BND-22 / Biond Biologics - LARVOL DELTA

Biond Biologics to Regain Full Rights to BND-22, a Novel Immune Checkpoint Inhibitor Targeting the ILT2 Receptor (PRNewswire) - "Biond Biologics Ltd...today announced that it would regain full rights to BND-22 (SAR444881) from Sanofi. Sanofi is returning the rights of BND-22 as part of their broader R&D prioritization to focus on programs that support the company's strategy. Biond and Sanofi, are working together to complete full transfer of the BND-22 program to Biond."

Commercial • Cholangiocarcinoma • Colorectal Cancer • Non Small Cell Lung Cancer

Study of SAR444881 Administered Alone and in Combination With Other Therapeutics in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=456 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gallbladder Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Final results from phase 1, first-in-human, dose escalation study of a first-in-class anti-ILT2 antibody, SAR444881, alone and with pembrolizumab or cetuximab, in patients with advanced solid tumors (SITC 2024) - P1/2 | "Based on these data, SAR444881 10 mg/kg has been defined as the initial dose for dose optimization. Conclusions These data provide initial clinical evidence for targeting ILT2 and warrant further exploration in dose optimization and expansion cohorts."

Clinical • IO biomarker • Metastases • P1 data • Oncology • Solid Tumor • CD69 • CD8 • EGFR • LAMP1

Phase II Biomarker Study of SAR444881 in Combination With Cemiplimab in Solid Tumors (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center

Biomarker • Combination therapy • New P2 trial • Oncology • Solid Tumor

Final results from phase I, first-in-human, dose escalation study of a first-in-class anti-ILT2 antibody, SAR444881, alone and with pembrolizumab or cetuximab, in patients with advanced solid tumors (ESMO 2024) - P1/2 | "These data provide initial clinical evidence for targeting ILT2 and warrant further exploration in dose optimization and expansion cohorts."

Clinical • IO biomarker • Metastases • P1 data • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CD8

Study of SAR444881 Administered Alone and in Combination With Other Therapeutics in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=456 | Recruiting | Sponsor: Sanofi | Trial completion date: Nov 2026 ➔ Feb 2027 | Trial primary completion date: Nov 2026 ➔ Feb 2027

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gallbladder Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Study of SAR444881 Administered Alone and in Combination With Other Therapeutics in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=456 | Recruiting | Sponsor: Sanofi | Trial completion date: Apr 2027 ➔ Nov 2026 | Trial primary completion date: Apr 2027 ➔ Nov 2026

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gallbladder Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Phase 1/2, Open-label Study of an Anti-ILT2 (LILRB1) Antibody, SAR444881, Administered Alone and in Combination With Pembrolizumab, With or Without Chemotherapy, or Cetuximab in Patients With Advanced Solid Tumors (ESMO-IO 2023) - P1/2 | "SAR444881 (BND-22), a novel humanized immunoglobulin G4 monoclonal antibody (mAb), selectively binds to ILT2 and blocks its interaction with MHC-I on tumor cells and may restore immune cell functions. Study is accruing patients in the United States and Israel. Study opened on March 2021 and has enrolled 71 patients as of August 2023."

Clinical • Combination therapy • Metastases • P1/2 data • Oncology • Solid Tumor • HLA-G • LILRB1

Study of SAR444881 Administered Alone and in Combination With Other Therapeutics in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=456 | Recruiting | Sponsor: Sanofi | N=130 ➔ 456 | Trial completion date: Jan 2024 ➔ May 2027 | Trial primary completion date: Sep 2023 ➔ May 2027

Combination therapy • Enrollment change • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gallbladder Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Evaluation of pharmacodynamic and patient enrichment biomarkers for SAR444881, a first-in-class anti-ILT2 monoclonal antibody for cancer immunotherapy. (ASCO 2022) - P1/2 | "SAR444881 (BND-22) is a novel humanized IgG4 monoclonal antagonist antibody which selectively binds to ILT2 and blocks its interaction with MHC I molecules...Concomitantly, combining SAR444881 with cetuximab resulted in increased phagocytosis compared to isotype control... These data inform the PD response biomarkers, combination, and patient enrichment strategies for the clinical development of SAR444881 to maximize its benefits for cancer patients. An ongoing phase 1/2 trial of SAR444881 mono- and combination therapy in patients with advanced solid tumors is testing these concepts in the clinic (NCT04717375)."

