| 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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| To: Rarebird who wrote (122) | 6/29/2022 10:45:08 AM | | From: Kirk © | | | | Agenus Shows Unprecedented Activity for Botensilimab/Balstilimab Combination in Microsatellite Stable Colorectal Cancer at ESMO World GI Congress
Agenus Shows Unprecedented Activity for Botensilimab/Balstilimab Combination in Microsatellite Stable Colorectal Cancer at ESMO World GI Congress
June 29, 2022
- Overall response rate of 24%, and disease control rate of 73%, in heavily pre-treated patients with a median of 4 prior lines of therapy
- Responses to botensilimab/balstilimab were durable, with 80% ongoing at data cut-off and median duration of response not reached
- Global, randomized Phase 2 study of botensilimab/balstilimab in MSS CRC to begin this year
- Agenus to host webcast today at 10:00 AM EDT
LEXINGTON, Mass., June 29, 2022 (GLOBE NEWSWIRE) -- Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of therapeutics designed to activate the immune response to cancers and infections, today announced expanded data from the Phase 1b study of botensilimab (Fc-enhanced anti-CTLA-4) and balstilimab (anti-PD-1) in patients with microsatellite stable colorectal cancer (MSS CRC). The data demonstrate that the combination offers strong durability and superior efficacy than what has been reported in separate trials for standard of care and other investigational therapies in 2L+ MSS CRC.
“These data reinforce the strong therapeutic potential of botensilimab, when used in combination with balstilimab, in cold tumors such as MSS CRC,” said Steven O’Day, MD, Chief Medical Officer at Agenus. “Thus far, botensilimab has demonstrated activity in nine cold and treatment-resistant cancers, and we plan to initiate a robust, global Phase 2 program, including in MSS CRC, later this year.”
Study Highlights
A total of 41 evaluable patients with metastatic MSS CRC received either 1 or 2 mg/kg botensilimab Q6W, and 3 mg/kg balstilimab Q2W. Patients were heavily pre-treated, with a median of 4 prior lines of therapy, and 34% had received prior immunotherapy. The botensilimab/balstilimab combination produced superior responses and strong durability, relative to what has been reported in separate trials for standard of care and other combinations currently in development.
Objective responses:
- 24% overall response rate
- 73% disease control rate (partial response + stable disease)
- 50% objective responses with greater than 50% tumor reduction
Durability:
- 80% objective responses ongoing at data cut-off
- 30% objective responses exceeding 1 year
Patient Sub-Populations:
- Objective responses in 5 patients with RAS mutations for a 24% overall response rate and 81% disease control rate in this population; other PD-1 combinations in separate trials have reported only rare responses in this population (=1% response rate)
- Responses observed in patients with metastases historically resistant to immunotherapy, including patients with malignant pleural effusions, soft tissue, peritoneal, retroperitoneal, and bone metastases
Tolerability:
- Botensilimab was well tolerated, with no grade 4/5 treatment-related adverse events
- Rates of gastrointestinal and skin toxicities were comparable to those reported with first-generation CTLA-4 inhibitors“
Colorectal cancer is the second leading cause of cancer-related death worldwide, with roughly 95% classified as microsatellite stable and historically unresponsive to immunotherapy. Treatment resistant MSS CRC patients lack effective options, with standard of care offering only a 1-2% response rate and a median expected survival ranging from 6 to 7 months,” said Anthony El-Khoueiry, MD, Phase I Program Director at the USC Norris Comprehensive Cancer Center, Keck Medicine of USC. “The combination of robust response rate, durability, and tolerability demonstrated by botensilimab and balstilimab supports further development of the combination in MSS CRC, as well as more broadly, in other cold and treatment-resistant tumors.”
Presentation Details
The data were presented today at 7:05 AM EDT in a late-breaking oral presentation at the ESMO World Congress on Gastrointestinal Cancer in Barcelona, Spain.
Abstract Title: Botensilimab, a Novel Innate/Adaptive Immune Activator, Plus Balstilimab (Anti-PD-1) for Metastatic Heavily Pretreated Microsatellite Stable Colorectal Cancer
Abstract Number: LBA-09
Presenting Author: Dr. Anthony El-Khoueiry, M.D., Associate Director of Clinical Research at the USC Norris Comprehensive Cancer Center, Keck School of Medicine
Investor Webcast
The Company will host an investor webcast today at 10:00 AM EDT to review these data. Participants may register here, or on the Investors section of the Agenus website at investor.agenusbio.com. The webcast will include presentations by the below speakers and will be followed by a Q&A session:
Steven O’Day, M.D., Agenus’ Chief Medical OfficerDr. Anthony El-Khoueiry, M.D., Associate Director of Clinical Research at the USC Norris Comprehensive Cancer Center, Keck School of MedicineDr. Manuel Hidalgo, Chief of the Division of Hematology and Medical Oncology at Weill Cornell Medicine/NewYork-Presbyterian Hospital, andDr. Heinz-Josef Lenz, M.D., Professor of Medicine and J. Terrence Lanni Chair in Gastrointestinal Cancer Research, Keck School of MedicineFollowing the webcast, an archived version will be available on the Agenus website.
