AGEN Agenus Inc.

3.84
+0.19  (+5%)
Previous Close 3.65
Open 3.65
52 Week Low 1.82
52 Week High 5.63
Market Cap $704,419,788
Shares 183,442,653
Float 163,930,063
Enterprise Value $680,925,052
Volume 1,344,724
Av. Daily Volume 2,779,144
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Upcoming Catalysts

Drug Stage Catalyst Date
AGEN1181 - 2nd gen CTLA
Advanced cancer
Phase 1
Phase 1
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Balstilimab
Cervical cancer
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Balstilimab (anti-PD-1) and zalifrelimab (anti-CTLA-4)
Cervical cancer
Phase 2
Phase 2
Phase 2 data presented at ESMO September 18, 2020. Balstilimab (PD-1) monotherapy response rates of 14% in all treated patients and 19% in PD-L1 positive patients. Balstilimab (PD-1) + zalifrelimab (CTLA-4) combination trial response rates of 22% in all patients and 27% in PD-L1 positive patients.
Zalifrelimab - AGEN1884 (anti-CTLA-4)
Solid cancers
Phase 1/2
Phase 1/2
Phase 3 expansion trial underway - noted August 6, 2020.
Shingrix
Shingles
Approved
Approved
Approval announced October 20, 2017.

Latest News

  1. LEXINGTON, Mass., Oct. 20, 2020 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ:AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapy, adjuvants, and vaccines designed to activate immune response to cancers and infections, today announced it will release its third quarter 2020 financial results before the market opens on Thursday, October 29, 2020. Agenus executives will host a conference call and webcast at 8:30 a.m. ET the same day to discuss the results and to provide a corporate update.

    Live Call: Dial (833) 614-1394 (US) or (914) 987-7115 (International)

    Webcast: The call will be accessible from the Company website's Events & Presentations page at https://investor.agenusbio.com/events-and-presentations

    LEXINGTON, Mass., Oct. 20, 2020 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ:AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapy, adjuvants, and vaccines designed to activate immune response to cancers and infections, today announced it will release its third quarter 2020 financial results before the market opens on Thursday, October 29, 2020. Agenus executives will host a conference call and webcast at 8:30 a.m. ET the same day to discuss the results and to provide a corporate update.

    Live Call: Dial (833) 614-1394 (US) or (914) 987-7115 (International)

    Webcast: The call will be accessible from the Company website's Events & Presentations page at https://investor.agenusbio.com/events-and-presentations or via https://edge.media-server.com/mmc/p/mbkjgw8w. A replay will be available after the call.

    About Agenus

    Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body's immune system to fight cancer. The Company's vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combination approaches that leverage a broad repertoire of antibody therapeutics, adoptive cell therapies (through its AgenTus Therapeutics subsidiary), and proprietary cancer vaccine platforms. The Company is equipped with a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support clinical programs. Agenus is headquartered in Lexington, MA. For more information, please visit www.agenusbio.com and our Twitter handle @agenus_bio. Information that may be important to investors will be routinely posted on our website and Twitter.

    Contact

    Agenus Inc.

    Caroline Bafundo

    212-994-8209

    Primary Logo

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    • Clinical Responses: AGEN1181 (Fc-enhanced anti-CTLA-4) +/- balstilimab
    • Clinical Data: Zalifrelimab efficacy in refractory rare tumors
    • Clinical & Preclinical Data: AGEN 2373 (anti-CD137)
    • Phase 2 Data: Optimizing treatment with balstilimab +/- zalifrelimab
    • Cell Therapy with Allogeneic Cells: AgenT-797 (iNKT cells)
    • Differentiated TIGIT: Fc enhancement to optimize anti-TIGIT antibody function
    • Artificial Intelligence (AI): Predicting responders and new targets with VISION platform

    LEXINGTON, Mass., Oct. 14, 2020 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ:AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapy, adjuvants, and vaccines designed to activate immune response to cancers and infections, today announced…

    • Clinical Responses: AGEN1181 (Fc-enhanced anti-CTLA-4) +/- balstilimab
    • Clinical Data: Zalifrelimab efficacy in refractory rare tumors
    • Clinical & Preclinical Data: AGEN 2373 (anti-CD137)
    • Phase 2 Data: Optimizing treatment with balstilimab +/- zalifrelimab
    • Cell Therapy with Allogeneic Cells: AgenT-797 (iNKT cells)
    • Differentiated TIGIT: Fc enhancement to optimize anti-TIGIT antibody function
    • Artificial Intelligence (AI): Predicting responders and new targets with VISION platform

    LEXINGTON, Mass., Oct. 14, 2020 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ:AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapy, adjuvants, and vaccines designed to activate immune response to cancers and infections, today announced that seven abstracts were accepted for presentation at the virtual SITC 2020 Annual Meeting from November 9-14, 2020.

