Biopharma Stocks (NYSE American: $ATNM) (NASDAQ: $BPTH) (NASDAQ: $STTK) (NASDAQ: $MBRX) Quest for Solutions for Acute Myeloid Leukemia (AML); @ActiniumPharma @BioPathHoldings @ShattuckLabs @moleculinbio
June
17, 2024 - Investorideas.com, a
go-to investing platform releases the first of a two-part series looking at developments
for the treatment of blood cancers. Today’s snapshot focuses in on acute
myeloid leukemia (AML) and the companies developing innovative solutions,
featuring Actinium Pharmaceuticals, Inc.
(NYSE AMERICAN:ATNM).
Actinium is a leader in the development of Antibody Radiation Conjugates (ARCs)
and other targeted radiotherapies.
“Acute
myeloid leukemia (AML) is a cancer of the bone marrow and the blood that
progresses rapidly without treatment. AML mostly affects cells that aren’t
fully developed, leaving these cells unable to carry out their normal functions.
It can be a difficult disease to treat; researchers are studying new approaches
to AML therapy in clinical trials,” says the Leukemia Lymphoma
Society.
There
is a huge market opportunity for companies that offer solutions for AML. The
Acute Myeloid Leukemia Market was valued at USD 2.1 billion in 2023 and is
estimated to grow at a CAGR of 10.7% between 2024, reports GMI
Insights .
With
breaking news on AML treatment, Actinium Pharmaceuticals, Inc. (NYSE AMERICAN:ATNM) just
announced 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.
Paid news
dissemination on behalf of Actinium
Read this article,
featuring ATNM in full at https://www.investorideas.com/news/2024/biotech/06171Biopharma-Stocks.asp
Actimab-A
+ Menin inhibitor combination results include:
-
Actimab-A as a single
agent showed potent AML cell killing activity in KMT2A harboring cells in both
MV-4-11 and MOLM-13 cell lines in vitro compared to the non-radio conjugated
CD33 antibody lintuzumab (p<0.0001)
-
Actimab-A enhanced AML
cell death when combined with both revumenib and ziftomenib at all dose levels
in difficult to treat KMT2A AML
-
The combination of
Actimab-A with leading menin inhibitors triggered an acute increase in AML
necrosis and cell death relative to single agent therapy within 72 hours of
dosing
-
Anti-tumor effect was
significantly potentiated and prolonged when combining Actimab-A with a leading
menin inhibitor compared to monotherapies in xenograft leukemia models in vivo
(p<0.0024 Actimab-A + menin) as shown in the exhibit below
The
Actimab-A + Menin Inhibitor combination presentation can be accessed on the
investor relations page of Actinium’s website here.
Actimab-A
targets CD33, a marker expressed ubiquitously in patients with AML, and is
conjugated with the alpha-partible payload Actinium-225. The broad expression
of CD33 and the differentiated mutation agnostic cell-killing mechanism of
targeted radiotherapy make Actimab-A broadly applicable for combinations with
chemotherapy, targeted agents including venetoclax, FLT3 and menin inhibitors,
immunotherapies and cellular therapies supporting its potential backbone
therapy profile across the AML patient treatment journey.
Sandesh
Seth, Actinium’s Chairman and CEO said, “Combining with menin inhibitors is an
exciting expansion of the already broad potential of Actimab-A in AML. Across
single agent and combination studies, Actimab-A has produced high rates of
response, MRD negativity and improved survival in high-risk, relapsed and
refractory patients including those with a TP53 mutation and venetoclax
failures. The broad expression of CD33 in AML coupled with the potency of
Actinium-225 make Actimab-A an ideal agent for treating radiation sensitive
AML. We are encouraged by this highly promising initial data and the
synergistic potential of Actimab-A with menin inhibitors, which has broad
potential across the AML treatment continuum including frontline, maintenance
and relapsed/refractory settings. We are eager to continue to study this
combination and generate additional data that could support advancing into
clinical studies of Actimab-A with menin inhibitors.”
