A Polish Adult Leukemia Group (PALG) prospective, multicenter clinical trial to compare the efficacy of two standard induction therapies (DA-90 vs DAC) and two standard salvage regimens (FLAG-IDA vs CLAG-M) in AML patients = 60 years of age - PALG-AML1/2016

Start Date27 Jun 2017

Sponsor / Collaborator-

NCT02923791 / CompletedPhase 1

A Phase I, Randomized Open-label, 2-period, Parallel Arm Study To Assess The Immunogenicity Of Multiple Subcutaneous (SC) Doses Of "Filgrastim Hospira" (US) Or US-approved Neupogen(Registered) Reference Product In Healthy Volunteers

This study compares the potential immunogenicity of two filgrastims, the proposed biosimilar Filgrastim Hospira (US) and the US-approved Neupogen reference product. Subjects will receive doses of one of the two filgrastims by injection of 5 micrograms/kilogram (mcg/kg). Subjects will receive 5 consecutive daily doses in Period 1 (Days 1-5) and a single dose on Day 1 of Period 2. Pre-dose and serial post-dose assessments of immunogenicity will be conducted each of the two study periods. In addition, safety assessments will be conducted throughout the study.

Start Date01 Oct 2016

Sponsor / Collaborator

Pfizer Inc.

NCT02543255 / CompletedPhase 2IIT

Anti-Androgens and Cabazitaxel in Defining Complete Response in Prostatectomy (ACDC-RP Trial): A Randomized, Open-label, Multi-centre Phase-2 Study Evaluating the Pathological Complete Response (pCR) Rate Following Neoadjuvant Therapy in Participants With High-risk Prostate Carcinoma for Whom Radical Prostatectomy is Indicated

This study evaluates the use of chemotherapy with cabazitaxel in addition to abiraterone acetate, prednisone, and leuprolide in neoadjuvant setting prior to radical prostatectomy in patients with high-risk prostate carcinoma. Half of the participants will receive treatment with abiraterone acetate, prednisone, leuprolide, and cabazitaxel, while the other half will receive only abiraterone acetate, prednisone, and leuprolide.

Start Date01 Sep 2016

Sponsor / Collaborator

University Health Network

100 Clinical Results associated with Filgrastim-AAFI(Hospira, Inc.)

100 Translational Medicine associated with Filgrastim-AAFI(Hospira, Inc.)

100 Patents (Medical) associated with Filgrastim-AAFI(Hospira, Inc.)

Literatures (Medical) associated with Filgrastim-AAFI(Hospira, Inc.)

02 Jul 2024·EXPERT OPINION ON BIOLOGICAL THERAPY

Industry perspective on regulatory authority (RA) quality reviews of biosimilar applications – an evaluation of RA guidance and expectations for chemical, manufacturing, and controls information through in-depth query analysis

Article

Author: Tennyson, Scott D ; Hufnagel, Heather Rae

PURPOSE:

Evaluate the type and quantity of quality information (i.e. Chemistry, Manufacturing, and Control) requested by the US FDA and EMA in queries pertaining to biosimilar applications.

METHODS:

Numbers/types of queries received following regulatory submissions (FDA/EMA, n = 7/n = 5) for seven biosimilars (PF-filgrastim [Nivestym], PF-rituximab [Ruxience®], PF-trastuzumab [Trazimera®], PF-bevacizumab [Zirabev®], PF-pegfilgrastim [Nyvepria®], PF-adalimumab [Abrilada™/Amsparity®], PF-infliximab [Ixifi]) from a single product portfolio were analyzed considering published regulatory authority (RA) guidance and in relation to sections/subsections of Module 3: Quality from the Common Technical Document regulatory dossier and topics based on keyword assignment.

RESULTS:

Queries were most frequently assigned (FDA/EMA %, range) to Drug Substance Manufacture (subsection 3.2.S.2; 21-35%/13-50%), Control of Drug Substance (3.2.S.4; 3-11%/5-17%), Drug Product Pharmaceutical Development (3.2.P.2; 1-12%/1-15%) and Manufacture (3.2.P.3; 17-41%/2-13%), and Analytical Similarity (3.2.R; 4-21%/4-20%). The proportion of Drug Substance and Drug Product queries was significantly different between RAs (n1 = 952, n2 = 468, p-value <0.001; two-sample proportion z-test). Topic assignments included: Control (12-27%/12-28%), Manufacturing (56-72%/34-66%), Stability (1-12%/2-24%), Biosimilarity (5-16%/5-25%), and Container Closure (0-3%/0-9%).

