GENEVA, BOSTON, & BEIJING—Selexis SA and Boston Immune Technologies and Therapeutics (BITT) announced that they have entered into a service agreement to develop the cell line for BITR2101, BITT’s lead tumor necrosis factor receptor 2 (TNFR2) antagonist antibody for the treatment of cancers and infectious diseases.
“The tumor microenvironment is incredibly complex and presents significant barriers to the development of targeted cancer immunotherapies that offer fewer side effects and higher response rates,” noted Dr. Yemi Onakunle, chief business officer of Selexis. “We are pleased to join BITT in the company’s efforts to leverage the human immune system to not only bring new treatments to patients with cancer but to potentially improve currently available therapies.”
Under the agreement, BITT will leverage Selexis’ SUREtechnology Platform, a suite of proprietary modular technologies that have been designed to overcome the complex challenges of protein expression, and deliver the high performance research cell banks necessary for pursuing clinical development.
BITT has developed a platform for targeting the TNFR2 oncogene, and the potent population of TNFR2 regulatory T cells (Tregs) in the tumor microenvironment. The TNFR2 epitope is densely expressed on Tregs in the tumor microenvironment, and they appear to play a role in resistance to checkpoint inhibitors — including PD1 and CTLA4. TNFR2 is also expressed on the surface of certain cancers as an NFkB-driven growth receptor oncogene.
“Progressing BITR2101 toward human studies is a significant milestone and it is imperative that we partner with the strongest cell line development company in the industry. Selexis is a standout player in the field, and one that is backed by proven technologies and a reputation for helping companies all over the world advance their programs,” stated Russell LaMontagne, co-founder, president, and CEO of BITT.
BITT has also recently entered into an option and license agreement with BeiGene, wherein BeiGene secured an option for an exclusive license to develop, manufacture, and commercialize BITT’s proprietary TNFR2 antagonist antibodies in Asia (excluding Japan), Australia, and New Zealand. The companies plan to conduct Phase 1 clinical trials of BITR2101 — including planned combination studies with tislelizumab, BeiGene’s anti-PD-1 antibody.
“BeiGene is a global company with an especially strong track record supporting biotechnology innovation and the ideal partner to help develop BITR2101, our investigational TNFR2 lead antibody,” LaMontagne said in a press release. “The collaboration with BeiGene is strong validation of BITT’s antibody platform and an opportunity to prove the potential of BITR2101 as a single agent and in combination with checkpoint inhibitors such as tislelizumab.”
Under the terms of the agreement, BITT will receive an upfront payment and potential near-term milestone payments totaling $16.6 million, inclusive of BeiGene’s exercise of the option to license following initial proof-of-concept studies. If BeiGene exercises the option, BITT will be eligible to receive development, regulatory, and sales milestones up to $105 million, together with tiered royalties on any product sales in the licensed territory. BeiGene has also invested $4 million in BITT’s Series A preferred stock financing.
“TNFR2 is an interesting target because of the high expression on the suppressive cells in the tumor microenvironment and a growing consensus that targeting TNFR2 may be a novel and effective approach to treating cancer. BITT has created antibodies that are highly specific to the tumor based on their unique and novel binding modality,” added Dr. Lusong Luo, senior vice president of External Innovation at BeiGene. “We look forward to collaborating with BITT and generating clinical data for BITR2101 as single agent and in combination with tislelizumab.”