Agenus Unveils New and Updated Botensilimab Data in Colorectal, Pancreatic, Lung, Melanoma, and Sarcoma
October 22 2023 - 11:00AM
Business Wire
U.S. BLA Filing in Microsatellite Stable (MSS)
Metastatic Colorectal Cancer (CRC) Planned for Midyear 2024
Potential Accelerated Filings for Advanced
Pancreatic Cancer and Melanoma in 2025
Opportunity to Expand into Early-Stage Cancers
Supported by Compelling Neoadjuvant CRC Data
Live Webcast Today at 1:00 p.m. EDT
Agenus Inc. (Nasdaq: AGEN), a leader in developing novel
immunological agents to treat cancers, today announced first-time
and updated data from its ongoing botensilimab/balstilimab
(BOT/BAL) clinical programs in advanced colorectal cancer (CRC),
neoadjuvant CRC, pancreatic cancer, non-small cell lung cancer
(NSCLC), melanoma, and sarcoma. Members of the Agenus leadership
team along with key opinion leaders will discuss these findings
during a live webcast at 1:00 p.m. EDT (19:00 CEST) at a corporate
event at the European Society for Medical Oncology 2023
Conference.
“These new and updated data underscore BOT’s broad effectiveness
across several advanced solid tumors, demonstrating its potential
beyond first-generation immunotherapies and current treatments,”
said Dr. Steven O’Day, Chief Medical Officer. “BOT’s versatility,
alone, in combination with BAL, or in combination with other
standard of care therapies, in early and late-stage solid tumors,
positions Agenus to transform cancer care, offering immense promise
to patients.”
Key highlights across solid tumors include:
Extended Follow-up and Additional Data in Refractory MSS CRC
Demonstrate Improved Responses and Durability
In 70 efficacy evaluable patients with MSS CRC and no active
liver metastases:
- Confirmed (RECIST 1.1) overall response rate (ORR) of 24% was
observed, compared to 2.8% reported with standard of care (SOC) in
2/3L+ MSS CRC patients with no active liver metastases1.
- 12-month overall survival (OS) of 74% and median OS (mOS) not
yet reached. Median follow up now 12.3 months.
Subsequent data from expanded cohorts and early signals from a
230 patient Phase 2 trial is consistent with the earlier cohort of
70 patients. Based on the totality of the evidence from the Phase 1
and Phase 2 trials, Agenus plans to submit its Biologics License
Application (BLA) to the U.S. Food & Drug Administration (FDA)
for BOT/BAL in patients with 2/3L+ MSS CRC in midyear 2024.
Interactions with U.S. and EU regulatory agencies are ongoing.
Robust Clinical Outcomes in Neoadjuvant MSS CRC Underscore
BOT/BAL’s Potential in Earlier-Stage Patients*
- All patients treated with one dose of BOT and two doses of
BAL.
- After dosing, observations of responses were made within
approximately four-weeks prior to surgery.
- 100% (3/3) of patients with MSI-H CRC had major pathological
responses (>90%).
- 67% (6/9) patients with MSS CRC had pathological responses of
>50%, which includes two complete
pathological responses.
- These findings offer an alternative path to minimize or
eliminate radical rectal surgery and its associated morbidities
such as colostomy dependance and sexual dysfunction, and
potentially avoid the need for systemic chemotherapy.
- Agenus plans to prioritize neoadjuvant development and is
evaluating study design for further regulatory activity.
Compelling Activity from Dose-escalation Portion of Phase 2
BOT/Chemotherapy Combination in Advanced (2L) Pancreatic
Cancer
- In FOLFIRINOX relapsed/refractory (2L) pancreatic cancer, 80%
of evaluable patients (n=5; 150mg BOT+gem-Abraxane) experienced
sustained tumor marker reductions. All patients had liver
metastases.
- Two partial responses were at 16 weeks with target lesion
reduction of -47% (confirmed) and -37% (pending confirmation), and
both responses remain ongoing.
- Two other patients showed stable disease with tumor reduction
of -20% and -13% at 8 weeks and remain on study awaiting 16-week
scans.
- A Phase 2 randomized study is enrolling.