CONCLUSION:

The focus of both RAs on topics related to manufacturing and controls is valuable in understanding expectations for scientific and technical content related to gaining biosimilar approval.

01 Feb 2024·Journal of clinical apheresis

Validation of Nivestym compared to Neupogen: An NMDP analysis

Article

Author: Maakaron, Joseph ; Devine, Steven M ; Cody, Meghann ; Tram, Kevin ; Bakken, Ruth ; Miller, John ; Picotte, Katie ; Stefanski, Heather E ; Oakes, Jason

31 Dec 2023·Journal of medical economics

Cost-efficiency analysis of conversion to biosimilar filgrastim for supportive cancer care and resultant expanded access analysis to supportive care and early-stage HER2+ breast cancer treatment in Saudi Arabia: simulation study

Article

Author: Yousef, Consuela Cheriece ; Al-Foheidi, Meteb ; AlAbdalkarim, Hana ; Alshamrani, Majed ; AlJedai, Ahmed ; Naeem, Anjum ; Khan, Mansoor Ahmed ; Almodaimegh, Hind ; Abraham, Ivo

AIMS:

This study estimated, for Saudi Arabia, the cost-efficiency of converting patients from reference Neupogen and Neulastim to one of two filgrastim biosimilars (Nivestim, Zarzio); the budget-neutral expanded access to supportive care with biosimilar filgrastim and therapeutic care to ado-trastuzumab emtansine thus afforded; and the number-needed-to-convert (NNC) to provide supportive or therapeutic treatment to one patient.

MATERIALS AND METHODS:

Replicating prior studies, we modeled the cost-efficiencies gained from converting varying proportions of a hypothetical panel of 4,000 patients undergoing six cycles of cancer treatment from Neupogen or Neulastim to one of the two biosimilar G-CSF formulations, using national cost inputs. Cost-savings in USD were used to estimate the additional doses of biosimilar G-CSF and expanded access to ado-trastuzumab emtansine on a budget-neutral basis, and NNC to purchase one additional dose of supportive or therapeutic treatment.

RESULTS:

Savings from conversion from reference to a biosimilar filgrastim were $3,086,400 (Nivestim) and $3,460,800 (Zarzio). With reference pegfilgrastim, savings from conversion were $11,712,240 (Nivestim) and $12,086,640 (Zarzio). Biosimilar conversion from reference to biosimilar filgrastim enabled expanded access to ado-trastuzumab emtansine ranging from 61 patients (5 days, Nivestim) to 191 patients (14 days, Zarzio). For supportive care, biosimilar conversion enabled expanded access ranging from 8,244 patients (5 days, Nivestim) to 25,882 patients (14 days, Zarzio). For biosimilar conversion from daily filgrastim, the NNC for treatment with ado-trastuzumab emtansine decreased as days of injections increased [5 days: 395 (Nivestim), 352 (Zarzio); 14 days: 141(Nivestim), 126 (Zarzio)]. Alternately, for biosimilar conversion from single-injection pegfilgrastim to daily biosimilar filgrastim, the NNC for treatment with ado-trastuzumab emtansine rose as days of injections increased, being highest under the 14-day scenario (146, Nivestim; 130, Zarzio).

CONCLUSION:

This simulation study demonstrated significant potential cost-savings from biosimilar conversion. These savings provide budget-neutral increased access to supportive and therapeutic cancer care.

News (Medical) associated with Filgrastim-AAFI(Hospira, Inc.)

18 Nov 2024

·www.prnewswire.com

Actinium Pharmaceuticals Highlights Antibody Radiation Conjugate Program Developments and Reports Financial Results for the Third Quarter 2024

