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Actinium’s Multi-billion Dollar Market for Targeted Conditioning with their revolutionary Antibody Warhead Enabling (AWE) platform!

Actinium Pharmaceuticals’ Antibody Warhead Enabling (AWE) Future Opportunities

Actinium Pharmaceuticals is a clinical stage biopharmaceutical company, with an impressive Antibody Warhead Enabling (AWE) technology. The technology enables the development of breakthrough Antibody Radiation-Conjugates (ARCs), that combine the targeting ability of antibodies with the cell killing ability of radiation.

Key Triggers

  • SIERRA TRIAL (Acute Myeloid Leukemia) enabling Apamistamab Iomab-B for serving 128,000 BMT patients by 2028, once approved, Ad hoc analysis expected in Q4:2020
  • Possibilities of AWE Platform- Delivers radiation directly to target cells
    • Myeloablative Conditioning in case of Bone Marrow Transplantation
    • Reduced Intensity Conditioning to deliver targeted conditioning agent with stem cell gene therapy for patients with HIV-related lymphoma
    • Safer and targeted lymphodepletion to expand patient access to Adoptive Cell Therapy (CAR-Ts)
    • Expanded programs involving Actimab-A in combination with chemotherapy, targeted agents and immunotherapy and Next-generation Empowered Antibodies via AWE Platform
  • Key Partnerships for research and development for AWE platform

 Things to know

  • The leading product, Apamistamab Iomab-B (131-I-labeled anti-CD45 antibody) is THE ATTRACTIVE product in the clinical pipeline with the consistent predictive trends at halfway point in SIERRA Trial for the R/R AML patients (aged above 55 years) undergoing BMT
    • 100% engraftment in AML patients at day 28
    • Provided 6X difference in efficacy (durable complete remission) vs BEAM chemotherapy conditioning at 50% enrollment
      • Need to show a 2x difference in dCR primary endpoint at full enrollment [Final goal]
    • The overall survival rate of the 36 relapsed or refractory AML patients in the proof of concept study was 30% at one year and approximately 20% at two years
    • Reduce time, burden and toxicities associated with conditioning
  • No competition [Well, supporting their indirect competitors with their attractive and un-resistible platform]

Actinium Pharmaceuticals’ Actinium’s Antibody Warhead Enabling (AWE) platform

Actinium’s Antibody Warhead Enabling (AWE) platform can be used to produce AWE conjugates, a highly potent and selective form of targeted therapy. Application of the AWE technology precisely targets the proven therapeutic power of radiation to tumors. The power of this technology lies in its alpha emitting payload actinium-225.

Current ongoing programs based on Actinium’s Antibody Warhead Enabling (AWE) platform.

Ongoing Clinical programs

Indications

Status

Updates

 Key Dates & Strategy

Iomab-B

Acute myeloid leukemia (AML)

Phase 3 (SIERRA TRIAL)

Phase 3 top-line data due 4Q 2020.

Topline data from ad hoc analysis: 2H:2020

BLA Filing/ Commercial Launch: 2021/2022

The Company has effectively set up the exoskeleton of a commercial infrastructure

Actimab-A

Acute Myeloid Leukemia (AML)

Phase 2

Phase 2 data presented at TAT April 2, 2019.

GeneTx proof of concept data: 2020

Secure CAR-T development partner, generate proof of concept data: 2020-2021

Expectation is that 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

Actimab-A and Venetoclax

Relapsed or refractory acute myeloid leukemia (AML)

Phase 1/2

Phase 1/2 trial initiation announced February 5, 2019.

Proof of concept data from Actimab-A venetoclax combination trial: 2H:2020

Actimab-A in combination with CLAG-M

Relapsed or refractory acute myeloid leukemia (AML)

Phase 1

Phase 1 third cohort to be completed mid-2020.

Complete 3rd dosing cohort and present additional study data: 2H:2020

Explore pivotal trial design and pathway: 2H:2020

Actimab-A in combination with chemotherapy regimen 7+3

Acute Myeloid Leukemia (AML)

Phase 1

Phase 1 initiation announced February 26, 2020.

Initiate patient dosing/POC data: 2H:2020/2021

Actimab-MDS

Myelodysplastic syndrome (MDS)

Phase 1

Phase 1 trial planned, to be followed by pivotal trial.

Generate proof of concept data, Initiate pivotal program: 2020 – 2021

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

Refractory multiple myeloma

Phase 1

Phase 1 ongoing.

