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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report
(Date of earliest event reported) November 11, 2024
Citius Oncology,
Inc.
(Exact name of
registrant as specified in its charter)
| Delaware |
|
001-41534 |
|
99-4362660 |
|
(State or other jurisdiction
of incorporation) |
|
(Commission File Number) |
|
(IRS Employer
Identification No.) |
| 11 Commerce Drive, 1st Floor, Cranford, NJ |
|
07016 |
| (Address of principal executive offices) |
|
(Zip Code) |
Registrant’s telephone number, including
area code: (908) 967-6677
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
| Common Stock |
|
CTOR |
|
Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act.
Item 8.01 Other Events.
On November 11, 2024, Citius Oncology, Inc. issued
a press release to announce preliminary results from an ongoing investigator-initiated Phase I clinical trial evaluating the safety and
efficacy of a combined regimen of pembrolizumab and LYMPHIR™ (denileukin diftitox-cxdl or E7777) in patients with recurrent solid
tumors. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
The following exhibits are
filed herewith:
SIGNATURE
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| |
|
CITIUS ONCOLOGY, INC. |
| |
|
|
| Date: |
November 12, 2024 |
/s/ Leonard Mazur |
| |
|
Leonard Mazur |
| |
|
Chairman and Chief Executive Officer |
2
Exhibit 99.1
Citius Pharmaceuticals, Inc. and Citius Oncology,
Inc. Announce Promising Preliminary Results of an Investigator-Initiated Phase I Clinical Trial of Pembrolizumab (KEYTRUDA®)
and LYMPHIR™ in Cancer Patients with Recurrent Solid Tumors
Study, in patients with solid tumors focusing
on gynecological malignant tumors such as ovarian, endometrial, and cervical, nearing completion with three remaining subjects to be enrolled
27% Objective Response Rate (ORR)
33% Clinical Benefit Rate (CBR) with a median
Progression Free Survival (PFS) of 57 weeks
Chemotherapy-free immunomodulatory regimen well-tolerated
with no documented serious immune-related adverse events
CRANFORD, N.J., November 11, 2024 -- Citius
Pharmaceuticals, Inc. (“Citius Pharma” or the “Company”) (Nasdaq: CTXR) and Citius Oncology, Inc. (“Citius Oncology”)
(Nasdaq: CTOR), today announced promising preliminary results from an ongoing investigator-initiated Phase I clinical trial evaluating
the safety and efficacy of a combined regimen of pembrolizumab and LYMPHIR™ (denileukin diftitox-cxdl or E7777) in patients with
recurrent solid tumors. The data was summarized in a poster presentation titled “T-regulatory Cell Depletion with E7777 (denileukin
diftitox-xcdl) Combined with Pembrolizumab in patients with recurrent solid tumors: Phase I trial” presented at the Society for
Immunotherapy of Cancer (SITC) 2024 Annual Meeting held November 8-10, 2024 (Abstract 614).
The trial is being conducted by Haider Mahdi,
M.D., Assistant Professor, Department of Obstetrics, Gynecology & Reproductive Sciences, at the University of Pittsburgh. The study
aims to identify an optimal dose for future trials and explore the impact of a treatment regimen combining pembrolizumab and LYMPHIR on
the tumor immune microenvironment.
“We have seen promising results in patients
with heavily pre-treated recurrent or metastatic gynecologic tumors and will enroll three additional patients before completing the Phase
I portion of this study,” said Mahdi. “We will further investigate in patients with gynecologic tumors and those with other
solid tumor histologies. We want to explore the impact of this therapy on Tregs, host immune-effector cells and the tumor microenvironment.”