- Aligned with FDA on operationally seamless Phase 2/3 trial for Actimab-A + CLAG-M in relapsed/refractory acute myeloid leukemia - Actimab-A selected for National Cancer Institute's recently opened myeloMATCH precision medicines program for patients with acute myeloid leukemia and myelodysplastic syndromes - Two Iomab-ACT INDs cleared by FDA: Commercial CAR-T trial at University of Texas Southwestern and sickle cell transplant trial at Columbia University; proof-of-concept safety and efficacy data expected in 2025 - Actinium seeking U.S. strategic partner for Iomab-B to conduct dose optimization and head-to-head Phase 3 trial based on FDA guidance in adult patients with active relapsed or refractory acute myeloid leukemia - Accomplished biopharma industry executive June Almenoff, M.D., Ph.D., appointed to Actinium's Board of Directors - Cash and cash equivalents of approximately $78.6 million as of September 30, 2024, is expected to fund operations into 2027 NEW YORK, Nov. 18, 2024 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies, today highlighted recent regulatory and development updates for its Iomab-B, Actimab-A and Iomab-ACT ARC clinical programs as well as its financial results for the third quarter ended September 30, 2024. Iomab-B is a first in class CD45 targeted conditioning agent to enable bone marrow transplant (BMT) and has been studied in over four hundred patients including the completed Phase 3 SIERRA trial for patients with relapsed or refractory acute myeloid leukemia (r/r AML). Actimab-A is a targeted radiotherapeutic that uses the Actinium-225 (Ac-225) isotope payload directed against CD33 with broad potential for development in AML and other myeloid indications including in collaboration with the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA). Iomab-ACT is a next-generation CD45 targeted conditioning agent being developed for cell and gene therapies for both malignant and non-malignant hematologic indications. Actinium is executing cutting-edge R&D focused on ARCs and other targeted radiotherapies for blood cancer and solid tumor indications leveraging its strong intellectual property portfolio of 230 patents and patent applications including several patents related to the manufacture of the isotope Ac-225 in a cyclotron. Sandesh Seth, Actinium's Chairman and CEO, stated, "During the third quarter and over the last several weeks, we have made significant progress with our three ARC clinical programs. Actinium is now positioned to advance exciting clinical trials for Actimab-A and Iomab-ACT in large indications with high unmet needs that can deliver impactful clinical data in 2025. Actimab-A's backbone therapy potential is poised to be realized with the operationally seamless Phase 2/3 trial following alignment with the FDA, additional clinical trials being planned under the NCI CRADA including the myeloMATCH program and via our R&D efforts to further elucidate Actimab-A's mutation agnostic mechanism of action. The clinical data anticipated from Iomab-ACT in 2025 from the commercial CAR-T and sickle cell transplant trials has the potential to establish Iomab-ACT as a best-in-class targeted conditioning agent for both malignant and non-malignant hematology indications. In addition, our recent meeting with the FDA regarding Iomab-B established a clear development pathway, which will be incredibly valuable in securing a U.S. strategic partner. Finally, I am delighted to welcome Dr. June Almenoff to our Board of Directors, who brings over 25 years of biopharma industry experience with a proven track record of leading drug development through approvals and executing value enhancing business development transactions." Actimab-A Regulatory and Development Update Actinium met with the FDA in the third quarter and aligned with the FDA on an operationally seamless randomized Phase 2/3 trial to study Actimab-A + CLAG-M In the Phase 2 portion of the study, the Actimab-A dose will be optimized in combination with CLAG-M The Phase 3 portion will study the optimized dose of Actimab-A + CLAG-M versus CLAG-M alone in patients with r/r AML Operationally seamless trial design is expected to reduce the required time and resources compared to separate Phase 2 and Phase 3 trials Actinium continues to evaluate and develop additional Actimab-A clinical trials under its CRADA with the NCI, investigator initiated, or Actinium sponsored studies Actimab-A selected by NCI for recently opened myeloMATCH precision medicine program for patients with AML and myelodysplastic syndrome (MDS) Iomab-ACT Program Update In the third quarter, the FDA cleared the investigational new drug (IND) applications for both the commercial CAR-T study led by the University of Texas Southwestern (UTSW) and the sickle cell trial being led by Columbia University The UTSW commercial CAR-T trial expected to initiate patient enrollment in 1Q 2025 with proof-of-concept clinical data expected by year end Commercial CAR-T sales exceeded $3.5 billion in 2023 with multiple CAR-T therapies approved for patients with lymphomas, leukemias and multiple myeloma Columbia University sickle cell transplant trial to study Iomab-ACT for targeted conditioning prior to BMT for the first time in a non-malignant hematology setting, which is a rapidly growing indication for BMT; patient enrollment expected to commence in the