generate Biomedicines has generated GB-0669, a highly specific, potent, half-life extended therapeutic antibody. Effective against diverse sarbecoviruses and multiple SARS-CoV-2 variants despite continued evolution Receptor-binding SARS-CoV-2 variants and GB-0669 EC50 Sotrovimab domain (RBD) other s
Slide 4: The First-In-Human Study of GB-0669 has completed enrolment
The First-In-Human Study of GB-0669 has completed enrolment GB-0669 has completed enrolment of its Phase 1 HV study Primary Phase 1 Trial Objective: Safety 2400 mg ▪ Single-ascending dose and Tolerability of ▪ Healthy volunteers 1200 mg Completed GB0669 ▪ IV administration ▪ N=51 (36 on treatment) 6
Slide 5: Adverse events were infrequent and mild with no evidence of relationship to dose
Data is preliminary (Datacut: 14May2024) GB-0669-101 Adverse Events were infrequent and mild with no evidence of relationship to dose Treatment-related AEs were mild ▪ No serious AEs ▪ All related AEs were mild (Grade 1-2) Unrelated AEs were mild ▪ No serious AEs ▪ All unrelated AEs were mild (Grade
Slide 6: PK is well behaved and dose proportional with low inter-subject variability
PK is well behaved and dose proportional with low inter-subject variability and is consistent with PK predicted from non-human primates Half-life 55 days Median Predicted Cmax of 1200 mg dose is 368,875 ng/ml Areas in green cover the 95% prediction intervals of thousand simulated profiles Solid line
Slide 7: PD: GB-0669 boosts neutralizing titer in a dose-dependent fashion
PD : GB-0669 boosts neutralizing titer in a dose-dependent fashion (MN50 live virus) Fold change from baseline Omicron XBB.1.5 Omicron BA.5.5 1200 mg dose provides a ~10-fold increase in titers in subjects with pre-existing SARS-CoV-2 titers (e.g XBB1.5) MN50
Slide 8: Significant need to treat persistent SARS-CoV-2 infection in B-cell depleted oncology patients
There remains a significant need to treat persistent SARS-CoV-2 infection in B-cell depleted oncology patients Nature Medicine 2024;30:2413–14 B-cell lymphoma patients ▪ B-cell depleting therapy is commonly employed for curative intent in patients with B-cell lymphoma ▪ Meta-analysis of 7,604 patien
Slide 9: Single dose of GB-0669 should provide maximal protection from hospitalization for over 60 days
Based on this threshold index established with multiple mABs and convalescent plasma, a single dose of GB-0669 should provide maximal protection from hospitalization against XBB1.5 and BA5.5 for over 60 days in subjects with low baseline titer levels Neutralizing Index against omicron variants follo
Slide 10: Interim analysis of first-in-human data supports advancement to phase 2
Interim analysis of first-in-human data supports advancement to phase 2 ▪ No dose-limiting toxicity observed ▪ Dose-proportional increases in pharmacokinetics. PK Half-life ~55 days ▪ Dose dependent fold increase in viral neutralizing titres. Viral neutralizing titres increased 10-fold from baseline
Slide 11: Acknowledgements
Acknowledgements Pre-clinical Protein Sciences Clinical Tech Ops Novel Therapeutics Grace Marden Nadine Shaban Francesco Borriello Lisa Wyman Anne Jecrois Eric Carlin Monica Menzenski Dinesh De Alwis Tyson Fetzer Joe Garlick Hongru Li Yanyan Lu Gavin Koh Vikram Sadineni Claudio Perez Geetika Sharma
Slide 12: Now we can
Now we can