OUR NEW PROFILE IS: (NYSE: ATNM)
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H.C. WAINWRIGHT & CO. PLACES $53.00 TARGET ON THIS $14 CLINICAL-STAGE BIOPHARMA STOCK INDICATING MASSIVE POTENTIAL UPSIDE
ACTINIUM-225 BASED ALPHA THERAPIES HAVE TREATED APPROXIMATELY 150 PATIENTS TREATED ACROSS SIX PHASE 1 AND PHASE 2 CLINICAL TRIALS
ACTINIUM ANNOUNCES POSITIVE FULL DATA RESULTS FROM THE PIVOTAL PHASE 3 SIERRA TRIAL IN PATIENTS WITH ACTIVE, RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA
READ THE INVESTOR PRESENTATION HERE
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Hello Everyone,
We want you to pull up ATNM immediately.
This is a company that we have profiled in the past before.
2023 has been a great year so far for the company as you can tell by the chart above.
There are a lot of moving parts to this profile but we want to zero in on one particular catalyst to start.
Over the weekend the company announced:
ACTINIUM ANNOUNCES POSITIVE FULL DATA RESULTS FROM THE PIVOTAL PHASE 3 SIERRA TRIAL IN PATIENTS WITH ACTIVE, RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA
– Iomab-B met the primary endpoint of durable Complete Remission (dCR) of 6-months following initial complete remission after BMT with high statistical significance (p-value of <0.0001), 22% of patients achieved dCR in the Iomab-B arm compared to 0% in the control arm
– In patients achieving 6-month dCR with Iomab-b, 1-year survival of 92% and 2-year survival of 60% was achieved; median overall survival (OS) has not been reached in these patients
– Iomab-B demonstrated significant improvement in Event Free Survival (EFS) with a Hazard Ratio = 0.22, p<0.0001
– Iomab-B doubled 1-year survival and median overall survival compared to control arm patients who did not crossover
– Iomab-B was well tolerated with a favorable safety profile – 4 times lower rate of sepsis than control arm
– Company to host conference call and webcast on Saturday, February 18, 2023 at 6:00 PM EST to highlight full SIERRA results
NEW YORK, Feb. 18, 2023 /PRNewswire/ — Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, today announced positive results for the primary and secondary endpoints from its pivotal Phase 3 SIERRA trial of Iomab-B in patients age 55 and above with active relapsed or refractory acute myeloid leukemia (r/r AML). Iomab-B met the primary endpoint of durable Complete Remission (dCR) of 6-months following initial complete remission following BMT with a high degree of statistical significance (p<0.0001). Additionally, Iomab-B produced a significant and clinically meaningful improvement in the secondary endpoint of Event-Free Survival (EFS), with a 78% reduction in the probability of an event (Hazard Ratio=0.22, p<0.0001). Iomab-B doubled 1-year survival compared to the control arm excluding cross over patients (26.1% vs 13.1%) as well as median overall survival (6.4 months vs. 3.2 months). Iomab-B was well tolerated with four times lower rates of sepsis (6.1% vs 28.6%) and lower rates of febrile neutropenia, mucositis and acute graph versus host disease (aGVHD). Iomab-B enabled unprecedented access to BMT with 100% engraftment in patients receiving a therapeutic dose of Iomab-B compared to 18% of patients in the control arm and Iomab-B produced a 75% post-BMT Complete Remission (CR) rate compared to 6.3% post-BMT CR in the control arm. These high rates of access and post-BMT CR enabled the highly significant primary endpoint results. The full SIERRA results were presented in the late-breaker session at the 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR).
…………….. I would be paying close attention in the morning to this one.
ANALYST COVERAGE:
According to TipRanks.com, on February 7, 2023, H.C. Wainwright analyst Joseph Pantginis reiterated coverage on Actinium Pharmaceuticals Inc. (NYSE: ATNM) with a target of $53.00.(28)
TARGET RANGE:
According to Barchart.com, shares of Actinium Pharmaceuticals Inc. (NYSE: ATNM) bounced off their 52 week low of $4.41 on 3/15/2022 indicating there could be an upside potential of 1,100% if they were to move from their 52 week low and reach the $53.00 target set by H.C. Wainwright. Not that a move to $53.00 is certain, but the potential upside needs to be noted. (28)
POTENTIAL FOR GROWTH:
Historically, small-cap stocks have outperformed large-cap stocks. A small-cap stock is generally that of a company with a market capitalization of between $300 million and $2 billion. And because they are smaller, small-cap stock share prices typically have a greater chance of growth. (29) As of 2/10/2023, the market capitalization Actinium Pharmaceuticals Inc. (NYSE: ATNM) is just over $309M according to MarketWatch.com. (31)
POSSIBLE ACQUISITION CANDIDATE:
Small cap companies are acquired more frequently than larger companies. Large companies can enter new markets or gain intellectual property by buying smaller businesses. Large companies usually pay a premium to acquire growth firms. (32) An acquisition announcement is not expected, but the potential needs to be noted.
INTELLECTUAL PROPERTY:
The company’s clinical pipeline was developed from its Antibody Warhead Enabling (“AWE”) technology platform, which is protected by over 195 issued and pending patents, trade secrets and know-how that Actinium Pharmaceuticals Inc. (NYSE: ATNM) is applying to the development of targeted radiotherapies for blood and solid tumor indications, independently and with collaborators. (33)
PIPELINE:
The company is advancing its pipeline of clinical-stage development programs that they believe can improve patient access to potentially curative treatments and improve patient outcomes. To the best of its knowledge, Actinium Pharmaceuticals Inc. (NYSE: ATNM) is developing the most advanced multi-indication, clinical-stage radiotherapy pipeline for targeted conditioning. In addition, the company believes they have the most experience with Actinium-225 based alpha therapies with approximately 150 patients treated across six Phase 1 and Phase 2 clinical trials. (33)
FDA APPLICATION:
In 2023, Actinium Pharmaceuticals Inc. (NYSE: ATNM) intends to submit a Biologics License Application (BLA) seeking approval for Iomab-B to address patients aged 55+ with r/r AML who cannot access bone marrow transplants (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.(33)
Biotechnology stocks are among the most high-risk, high-reward stocks in the market. Many biotech companies are working to develop one or two world-changing drugs or therapies for billion-dollar markets. (32) One of these biotech stocks, Actinium Pharmaceuticals Inc (ATNM) just received a $53.00 target indicating a potential upside of approx. 328% according to Benzinga.(27)
(27)
IF ACTINIUM PHARMACEUTICALS INC. (NYSE: ATNM) IS ABLE TO REACH THE $53.00 TARGET SET BY H.C. WAINWRIGHT ANALYST JOSEPH PANTGINIS, WE COULD WITNESS AN UPSIDE POTENTIAL OF APPROX. 1,100% AFTER BOUNCING OFF ITS 52-WEEK LOW OF $4.41… (28)(29)
(35)
Listen. Nothing is certain. But look at the Actinium Pharmaceuticals Inc. (NYSE: ATNM) daily chart above and do a little technical analysis using StockCharts.com. You can see the following moving averages:(35)
• Daily average price is: $13.00 (as of 2/10/23)
• 50-day moving average at $10.89
• 200-day moving average is $7.98
Shares of Actinium Pharmaceuticals Inc. (NYSE: ATNM) are trading over its 50-day moving average price of $10.89 and 200-day moving average price of $7.98 (as of 2/10/2023).
