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Solid Tumors and Unmet Needs

Advances in the field of immuno-oncology have led to new and better treatment outcomes for a range of cancers, and particularly, blood cancers. However, even with the advent of checkpoint inhibitors as immunotherapies for solid tumors, significant challenges remain. This is in part due to dynamics in the tumor microenvironment, wherein regulatory T cells [Tregs] proliferate and suppress the immune responses to tumor cells.

The Treg is a type of T cell that is important in preventing autoimmunity by keeping effector T cells [Teffs] “in-check” to prevent destruction of healthy tissues. However, around tumors, Tregs create an immunosuppressive environment and block the work of Teffs to do what they do well – kill cancer cells. So, targeting depletion of Tregs to control tumors has emerged as an area of interest in oncology over the past several years.

Fortunately, Tregs express a protein, CD25, that allows them to be killed with an anti-CD25 antibody. Unfortunately, that protein is part of the interleukin-2 [IL-2] signaling, which also activates Teffs. This is what has presented a challenge; anti-CD25 antibodies can deplete Tregs, but unless they have certain characteristics, those antibodies also prevent Teffs from cancer cell killing, thereby resulting in a failure as a therapeutic to control tumor growth and metastasis.

Development Status

Anti-tumor responses have been observed in pre-clinical models of disease using IBIO-101 as a monotherapy, as well as in combination with checkpoint inhibitors.
Line graph of Tumor Size to Days Post Engraftment. The control, line shows exponential tumor growth over 25 days. Where IBIO-101 was administered, tumor growth rate decreases.

In a colon cancer xenograft model, IBIO-101 alone dose-dependently inhibited tumor growth

Line graph of Tumor volume to Days Post Grouping. Minimal tumor growth observed when treated with IBIO-101 combined with PD1 antibody. Tumor volume increased when treated with either IBIO-101 or PD1 antibody alone, but were still lower than PBS samples.

In combination with a PD1 antibody, IBIO-101 reduced tumor growth in a humanized adenocarcinoma model

IBIO-101 has favorable characteristics for CMC Development

Potential for Master Cell Bank (MCB) development from 8 promising cell lines
Unoptimized cell lines already show promising IBIO-101 yields