| To: Alejandroo Green who wrote () | 11/11/2019 10:45:39 AM | | From: Kirk © | | | | News Release Issued: Nov 11, 2019 (8:00am EST)
Agenus receives $10M from UroGen Pharma for rights to Zalifrelimab (CTLA-4) for intravesical treatment of urinary tract cancers
- UroGen receives rights to zalifrelimab to be used in its proprietary sustained release formulation for
patients with high-grade non-muscle invasive bladder cancer LEXINGTON, Mass., Nov. 11, 2019 / PRNewswire/ -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, adoptive cell therapies1 and cancer vaccines, announced today that it received $10M upfront for a License Agreement with UroGen Pharma Ltd. Under the agreement Agenus is providing access to zalifrelimab (AGEN1884, anti-CTLA-4 antibody) for use with UroGen's sustained release technology for intravesical delivery in patients with urinary tract cancers. Agenus is conducting clinical trials for zalifrelimab in combination with Agenus' anti-PD-1 antibody balstilimab (AGEN2034) for a planned BLA filing in cervical cancer. In addition, zalifrelimab is being evaluated as a monotherapy in PD-1 refractory patients.
Under the terms of the agreement, in addition to the $10 million upfront payment, Agenus is eligible to receive up to $200M in potential development, regulatory and commercial milestones, as well as 14-20% royalties on net sales.
"In our ongoing clinical trials, zalifrelimab and the combination of zalifrelimab plus balstilimab (AGEN2034, anti-PD-1 antibody) have delivered durable as well as curative responses in patients across a broad range of tumors. Agenus is developing the combination in multiple solid tumors with a first planned BLA filing in 2020," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "We are enthusiastic to expand the benefit of zalifrelimab through intravesical delivery to patients with urinary tract cancer in this exciting collaboration with UroGen."
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 with combination approaches that leverage a broad repertoire of antibody therapeutics, adoptive cell therapies (through its AgenTus Therapeutics subsidiary) and its proprietary cancer vaccine platforms. Agenus has a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support early phase 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' clinical development and regulatory plans and timelines and the anticipated benefits of the UroGen collaboration. 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
Jennifer.Buell@agenusbio.com
1Through AgenTus Therapeutics, a subsidiary of Agenus
SOURCE Agenus Inc.
To view this release online and get more information about Agenus Bio InvestorRoom visit: investor.agenusbio.com |
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| To: Rarebird who wrote (122) | 12/19/2019 11:53:38 AM | | From: Kirk © | | | | News Release Issued: Dec 19, 2019 (7:30am EST)
Agenus Commences Combination Trial of its Next-Gen CTLA-4 with its PD-1 Antibody
LEXINGTON, Mass., Dec. 19, 2019 / PRNewswire/ -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, adoptive cell therapies1 and cancer vaccines, today announced the first patient dosed with AGEN1181, an anti-CTLA-4 antibody, in combination with balstilimab, Agenus' PD-1 inhibitor. Agenus began this study as a monotherapy in patients with advanced solid tumors within a Phase 1 dose escalation study (NCT03860272) in April 2019.
The first patients to be treated with AGEN1181 as a monotherapy as well as the combination trial with PD-1 were dosed by Dr. Steven O'Day, Executive Director of the John Wayne Cancer Institute & Cancer Clinic, and a pioneer in delivering immune therapies to patients with cancer.
"AGEN1181, with its potential for enhanced immune activation and tumor fighting abilities, may bring superior benefit to a broader group of patients compared to first generation anti-CTLA-4 antibodies," said Dr. O'Day. "The pre-clinical data suggest the superiority of this molecule as a monotherapy and in combination with anti-PD-1, like balstilimab. Furthermore, AGEN1181 was designed to bring benefit to a broad population of patients both who respond to first generation molecules and those who do not respond due to a genetic polymorphism. Expanding the important immune priming benefit of CTLA-4 to a broad group of patients would be outstanding. I am thrilled to be working with this compound."
