AGEN Agenus Inc.

3.34
-0.08  -2%
Previous Close 3.42
Open 3.48
52 Week Low 1.82
52 Week High 5.63
Market Cap $635,098,665
Shares 190,149,301
Float 170,636,711
Enterprise Value $559,609,158
Volume 2,039,942
Av. Daily Volume 2,160,575
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Upcoming Catalysts

Drug Stage Catalyst Date
Balstilimab
Cervical cancer
BLA Filing
BLA Filing
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Drug Pipeline

Drug Stage Notes
AGEN1181 and balstilimab (anti-PD-1)
Colon cancer
Phase 2
Phase 2
Phase 2 trial expansion into colon cancer announced December 1, 2020.
MK-4830
Non-small cell lung cancer
Phase 2
Phase 2
Phase 2 trial ongoing.
agenT-797
COVID-19
Phase 1
Phase 1
Phase 1 initiation of dosing announced November 2, 2020.
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., Dec. 03, 2020 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ:AGEN), an immuno-oncology company with a broad pipeline which includes checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, today announced updated timing of the balstilimab BLA filing to meet the FDA feedback to follow all patients for a median of 12 months and responders for a minimum of 6 months. Due to two newly-identified late responses in the trial, the completion of the BLA filing is planned for the first half of 2021. In parallel, Agenus is working with the FDA to clarify diagnostic requirements for PD-L1 testing.

    The additional follow-up is required to present data on two patients who experienced…

    LEXINGTON, Mass., Dec. 03, 2020 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ:AGEN), an immuno-oncology company with a broad pipeline which includes checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, today announced updated timing of the balstilimab BLA filing to meet the FDA feedback to follow all patients for a median of 12 months and responders for a minimum of 6 months. Due to two newly-identified late responses in the trial, the completion of the BLA filing is planned for the first half of 2021. In parallel, Agenus is working with the FDA to clarify diagnostic requirements for PD-L1 testing.

    The additional follow-up is required to present data on two patients who experienced durable disease stabilization and converted to confirmed responses on long-term balstilimab therapy.

    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 regulatory timelines for the BLA filings of balstilimab alone and in combination with zalifrelimab. 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



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  2. LEXINGTON, Mass., Dec. 01, 2020 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ:AGEN), an immuno-oncology company with a broad pipeline which includes checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, today announced the expansion of a Phase 2 trial into colon cancer based on a new objective clinical response in a colorectal cancer patient in addition to a significant tumor reduction of 27% and biomarker reduction observed in a patient with MSS colon cancer.

    With this recent response in colon cancer, AGEN1181 +/- balstilimab (anti-PD-1) has reported 4 clinical responses plus a significant tumor reduction of more than 27% in a fifth patient. In addition, 19 patients have…

    LEXINGTON, Mass., Dec. 01, 2020 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ:AGEN), an immuno-oncology company with a broad pipeline which includes checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, today announced the expansion of a Phase 2 trial into colon cancer based on a new objective clinical response in a colorectal cancer patient in addition to a significant tumor reduction of 27% and biomarker reduction observed in a patient with MSS colon cancer.

    With this recent response in colon cancer, AGEN1181 +/- balstilimab (anti-PD-1) has reported 4 clinical responses plus a significant tumor reduction of more than 27% in a fifth patient. In addition, 19 patients have achieved disease stabilization out of 41 patients treated in what was designed as a dose escalation study.

    Recently, Agenus also presented on the first-ever report of intratumoral Treg depletion with a CTLA-4 antibody in clinical trials. The summary of responses achieved with AGEN1181 alone or in combination with balstilimab are as follows:

    • CR in PD-L1(-) MSS endometrial cancer patient (1181 monotherapy)
    • CR in PD-L1(-) MSS endometrial cancer patient (1181 + bali)
    • PR in a colorectal cancer patient (1181 + bali)
    • PR in PD-L1(-) refractory ovarian cancer patient (rescued with 1181 + bali) – previous stable disease for 66 weeks with 1181 monotherapy
    • Major tumor reduction (27%) in MSS colorectal cancer with remarkable CEA biomarker reduction from 298 to 2 (1181 + bali)

    In the phase 1 trial of AGEN1181, clinical benefit and responses have been seen in patients with polymorphism in FcyRIIIA alleles who are not responsive to first-generation CTLA-4 antibodies.

    The Phase 2, open-label, multicenter study will focus primarily on colorectal cancer and select solid tumors, such as lung cancer and melanoma.

    "These early data are very exciting, particularly in aggressive tumors that have traditionally been unresponsive to immune therapies, like colorectal cancer," said Dr. Joseph Grossman, expert in gastrointestinal cancers and the Head of Exploratory Medicine at Agenus. "AGEN1181 has potential to not only broaden the population of responders to CPIs, but also to reach tumors traditionally considered "cold" or unresponsive to immune therapies. I am excited to see the potential broadened benefit of our next-generation anti-CTLA-4's design, particularly its Fc-enhancement, and the validation of Agenus' incredible R&D capabilities."