    Presentation Details:

    Abstract title: AGEN1181, an Fc engineered anti-CTLA-4 antibody, demonstrates clinical activity, alone or in combination with balstilimab (anti-PD-1), and broadens the therapeutic potential of CTLA-4 therapy (NCT03860272)

    Abstract number: 398

    Presenting author: Dr. Stephen O'Day

    ePoster and audio session times: 11/12 4:50-5:20pm; 11/14 1:00-1:30pm

    Abstract title: Single-agent Zalifrelimab (anti-CTLA-4) Shows Clinical Benefit in Rare Tumors - Case Report from Phase 2 Study (NCT03104699)

    Abstract number: 245

    Presenting author: Dr. Cesar Perez

    ePoster and audio session times: 11/11 5:15-5:45pm; 11/13 4:40-5:10pm

    Abstract title: AGEN2373 is a CD137 agonist antibody designed to leverage optimal CD137 and FcγR co-targeting to promote antitumor immunologic effects

    Abstract number: 377

    Presenting author: Dr. Claire Galand

    ePoster and audio session times: 11/11 5:15-5:45; 11/13 4:40-5:10pm

    Abstract title: Pseudoprogression Patterns: Analysis from 2 Independent Phase-2 Studies with Immunotherapy for Recurrent Cervical Cancer

    Abstract number: 267

    Presenting author: Dr. David O'Malley

    ePoster and audio session times: 11/11 5:15-5:45pm; 11/13 4:40-5:10pm

    Abstract title: AgenT-797, a novel allogenic and "off-the shelf" iNKT cell therapy promotes effective tumor killing

    Abstract number: 164

    Presenting author: Dr. Burcu Yigit

    ePoster and audio session times: 11/12 4:50-5:20; 11/14 1:00-1:30pm

    Abstract title: Anti-TIGIT antibodies require enhanced FcγR co-engagement for optimal T and NK cell-dependent anti-tumor immunity

    Abstract number: 253

    Presenting author: Rebecca Ward

    ePoster and audio session times: 11/11 5:15-5:45pm; 11/13 4:40-5:10pm

    Abstract title: Beyond PD-L1: novel PD-1 biomarkers identified by driving T cell dysfunction in vitro

    Abstract number: 70

    Presenting author: Dr. Simarjot Pabla

    ePoster and audio session times: 11/12 4:50-5:20pm; 11/14 1:00-1:30pm

    There was a premature disclosure of at least one Agenus abstract on the conference website, which reflected data that was only available at the time of abstract submission in August 2020. Updated data will be presented at the conference and will become available on the Agenus website at https://investor.agenusbio.com/events-and-presentations following the presentations on November 9-14, 2020.

    About Agenus

    Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body's immune system to fight cancer. The Company's vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combination approaches that leverage a broad repertoire of antibody therapeutics, adoptive cell therapies (through its AgenTus Therapeutics subsidiary), and proprietary cancer vaccine platforms. The Company is equipped with a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support clinical programs. Agenus is headquartered in Lexington, MA. For more information, please visit www.agenusbio.com and our Twitter handle @agenus_bio. Information that may be important to investors will be routinely posted on our website and Twitter.

    Forward-Looking Statements

    This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the therapeutic potential of Agenus' product candidates, as well as the anticipated presentation of updated clinical and preclinical data. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Quarterly Report on Form 10-Q or Annual Report on Form 10-K filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

    Contact:

    Agenus Inc. 

    Caroline Bafundo

    212-994-8209

    Primary Logo

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  2. LEXINGTON, Mass., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ:AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapy, adjuvants, and vaccines designed to activate immune response to cancers and infections, today announced the election of Ms. Susan Hirsch to Agenus' Board of Directors.

    "I am delighted to welcome Susan Hirsch to our Board as we prepare to launch our first commercial products," said Garo Armen, PhD, Chairman and CEO of Agenus. "As an early adopter of disruptive and value-creating platform companies, like Amazon, Susan has an impeccable record of identifying high value companies at their early inflection point."

