FDA Grants Fast Track designation for BOT/BAL
in metastatic, refractory colorectal cancer (CRC) patients who have
failed 1st and 2nd line standard of care treatments
Data from Phase 1 of BOT/BAL in refractory CRC
showed durable ORR of 24% in patients with non-active liver
metastases (NLM); Completed enrollment of randomized Phase 2 trial
(n=230)
Clinical data sets path for expansion
opportunities in pancreas, lung, neoadjuvant CRC, and melanoma
Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in discovering
and developing novel immunological agents to treat various cancers,
today provided a corporate update and reported financial results
for the fourth quarter and full year 2023.
“In 2023, Agenus made significant advances across our BOT/BAL
development program. Our first target indication is metastatic,
refractory colorectal cancer that is not MSI-H/dMMR, for which we
are focused on pursuing accelerated approval,” said Garo Armen,
Ph.D., Chief Executive Officer. “We are also pursuing multiple
strategies to capitalize the company through this important path in
our efforts to bring BOT and BOT/BAL to the forefront of solid
tumor cancer treatment. Our vision is to maximize BOT's utility to
benefit patients in combination with other immune therapies as well
as current standards of care for patients with both early and
late-stage tumors.”
2023 Highlights on
Botensilimab
Colorectal Cancer:
- Received Fast Track designation for patients with metastatic
colorectal cancer that is not MSI-H/dMMR and who do not have liver
metastases, and who were previously treated with standard
combination chemotherapy, anti-VEGF and anti-EGFR if RAS wild type
(“refractory MSS mCRC NLM”)
- Completed enrollment of patients with refractory MSS mCRC NLM
in a Phase 1 (n=150) and randomized Phase 2 (n=230) in October
2023.
- Clinical data reported by Agenus in October 2023 revealed:
- Among the 70 efficacy evaluable ("EE") patients in the
refractory MSS mCRC NLM treatment setting, a 24% RECIST v1.1
response rate was observed in those treated with the BOT/BAL
combination. Based on literature review, the response rate in a
similar population treated with standard of care therapies ranges
from 1% to 6.1%1, 2.
- The 12-month overall survival (OS) rate is 74% with median OS
not yet reached.
- Topline data from the ongoing Phase 2 study are expected in 2H
2024.
- The most common safety observations are immune-related diarrhea
and colitis, which are managed in accordance with standard
therapies. Grade 3 treatment related diarrhea/colitis occurred in
approximately 14% of patients.
Neoadjuvant CRC:
- Clinical data presented at ASCO-GI January 2024:
- In an investigator sponsored trial (IST) led by Dr. Pashtoon
Kasi at Weill-Cornell Medicine, patients diagnosed with resectable
localized colon or rectal cancer were treated with one dose of BOT
and two doses of BAL approximately 4 weeks prior to planned
surgery. After surgery, pathologic analysis reported significant
tumor shrinkage.
- 3/3 patients (100%) with MSI-H CRC experienced major
pathological responses (>90% tumor shrinkage) in less than 4
weeks, while 6/9 (67%) MSS CRC patients had tumor shrinkage of 50%
or more.
- IST is expanding to 24 patients with an extended follow-up time
(6-8 weeks); Agenus plans to prioritize neoadjuvant development and
is evaluating study designs for subsequent pivotal trials.
2L Metastatic Pancreatic:
- In patients with metastatic pancreatic cancer who have failed
or don’t respond to FOLFIRINOX (2L Pancreatic) and received
treatment with BOT in combination with gemcitabine+nab-paclitaxel,
significant tumor marker reductions were observed in 4 of 5
patients, all with liver metastases.
- Two (2) of the 4 patients achieved PRs at 16 weeks (target
lesion reductions of 47% (confirmed) and -37% (pending
confirmation). Two other patients showed stable disease at their
first 8-week scan with tumor reductions of -20% and -13%.
- A Phase 2 randomized study is in progress, with preliminary
data expected to be available mid-year.
CTLA-4/PD-1 Relapsed Refractory Advanced Melanoma (“2L+
Melanoma”):
- Phase 1b expansion cohort in 2L+ Melanoma reported a 30% ORR
and 60% disease control rate (n=10; 2/8 BOT responses and 1/2
BOT/BAL responses); all patients had failed anti-PD-1 therapy and
8/10 had failed both anti-PD-1/CTLA-4 therapy.