first half of 2025 Iomab-B Regulatory Status and Program Update Actinium is seeking a U.S. strategic partner to advance clinical development of Iomab-B including the Phase 3 trial Actinium met with the FDA in the fourth quarter and aligned on the patient population for the head-to-head Phase 3 trial to evaluate allogeneic BMT using Iomab-B plus a reduced intensity conditioning regimen of fludarabine and total body irradiation (Flu/TBI) versus allogeneic BMT using reduced intensity conditioning comprised of cyclophosphamide plus Flu/TBI Head-to-head Phase 3 trial to enroll adult patients aged 18 and above with active AML with blasts counts greater than 5% and less than 20%, representing a broader patient population than that in the SIERRA trial Dose optimization trial to be completed prior to initiating the head-to-head Phase 3 trial to determine the dose for Iomab-B based on radiation to the bone marrow rather than the maximum tolerable dose of 24 Gy of radiation to the liver as was done in the SIERRA trial based on several interactions with the FDA before starting the SIERRA trial Mr. Seth added, "We are excited by our recent progress and committed to delivering on several milestones in the near-term and throughout 2025. Our current balance sheet provides strong runway into 2027, which enables us to deliver important clinical data and further realize our vision of being a leading fully integrated specialty radiopharmaceutical company." Third Quarter 2024 Financial Results Cash and cash equivalents of approximately $78.6 million as of September 30, 2024. Based on Actinium's current operating plan, cash and cash equivalents are expected to fund operations into 2027. Research and Development Expense, net of reimbursements Research and development expenses of $9.8 million for the three months ended September 30, 2024 decreased $1.8 million from $11.6 million for the three months ended September 30, 2023. The decrease is primarily a result of a decline in Chemistry, manufacturing and controls, or CMC, expenses of $5.5 million and lower consulting expenses of $0.5 million, both due to lower activity in 2024 related to Iomab-B. These declines were partially offset by increased preclinical expenses of $3.9 million. General and administrative expense General and administrative expenses of $2.8 million for the three months ended September 30, 2024 increased by $0.1 million from $2.7 million for the three months ended September 30, 2023, primarily due to higher non-cash stock compensation expense of $0.5 million, partially offset by lower compensation expense of $0.3 million due to lower headcount. In the third quarter of 2024, our overall headcount reduced by approximately twenty percent, with a majority of these former employees being from our clinical and CMC groups. As a result of these departures, we expect our personnel expenses to be reduced by approximately $3.7 million in 2025, which may be offset by additional hires or consultants. We do not expect these departures to have a material impact on our operations or ability to execute our operating plan and we are actively seeking a strategic partner for Iomab-B in the U.S. to advance the clinical development activity for Iomab-B including the planned Phase 3 trial. Other income Other income is comprised of net interest income in both reporting periods. The amount for the three months ended September 30, 2024 and 2023 of $1.0 million in each reporting period was virtually unchanged from the same time period in the prior year. Net loss Net loss of $11.6 million for the three months ended September 30, 2024 decreased by $1.7 million from $13.3 million for the three months ended September 30, 2023 due to lower research and development expenses partially offset by higher general and administrative expenses. About Actinium Pharmaceuticals, Inc. Actinium develops Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies intended to meaningfully improve outcomes for people who have failed existing oncology therapies. The company continues to advance its development for product candidate Actimab-A, a therapeutic agent that has demonstrated potential activity in r/r AML patients. In addition, Actinium is engaged with the National Cancer Institute (NCI) under the Cooperative Research and Development Agreement (CRADA) for development of Actimab-A in AML and other myeloid malignancies. Iomab-ACT, Actinium's next generation conditioning candidate, is being developed with the goal of improving patient access and outcomes for potentially curative cell and gene therapies. Iomab-B is an induction and conditioning agent prior to bone marrow transplant in patients with relapsed and refractory acute myeloid leukemia (r/r AML), which Actinium is seeking a potential strategic partner for in the U.S. In addition, the company's R&D efforts are primarily focused on advancing several preclinical programs for solid tumor indications. Actinium holds 230 patents and patent applications including several patents related to the manufacture of the isotope Ac-225 in a cyclotron. For more information, please visit: Forward-Looking Statements This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time. Investors: [email protected] SOURCE Actinium Pharmaceuticals, Inc. 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Phase 3Financial StatementPhase 2Radiation Therapy