“The preliminary results from this Phase
I trial of patients with recurrent gynecological cancers are highly encouraging. This novel chemo-free immunomodulatory combination regimen
has been well tolerated, including at the highest dosage. This efficacy data strongly suggests that LYMPHIR may have the ability to improve
and prolong the anti-tumor activity of immune checkpoint inhibitors. To date, this unique regimen has not been associated with significant
immune-related adverse events. Moreover, of the 15 evaluable patients, one third experienced a clinical benefit with a median of more
than 12 months of progression free survival,” stated Dr. Myron Czuczman, Chief Medical Officer of Citius Pharmaceuticals and Citius
Oncology.
“There is reason to be optimistic about the
potential of LYMPHIR to boost a patient’s response to pembrolizumab by temporarily depleting Tregs that modulate the tumor microenvironment,
without triggering an autoimmune response from the patient’s body. We believe the positive signals from this data support expanding
the research in a Phase II study to further evaluate the combination’s benefits across a broader range of solid tumor types,”
he added.
PD-1 inhibitors such as pembrolizumab are a type
of immune checkpoint inhibitor that works by blocking the PD-1 protein on T cells, enabling the immune system to recognize and attack
cancer cells. Pembrolizumab, developed by Merck and sold under the brand name KEYTRUDA®, is the leading PD-1 inhibitor
and world’s most prescribed drug, generating $25 billion in sales in 2023.
Preliminary Results
The
results of this chemotherapy-free regimen combining two immuno-modulator agents, pembrolizumab (anti-PD-1) and LYMPHIR (transient Treg
depletion) demonstrated:
| ● | An
overall response rate (ORR) of 27% (4/15) and a clinical benefit rate of 33% (5/15) among
evaluable patients; and, |
| ● | Median
progression-free survival (PFS) for patients achieving clinical benefit of 57 weeks, with
a range of 30 to 96 weeks. |
| ● | Notably,
two of the four patients who achieved partial remission had received prior checkpoint inhibitors
(i.e. anti-PD-1 therapy). This highlights the therapeutic potential of LYMPHIR plus immune
checkpoint inhibitors to be effective in patients who fail prior anti-PD-1/L1 therapy. |
The trial enrolled 21 patients with recurrent
or metastatic solid tumors. Among the evaluable participants, four patients achieved a partial response, and one patient demonstrated
durable stable disease lasting over six months. The combination regimen was generally well tolerated, with most adverse events related
to the patients’ underlying disease. Importantly, no significant immune-related adverse events were observed, and only one case of dose-limiting
toxicity (capillary leak syndrome) was reported at the highest dose level (12 mcg/kg).
Table 1: Efficacy Data
| |
Value |
| Patients Enrolled |
21 |
| Patients Evaluable for Response |
15 |
| Partial Responses (PR) |
4 (27%) |
| Stable Disease (≥ 6 months) |
1 |
| Clinical Benefit Rate (CBR) |
33% (PR + SD ≥ 6 months) |
| Median Progression-Free Survival (PFS) |
57 weeks (range: 30-96 weeks) |
Table 2: Safety Data
| |
Value |
| Dose-Limiting Toxicities (DLTs) |
1 (Capillary Leak Syndrome at 12 mcg/kg) |
| Immune-Related Adverse Events (irAEs) |
None documented (≥ Grade 3) |
| Adverse Events (Grade ≥ 3) |
Most related to underlying disease |
Trial Design
The Phase I trial is an open-label study designed
to evaluate the safety and preliminary efficacy of pembrolizumab, an anti PD-1 inhibitor, in combination with LYMPHIR in patients with
recurrent or metastatic solid tumors. The trial employs a dose-escalation approach, with LYMPHIR administered in four dose levels (3,
6, 9, and 12 mcg/kg) in combination with pembrolizumab (200 mg) on a 21-day cycle for eight cycles. Following the combination regimen,
patients receive pembrolizumab monotherapy as maintenance therapy. The study utilizes the Time-to-Event Continual Reassessment Method
(TITE-CRM) to assess dose-limiting toxicities (DLTs) and determine the recommended Phase II dose (RP2D).