On that same day, (ATNM) reached an intraday high of $13.00 meaning shares have already moved over 194% since bouncing off its 52-week low of $4.41 which was set on 3/15/2022 according to BarChart.com. (29)
If shares of Actinium Pharmaceuticals Inc. (NYSE: ATNM) reached the $53.00 target set by H.C. Wainwright analyst Joseph Pantginis, we could witness a potential move of approx. 1,100% after bouncing off its 52-week low of $4.41… (28,29)
ACTINIUM PHARMACEUTICALS INC. (NYSE: ATNM)’S POTENTIAL FOR GROWTHTHE TERM SMALL CAP REFERS TO STOCKS WITH A SMALL MARKET CAPITALIZATION, BETWEEN $300 MILLION AND $2 BILLION. STOCKS WITH A MARKET CAP BELOW $300 MILLION ARE REFERRED TO AS MICRO CAPS, AND THOSE BELOW $50 MILLION ARE CALLED NANO CAPS.(32)
Actinium Pharmaceuticals Inc. (NYSE: ATNM) is just over $309M according to MarketWatch.com. (31)
Small-cap stocks can trade on any exchange. However, the majority of them are found on the Nasdaq or the OTCBB. That should not be surprising, as those exchanges have more lenient listing requirements.(32)
However, Actinium Pharmaceuticals Inc. (NYSE: ATNM) trades on the NYSE, which is typically reserved for more established companies. (37)
Merger and acquisition activity provides another opportunity for small-cap companies. (32)
Small caps are acquired more frequently than larger companies.
Large companies can enter new markets or gain intellectual property by buying smaller businesses.
Actinium Pharmaceuticals Inc. (NYSE: ATNM) has over 195 issued and pending patents in its intellectual property portfolio.(33)
Acquisitive companies usually pay a premium to acquire growth firms, leading to profits as soon as a deal is announced publicly.
Undervalued small companies can also make tempting takeover targets, especially when they are selling for below book value.(32)
Actinium Pharmaceuticals Inc. (NYSE: ATNM) is a clinical-stage, biopharmaceutical company applying its proprietary platform technology and clinical experience to develop novel targeted radiotherapies for patients with unmet needs.(33)
The company’s targeted radiotherapies combine the cell-killing ability of radiation via a radioisotope payload with a targeting agent, such as a monoclonal antibody, to deliver radiation in a precise manner inside the body to specific, targeted cells such as cancer cells, to potentially achieve greater efficacy with lower toxicity than with cytotoxic chemotherapy or external beam radiation. (33)
Targeted radiotherapies also enable the broader application of radiation than external beam radiation as they can be used in the treatment of both solid tumors and blood cancers, which generally cannot be treated with external radiation given their diffuse nature. CD45 and CD33 are both expressed in multiple hematologic cancers, which are known to be highly sensitive to radiation. (33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM)’s clinical programs against these targets are focused on two primary areas: (33)
• targeted conditioning prior to a bone marrow transplant (“BMT”), adoptive cell therapy (“ACT”) such as CAR-T or gene therapy with Iomab-B and
• targeted radiotherapy combinations with Actimab-A and other therapeutic agents.
Actinium Pharmaceuticals Inc. (NYSE: ATNM)’s most advanced clinical development program is Iomab-B, a CD45 targeting radiotherapy being developed to enable patients with blood cancers and other conditions to receive cellular and gene therapies. Iomab-B is being studied in the pivotal Phase SIERRA trial to enable a bone marrow transplant (“BMT”) in patients with active, relapsed, or refractory acute myeloid leukemia (“r/r AML”) age 55 and above, a patient population not considered eligible for BMT, which is the only potentially curative treatment option, with current approaches. (33)
On October 31, 2022, Actinium Pharmaceuticals Inc. (NYSE: ATNM) announced that Iomab-B met the primary endpoint of the SIERRA trial with a high degree of statistical significance (p<0.0001). (33)
The trial was conducted in patients 55 years of age or older with r/r AML who typically cannot access a potentially lifesaving bone marrow transplant (BMT) as they are deemed unfit and thus unable to tolerate standard chemotherapy-based conditioning. (33)
Trial results showed that with Iomab-B conditioning, these patients have increased access to a BMT with a clinically meaningful duration of complete remission, along with a favorable safety profile, potentially establishing a new treatment option for the majority of the 10,000 r/r AML patients in the U.S. who are deemed unfit for BMT with current approaches.(33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM)’s second most advanced clinical program is Actimab-A, a CD33 targeting radiotherapy that we are developing as a therapeutic to be used in combination with the company’s treatment modalities to leverage the potential synergistic mechanism of targeted radiation. (33)
(33)
Actimab-A is being studied in a Phase 1/2 combination trial with the salvage regimen CLAG-M in patients with r/r AML fit for intensive therapy and in a Phase 1/2 combination trial with Venetoclax, a targeted therapy, in patients with r/r AML who are both fit and unfit for intensive therapy.
On November 3, 2022, Actinium Pharmaceuticals Inc. (NYSE: ATNM) announced that Phase 1 results from the Actimab-A CLAG-M trial were accepted for oral presentation at the American Society of Hematology (“ASH”) Annual Meeting & Symposium on December 10, 2022. (33)
The study enrolled patients with r/r AML with a median age of 63, 2 lines of prior therapies (range: 1- 5), and 67% had adverse cytogenetics with 52% having a TP53 mutation. Prior treatment included BMT in 57% and prior Venetoclax therapy in 57% of patients. This patient population has dismal survival outcomes and outside of this novel combination clinical trial, would not be treated with CLAG-M. There was a 67% overall response rate (“ORR”) across all dose cohorts and an 83% ORR at the recommended Phase 2 dose (“RP2D”). (33)
Overall, 72% of patients achieving a Complete Remission (“CR”) or Complete Remission with incomplete count recovery (“CRi”) were minimal residual disease (“MRD”) negative and 83% of patients receiving the RP2D were “MRD negative.” (33)
Median overall survival was 12 months with a 53% 1-year overall survival rate and 32% 2-year overall survival rate. (33)
To provide context for this analysis, the median OS in patients who relapse post Venetoclax is less than 3 months and the median OS in patients who relapse with a TP53 mutation is less than 2 months.
Data from our Actimab-A Venetoclax combination trial has been accepted for poster presentation at ASH. This trial is exploring the potential mechanistic synergy we elucidated in preclinical models, that depleting Mcl-1 via targeted radiation from Actimab-A can re-sensitize or reduce resistance to Venetoclax.
Actinium Pharmaceuticals Inc. (NYSE: ATNM) has observed responses including a CR in early-dose cohorts. This trial is ongoing with dose escalation and scheduling optimization ongoing. The company expects to present proof of concept from the Phase 1 portion of this study in 2023. (33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM) is studying Iomab-ACT, a low-dose version of Iomab-B, for conditioning before CAR-T cellular therapy in collaboration with Memorial Sloan Kettering Cancer Center, which is funded by the National Institutes of Health (“NIH”) grant. The company has completed the treatment of an initial cohort of 3 patients and will expand to a second cohort. (33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM) expects to present proof of concept data from this study in 2023.