12 Dec 2022

·www.prnewswire.com

Actinium Highlights Survival Data in Relapsed/Refractory AML Patients with Prior Venetoclax Treatment and/or with a TP53 Mutation from the Actimab-A CLAG-M Combination Trial Oral Presentation at ASH

- 59% 1-year overall survival and 32% 2-year overall survival in patients with prior Venetoclax treatment - 52% 1-year overall survival and 19% 2-year overall survival in patients with a TP53 mutation - 75% measurable residual disease negativity achieved in heavily pretreated, high-risk relapsed or refractory patients - Actimab-A + CLAG-M was well tolerated with a manageable safety profile NEW YORK, Dec. 12, 2022 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company) a leader in the development of targeted radiotherapies, today highlighted high rates of Complete Remission (CR/CRi) and rates of measurable residual disease (MRD) negativity with improved overall survival in its Actimab-A CLAG-M combination trial in high-risk patients with relapsed or refractory (r/r) acute myeloid leukemia (AML). These data were detailed in an oral presentation at the 64th Annual ASH Meeting & Symposium being held December 10-13, 2022 in New Orleans, Louisiana. The trial enrolled patients with intermediate and adverse cytogenetics including over 50% with a TP53 mutation and significant prior treatment with a median of 2 lines of therapy and over 57% having prior Venetoclax based therapy. The addition of Actimab-A to CLAG-M was well tolerated with expected toxicities. Dr. Sameem Abedin, Assistant Professor at Froedtert & Medical College Wisconsin and Principal Investigator of the Study, commented, "The high rates of MRD negativity and strong survival outcomes, especially in the TP53 mutant and Venetoclax treated patients, is highly encouraging and represents a significant improvement compared to available therapies for these patients. The patients enrolled on this trial have very difficult to treat AML and a dismal prognosis with an expected survival of 2 to 3 months or less. They also have very limited treatment options. High rates of 1-year survival are rare in these patients and 2-year survival is rarely achieved. With Venetoclax treatment becoming standard of care, it is critical that we find a therapy for the high percentage of patients who do not respond or relapse and therapies with better outcomes for all relapsed or refractory patients. Outside of this novel clinical trial, these patients would not have been considered for CLAG-M treatment as it would not be expected to have this type of effect in patients who had failed venetoclax based on our considerable prior experience with this regimen. Importantly, the combination was well tolerated with manageable toxicities and enabled a significant number of patients to proceed to transplant. These data support advancing the Actimab-A CLAG-M combination in a registration enabling study." Overall Survival Dr. Avinash Desai, Actinium's Chief Medical Officer, commented, "As a first-in-class targeted radiotherapy, Actimab-A represents a novel treatment for patients with relapsed or refractory AML. Its differentiated mechanism of action attacks leukemia cells with a radioactive payload that the cancer cells have never been exposed to, which we believe is driving improved outcomes in these heavily pretreated and adverse cytogenetic patients. The high rates and deep remissions evidenced by the 75% measurable residual disease negativity are exciting and support the hypothesis of this combination. We are thrilled to show improved survival, especially in the TP53 mutant and Venetoclax treated patients who have dismal outcomes with expected survival of less than 3 months and few, if any, treatment options. With enrollment of this study complete, we look forward to leveraging the strong survival, MRD negativity and complete remission results to rapidly establish an efficient development and regulatory strategy." MRD Negativity and Response Rates MRD negativity was 75% in patients achieving CRc, assessed by multiparametric flow cytometry. Patient Characteristics Patients received a median of two lines of prior therapy (Range: 1 – 5 lines) 57% received prior treatment with Venetoclax 67% of patients had adverse cytogenetics, 52% had TP53 mutations 52% of patients had secondary AML or treatment related AML About Actinium Pharmaceuticals, Inc. Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level precision to treat patients with high unmet needs. Actinium's clinical pipeline is led by radiotherapies that are being applied to targeted conditioning, which is intended to selectively deplete a patient's disease or cancer cells and certain immune cells prior to a bone marrow transplant (BMT), gene therapy or adoptive cell therapy, such as CAR-T, to enable engraftment of these transplanted cells with minimal toxicities. Our lead product candidate, I-131 apamistamab (Iomab-B) has been studied in over four hundred patients, including the pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia (SIERRA) trial for BMT conditioning. Topline data from the SIERRA trial was positive with the study meeting its primary endpoint with a high statistical significance (p<0.0001). Additional data from the SIERRA trial is expected to be presented at a BMT focused medical conference in 2023. Iomab-ACT, low dose I-131 apamistamab, is being studied as a targeted conditioning agent in a Phase 1 study with a CD19 CAR T-cell Therapy with Memorial Sloan Kettering Cancer Center with NIH funding. Actimab-A, our second most advanced product candidate has been studied in approximately 150 patients with Acute Myeloid Leukemia or AML, including in ongoing combination trials with the chemotherapy regimen CLAG-M and with venetoclax, a targeted therapy. Actimab-A or lintuzumab-Ac225 is an Actinium-225 based antibody radiation conjugate targeting CD33, a validated target in AML. Actinium is a pioneer and leader in the field of Actinium-225 alpha therapies with an industry leading technology platform comprising over 190 patents and patent applications including methods of producing the radioisotope AC-225. Our technology and expertise have enabled collaborative research partnerships with Astellas Pharma, Inc. for solid tumor theranostics, with AVEO Oncology Inc. to create an Actinium-225 HER3 targeting radiotherapy for solid tumors, and with EpicentRx, Inc. to create targeted radiotherapy combinations with their novel, clinical stage small molecule CD47-SIRPα inhibitor. More information is available on Actinium's website: . Forward-Looking Statements for Actinium Pharmaceuticals, Inc. This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time. Investors: Hans Vitzthum LifeSci Advisors, LLC [email protected] (617) 430-7578 SOURCE Actinium Pharmaceuticals, Inc.

