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Actinium completes the SIERRA Trial of Iomab-B in the Pivotal Phase 3 trial IonaB completed the Isoba-b test

Actinium completes the SIERRA Trial of Iomab-B in the Pivotal Phase 3 trial IonaB completed the Isoba-b test

NEW YORK, Sept. 15, 2021 /PRNewswire/ -- Today, the 15th of Sept - 2022, &PR Newswire -- -- November 15, 2019,, NEWYorK -- September Actinium Pharmaceuticals, Inc. The company announced today that it has completed the pivotal Phase 3 SIERRA trial for Iomab-B, an antibody radiation conjugate (ARC), containing apamistamab, a CD45 targeting antibody The SIERRA trial is a 150-patient study conducted at 24 leading bone marrow transplant centers in the United States and Canada. The study is controlled by randomized controlled trials of 150 patients. SIERRA is the only randomized Phase 3 trial to offer bone marrow transplant (BMT) to patients with active, relapsed or fractory acute leukemia (AML) age 55 and above, with

Actinium expects to present data updates from the SIERRA trial in the fourth quarter of 2021 and announce topline data for the primary endpoint of six-month durable Complete Remission (dCR) in mid-2022. This data is expected to help register the Biologic License Application (BLA) for Iomab-B.

The SIERRA trial is a valuable trial for bone marrow transplant, as Iomab-B is potential to be able to improve BMT condition. I know firsthand what a targeted conditioning agent like Iomab-B can offer patients and transplant physicians. I spent my career researching the use of transplant medicine to improve patient outcomes. Given its targeted nature, Iomab-B demonstrated the ability to achieve effective myeloablation even in patients with high disease burdens, while being well tolerated. This has shown that more patients, including those with significant comorbidities, can successfully obtain bone marrow transplants and successfully engraft."

"We're thrilled that the SIERRA trial is fully enrolled. Since I joined Actinium last November, I have ensured our clinical, CMC and supply chain teams focused on execution and achievement of this important milestone. In this patient population, Iomab-B was developed to address the unmet need of patients who could benefit and possibly cure their blood cancer by a bone marrow transplant but not by the disease of the patient, because We are confident that Iomab-B will address this unmet need, given its targeted nature and ability to deliver high amounts of radiation directly to the bone marrow, thereby reducing myeloablation while A SIERRA trial was designed to evaluate the rate of dCR of at least six months in patients receiving Iomab and BMT to those receiving salvage chemotherapy. With enrollment complete, we will focus on preparing a BLA submission with the aim of making Iomab-B available to the patients as soon as possible after receiving the topline results from the SIERRA trial. We sincerely thank all of the patients, their families, caregivers, staff and investigators who participated in this important study.

"Completion of SIERRA enrollment is a major milestone for Actinium." It was exciting seeing that trial concludes with strong momentum under Dr. Desai's leadership. Through strong interactions with our sites, our revitalized clinical team successfully surmount obstacles arose from the third wave of COVID-19 pandemic and recruit the last 25% faster patients than any previous cohort of patients. Their performance proves our performance has never been stronger. We're eager to present the additional data from SIERRA later this year and expect to report topline data next year. As we look ahead, our team will prepare a BLA to support regulatory approval of Iomab-B in patients with active r/r AML and execute market access and pre-commercial activities to help u.

In addition, we will explore opportunities to expand the use of Iomab-B in other indications to support our target and targeted commercial business unit vision. We believe that there is a significant market opportunity. Since Iomab-B is the only CD45 targeting agent in clinical development and that it is expressed in all blood cancers, we believe there's slick potential This multi-indication opportunity excites us, as our commercial efforts target a concentrated number of transplant centers and physicians that we believe will result in significant operating leverage. Mr. Seth concluded that we will continue to leverage our targeted radiotherapy expertise, particularly in the field of Actinium-225 based alpha therapies, to be the forefront of innovation focused on bringing value to patients and investors."

The information and key points from 75% Enrollment Guarantee.

(presented at the Annual Meeting of 2021 Transplantation and Cellular Therapy Annual meeting)

- 100% (49/49) BMT access and engraftment rates for patients receiving therapeutic doses of Iomab-B compared to 18% (10/57) of patients who receive physician's choice of salvage

- 79% (89/113) of all patients enrolled on SIERRA were able to get BMT despite being a patient population not considered eligible for BTM with standard approaches due to cross over the next two years.