Key inclusion criteria include measurable disease,
ECOG performance status of 0-1, and adequate organ function. Patients with recurrent or metastatic solid tumors who have received at least
one prior line of therapy were eligible for enrollment.
The trial enrolled
patients with a variety of recurrent or metastatic solid tumors, including ovarian, endometrial, and cervical cancers.
| ● | Ovarian
Cancer: Ovarian cancer is the eighth most common cancer in women worldwide, with an estimated
324,000 new cases diagnosed annually. In the United States, approximately 240,000 women are
currently living with ovarian cancer. |
| | | |
| | ● | Endometrial
Cancer: Worldwide, approximately 420,000 new cases are diagnosed each year. Endometrial
cancer is the most common gynecologic cancer in the United States, with approximately 66,000
new cases diagnosed each year. It is estimated that over 600,000 women in the U.S. are living
with endometrial cancer. |
| | | |
| | ● | Cervical
Cancer: Cervical cancer remains a major health concern globally, with around 660,000
new cases annually. It is the fourth most common cancer among women. In the United States,
approximately 11,500 women are diagnosed each year. |
About
LYMPHIR™ (denileukin diftitox-cxdl)
LYMPHIR
is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease
after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria
toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered
cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein
synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes
(Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.
In 2021, denileukin diftitox received regulatory
approval in Japan for the treatment of CTCL and PTCL. Subsequently, in 2021, Citius acquired an exclusive license with rights to develop
and commercialize LYMPHIR in all markets except for Japan and certain parts of Asia. LYMPHIR was approved by the FDA in August 2024.
INDICATION
LYMPHIR is an IL2-receptor-directed cytotoxin
indicated for the treatment of adult patients with r/r Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic
therapy.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: CAPILLARY LEAK SYNDROME
Capillary leak syndrome (CLS), including life-threatening
or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold
LYMPHIR until CLS resolves, or permanently discontinue based on severity.
WARNINGS AND PRECAUTIONS
Capillary Leak Syndrome
LYMPHIR can cause capillary leak syndrome (CLS),
including life-threatening or fatal reactions. CLS was defined in the clinical trials as the occurrence of at least 2 of the following
symptoms at any time during LYMPHIR therapy: hypotension, edema, and serum albumin <3 g/dL. These symptoms were not required to occur
simultaneously to be characterized as capillary leak syndrome.
As defined, CLS occurred in 27% of patients in
the pooled population across 3 clinical trials, including 8% with Grade 3. There was one (0.8%) fatal occurrence of CLS. Of the patients
with CLS, 22% had recurrence. The majority of CLS events (81%) occurred within the first 2 cycles of treatment. The median time to onset
from Cycle 1, Day 1 was 6.5 days (range: 1 to 77), the median duration of CLS was 14 days (range: 2 to 40), and 75% of patients had resolution.
The most common symptoms included edema, hypoalbuminemia, and hypotension. Pleural effusion, pericardial effusion, and dehydration also
occurred.
Regularly assess patients for weight gain, new
onset or worsening of edema, dyspnea, and hypotension (including orthostatic changes). Monitor serum albumin levels prior to the initiation
of each cycle of therapy and more often as clinically indicated.
Withhold, reduce dose, or permanently discontinue
based on severity. If LYMPHIR is withheld, resume LYMPHIR following resolution of CLS and when serum albumin is greater than or equal
to 3 g/dL.
Visual Impairment
LYMPHIR can cause serious visual impairment, including
changes in visual acuity and color vision. In the pooled population across 3 clinical trials, visual impairment occurred in 9%, with Grade
1 in 8% and Grade 2 in 1%. The most commonly reported symptom was blurred vision. Of the patients with visual impairment, 67% had resolution
of their visual impairment.
Perform baseline ophthalmic examination and monitor
as clinically indicated. If patients experience symptoms of visual impairment, such as changes in visual acuity, changes in color vision,
or blurred vision, refer for ophthalmologic evaluation.
