On January 12, 2021 Biond Biologics Ltd. ("Biond" or the "Company"), a privately-held biopharmaceutical company, developing novel immunotherapies for cancer and a platform enabling the intracellular delivery of biologics, reported that it has entered into an exclusive worldwide license agreement with Sanofi (EURONEXT: SAN) (NASDAQ: SNY), for the development and commercialization of BND-22 (Press release, Biond Biologics, JAN 12, 2021, View Source [SID1234573934]).
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BND-22 is a humanized IgG4, antagonist antibody targeting the Ig-like transcript 2 (ILT2) receptor in development for the treatment of solid tumors. ILT2, a member of the ILT family of immuno-modulating receptors, is an inhibitory receptor expressed on both innate and adaptive immune cells that binds MHC class I molecules including HLA-G, an immunosuppressive protein expressed by multiple tumor types.
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. Biond will lead the first-in-human, phase 1a study of BND-22, evaluating its safety and tolerability as a single agent and in combination with approved cancer therapeutics as well as exploring potential associations between BND-22 anti-tumor activity and select tumor and blood-based biomarkers; Sanofi will assume clinical development and commercialization responsibilities thereafter.
BND-22 has been shown in preclinical studies to have a broad anti-tumor effect by targeting ILT2-mediated "do not eat me" signals in macrophages and by activating natural killer (NK) and CD8+ lymphocytes. The program is supported by a comprehensive biomarker strategy designed to guide patient enrollment in advanced clinical trials. 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.
"We are thrilled to partner with Sanofi, an organization with a global footprint and exceptional drug development and commercialization capabilities," said Ori Shilo, Co-Founder and Chief Financial Officer at Biond. "We believe this collaboration creates substantial value for our shareholders and validates Biond’s long term strategy to establish valuable partnerships with leading biopharmaceutical companies."
"The emphasis in the development of cancer immunotherapies has been placed so far mainly on drugs that stimulate the adaptive immune system to attack malignant cells, in particular T lymphocytes. Unfortunately, many advanced cancer patients do not derive a durable benefit from these drugs," said Tehila Ben-Moshe, Ph.D., Co-Founder and Chief Executive Officer at Biond. "Biond Biologics was founded with a unique model that enables focused development of breakthrough cancer therapies, reaching clinical trials more quickly. BND-22, the first clinical drug candidate to graduate Biond’s development model, is a novel immunotherapy that targets both adaptive and innate immune cells and takes advantage of the anti-tumor activity of not only T cells but also that of additional immune cells, such as NK cells and macrophages. We look forward to progressing BND-22 into the clinic together with our new partner Sanofi, using our in-depth knowledge of the ILT2 pathway and expertise in immuno-oncology."