Balstilimab, the company's proprietary anti-PD-1 antibody, is currently being evaluated as a monotherapy and in combination with zalfrelimab (a first generation CTLA-4) in trials designed to support a planned BLA filing in 2020 for patients with relapsed/refractory cervical cancer.
This expanded trial is another example of Agenus' ability to rapidly advance its novel pipeline. Next-Gen CTLA-4 is a novel antibody from Agenus' discovery engine, and with its own PD-1 molecule, Agenus has been able to move this important combination into the clinic with a high sense of urgency.
About AGEN1181
AGEN1181, a novel 'Fc engineered' antibody with potential for enhanced anti-tumor functions, is specifically designed to boost cancer killing immune cells and deplete intratumoral regulatory T cells that promote immune evasion. By enhancing binding to a specific Fc receptor, Fc?RIIIA, on antigen-presenting cells or natural killer cells, AGEN1181 significantly enhances the therapeutic potential of anti-CTLA-4 therapy leveraging novel mechanisms that are not captured by the first-generation anti-CTLA-4 therapies. AGEN1181's Fc engineered backbone improves the cross-talk between antigen-presenting cells and T cells, to enable optimal T cell priming, activation and formation of durable memory responses. Moreover, AGEN1181 enhanced binding to Fc?RIIIA, significantly increases the potential to deplete intratumoral regulatory T cells, a significant barrier to successful anti-cancer immune responses. Notably, AGEN1181 is engineered to strongly bind both the low affinity and high affinity Fc?RIIIA polymorphisms, unlike first generation molecules which weakly bind the low affinity polymorphism. AGEN1181 is designed to expand the benefit to an additional ~40% of patients with the low affinity polymorphism and enhance the benefits of CTLA-4 in 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 with combination approaches that leverage a broad repertoire of antibody therapeutics, adoptive cell therapies (through its AgenTus Therapeutics subsidiary) and its proprietary cancer vaccine platforms. Agenus has a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support early phase 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' clinical development and regulatory plans and timelines and the potential therapeutic benefit 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.
Jennifer Buell, PhD
Jennifer.Buell@agenusbio.com
1Through AgenTus Therapeutics, a subsidiary of Agenus
SOURCE Agenus
To view this release online and get more information about Agenus Bio InvestorRoom visit: investor.agenusbio.com |
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| To: Area51 who wrote (30) | 3/10/2020 1:01:37 PM | | From: Kirk © | | | | It is great to see good news move the stock!
First QS-21 Royalty Payment Due to Agenus is Triggered
$15.1M Milestone from HealthCare Royalty Partners
LEXINGTON, Mass., March 10, 2020 / PRNewswire/ -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers, announced the triggering of a $15.1M milestone payment from HealthCare Royalty Partners (HCR) based on net sales of GlaxoSmithKline's (GSK's) Shingrix vaccine exceeding $2.0B in 2019.
Agenus' proprietary QS-21 Stimulon™ is one of the most potent adjuvants known and is a key component in GSK's Shingrix vaccine, which has generated blockbuster sales exceeding $2.3Bn in its second year after launch. Agenus is due another milestone amounting to $25.5M if Shingrix net sales exceed $2.75B over four consecutive quarters before 2026.
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 additional milestone payment of $25 million based on GSK's sales of Shingrix. 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.
Regina Grebla, PhD
781-674-4495
Regina.Grebla@agenusbio.com
SOURCE Agenus Inc.
News Release Issued: Mar 10, 2020 (9:14am EDT)
To view this release online and get more information about Agenus Bio InvestorRoom visit: investor.agenusbio.com |
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| To: Rarebird who wrote (122) | 5/13/2020 3:54:28 PM | | From: Kirk © | | | | I wasn't aware their cancer therapy would also help with COVID-19, but it makes sense that it would.