Withhold LYMPHIR until visual impairment resolves
or permanently discontinue based on severity.
Infusion-Related Reactions
LYMPHIR can cause serious infusion-related reactions.
Infusion-related reactions were reported in 69% of patients in the pooled population across 3 clinical trials of patients who received
LYMPHIR, with Grade 3 infusion-related reactions in 3.4% [see Adverse Reactions (6.1)]. Eighty-three percent of infusion-related reactions
occurred in Cycles 1 and 2. The most common symptoms included nausea, fatigue, chills, musculoskeletal pain, vomiting, fever, and arthralgia.
Premedicate patients for the first three cycles
prior to starting a LYMPHIR infusion [see Dosage and Administration (2.3)]. Monitor patients frequently during infusion. For Grade 2 or
higher infusion reactions, premedicate at least 30 minutes prior to each subsequent infusion with a systemic steroid for at least 3 cycles.
Interrupt or discontinue LYMPHIR based on severity
[see Dosage and Administration (2.4)]. Institute appropriate medical management.
Hepatotoxicity
LYMPHIR can cause hepatotoxicity. In the pooled
safety population, elevated ALT occurred in 70% of patients, with Grade 3 ALT occurring in 22%; elevated AST occurred in 64% of patients,
with Grade 3 AST elevation occurring in 9%. For Grade 3 events, median time to onset was 8 days (range: 1 to 15 days); median time to
resolution was 15 days (range: 7 to 50 days); all cases of Grade 3 ALT or AST elevations resolved [see Adverse Reactions (6.1)]. Elevated
total bilirubin occurred in 5% of patients, with Grade 3 occurring in 0.9%.
Monitor liver enzymes and bilirubin at baseline
and during treatment as clinically indicated. Withhold, reduce dose, or permanently discontinue LYMPHIR based on severity.
Embryo-Fetal Toxicity
Based on its mechanism of action, LYMPHIR can
cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to the
initiation of LYMPHIR. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective
contraception during treatment and for 7 days following the last dose of LYMPHIR.
ADVERSE REACTIONS
The most common adverse reactions (≥20%), including
laboratory abnormalities, are increased transaminases, albumin decreased, nausea, edema, hemoglobin decreased, fatigue, musculoskeletal
pain, rash, chills, constipation, pyrexia, and capillary leak syndrome
USE IN SPECIFIC POPULATIONS
Pregnancy
Risk Summary
Based on its mechanism of action, LYMPHIR can
cause fetal harm when administered to a pregnant woman. There are no available data on the use of LYMPHIR in pregnant women to evaluate
for a drug-associated risk. No animal reproductive and developmental toxicity studies have been conducted with denileukin diftitox.
Denileukin diftitox-cxdl causes depletion of regulatory
T lymphocytes (Treg), immune activation, and capillary leak syndrome, compromising pregnancy maintenance. Advise pregnant women of the
potential risk to a fetus.
In the U.S. general population, the estimated
background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively.
Lactation
Risk Summary
No data are available regarding the presence of
denileukin diftitox-cxdl in human milk, the effects on the breastfed child, or on milk production. Because of the potential for serious
adverse reactions in breastfed children, advise women not to breastfeed during treatment with LYMPHIR and for 7 days after the last dose.
Females and Males of Reproductive Potential
Based on its mechanism of action, LYMPHIR can
cause fetal harm when administered to a pregnant woman.
Pregnancy Testing
Verify the pregnancy status of females of reproductive
potential prior to initiating LYMPHIR.
Contraception
Females
Advise females of reproductive potential to use
effective contraception during treatment with LYMPHIR and for 7 days after the last dose.
Infertility
Males
Based on findings in rats, male fertility may
be compromised by treatment with. The reversibility of the effect on fertility is unknown.
Pediatric Use
Safety and effectiveness of LYMPHIR in pediatric
patients have not been established.