    Susan has over 40 years of experience in investment management…

    LEXINGTON, Mass., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ:AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapy, adjuvants, and vaccines designed to activate immune response to cancers and infections, today announced the election of Ms. Susan Hirsch to Agenus' Board of Directors.

    "I am delighted to welcome Susan Hirsch to our Board as we prepare to launch our first commercial products," said Garo Armen, PhD, Chairman and CEO of Agenus. "As an early adopter of disruptive and value-creating platform companies, like Amazon, Susan has an impeccable record of identifying high value companies at their early inflection point."

    Susan has over 40 years of experience in investment management and finance, including her most recent position as a Managing Director at Nuveen, a TIAA company, where she was responsible for Nuveen's TIAA-CREF Large-Cap Growth Fund with $6.6 billion in assets. She previously held investment management positions at Jennison Associates, Lehman Brothers Global Asset Management, and Delphi Asset Management. Susan holds a BS in Accounting from Brooklyn College.

    "I am thrilled to join Agenus at this important time in its development," said Susan Hirsch. "Agenus has established an impressive set of technology platforms, capabilities, and products designed to bring solutions to patients with cancer."

    About Agenus

    Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body's immune system to fight cancer. The Company's vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combination approaches that leverage a broad repertoire of antibody therapeutics, adoptive cell therapies (through its AgenTus Therapeutics subsidiary), and proprietary cancer vaccine platforms. The Company is equipped with a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support clinical programs. Agenus is headquartered in Lexington, MA. For more information, please visit www.agenusbio.com and our Twitter handle @agenus_bio. Information that may be important to investors will be routinely posted on our website and Twitter.

    Forward-Looking Statements

    This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding Agenus' anticipated commercial launch. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Quarterly Report on Form 10-Q or Annual Report on Form 10-K filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

    Contact:

    Agenus Inc. 

    Caroline Bafundo        

    212-994-8209

    C  

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/fbecb31e-2ab1-4c6c-848d-681d04f719b5

    Primary Logo

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  3. LEXINGTON, Mass., Sept. 18, 2020 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ:AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapy, adjuvants, and vaccines designed to activate immune response to cancers and infections, announced the initiation of the rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for balstilimab alone for the treatment of recurrent/metastatic cervical cancer.

    Data from the largest phase 2 trial of anti-PD-1 in patients with refractory cervical cancer was presented today at the European Society for Medical Oncology (ESMO) Virtual Congress https://agenusbio.com/balstilimab-balstilimab-zalifrelimab/.  Data from more than…

    LEXINGTON, Mass., Sept. 18, 2020 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ:AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapy, adjuvants, and vaccines designed to activate immune response to cancers and infections, announced the initiation of the rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for balstilimab alone for the treatment of recurrent/metastatic cervical cancer.

    Data from the largest phase 2 trial of anti-PD-1 in patients with refractory cervical cancer was presented today at the European Society for Medical Oncology (ESMO) Virtual Congress https://agenusbio.com/balstilimab-balstilimab-zalifrelimab/.  Data from more than 160 patients treated with balstilimab (anti-PD-1) monotherapy achieved response rates of 19% in PD-L1 positive patients and 14% in all treated patients and will support the balstilimab BLA filing.

    Balstilimab is a novel anti-PD-1 human monoclonal antibody that has demonstrated promising clinical benefit in second line treatment of cervical cancer.

    "The initiation of the rolling BLA is an exciting step forward for Agenus as we are closer to making our therapies commercially available for patients with cervical cancer who have limited treatment options available," said Dr. Jennifer Buell, President and COO of Agenus. "We continue to collaborate with the leading KOLs and the FDA in our efforts to make these treatments available to patients."

    A rolling submission allows Agenus to submit each section of the BLA as it is completed, which enables the FDA to review the submitted sections in parallel with Agenus's completion of the balance of the BLA application.

    The American Cancer Society estimates around 14,000 new cases of invasive cervical cancer to be diagnosed this year and nearly 4,300 cervical cancer deaths. This population needs new therapies that safely provide clinical benefit across all patients. 

    About Agenus

    Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body's immune system to fight cancer. The Company's vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combination approaches that leverage a broad repertoire of antibody therapeutics, adoptive cell therapies (through its AgenTus Therapeutics subsidiary), and proprietary cancer vaccine platforms. The Company is equipped with a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support clinical programs. Agenus is headquartered in Lexington, MA. For more information, please visit www.agenusbio.com and our Twitter handle @agenus_bio. Information that may be important to investors will be routinely posted on our website and Twitter.

