Treatment of Blood
Cancers – Stocks to watch (NYSE AMERICAN: $ATNM) (NASDAQ: $KURA) (NASDAQ: $SYRS) (NASDAQ: $SLS)
@ActiniumPharma @kuraoncology @SyrosPharma @SellasLife
Biopharma
Companies Building out their Pipeline of Solutions
June
18, 2024 - Investorideas.com, a
go-to investing platform covering biotech and medical technology stocks releases
the second of a two-part series looking at developments for the treatment of
blood cancers, including AML, featuring Actinium Pharmaceuticals, Inc. (NYSE AMERICAN:ATNM).
Actinium is a leader in the development of Antibody Radiation Conjugates (ARCs)
and other targeted radiotherapies.
Approximately
every 3 minutes, one person in the US is diagnosed with leukemia, lymphoma or
myeloma. Approximately every 9 minutes, someone in the US dies from a blood
cancer. This statistic represents approximately 157 people each day or more
than six people every hour. This data from the
Leukemia and Lymphoma Society demonstrates the
growing and urgent demand for solutions.
Behind
the scenes and the data, biopharma stocks are developing their unique approaches
to treatment and building a pipeline of potential answers.
Actinium
Pharmaceuticals, Inc. (NYSE AMERICAN:ATNM) is
building out its pipeline and has
recently announced progress on several products.
Actinium
develops targeted radiotherapies to meaningfully improve survival for people
who have failed existing oncology therapies.
“Our
Iomab-B and Actimab-A advanced product candidates fill the major unmet medical
needs in relapsed or refractory AML in a complementary fashion directed at
different parts of the patient journey,” they say on their website.
Paid news
dissemination on behalf of Actinium
Read this article,
featuring ATNM in full at https://www.investorideas.com/news/2024/biotech/06181Treatment-of-Blood-Cancers.asp
Actinium
announced yesterday
that an
abstract detailing the first ever preclinical data from the combination of
menin inhibitors with Actinium’s ARC Actimab-A in acute myeloid leukemia (AML)
models was presented at the 2024 European Hematology Association (EHA) Congress
held June 13 – 16, 2024, in Madrid, Spain. Actinium studied Actimab-A in
combination with the leading menin inhibitors, revumenib (Syndax
Pharmaceuticals, Inc.) and ziftomenib (Kura Oncology, Inc.), which are being
developed for patients with KMT2A rearrangements and NMP1 mutations, which are
present in approximately 10% and 30% of AML patients, respectively.
On
June 14th, Actinium announced that
results from the Phase 3 SIERRA trial of Iomab-B were presented at the 2024
European Hematology Association (EHA) Hybrid Congress being held June 13 – 16,
2024, in Madrid, Spain. The two presentations at EHA highlighted outcomes in
patients with active relapsed or refractory acute myeloid leukemia (r/r AML)
enrolled in the SIERRA trial who had a TP53 mutation and long-term efficacy
results in this older patient population.
From the news: The
Phase 3 SIERRA trial enrolled 153 patients ages 55 and above with active r/r
AML and compared outcomes of patients receiving an Iomab-B led bone marrow
transplant (BMT) to those of patients receiving physician's choice of care in
the control arm. Across all patients in SIERRA study, only patients receiving
an Iomab-B led BMT achieved the trial's primary endpoint of durable complete
remission with these patients having 92% 1-year survival and 69% 2-year
survival with statistically significant higher event free survival. The SIERRA
trial enrolled high-risk patients including those with one or more of the
following: a TP53 mutation, advanced age up to 77 years old, complex
cytogenetics and prior therapy including venetoclax and other targeted agents.
Actinium
plans to advance Iomab-B for other blood cancers and next generation
conditioning candidate Iomab-ACT to improve cell and gene therapy outcomes.
On
June 11th, Actinium highlighted data from
the completed Phase 1b combination trial of Actimab-A + CLAG-M in patients with
relapsed or refractory acute myeloid leukemia (r/r AML) at the 2024 Society of
Nuclear Medicine & Molecular Imaging (SNMMI) Annual Meeting held June 8 –
11, 2024, in Toronto, Canada. Actimab-A is an ARC comprised of a CD33 targeting
monoclonal antibody conjugated with the alpha-particle emitter Actinium-225 isotope
payload. Actimab-A has been studied as a single agent and in combination with
chemotherapies and targeted therapies in Phase 1 and Phase 2 trials.
In
mid-May, Kura Oncology, Inc. (Nasdaq:KURA), a
clinical-stage biopharmaceutical company committed to realizing the promise of
precision medicines for the treatment of cancer, announced that it
has completed enrollment of 85 patients in the Phase 2 portion of KOMET-001, a
registration-directed clinical trial of the Company’s menin inhibitor,
ziftomenib (KO-539), in patients with relapsed or refractory (R/R) NPM1-mutant
acute myeloid leukemia (AML). The Company expects to report topline data from
the trial in early 2025.
From the news: “We are
thrilled to announce this critical milestone, which brings us one step closer
to delivering ziftomenib as a potentially best-in-class treatment for patients
with genetically defined acute leukemias,” said Troy Wilson, Ph.D., J.D.,
President and Chief Executive Officer of Kura Oncology. “Our confidence is
supported by our recently announced Breakthrough Therapy Designation from the
U.S. Food and Drug Administration (FDA), which recognizes ziftomenib’s
potential as an innovative medicine for patients with R/R NPM1-mutant AML and
is intended to expedite review as we prepare for submission of a New Drug
Application. We are grateful for the KOMET-001 investigators, patients and
their families, and we look forward to sharing topline data from this pivotal
study early next year.”