- Iomab-B delivers high doses of targeted radiation to the bone marrow with minimal impact on other organs resulting in lower rates and severity of adverse events.

Phase 3 SIERRA 75% Enrollment Results.

Characteristics from the baseline, the basisline and the Baseline Characterists.

Iomab-B Arm (N=56)

Conventional Care (CC) Arm(N=57) (Traditional Support) arm(n=56)

Age (years)Median (Range)

63 (55-77) (557-577).

65 (55-77)

Risks on cytogenetic and molecular scale are associated with Cytogenetic Risk and the Molecular Risk. 12

46% Intermediate: 35% Favorable: 55%.

61 % of respondents are negative.

5 % Favorable: 5 55%.

32%

63 % of the population is affected.

% TransplantedIntent-to-Treat Group - TransPlantedintent to-Traat / 0% Trans PlantedGroup TransplainttoTrent Group; & 1% Integrated

88 % (49/56) (48/51).

18% (10/57)

66 % (30/47)

Results

Underwent Iomab-B based Conditioning and BMT (N=49) (underwent a conditional test. 3

At the level of achievement, CR was achieved and received standard of care BMT (N=10).

Iomab-B with BMT (N=30) with randomization to conventional care and crossed to Iomeb/B. 4

The Crossover rate is the same as the Cross-over Rate.

s/o n/a / a/n d/d.

n.d.a.

64 % (30/47)

% Transplanted / Trans Planted Total Transplantation : Transpolation of Total Total Spend, Transposition of Expenditures Transponed & Added - 2%

100% (49/49) (Hello) (24/469).

18% (10/57)

100 % (30/30)

Randomization Median (Range) % Marrow Blast - Randomized Media (Marrow) Randomisation Media.

29 % (4-95) (4-19). 5

20 % (5-97)

68 % (6-87)

Days to ANC Engraftment.

14 (9-22) 6

17 (13-83): 13-18. 7

14 (10-10-37) 8

Days to Platelet Engraftment: Days of Platelets Day to Mount Engledging.

18 (4-39) 6

22 (8-35) 7

19 (1-38): 13 o'clock. 8

Post-regularization: Days to BMT (Post-Regulation) Days - Days.

30 (23-60):

67 (52-104), twelfth 501 (53-105).

62 (36-100) and 61 (62). 9

Myeloablative Dose Delivered to Bone Marrow and then re-opened.

Gv 1,7 (4,6-32) gv 4,6 (4.6-36) Gw

s/o a/ n/a //

Gv 14,5 (6,3-42) GVP 16,5 (5,6-4) GVS 32,5 % vs.

mCi 592 (313-1013) - 501 (393-333) : 008

mCi 646 (354-10) fee 644 (334-1107) neo-mue 545 (mci) 446 (354) 354 oz te

Mortality attributed to Transplant-Related Mortality by 100 days a day, non-relapsed.

4% 4 %.

(2/24) Evaluable (2/45)

20 %

(2/10 Evaluable)

10,7%

(3/28 Evaluable) (seventh evaluator)

4) Iomab-B, and patient was excluded (1) (1) Iiomata-A arm: data unavailable (4) and the patient's was removed (1).

2 Per NCCN guidelines version 3. 2020

3) No therapy dose (7) due to: decreasing KPS (4), infusion reaction (1), unfavorable biodistribution (1); post-randomization eligibility (1). Two (2) did not receive DI and five

4) Thirteen (13) patients are ineligible for crossover due to: hospice care/progression (4), declined/ineligibility for BMT (5), died pre-crossover (8). A decrease in KPS allowed four (4) patients to cross and receive Iomab-B, which also prevented the cancellation of the request.

5) One (1) patient with 44% blasts in the marrow had circulating AML blast.

6) ANC engraftment data available (4), platelet entgraftion data unavailable (7), resuscitation data (8), inexpressible (5), non-excessive (6)

7) ANC and platelet engraftment data not available (1) 6)...

8) ANC engraftment data isn't available (1), platelet agraftest data arent sold (2), (8) ACC entrant data in are not available (2).

