Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage
biotechnology company discovering and developing tumor-activated
immuno-oncology therapies for people living with cancer, today
announced pipeline progress and business updates and reported
financial results for the second quarter ended June 30, 2023.
“In the second quarter, we reported encouraging initial
monotherapy data from our Phase 1 trial of XTX101, a
tumor-activated, Fc-enhanced anti-CTLA-4, including a partial
response in a patient with advanced non-small cell lung cancer and
a favorable preliminary safety profile at the recommended Phase 2
dose,” said René Russo, Pharm.D., chief executive officer of Xilio.
“Building on these data, today we are pleased to announce a
clinical trial collaboration with Roche to evaluate XTX101 in
combination with atezolizumab in patients with MSS colorectal
cancer. Currently, there are no approved immunotherapies for
patients living with this cold tumor type. We believe the
combination of our tumor-activated anti-CTLA-4 with an anti-PD-L1
represents a promising combination for evaluation in MSS colorectal
cancer and potentially other cold tumor types with limited
treatment options. We also look forward to reporting preliminary
clinical data later this year from our ongoing trials of XTX202, a
tumor-activated IL-2, and XTX301, a tumor-activated IL-12.”
Pipeline and Business Updates
XTX101: tumor-activated, Fc-enhanced
anti-CTLA-4
XTX101 is an investigational tumor-activated, Fc-enhanced, high
affinity binding anti-CTLA-4 designed to block CTLA-4 and deplete
regulatory T cells when activated (unmasked) in the tumor
microenvironment (TME). XTX101 has completed monotherapy dose
escalation (Part 1A) and is currently being evaluated at the
recommended Phase 2 dose and schedule of 150 mg once every six
weeks (RP2D) in monotherapy dose expansion (Part 1B) of an ongoing
Phase 1 clinical trial in patients with advanced solid tumors.
- Xilio today announced that it has entered into a clinical trial
collaboration with Roche to evaluate XTX101 in combination with
atezolizumab (Tecentriq®) in a Phase 1/2 clinical trial consisting
of Phase 1 combination dose escalation in patients with advanced
solid tumors and Phase 2 in patients with microsatellite stable
colorectal cancer (MSS CRC). Under the clinical trial supply
agreement, Xilio is eligible to receive specified cost-sharing
payments from Roche, and each company will supply its respective
anti-cancer agent to support the clinical trial. Xilio will sponsor
and conduct the Phase 1/2 clinical trial and retains global
development and commercialization rights to XTX101.
- In May 2023, Xilio announced preliminary monotherapy data from
its Phase 1 clinical trial evaluating XTX101 in patients with
advanced solid tumors. These data included a confirmed partial
response observed in a patient with advanced non-small cell lung
cancer and a favorable preliminary safety profile observed at the
RP2D. For more information, read the press release here.
- Xilio today announced updated monotherapy data from its Phase 1
clinical trial evaluating XTX101 in patients with advanced solid
tumors at the RP2D. As of a data cutoff date of August 3, 2023, 11
patients had been treated at the RP2D. Across all dosing levels and
dosing intervals, no Grade 4 or Grade 5 treatment-related adverse
events (AEs) were reported by investigators. Among the 9 patients
who received XTX101 administered at the RP2D and for whom safety
data were available as of the data cutoff date, the most common
treatment-related AEs (≥10% incidence) of any grade reported by
investigators were diarrhea (11%), fatigue (11%), decreased
appetite (11%) and dermatitis (11%). In these patients, no
treatment-related colitis or infusion related reaction of any grade
was observed. In addition to a previously reported Grade 3
treatment-related AE of diarrhea, which resolved after five days
without steroid use, investigators observed one Grade 3
treatment-related AE of dermatitis. As of the data cutoff date of
August 3, 2023, no patients who received XTX101 administered at the
RP2D have discontinued treatment due to a treatment-related AE. In
addition, Xilio reported data showing a durable, continuing partial
response of 36 weeks in the previously reported patient with
advanced non-small cell lung cancer, with treatment ongoing as of
the data cutoff date.
Xilio anticipates activating clinical trial sites for the Phase
1 dose escalation portion of the clinical trial evaluating XTX101
in combination with atezolizumab in the fourth quarter of 2023.
XTX202: tumor-activated, engineered, beta-gamma biased
IL-2
XTX202 is an investigational tumor-activated beta-gamma biased,
engineered IL-2 molecule designed to potently stimulate CD8+
effector T cells and natural killer (NK) cells without concomitant
stimulation of regulatory T cells when activated (unmasked) in the
TME. XTX202 is currently being evaluated in an ongoing Phase 1/2
clinical trial in patients with advanced solid tumors.
- Xilio recently cleared the 2.8 mg/kg dose level (dose level
six) in monotherapy dose escalation for the Phase 1 clinical trial.