Menin
inhibitors are a class of drug candidates being developed for patients with AML
that have a rearrangement of the KMT2A gene, previously known as the
mixed-lineage leukemia (MLL) or mutation of the NPM1 gene. There are multiple
menin inhibitors in development for these patients with revumenib (Syndax
Pharmaceuticals, Inc.) being most advanced having a PDUFA data of September
2024 and ziftomenib (Kura Oncology, Inc.) enrolling patients in a registration
Phase 2 trial. Multiple menin inhibitors are being studied in Phase 1 clinical
trials by companies including Johnson & Johnson, Sumitomo Pharma Co., Ltd.,
Hutchmed, Biomea Fusion, Inc. and BioNova Pharmaceuticals Pvt Ltd.
Bio-Path
Holdings, Inc. (NASDAQ:BPTH), a
biotechnology company leveraging its proprietary DNAbilize® liposomal delivery
and antisense technology to develop a portfolio of targeted nucleic acid cancer
drugs, announced it has presented
interim results from the Company’s Phase 2 study of prexigebersen (BP1001) in
combination with decitabine and venetoclax for the treatment of acute myeloid leukemia
(AML) in a poster presentation at 2024 European Hematology Association (EHA)
Congress, on June 14, 2024 in Madrid, Spain.
More from the News:
Jorge
Cortes, M.D., Director of the Georgia Cancer Center, presented data showing
prexigebersen continues to be well-tolerated and has now demonstrated
compelling efficacy results in two reporting cohorts including evaluable newly
diagnosed AML patients and evaluable refractory/relapsed AML patients, both of
which exceeded outcomes with frontline therapy.
“It
was a pleasure to present these compelling data to an audience of European
oncologists who treat AML patients and understand the continued great need for
new therapeutic options,” said Peter Nielsen, Chief Executive Officer of
Bio-Path. “Given that our study is being conducted in the U.S., this encore
presentation is an important step towards educating global oncology leaders on
the benefits of prexigebersen and its potential to be another tool in their
fight against AML.”
Also
looking for answers for AML patients, Shattuck Labs, Inc. (Nasdaq: STTK), a
clinical-stage biotechnology company pioneering the development of bifunctional
fusion proteins as a potential new class of biologic medicine for the treatment
of patients with cancer and autoimmune disease, recently announced updated
interim data from the Phase 1B dose expansion clinical trial of SL-172154 in
combination with AZA in frontline HR-MDS and TP53m AML patients. These data are
to be featured in a poster presentation on June 14, 2024 at 18:00 CEST, during
the European Hematology Association (EHA) 2024 Congress.
“We
are pleased to present additional data from our Phase 1B dose expansion
clinical trial, which further supports our differentiated mechanism of action
and underscores SL-172154’s emergence as the leading CD47 inhibitor in
hematologic malignancies,” said Taylor Schreiber, M.D., Ph.D., Chief Executive
Officer of Shattuck. “This update shows that the rate of complete remission has
improved since our last data release in December, with additional patients in both
cohorts who continue to improve on therapy. As a result of these encouraging
data, and our expectation of rapid enrollment and progress in our ongoing
randomized, controlled cohort in HR-MDS, we are focusing our efforts on our
opportunity in HR-MDS and TP53m AML. These are indications with high unmet
need, limited competition, and potential for accelerated paths to approval.”
More from the news: Dr.
Lini Pandite, MBChB, M.B.A., Chief Medical Officer of Shattuck added, “We are
encouraged by the maturing data that continues to underscore the therapeutic
potential, and manageable safety profile, of SL-172154 for patients with
previously untreated HR-MDS and TP53m AML. Accumulating clinical evidence now
shows the pharmacodynamic contribution of CD40 activation in the peripheral
blood, and an emerging correlation between clinical remission and CD40 mediated
induction of certain cytokines. The TP53m AML and HR-MDS patients we have
treated represent a high-risk group with short duration of complete remission
and overall survival when treated with azacitidine alone. Median overall
survival and duration of remission have not yet been achieved, and we look
forward to sharing additional durability data later this year. Enrollment is
now underway for our randomized, controlled expansion cohort in frontline
HR-MDS patients, and we expect to engage in regulatory discussions later this
year regarding the registrational strategy for SL-172154.”
