- At a late-breaking presentation at ASCO-GI,
botensilimab/balstilimab combination demonstrated a 63% 12-month
overall survival rate in metastatic colorectal cancer patients who
have failed a median of four prior treatments, more than double the
survival rate reported for available treatments
- Botensilimab/balstilimab combination data update selected for
late-breaking oral session at the ESMO-GI conference in June
2023
- FDA granted Fast Track Designation to the
botensilimab/balstilimab combination in colorectal cancer in April
2023
- At a plenary session at SGO, botensilimab/balstilimab
combination showed 33% overall response rate in platinum-resistant
ovarian cancer patients
- Phase II ACTIVATE trials expected to fully enroll in second
half of 2023
- AGEN2373 monotherapy data to be presented at ASCO in June
2023
- Balstilimab/zalifrelimab data in the treatment of sarcoma to be
presented at ASCO oral session in June 2023
Agenus Inc. (Nasdaq: AGEN), an immuno-oncology company with an
extensive pipeline of clinical and preclinical-stage cancer
treatments, today provided a corporate update and reported
financial results for the first quarter 2023.
"With over 350 patients dosed with botensilimab in our Phase 1
study, we have demonstrated 20-50% response rates in 9 solid tumor
cancers. These results suggest that botensilimab could provide
significant benefit to patients who have not responded to or failed
other available treatments,” said Dr. Garo Armen, Chief Executive
Officer of Agenus. “Agenus is committed to advancing our
development programs to make botensilimab available to patients
ASAP."
Botensilimab Combination
Unprecedented activity in 70 patients with non-MSI-H colorectal
cancer and 24 patients with recurrent platinum resistant/refractory
ovarian cancer:
- Agenus presented botensilimab/balstilimab combination data at a
late-breaking oral session at the American Society of Clinical
Oncology – Gastrointestinal Cancers Symposium (ASCO-GI) in January
2023 and at the Society of Gynecologic Oncology (SGO) 2023 Annual
Meeting on Women’s Cancer in March 2023
- The combination showed unprecedented responses and survival
benefit in 70 patients with non-microsatellite instability-high
(non-MSI-H) colorectal cancer, including:
- 12-month overall survival of 63% (compared to 25% reported for
standard of care) 1,2
- Overall response rate of 23% (compared to 1-2%1,2 reported for
standard of care and 1-5%3,4 reported for other PD-(L)1 + CTLA-4
combinations)
- In April 2023, the FDA granted Fast Track Designation to the
botensilimab/balstilimab combination for the treatment of
non-MSI-H/deficient mismatch repair (dMMR) metastatic colorectal
cancer patients without active liver involvement who are resistant
or intolerant to fluoropyrimidine, oxaliplatin, or irinotecan, and
have also received a VEGF inhibitor, an EGFR inhibitor, and/or a
BRAF inhibitor
- Agenus is conducting a global, randomized Phase 2 trial in this
patient population under its ACTIVATE trial program, and a global
Phase 3 trial is expected to commence in 2023
- In 24 ovarian cancer patients who were resistant or refractory
to platinum chemotherapy, the botensilimab/balstilimab combination
showed a 33% response rate (compared to ~10% reported for standard
of care5 and 3-10% for other PD-(L)1 + CTLA-4 combinations6,7)
- Agenus continues to enroll PD-(L)1 relapsed/refractory NSCLC
patients in its Phase 1b study and plans to launch a randomized
phase 3 study if the previously reported ~50% response rates
continue
Upcoming Presentations
- Updated data on the botensilimab/balstilimab combination in
non-MSI-H metastatic colorectal cancer patients selected for a late
breaking oral presentation at the upcoming ESMO World Congress on
Gastrointestinal Cancer (ESMO-GI), to be held June 18 – July 1,
2023 in Barcelona, Spain
- Data from a single-arm, open-label Phase 2 study of balstilimab
and zalifrelimab (1st generation CTLA-4) plus doxorubicin in
patients with advanced sarcomas selected for oral presentation at
the ASCO 2023 Annual Meeting, to be held June 2-6 in Chicago,
IL
- Complete results from the monotherapy arm of the first-in-human
dose escalation study of AGEN2373 in patients with advanced solid
tumors will also be presented in a poster discussion at ASCO
Clinical Pipeline and Corporate Partnerships
Additional presentation at ASCO involving Agenus's clinical
pipeline involving collaborations include:
- Abstract #424868: Targeting minimal residual disease (MRD) in
resected RAS mutated pancreatic cancer with vaccine TG01/QS-21 +/-
PD-1 inhibitor, balstilimab: A randomized phase II study
(TESLA)
- Abstract # TPS6104: Phase 2 Trial of Retifanlimab (anti–PD-1)
in Combination With INCAGN02385 (anti–LAG-3) and INCAGN02390
(anti–TIM-3) as First-Line Treatment in Patients With
PD-L1–Positive Recurrent/Metastatic Squamous Cell Carcinoma of the
Head and Neck
- Abstract #2599: A Phase 1/2 Study of retifanlimab (INCMGA00012,
Anti–PD-1), INCAGN02385 (Anti–LAG-3), and INCAGN02390 (Anti–TIM-3)
Combination Therapy in Patients (Pts) With Advanced Solid
Tumors
- Abstract #2541: A phase 1/2 study of the safety, tolerability,
and preliminary efficacy of the anti-GITR monoclonal antibody,
INCAGN01876, combined with immunotherapies (IO) in patients (Pts)
with advanced cancers
Agenus shareholders received dividend of shares in MiNK
Therapeutics (NASDAQ: INKT)
On May 1st, 2023, Agenus distributed a dividend of approximately
5,000,000 shares it owned of its subsidiary MiNK Therapeutics’
common stock to shareholders who held Agenus shares as of April 17,
2023, with a ratio of 0.0146 shares of MiNK (NASDAQ: INKT) per
share of Agenus. The announced dividend distribution preceded
MiNK's presentation of its lead product, agenT-797, an allo-INKT
cell therapy, showing clinical and biomarker responses in solid
tumor cancers at AACR in April 2023. This distribution allows
Agenus shareholders to benefit from future growth of MiNK through
direct ownership. The shares that were distributed as part of this
dividend were not part of a new stock offering.
