SAR441000 / Sanofi, BioNTech - LARVOL DELTA

A phase 1, first-in-human, dose-escalation, expansion trial of cytokine encoding synthetic mRNA-mixture alone or with cemiplimab in advanced solid tumors. (PubMed, Clin Cancer Res) - "Intratumoral administration of SAR441000 in combination with cemiplimab, was generally well tolerated with anti-tumor activity in loco-regional disease setting. Anecdotal evidence of pharmacodynamic immune-modulatory effect and distant non-injected lesion anti-tumor response was observed, without significant effect in patients with advanced solid tumors previously treated with anti-PD1 therapies."

Journal • P1 data • Fatigue • Melanoma • Oncology • Pain • Solid Tumor • IFNA1 • IFNG • IL15

A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=77 | Terminated | Sponsor: Sanofi | Completed ➔ Terminated; Sponsor terminated the study for non-safety reasons

Combination therapy • Metastases • Monotherapy • Trial termination • Head and Neck Cancer • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer

A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=77 | Completed | Sponsor: Sanofi | Active, not recruiting ➔ Completed

Combination therapy • Metastases • Monotherapy • Trial completion • Head and Neck Cancer • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer

A first-in-human, open-label, multicenter study of intratumoral SAR441000 (mixture of cytokine encoding mRNAs), as monotherapy and in combination with cemiplimab in patients with advanced solid tumors (AACR 2023) - P1 | "IT with SAR441000 in combination with cemiplimab was generally well tolerated and demonstrated anti-tumor activity and immune cell infiltration in both injected and non-injected tumors."

Clinical • Combination therapy • Late-breaking abstract • Metastases • Monotherapy • P1 data • Melanoma • Oncology • Solid Tumor • CD8 • CSF2 • IFNA1 • IFNG • IL12A

A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=77 | Active, not recruiting | Sponsor: Sanofi | N=231 ➔ 77

Combination therapy • Enrollment change • Monotherapy • Head and Neck Cancer • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer

A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=231 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Monotherapy • Head and Neck Cancer • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=231; Recruiting; Sponsor: Sanofi; Trial completion date: Jan 2024 ➔ Apr 2024

Clinical • Combination therapy • Monotherapy • Trial completion date • Head and Neck Cancer • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

[VIRTUAL] A first-in-human study of intratumoral SAR441000, an mRNA mixture encoding IL-12sc, interferon alpha2b, GM-CSF and IL-15sushi as monotherapy and in combination with cemiplimab in advanced solid tumors (SITC 2020) - "These data support further clinical evaluation of SAR441000. Ethics Approval The study was approved by each participating Institution’s Ethics or Institutional Review Board(s)."

Combination therapy • Monotherapy • P1 data • Melanoma • Oncology • Sarcoma • Solid Tumor • CD8 • CSF2 • GZMB • IFNG • IL12A • IL15

A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=231; Recruiting; Sponsor: Sanofi; Trial primary completion date: Oct 2023 ➔ Jun 2022

Clinical • Combination therapy • Monotherapy • Trial primary completion date • Head and Neck Cancer • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

[VIRTUAL] A first-in-human study of intratumoral SAR441000, an mRNA mixture encoding IL-12sc, interferon alpha2b, GM-CSF and IL-15sushi as monotherapy and in combination with cemiplimab in advanced solid tumors (SITC 2020) - "These data support further clinical evaluation of SAR441000. Ethics Approval The study was approved by each participating Institution’s Ethics or Institutional Review Board(s)."

Combination therapy • Monotherapy • P1 data • Melanoma • Oncology • Sarcoma • Solid Tumor • CD8 • CSF2 • GZMB • IFNG • IL12A • IL15

BioNTech to Present Data from BNT311 (GEN1046) and BNT131 (SAR441000) Programs at SITC 35th Annual Meeting (GlobeNewswire) - "BioNTech SE...announced that results from three clinical and preclinical studies have been accepted for presentation at the Society for Immunotherapy of Cancer (SITC) 35th Annual Meeting. The data represent the first clinical results from BioNTech’s ongoing collaborations with Genmab and Sanofi from both its mRNA and antibody drug class portfolios...preliminary data from the first in-human dose escalation trial of intratumoral immunotherapy BNT131 (SAR441000) in collaboration with Sanofi will be shared as e-poster presentation. The full abstracts are scheduled to be available on the SITC website on November 9, 2020."

P1 data • Oncology • Solid Tumor

A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=264; Recruiting; Sponsor: Sanofi; Trial completion date: Feb 2024 ➔ Aug 2023; Trial primary completion date: Oct 2023 ➔ Apr 2023

Clinical • Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Head and Neck Cancer • Hematological Malignancies • Lymphoma • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=264; Recruiting; Sponsor: Sanofi; Trial completion date: Dec 2021 ➔ Feb 2024; Trial primary completion date: Aug 2021 ➔ Oct 2023

Clinical • Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Hematological Disorders • Hematological Malignancies • Lymphoma • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

BioNTech announces first quarter 2020 financial results and corporate progress (GlobeNewswire) - "BNT131 – Data update from Phase 1/2 trial in solid tumors remains on track for 2H 2020; BNT211 – Initiation of a Phase 1/2a trial in multiple solid tumors (CLDN6) is now expected in 2H 2020; BNT311 – The expansion cohort has been initiated in the Phase 1/2 trial in multiple solid tumors for BNT311 (PD-L1x4-1BB). BioNTech expects to provide a data update, to include dose-escalation and potentially some limited expansion data from the trial in 2H 2020; BNT411 – A Phase 1/2a clinical trial of BNT411 is still expected to be initiated in multiple solid tumors in 2H 2020."

New P1/2 trial • P1/2 data • Oncology • Solid Tumor

BioNTech announces full year 2019 financial results and corporate update (GlobeNewswire) - "BNT131 – Data update from Phase 1/2 trial in solid tumors remains on track for 2H 2020; BNT311 – BioNTech now expects to provide a data update from the Phase 1/2 trial in multiple solid tumors (PD-L1x4-1BB) in 2H 2020; BNT321 (MVT-5873) – Dosing has begun in the resumed Phase 1 study, evaluating the safety, maximum tolerated dose and recommended Phase 2 dose of BNT321 as a single agent in patients with pancreatic and other CA19-9 positive malignancies."

Enrollment open • P1/2 data

A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=264; Recruiting; Sponsor: Sanofi

Clinical • Combination therapy • Monotherapy • New P1 trial