Clinical ResultPhase 3Cell TherapyPhase 1Radiation Therapy

02 Nov 2022

·www.biospace.com

Actinium Appoints Seasoned Leader Caroline Yarbrough as Chief Commercial Officer to Spearhead Iomab-B Commercialization

-Caroline joins Actinium from Novartis where she served as Portfolio General Manager, US Oncology -Proven commercial leadership experience spans hematology, oncology and rare diseases at Novartis, Glaxo SmithKline, Bristol Myers Squibb, ViroPharma and Merck & Co. NEW YORK, Nov. 2, 2022 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, today announced the appointment of Caroline Yarbrough as Chief Commercial Officer. Caroline joins Actinium from Novartis where she most recently served as Portfolio General Manager, US Oncology, with full P&L responsibility of a diverse portfolio of brands and development assets with revenues in excess of a billion dollars. Previously, she led the chronic myelogenous leukemia (CML) portfolio, a billion-dollar business comprising TASIGNA® and SCEMBLIX®. She also led strategic account management during the launch period for KYMRIAH®, the first approved CAR-T cell therapy. "I am excited that Caroline has joined our team to build the commercial organization at this juncture given the recently announced positive and statistically significant topline data from the Iomab-B pivotal Phase 3 SIERRA trial," stated Sandesh Seth, Actinium's Chairman and Chief Executive Officer. "In our view, Iomab-B has the potential to change the treatment paradigm for elderly AML patients who have active disease. These patients are currently unable to access a potentially curative bone marrow transplant as chemotherapy based conditioning regimens are either unsafe or ineffective. The number of patients who fall into this category far outnumber those patients in remission who are currently transplanted and thus Iomab-B, if approved, has the potential to set a new standard of care and greatly expand the eligible patient pool. Given, this opportunity, a person of Caroline's caliber and skill set is the right commercial leader for Actinium at this time." "Caroline's broad commercial expertise includes building organizations and successful launches in a variety of cancer treatment settings including hematology, CAR-T cellular therapy and rare diseases. Her mix of skills and deep understanding of the strategies and tactics required to successfully commercialize a complex CAR-T like KYMRIAH will serve Actinium well as she propels forward our commercialization plans for Iomab-B. Caroline will lead our efforts to build a highly focused, nimble commercial organization that can successfully realize the market potential of Iomab-B as a first in class product in an area of high unmet need," Mr. Seth stated. Mr. Seth added, "We also look forward to the overall survival data from the Actimab-A+CLAG-M trial by year-end and with business development opportunities growing it was prudent to expand the leadership team appropriately so that Dr. Swaminathan can focus exclusively on leading our business development efforts as Chief Business Officer. The team thanks him for his work in preparing a solid plan upon which Caroline can build and looks forward to leveraging his extensive business development expertise." Prior to Novartis, Caroline's career spanned multiple large pharmaceutical and biotechnology companies, including Glaxo SmithKline (GSK), Bristol Myers Squibb (BMS), ViroPharma and Merck, where she held roles with increasing responsibilities. At GSK, she led marketing for Votrient® and Tykerb® in breast cancer, renal cell carcinoma and soft tissue sarcoma, which comprised fifty percent of GSK's oncology revenue for the US. For nearly a decade, Caroline held roles at BMS leading commercial activities in neuroscience, immunology, multiple myeloma, CML and other solid tumors. Caroline has a BA in Biology from the University of Delaware, where she received the Peter White Undergraduate Research Fellowship, an MBA from the Goizueta Business School at Emory University and a drs in International Business from Nijenrode University. Caroline Yarbrough added, "I feel fortunate to become a key part of the Actinium team and lead its efforts to commercialize this potentially transformational radiotherapy. The recent positive Phase 3 topline data and Iomab-B's strong historical results hold the promise of expanding the market for BMT, initially for older patients with relapsed/refractory AML who have a very poor survival prognosis as they cannot access a BMT. Excitingly, given the prior clinical use of Iomab-B, which demonstrated its potential in multiple other transplant settings, we look forward to label expansion opportunities and enabling Iomab-B to realize its full potential as a first in class conditioning regimen that can change the treatment paradigm and establish a new standard of care." About Iomab-B and the Pivotal Phase 3 Trial Iomab-B is a first-in-class targeted radiotherapy intended to improve patient access to a potentially curative bone marrow transplant by simultaneously and rapidly depleting blood cancer, immune and bone marrow stem cells that uniquely express CD45. Multiple studies have demonstrated increased survival in patients receiving a BMT, however, an overwhelming majority of relapsed or refractory patients with blood cancers do not receive BMT as current treatment approaches do not produce a remission, which is required to be considered eligible for receiving a successfully BMT. Studied in over 400 patients, Iomab-B