10 January 2022
Aptevo Therapeutics
A Leading Bispecific Antibody Company
NASDAQ: APVO
Forward-Looking Statements
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, Aptevo's expectations about the activity, efficacy and safety of its therapeutic candidates and potential use of any such candidates as therapeutics for treatment of disease, advancement of its clinical trials and its expectations regarding the effectiveness of its ADAPTIR and ADAPTIR-FLEX platforms, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "optimism," "potential," "designed," "engineered," "breakthrough," "innovative," "innovation," "promising," "plans," "forecasts," "estimates," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement.
There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward- looking statements, including a deterioration in Aptevo's business or prospects; adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; adverse developments in the U.S. or global capital markets, credit markets or economies generally; and changes in regulatory, social, and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the initiation, enrollment and maintenance of patients, and completion of clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, including our ability to obtain regulatory clearance to commence clinical trials, expectations for regulatory approvals, the impact of competitive products, actions of activist stockholders, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID- 19). These risks are not exhaustive, Aptevo faces known and unknown risks. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2020, and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances.
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Aptevo at-a-Glance
- Clinical-stageimmunotherapy company focused on developing novel immuno-oncology therapeutics
- Differentiated bispecific and multi-specific antibody platform technologies ADAPTIR™ and ADAPTIR-FLEX™
- Enables generation of novel candidates designed for multiple MOAs
- Utilizes best structure to fit desired biology, specificity and affinity
- Clinical portfolio: Lead candidate, APVO436, currently in Phase 1b clinical trials, for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)1
- Positive results reported for the dose escalation trial (AML/MDS)
- Results published in two peer-reviewed journals, presented at ASH
- Activation2 of expansion trial reported (AML)
- Reported first complete remission in expansion trial (11/23)
- Broad preclinical portfolio: Multiple novel candidates in development
- ALG.APV-527:Designed for treatment of both solid and liquid tumors expressing tumor antigen 5T4; planned IND1H22
- APVO603: Designed for treatment of solid tumors
- APVO442: Designed for treatment of prostate cancer; lower affinity, monovalent anti-CD3 designed to improve biodistribution to prostate tumors
(1) | Data initially reported May 26, 2021 | 3 |
(2) | Currently enrolling patients |
Experienced Leadership
Senior Management
Marvin White - President & CEO
Emergent Director; Former CFO, St. Vincent's Health; Former Executive Director & CFO, Lilly USA
Jeff Lamothe - SVP, CFO
Former Emergent VP, Finance; Former CFO, Cangene
Corporation
Dirk Huebner, MD - Senior Medical Advisor*
Former CMO of Mersana, Head of Development of Boston Biomedical, Executive Medical Director of Millennium/Takeda
Jane Gross, Ph.D. - CSO*
Former Emergent VP, Research/Non-Clinical Development; Former VP Immunology Research ZymoGenetics Inc.
SoYoung Kwon - SVP, GC, Corporate Affairs &
HR
Former SVP, GC and Corporate Secretary, AGC Biologics
Daphne Taylor- VP, Finance
Former Chief Financial Officer at BioLife Solutions, VP, Chief Accounting Officer & Controller at Cardiac Science Corporation
Board of Directors
Fuad El-Hibri
Founder, Executive Chairman, Emergent BioSolutions
Marvin White
Emergent Director; Former CFO, St. Vincent's Health; Former Executive Director & CFO, Lilly USA
Daniel Abdun-Nabi
Former President & CEO, COO, Emergent BioSolutions,
Former General Counsel, IGEN International, Inc.
Grady Grant, III
Former Vice President of Sales, Tissue Tech Limited; Former Reckitt Benckiser Group; Former Eli Lilly & Co.
Zsolt Harsanyi, Ph.D.
N-Gene Research Labs; Exponential Biotherapies; Porton Int'l
Barbara Lopez Kunz
DIA; Battelle; Thermo Fisher Scientific; ICI/Uniqema
John Niederhuber, M.D.
Inova Translational Medicine Institute; National Cancer Institute; Johns Hopkins University
Extensive R&D, Manufacturing, Commercial | |
and Financial Expertise and Experience | 4 |
*Drs. Huebner and Gross are consultants to the Company.
Robust Pipeline: Potential for Multiple Shots on
Goal in Hematologic Malignancies and Solid Tumors
Product/ | Technology | Potential | Pre- | Clinical Development Stage | Marketed | Milestones/Highlights | |||||
Candidate | |||||||||||
Indications | Clinical | Phase | Phase | Phase | |||||||
Target | |||||||||||
I | II | III | |||||||||
APVO436 | Redirected T cell | Phase 1 dose escalation | |||||||||
AML/MDS | reported positive results; | ||||||||||
Cytotoxicity | |||||||||||
CD3/CD123 | Part 2 dose expansion on- | ||||||||||
(RTCC) | |||||||||||
going | |||||||||||
ALG.APV-527* | T cell | Solid | Advancing into clinical | ||||||||
development in solid | |||||||||||
4-1BB/5T4 | Co-Stimulation | Tumors | tumors expressing 5T4. | ||||||||
IND planned: 1H22 | |||||||||||
APVO603 | Dual T cell | Solid | Unique asset for use in | ||||||||
solid tumors, APVO603 | |||||||||||
4-1BB/OX40 | Co-stimulation | Tumors | |||||||||
lead candidate identified | |||||||||||
APVO442 | Redirected T cell | Prostate | Low affinity CD3, | ||||||||
PSMA/CD3 | Cytotoxicity | Cancer | advancing lead candidate | ||||||||
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- Partnered with Alligator Bioscience
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Aptevo Therapeutics Inc. published this content on 10 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 10 January 2022 15:57:01 UTC.