- In the Phase 2 study in 2L+ Melanoma, data from the fully
enrolled BOT monotherapy arm and a cohort of patients on BOT/BAL
(n=30) are anticipated in 2H2024.
Refractory Non-Small Cell Lung Cancer (NSCLC):
- In the PD(L)-1 refractory cohort, a 56% ORR and an 89% disease
control rate were observed in patients treated with the BOT/BAL
combination (n=9).
- In a TKI-refractory cohort, 2 out of 7 patients experienced
complete confirmed objective responses after treatment with
BOT/BAL*.
Advanced Sarcomas:
- Updated findings from a Phase 1b study of 41 efficacy evaluable
patients treated with BOT/BAL showed durable responses with an ORR
of 20%, a median response duration of 19.4 months (iRECIST), and a
6-month progression-free survival rate of 40%.
- A higher ORR was observed by dose level, with 29% at 2 mg/kg
BOT compared to 15% at 1 mg/kg BOT.
Refractory Ovarian:
- In a total of 24 evaluable patients treated with BOT/BAL, with
a median of four prior lines of therapy, an overall response rate
of 33% was observed. The disease control rate was 67% and the
median Duration of Response (DOR) was not yet reached.
Finance
- $25 million milestone payment from BMS triggered by the
commencement of a Phase 2 study with BMS-986442 in December
2023.
- Advancing in our discussions on monetizing non-strategic
assets, royalty monetization, and project financing, with the
potential to yield $100-200 million in cash proceeds.
- Currently we are in active discussions with several potential
biopharma partners for potential co-development and
co-commercialization of BOT/BAL.
Fourth Quarter and Full Year 2023
Financial Results
For the year ended December 31, 2023, we recognized revenue of
$156 million and incurred a net loss of $257 million, or $0.69 per
share. For the fourth quarter ended December 31, 2023, we
recognized revenue of $84 million and incurred a net loss of $49
million or $0.13 per share. Revenue primarily includes revenue
under our collaboration agreements, including milestones achieved,
and revenue related to non-cash royalties earned.
We ended the year with a $76.1 million cash balance; subsequent
to which in January 2024 we received the $25 million milestone
payment from BMS triggered by the commencement of a Phase 2 study
with BMS-986442, the AGENUS discovered TIGIT bispecific antibody.
Additionally, we've progressed in monetizing non-strategic assets
and future milestones and royalties from ongoing partnerships.
These efforts are expected to yield significant cash proceeds by
mid 2024. Accordingly, we anticipate being funded through 2024. In
parallel, we're pursuing potential partnership discussions with
several biopharmaceuiticsl parties to further expand our cash
resources.
December 31,
2023
2022
Cash, cash equivalents and short-term investments
$
76,110
$
193,358
Three months ended December 31, Year ended December
31,
2023
2022
2023
2022
Revenues, research and development
$
30,249
$
3,755
$
38,764
$
16,975
Revenues, non-cash royalty
53,038
18,284
114,572
45,285
Revenues, royalty sales milestone
-
-
-
25,250
Revenues, other
514
6,347
2,978
10,514
Total Revenue
83,801
28,386
156,314
98,024
Research and development expenses
66,723
53,279
234,569
186,691
General and administrative expenses
21,177
25,036
78,739
81,007
Cost of service revenue
260
7,693
3,111
10,568
Other income
(193
)
(3,918
)
(2,663
)
(10,944
)
Non-cash interest expense
44,574
18,326
100,551
62,955
(Gain) loss related to debt
-
1,937
-
(782
)
Non-cash contingent consideration fair value adjustment
(158
)
135
(556
)
(815
)
Net loss
$
(48,582
)
$
(74,102
)
$
(257,437
)
$
(230,656
)
Net loss per share attributable to Agenus Inc. common
stockholders
$
(0.13
)
$
(0.24
)
$
(0.69
)
$
(0.78
)
Cash used in operations
$
40,590
$
47,338
$
224,202
$
175,373
Non-cash operating expenses
$
56,455
$
32,777
$
139,015
$
96,286
Conference Call
Date: March 14th, 2024, 8:30 a.m. ET
To access dial-in numbers, please register here.
Conference ID: 73242
Webcast
A live webcast and replay of the conference call will be
accessible on the company’s website at
https://investor.agenusbio.com/events-and-presentations and via
https://events.q4inc.com/attendee/678927380.
References
1 Prager et. al NEJM 2023
2 Grothey et al. Lancet 2013
* 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 900 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 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 at
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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