Monotherapy Activity in CTLA-4 Relapsed/Refractory Advanced
(2L+) Melanoma
- Phase 1 expansion cohort in relapsed/refractory (2L+) melanoma
(n=10) showed a 30% ORR and 60% disease control rate; 8/10 patients
had multiple prior lines including anti-PD-1/CTLA-4 and failed BRAF
targeted therapy (n=5).
- An accelerated Phase 2 trial in patients who have failed
anti-CTLA-4 and PD-1 is underway; BOT monotherapy cohort is fully
enrolled and BOT/BAL combination is enrolling.
Compelling Responses in Refractory NSCLC
- Patients treated with PD(L)-1 refractory NSCLC were treated
with BOT/BAL combination and showed a 56% ORR and 89% disease
control rate (n=9).
- Importantly, in patients with EGFR mutations refractory to SOC
responded to the BOT/BAL combo, with one patient experiencing an
-90% tumor reduction** at 12 weeks and the second having a -42%
tumor reduction at 6 weeks and is pending confirmation.
- Expansion cohorts are underway with anticipated enrollment of
100 patients by 1Q 2024.
- Additional data from this study will be reported in midyear
2024.
Broad and Durable Activity in Advanced Sarcomas
Updated data was presented at ESMO 2023 from the Phase 1b study
in 41 efficacy evaluable heavily pretreated advanced sarcoma
patients, demonstrating durability with extended follow-up and
additional activity in difficult-to-treat subtypes such as
leiomyosarcoma.
- BOT/BAL combination demonstrated 6-month progression-free
survival of 40%, ORR of 20%, and median response duration of 19.4
months (iRECIST).
- Differential responses observed by dose level, with 29% ORR at
2 mg/kg BOT compared to 15% at 1 mg/kg BOT.
Webcast Details
A live webcast will be held today at 19:00
– 21:00 CEST (1:00 p.m. – 3:00 p.m. EDT). To register for the
webcast, please click here.
References:
- Cohen et al. "Prognostic value of liver metastases in
colorectal cancer treated by systemic therapy: An ARCAD pooled
analysis." ASCO Annual Meeting 2023, Abstract 3554
*Investigator Sponsored Trial **Investigator reported, subject
to change.
About Botensilimab
Botensilimab is an investigational multifunctional anti-CTLA-4
immune activator (antibody) designed to boost both innate and
adaptive anti-tumor immune responses. Its novel design leverages
mechanisms of action to extend immunotherapy benefits to "cold"
tumors which generally respond poorly to standard of care or are
refractory to conventional PD-1/CTLA-4 therapies and
investigational therapies. Botensilimab augments immune responses
across a wide range of tumor types by priming and activating T
cells, downregulating intratumoral regulatory T cells, activating
myeloid cells and inducing long-term memory responses.
Approximately 750 patients have been treated with botensilimab
in phase 1 and phase 2 clinical trials. Botensilimab alone, or in
combination with Agenus’ investigational PD-1 antibody,
balstilimab, has shown clinical responses across nine metastatic,
late-line cancers. For more information about botensilimab trials,
visit www.clinicaltrials.gov with the identifiers NCT03860272,
NCT05608044, NCT05630183, and NCT05529316.
About Agenus
Agenus is a leading immuno-oncology company targeting cancer and
infectious diseases with a comprehensive pipeline of immunological
agents. The company’s mission is to expand patient populations
benefiting from cancer immunotherapy through combination
approaches, using a broad repertoire of antibody therapeutics,
adoptive cell therapies (through MiNK Therapeutics) and adjuvants
(through SaponiQx). Agenus is headquartered in Lexington, MA. For
more information, visit www.agenusbio.com or @agenus_bio.
Information that may be important to investors will be routinely
posted on our website and social media channels.
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 a its botensilimab
and balstilimab programs, expected regulatory timelines and
filings, and any other statements containing the words "may,"
"believes," "expects," "anticipates," "hopes," "intends," "plans,"
"forecasts," "estimates," "will," “establish,” “potential,”
“superiority,” “best in class,” 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 Annual Report on
Form 10-K for 2022, and subsequent Quarterly Reports on Form 10-Q
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231022881056/en/
Investors 917-362-1370
investor@agenusbio.com
Media 781-674-4784
communications@agenusbio.com
Agenus (NASDAQ:AGEN)
Historical Stock Chart
From Apr 2024 to May 2024
Agenus (NASDAQ:AGEN)
Historical Stock Chart
From May 2023 to May 2024