    Forward-Looking Statements

    This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding clinical development and regulatory plans and timelines. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Quarterly Report on Form 10-Q or Annual Report on Form 10-K filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

    Contact:

    Agenus Inc. 

    Jennifer Buell, PhD

    781-674-4420 

    Primary Logo

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    • 160 patient balstilimab (PD-1) monotherapy trial achieves response rates of 14% in all treated patients and 19% in PD-L1 positive patients
    • 155 patient balstilimab (PD-1) + zalifrelimab (CTLA-4) combination trial achieves response rates of 22% in all patients and 27% in PD-L1 positive patients

    LEXINGTON, Mass., Sept. 18, 2020 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ:AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapy, adjuvants, and vaccines designed to activate immune response to cancers and infections, today presented preliminary results from two large clinical trials of more than 150 patients each at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. Both trials were conducted…

    • 160 patient balstilimab (PD-1) monotherapy trial achieves response rates of 14% in all treated patients and 19% in PD-L1 positive patients
    • 155 patient balstilimab (PD-1) + zalifrelimab (CTLA-4) combination trial achieves response rates of 22% in all patients and 27% in PD-L1 positive patients

    LEXINGTON, Mass., Sept. 18, 2020 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ:AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapy, adjuvants, and vaccines designed to activate immune response to cancers and infections, today presented preliminary results from two large clinical trials of more than 150 patients each at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. Both trials were conducted in patients with recurrent/metastatic cervical cancer which has limited effective treatment options and disproportionately affects younger women.

    "Balstilimab has shown activity in both PD-L1 positive and negative tumors, suggesting that we may have a potentially differentiated PD-1," said Dr. Garo Armen, Chairman and CEO of Agenus. "Furthermore, we have also shown important expansion in response rates, to near doubling in PD-L1 positive patients, and durability of response when patients receive zalifrelimab in combination with balstilimab."

    The presentation was made by Dr. David O'Malley, Professor of Obstetrics and Gynecology at The Ohio State University College of Medicine and the Director of the Division of Gynecologic Oncology, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James). Dr. O'Malley is the lead investigator of the trials presented.

    "These trials represent the largest trials of immuno-oncology therapies in relapsed cervical cancer to date and show that balstilimab and zalifrelimab may present meaningful new therapies for patients with cervical cancer," said Dr. O'Malley. "Advances in these agents offer renewed hope for patients who have limited treatment options."

    Summary of Data Presented at ESMO2020

     AGEN PD-1

    Balstilimab

    n=160*
    AGEN PD-1 + CTLA-4

    Balstilimab + Zalifrelimab

    n=143*
     

    Response rates (ORR)

    PD-L1(+)

    PD-L1(-)





    14%

    19%

    10%


    22%

    27%

    11%



    ORR by tumor histology

    Squamous cell carcinoma





     

    18%





    27%



    Median duration of response (months)





    15.4 months



    Not Reached

    *  mITT population; data cut-off: July 31, 2020

    Agenus Presentation at ESMO Virtual Congress 2020:

    Balstilimab (anti-PD-1) Alone and in Combination with Zalifrelimab (anti-CTLA-4) for Recurrent/Metastatic (R/M) Cervical Cancer (CC). Preliminary Results of Two Independent Ph2 Trials

    Author: O'Malley

    Session: Mini Oral - Gynecological cancers 2

    Session Time: Friday, September 18 at 9:00 am CEST

    About Agenus

    Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body's immune system to fight cancer. The Company's vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combination approaches that leverage a broad repertoire of antibody therapeutics, adoptive cell therapies (through its AgenTus Therapeutics subsidiary), and proprietary cancer vaccine platforms. The Company is equipped with a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support clinical programs. Agenus is headquartered in Lexington, MA. For more information, please visit www.agenusbio.com and our Twitter handle @agenus_bio. Information that may be important to investors will be routinely posted on our website and Twitter.

    Forward-Looking Statements

    This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the anticipated benefits of balstilimab and zalifrelimab based on preliminary results. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Quarterly Report on Form 10-Q or Annual Report on Form 10-K filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

    Contact:

    Agenus Inc.

    Jennifer Buell, PhD

    781-674-4420

    Primary Logo

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