FDA Clears AgenTus IND for Allogeneic iNKT Cell Therapy -
- Cancer and COVID-19 Clinical trials expected to commence soon
- Designed for anti-cancer treatment & iNKTs are synergistic with Agenus' checkpoint antibodies
- Potential to clear SARS-CoV-2 virus and control harmful inflammation
- COVID-19 IND expected to clear shortly
LEXINGTON, Mass., May 13, 2020 / PRNewswire/ -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers and infectious diseases, announced today the FDA acceptance of the IND application for an allogeneic iNKT therapy, agenT-797, submitted by its subsidiary, AgenTus Therapeutics. A clinical trial for the treatment of patients with cancer is expected to commence 2H2020. AgenTus has also submitted a separate IND for the treatment of COVID-19, which is expected to clear soon.
"We are extremely pleased to rapidly advance our proprietary iNKT cell therapy to the clinic to combat cancer and also address the urgent COVID-19 pandemic," said Dr. Walter Flamenbaum, CEO of AgenTus Therapeutics. "We expect our clinical trials to demonstrate the key features of agent-797 and the benefits of combinations of our allogeneic iNKTs with Agenus' pipeline of checkpoint antibodies in solid tumors."
"I am heartened by our team's efforts to rapidly advance our allogeneic iNKT cells to treat patients with cancer and COVID-19," said Dr. Garo Armen, Chairman and CEO of Agenus and Chairman of AgenTus Therapeutics. "Our iNKTs are streamlined for treating large numbers of patients from a single batch. They are manufactured without the need for genetic manipulation, are expected to suppress graft-versus-host disease, can be manufactured affordably, and are designed for quick access by patients."
Separately, Agenus indicated that it is contemplating several options with regard to its AgenTus Therapeutics subsidiary. This is given its previous guidance and the advancement of AgenTus' first cell therapy candidates towards the clinic. These options include the potential spinning out of AgenTus and issuing a portion of its holdings in AgenTus to Agenus shareholders in the form of a stock dividend. Agenus expects that such a decision will be made by the end of this year.
About AgenTus Therapeutics, Inc.
AgenTus Therapeutics is a biopharmaceutical company focused on the discovery, development, and commercialization of breakthrough allogeneic iNKT cells in the unmodified and modified with engineered receptors, such as T cell receptors (TCRs) and Chimeric Antigen Receptors (CARs), designed to supercharge the human immune system cells to seek and destroy cancer. AgenTus also aims to advance adoptive cell therapy formats which would enable off-the-shelf living drugs. AgenTus has locations in Lexington, MA and Cambridge, UK. For more information, please visit www.agentustherapeutics.com.
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 commencement of cell therapy clinical trials for cancer and COVID-19, the expected benefits to be observed in these trials and with these cell therapy treatments generally, the potential spinning out of AgenTus therapeutics and issuing a portion of Agenus' holdings in AgenTus to Agenus shareholders in the form of a stock dividend, and the expectation to make such a decision by the end of 2020. 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
Jennifer.Buell@agenusbio.com
To view this release online and get more information about Agenus Bio InvestorRoom visit: investor.agenusbio.com |
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| To: Alejandroo Green who wrote () | 5/29/2020 10:20:53 AM | | From: Kirk © | | | | More Good News:
ASCO Presentation of Agenus' AGEN1181 by Dr. Steven O'Day
- -- No complement mediated toxicities and up to 70% clinical benefit¹ across multiple solid tumors
- -- Combination of AGEN1181 with Agenus's balstilimab (PD-1) advancing in the clinic
- -- B. Riley to host conference call with Drs. Steven O'Day and Charles Drake on Next-Generation CTLA-4 agents - June 2, 2020
LEXINGTON, Mass., May 29, 2020 / PRNewswire/ -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers and infections, announced the American Society of Clinical Oncology (ASCO2020) Virtual Scientific Program on AGEN1181 by Dr. Steven J. O'Day, the Executive Director of the John Wayne Cancer Institute and Cancer Clinic and Director of Providence Los Angeles Regional Research.