THE ACTINIUM PHARMACEUTICALS INC. (NYSE: ATNM) PATENTS
(39)
The Actinium Pharmaceuticals Inc. (NYSE: ATNM) clinical pipeline has been developed from the company’s Antibody Warhead Enabling (“AWE”) technology platform, which is protected by over 195 issued and pending patents, trade secrets, and know-how that the company is applying to the development of targeted radiotherapies for blood and solid tumor indications, independently and with collaborators. (33)(33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM) is also utilizing its AWE technology platform to advance its research objectives focused on developing next-generation targeted radiotherapies with its expanded research and development organization and research laboratories leveraging its drug development experience. (33)
ACTINIUM PHARMACEUTICALS INC. (NYSE: ATNM)’ S PIPELINE (33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM) is advancing a pipeline of clinical-stage development programs that it believes can improve patient access to potentially curative treatments and improve patient outcomes. To the best of the company’s knowledge, it is developing the most advanced multi-indication, clinical-stage radiotherapy pipeline for targeted conditioning.(33)
In addition, the company believes it has the most experience with Actinium-225-based alpha therapies with approximately 150 patients treated across six Phase 1 and Phase 2 clinical trials. (33)
(33)
The Actinium Pharmaceuticals Inc. (NYSE: ATNM) product development strategy is actively informed by clinical data with our drug candidates Iomab-B, Actimab-A, and Iomab-ACT in approximately 600 patients and 19 clinical trials, including the Pivotal Phase 3 SIERRA trial for Iomab-B, 12 prior clinical trials with Iomab-B at the Fred Hutchinson Cancer Research Center, 6 trials with Actimab-A and the MSKCC/NIH trial with Iomab-ACT. (33)
(33)
The company is applying its clinical experience to address unmet patient needs with its programs: (33)
Targeted Conditioning Programs for Cell and Gene Therapy: Iomab-B and Iomab-ACT are intended to potentially enable improved access and outcomes to cell-based therapies with curative potential, including BMT, ACT, and gene therapy. (33)
Conditioning in the context of BMT, ACT, or gene therapy is the act of depleting certain blood and immune-forming cells, including bone marrow stem cells and, in some cases, cancer cells prior to transplanting new cells into a patient. Currently, conditioning is accomplished using a combination of cytotoxic chemotherapeutic agents and external radiation. (33)
These non-targeted conditioning regimens are highly toxic and may prevent a patient from receiving a potentially curative therapy and hinder outcomes.
Actinium Pharmaceuticals Inc. (NYSE: ATNM) believes its targeted conditioning agents have the potential to increase patient access and outcomes by way of their ability to selectively deplete targeted cells while sparing normal healthy cells, resulting in potentially lower systemic and off-target toxicities. (33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM) intends to develop its targeted conditioning programs for BMT, ACT, and gene therapy applications for malignant and non-malignant diseases and believes that multiple radioisotopes may be utilized including alpha and beta emitters. (33)
Actinium-225 Based Therapeutic Backbone Therapy Program in AML: The company’s Actimab-A program demonstrates its leadership in the clinical development of Ac-225 therapeutics, as it focuses this industry-leading alpha-isotope based radiotherapy program as a backbone therapy for novel combinations in r/r AML. (33)
Actimab-A is the first radiotherapeutic for r/r AML and has the unique value proposition of broad applicability, a differentiated mechanism of action, and targeted precision that is well-tolerated with minimal toxicity. Specifically, Actimab-A targets CD33, which is expressed in virtually all AML patients regardless of cytogenetics or mutations and enables potent alpha radiation to be directed against radiosensitive AML cells that have no known resistance or repair mechanism when hit with the Ac-225 isotope payload that causes double-stranded breaks in DNA. (33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM) believes that Actimab-A in combination with chemotherapy, targeted agents, or immunotherapy, in r/r AML as a backbone therapy, represents a significant opportunity to improve patient outcomes in AML and is developing its product candidates according to this strategy. (33)
Platform Collaborations and Preclinical Programs: The company is leveraging its clinical experience, robust intellectual property, and radiotherapy know-how through research collaborations and its own preclinical development programs. Through the company’s research collaborations, such as with Astellas, they are advancing into solid tumor indications. (33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM) can utilize the ability of radioisotopes to be used for diagnostic purposes as well as therapeutics, which are referred to as theranostics. (33)
The company is also exploring novel targeted radiotherapies in solid tumors and blood cancers such as HER3 expressing solid tumors in collaboration with AVEO and combinations with immunotherapies such as CD47 immune checkpoint inhibitors with EpicentRx. (33)
DEVELOPMENT STRATEGY FOR RELAPSED AND REFRACTORY AML(33)
We are developing Iomab-B and Actimab-A to holistically address the unmet needs of both fit and unfit patients with AML, initially targeting the estimated 10,000 patients with relapsed or refractory disease. (33)
These patients are largely treated in approximately 100 centers and a majority of the BMTs are done in the top 50 centers. There is virtually total overlap between the top 50 BMT centers and the top 100 AML treatment centers. (33)
By developing two targeted radiotherapies for this indication, Actinium Pharmaceuticals Inc. (NYSE: ATNM) believes it can address a significant number of patients at various stages of their disease and treatment journey. (33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM) believes it can produce operating leverage through synergies in the supply chain and commercialization across both drug candidates. (33)
In addition, the company believes both Iomab-B and Actimab-A have the potential to be used in other blood cancer indications. (33)
(33)
Iomab-B enables patients with r/rr AML with active disease, who cannot tolerate intensive therapy and who otherwise would not be considered for BMT, to receive a potentially curative BMT. (33)
The SIERRA trial demonstrated the ability of Iomab-B conditioning to enable 100% of patients to proceed to BMT and achieve rapid engraftment resulting in significantly higher rates of patients with Complete Remissions and durable Complete Remissions. (33)
The tolerable safety profile of Iomab-B and efficacy as shown in SIERRA trial could transform the treatment paradigm for r/r AML.