    Dr. Joseph Grossman recently joined Agenus as head of exploratory medicine from Harvard Medical School, where he was an instructor in medicine, and Beth Israel Deaconess Medical Center, where he served as an attending physician in GI oncology. He completed his residency and fellowship in hematology oncology at Beth Israel Deaconess Medical Center. He holds a postbaccalaureate certificate in premedical sciences from Columbia University in the City of New York and an MD from Brown Medical School.

    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 and curative potential of AGEN1181. 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

     



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  3. LEXINGTON, Mass., Nov. 25, 2020 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ:AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, today announced that Dr. Jennifer Buell, President and COO of Agenus, will participate in a fireside chat hosted by Umer Raffat at the Evercore ISI 3rd Annual HealthCONx Conference on Thursday, December 3, 2020 from 10:55 AM – 11:15 AM EST.

    Dr. Buell will provide an update on clinical programs, including AGEN1181, and corporate progress.

    Registration for the webinar can be done in advance at https://wsw.com/webcast/evercore11/register.aspx?conf=evercore11&page=agen&url=https://wsw.com/webcast/eve

    LEXINGTON, Mass., Nov. 25, 2020 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ:AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, today announced that Dr. Jennifer Buell, President and COO of Agenus, will participate in a fireside chat hosted by Umer Raffat at the Evercore ISI 3rd Annual HealthCONx Conference on Thursday, December 3, 2020 from 10:55 AM – 11:15 AM EST.

    Dr. Buell will provide an update on clinical programs, including AGEN1181, and corporate progress.

    Registration for the webinar can be done in advance at https://wsw.com/webcast/evercore11/register.aspx?conf=evercore11&page=agen&url=https://wsw.com/webcast/evercore11/agen/2321775.

    A replay will be available after the call on the Events & Presentations page of the Agenus website at https://investor.agenusbio.com/events-and-presentations.   

    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



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  4. - Interim data show promising disease control rates in patients vaccinated with VBI-1901 combined with the GM-CSF adjuvant (40%), and with VBI-1901 combined with GSK's adjuvant AS011 (56%)

    - 2 partial responses observed in VBI-1901 + GM-CSF study arm, with tumor reduction of more than 50%, and 7 stable disease observations across both vaccinated groups

    - VBI-1901 was well-tolerated with both adjuvants – no safety signals observed in either vaccinated group

    VBI Vaccines Inc. (NASDAQ:VBIV) ("VBI") a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced Phase 2a (Part B) data from its ongoing Phase 1/2a study of VBI-1901, the company's cancer vaccine immunotherapeutic…

    - Interim data show promising disease control rates in patients vaccinated with VBI-1901 combined with the GM-CSF adjuvant (40%), and with VBI-1901 combined with GSK's adjuvant AS011 (56%)

    - 2 partial responses observed in VBI-1901 + GM-CSF study arm, with tumor reduction of more than 50%, and 7 stable disease observations across both vaccinated groups

    - VBI-1901 was well-tolerated with both adjuvants – no safety signals observed in either vaccinated group

    VBI Vaccines Inc. (NASDAQ:VBIV) ("VBI") a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced Phase 2a (Part B) data from its ongoing Phase 1/2a study of VBI-1901, the company's cancer vaccine immunotherapeutic candidate designed to target cytomegalovirus (CMV) as a foreign viral antigen in recurrent glioblastoma (GBM). The data were presented in an e-poster at the Society for Neuro-Oncology (SNO) 2020 Annual Meeting, November 19-21, 2020.

    Data from Phase 2a (Part B) of the ongoing study showed:

    • 2 partial responses (PRs) and 2 stable disease (SD) observed in the VBI-1901 + GM-CSF vaccinated group, resulting in a disease control rate of 40% (n=4/10)
    • A 56% disease control rate achieved in the group vaccinated with VBI-1901 + AS01, with 5 stable disease observations (n=5/9) – tumor response data for the 10th patient enrolled is pending
    • Presumed pseudoprogression was observed in both vaccinated groups– defined as immune infiltration into the tumor which appears initially as tumor growth, but later subsides resulting in tumor growth stabilization and/or shrinkage

    Andrew B. Lassman, M.D., Chief of Neuro-oncology at Columbia University Irving Medical Center and Associate Director for Clinical Trials at the Herbert Irving Comprehensive Cancer Center, and principal investigator of the study presented the e-poster, commenting, "Tumor response data is one of the most objective measures of efficacy in open label studies, especially in this difficult-to-treat patient population. Few treatment options are available to recurrent glioblastoma patients, and the tumor response data seen to-date in this ongoing study are encouraging. Any treatment that could demonstrate clinical benefit would be incredibly meaningful."

    Emmanuel Hanon, Senior Vice President, Head of R&D Vaccines at GSK, commented, "The early data seen to-date in this ongoing study are encouraging, underscoring the potential benefit of adjuvants in combination with VBI-1901 in the clinical setting. Previous research in the context of other vaccines has shown AS01's ability to boost T cell-mediated immunity. This is the first time GSK's adjuvant system is assessed in oncology and we are looking forward to getting more data about the potential of therapeutic vaccination to treat such an aggressive and recurring disease."