Actimab-M has the potential for also providing enhanced access to bone marrow transplant and improved outcomes due to improved myeloablation. 

Market driving therapies of Actinium under AWE platform

Actinium Pharmaceuticals’, AWE platform powers up their Antibody Radiation-Conjugate (ARC) pipeline, Iomab-B BMT i.e. CD45, one of the most top programs under this Platform for multiple targeting Leukemia, Lymphoma and immune cells.

  • CD45- Iomab-B BMT

Actinium’s lead CD45 targeted conditioning product candidate, Iomab-B uses high doses of I-131 to achieve myeloablative conditioning prior to a BMT. Iomab-B is currently being studied in the pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory acute myeloid leukemia (AML), or SIERRA, clinical trial for targeted conditioning.

In patients with r/r AML, despite new targeted therapies such as venetoclax (Venclexta; Genentech, AbbVie) and IDH inhibitors, patients with relapsed or refractory AML have very few treatment options outside of allogeneic HSCT. Specially, patients aged 55 years and older who cannot tolerate multiple cycles of intensive therapy to achieve complete remission prior to transplant, nor can they tolerate more intense myeloablative conditioning.

Dr Richard T. Maziarz, MD, Oregon Health & Science University said,

“This could be a viable option and a change of practice for a patient population suffering with refractory leukemia who has failed multiple chemotherapy regimens and other interventions, for whom we have nothing else to offer”

  • CD33-Alpha Program

ARC approach is driving therapeutic combinations and novel trials in indications with unmet needs. 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 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. Currently there are 3 different programmes for different indications:

Ongoing Clinical programs

Indications

Status

·       Actimab-MDS

Myelodysplastic syndrome (MDS)

Phase 1

·       Actimab-A in Combination:

·              CLAG-M

·              Venetoclax

·              chemotherapy regimen 7+3

Acute Myeloid Leukemia (AML)

Phase 2

·       Actimab-M

Refractory multiple myeloma

Phase 1

 

Key takeaways from Actinium’s impressive pipeline- Mellalta Meets findings

  • Actinium’s Iomab-B, Highly Differentiated Position in AML

Despite 8 AML drug approvals, none are curative and  significant patient population remains where Iomab-B has a clear and compelling value proposition as it is the only path to a potentially curative BMT in relapsed/refractory AML. Actinium’s Iomab-B target conditioning would represent a paradigm change in conditioning as it is both an induction and conditioning agent unlike currently used agents and enable patients to go directly to a BMT without being in remission. This is one of the most standout factor.

  • CD45 Targeted Conditioning Asset and Program

This is the only clinical stage Targeted Conditioning program with applications in BMT, GeneTx, CAR-T and other adoptive cell therapies.

  • Iomab-ACT: Targeted Conditioning for Anti-HIV Stem Cell GeneTx

UC Davis led study to combine Actinium’s dual acting anti-tumor and next-generation targeted conditioning agent with stem cell gene therapy for patients with HIV-related lymphoma.

The updates showed some great efficacy, when administered to patients with high-risk, relapsed or refractory lymphoma prior to autologous stem cell transplant, it was well tolerated with no dose limiting toxicities and minimal non-hematologic toxicities observed. Median Overall Survival not reached (range: 29 months to infinity) and 31% of patients in prolonged remission at a median of 36 months follow up (range: 25-41 months)

Antibody Warhead Enabling (AWE) platform- Market Opportunity

Actiniums Significant investment in R&D and AWE platform since 2018 and as a World leader in Ac-225 R&D with comprehensive IP portfolio is looking forward for next generation empowered antibodies through its AWE platform and different ARCs capabilities which is very ideal for multiple area of development.

In 2018, Actinium went into a collaborative research partnership with Astellas Pharma, Inc. that leverages Actinium’s AWE Technology Platform. Conjugation of Daratumumab with 225Actinium under the AWE platform has already showed some gigantic efficacy, greatly increasing its antitumor activity against Multiple Myeloma Tumors.

Market Attractiveness for Targeted Conditioning Platform

Actinium AWE Platform Market Opportunities

Actinium’s clinical program which are still ongoing have already shown some high efficacy and what we, Mellalta Meets could say, that the promising new platform of AWE based target conditioning therapies and their unique combination approach is going to be something to keep an eye for, as the company looks for BLA submission for its lead product by 2021-2022.

Submit your Request for Proposals at bd@mellalta.com

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