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 the initiation of a
global Phase 2 program of botensilimab, an Fc-enhanced anti-CTLA-4
that activates innate and adaptive immune responses. These trials
include ACTIVATE-Colorectal, a Phase 2 study designed to evaluate
botensilimab as monotherapy and in combination with balstilimab
(anti-PD-1) for the treatment of microsatellite stable colorectal
cancer (MSS CRC), and ACTIVATE-Melanoma, a Phase 2 study designed
to evaluate botensilimab as a single agent for advanced melanoma,
refractory to either prior anti-PD-1 or combined
anti-PD-1/anti-CTLA-4 therapy. An additional Phase 2 study in
pancreatic cancer is anticipated to begin later in 2022.
“The Phase 1 botensilimab program demonstrated remarkable
activity in poorly immunogenic and difficult to treat tumor types,”
said Steven O’Day, MD, Chief Medical Officer at Agenus. “In light
of our compelling clinical data, we have received clearance from
the FDA to initiate our Phase 2 development program in two
indications and intend to expand to multiple additional indications
as rapidly as possible with the aim of delivering a transformative
new treatment option to patients in need.”
ACTIVATE-Colorectal is a global, randomized, open-label,
dose-optimization study evaluating the safety and efficacy of
botensilimab as monotherapy and in combination with balstilimab in
advanced refractory MSS CRC patients. Key elements of
ACTIVATE-Colorectal include:
- Patients must have received at least one prior chemotherapy
regimen
- Patients cannot have received prior PD-1, CTLA-4 or other
immune checkpoint inhibitor therapy
- Primary endpoint is overall response rate (ORR); secondary
endpoints include duration of response (DOR), progression-free
survival (PFS) and overall survival (OS)
- Recruitment will be global, including sites in the United
States and Europe
ACTIVATE-Melanoma is a global, randomized, open-label,
multi-cohort, dose-optimization study evaluating the safety and
efficacy of botensilimab as a single agent in advanced refractory
melanoma. Key elements of ACTIVATE-Melanoma include:
- Study will enroll patients who have failed prior anti-PD-1
therapy (cohort A) or both anti-PD1 and anti-CTLA-4 therapy (cohort
B)
- Primary endpoint is overall response rate (ORR); secondary
endpoints include duration of response (DOR), progression-free
survival (PFS) and overall survival (OS)
- Recruitment will be global, including sites in the United
States and Europe
About Microsatellite Stable Colorectal
Cancer
Colorectal cancer remains the third most common cancer diagnosis
and second-leading cause of cancer death worldwide, affecting 1.93
million and 916,000 individuals each year1. MSS colorectal cancer
is a form of colorectal cancer where the cells’ DNA repair
mechanisms remain intact2. It accounts for over 95% of metastatic
colorectal cancer cases3 and has historically been unresponsive to
immune checkpoint therapy4. Standard of care in pretreated
metastatic MSS colorectal cancer offers limited benefit, with an
approximate 1-2% response rate and a median of 6-7 months of
survival5,6.
About Advanced Refractory Melanoma
Melanoma is a serious skin cancer that affects approximately
132,000 individuals each year and has been growing in incidence7.
Advanced refractory melanoma refers to cancer that has spread to
other parts of the body and stopped responding to medical therapy.
Recent advances in the use of targeted therapy and immunotherapy,
including anti-PD-1 and anti-CTLA-4, have improved survival for
patients diagnosed with advanced melanoma. However, while anti-PD-1
monotherapy can be effective as a first-line treatment for some
patients with metastatic melanoma, roughly half fail to achieve an
objective response and those who do often subsequently relapse.8,
9, 10 Those patients with non-BRAF mutated tumors who are
refractory to or who relapse after having received anti-PD-1 and
anti-CTLA-4 therapy have few effective treatment options.
About Botensilimab
Botensilimab is a novel innate and adaptive immune activator
that binds CTLA-4. The antibody was designed to enhance FcγR
effector functions while avoiding complement-related toxicities and
has demonstrated activity in cancer patients for whom current
immuno-oncology agents have historically been ineffective. As
presented at SITC 2021, botensilimab is the first CTLA-4 inhibitor
to demonstrate clinical responses across nine cold and
treatment-resistant cancers. At ESMO GI 2022, botensilimab
demonstrated unprecedented activity in combination with balstilimab
in MSS colorectal cancer, with a 24% response rate and 73% disease
control rate in heavily pre-treated patients with a median of 4
prior lines of 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 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
1 World Health Organization. (n.d.). Cancer. Retrieved September
8, 20222 Li, K., Luo, H., Huang, L. et al. Cancer Cell Int 20, 16
(2020) 3 Koopman et al. Br J Cancer 2009 Jan 27;100(2):266-734
Sahin et al. American Society of Clinical Oncology Educational Book
42 (June 3, 2022) 242-2535 Grothey et al. Lancet 2013 Jan
26;381(9863):303-126 Mayer et al. N Engl J Med 2015 May
14;372(20):1909-197 World Health Organization. (n.d.). Radiation:
Ultraviolet (UV) radiation and skin cancer. Retrieved September 8,
20228 Larkin J, Hodi FS, Wolchok JD. N Engl J Med 2015 Sep
24;373(13):1270-19 Gide TN, Wilmott JS, Scolyer RA, Long GV. Clin
Cancer Res 2018 Mar 15;24(6):1260-127010 Kluger HM, Tawbi HA,
Ascierto ML, et al. J Immunother Cancer 2020 Mar;8(1):e000398
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