No signs or symptoms of vascular leak syndrome have been observed
in patients through the 2.8 mg/kg dose level.
- Xilio is currently dosing patients at the 4.0 mg/kg dose level
(dose level seven) in monotherapy dose escalation for the Phase 1
clinical trial. A maximum tolerated dose has not yet been
determined, and enrollment in the Phase 1 clinical trial is
ongoing.
- In addition, Xilio continues to dose patients at the 1.4 mg/kg
dose level in the Phase 2 clinical trial evaluating XTX202 as a
monotherapy in patients with unresectable or metastatic melanoma
and metastatic renal cell carcinoma who have progressed on
standard-of-care treatment. Based on continued Phase 1 monotherapy
dose escalation, Xilio also plans to explore opportunities to
evaluate XTX202 at an additional, higher dose level in the Phase 2
clinical trial.
Xilio anticipates reporting preliminary anti-tumor activity,
safety, pharmacokinetic and pharmacodynamic data from the Phase 1/2
clinical trial in early November 2023. The company anticipates the
reported data will include at least 20 evaluable patients across a
range of solid tumors treated at dose levels of 1.0 mg/kg or higher
across all cohorts in the Phase 1/2 clinical trial.
In addition, Xilio today announced the acceptance of an abstract
for XTX202 at the Society for Immunotherapy of Cancer (SITC) 38th
Annual Meeting on November 1-5, 2023.
XTX301: tumor-activated, engineered IL-12
XTX301 is an investigational tumor-activated, engineered IL-12
molecule designed to potently stimulate anti-tumor immunity and
reprogram the TME of poorly immunogenic “cold” tumors towards an
inflamed or “hot” state.
- Xilio is currently dosing patients in monotherapy dose
escalation of an ongoing Phase 1 clinical trial evaluating the
safety and tolerability of XTX301 in patients with advanced solid
tumors.
- Xilio anticipates reporting preliminary safety data from the
Phase 1 clinical trial into the third dose level in the fourth
quarter of 2023.
Corporate Highlights
- In August 2023, Xilio announced the promotion of Chris
Frankenfield to Chief Operating Officer.
Virtual Spotlight Program on XTX101
Xilio will host a live virtual program on Thursday, August 17,
2023, at 12:30 p.m. ET spotlighting XTX101, including highlights
from the recently reported Phase 1 monotherapy data for XTX101 and
clinical development plans in MSS CRC.
- The event will feature members of Xilio’s management team as
well as Dr. Diwakar Davar, MBBS, M.Sc., a key opinion leader and
assistant professor of medicine and a medical
oncologist/hematologist from UPMC Hillman Cancer Center. Dr. Davar
will discuss the anti-CTLA-4 treatment landscape, including recent
advances observed in patients with previously I-O refractory cold
tumors, such as MSS CRC. A live question and answer session will
follow the presentation.
- To register in advance for the webcast, please click here. A
live webcast of the event will also be available under “Events and
Presentations” in the Investors & Media section of Xilio’s
website at https://ir.xiliotx.com. A replay of the webcast will be
archived on Xilio’s website for 90 days following the event.
Second Quarter 2023 Financial Results
- Cash Position: Cash and cash equivalents
were $75.4 million as of June 30, 2023, compared to $120.4 million
as of December 31, 2022.
- Research & Development (R&D)
Expenses: R&D expenses were $13.2 million for the
quarter ended June 30, 2023, compared to $16.2 million for the
quarter ended June 30, 2022. The decrease was primarily driven by
decreased manufacturing and clinical development activities for
XTX101 and decreased manufacturing and preclinical activities for
XTX301. These decreases were partially offset by increases in
clinical activities for XTX202 and XTX301.
- General & Administrative (G&A)
Expenses: G&A expenses were $6.9 million for the
quarter ended June 30, 2023, compared to $8.3 million for the
quarter ended June 30, 2022. The decrease was primarily driven by a
decrease in personnel-related costs, including stock-based
compensation.
- Net Loss: Net loss was $19.4 million for
the quarter ended June 30, 2023, compared to $24.6 million for the
quarter ended June 30, 2022.
Financial Guidance
Xilio continues to anticipate that its existing cash and cash
equivalents will be sufficient to fund its operating expenses and
capital expenditure requirements into the end of the second quarter
of 2024.
About XTX101 (anti-CTLA-4) and the Phase 1 Monotherapy
and Phase 1/2 Combination Clinical Trials
XTX101 is an investigational tumor-activated, Fc-enhanced, high
affinity binding anti-CTLA-4 monoclonal antibody designed to block
CTLA-4 and deplete regulatory T cells when activated (unmasked) in
the tumor microenvironment (TME). The Phase 1 clinical trial is a
first-in-human, multi-center, open-label trial designed to evaluate
the safety and tolerability of XTX101 for the treatment of adult
patients with advanced solid tumors. Xilio has completed
monotherapy dose escalation (Part 1A) and is currently enrolling
patients at the recommended Phase 2 dose and schedule of 150 mg
once every six weeks in monotherapy dose expansion (Part 1B).