AGEN1181 is a multifunctional Fc-engineered next generation anti-CTLA-4 antibody specifically designed to improve the safety and efficacy of first-generation CTLA-4 antibodies. AGEN1181 is advancing in the clinic both as monotherapy and in combination with balstilimab (Agenus's anti-PD-1). Patients receiving this multifunctional antibody have progressed on prior treatments including other I-O agents, such as anti-PD-1.
"I am very pleased to report data on AGEN1181 alone and in combination with balstilimab (anti-PD-1). Preliminary efficacy is encouraging with objective responses (both complete and partial) as well as prolonged stable disease in a variety of advanced cancers progressing after standard therapies," said Dr. Steven O'Day, Executive Director of the John Wayne Cancer Institute and Cancer Clinic. "Importantly, unlike first-generation CTLA-4 antibodies, we have seen no evidence of complement mediated toxicities, such as hypophysitis, with AGEN1181. These early data, including responses in patients with CD16 polymorphisms, support the accelerated development of AGEN1181 into multiple tumors, including PD-1 refractory melanoma, NSCLC, and others."
Abstract:
| TPS3157
| Title:
| AGEN1181, A Clinical Stage Fc-engineered anti-CTLA-4 Antibody with Improved Therapeutic Potential for the Treatment of Patients with Advanced Malignancies
| Presenter:
| Dr. Steven J. O'Day
| Session:
| Developmental Therapeutics—Immunotherapy
| Date/Time:
| May 29, 2020; 8:00-11:00AM
|
Conference call scheduled on June 2, 2020
B.Riley FBR Senior Analyst Mayank Mamtani, will host a conference call for investors on Tuesday, June 2, 2020 with Dr. Steven O'Day and Dr. Charles Drake, Co-Director of the Cancer Immunotherapy Program and Co-Leader of the Tumor Biology & Microenvironment Program at Columbia University, and Jennifer Buell, PhD and President and COO of Agenus, to discuss the data coming out of the ASCO2020 Virtual Scientific Program.
Date: Tuesday, June 2, 2020
Time: 5:30 PM ET
Dial-in details: Investor access: 800.267.2845/973.413.6102 (Passcode: 842069)
The presentation will be available for on-demand viewing online at c212.net.
 
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 and infections. 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 an upcoming presentation at ASCO on Agenus' clinical data of AGEN1181 alone and in combination with balstilimab (anti-PD-1), the anticipated benefits of AGEN1181 and clinical development plans and timelines for 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.
Jennifer Buell, PhD
781-674-4420
Jennifer.Buell@agenusbio.com
1Clinical benefit includes complete response, partial response, disease stabilization
SOURCE Agenus |
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| To: Investor2 who wrote (100) | 6/22/2020 2:35:20 PM | | From: Kirk © | | | | Agenus and Betta Pharmaceuticals Enter Into a License Agreement for Balstilimab and Zalifrelimab in Greater China
- - Agenus to receive $35M upfront with $100M in milestones plus royalties
- - Betta receives exclusive license of balstilimab (anti-PD-1) and zalifrelimab (anti-CTLA-4) in Greater China
LEXINGTON, Mass., June 22, 2020 /PRNewswire/ -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with an extensive pipeline of agents designed to activate immune response to cancers, announced today that it has entered into an agreement with Betta Pharmaceuticals (SZ300558), a top Chinese pharmaceutical company focusing on the development of innovative oncology therapies, for an exclusive collaboration and license agreement for the development and commercialization of balstilimab and zalifrelimab in Greater China, including Mainland China, Hong Kong, Macau and Taiwan.
Under the terms of the agreement, Agenus will receive $35 million, which includes $15 million in upfront cash and a $20 million equity investment. The agreement also includes $100 million in potential milestones plus royalties on net sales. Betta receives exclusive rights for the development and commercialization of balstilimab and zalifrelimab to either as monotherapies or combination therapies, excluding intravesical delivery in greater China.