Geriatric Use
Of the 69 patients with Stage I-III r/r CTCL who
received LYMPHIR, 34 patients (49%) were 65 years of age and older and 10 patients (14%) were 75 years of age and older. Clinical studies
of LYMPHIR did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from
younger adult patients.
You may report side effects to the FDA at 1-800-FDA-1088
or www.fda.gov/medwatch. You may also report side effects to Citius Pharmaceuticals at 1-844-459-6744.
Please read Important Safety Information and
full Prescribing Information, including Boxed WARNING, for LYMPHIR™.
Please see Prescribing Information for KEYTRUDA®
(pembrolizumab) and Medication Guide for KEYTRUDA.
KEYTRUDA® is a registered trademark of Merck Sharp &
Dohme Corp., a subsidiary of Merck & Co., Inc.
About Citius Oncology, Inc.
Citius Oncology, Inc. (Nasdaq: CTOR) is a platform
to develop and commercialize novel targeted oncology therapies. In August 2024, its primary asset, LYMPHIR, was approved by the FDA for
the treatment of adults with relapsed or refractory CTCL who had had at least one prior systemic therapy. Management estimates the initial
market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust intellectual property
protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination
therapy with checkpoint inhibitors would further support Citius Oncology’s competitive positioning. For more information, please
visit www.citiusonc.com.
About Citius Pharmaceuticals, Inc.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is
a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. In August 2024,
the FDA approved LYMPHIR, a targeted immunotherapy for an initial indication in the treatment of cutaneous T-cell lymphoma. Citius Pharma’s
late-stage pipeline also includes Mino-Lok®, an antibiotic lock solution to salvage catheters in patients with catheter-related
bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A Pivotal Phase 3 Trial for Mino-Lok
and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 Trial. Citius is
actively engaged with the FDA to outline next steps for both programs. Citius Pharmaceuticals owns 92% of Citius Oncology. For more information,
please visit www.citiuspharma.com.
Forward-Looking Statements
This press release may contain “forward-looking
statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.
Such statements are made based on our expectations and beliefs concerning future events impacting Citius. You can identify these statements
by the fact that they use words such as “will,” “anticipate,” “estimate,” “expect,” “plan,”
“should,” and “may” and other words and terms of similar meaning or use of future dates. Forward-looking statements
are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating
results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated,
and, unless noted otherwise, that apply to Citius Pharma and Citius Oncology, are: risks relating to the results of research and development
activities, including those from our existing and any new pipeline assets; risks related to research using our assets but conducted by
third parties; our need for substantial additional funds; Citius Pharma’s ability to meet Nasdaq’s continued listing standards;
our ability to commercialize LYMPHIR and any of our other product candidates that may be approved by the FDA; the estimated markets for
our product candidates and the acceptance thereof by any market; the ability of our product candidates to impact the quality of life of
our target patient populations; our dependence on third-party suppliers; our ability to procure cGMP commercial-scale supply; our ability
to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and
clinical testing; the early stage of products under development; market and other conditions; risks related to our growth strategy; patent
and intellectual property matters; our ability to identify, acquire, close and integrate product candidates and companies successfully
and on a timely basis; government regulation; competition; as well as other risks described in our SEC filings. These risks have been
and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees
of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business
are described in detail in our Securities and Exchange Commission (“SEC”) filings which are available on the SEC’s website
at www.sec.gov, including in Citius Pharma’s Annual Report on Form 10-K for the year ended September 30, 2023, filed with the SEC
on December 29, 2023, Citius Oncology’s Current Report on Form 8-K, filed with the Commission on August 16, 2024 (as amended by
Amendment No. 1 to Form 8-K, filed on August 26, 2024), both as updated by our subsequent filings with the Securities and Exchange Commission.
These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any
changes in events, conditions or circumstances on which any such statement is based, except as required by law.
Investor Relations for Citius Pharmaceuticals:
Investor Contact:
Ilanit Allen
ir@citiuspharma.com
908-967-6677 x113
Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com
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