For r/r AML patients requiring salvage therapy, Actinium Pharmaceuticals Inc. (NYSE: ATNM) believes combinations based on its Actimab-A alpha therapy have the potential to improve patient outcomes. The company is combining Actimab-A with CLAG-M for patients fit for intensive therapy in a Phase 1 trial conducted at the Medical College of Wisconsin (“MCW”). (33)
(33)
This novel combination trial enrolled patients who otherwise would not be considered for CLAG-M and added Actimab-A to precisely target and kill any residual AML cells following treatment with CLAG-M. (33)
The Actimab-A CLAG-M combination has a manageable safety profile and produced high response rates, high rates of MRD negativity and 53% 1- year and 32% 2-year median overall survival in a cohort of heavily pretreated patients with adverse cytogenetics, including 52% of patients who had a TP53 mutation. (33)
These survival outcomes represent a significant improvement over current dismal survival rates in these very hard-to-treat patients and support continued development. (33)
(33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM) is studying Actimab in combination with Venetoclax for patients who are both unfit and fit for intensive therapy. Venetoclax is approved in combination with HMAs, and the company believes Actimab-A has a more synergistic mechanism and that its targeted nature can produce better patient outcomes than Venetoclax HMA combinations. (33)
They are currently conducting a multi-center Phase 1/2 trial of this novel combination and are optimizing the dosing regimen for the anticipated Phase 2 portion of the trial. (33)
ACTINIUM PHARMACEUTICALS INC. (NYSE: ATNM)’S LEAD CANDIDATE AND TARGETED CONDITIONING AGENT: IOMAB-B (33)
Iomab-B (I-131 apamistamab), the company’s lead candidate and targeted conditioning agent is comprised of the anti-CD45 monoclonal antibody known as apamistamab (formerly BC8) and the radioisotope Iodine-131 (“I-131”). Iomab-B is a first-in-class targeted radiotherapy intended to improve patient access to potentially curative BMT by simultaneously and rapidly depleting blood cancer, immune and bone marrow stem cells that uniquely express CD45. CD45 is an antigen expressed on leukemia, lymphoma and myeloma cancer cells, but is not expressed outside of the hematopoietic, or blood-forming system.(33)
This unique expression on blood cancer and immune cells enables simultaneous depletion of both cell types, making CD45 an optimal antigen for targeted conditioning applications. (33)
CD45 is a cell surface antigen with an average expression of 200,000 copies per cell, however, it only internalizes at a rate of 10-15%. (33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM) believes its targeted radiotherapy approach is the most effective method to target CD45 positive cells, as the radioisotope payload linear energy transfer can readily ablate a targeted cell without requiring payload internalization like an antibody-dr-ug conjugate or without relying on biological effector function processes like a naked antibody. (33)
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. Studied in over 400 patients, prior studies with Iomab-B have demonstrated nearly universal access to BMT, increased survival and 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 age 55 and above. (33)
ACTINIUM PHARMACEUTICALS INC. (NYSE: ATNM)’S PIVOTAL PHASE 3 SIERRA TRIAL (33)
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. (33)
(33)
Patients with active, r/r AML are not considered eligible for BMT with current approaches, and the SIERRA trial is the only randomized Phase 3 trial to offer BMT as a treatment option for this patient population. (33)
The SIERRA trial compares outcomes of patients randomized to receive Iomab-B and a BMT (the “study arm”) to those patients randomized to receive a physician’s choice of salvage therapy (the “control arm”). (33)
The control arm is also defined as conventional care, as no standard of care exists for this patient population, and includes over 20 agents that may be used as single agents or in combination including Venetoclax, a targeted Bcl-2 inhibitor, Midostaurin, and Sorafenib, targeted FLT3 inhibitors, hypomethylating agents and cytotoxic chemotherapies.(33)
Patients who fail to achieve a Complete Remission (“CR”) on the control arm are ineligible to proceed to a BMT, but the trial design permits these patients to “cross over” to receive the study arm treatment if they meet the eligibility criteria. The primary endpoint of the SIERRA trial is durable Complete Remission (“dCR”) of 180 days and the secondary endpoints are Overall Survival (“OS”) and Event Free Survival (“EFS”). (33)
On October 31, 2022, Actinium Pharmaceuticals Inc. (NYSE: ATNM) announced positive topline results from the SIERRA trial that Iomab-B met the study’s dCR primary endpoint with a high degree of statistical significance (p<0.0001). (33)
Data from full patient enrollment in the SIERRA trial (153 patients), was previously presented at several key meetings including; the Transplantation & Cellular Therapy (TCT) Tandem Meetings of ASTCT and CIBMTR combined annual meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) in April 2022 and at ASH. (33)
The meetings highlighted that 100% of the patients (66/66) on the study arm received a therapeutic dose of Iomab-B received a BMT, with a median time to BMT of 30 days, and all patients achieved neutrophil and platelet engraftment in a median time of 18 days despite a high median blast count of 30%. (33)
(34)
Actinium Pharmaceuticals Inc. (NYSE: ATNM) intends to submit a Biologics License Application (BLA) in 2023, seeking approval for Iomab-B to address patients aged 55+ with r/r AML who cannot 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.(33)
If approved, Actinium Pharmaceuticals Inc. (NYSE: ATNM) expects its initial commercial launch will target the leading 50-100 BMT and medical centers that perform the vast majority of BMTs in the United States. (33)
(33)
In the European Union (“EU”), the company received favorable feedback from the European Medicines Agency (“EMA”) via their scientific advice program that the trial design, primary endpoint, and planned statistical analysis from the SIERRA trial are acceptable as the basis for a Marketing Authorization Application, or MAA. (33)
Additionally, the European Medicines Agency (EMA) commented that it does not anticipate the need for further standalone preclinical toxicology or safety studies. (33)
Overall, transplant procedures in the EU are approximately fifty percent higher than in the United States with a similar market dynamic, with a majority of BMT volume being conducted in a concentrated number of leading medical centers. (33)
In April 2022, Actinium Pharmaceuticals Inc. (NYSE: ATNM) entered into a license and supply agreement with Immedica Pharma AB, or Immedica, pursuant to which Immedica licensed the exclusive product rights for commercialization of Iomab-B in the European Economic Area, Middle East and North Africa, including Algeria, Andorra, Bahrain, Cyprus, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya. Monaco, Morocco, Oman, Palestine, Qatar, San Marino, Saudi Arabia, Switzerland, Syria, Tunisia, Turkey, the United Arab Emirates, the United Kingdom, the Vatican City and Yemen. (3)
(33)
Upon signing, Actinium Pharmaceuticals Inc. (NYSE: ATNM) was entitled to an upfront payment of $35 million from Immedica, which they received in May 2022. Under the terms of the agreement, we are eligible to receive regulatory and commercial milestone payments and we are entitled to receive royalties in the mid-20 percent range on net sales of the product in certain countries that may result from the License Agreement. Actinium Pharmaceuticals Inc. (NYSE: ATNM) will continue to be responsible for certain clinical development activities and the manufacturing of Iomab-B and will retain commercialization rights in the U.S. and the rest of the world. (33)
ACTINIUM PHARMACEUTICALS INC. (NYSE: ATNM)’S IOMAB-ACT (33)
The company’s Iomab-ACT program is intended for targeted conditioning prior to ACT or gene therapy and uses the same I-131-apamistamab construct as Iomab-B at varying doses. (33)
At lower doses of one-eighth to one-sixth of the myeloablative dose, it is applicable for lymphodepletion prior to CAR-T or certain gene therapy applications where stem cell myeloablation is not necessary. At higher doses, it is applicable for gene therapy applications where stem cell myeloablation is necessary. (33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM) believes its Iomab-ACT program is highly differentiated when compared to Fludarabine and Cyclophosphamide (“Flu/Cy”) or other chemotherapy-based regimens that are used as the standard of practice today for lymphodepletion prior to CAR-T. (33)
CD45 is an antigen expressed on certain immune cell types that are relevant to the mechanism of CAR-T therapies including lymphocytes, regulatory T-cells, and macrophages that have been associated with clinical responses that may limit the safety, efficacy, and durability of response of these CAR-T therapies including cytokine release syndrome (“CRS”) and neurotoxicity. Some of these limitations may be attributable to the chemotherapy-based conditioning agents that are being used prior to CAR-T therapies. (33)
(33)
Unlike chemotherapy, Iomab-ACT is targeted in nature and due to this CD45-directed targeting, the company expects it can improve CAR-T cell expansion, potentially resulting in responses that are more durable, but also resulting in reduced CAR-T related toxicities.(33)
Importantly, Actinium Pharmaceuticals Inc. (NYSE: ATNM) expects the Iomab-ACT program construct to enable lymphodepletion through a single-dose, outpatient administration versus Flu/Cy or other chemotherapy-based lymphodepletion regimens that can require multiple infusion cycles over several days. (33)
Because of this potentially superior profile, the Iomab-ACT construct could result in improved access to CAR-T therapy and better outcomes. (33)
ACTINIUM PHARMACEUTICALS INC. (NYSE: ATNM) INVOLVED IN FIRST-OF-ITS-KIND STUDY (33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM) is studying Iomab-ACT in a clinical collaboration with Memorial Sloan Kettering Cancer Center (“MSKCC”) for targeted conditioning prior to administration of MSKCC’s 19-28z CD19, targeting CAR-T in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (“ALL”) or diffuse large B-cell lymphoma (“DLBCL”). (33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM) received grant funding from the National Institute of Health (“NIH”) to fund this trial with MSKCC being a co-recipient of this grant. This is a first-of-its-kind study to use an ARC-based conditioning regimen with CAR-T therapy. The hypothesized rationale for this study is that Iomab-ACT will exert an anti-tumor effect on the chemotherapy-refractory B-ALL cells that are sensitive to radiation, resulting in reduced disease burden and simultaneously deplete CD45 expressing immune cells implicated in CAR-T-related toxicities, resulting in an optimal homeostatic environment for the CAR-T cells. (33)
The study will evaluate the feasibility of using a targeted radiotherapy-based conditioning regimen with CAR-T therapy and will evaluate safety measures including the incidence of CRS and neurotoxicity and efficacy measures, including responses and survival outcomes.
