Ikena Oncology, Inc. (Nasdaq: IKNA, “Ikena,” “Company”), a targeted
oncology company forging new territory in patient-directed cancer
treatment, today announced financial results for the quarter ended
September 30, 2023, and provided a corporate update. The Company
also shared initial data from twenty-six (26) patients treated in
the ongoing dose escalation portion of the Phase I clinical trial
of IK-930, a novel, oral, potent, and highly selective Hippo
pathway inhibitor.
“This early look at the IK-930 dose escalation data strongly
supports our differentiated approach to targeting the Hippo
pathway. Importantly, following the target biology and initially
focusing on EHE has allowed us to observe clinical activity of
IK-930 early in our dose escalation. Even in the projected
efficacious exposure range and at doses with clinical activity,
IK-930 has thus far circumvented the renal toxicity observed with
pan-TEAD inhibitors,” commented Mark Manfredi, Ph.D., Chief
Executive Officer of Ikena. “Now, with IK-930’s safety profile
allowing us to potentially dose patients to their optimal benefit,
combined with sufficient capital to drive us through multiple data
readouts, we are looking ahead to a series of rapid next steps with
the program. We are increasing our focus on our targeted
monotherapy indications, such as EHE and mesothelioma, and have
growing confidence that as we continue the program IK-930 may be
able provide the therapeutic window and clinical benefit these
patient populations need.”
IK-930 Dose Escalation Summary and Emerging Proof of
Concept in EHE
IK-930 selectively binds TEAD1 and broadly represses oncogenic
TEAD signaling as a potent Hippo-pathway inhibitor, a known
suppressor pathway in cancers such as epithelioid
hemangioendothelioma (EHE), mesothelioma, meningioma, and others.
IK-930’s differentiated paralog selectivity and robust repressor
activity in complex with VGLL4 are key characteristics supporting
anti-tumor effect in preclinical models. IK-930 is designed to
circumvent renal toxicity, potentially resulting in an optimized
therapeutic index. Twenty-six patients with a range of solid tumors
were treated in the dose escalation portion of the study as of
October 31, 2023. The most common tumor type enrolled was EHE.
Differentiated Safety Profile
- 26 patients have been treated with
IK-930 in dose escalation as of October 31, 2023
- IK-930 is in the final stages of
dose optimization; the tolerability profile observed thus far
supports the hypothesis that IK-930’s selectivity could provide a
wider therapeutic index for this new class of compounds
- Proteinuria is an adverse effect of
special interest as it may be an on-target effect of broad TEAD
inhibition
- Treatment-related proteinuria was
recorded in 3 out of 26 dose escalation patients and was limited to
grade 1-2
- The observed proteinuria did not
result in dose reduction or treatment interruption; no proteinuria
events were considered dose-limiting and in all cases was fully
reversible
- Other safety observations include:
- Frequent adverse events to date have
been low-grade nausea, fatigue, and diarrhea, and have not required
any dose reduction
- Two EHE patients with significant
liver metastases experienced reversible liver enzyme elevation
- One of these patients developed
treatment-related grade 3 elevation, deemed dose limiting (the only
DLT observed), and the patient remains on study after dose
adjustment
- The other patient experienced grade
3-4 elevation that was deemed possibly treatment related;
- Dose escalation is currently
ongoing
- 15 patients were treated with doses
within the projected efficacious exposure range and pharmacokinetic
data showed some variability
- 7 out of 15 patients were determined
to reach efficacious exposure
- Target engagement in tumor, as
determined by decreased TEAD gene signature, has been demonstrated
in the efficacious dose range
- To minimize IK-930 exposure
variability, a next generation formulation is now being evaluated
in the dose escalation
- Recommended dosing for the next
stage of the IK-930 program is expected to be determined in the
near-term
Emerging Proof of Concept in EHEEpithelioid
hemangioendothelioma is a rare vascular sarcoma defined by gene
fusions of either YAP or TAZ genes in the Hippo pathway with other
transcriptional regulators. EHE is a slow-growing, invasive tumor
with no approved treatment options and is challenging to measure
due to diffuse infiltration of multiple organs. It can occur in
multiple areas of the body, including the liver, lungs, bones, and
blood vessels. People with EHE suffer symptoms that relentlessly
affect their quality of life and are consistent with the site of
the EHE growth, including liver failure, respiratory issues, and
gastrointestinal symptoms, which are frequently accompanied by
severe pain across the body. With no approved standard of care,
there is substantial need for innovative treatments that can
provide clinical benefit and symptom relief and slow or limit the
progression of disease.