Agenus' balstilimab (anti-PD-1) is advancing in trials planned for BLA filing this year as a monotherapy and in combination with zalifrelimab (anti-CTLA-4) for the treatment of refractory or metastatic cervical cancer. Agenus has recently reported positive results suggesting robust and durable responses of balstilimab and zalifrelimab in patients with relapsed or refractory metastatic cervical cancer. The US FDA recently granted Fast Track designation for balstilimab alone and in combination with zalifrelimab in this indication.
"Betta has a strong track record of advancing innovative products in China and a growing portfolio of complementary oncology therapies," said Garo Armen, Chairman and Chief Executive Officer of Agenus. "Betta is an ideal partner to enable us to address significant patient needs in China while also advancing global development of balstilimab and zalifrelimab."
"We are delighted to enter this collaboration with Agenus, a leader in the immuno-oncology field, as the first step in a long-term strategic partnership," said Lieming Ding, Chairman and Chief Executive Officer of Betta Pharmaceuticals. " Based on the compelling clinical data reported to date, we believe Agenus' balstilimab and zalifrelimab hold great promise for Chinese patients with cervical cancer, with the potential to further expand in additional tumor types through synergistic combinations with Betta's existing pipeline programs."
The equity purchase component of the transaction is subject to China regulatory approval and other customary closing conditions.
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.
About Betta Pharmaceuticals
Betta Pharmaceuticals Co., Ltd. (SZ300558), established in 2003 in Hangzhou, China, is one of the leading Chinese pharmaceutical companies dedicated to develop and commercialize innovative oncology products to meet high unmet medical needs. With over 1,300 employees in Hangzhou and Beijing, Betta's development capabilities range from small-molecule to biologics discovery, clinical development, manufacturing, sales and marketing. Betta's leading product – icotinib (Conmana®), the first innovative oncology product developed and launched in China – is one of the top selling targeted therapies for patients with non-small cell lung cancer, having achieved 1.55 billion RMB annual sales in 2019. Betta currently has two programs under NDA review by the NMPA, two programs under late-stage clinical development, eight programs under proof-of-concept clinical development, and multiple small-molecule and biologics programs under pre-clinical discovery. Throughout the years, Betta has set up strategic partnerships with Amgen Inc., Xcovery LLC., Beijing Mabworks Biotech Co., Ltd., Tyrogenex Inc., InventisBio lnc., and Merus N.V.. For additional information, please visit bettapharma.com
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 closing and expected benefits of the collaboration, as well as timing for planned BLA filings. 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 S. Buell, PhD
781-674-4420
Jennifer.Buell@agenusbio.com
SOURCE Agenus Inc.
News Release Issued: Jun 22, 2020 (7:00am EDT)
To view this release online and get more information about Agenus Bio InvestorRoom visit: investor.agenusbio.com
 |
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| From: Kirk © | 2/4/2021 12:32:09 PM | | | | | | Agenus Announces Positive Preliminary Results of iNKT Cell Therapy Trial in COVID-19
Thu February 4, 2021 8:30
- 3 out of 4 intubated patients were discharged after treatment
- 2 out of 4 patients were extubated within 24 hours of dosing
investor.agenusbio.com |
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| To: Rarebird who wrote (122) | 4/11/2021 1:47:04 PM | | From: Kirk © | | | | New Clinical Responses for AGEN1181 Presented at AACR
April 10, 2021
Download PDF
7 objective responses observed to date in multiple tumor typesNew responses reported in patients with melanoma and ovarian cancerBenefit seen in patients typically unresponsive to I-O agents
LEXINGTON, Mass., April 10, 2021 (GLOBE NEWSWIRE) -- Agenus (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 presented new clinical data on AGEN1181, its next-generation anti-CTLA-4 antibody, at the American Association for Cancer Research (AACR) Annual Meeting from April 10 - 15, 2021.
