MonTa Biosciences Announces Investment to Complete the Ongoing Phase I Monotherapy Trial on MBS8, and a Combination Phase IB/IIA Trial with MBS8 and a Currently Approved Oncology Drug.

COPENHAGEN, Denmark, October 20, 2022 — MonTa Biosciences, a clinical-stage biotechnology company focused on stimulating the immune system of cancer patients to induce immune cell-based tumor cell killing and to generate an immune memory response, announced today that it has raised investment capital to complete two clinical studies.

MonTa Biosciences is currently evaluating the drug candidate MBS8, which is a TLR7 agonist micelle formulation, in a phase I clinical trial. The monotherapy trial is divided into a dose-escalation and a dose-expansion part. So far 17 patients have been treated with MBS8 and have shown good tolerability and several interesting biomarker findings. The study is expected to be completed in Q4, 2023, with an established, Recommended Phase 2 Dose (RP2D). The investment will secure MonTa Biosciences to complete this phase I trial with enrollment of up to 24 patients for the expansion part.

The investment will in addition, secure the completion of a planned phase IB/IIA trial with MBS8 in combination with an oncology drug currently approved in several indications, and where MonTa Biosciences has demonstrated a strong synergistic effect in preclinical models with MBS8. Data from the ongoing phase 1 study support support these findings.The combination study is expected to be initiated during 2023, with the first patient treated by Q4 2023.

Simon S Jensen, CEO of MonTa Biosciences, said: “We are extremely happy to secure investment to further develop MBS8 in clinical trials aiming towards better treatment for cancer patients. We expectthe current studies will enable MonTa Biosciences to continue the clinical development towards an Accelerated Approval strategy”. The investment of 11 mEUR is raised from existing investors in MonTa Biosciences and will allow continued development to the end of 2025.

Simon S Jensen further stated, “We have met our deadlines and reached our milestones timely during the last years, and through this process built strong and trusted relations with our investors. The investment provides us the time and resources to pursue a focused clinical development of MBS8 and demonstrate its true value as a potential novel oncology drug”.

About MonTa Biosciences. MonTa Biosciences is a clinical-stage immune oncology company working on a novel formulation of an TLR7 agonist small-molecule drug formulated in micelles termed MBS8. MBS8 is administered by infusion to patients and stimulate both the innate and adaptive immune system. MBS8 stimulates initially neutrophil migration to tumor tissue leading to tumor cell killing, followed by induction of an immune memory response with activation of CD8 T-cells which can specifically recognize tumor antigens and lead to further tumor cell killing.