has demonstrated nearly universal access to BMT, increased survival and good tolerability in multiple clinical trials including the recently completed pivotal Phase 3 SIERRA trial in patients with active (leukemic blasts >5%), relapsed or refractory acute myeloid leukemia (r/r AML) age 55 and above. The SIERRA trial produced positive topline results, meeting its primary endpoint of durable Complete Remission (dCR) of 6 months with a high degree of statistical significance (p<0.0001). Actinium intends to prepare and submit a Biologics License Application (BLA) seeking approval for Iomab-B to address the estimated 10,000 patients annually age 55+ with r/r AML who do not access BMT with currently available therapies. Iomab-B has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and has patent protection into 2037. The pivotal Phase 3 SIERRA (Study of Iomab-B in Elderly relapsed or refractory AML) is a 153-patient, randomized, multi-center clinical trial, studying Iomab-B compared to the control arm of physician's choice of salvage therapy. Control arm options included chemotherapies like cytarabine and daunorubicin and targeted agents such as a Bcl-2 inhibitor (Venetoclax), FLT3 inhibitors and IDH 1/2 inhibitors. The SIERRA control arm reflects real-world treatment of r/r AML patients with over 20 single agents or combination of agents as no standard of care exists for this patient population. Data from full patient enrollment was presented at the Transplantation & Cellular Therapy Tandem Meetings in April 2022 showing that 100% of patients receiving Iomab-B accessed BMT and engrafted without delay. Iomab-B was also shown to be well tolerated given its targeted nature, consistent with its previous clinical data. The SIERRA trial enrolled patients at 24 leading transplant centers in the United States and Canada that perform over 30% of AML BMTs. Developed at the Fred Hutchinson Cancer Research Center, a pioneer in the field of BMT, Iomab-B is supported by data in six disease indications including leukemias, lymphomas and multiple myeloma, which afflict over 100,000 patients annually. Actinium intends to pursue additional indications for Iomab-B leveraging the positive SIERRA trial data and its robust clinical experience. Actinium also intends to pursue international regulatory approvals independently and through partnerships. In April 2022, Actinium licensed the European, Middle East and North African commercial rights for Iomab-B to Immedica AB, a fully-fledged independent pharmaceutical company headquartered in Sweden. In exchange, Actinium received an upfront payment of $35 million USD with the potential for an additional $417 million USD in regulatory and sales milestones and mid-twenty percent royalties. Europe represents a commercial opportunity double the size of the United States by number of patients with AML receiving BMT. Iomab-B has been granted Orphan Drug Designation by the European Medicines Agency (EMA) and has received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the EMA indicating that the Phase 3 SIERRA trial design, primary endpoint and planned statistical analysis are acceptable as the basis for a Marketing Authorization Application. About Actinium Pharmaceuticals, Inc. Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level precision to treat patients with high unmet needs. Actinium's clinical pipeline is led by radiotherapies that are being applied to targeted conditioning, which is intended to selectively deplete a patient's disease or cancer cells and certain immune cells prior to a bone marrow transplant (BMT), gene therapy or adoptive cell therapy, such as CAR-T, to enable engraftment of these transplanted cells with minimal toxicities. Our lead product candidate, I-131 apamistamab (Iomab-B) has been studied in over four hundred patients, including the pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia (SIERRA) trial for BMT conditioning. Topline data from the SIERRA trial was positive with the study meeting its primary endpoint with a high statistical significance (p<0.0001). Additional data from the SIERRA trial is expected to be presented by year-end. Iomab-ACT, low dose I-131 apamistamab, is being studied as a targeted conditioning agent in a Phase 1 study with a CD19 CAR T-cell Therapy with Memorial Sloan Kettering Cancer Center with NIH funding. Actimab-A, our second most advanced product candidate has been studied in approximately 150 patients with Acute Myeloid Leukemia or AML, including in ongoing combination trials with the chemotherapy regimen CLAG-M and with venetoclax, a targeted therapy. Actimab-A or lintuzumab-Ac225 is an Actinium-225 based antibody radiation conjugate targeting CD33, a validated target in AML. Actinium is a pioneer and leader in the field of Actinium-225 alpha therapies with an industry leading technology platform comprising over 190 patents and patent applications including methods of producing the radioisotope AC-225. Our technology and expertise have enabled collaborative research partnerships with Astellas Pharma, Inc. for solid tumor theranostics, with AVEO Oncology Inc. to create an Actinium-225 HER3 targeting radiotherapy for solid tumors, and with EpicentRx, Inc. to create targeted radiotherapy combinations with their novel, clinical stage small molecule CD47-SIRPα inhibitor. More information is available on Actinium's website: . Investors: Hans Vitzthum LifeSci Advisors, LLC Hans@LifeSciAdvisors.com (617) 430-7578 Company Codes: AMEX:ATNM