- Seven patients with EHE have been
treated with IK-930 in the dose escalation portion of the trial
- 7 out of 7 EHE patients reached stable disease as a best
response so far as measured by RECIST
- 3 out of the 7 patients experienced tumor shrinkage in multiple
target and non-target lesions
- 4 out of 7 highly symptomatic EHE patients enrolled across
multiple dose levels reported symptomatic improvement and
subjective improvement of quality of life such as improved energy,
weight gain, and pain control
- 3 out of the 7 patients continue on treatment with time on
treatment ranging from 18 to 26 weeks and ongoing
- As a result of these initial
tolerability and antitumor activity findings, enrollment in the
dose escalation phase continues to progress in targeted populations
including mesothelioma and meningioma, in addition to EHE
- Based on preclinical data
indicating IK-930 synergy with EGFR inhibitors to combat
therapeutic resistance, a combination cohort for IK-930 and
osimertinib in patients with EGFR-mutant non-small cell lung cancer
(NSCLC) is planned to initiate in 2024
- An additional data update from the IK-930 clinical program is
planned for the second half of 2024
“EHE is a rare soft tissue sarcoma for which there is no known
treatment. This tumor is 100% driven by the Hippo pathway which has
motivated our initial development of IK-930 in EHE, despite the
challenge of assessing the disease burden and treatment effects.
The EHE patient community is one of the strongest I have worked
with. The physicians, patients, and supportive community are deeply
committed to finding innovative solutions in EHE, and we are
immensely grateful for their partnership in these early days of the
IK-930 clinical program,” commented Sergio Santillana, M.D., Chief
Medical Officer of Ikena.
“The EHE community is excited by this early data from IK-930,
the first targeted agent for patients with EHE, and we eagerly
await more data. Rare cancers, like EHE, present significant
challenges for drug developers, and we are encouraged by Ikena’s
commitment to this program. We are grateful for the participation
of EHE patients, caregivers, and physicians in the trial, and we
look forward to continuing our partnership with Ikena,” commented
Tammy Silverthorne, Executive Director of The EHE
Foundation.
Summary of Additional Recent Pipeline Progress and
Corporate Updates
IK-595: MEK-RAF Molecular Glue
- IK-595 clinical trial anticipated
to initiate by year end 2023
- Additional preclinical updates were
presented at the 5th Annual RAS-Targeted Drug Development
Conference in September and AACR-NCI-EORTC International Conference
on Molecular Targets and Cancer Therapeutics in October
IK-175: AHR Inhibitor in Collaboration with Bristol
Myers Squibb
- The Phase 1 clinical trial in urothelial carcinoma has
completed enrollment and the program is eligible for opt-in from
Bristol Myers Squibb through early 2024
Corporate Updates
- In August 2023, the Company
acquired Pionyr Immunotherapeutics, Inc. (“Pionyr”), a privately
held biotech company, in an all-stock transaction
- Ikena acquired all of Pionyr assets, including approximately
$43 million in net cash in exchange for shares of Ikena stock at
price of $7.15 per share
- The valuation for the transaction was determined solely by net
cash available at closing
- The Company believes that cash at
hand will be sufficient to meet its operating requirements into
2026 through multiple data events for both IK-930 and IK-595
Financial Results for the Quarter Ended September 30,
2023
As of September 30, 2023, Ikena had $196.9 million in cash, cash
equivalents and marketable securities. Net cash used in operating
activities was $19.9 million for the three months ended September
30, 2023, as compared to $17.2 million of cash used in operating
activities for the same period in 2022.
Collaboration revenue was $1.2 million and $6.4 million for the
three months ended September 30, 2023 and 2022, respectively. The
decrease in revenue of $5.2 million was primarily due to an
increase in manufacturing activities as a result of the substantial
completion of manufacturing efforts related to the IK-412 program
during the three months ended September 30, 2022.
Research and development expenses were $14.7 million and $18.9
million for the three months ended September 30, 2023 and 2022,
respectively. The decrease in research and development expenses of
$4.2 million was primarily due to decreases in clinical trial costs
related to IK-175 and decreases in other discovery stage programs
as a result of the Company prioritizing its focus on advancing its
clinical stage programs, partially offset by costs incurred to wind
down Pionyr clinical trials.
General and administrative expenses were $6.0 million and $5.4
million for the three months ended September 30, 2023 and 2022,
respectively. The increase in general and administrative expenses
of $0.6 million was primarily attributable to an increase in legal
expenses.
About Ikena OncologyIkena Oncology® is focused
on developing differentiated therapies for patients in need that
target nodes of cancer growth, spread, and therapeutic resistance
in the Hippo and RAS onco-signaling network. The Company’s lead
targeted oncology program, IK-930, is a TEAD1 selective Hippo
pathway inhibitor, a known tumor suppressor pathway that also
drives resistance to multiple targeted therapies. The Company’s
additional research spans other targets in the Hippo pathway as
well as the RAS signaling pathway, including developing IK-595, a
novel MEK-RAF inhibitor. Additionally, IK-175, an AHR antagonist,
is being developed in collaboration with Bristol Myers Squibb.
