Strong finish to 2017 sets stage for series of value enhancing milestones in 2018
Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) ("Actinium" or "the Company")
announced today that it has issued a letter to investors providing a
company update and outlook for 2018. The letter to investors is
available on the Company’s investor relations page of its website https://ir.actiniumpharma.com/shareholder-letters. In addition, an 8-K has been filed with the SEC.
Sandesh
Seth, Actinium’s Chairman and CEO said, “In December 2017, we announced
several exciting developments that exemplify Actinium’s functionality,
enhanced capabilities, and most importantly, a focus on execution. We
finished 2017 with strong momentum in our Iomab-B and Actimab-A clinical
programs, added to our CD33 program and growing bone marrow transplant
franchise with the announcement of Actimab-MDS and reinvigorated our
research and development efforts with the launch of our AWE Program.
This momentum gives our team phenomenal energy for 2018 and we look
forward to continued strong execution on the numerous clinical
milestones that we expect can unlock significant value for investors.”
Year End 2017 Highlights:
- Announced
Actimab-MDS, a new clinical initiative focused on improving transplant
outcomes as measured by 1-year overall survival for patients with
high-risk myelodysplastic syndrome with a p53 genetic mutation. We
intend to begin a Phase 2 trial with Actimab-MDS that will be led by
principal investigator Dr. Gail Roboz of Weill-Cornell and the MDS
Clinical Research Consortium that is comprised of the Cleveland Clinic,
Dana-Farber Cancer Institute, Johns Hopkins, MD Andersen Cancer Center,
Moffitt Cancer Center.
- Presented Phase 2 data at ASH
from our Actimab-A clinical trial showing a 69% overall response rate in
patients with AML who are older and unfit for induction chemotherapy.
Actimab-A produced these results as a single agent that is administered
via two infusions on day 1 and day 8.
- Launched the AWE
Program that is focused on creating ARCs or antibody radio-conjugates
or biobetters utilizing actinium-225 in partnership or collaboration
with biopharmaceutical companies.
- Presented preliminary
preclinical data from our AWE Program at ASH where we showed an up to
ten-fold increase in the cell killing ability of daratumumab, a
blockbuster CD38 antibody therapy for patients with multiple myeloma
that is marketed by Johnson & Johnson.
- An abstract was published in the ASH volume of blood®
confirming the expression of CD33 in patients with multiple myeloma
from a large U.S. patient database, providing further validation for our
Actimab-M clinical trial in refractory multiple myeloma patients, which
is the first CD33 targeted therapy for this patient population.
- Announced that the independent data monitoring committee reviewed initial data from the first 20 patients in the pivotal Phase 3 SIERRA trial for Iomab-B and recommended that the trial continue as planned.
2018 Outlook:
Unlocking Significant Value in Myeloablation for Bone Marrow Transplant
With
the announcement of Actimab-MDS, Actinium is now the only company with a
multi-disease, multi-product pipeline focused on improving bone marrow
transplant access and outcomes via improved myeloablation. Bone marrow
transplant is a potentially curative treatment option for patients with
blood cancers and diseases such as leukemias, lymphomas and
myelodysplastic syndromes. A majority of bone marrow transplants are
performed in fifty leading hospitals in the U.S., which is where
Actinium will initially focus and build on its existing presence in
leading centers that account for over 35 percent of transplant volume.
Actinium is committed to building a franchise serving the bone marrow
transplant market and expects to achieve the following milestones in
2018 and beyond for Iomab-B as it strives to be the leader in the field:
Iomab-B:
- Complete enrollment of the pivotal Phase 3 SIERRA trial for Iomab-B by the end of 2018
- Have successful DMC safety analyses when 25%, 50% and 75% of patients have been enrolled and potential interim analyses when 70 and 110 patients have reached the primary endpoint
- Report topline data results in the second half of 2019
- Prepare for a BLA filing to obtain FDA approval
- Scale up for commercial operations
Actimab-MDS:
- Have a meeting with the FDA in the first half of 2018 to set a regulatory pathway
- Initiate Phase 2 clinical trial in the second half of 2018
Building an Industry Leading CD33 Program with Multiple Shots on Goal
The
Company is developing a potentially leading CD33 targeting program in
the industry with clinical programs in three indications. Actinium is
the only commercial sponsor to have a clinical trial in multiple myeloma
that is focused on targeting CD33. In addition, Actinium is the only
commercial sponsor to utilize an alpha particle payload in these
radiation sensitive cancers. Actinium believes the following programs
are best-in-class and/or first-in-class:
- Actimab-A for unfit elderly AML patients in Phase 2
- Actimab-M for refractory multiple myeloma in a proof of concept Phase 1 trial
