- Aligned with FDA on operationally
seamless Phase 2/3 trial for Actimab-A + CLAG-M in
relapsed/refractory acute myeloid leukemia
- Actimab-A selected for National Cancer
Institute's recently opened myeloMATCH precision medicines program
for patients with acute myeloid leukemia and myelodysplastic
syndromes
- Two Iomab-ACT INDs cleared by FDA:
Commercial CAR-T trial at University of
Texas Southwestern and sickle cell transplant trial at
Columbia University; proof-of-concept
safety and efficacy data expected in 2025
- Actinium seeking U.S. strategic partner
for Iomab-B to conduct dose optimization and head-to-head Phase 3
trial based on FDA guidance in adult patients with active relapsed
or refractory acute myeloid leukemia
- Accomplished biopharma industry executive
June Almenoff, M.D., Ph.D.,
appointed to Actinium's Board of Directors
- Cash and cash equivalents of
approximately $78.6 million as of
September 30, 2024, is expected to
fund operations into 2027
NEW
YORK, Nov. 18, 2024 /PRNewswire/ -- Actinium
Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the
Company), a leader in the development of Antibody Radiation
Conjugates (ARCs) and other targeted radiotherapies, today
highlighted recent regulatory and development updates for its
Iomab-B, Actimab-A and Iomab-ACT ARC clinical programs as well as
its financial results for the third quarter ended September 30, 2024. Iomab-B is a first in class
CD45 targeted conditioning agent to enable bone marrow transplant
(BMT) and has been studied in over four hundred patients including
the completed Phase 3 SIERRA trial for patients with relapsed or
refractory acute myeloid leukemia (r/r AML). Actimab-A is a
targeted radiotherapeutic that uses the Actinium-225 (Ac-225)
isotope payload directed against CD33 with broad potential for
development in AML and other myeloid indications including in
collaboration with the National Cancer Institute (NCI) under a
Cooperative Research and Development Agreement (CRADA). Iomab-ACT
is a next-generation CD45 targeted conditioning agent being
developed for cell and gene therapies for both malignant and
non-malignant hematologic indications. Actinium is executing
cutting-edge R&D focused on ARCs and other targeted
radiotherapies for blood cancer and solid tumor indications
leveraging its strong intellectual property portfolio of 230
patents and patent applications including several patents related
to the manufacture of the isotope Ac-225 in a cyclotron.
Sandesh Seth, Actinium's Chairman
and CEO, stated, "During the third quarter and over the last
several weeks, we have made significant progress with our three ARC
clinical programs. Actinium is now positioned to advance exciting
clinical trials for Actimab-A and Iomab-ACT in large indications
with high unmet needs that can deliver impactful clinical data in
2025. Actimab-A's backbone therapy potential is poised to be
realized with the operationally seamless Phase 2/3 trial following
alignment with the FDA, additional clinical trials being planned
under the NCI CRADA including the myeloMATCH program and via our
R&D efforts to further elucidate Actimab-A's mutation agnostic
mechanism of action. The clinical data anticipated from Iomab-ACT
in 2025 from the commercial CAR-T and sickle cell transplant trials
has the potential to establish Iomab-ACT as a best-in-class
targeted conditioning agent for both malignant and non-malignant
hematology indications. In addition, our recent meeting with the
FDA regarding Iomab-B established a clear development pathway,
which will be incredibly valuable in securing a U.S. strategic
partner. Finally, I am delighted to welcome Dr. June Almenoff to our Board of Directors, who
brings over 25 years of biopharma industry experience with a proven
track record of leading drug development through approvals and
executing value enhancing business development transactions."
Actimab-A Regulatory and Development Update
- Actinium met with the FDA in the third quarter and aligned with
the FDA on an operationally seamless randomized Phase 2/3 trial to
study Actimab-A + CLAG-M
- In the Phase 2 portion of the study, the Actimab-A dose will be
optimized in combination with CLAG-M
- The Phase 3 portion will study the optimized dose of Actimab-A
+ CLAG-M versus CLAG-M alone in patients with r/r AML
- Operationally seamless trial design is expected to reduce the
required time and resources compared to separate Phase 2 and Phase
3 trials
- Actinium continues to evaluate and develop additional Actimab-A
clinical trials under its CRADA with the NCI, investigator
initiated, or Actinium sponsored studies
- Actimab-A selected by NCI for recently opened myeloMATCH
precision medicine program for patients with AML and
myelodysplastic syndrome (MDS)
Iomab-ACT Program Update
- In the third quarter, the FDA cleared the investigational new
drug (IND) applications for both the commercial CAR-T study led by
the University of Texas Southwestern
(UTSW) and the sickle cell trial being led by Columbia University
- The UTSW commercial CAR-T trial expected to initiate patient
enrollment in 1Q 2025 with proof-of-concept clinical data expected
by year end
- Commercial CAR-T sales exceeded $3.5
billion in 2023 with multiple CAR-T therapies approved for
patients with lymphomas, leukemias and multiple myeloma
- Columbia University sickle cell
transplant trial to study Iomab-ACT for targeted conditioning prior
to BMT for the first time in a non-malignant hematology setting,
which is a rapidly growing indication for BMT; patient enrollment
expected to commence in the first half of 2025
Iomab-B Regulatory Status and Program Update
- Actinium is seeking a U.S. strategic partner to advance
clinical development of Iomab-B including the Phase 3 trial
- Actinium met with the FDA in the fourth quarter and aligned on
the patient population for the head-to-head Phase 3 trial to
evaluate allogeneic BMT using Iomab-B plus a reduced intensity
conditioning regimen of fludarabine and total body irradiation
(Flu/TBI) versus allogeneic BMT using reduced intensity
conditioning comprised of cyclophosphamide plus Flu/TBI
- Head-to-head Phase 3 trial to enroll adult patients aged 18 and
above with active AML with blasts counts greater than 5% and less
than 20%, representing a broader patient population than that in
the SIERRA trial
- Dose optimization trial to be completed prior to initiating the
head-to-head Phase 3 trial to determine the dose for Iomab-B based
on radiation to the bone marrow rather than the maximum tolerable
dose of 24 Gy of radiation to the liver as was done in the SIERRA
trial based on several interactions with the FDA before starting
the SIERRA trial
Mr. Seth added, "We are excited by our recent progress and
committed to delivering on several milestones in the near-term and
throughout 2025. Our current balance sheet provides strong runway
into 2027, which enables us to deliver important clinical data and
further realize our vision of being a leading fully integrated
specialty radiopharmaceutical company."