After 161 days, one (1) patient at 161, had delayed the transplant due to infection & respiratory failure, received Iomab - he re-transplant when stable, not included in range,

The adverse event occurs

Underwent a conditioning and BMT (N=49) with Iomab-B based conditioning. 1 % (N) (%) / - : 0 p.

Achievementd CR and received standard of care BMT (N=10)% (n) (A) Achieved and achieved achieved tens of percent (B) and earned a standard sulfate of affection

If the bm counted to conventional care, and crossed onto Iomab-B with BMT (N=30) and I Omama B (Rading to Conventional Care) with 2 % (N),.

Sepsis is a form of septic.

4 (2)

(3) (3)

23 (7) (8).

Febrile Neutropenia Gr 3-4

42 (20)

50 (5) (6) (4) (7) (8) a.m.

12 12: 40 12

Mucositis Gr 3-4 Muskosits Grs.

10) (5) (6) a.m.

(3)

17 (5) (7) (4) (8) (6) t l 17.

Mortality on Day +100 non-relapses. 3

2/45(4.4)

2/10(20.0)

3/28 (10.7), ten.7.

1) Randomized results for 46 patients of 47 eligible patients with evaluable results. 1) Adverse events data available for 48 patients on 47 of the 47 valuably able patients.

2) Adverse Event data available for 27 of 30 eligible patients. 2) For evaluable patients, 27 in 30 will be able to evaluate their performance.

3 Iomab-B: 4 patients unavaluable. 4 patients are unvaluable, but the value of their quality is unconcerned.

Patient Group is a patient group.

No. of patients with no success.

The Marrow is treated with radiation radiation. Median

Radiation dose to GI tract. Median

Iomab-B Ismobb

49

14 Gy

2,8 g/s

About the SIERRA phase 3 trial.

The SIERRA trial is a 150-patient clinical trial, randomized to study Iomab-B compared to physician's choice of salvage therapy in patients with active, persistent or refractory acute mye Patients receiving Iomab-B, those who achieving remission after salvage therapy or those patients who cannot recover from Imba B were offered a bone marrow transplant (BMT), the only treatment option The SIERRA trial is the only randomized Phase 3 trial that allows this patient population to gain BMT. Unlike the clerical arm of SIERRA, there were over 20 single or combination treatments, such as salvage chemotherapy and recently approved targeted agents, including Bcl-2 inhibitor (Venetoclax), FLT3 The trial of SIERRA was conducted at 24 sites in the United States and Canada.

Iomab-B About I-Mass - I Omba Y osmiz iobbi.

Amid the oxidation of the I-131 radioisotope, the diabene molecule is a powerful antigen called iodine-101. It is capable of destroying marrow

Iomab-B was licensed by the Fred Hutchinson Cancer Research Center, where it was studied in nearly 300 patients and in six clinical trials in blood cancer indications. The SIERRA trial was conducted at 24 preeminent transplant centers in the United States and Canada. The trial is based on the pivotal Phase 3 study of Iomab-B in Relapsed or Refrac A bone marrow transplant is a potential solution for blood-borne cancers and blood disorders. More information on Iomab-B and the Phase 3 clinical trial can be found at www.sierratrial.com

Actinium Pharmaceuticals, Inc.

Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing targeted radiotherapies to treat cancer-killing patients with high unmet needs not addressed by traditional cancer therapies. Using a set of evaluative relapsed or faeces for lung transplants, the resulting randomized trials are based on cfi-torone and pyxy Among all the other techniques, we are the leading in Actinium-225 alpha therapies. We are developing our proprietary AWE (Antibody Warhead Enabling) technology platform. The platform is being developed to build and study novel ARC and a VC-based design platform, with over 160 patents, know-

Actinium Pharmaceuticals, Inc., has forward-looking Statements.

This press release may contain projections or other "forward-looking statements" under the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of a Company that the Company undertake The following year, the Annual Report on Form 10-K and Forms 8-K are based on management's current expectations and are subject to risks and uncertainties that may impede the realization of future results, such as the ultimate final results

Investors: Hans VitzthumLifeSci Advisors, LLC[email protected] (617) 430-7578.

SOURCE Actinium Pharmaceuticals, Inc.

Related Links

http://www.actiniumpharma.com/

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