Please refer to NCT04896697 on www.clinicaltrials.gov for
additional details.
In addition, Xilio plans to evaluate the safety, tolerability
and efficacy of XTX101 in combination with atezolizumab
(Tecentriq®) in the Phase 1/2 clinical trial. The Phase 1 portion
is designed to assess the safety and tolerability of XTX101 in
combination with atezolizumab in dose escalation in patients with
advanced solid tumors. The planned Phase 2 portion is designed to
evaluate the safety and efficacy of the combination in patients
with microsatellite stable colorectal cancer (MSS CRC).
About XTX202 (IL-2) and the Phase 1/2 Clinical
Trials
XTX202 is an investigational tumor-activated beta-gamma biased,
engineered IL-2 molecule designed to potently stimulate CD8+
effector T cells and natural killer (NK) cells without concomitant
stimulation of regulatory T cells when activated (unmasked) in the
tumor microenvironment (TME). The Phase 1 clinical trial for XTX202
is a first-in-human, multi-center, open-label trial designed to
evaluate the safety and tolerability of XTX202 as a monotherapy in
patients with advanced solid tumors. The Phase 2 clinical trial for
XTX202 is a multi-center, open-label trial designed to evaluate the
safety and efficacy of XTX202 as a monotherapy in patients with
unresectable or metastatic melanoma and metastatic renal cell
carcinoma who have progressed on standard-of-care treatment. Please
refer to NCT05052268 on www.clinicaltrials.gov for additional
details.
About XTX301 (IL-12) and the Phase 1 Clinical
Trial
XTX301 is an investigational tumor-activated, engineered IL-12
molecule designed to potently stimulate anti-tumor immunity and
reprogram the tumor microenvironment (TME) of poorly immunogenic
“cold” tumors towards an inflamed or “hot” state. The Phase 1
clinical trial for XTX301 is a first-in-human, multi-center,
open-label trial designed to evaluate the safety and tolerability
of XTX301 as a monotherapy in patients with advanced solid tumors.
Please refer to NCT05684965 on www.clinicaltrials.gov for
additional details.
About Xilio Therapeutics
Xilio Therapeutics is a clinical-stage biotechnology company
discovering and developing tumor-activated immuno-oncology (I-O)
therapies with the goal of significantly improving outcomes for
people living with cancer without the systemic side effects of
current I-O treatments. The company is using its proprietary
geographically precise solutions (GPS) platform to build a pipeline
of novel, tumor-activated molecules, including antibodies,
cytokines and other biologics, which are designed to optimize their
therapeutic index and localize anti-tumor activity within the tumor
microenvironment. Xilio is currently advancing multiple programs
for tumor-activated I-O treatments in clinical development, as well
as programs in preclinical development. Learn more by visiting
www.xiliotx.com and follow us on Twitter (@xiliotx) and LinkedIn
(Xilio Therapeutics, Inc.).
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, statements
regarding plans, timing and expectations related to reporting
preliminary data from the Phase 1/2 clinical trial for XTX202,
including the anticipated number of patients treated at the 1 mg/kg
dose level or higher; evaluating XTX202 at a second dose level in
the Phase 2 clinical trial; reporting preliminary safety data from
the Phase 1 clinical trial for XTX301; activating clinical trial
sites for Phase 1 combination dose escalation portion of the
clinical trial evaluating XTX101 in combination with atezolizumab
in patients with advanced solid tumors; the potential benefits of
any of Xilio’s current or future product candidates in treating
patients; Xilio’s ability to obtain and maintain sufficient cash
resources to fund its operations beyond the end of the second
quarter of 2024; and Xilio’s strategy, goals and anticipated
financial performance, milestones, business plans and focus. The
words “aim,” “may,” “will,” “could,” “would,” “should,” “expect,”
“plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,”
“project,” “potential,” “continue,” “seek,” “target” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Any forward-looking statements in this press
release are based on management’s current expectations and beliefs
and are subject to a number of important risks, uncertainties and
other factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without
limitation, risks and uncertainties related to ongoing and planned
research and development activities, including initiating,
conducting or completing preclinical studies and clinical trials
and the timing and results of such preclinical studies or clinical
trials; the delay of any current or planned preclinical studies or
clinical trials or the development of Xilio’s current or future