Third Quarter 2024 Financial Results
Cash and cash equivalents of approximately $78.6 million as of September 30, 2024. Based on Actinium's current
operating plan, cash and cash equivalents are expected to fund
operations into 2027.
Research and Development Expense, net of
reimbursements
Research and development expenses of $9.8
million for the three months ended September 30, 2024 decreased $1.8 million from $11.6
million for the three months ended September 30, 2023. The decrease is primarily a
result of a decline in Chemistry, manufacturing and controls, or
CMC, expenses of $5.5 million and
lower consulting expenses of $0.5
million, both due to lower activity in 2024 related to
Iomab-B. These declines were partially offset by increased
preclinical expenses of $3.9
million.
General and administrative expense
General and administrative expenses of $2.8 million for the three months ended
September 30, 2024 increased by
$0.1 million from $2.7 million for the three months ended
September 30, 2023, primarily due to
higher non-cash stock compensation expense of $0.5 million, partially offset by lower
compensation expense of $0.3 million
due to lower headcount.
In the third quarter of 2024, our overall headcount reduced by
approximately twenty percent, with a majority of these former
employees being from our clinical and CMC groups. As a result of
these departures, we expect our personnel expenses to be reduced by
approximately $3.7 million in 2025,
which may be offset by additional hires or consultants. We do not
expect these departures to have a material impact on our operations
or ability to execute our operating plan and we are actively
seeking a strategic partner for Iomab-B in the U.S. to advance the
clinical development activity for Iomab-B including the planned
Phase 3 trial.
Other income
Other income is comprised of net interest income in both
reporting periods. The amount for the three months ended
September 30, 2024 and 2023 of
$1.0 million in each reporting period
was virtually unchanged from the same time period in the prior
year.
Net loss
Net loss of $11.6 million for the
three months ended September 30, 2024
decreased by $1.7 million from
$13.3 million for the three months
ended September 30, 2023 due to lower
research and development expenses partially offset by higher
general and administrative expenses.
About Actinium Pharmaceuticals, Inc.
Actinium develops Antibody Radiation Conjugates (ARCs) and other
targeted radiotherapies intended to meaningfully improve outcomes
for people who have failed existing oncology therapies. The company
continues to advance its development for product candidate
Actimab-A, a therapeutic agent that has demonstrated potential
activity in r/r AML patients. In addition, Actinium is engaged with
the National Cancer Institute (NCI) under the Cooperative Research
and Development Agreement (CRADA) for development of Actimab-A in
AML and other myeloid malignancies. Iomab-ACT, Actinium's next
generation conditioning candidate, is being developed with the goal
of improving patient access and outcomes for potentially curative
cell and gene therapies. Iomab-B is an induction and conditioning
agent prior to bone marrow transplant in patients with relapsed and
refractory acute myeloid leukemia (r/r AML), which Actinium is
seeking a potential strategic partner for in the U.S. In addition,
the company's R&D efforts are primarily focused on advancing
several preclinical programs for solid tumor indications. Actinium
holds 230 patents and patent applications including several patents
related to the manufacture of the isotope Ac-225 in a
cyclotron.
For more information, please
visit: https://www.actiniumpharma.com/
Forward-Looking Statements
This press release may contain projections or other
"forward-looking statements" within the meaning of the
"safe-harbor" provisions of the private securities litigation
reform act of 1995 regarding future events or the future financial
performance of the Company which the Company undertakes no
obligation to update. These statements are based on management's
current expectations and are subject to risks and uncertainties
that may cause actual results to differ materially from the
anticipated or estimated future results, including the risks and
uncertainties associated with preliminary study results varying
from final results, estimates of potential markets for drugs under
development, clinical trials, actions by the FDA and other
governmental agencies, regulatory clearances, responses to
regulatory matters, the market demand for and acceptance of
Actinium's products and services, performance of clinical research
organizations and other risks detailed from time to time in
Actinium's filings with the Securities and Exchange Commission (the
"SEC"), including without limitation its most recent annual report
on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms
8-K, each as amended and supplemented from time to time.
Investors:
investorrelations@actiniumpharma.com
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SOURCE Actinium Pharmaceuticals, Inc.