Biomarker • Clinical • IO biomarker • Patient Enrichment • PK/PD data • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8 • IFNG • PD-L1 • TNFA

BND-22, a first-in-class humanized ILT2-blocking antibody, promotes antitumor immunity and tumor regression. (PubMed, J Immunother Cancer) - P1/2 | "BND-22 is a first-in-human ILT2 blocking antibody which has demonstrated efficient antitumor activity in various preclinical models as well as a favorable safety profile. Clinical evaluation of BND-22 as a monotherapy or in combination with other therapeutics is under way in patients with cancer."

Journal • Oncology

Biond Biologics Announces First Patients Dosed with BND-22 (SAR444881) Combinations in Phase 1 Clinical Trial (PRNewswire) - "Biond Biologics Ltd...announced that first patients have been dosed in the first-in-human, phase 1 clinical trial's sub-part evaluating BND-22 (SAR444881), an Ig-Like Transcript 2 (ILT2) receptor blocking antibody, in combination with pembrolizumab or with cetuximab. The phase 1 trial is an open-label, dose escalation and expansion study exploring the safety, tolerability, pharmacokinetics (PK), anti-tumor activity, and exploratory biomarkers for BND-22 activity in patients with select advanced solid tumors. The trial is enrolling participants in medical centers in the USA and Israel."

Trial status • Oncology • Solid Tumor

Biond Biologics to Present at the Raymond James LILRB/ILT Symposium (PRNewswire) - "Biond Biologics Ltd...announced that Tehila Ben Moshe, Ph.D., Co-Founder, and Chief Executive Officer and Ilana Mandel, Ph.D. and VP R&D, will be presenting therapeutics targeting ILTs (also known as LILRBs) at the LILRB/ILT Virtual Symposium....Biond will be presenting BND-22 (SAR444881), a multi-cell checkpoint inhibitor targeting the Immunoglobulin-like transcript receptor 2 or ILT2 (also known as Leukocyte Immunoglobulin Like Receptor B1 or LILRB1) that was partnered with Sanofi and is now in phase 1 for evaluating safety, tolerability, and anti-tumor activity in advanced cancer patients. Biond will also present BND-35 – an ILT3 (LILRB4( blocking antibody, that targets suppressive myeloid cells in the tumor microenvironment."

Clinical data • Oncology

Study of BND-22 Administered Alone and in Combination With Other Therapeutics in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=130; Recruiting; Sponsor: Biond Biologics; N=100 ➔ 130

Clinical • Combination therapy • Enrollment change • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gallbladder Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Biond Biologics Announces First Patient Dosed in Phase 1 Clinical Trial of BND-22, a Novel Immune Checkpoint Inhibitor Targeting the ILT2 Receptor (PRNewswire) - "Biond Biologics...announced that the first patient has been dosed in the first-in-human, phase 1 clinical trial of BND-22 (SAR444881), an Ig-Like Transcript 2 (ILT2) receptor blocking antibody. The first patient was administered BND-22 at the Oncology Research Unit of the Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, one of the six US and Israel trial sites planned to initially participate in the phase 1, open-label, dose escalation study exploring the safety, tolerability, pharmacokinetics (PK), anti-tumor activity, and exploratory biomarkers for BND-22 activity in patients with select advanced solid tumors."

Trial status • Oncology • Solid Tumor

Study of BND-22 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=100; Recruiting; Sponsor: Biond Biologics; Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gallbladder Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

"Immunotherapy BND-22 Brings Biond Biologics and Sanofi Together in a Global Licensing Agreement #oncology #businessoncology https://t.co/e0BKsVvSgw" (@OncLive)

Clinical • Oncology

Study of BND-22 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=100; Not yet recruiting; Sponsor: Biond Biologics

Clinical • New P1/2 trial • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gallbladder Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Deal Watch: Sanofi Teams Up With Biond On Novel Checkpoint Inhibitor (Scripintelligence) - "...Sanofi partners with Israel’s Biond on IO candidate targeting ILT2."

Licensing / partnership • Oncology

Biond Biologics and Sanofi Enter into Global Licensing Agreement for BND-22, a Novel Immune Checkpoint Inhibitor Targeting the ILT2 Receptor (PRNewswire) - "Biond Biologics Ltd...announced that it has entered into an exclusive worldwide license agreement with Sanofi...for the development and commercialization of BND-22...Under the terms of the agreement, Biond will receive a $125 million upfront payment in cash and will be entitled to receive more than $1 billion in development, regulatory, and sales milestones, as well as tiered double digit royalty payments....An Investigational New Drug (IND) application for BND-22 has recently been submitted to FDA and a phase 1 study to evaluate the safety, tolerability, and preliminary anti-tumor activity of BND-22 in advanced cancer patients is planned to start by mid-2021."

IND • Licensing / partnership • New P1 trial • Oncology