    David E. Anderson, Ph.D., VBI's Chief Scientific Officer, commented, "This ongoing study continues to demonstrate the potential of VBI-1901, with both the GM-CSF adjuvant and GSK's AS01 adjuvant system, to be an effective cancer vaccine immunotherapeutic. The tumor responses seen to-date across both study arms, including 2 partial responses and 7 stable disease, are meaningful, especially as an outcome of a monotherapy. This data supports the continued development of the program, both as a monotherapy as well as part of a combination regimen."

    Based on the available data, VBI is exploring a randomized, controlled clinical study, including a potential registration study, for the next phase of development, which could begin in 2021, pending approval from regulatory bodies.

    A webcast of Dr. Anderson discussing these data with Jeff Baxter, VBI's President and CEO, can be found here: https://www.vbivaccines.com/wire/vbi-1901-sno-2020-update/.

    A copy of the e-poster is available on the "Events/Presentations" page in the "Investors" section of the VBI Vaccines website.

    About the Phase 1/2a Study Design

    VBI's two-part Phase 1/2a study is a multi-center, open-label, dose-escalation study of VBI-1901 in up to 38 patients with recurrent GBM:

    • Phase 1 (Part A)
      • Dose-escalation phase that defined the safety, tolerability, and optimal dose level of VBI-1901 adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent GBM patients with any number of prior recurrences.
      • This phase enrolled 18 recurrent GBM patients across three dose cohorts of VBI-1901: 0.4 µg, 2.0 µg, and 10.0 µg.
      • Enrollment completed in December 2018.
    • Phase 2a (Part B)
      • Subsequent extension of the optimal dose level, 10.0 µg, as defined in the Part A dose escalation phase.
      • This phase is a two-arm study, enrolling 10 first-recurrent GBM patients in each vaccinated group, assessing 10.0 µg of VBI-1901 in combination with either GM-CSF or GSK's proprietary AS01 adjuvant system as immunomodulatory adjuvants.
      • Enrollment of the 10 patients in each adjuvant group is complete.

    VBI-1901 is administered intradermally when adjuvanted with GM-CSF and intramuscularly when adjuvanted with GSK's AS01 adjuvant system. Patients in both phases of the study receive the vaccine immunotherapeutic every four weeks until tumor progression.

    About VBI-1901 and GBM

    VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI's enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 12,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and has a high mortality.

    About VBI Vaccines Inc.

    VBI Vaccines Inc. ((VBIV) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI is advancing the prevention and treatment of hepatitis B, with the only 3-antigen hepatitis B vaccine, Sci-B-Vac®, which is approved for use and commercially available in Israel, and recently completed its Phase 3 program in the U.S., Europe, and Canada, and with an immunotherapeutic in development for a functional cure for chronic hepatitis B. VBI's enveloped virus-like particle (eVLP) platform technology enables development of eVLPs that closely mimic the target virus to elicit a potent immune response. VBI's lead eVLP programs include a vaccine immunotherapeutic candidate targeting glioblastoma (GBM), a prophylactic cytomegalovirus (CMV) vaccine candidate, and a prophylactic coronavirus vaccine program. VBI is headquartered in Cambridge, MA, with research operations in Ottawa, Canada, and research and manufacturing facilities in Rehovot, Israel.

    Website Home: http://www.vbivaccines.com/

    News and Insights: http://www.vbivaccines.com/wire/

    Investors: http://www.vbivaccines.com/investors/

    Cautionary Statement on Forward-looking Information

    Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, "forward-looking statements"). The Company cautions that such statements involve risks and uncertainties that may materially affect the Company's results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the recent COVID-19 outbreak on our clinical studies, manufacturing, business plan, and the global economy; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company's ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company's products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company's filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 5, 2020, and filed with the Canadian security authorities at sedar.com on March 5, 2020, as may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.

    1The GSK proprietary AS01 adjuvant system contains QS-21 StimulonTM adjuvant licensed from Agenus Inc. (NASDAQ:AGEN)

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  5. LEXINGTON, Mass., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ:AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, today announced that Dr. Jennifer Buell, President and COO of Agenus, will participate in a fireside chat at the Jefferies 2020 Virtual London Healthcare Conference on Tuesday, November 17, 2020 from 4:25 PM – 4:55 PM GMT / 11:25 AM – 11:55 AM EST.

    Registration for the webinar can be done in advance at https://wsw.com/webcast/jeff141/agen/1816875.

    A replay will be available after the call on the Events & Presentations page of the Agenus website at https://investor.agenusbio.com/events-and-presentations

    LEXINGTON, Mass., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ:AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, today announced that Dr. Jennifer Buell, President and COO of Agenus, will participate in a fireside chat at the Jefferies 2020 Virtual London Healthcare Conference on Tuesday, November 17, 2020 from 4:25 PM – 4:55 PM GMT / 11:25 AM – 11:55 AM EST.

    Registration for the webinar can be done in advance at https://wsw.com/webcast/jeff141/agen/1816875.

    A replay will be available after the call on the Events & Presentations page of the Agenus website at https://investor.agenusbio.com/events-and-presentations.

    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



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