CollaborateGene TherapyAntibodyOrphan DrugFirst in Class

100 Deals associated with Filgrastim-AAFI(Hospira, Inc.)

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Acute Myeloid Leukemia	US	Hospira, Inc.	20 Jul 2018
Febrile Neutropenia	EU	Pfizer Europe MA EEIG	07 Jun 2010
Febrile Neutropenia	IS	Pfizer Europe MA EEIG	07 Jun 2010
Febrile Neutropenia	LI	Pfizer Europe MA EEIG	07 Jun 2010
Febrile Neutropenia	NO	Pfizer Europe MA EEIG	07 Jun 2010
Neutropenia	EU	Pfizer Europe MA EEIG	07 Jun 2010
Neutropenia	IS	Pfizer Europe MA EEIG	07 Jun 2010
Neutropenia	LI	Pfizer Europe MA EEIG	07 Jun 2010
Neutropenia	NO	Pfizer Europe MA EEIG	07 Jun 2010

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Leukopenia	Phase 1	US	Pfizer Inc.	01 Dec 2015

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Tandem Meetings ASTCT and CIBMTR2024	Not Applicable	Peripheral Stem Cell Transplantation	541	Nivestym	kfesmnnsxw(vbsvyympsy) = qjkkiexupi tvjmsktblj (ifqzbvroqq ) View more	Positive	01 Feb 2024
				Neupogen	kfesmnnsxw(vbsvyympsy) = qlvhbszgqn tvjmsktblj (ifqzbvroqq ) View more
ASH2023	Not Applicable	Peripheral Stem Cell Transplantation	541	Nivestym	udfhmrczks(aftczqopdn) = wbliqowfqf zjwkauqvyy (ywdjnbektz ) View more	-	10 Dec 2023
				Neupogen	udfhmrczks(aftczqopdn) = kjwprlalnl zjwkauqvyy (ywdjnbektz ) View more
EBMT2018	Not Applicable	Stem cell mobilisation	160	Neupogen	vbeovaxqsu(txgxojikko) = simmsrhvol epjblxbyqe (vuawuizqgx ) View more	-	19 Nov 2018
				Nivestim	vbeovaxqsu(txgxojikko) = mjadqbcmqz epjblxbyqe (vuawuizqgx ) View more
NCT00520130 (CTgov)	Phase 1/2	Hodgkin's Lymphoma \| Multiple Myeloma \| acute leukemia ... View more	92	Conditioning Chemotherapy+Etoposide+Fludarabine+Cyclophosphamide+Prednisone+Doxorubicin+Filgrastim+Rituximab (A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm)	zkybxtzvyr(emgqeavupn) = ldgyxlhceg kbrqdqoeee (jccroqedhm, wpdygfghml - nhzyhjcpep) View more	-	24 Aug 2017
				Conditioning Chemotherapy+cyclosporine+Etoposide+Fludarabine+Cyclophosphamide+Prednisone+Doxorubicin+Filgrastim+Rituximab+Alemtuzumab (B - Cyclosporine (AC) Arm)	zkybxtzvyr(emgqeavupn) = ataxtweuaj kbrqdqoeee (jccroqedhm, tqwpkiywng - vjvmljeysd) View more

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