Conditionally Active Antibodies for Immuno-oncology
NOVEMBER 2023 | Nasdaq: SNSE
Disclaimer
This presentation has been prepared by Sensei Biotherapeutics, Inc. (the "Company," "we," "us") and is made for informational purposes only. The information set forth herein does not purport to be complete or to contain all of the information you may desire. Statements contained herein are made as of the date of this presentation unless stated otherwise, and neither the delivery of this presentation at any time, nor any sale of securities, shall under any circumstances create an implication that the information contained herein is correct as of any time after such date or that information will be updated or revised to reflect information that subsequently becomes available or changes occurring after the date hereof.
This presentation contains estimates and other statistical data made by independent parties and by us relating to market shares and other data about our industry. This presentation also contains "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 that are based on our management's beliefs and assumptions and on information currently available to management. These forward-looking statements include, without limitation, expectations regarding the development and potential therapeutic benefits of our product candidates; the expected safety profile and pharmacokinetic profile of our product candidates, including SNS-101; the expected timing of clinical data from our Phase 1/2 clinical trial of SNS-101; the availability of data from our preclinical studies; the timing of discovery and selection of product candidates; and our belief that our existing cash and cash equivalents will be sufficient to fund our operations at least into the second half of 2025 and reach midway into Phase 2 clinical studies of SNS-101.
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sources. In addition, all of the market data included in this presentation involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while we believe our own internal research is reliable, such research has not been verified by any independent source.
Engineered Selectivity to Extend the Clinical Reach of Immuno-oncology Agents
LEAD PROGRAM
SNS-101, a conditionally active antibody targeting VISTA
Initial Phase 1 data demonstrate well tolerated safety profile & potentially best-in- class pharmacokinetics (PK)
TMAb PLATFORM
Conditionally active antibodies designed to widen therapeutic window and enable druggability of promising oncology targets
EXPECTED MILESTONES
Initial PK & safety combination data in Q1 2024
Topline monotherapy data in Q2 2024
Topline combination data in 2024
FINANCIALS
Ended Q2 2023: $78.8M*
Cash runway into 2H 2025
Cash currently sufficient to reach midway into
Phase 2 clinical studies for SNS-101
3
*Consists of cash, cash equivalents and marketable securities
Lack of Tumor Targeting is a Major Obstacle to IO Innovation
Industry Problem
Conventional antibodies target immune checkpoints that are highly expressed in normal tissues, resulting in:
Dose-limiting toxicities due to on-target/off-tumor action
Pharmacological sink effect requires higher and more frequent dosing
Suboptimal activity due to poor PK and dose-limiting toxicities
Sensei's Solution
Conditionally active antibodies are selectively targeted to the tumor microenvironment, potentially providing:
Little or no toxicity due to selective on-target/on-tumor action
Lower and less frequent doses by avoiding normal tissue binding
Powerful activity selectively focused on the tumor microenvironment
Only one new checkpoint inhibitor has been approved since the original CTLA-4 and PD-1/PD-L1 group
IpilimumabPembrolizumab
(anti-CTLA-4)(anti-PD-1)
2011 | 2014 |
Relatlimab
(anti-LAG-3)
2022
4
TMAb Antibodies are Designed to Bind Selectively in the Tumor
Microenvironment
Lack of peripheral target engagement can improve safety and pharmacokinetic parameters while focusing action to the tumor microenvironment
5
Innovative Pipeline of IO Drugs with Broad Commercial Potential
*Sensei has entered into a clinical supply agreement with Regeneron supporting the planned evaluation of SNS-101 in combination with Regeneron's anti-PD-1 therapy Libtayo® (cemiplimab) in a Phase 1/2 clinical trial in solid tumors.
*Sensei has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute. The goal of this collaborative effort is to further elucidate the role of VISTA in immune checkpoint resistance and expand the potential of SNS-101 as a combination therapy beyond anti-PD-1.
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SNS-101
VISTA is a Potent T cell Checkpoint Extensively Expressed on Myeloid Cells1
VISTA is a B7 family member that suppresses T cell function and is expressed extensively by myeloid cells
SNS-101 targets immunosuppressive function mediated by PSGL-1 and other receptors
VISTA has inherent pH sensitivity: its extracellular domain is uniquely rich in histidines2
SNS-101 has monovalent affinity of 0.218 nM at pH 6.0, with no observed binding at neutral pH
Myeloid lineage cell or
tumor cell (less common)
T-cell proliferation & activation
1. Lines et al. Cancer research vol. 74,7 (2014) | 8 |
2. Johnston et al., Nature 2019 |
Historical Challenges Targeting VISTA-Positive Myeloid Cells Resulted in Early
Clinical Trial Termination
Dose-limiting toxicity
Grade 3 CRS-associated encephalopathy
- JNJ-61610588(CI-8993) was the first anti-VISTA antibody to be studied in clinical trials in 2016 (NCT02671955) 1
-
Transient Cytokine Release Syndrome (CRS) observed in several patients at
0.15 mg/kg - Transient Grade 3 CRS-associated encephalopathy observed at 0.3 mg/kg, after which Janssen halted the study
Challenging PK profile
Non-linear PK, short t1/2
JNJ-61610588 Human Plasma Concentration
1 Curis, Inc., Corporate Presentation, Feb 2022
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SNS-101 is a Differentiated, pH-Sensitive Antibody Designed to Overcome the
Unique Challenges of VISTA
Differentiated Design and Mechanism
Rapidly Enrolling Phase 1/2 Clinical Trial
IgG1, Fc-active antibody designed to selectively block VISTA in the low-pH tumor microenvironment
Multi-center U.S. study as single agent and in combination with PD-1 inhibitor Libtayo®
Potential Best-in-Class Safety and PK | No observed CRS or dose-limiting toxicity and no | |
Profile Supported by Initial Clinical Data | evidence of target-mediated drug disposition* | |
Achieving "Firsts" for the VISTA Field | First VISTA-blocking antibody administered at a dose | |
anticipated to be therapeutically relevant without eliciting | ||
dose-limiting toxicity | ||
Approaching Near-Term Clinical | Anticipate initial combination PK/safety data in Q1 2024 | |
with topline monotherapy data in Q2 2024 and topline | ||
Milestones | ||
combination data in 2024 | ||
*As of safety cut-off date of October 3, 2023 | 10 |
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Sensei Biotherapeutics Inc. published this content on 03 November 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 03 November 2023 20:14:07 UTC.