First Quarter 2023 Financial Results:
We ended our first quarter 2023 with a cash, cash equivalent and
short-term investment balance of $189.2 million, compared to $193.4
million at December 31, 2022. Since quarter end we have raised
$13.6 million through sales under our at market issuance sales
agreement.
For the first quarter ended March 31, 2023, we recognized
revenue of $22.9 million and incurred a net loss of $70.9 million
(including non-cash expenses of $24.9 million) or $0.22 per
share.
Financial Highlights (in thousands, except per share data)
(unaudited)
March 31,
December 31,
2023
2022
Cash, cash equivalents and short-term investments
$
189,233
$
193,358
Three months ended March 31,
2023
2022
Revenues, research and development
$
2,612
$
6,740
Revenues, non-cash royalty
19,106
17,634
Revenues, other
1,184
1,567
Total Revenue
22,902
25,941
Research and development expenses
57,118
42,442
General and administrative expenses
18,237
18,953
Cost of service revenue
2,294
543
Other (income) loss
(721
)
191
Non-cash interest expense
17,273
14,952
Non-cash contingent consideration fair value adjustment
(406
)
(536
)
Net loss
$
(70,893
)
$
(50,604
)
Net loss per share attributable to Agenus Inc. common
stockholders
$
(0.22
)
$
(0.19
)
Cash used in operations
$
58,526
$
52,391
Non-cash operating expenses
$
24,935
$
21,069
Conference Call
Date: May 9, 2023, 8:30am ET Dial-in numbers:
646-307-1963 (US-NY) & 800-715-9871 (Ex-US) Event ID:
9144113
Webcast
A webcast and replay of the conference call will be accessible
from the Events & Presentations page of the Company’s website
at https://investor.agenusbio.com/events-and-presentations and via
https://edge.media-server.com/mmc/p/v54y2wy9.
References
1 Mayer et al. NEJM 2015 2 Grothey et al. Lancet 2013 3 Chen et
al. JAMA Oncol. 2020 4 Overman et al. ASCO 2016 5 Mutch DG, et al.
J Clin Oncol. 2007;25(19): 2811-2818 6
https://clinicaltrials.gov/ct2/show/results/NCT01928394 7
Hinchcliff et al. Gynecologic Oncology 2021
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, as well as to expand clinical
benefit in “hot” tumors, where immunotherapies are approved but
benefit only a minority of patients. In addition to binding to the
CTLA-4 receptor, its Fc-enhanced structure induces a memory immune
response, downregulates regulatory T cells, activates existing T
cells, as well as primes and expands new T cells, thereby promoting
a more effective and durable immune response to cancer.
In a Phase 1 clinical study of more than 350 patients,
botensilimab has demonstrated clinical responses in nine different
cold and treatment-refractory solid tumor cancers, either alone or
in combination with Agenus’ PD-1 antibody, balstilimab (data
presented at ASCO GI 2023, SGO 2023, SITC 2022, and CTOS 2022).
Agenus is conducting global, randomized Phase 2 trials in non-MSI-H
colorectal cancer, melanoma, and pancreatic cancer 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 colorectal cancer
is expected to launch in 2023.
About AGEN2373
AGEN2373 is a novel anti-CD137 agonist that has been designed to
activate T and NK cells while mitigating liver toxicities common to
the CD137 target class. CD137 (4-1BB) is an activating receptor
expressed on T and NK cells. Upon binging to CD137, AGEN2373 is
designed to stimulate the growth and activation of cytotoxic T and
NK cells, triggering a lasting memory response to cancer. AGEN2373
binds to a unique epitope designed to achieve this response
specifically within the tumor microenvironment. This selective
binding is designed to avoid serious side effects associated with
CD137 activation in the liver that have been reported by competitor
molecules. AGEN2373 has demonstrated preliminary clinical activity
and has been well tolerated by patients without signs of liver
toxicity (Tolcher et al. ASCO 2021).
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.
About MiNK Therapeutics
MiNK Therapeutics is a clinical-stage biopharmaceutical company
pioneering the discovery, development, and commercialization of
allogeneic invariant natural killer T (iNKT) cell therapies to
treat cancer and other immune-mediated diseases. MiNK is advancing
a pipeline of both native and next-generation engineered iNKT
programs, with a platform designed to facilitate scalable and
reproducible manufacturing for off-the-shelf delivery. The company
is headquartered in New York, NY. For more information, visit
https://minktherapeutics.com/ and Twitter handle @MiNK_iNKT.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230509005321/en/
Agenus Inc. Zack Armen Head of Investor Relations 917-362-1370
zack.armen@agenusbio.com
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