Actinium Pharmaceuticals Inc. (NYSE: ATNM) expects proof of concept data from this study in 2023. (33) In addition, Actinium Pharmaceuticals Inc. (NYSE: ATNM) is working in collaboration with the University of California Davis to utilize Iomab-ACT conditioning with a novel anti-HIV autologous gene therapy. The company continues to identify additional gene therapies for which Iomab-ACT can be used for targeted conditioning with the goal of collaborating with multiple academic or industry developers to establish Iomab-ACT as a non-chemotherapy universal targeted conditioning solution (33)
ACTINIUM-225 BASED THERAPEUTIC BACKBONE THERAPY PROGRAM IN AML (33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM)’s CD33 Alpha program is evaluating the clinical utility of Actimab-A, comprised of the anti-CD33 mAb lintuzumab linked to the potent alpha-emitting radioisotope Actinium-225 (“Ac-225”). (33)
CD33 is expressed in the majority of patients with AML and myelodysplastic syndrome (“MDS”) as well as approximately one-third of patients with multiple myeloma. Ac-225 emits four alpha particles and can kill a cell with one alpha-particle hit, making it one of the most powerful cell-killing agents with no known resistance mechanism to the double-strand DNA breaks it can cause.(33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM) sources Ac-225 from the Department of Energy’s Oak Ridge National Laboratory. The company’s CD33 development program is driven by data obtained from over 150 treated patients, including results from a Phase 1/2 trial that studied Actimab-A as a single agent at multiple dose levels in 58 patients with newly diagnosed AML, which was completed in 2018, as well as trials studying Actimab-A in combination with other agents.(33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM) believes that radiation delivered internally via a targeting moiety can be synergistic when used in combination with chemotherapy, targeted agents, and immunotherapy based on mechanistic rationales supported by our own clinical data, preclinical research, and scientific and clinical evidence in the literature. (33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM) has prioritized its efforts and resources in favor of combination trials for our CD33 program development strategy, rather than single agent trials at this time as we believe Actimab-A can be a backbone therapy in AML when combined with other therapeutic modalities. (33)
The company’s CD33 development program encompasses the following ongoing trials:
Actimab-A + CLAG-M (33)
Actimab-A combined with CLAG-M has been studied in a Phase 1 combination trial that was conducted in collaboration with the Medical College of Wisconsin in patients aged 18 and above with r/r AML. CLAG-M (cladribine, cytarabine, filgrastim, and mitoxantrone) is a salvage chemotherapy regimen routinely used to treat patients with r/r AML. Data from the Phase 1 combination trial of Actimab-A + CLAG-M has been accepted for an oral presentation at ASH in December 2022. (33)
Patients enrolled in this study were a median of 63 years of age and were heavily pretreated with a median of 2 lines of prior treatment (range: 1-5) with 55% of patients receiving prior Venetoclax therapy and 55% receiving a prior BMT. Patients had high-risk cytogenetics with 67% having adverse features including 52% having a TP53 mutation. In addition, 52% of patients had secondary AML. Patients with r/r AML with a TP53 mutation have an expected median OS of 2 months and r/r AML patients who relapse after Venetoclax therapy have an expected survival of 2.4 months. Patients with these characteristics would not typically be considered for CLAG-M therapy outside of this clinical trial of the novel Actimab-A combination. (33)
In the 21 patients evaluable for a response who received Actimab-A CLAG-M, median 1-year overall survival is 53% and 2-year overall survival is 32%. These survival results are in conjunction with a 72% rate of minimal residual disease (“MRD) negativity. (33)
In patients receiving the recommended Phase 2 dose, an 83% overall response rate (“ORR”) and 75% MRD negativity rate were achieved. (33)
Based on these positive results, Actinium Pharmaceuticals Inc. (NYSE: ATNM) is working to develop a regulatory and development pathway for the Actimab-A CLAG-M combination and will be evaluating potential registration-enabling strategies. (33)
In addition, Actinium Pharmaceuticals Inc. (NYSE: ATNM) believes this Actimab-A + CLAG-M combination study has provided proof of principle that the addition of Actimab-A to other AML therapies can lead to well-tolerated regimens with improved responses and survival, which supports its Actimab-A backbone therapy strategy for patients with AML.(33)
ACTIMAB-A + VENETOCLAX
Actinium Pharmaceuticals Inc. (NYSE: ATNM) is also conducting a Phase 1/2 trial combining Actimab-A with the Bcl-2 inhibitor Venetoclax in both fit and unfit patients age 18 and above with relapsed or refractory AML. (33)
This multi-center trial is being led by UCLA Medical Center. This combination is supported by mechanistic evidence in preclinical studies using Venetoclax -resistant AML tumor cell lines. (33)
In these models, Actinium Pharmaceuticals Inc. (NYSE: ATNM) has demonstrated that Actimab-A can deplete Mcl-1 and Bcl-XL, two proteins implicated in mediating resistance to Venetoclax, in addition to causing potentially lethal double-stranded DNA breaks in these CD33 expressing cells. (33)
Furthermore, in vivo studies in animal models of Venetoclax-resistant AML demonstrated robust tumor regression and improved survival in cohorts receiving the Actimab-A Venetoclax combination compared to Venetoclax alone. (33)
The rationale for this clinical study is that the addition of Actimab-A will;
1) have a direct anti-tumor effect via double-stranded DNA breaks and
2) deplete Mcl-1 and Bcl-XL making the AML cells more susceptible to Venetoclax. (33)
The Actimab-A Venetoclax combination has been well tolerated with responses, including a CR and a partial response in early dose escalation cohorts.(33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM) is continuing dose escalation and evaluating the appropriate dose sequence to determine its strategy for the Phase 2 portion of this study. (33) Proof of concept for this novel combination is expected in early 2023 (33)
ANTIBODY WARHEAD ENABLING TECHNOLOGY PLATFORM(33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM)’s proprietary AWE technology platform is supported by intellectual property, know-how, and trade secrets that cover the generation, development, methods of use and manufacture of targeted radiotherapies and certain of their components.(33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM)’s AWE technology patent portfolio presently includes 43 patent families comprised of over 195 issued patents and pending patent applications, of which 10 are issued and 37 are pending in the United States, and 144 are issued or pending internationally.(33)