Ikena aims to utilize their depth of institutional knowledge and
breadth of tools to efficiently develop the right drug using the
right modality for the right patient. To learn more, visit
www.ikenaoncology.com or follow us on Twitter and LinkedIn.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995, as amended,
including, without limitation, implied and express statements
regarding: the timing and advancement of our targeted oncology
programs, including the timing of updates; our expectations
regarding the therapeutic benefit of our targeted oncology
programs; our ability to efficiently discover and develop product
candidates; our ability to obtain and maintain regulatory approval
of our product candidates; expectations with respect to projected
cash runway; the anticipated use of proceeds from the Pionyr
acquisition; the implementation of our business model; and
strategic plans for our business and product candidates. The words
“may,” “will,” “could,” “would,” “should,” “expect,” “plan,”
“anticipate,” “intend,” “believe,” “estimate,” “predict,”
“project,” “potential,” “continue,” “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 risks, uncertainties and important
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, those risks and uncertainties related to the timing and
advancement of our targeted oncology programs; our expectations
regarding the therapeutic benefit of our targeted oncology
programs; our ability to efficiently discover and develop product
candidates; the implementation of our business model, and strategic
plans for our business and product candidates, the sufficiency of
the Company’s capital resources to fund operating expenses and
capital expenditure requirements and the period in which such
resources are expected to be available, and other factors discussed
in the “Risk Factors” section of Ikena’s Quarterly Report on Form
10-Q for the quarter ended June 30, 2023, which is on file with the
SEC, as updated by any subsequent SEC filings. We caution you not
to place undue reliance on any forward-looking statements, which
speak only as of the date they are made. We disclaim any obligation
to publicly update or revise any such statements to reflect any
change in expectations or in events, conditions or circumstances on
which any such statements may be based, or that may affect the
likelihood that actual results will differ from those set forth in
the forward-looking statements. Any forward-looking statements
contained in this press release represent our views only as of the
date hereof and should not be relied upon as representing its views
as of any subsequent date. We explicitly disclaim any obligation to
update any forward-looking statements.
Investor Contact:Rebecca CohenIkena
Oncologyrcohen@ikenaoncology.com
Media Contact:Luke ShiploLifeSci
Communicationslshiplo@lifescicomms.com
Selected Balance Sheet Items: |
|
September 30,2023 |
|
December 31,2022 |
Cash and cash equivalents |
|
$ |
121,277 |
|
|
$ |
59,919 |
|
Marketable securities |
|
$ |
75,656 |
|
|
$ |
97,028 |
|
Total assets |
|
$ |
215,335 |
|
|
$ |
172,259 |
|
Total liabilities |
|
$ |
28,146 |
|
|
$ |
25,290 |
|
Convertible Preferred Stock |
|
$ |
31,845 |
|
|
$ |
- |
|
Additional paid-in-capital |
|
$ |
418,486 |
|
|
$ |
361,915 |
|
Accumulated deficit |
|
$ |
(262,896 |
) |
|
$ |
(214,219 |
) |
Total stockholders' equity |
|
$ |
155,344 |
|
|
$ |
146,969 |
|
Selected Financial Information |
(in thousands, except share and per share
data) |
|
Statement of Operations Items: |
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Research and development revenue under collaboration agreement |
|
$ |
1,185 |
|
|
$ |
6,402 |
|
|
$ |
8,501 |
|
|
$ |
10,168 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
14,654 |
|
|
|
18,850 |
|
|
|
45,378 |
|
|
|
48,682 |
|
General and administrative |
|
|
6,034 |
|
|
|
5,428 |
|
|
|
16,632 |
|
|
|
17,276 |
|
Total operating expenses |
|
|
20,688 |
|
|
|
24,278 |
|
|
|
62,010 |
|
|
|
65,958 |
|
Loss from operations |
|
|
(19,503 |
) |
|
|
(17,876 |
) |
|
|
(53,509 |
) |
|
|
(55,790 |
) |
Investment income |
|
|
2,162 |
|
|
|
550 |
|
|
|
4,840 |
|
|
|
1,135 |
|
Other expense |
|
|
(2 |
) |
|
|
(12 |
) |
|
|
(8 |
) |
|
|
(13 |
) |
Total other income, net |
|
|
2,160 |
|
|
|
538 |
|
|
|
4,832 |
|
|
|
1,122 |
|
Net loss |
|
$ |
(17,343 |
) |
|
$ |
(17,338 |
) |
|
$ |
(48,677 |
) |
|
$ |
(54,668 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
Unrealized gain (loss) on marketable securities |
|
|
166 |
|
|
|
(77 |
) |
|
|
(290 |
) |
|
|
(1,181 |
) |
Total comprehensive loss |
|
$ |
(17,177 |
) |
|
$ |
(17,415 |
) |
|
$ |
(48,967 |
) |
|
$ |
(55,849 |
) |
Net loss per share: |
|
|
|
|
|
|
|
|
Net loss per share attributable to common stockholders basic and
diluted |
|
$ |
(0.40 |
) |
|
$ |
(0.48 |
) |
|
$ |
(1.23 |
) |
|
$ |
(1.51 |
) |
Weighted-average common stocks outstanding, basic and diluted |
|
|
43,437,844 |
|
|
|
36,257,074 |
|
|
|
39,688,984 |
|
|
|
36,165,143 |
|
|
|
|
|
|
|
|
|
|
Ikena Oncology (NASDAQ:IKNA)
과거 데이터 주식 차트
부터 8월(8) 2024 으로 9월(9) 2024
Ikena Oncology (NASDAQ:IKNA)
과거 데이터 주식 차트
부터 9월(9) 2023 으로 9월(9) 2024