product candidates; Xilio’s ability to obtain and maintain
sufficient preclinical and clinical supply of current or future
product candidates; Xilio’s advancement of multiple early-stage
programs; there can be no assurance that interim or preliminary
preclinical or clinical data or results will be predictive of
future preclinical or clinical data or results; Xilio’s ability to
successfully demonstrate the safety and efficacy of its product
candidates and gain approval of its product candidates on a timely
basis, if at all; results from preclinical studies or clinical
trials for Xilio’s product candidates, which may not support
further development of such product candidates; actions of
regulatory agencies, which may affect the initiation, timing and
progress of current or future clinical trials; Xilio’s ability to
obtain, maintain and enforce patent and other intellectual property
protection for current or future product candidates; Xilio’s
ability to obtain and maintain sufficient cash resources to fund
its operations beyond the end of the second quarter of 2024; the
impact of international trade policies on Xilio’s business,
including U.S. and China trade policies; and Xilio’s ability to
maintain its clinical trial collaboration with Roche to develop
XTX101 in combination with atezolizumab. These and other risks and
uncertainties are described in greater detail in the sections
entitled “Risk Factor Summary” and “Risk Factors” in Xilio’s
filings with the U.S. Securities and Exchange Commission (SEC),
including Xilio’s most recent Quarterly Report on Form 10-Q
and any other filings that Xilio has made or may make with the SEC
in the future. Any forward-looking statements contained in this
press release represent Xilio’s views only as of the date hereof
and should not be relied upon as representing its views as of any
subsequent date. Except as required by law, Xilio explicitly
disclaims any obligation to update any forward-looking
statements.
This press release contains hyperlinks to information that is
not deemed to be incorporated by reference in this press
release.
TECENTRIQ is a registered trademark of Genentech USA, Inc., a
member of the Roche Group.
For Investor and Media Inquiries: Julissa
VianaVice President, Head of Investor Relations and Corporate
Communicationsinvestors@xiliotx.com
Melissa ForstArgot PartnersXilio@argotpartners.com
XILIO THERAPEUTICS, INC.Condensed
Consolidated Balance Sheets(In
thousands)(Unaudited) |
|
|
June 30, |
|
December 31, |
|
|
2023 |
|
2022 |
Assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
75,383 |
|
$ |
120,385 |
Other assets |
|
|
16,976 |
|
|
18,780 |
Total assets |
|
$ |
92,359 |
|
$ |
139,165 |
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
Liabilities |
|
$ |
24,982 |
|
$ |
33,518 |
Stockholders’ equity |
|
|
67,377 |
|
|
105,647 |
Total liabilities and stockholders’ equity |
|
$ |
92,359 |
|
$ |
139,165 |
XILIO THERAPEUTICS, INC.Condensed
Consolidated Statements of Operations and Comprehensive
Loss(In thousands, except share and per share
data)(Unaudited) |
|
|
Three Months EndedJune
30, |
|
Six Months EndedJune
30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating expenses(1) |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
13,218 |
|
|
$ |
16,246 |
|
|
$ |
29,349 |
|
|
$ |
31,166 |
|
General and administrative |
|
|
6,898 |
|
|
|
8,306 |
|
|
|
14,293 |
|
|
|
14,610 |
|
Total operating expenses |
|
|
20,116 |
|
|
|
24,552 |
|
|
|
43,642 |
|
|
|
45,776 |
|
Loss from operations |
|
|
(20,116 |
) |
|
|
(24,552 |
) |
|
|
(43,642 |
) |
|
|
(45,776 |
) |
Other income (expense),
net |
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net |
|
|
761 |
|
|
|
(61 |
) |
|
|
1,641 |
|
|
|
(190 |
) |
Total other income (expense), net |
|
|
761 |
|
|
|
(61 |
) |
|
|
1,641 |
|
|
|
(190 |
) |
Net loss and comprehensive
loss |
|
$ |
(19,355 |
) |
|
$ |
(24,613 |
) |
|
$ |
(42,001 |
) |
|
$ |
(45,966 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.70 |
) |
|
$ |
(0.90 |
) |
|
$ |
(1.53 |
) |
|
$ |
(1.68 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
27,468,668 |
|
|
|
27,384,614 |
|
|
|
27,451,058 |
|
|
|
27,376,043 |
|
________________________(1) Operating expenses include the
following amounts of non-cash stock-based compensation expense:
|
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
|
2023 |
|
2022 |
|
2023 |
|
|
2022 |
Research and development expense |
|
$ |
549 |
|
$ |
637 |
|
$ |
1,122 |
|
$ |
1,233 |
General and administrative
expense |
|
|
1,251 |
|
|
2,072 |
|
|
2,469 |
|
|
3,505 |
Total stock-based compensation expense |
|
$ |
1,800 |
|
$ |
2,709 |
|
$ |
3,591 |
|
$ |
4,738 |
Xilio Therapeutics (NASDAQ:XLO)
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