“The preclinical and translational data in conjunction with our updated clinical data with AGEN1181 alone or in combination with our PD-1, balstilimab, continue to strongly support and differentiate our next-generation CTLA-4 antibody,” said Steven O’Day, MD, Chief Medical Officer of Agenus. “AGEN1181 is showing activity in patients with tumors which typically do not respond to first-generation CTLA-4 and PD-1 antibodies. Equally important, the safety data continues to show no immune mediated hypophysitis, pneumonitis, or hepatitis to date. Given the efficacy and favorable safety profile, we have expanded AGEN1181 into Phase 2 in colorectal cancer patients as a first step in our efforts to expand to additional important cancer indications.”
In two separate presentations at AACR, Agenus showcased the optimal performance of AGEN1181 in relevant models. In addition, as the clinical data matures, additional responses as well as a conversion from a partial response to a complete response, have been observed. The new data announced today include the following clinical responses:
New partial response in the first melanoma patient treated (monotherapy)
New conversion to complete response in ovarian cancer patient (AGEN1181 plus balstilimab)
Partial response in microsatellite stable (MSS) colorectal cancer patient (AGEN1181 plus balstilimab)
Partial response in PD-L1(-) ovarian cancer patient (AGEN1181 plus balstilimab)
Partial response in MSS colorectal cancer patient (AGEN1181 plus balstilimab)
Complete response in PD-L1(-) MSS endometrial cancer patient (monotherapy)
Complete response by PET in PD-L1(-) MSS endometrial cancer patient (AGEN1181 plus balstilimab)
Presentation Details:
E-poster presentations were made available on the conference platform on April 10 at 8:30am ET. Posters with accompanying audio will be available for viewing to meeting registrants until June 21.
Session: PO.IM02.10 - Therapeutic Antibodies, Including Engineered Antibodies
Poster title: Fc-enhanced anti-CTLA-4 antibody, AGEN1181: New mechanistic insights for potent antitumor immunity and combination potential in treatment-resistant solid tumors
Abstract number: 1878
Presenting author: Antoine Tanne, PhD
Session: PO.IM02.05 - Immune Monitoring / Clinical Correlates
Poster title: Characterization of the pharmacodynamic activity of AGEN1181, an Fc-enhanced CTLA-4 antibody, alone and in combination with the PD-1 antibody balstilimab
Abstract number: 1677
Presenting author: Irina Shapiro, PhD
In addition, Dr. Steven O’Day, Chief Medical Officer, Dr. Dhan Chand, Scientific Director, Head of Drug Discovery, and Dr. Jennifer Buell, President and COO, at Agenus, will participate in a webcast hosted by Dr. Matt Phipps of William Blair on Saturday, April 10, 2021 at 10:30 a.m. ET.
Registration for the webinar can be done in advance at globenewswire.com.
A replay will be available after the call on the Events & Presentations page of the Agenus website at globenewswire.com.
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 AGEN1181 alone and in combination with other agents, as well as the potential to use such therapies in additional cancer indications. 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 Investor Relations
Jan Medina, CFA
Agenus
781-674-4490
Jan.Medina@agenusbio.com
Agenus Media Relations
Kimberly Ha
KKH Advisors
917-291-5744
kimberly.ha@kkhadvisors.com |
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| To: Area51 who wrote (30) | 6/17/2021 9:32:23 AM | | From: Kirk © | | | | Agenus Gets FDA Priority Review of Balstilimab in Cervical Cancer
DJ REALTIME NEWS – 9:01 AM ET 06/17/2021
Agenus Inc. ( AGEN ) on Thursday said the U.S. Food and Drug Administration granted priority review to its biologics license application for balstilimab for the treatment of recurrent or metastatic cervical cancer. The Lexington, Mass., clinical-stage immuno-oncology company said the agency set a target action date of Dec. 16 for the application, which covers balstilimab in cervical cancer with disease progression on or after chemotherapy
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