Exhibit 99.2

 

 

 

Addendum

 

Key December Events and Their Relevance

&

Company Fact Sheet

 

 

 

 

 

 

 

 

 

 

Investor Contacts:

 

Steve O’Loughlin   Marek Ciszewski, J.D.
Principal Financial Officer.   Managing Director, Head of Life Sciences
Actinium Pharmaceuticals, Inc.   Liolios Investor Relations
soloughlin@actiniumpharma.com   ATNM@liolios.com

 

Actinium Pharmaceuticals, Inc.

275 Madison Avenue, Suite 702

New York, New York 10016

 

 

 

Key December Events and Their Relevance

 

Iomab-B - Pivotal SIERRA Trial Update.

 

The company met its milestone of a trial update which included; the DMC opinion to continue the trial, enrollment progress, supply chain capabilities including supply for crossovers, and protocol modifications designed to boost participation in 2018. Iomab-B, a CD-45 targeting ARC or Antibody Radio-Conjugate is being developed to enable expanded access to Bone Marrow Transplant or BMT with improved outcomes via improved myeloablation in elderly relapsed or refractory patients with AML or Acute Myeloid Leukemia.

 

Why is this important for Actinium?

 

Clinical operations are now fully functional with over fifty patients enrolled across all 3 clinical trials as of early December with the overwhelming majority enrolled after June 2017. Enrollment is expected to be bolstered as investigator requests for including more choices in the control arm is accommodated and as all of the 15 activated sites begin to accrue patients. Enrollment of Iomab-B is approaching 30 patients and is on track stage for the significant milestones expected in 2018.

 

The supply chain team has delivered product unfailingly on-demand to the 15 trial sites which represent over 30 percent of BMT volume. This is especially meaningful given that 80 percent of BMT patients are treated in the top 50 or so major teaching hospitals. The Company has effectively set up the exoskeleton of a commercial infrastructure at this time.

 

Actimab-A Phase 2 Trial Update

 

Actimab-A, a CD33 targeting ARC is being tested as an induction agent in elderly, unfit AML patients with an update provided as per company guidance at the ASH or American Society of Hematology Annual Meeting. Results included high, 69% single agent overall response rate and 98% median reduction in bone marrow blasts or immature cancer cells at the 2.0 uCi/kg high dose and the rationale for migration to the 1.5 uCi/kg dose due to myelosuppression.

 

Why is this important for Actinium?

 

The results further demonstrated the potent single agent activity of Actimab-A and its tolerability outside of myelosuppression. Importantly, the 1.5 uCi/kg dose showed a higher ORR than the 2.0 uCi/kg high dose (67% vs 50%) in the Phase 1 portion of the trial and the expectation is that this leg of the trial will result in the balance of safety and efficacy required to support a pivotal trial either as a single agent or in combination like most other drug candidates. Enrollment of Actimab-A which was lackluster in years prior is now robust despite 4 recent product approvals in AML and this trial is on track for topline results as per prior guidance.

 

Importantly, the team has leveraged the myelosuppressive capability of this CD33 construct into a potentially transformative clinical initiative in MDS or Myelodysplastic Syndromes via Actimab-MDS.

 

 

 

Actimab-MDS Unveiling of a New Clinical Initiative in MDS

 

Actimab-MDS is a new clinical initiative led by Dr. Gail Roboz of Cornell University and a high-profile consortium of world renowned medical centers that comprise the MDS Clinical Research Consortium. The plan is to initiate in a Phase 2 trial in 2018 that tests a high-dose of our CD33 targeting ARC or Antibody Radio-Conjugate as an improved myeloablation approach to enhance access to transplant and improve outcomes in underserved, high-risk p53+ patients with MDS or Myelodysplastic Syndromes.

 

Why is this important for Actinium?

 

Actimab-MDS provides the Company another product candidate in the bone marrow transplant area. The Phase 2 trial costs are significantly defrayed due to participation of the Consortium and on hand availability of major components of clinical drug supply. Actimab-MDS would be commercialized in the same transplant centers as Iomab-B and the concentration of this market will enable leverage of the supply chain and call point relationships.

 

Actimab-M and AWE Publications at ASH Rebuilding Scientific Capabilities

 

The Actimab-M related poster at ASH provided support for the scientific rationale for targeting CD33 in Multiple Myeloma. Actimab-M is a low dose CD33 targeting ARC that is being tested as an induction agent in fourth-line refractory multiple myeloma patients. Launch of the AWE Program or Actinium Warhead Enabling program by showcasing at ASH the 10x superior cell killing power of Darzalex, a blockbuster CD38 targeting antibody when labelled with Ac-225 compared to the unlabeled antibody.

 

Why is this important for Actinium?

 

Actimab-M has the potential for also providing enhanced access to bone marrow transplant and improved outcomes due to improved myeloablation. It provides another shot on goal for Actinium’s CD33 Program.

 

The ARC approach can provide superior outcomes versus ADCs or naked antibodies as demonstrated by the clinical promise of the CD33 program and the CD38 labelling experiments with Darzalex. The launch of the AWE Program is designed to build on these results both for internal purposes but also for collaborations. Our new Chief Scientific Officer, Dr. Dale Ludwig is expected to add material value to these efforts going forward.