Immunotherapy BND-22 Brings Biond Biologics and Sanofi Together in a Global Licensing Agreement

Pipeline Report | <b>Pipeline Report: January 2021</b>

Biond Biologics Ltd. will join Sanofi in an exclusive worldwide license agreement for the development and commercialization of the novel immunotherapy BND-22.

Biond Biologics Ltd. will join Sanofi in an exclusive worldwide license agreement for the development and commercialization of the novel immunotherapy, BND-22, according to a press release from Biond.1 

The agreement was announced after an investigational new drug application had been submitted to the FDA for BND-22. Biond will receive a $125 million payment up front and will obtain the rights to more than $1 billion in development, regulatory, and sales milestones in addition to tiered royalty payments, according to the terms of the agreement. 

“We are thrilled to partner with Sanofi, an organization with a global footprint and exceptional drug development and commercialization capabilities,” Ori Shilo, co-founder and chief financial officer at Biond, stated in a press release. “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.”

BND-22 is a humanized IgG4 antibody antagonist that targets the Ig-like transcript 2 (ILT2) receptor. The agent is currently in development for the treatment of solid tumors. ILT2, an inhibitory receptor and member of the ILT immunomodulatory receptors, is expressed on innate and adaptive immune cells that binds MHC class I molecules, such as human leukocyte antigen-G, an immunosuppressive protein expressed across several tumor types. 

In preclinical studies, BND-22 demonstrated broad antitumor activity by targeting ILT2-mediated “do-not-eat-me” signals in macrophages and by activating natural killer and CD8+ lymphocytes. 

“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,” Tehila Ben-Moshe, PhD, co-founder and chief executive officer at Biond, said in a press release. “BND-22 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.” 

Biond will spearhead the first-in-human, phase 1a study of BND-22 (NCT04717375),2 slated to assess the safety and tolerability of the agent alone and in combination with approved cancer therapies in patients with advanced malignancies.

The open-label, multicenter study plans to enroll 100 patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy. The study protocol is comprised of 2 parts: an initial 3 + 3 dose-escalation phase followed by a dose-expansion phase.

Potential correlations between the antitumor activity of BND-22 and select tumor and blood-based biomarkers will also be evaluated, after which Sanofi will assume all clinical development and commercialization responsibilities.

The phase 1 study is expected to launch in March of 2021.

“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,” concluded Ben-Moshe.

References

  1. Biond Biologics and Sanofi enter into global licensing agreement for BND-22, a novel immune checkpoint inhibitor targeting the ILT2 receptor. News release. January 12, 2021. Accessed January 26, 2021. https://bit.ly/3ce0M9n
  2. Study of BND-22 in participants with advanced solid tumors. ClinicalTrials.gov. January 22, 2021. Updated January 26, 2021. Accessed January 26, 2021. https://clinicaltrials.gov/ct2/show/NCT04717375