Eganelisib
Addressing Significant Patient Need With
Next-Generation Immunotherapies
Adelene Perkins, CEO
40th Annual J.P. Morgan Healthcare Conference
January 10-13, 2022
Cautionary Note Regarding Forward-Looking Statements
This presentation contains forward-looking statements and information of Infinity Pharmaceuticals, Inc. ("we," "us," "our," "Infinity" or the "Company") within the meaning of The Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. We often use words such as "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "milestone," "goal," "potential," "will," "would," "could," "should," "continue," and other words and terms of similar meaning to help identify forward-looking statements, although not all forward-looking statements contain these identifying words. You also can identify these forward- looking statements by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements include those regarding the therapeutic potential of eganelisib; plans to initiate the MARIO-4 registration study and the MARIO-P platform study; design plans for MARIO-4; plans to release clinical data; the Company's estimated year end 2021 cash balance; financial guidance; plans to release 2021 financial results; and the Company's ability to execute on its strategic plans. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the company's current expectations. For example, there can be no guarantee that eganelisib will successfully complete necessary preclinical and clinical development phases or that any positive developments with eganelisib will result in stock price appreciation. Management's expectations and, therefore, any forward-looking statements in this presentation, could also be affected by risks and uncertainties relating to a number of other factors, including the following: Infinity's results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; Infinity's ability to obtain, maintain and enforce patent and other intellectual property protection for eganelisib; the content and timing of decisions made by the U.S. FDA and other regulatory authorities; Infinity's ability to obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; and development of agents by Infinity's competitors for diseases in which Infinity is currently developing or intends to develop eganelisib. These and other risks which may impact management's expectations are described in greater detail under the caption "Risk Factors" included in Infinity's annual report and quarterly reports filed with the Securities and Exchange Commission (SEC), and other filings filed by Infinity with the SEC, available on the SEC's website at www.sec.gov. Any forward-looking statements contained in this presentation speak only as of the date hereof, and Infinity expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Infinity regularly uses its website to post information regarding its business, product development programs and governance.
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Eganelisib: Potential Best-In-ClassNext-Generation Immunotherapy
First-in-class, oral, potent and selective macrophage reprogramming therapeutic
- Strong preclinical/translational medicine data demonstrating reprogramming of tumor associated macrophages
- Uniquely differentiated, next-generation immunotherapy
Clinical activity, safety & translational data in P2 settings where CPIs have shown little or no patient benefit
- 1L advanced/metastatic Triple Negative Breast Cancer (TNBC) in combination with CPI + chemo
- 2L metastatic Urothelial Cancer in combination with CPI
- Clinical/Translational Data releases in 4 tumor types in 2022
Registration enabling study in frontline advanced/metastatic TNBC - to be initiated by end of 2022
Platform study to rapidly and efficiently evaluate eganelisib in indications where tumor associated macrophages limit effectiveness of current therapies - to be initiated in 3Q2022
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Advancing and Expanding MARIO Clinical Development Program MAcrophage Reprogramming in Immuno-Oncology
PHASE 1 | PHASE 1B | PHASE 2 | PHASE 3 | ||||||
Frontline mTNBC | |||||||||
MARIO-4: Registration study | Initiate study by YE 2022 | ||||||||
eganelisib + CPI + chemo vs. standard of care | |||||||||
MARIO-3: Open label eganelisib triplet on top of | Data in 2H 2022 | ||||||||
Impassion130 doublet of Tecentriq® and Abraxane® | |||||||||
UC, RCC, HNSCC | |||||||||
MARIO-275: Randomized controlled study | Data in 2H 2022 | ||||||||
eganelisib + Opdivo® vs. Opdivo in 2L UC | |||||||||
MARIO-3: Open label study | Data in 2H 2022 | ||||||||
eganelisb + Tecentriq + Avastin® in 1L RCC | |||||||||
HNSCC: IST WoO monotherapy study | Data in 2H 2022 | ||||||||
MARIO-P Platform Study | |||||||||
Ovarian Cancer | |||||||||
NSCLC | Initiate on a rolling basis in 3Q 2022 | ||||||||
Soft Tissue Sarcoma | (20-40 patients per cohort) | ||||||||
Prostate Cancer | |||||||||
Triple Negative Breast Cancer (TNBC ) | Tecentriq® is a registered trademark of | Genentech, Inc. | |||||||
Urothelial Cancer (UC) | Abraxane® is a registered trademark of Abraxis BioScience, LLC. | ||||||||
Renal Cell Carcinoma (RCC) | Opdivo® is a registered trademark of Bristol Myers Squibb. | 4 | |||||||
Head and Neck Squamous Cell Cancer (HNSCC) | Avastin® is a registered trademark of Genentech, Inc. |
Non Small Cell Lung Cancer (NSCLC)
How Tumors Evade the Immune System
Activated T cell Exhausted T cell
Immunosuppressive molecule (e.g., PD-L1)
Macrophage
Tumor
Tumor Invisible to | Tumor Visible | Tumor Visible but Microenvironment | ||||||
Immune Attack | but T cells Exhausted | (TME) Suppresses T cell Response | ||||||
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Infinity Pharmaceuticals Inc. published this content on 13 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 January 2022 19:30:01 UTC.