- Actimab-MDS for BMT conditioning in high-risk MDS patients with a planned Phase 2
Actinium expects numerous milestones from these programs in 2018 including:
Actimab-A:
- Complete enrollment of the Phase 2 trial in the first half of 2018
- Report top line data in the second half of 2018
Actimab-M:
- Complete enrollment of the Phase 1 trial in second half of 2018
- Report top line data by the end of 2018
Actimab-MDS:
- Have a meeting with the FDA in the first half of 2018 to set a regulatory pathway
- Initiate Phase 2 clinical trial in the second half of 2 clinical trial
Leading Innovation Via the AWE Technology Platform
Actinium
announced its Actinium Warhead Enabling or AWE Technology Platform to
capitalize on the utilization of actinium-225 to enhance the cell
killing power of targeting agents such as antibodies, peptides, Fab
fragments and other modalities. Using the AWE program, Actinium intends
to create ARCs or antibody radio-conjugates and biobetters in
collaboration or partnership with biopharmaceutical companies. In
January, Actinium announced that Dr. Dale Ludwig was appointed Chief
Scientific Officer and would be tasked with managing the AWE Technology
Platform. In 2018, Actinium expects to achieve the following with its
AWE Program:
- Present additional data from its work with labeling daratumumab with actinium-225
- Label additional targeting agents with actinium-225
- Secure a collaboration based on the AWE Technology Platform
The
Company reiterates its intent to build upon the promise of both the
CD45 and CD33 programs over the next three to five years by gaining
approval and commercializing multiple product candidates based on these
programs to enhance access to bone marrow transplant with improved
outcomes via its improved myeloablation approach and to partner
strategically to enhance the value of its programs and technology
platforms.
About Actinium Pharmaceuticals, Inc.
Actinium
Pharmaceuticals Inc. is a clinical-stage biopharmaceutical company
focused on developing and commercializing targeted therapies for
potentially superior myeloablation and conditioning of the bone marrow
prior to a bone marrow transplant and for the targeting and killing of
cancer cells. Our targeted therapies have demonstrated the potential to
result in significantly improved access to bone marrow transplant with
better outcomes, namely increased marrow engraftment and survival. Our
targeted therapies are ARC’s or Antibody Radio-Conjugates that combine
the targeting ability of monoclonal antibodies with the cell killing
ability of radioisotopes. Three of our four ARC drug candidates are
based on our AWE or Actinium Warhead Enabling Technology Platform that
utilizes the isotope Actinium-225 (Ac-225) which emits alpha particles.
We are currently conducting clinical trials for our four product
candidates; Iomab-B, Actimab-A Actimab-M and Actimab-MDS, as well as
performing research on other potential drug candidates utilizing our
proprietary AWE Technology Platform. Our most advanced product
candidate, Iomab-B, an ARC developed by the Fred Hutchinson Cancer
Research Center, is comprised of an anti-CD45 monoclonal antibody
labeled with iodine-131. We are currently conducting a pivotal Phase 3
trial of Iomab-B for myeloablation and conditioning of the bone marrow
prior to a bone marrow transplant for patients with relapsed or
refractory acute myeloid leukemia (AML) age 55 and older. A bone marrow
transplant is a potentially curative treatment for patients with AML and
other blood cancers including leukemias, lymphomas and multiple myeloma
as well as certain blood disorders. Iomab-B has been tested in several
of these other cancers with over five hundred patients treated in
several Phase 1 and 2 trials with promising results. Upon successful
completion of our Phase 3 clinical trial for Iomab-B we intend to submit
this candidate for marketing approval in the U.S. and European Union
where it has been designated as an Orphan Drug. We are also developing a
potentially best in class CD33 program using an ARC comprised of the
anti-CD33 monoclonal antibody lintuzumab labeled with the alpha-particle
emitter Ac-225. Our most CD33 program candidate, Actimab-A, is
currently in a Phase 2 clinical trial for patients advanced over the age
of 60 who are newly diagnosed with AML and ineligible for standard
induction chemotherapy. Actimab-A also has Orphan Drug designation in
the US and EU. Actimab-M, our second CD33 targeting ARC, is being
studied in a Phase 1 trial for patients with refractory multiple
myeloma. Actinium is also planning a Phase 2 trial for Actimab-MDS, our
third CD33 program candidate, as a conditioning regimen prior to a bone
marrow transplant for patients with MDS that have a p53 genetic
mutation. Our AWE or Actinium Warhead Enabling Technology Platform,
originally developed in conjunction with Memorial Sloan Kettering Cancer
Center, is focused on leveraging Actinium’s know how and intellectual
property to create additional ARC drug candidates by labeling Ac-225 to
targeting moieties that we will either progress in clinical trials
ourselves or out-license.
More information is available at www.actiniumpharma.com
No comments:
Post a Comment