Moleculin
Biotech, Inc., (Nasdaq:MBRX), a
clinical stage pharmaceutical company with a broad portfolio of drug candidates
targeting hard-to-treat tumors and viruses, last week reported
additional efficacy findings from the Company's ongoing Phase 1B/2 (MB-106)
clinical trial evaluating Annamycin in combination with Cytarabine (also known
as "Ara-C" and for which the combination of Annamycin and Ara-C is
referred to as AnnAraC) for the treatment of subjects with acute myeloid
leukemia (AML). The preliminary data was presented at the European Hematology
Association (EHA) 2024 Hybrid Congress. The Company also hosted a data
presentation to leading AML experts as part of a KOL meeting held in
conjunction with EHA 2024 Congress.
More from the news:
To
date, a total of 22 subjects have been enrolled (the Intent-to-Treat
population, ITT), 20 (Lines 1st-7th) of whom have completed efficacy
evaluations with 9 subjects (45%) achieving a composite complete remission (CRc
or CR/CRi), consisting of 8 (40%) subjects with complete remission (CR) and one
subject with complete remission with an incomplete recovery of peripheral blood
counts (CRi), following treatment with AnnAraC. Efficacy outcomes for 2
additional subjects (enrolled and treated) are pending.
Of
the 10 ITT subjects for whom AnnAraC was administered in the 2nd line setting,
5 achieved a CR (50%) and 6 achieved a CRc (60%). Of the 13 subjects in the ITT
evaluable population that were 1st or 2nd line treatment, 7 achieved a CR (54%)
and 8 achieved a CRc (62%). The mDOR for the 9 subjects who achieved a CRc is
approximately 6 months and climbing. Additionally, the median overall survival
in the 2nd line subjects (n=10) is approximately 6 months and increasing.
Continued:
Additionally, 89% of the subjects included in the CRc group (n=9) had
cytogenetics and/or mutations generally considered to contribute to a poor
prognosis. These include FLT3, IDH2, ASXL1, KMT2A and others. While not yet
statistically relevant, the Company believes such cytogenetic and mutation data
are informative to clinicians.
"We
continue to be highly encouraged by the positive growing body of preliminary
clinical data demonstrated by Annamycin in the treatment of patients with
AML," commented Walter Klemp, Chairman and Chief Executive Officer of
Moleculin. "While still preliminary, we believe the efficacy to date
including the climbing durability of response demonstrated by AnnAraC in 2nd line
patients continues to significantly exceed the performance reported by any drug
currently approved for use in 2nd line AML. We are incredibly pleased with the
progress of the trial and the data and continue to advance our preparations for
an End of Phase 2 meeting with FDA."
The
American Cancer Society’s estimates for
leukemia in the United States for 2024 are: “About 62,770 new
cases of leukemia (all kinds) and 23,670 deaths from leukemia (all kinds), .about
20,800 new cases of acute myeloid leukemia (AML);most will be in adults. About
11,220 deaths from AML; almost all will be in adults.”
In
addition to Actinium’s (NYSE AMERICAN:ATNM) ARC
Actimab-A, Iomab-B, their lead
asset is being studied in the pivotal Phase 3 SIERRA clinical trial as an
induction and conditioning agent in patients over the age of 55 with active
relapsed or refractory Acute Myeloid Leukemia (AML) prior to receiving a bone
marrow transplant (BMT), also known as a hematopoietic stem cell transplant or
HSCT.
Actinium’s
ambitions expand beyond AML, with the company saying, “We are
continuing to expand our drug development pipeline of targeted radiotherapies
for patients with blood cancers and solid tumors. Our intellectual property
portfolio includes more than 220 patents and patent applications worldwide.”
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