The effective lives of the issued patents in the company’s portfolio, or patents that may issue from the pending applications in its portfolio, range from expirations between 2024 and 2042. (33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM)’s technology enables the direct labeling, or conjugation and labeling, of a biomolecular targeting agent to a radionuclide warhead and its development and use as a therapeutic regimen for the treatment of diseases such as cancer. The company’s AWE intellectual property covers various methods of use in multiple diseases, including indication, dose and scheduling, radionuclide warhead, and therapeutic combinations. (33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM) has particular expertise in utilizing the alpha-emitting isotope Ac-225 including clinical experience in treating approximately 150 patients with its alpha-emitter-based therapies, “gold standard” linker technology and 5 issued patents in the United States and 49 patents internationally related to the manufacturing or Ac-225 in a cyclotron, which we believe has the potential to produce higher quantities of Ac-225 than currently utilized methods.(33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM)’s research is focused on applying its AWE technology platform to the development of radiation conjugates and to execute on research collaborations. The company’s R&D efforts employ a multidisciplinary approach leveraging its team’s knowledge and experience in cancer cell biology, radiochemistry, radiation sciences, immunology, and oncology drug development. (33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM) intends to focus on generating targeted radiotherapies using our existing intellectual property, evaluating assets for in-licensing to complement our existing clinical pipeline, and securing collaborations and partnerships with biopharmaceutical companies. By adding research and development capabilities to its clinical development and clinical supply chain capabilities, they seek to enable the rapid translation of radiotherapies. (33)
The company’s AWE technology platform is being utilized in its ongoing research collaboration with Astellas to arm select targeting agents owned by Astellas with the alpha-emitting radioisotope Ac-225 for the development of theranostics for solid tumor indications, which combine the ability of radioisotopes to be used for both diagnostic and therapeutic purposes. (33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM) is also collaborating with AVEO Oncology (“AVEO”) to develop a targeted radiotherapy against ErbB3, also known as HER3, with the Ac-225 isotope for solid tumor indications. (33)
HER3 is overexpressed in several solid tumor indications with high unmet needs, including colorectal, gastric, head and neck, breast, ovarian, melanoma, prostate and bladder cancers with HER3 agents under development demonstrating activity in preclinical and clinical studies. (33)
To the company’s knowledge, this is the first HER3 targeting radiotherapy in development. AVEO is developing high-affinity antibodies including HER3 targeting AV-203, which has demonstrated preclinical activity across a number of solid tumor indications and was studied in Phase 1 open-label trial in patients with advanced solid tumors where it was found to be safe and generally well tolerated. (33)
In April 2022, Actinium Pharmaceuticals Inc. (NYSE: ATNM) presented data at the AACR Annual Meeting showing potent tumor cell cytotoxicity, enhanced antitumor effects, and significantly improved survival with an Ac-225 radiolabeled HER3 antibody compared to a naked HER3 antibody in a preclinical NSCLC model. The company is continuing to explore the feasibility of this approach as part of the partnership. (33)
ACTINIUM PHARMACEUTICALS INC. (NYSE: ATNM) COLLABORATES ON NEXT-GEN SMALL-MOLECULE IMMUNOTHERAPY (33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM) is also collaborating with EpicentRx to evaluate Actimab-A in combination with EpicentRx’s RRx-001in AML. (33)
EpicentRx’s RRx-001, currently under investigation in a Phase 3 trial for Small Cell Lung Cancer and in other oncology and non-oncology indications, is a versatile next-generation small molecule immunotherapeutic that targets the CD47-SIRPα axis and the NLRP3 inflammasome to alter the tumor microenvironment and optimize immune response. (33)
This collaboration will explore the mechanistic synergy of RRx-001’s CD47–SIRP downregulation with Actinium’s targeted radiotherapy calreticulin upregulation to increase the immune detection and destruction of cancer cells. Preclinical experiments have begun exploring this combination in AML models. Actinium Pharmaceuticals Inc. (NYSE: ATNM) intends to leverage its experience with CD47 targeting agents such as magrolimab in this collaboration. Based on Actimab-A and RRx-001 both being clinical-stage assets, the company believes there is a potentially faster pathway to clinical trials with this novel combination, particularly if the preclinical safety and efficacy profile is in line with what was observed with Actimab-A and magrolimab. (33)
Actinium Pharmaceuticals Inc. (NYSE: ATNM) also utilized AWE to create a HER2-targeting radiotherapy using the antibody Trastuzumab with either Ac-225 or Lu-177 radioisotopes to study in combination with magrolimab for solid tumors. (33)
Anti-CD47 monotherapies, such as magrolimab, have not shown meaningful responses in clinical studies in solid tumors. The company hypothesized that radiation directed at HER2-expressing cells would upregulate cell surface calreticulin, a pro-phagocytic “eat me” signal, that when combined with an anti-CD47 blockade therapy would enhance antitumor activity. (33)
The combination of the Ac-225 or Lu-117 Trastuzumab with magrolimab slowed tumor growth in animal models of solid tumors compared to either the radiolabeled Trastuzumab or magrolimab as single agents. Actinium Pharmaceuticals Inc. (NYSE: ATNM) is continuing to evaluate this combination in additional tumor models, and it intends to continue to study this combination with the goal of advancing to human clinical trials.(33)
ACTINIUM PHARMACEUTICALS INC. (NYSE: ATNM) HIGHLIGHTS (33)
- Positive top-line results from the pivotal Phase 3 SIERRA trial p< 0 0001 for primary endpoint durable Complete Remission
- Iomab-B addresses the initial market of 10,000 r/r AML patients who do not access potentially curative BMT with current approaches
- Data supports continued expansion of targeted conditioning for BMT in other blood cancers and for cellular therapy and gene therapy indications
- 1 year and 2 year OS data from Actimab A CLAG M combination trial compares favorably to current therapies for r/r AML patients and supports backbone therapy strategy in AML
- Leadingedge innovation in radio pharma R&D drives partnerships including Astellas in solid tumor theranostics, first in class radiotherapy combinations in solid tumors including HER 3 with AVEO and EpicentRx with CD 47 immunotherapy
- Strong balance sheet with over $111 million enables multiple milestones including SIERRA BLA filing/potential approval
RECENT NEWS
Actinium Pharmaceuticals Announces Iomab-B SIERRA Trial Database Lock, Provides Corporate Update Highlighting Key Upcoming Milestones (27)
On February 6, 2023, Actinium Pharmaceuticals, Inc. (NYSE: ATNM) announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes for Health (NIH), to develop Actimab-A for the treatment of patients with acute myeloid leukemia (AML) and other hematologic malignancies. (40)
Under the terms of the CRADA, the NCI will serve as the regulatory sponsor for any clinical trials mutually approved by both parties to study Actimab-A while Actinium will be responsible for supplying and distributing Actimab-A to participating clinical sites and providing additional support as needed. (40)
The CRADA will provide broad support for the development of Actimab-A alone or in combination with chemotherapy, immunotherapy, targeted agents and other novel combinations, in line with Actinium’s strategy of leveraging Actimab-A’s targeted radiotherapy mechanism to elicit synergistic effects. (40)
The CRADA studies will be overseen by NCI in collaboration with Actinium’s clinical development team. (40)
Through the CRADA, Actimab-A will be available at over 2,000 clinical trial sites under the Experimental Therapeutics Clinical Trials Network (ETCTN) and the National Clinical Trials Network (NCTN) that includes leading oncology network groups such as Eastern Cooperative Oncology Group and the American College of Radiology Imaging Network (ECOG-ACRIN), Southwest Oncology Group (SWOG) and the Alliance for Clinical Trials in Oncology. Actimab-A studies may also be conducted through NCI’s MyeloMATCH program. (40)