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 subsidiary MiNK Therapeutics), and adjuvants (through its subsidiary SaponiQx). 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 relating to our technologies, therapeutic candidates, and capabilities, for instance, statements regarding therapeutic benefit and efficacy, mechanism of action, potency, durability, and safety and tolerability profile of our therapeutic candidates, both alone and in combination with each other and/or other agents; statements regarding future plans, including research, clinical, regulatory, and commercialization plans; and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "will" and similar expressions are intended to identify forward-looking statements. 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 and available on our website: www.agenusbio.com. 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
Ethan Lovell
Chief External Affairs & Communications Officer
339-927-1763
ethan.lovell@agenusbio.com |
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| To: Rarebird who wrote (122) | 4/17/2023 10:22:35 AM | | From: Kirk © | | | | Great news!
Agenus Receives Fast Track Designation for Botensilimab and Balstilimab in Colorectal Cancer
LEXINGTON, Mass.--(BUSINESS WIRE)--Apr. 17, 2023-- Agenus Inc. (Nasdaq: AGEN), a leading immuno-oncology company specializing in immunological agents for cancer and infectious diseases, has been granted Fast Track Designation from the US Food and Drug Administration (FDA) for the investigation of the combination of botensilimab (AGEN1181) and balstilimab (AGEN2034). The designation is for patients with non-microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) metastatic colorectal cancer with no active liver involvement. Patients targeted with this designation are heavily pretreated are resistant or intolerant to a fluoropyrimidine, oxaliplatin, and irinotecan, and who have also received a VEGF inhibitor, an EGFR inhibitor and/or a BRAF inhibitor, if indicated. The company is conducting a global, randomized Phase 2 trial of botensilimab in combination with balstilimab compared to standard of care in non-microsatellite instability-high (non-MSI-H) colorectal cancer patients.
"We are pleased that the FDA has granted Fast Track designation for the combination of botensilimab with balstilimab in patients with non-MSI-H colorectal cancer, recognizing the high unmet medical need in this population," said Dr. Steven O’Day, Chief Medical Officer of Agenus. "The Fast Track designation offers important benefits, including the potential eligibility for a Priority Review, and we will be working with the FDA and all key stakeholders to rapidly advance the botensilimab/balstilimab combination in colorectal cancer as well as other solid tumor indications.”
During the American Society of Clinical Oncology – Gastrointestinal Cancers Symposium in January 2023, Agenus presented positive results from its ongoing clinical trials of the botensilimab/balstilimab combination in patients with non-MSI-H colorectal cancer. The combination therapy showed an overall response rate of 23% and a 12-month survival rate of 63%, which compares to very limited activity of 1-2% overall response rate and ~25% 12-month survival rate reported for the standard of care. Responses to the botensilimab/balstilimab therapy have been durable, with 69% ongoing at data cut-off, and median overall survival not reached.
About Botensilimab
Botensilimab is a novel, multifunctional CTLA-4 investigational antibody that has been designed to extend clinical benefits to “cold” tumors that have not historically responded to standard of care or investigational therapies. In addition to binding to the CTLA-4 receptor, its Fc-enhanced structure induces a memory immune response, downregulates regulatory T cells, and delivers better priming and activation of T cells, thereby amplifying immune responses.
In a Phase 1b clinical study of more than 350 patients, botensilimab has demonstrated clinical responses in nine, previously IO unresponsive, solid tumor cancers, either alone or in combination with Agenus’ PD-1 antibody, balstilimab (data presented at ASCO GI 2023, SGO 2023, CTOS 2022, SITC 2022). Agenus is conducting global, randomized Phase 2 trials in non-MSI-H colorectal cancer, pancreatic cancer, and melanoma as part of its ACTIVATE trial programs. Additional information about these botensilimab trials can be found at www.clinicaltrials.gov under the identifiers NCT05608044, NCT05630183, and NCT05529316, respectively. A global Phase 3 trial in non-MSI-H CRC is expected to launch in 2023.
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 subsidiary MiNK Therapeutics), and adjuvants (through its subsidiary SaponiQx). 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 relating to our technologies, therapeutic candidates, and capabilities, for instance, statements regarding therapeutic benefit and efficacy, mechanism of action, potency, durability, and safety and tolerability profile of our therapeutic candidates, both alone and in combination with each other and/or other agents; statements regarding future plans, including research, clinical, regulatory, and commercialization plans; and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "will" and similar expressions are intended to identify forward-looking statements. 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 and available on our website: www.agenusbio.com. 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.
View source version on businesswire.com: businesswire.com
Zack Armen
Head of Investor Relations
917-362-1370
zack.armen@agenusbio.com
Source: Agenus Inc. |
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