Continued: Kura
announced the first patients dosed in the Phase 2 portion of KOMET-001 in
February 2023. The registration-directed study is designed to assess evidence
of clinical activity, safety and tolerability of ziftomenib in patients with
R/R NPM1-mutant AML, with a primary endpoint of complete response. The study
has completed enrollment of the 85 patients necessary to support the primary
endpoint analysis.
“The
rapid enrollment of this study reflects the urgent need for more effective
treatment options in AML as well as the potential for ziftomenib to address
this need,” said Eunice Wang, M.D., Chief of the Leukemia Service at Roswell
Park Comprehensive Cancer Center and principal investigator of the trial.
“NPM1-mutant AML represents approximately 30% of new AML cases annually and is
a disease of significant unmet need for which there is no approved targeted
therapy. The favorable safety profile and encouraging clinical activity
demonstrated by ziftomenib to date offer the potential to transform the
standard of care for these AML patients.”
Syros
Pharmaceuticals (NASDAQ:SYRS) is
developing tamibarotene, an oral selective RARα agonist in frontline patients
with higher-risk myelodysplastic syndrome and acute myeloid leukemia with RARA
gene overexpression.
Syros
announced earlier
this year that the United States Food and Drug Administration (USFDA) has
granted Fast Track Designation to tamibarotene in combination with azacitidine
and venetoclax for the treatment of newly diagnosed acute myeloid leukemia
(AML) with RARA overexpression as detected by an FDA approved test in adults
who are over age 75 years or who have comorbidities that preclude the use of
intensive induction chemotherapy. Tamibarotene, an oral first-in-class
selective retinoic acid receptor alpha (RARα) agonist, is currently being
evaluated in combination with venetoclax and azacitidine for the treatment of
newly diagnosed AML patients with RARA gene overexpression.
"We
are pleased to receive Fast Track designation for tamibarotene for the
treatment of AML. This designation reflects the tremendous need for a safe and
effective therapy, which can improve the clinical outcomes and prognosis among
people diagnosed with AML, many of whom cannot tolerate intensive
treatment," said David A. Roth, M.D., Chief Medical Officer of Syros
Pharmaceuticals. "We are particularly encouraged to secure Fast Track
designation following initial randomized data from a prespecified interim analysis
of our ongoing SELECT-AML-1 clinical trial, in which treatment with our RARα
agonist, tamibarotene, in combination with venetoclax and azacitidine resulted
in a 100% CR/CRi rate compared with a 70% CR/CRi rate for the comparator of
venetoclax and azacitidine. Additionally, tamibarotene in combination with
venetoclax and azacitidine demonstrated no added toxicity relative to
venetoclax and azacitidine alone. We look forward to sharing additional data
from SELECT-AML-1 later this year, and to potentially accelerate the delivery
of tamibarotene as a new frontline option for the approximately 30% of AML
patients who are positive for RARA overexpression."
SELLAS
Life Sciences Group, Inc. (NASDAQ:SLS), a late-stage
clinical biopharmaceutical company focused on the development of novel
therapies for a broad range of cancer indications, announced on June
10th the
completion of enrollment as well as positive initial data from the ongoing
Phase 2a trial of SLS009, a highly selective CDK9 inhibitor, in
relapsed/refractory acute myeloid leukemia (r/r AML).
From the news: “We are
pleased to announce the completion of enrollment in the initial portion of our
Phase 2a trial representing a significant milestone in the development of
SLS009 in AML,” said Angelos Stergiou, MD, ScD h.c., President and Chief
Executive Officer of SELLAS. “There has been a high level of enthusiasm from
the clinical sites, trial investigators, and patients, reflecting the
significant unmet need in the AML patient population previously treated with
venetoclax-based regimens. We are extremely grateful to everyone who has helped
us achieve this important milestone ahead of schedule.”
Continued: Dr.
Stergiou continued: “In addition, we are excited to share very promising
initial data from this Phase 2a trial. Efficacy was demonstrated across all
cohorts far exceeding the targeted ORR of 20% and median overall survival (mOS)
of 3 months. The results also showed that SLS009 was well-tolerated across all
doses. These data give us increased confidence in SLS009 as a potential new
treatment for AML. We remain committed to advancing the treatment landscape for
this underserved patient population and we look forward to continuing the
trial, mainly the expansion cohorts, and reporting additional study updates and
data in Q3 of this year.”
AML is one of the most common types of leukemia and its incidence is rising
globally, including in the Asia-Pacific region, says DataBridgeInsights.
They
also reported,
“According to a survey by Bristol-Myers Squibb, approximately 1.85 million new
cases of blood cancer will be diagnosed worldwide in 2040, with 918,872 cases
of lymphoma, 656,345 cases of leukaemia, and 275,047 cases of myeloma.
Furthermore, the survey predicted that by 2040, there will be around 1,100,000
fatalities worldwide owing to blood cancer.”
Biopharmaceutical
stocks like Actinium Pharmaceuticals, Inc.
(NYSE AMERICAN:ATNM) are on
the hunt for solutions. Iomab-B was
developed at the Fred Hutchinson Cancer Research Center where it was studied in
several Phase 1 and Phase 2 trials in almost 300 patients in multiple blood
cancer indications, including acute myeloid leukemia (AML), myelodysplastic
syndrome (MDS), chronic myeloid leukemia (CML), acute lymphoblastic leukemia
(ALL), chronic lymphocytic leukemia (CLL), Hodgkin's disease (HD), Non-Hodgkin
lymphomas (NHL) and multiple myeloma (MM) and is currently being studied in
several ongoing physician trials. Iomab-B has been granted Orphan Drug
Designation for relapsed or refractory AML in patients 55 and above by the US
Food and Drug Administration (USFDA) and the European Medicines Agency.
Read
part one of the series on Investorideas.com
https://www.investorideas.com/news/2024/biotech/06171Biopharma-Stocks.asp
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