NCI Cancer Therapy Evaluation Program (CTEP), which sponsors approximately two thirds of all combination cancer studies, will be accepting Letters of Intent (LOIs) or concepts for Phase 1, 2 or 3 studies of Actimab-A in AML and other hematological malignancies. (40)
Sandesh Seth, Actinium’s Chairman and CEO, said, “We are incredibly honored to be collaborating with NCI and excited that they share our vision for Actimab-A’s potential for the treatment of AML and other blood cancers. The CRADA will allow Actimab-A’s broad applicability to be fully studied and developed by leading oncology network groups as well as NCI’s leading-edge MyeloMATCH program in ways Actinium could not do independently. NCI’s sponsorship will also allow us to accelerate novel Actimab-A combinations and broaden its use in AML and other hematological indications, while the collaboration with NCI, who funds and maintains the largest centralized clinical trial support systems in the United States, will help preserve our balance sheet for additional corporate priorities.” (40)
Dr. Avinash Desai, Chief Medical Officer of Actinium Pharmaceuticals, commented, “NCI’s broad support under the CRADA is a strong encouragement for us to together explore Actimab-A’s potential for the treatment of AML and other hematologic malignancies. As the only CD33 targeting radiotherapy in development, Actimab-A is uniquely positioned to address the challenges in treating relapsed or refractory AML patients who do not respond well to front line therapies and those whose disease stops responding to traditional cytotoxic or available targeted therapies. We are highly encouraged by the high rates of responses, minimal residual disease negativity and strong survival benefit at 1 and 2 years in heavily treated patients, including prior Venetoclax treatment and/or transplant, and those with adverse cytogenetics, including TP53 mutations, recently reported from the Actimab-A CLAG-M combination study. We look forward to working collaboratively with the NCI and all investigators through this CRADA to complete multiple clinical trials to further realize Actimab-A’s therapeutic potential.” (40)
THE MANAGEMENT TEAM
SANDESH SETH – CHIEF EXECUTIVE OFFICER AND CHAIRMAN OF THE BOARD
Sandesh has 25+ years of experience in investment banking (Laidlaw& Co (UK) Ltd., Cowen & Co.), equity research (Bear Stearns, Commonwealth Associates) and in the pharma industry (Pfizer, Warner-Lambert, SmithKline in strategic planning, business development and R&D project management). Sandesh was chairman of Relmada Therapeutics Inc., a specialty pharma company focused on CNS therapeutics, which he helped co-found. Sandesh has an MBA in Finance from New York University; an M.S. in the Pharmaceutical Sciences from the University of Oklahoma Health Center and a B.Sc. in Chemistry from Bombay University. He has published several scientific articles and was awarded the University Regents Award for Research Excellence at the University of Oklahoma. Sandesh was designated as Regulatory Affairs Certified by the Regulatory Affairs Professionals Society which signifies proficiency with U.S. FDA regulations. He has several patents related to use of radiopharmaceuticals as conditioning agents for adoptive cell therapies and as therapeutic combinations.
MADHURI VUSIRIKALA, M.D. – VICE PRESIDENT, CLINICAL DEVELOPMENT BMT AND CELLULAR THERAPY
Madhuri is an accomplished bone marrow transplant physician and hematologist with over 20 years of clinical experience. She is board certified in internal medicine, hematology and oncology. Madhuri joins Actinium from UT Southwestern Medical Center in Dallas, Texas, where she has been a Professor of Internal Medicine in the Division of Hematology/Oncology and Medical Director of the Adult Allogeneic Bone Marrow Transplant Program. She specialized in managing a variety of hematologic malignancies and performing allogeneic bone marrow transplants for these patients when indicated. She also served as primary investigator for most of the clinical trials at UT Southwestern related to BMT. Madhuri earned her medical degree (M.B.B.S.) at India’s Lady Hardinge Medical College before completing an internal medicine internship at Maulana Azad Medical College-Delhi University and an internal medicine internship and residency at The State University of New York, Syracuse. She also completed a hematology and oncology fellowship at the University of Pittsburgh and an advanced fellowship in bone marrow transplantation at Vanderbilt University Medical Center. Madhuri is a member of the American Society of Hematology, American Society of Transplantation and Cellular Therapy. She serves as a member on the NCCN panels for Hematopoietic Cell Transplantation and Acute Lymphoblastic Leukemia committees.
PATRIK BRODIN, MSC, PH.D. – VICE PRESIDENT, HEAD OF RADIATION SCIENCES
Patrik is a board certified Medical Physicist, and a Diplomat of the American Board of Radiology in the discipline of Therapeutic Medical Physics, and previously, was an Assistant Professor and Senior Physicist at the department of Radiation Oncology at Montefiore/Einstein. By combining his expertise in radiation physics and data analysis with biology-based research methods, he spearheaded the development of new approaches in radiation-driven immunotherapy, and solutions for reducing the risk of severe treatment complications associated with receiving high-dose radiation therapy. Patrik has experience and expertise in clinical medical physics, biostatistics and advanced analytical methods including quantitative image analysis, and novel experimental design. He has authored more than 60 peer-reviewed publications and presented at national and international meetings including oral presentations at the ESTRO, ASTRO, AAPM and PTCOG annual meetings. Patrik trained in Medical Physics at Lund University, Sweden, followed by a PhD at the Niels Bohr Institute at the University of Copenhagen, Denmark, and received his M.Sc. in Clinical Research Methods from Yeshiva University upon coming to the United States.
AVINASH DESAI, M.D. – CHIEF MEDICAL OFFICER
Avinash is an industry veteran in the hematology and oncology field, most recently serving as Vice President, Head of U.S. Medical Affairs – Oncology at Glaxo Smith Kline (GSK). Over the course of his twenty-five-year career, Avinash successfully designed and implemented clinical development, U.S. and global medical affairs, and life cycle management plans for a variety of pharmaceutical products. This has included participation in multiple INDs, NDAs, and sNDA submissions and efficiently managing the product Scientific Advisory Boards (SAB) and Data and Safety Monitoring Boards (DSMB) for hematology, oncology and therapeutic candidates. At GSK, he established the U.S. medical affairs oncology team that oversaw the launch readiness plans for three novel oncology products—Blenrep® in multiple myeloma, Zejula® in ovarian cancer, and dostarlimab in endometrial cancer. In addition to GSK, Avinash has overseen the clinical development, implementation and delivery of oncology life cycle management plans for various oncology therapies at several leading global pharmaceutical companies, including Eli Lilly & Company (Lilly), Janssen Pharmaceuticals, Inc. and Takeda, Inc. Prior to GSK, he was the VP of Global Medical Affairs at Lilly, during which time he oversaw the global medical affairs team for Lilly’s GI Oncology portfolio. Earlier in his career, Avinash contributed to the approval of Janssen’s myeloma drug Darzalex® (daratumumab) and leading and strategically executing medical affairs activities globally for Velcade® (bortezomib). Prior to Janssen, Avinash was responsible for the international development of oncology products in solid tumors and hematological malignancies at Sanofi, where he successfully executed pivotal trials that led to NDA submission for Jevtana® (cabazitaxel).
DR. MARY MEI CHEN, M.D., PH.D. – VICE PRESIDENT, CLINICAL DEVELOPMENT
Mary leads clinical development programs in hematological malignancies and solid tumors at Actinium Pharmaceuticals, Inc. Prior to joining Actinium, she led multiple clinical trials including the global pivotal Phase 3 study of Uproleselan in AML as well as Phase 1 through Phase 3 clinical trials in patients with multiple myeloma, and solid tumors. She successfully led multidisciplinary teams in the submission of multiple INDs/Clinical Trial Application and participate multiple NDA applications in the US, EU, and other regions at Takeda Inc and Pfizer (Wyeth). She received training in both hematology (M.D.) and immunology (Ph.D.) followed by over twenty years of hematology oncology experience from academics and industry. Before moving her career to industry, she was a faculty, Instructor in Medicine, at Harvard Medical School, Brigham and Women’s Hospital. Mary received her Doctor of Medicine degree from Shanghai Jiao Tong University, School of Medicine. and her Ph.D. in Immunology from Chiba University, Graduate School of Medicine in Tokyo, Japan. She completed her postdoctoral fellowship in Harvard Medical School, Boston. Over the course of her career, she has authored over 60 peer reviewed publications in high impact journals.
NEWS
ACTINIUM TO PRESENT FULL RESULTS FROM PIVOTAL PHASE 3 IOMAB-B SIERRA TRIAL ON INVESTOR CALL FOLLOWING THE LATE-BREAKER PRESENTATION AT THE 2023 TRANSPLANTATION & CELLULAR THERAPY TANDEM MEETINGS ON SATURDAY, FEBRUARY 18, 2023
FEB 14, 2023
ACTINIUM SIGNS COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT WITH NATIONAL CANCER INSTITUTE TO FURTHER ENHANCE CLINICAL AND NON-CLINICAL DEVELOPMENT OF ACTIMAB-A FOR THE TREATMENT OF ACUTE MYELOID LEUKEMIA AND OTHER HEMATOLOGIC MALIGNANCIES
FEB 6, 2023
ACTINIUM PHARMACEUTICALS, INC. TO PRESENT AT THE 3RD ANNUAL B. RILEY SECURITIES ONCOLOGY CONFERENCE
JAN 17, 2023
ACTINIUM ANNOUNCES PHASE 3 IOMAB-B SIERRA DATA ACCEPTED FOR LATE-BREAKER PRESENTATION AT THE TRANSPLANTATION & CELLULAR THERAPY TANDEM MEETINGS
JAN 12, 2023
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
DEC 12, 2022
ACTINIUM PHARMACEUTICALS, INC. ANNOUNCES RESEARCH COLLABORATION WITH COLUMBIA UNIVERSITY TO STUDY ACTIMAB-A IN AML FOLLOWING TRANSPLANT OF ENGINEERED HEMATOPOIETIC STEM CELLS GENE EDITED TO BE CD33 NEGATIVE
DEC 8, 2022
ACTINIUM ANNOUNCES POSITIVE 1-YEAR AND 2-YEAR OVERALL SURVIVAL DATA FOR PATIENTS WITH RELAPSED OR REFRACTORY AML IN PHASE 1 ACTIMAB-A CLAG-M COMBINATION TRIAL
NOV 3, 2022
ACTINIUM APPOINTS SEASONED LEADER CAROLINE YARBROUGH AS CHIEF COMMERCIAL OFFICER TO SPEARHEAD IOMAB-B COMMERCIALIZATION
NOV 2, 2022
ACTINIUM ANNOUNCES POSITIVE TOP-LINE RESULTS FROM PIVOTAL PHASE 3 SIERRA TRIAL OF IOMAB-B IN PATIENTS WITH ACTIVE RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA
OCT 31, 2022
ACTINIUM EXPANDS CLINICAL LEADERSHIP TEAM TO SUPPORT KEY DEVELOPMENT PROGRAMS FOR IOMAB-B AND ACTIMAB-A
OCT 27, 2022
ACTINIUM PHARMACEUTICALS TO PARTICIPATE IN THE 2022 BIO-EUROPE CONFERENCE
OCT 26, 2022
ACTINIUM BOLSTERS ITS SENIOR LEADERSHIP TEAM AHEAD OF UPCOMING CLINICAL DATA FOR IOMAB-B
OCT 25, 2022
ACTINIUM TO PRESENT AT THE CANTOR FITZGERALD ONCOLOGY, HEMATOLOGY & HEMEONC CONFERENCE
SEP 26, 2022
Sincerely,
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![Rodney Varner, CEO of Austin-based biotech company Genprex, stands at the podium during the closing bell ceremony for the Nasdaq exchange in 2018 following the company's initial public offering of stock. [Photo courtesy Genprex]](https://www.gannett-cdn.com/authoring/2020/02/24/NAAS/ghows-TX-ade062b1-031d-455e-8c47-8ec9f0909c2f-453ac4bb.jpeg?width=660&height=441&fit=crop&format=pjpg&auto=webp)
REQORSA + Tarceva Combination: Phase 2 data in subjects with or without EGFR mutationsACCLAIM-1
COMBINING REQORSA™ IMMUNOGENE THERAPY WITH TAGRISSO (OSIMERTINIB)Preliminary analysis of the interim data from the Phase 2 portion of our ONC-002 trial supported our belief that REQORSA™ may provide medical benefit in several subpopulations of NSCLC patients for which there is an unmet medical need, and may provide pathways for accelerated approval by the U.S. Food and Drug Administration, or FDA. Data from our clinical trials, along with our preclinical data, provided the basis for our application for a Fast Track Designation, which was granted by FDA on January 14, 2020.In granting our Fast Track Designation, the FDA found that REQORSA may provide a benefit over existing therapies for patients whose tumors progress on AstraZeneca’s Tagrisso. The FDA Fast Track Designation is for use of REQORSA in combination with TKI Tagrisso for the treatment of NSCLC patients with EGFR mutations whose tumors progressed after treatment with Tagrisso. We believe that the Fast Track Designation provides a clearly defined pathway toward FDA approval of the combination of REQORSA with Tagrisso.We initiated the Acclaim-1 clinical trial in June 2021, a Phase 1/2 clinical trial of REQORSA combined with Tagrisso. To learn more about Acclaim-1, please visit 
COMBINING REQORSA™ IMMUNOGENE THERAPY WITH KEYTRUDA (PEMBROLIZUMAB)Researchers at MD Anderson Cancer Center have conducted preclinical studies evaluating REQORSA™ in combination with anti-PD1 checkpoint inhibitors, including Merck’s Keytruda.Positive and encouraging data indicate that REQORSA is synergistic with immunotherapies.In April 2019, we reported that our collaborators at MD Anderson presented positive preclinical data for the combination of TUSC2 with pembrolizumab, demonstrating that TUSC2 combined with checkpoint blockade was more effective than checkpoint blockade alone in increasing the survival of mice with human immune cells, that had metastatic lung cancer.In November 2019, we reported that our collaborators at MD Anderson presented positive preclinical data for the combination of TUSC2, pembrolizumab and chemotherapy for the treatment of some of the most resistant metastatic lung cancers. This study found that the combination of TUSC2 increases the effectiveness of pembrolizumab and chemotherapy, and thus, may improve on first-line standard of care for lung cancer.In May 2020, we entered into a worldwide, exclusive license agreement with The Board of Regents of the University of Texas System on behalf of MD Anderson for the use of TUSC2 in combination with immunotherapies, including Keytruda, and also for the use of TUSC2 in a three-drug combination of TUSC2, immunotherapy and chemotherapy.In December 2021, we received Fast Track Designation from the FDA for use of REQORSA in combination with the checkpoint inhibitor Keytruda for the treatment of advanced NSCLC patients whose tumors progressed after treatment with Keytruda.In March 2022, we opened the Acclaim-2 clinical trial for patient enrollment, a Phase 1/2 clinical trial of REQORSA combined with Keytruda. To learn more about Acclaim-2, please visit 
