On June 10, 2024 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies, reported data from multiple abstracts that were presented at the 2024 Society of Nuclear Medicine & Molecular Imaging (SNMMI) Annual Meeting being held June 8 – 11, 2024, in Toronto, Canada (Press release, Actinium Pharmaceuticals, JUN 10, 2024, View Source [SID1234644229]). The presentations featured results from the Phase 3 SIERRA trial of Iomab-B, a CD45 targeting ARC with the Iodine-131 payload, intended for conditioning to prepare patients with active relapsed or refractory acute myeloid leukemia (r/r AML) for a potentially curative bone marrow transplant (BMT). The Phase 3 SIERRA trial enrolled 153 r/r AML patients. Iomab-B achieved the primary endpoint of durable Complete Remission (dCR) with high statistical significance (p<0.0001). Additionally, Actinium’s novel linker technology was highlighted in a presentation demonstrating high tumor uptake and in vivo stability in preclinical models with significantly lower kidney and liver uptake compared to standard DOTA linkers.

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Actinium’s Iomab-B SNMMI presentations and highlights:

Survival Outcomes and Dosimetric Analysis of Iomab-B (131I-apamistamab) Followed by Allogeneic Hematopoietic Cell Transplant for Patients with TP53 Mutated Relapsed/Refractory AML

37 patients (24%) enrolled on SIERRA had a TP53 mutation with 27 patients receiving Iomab-B (either through randomization or cross over) and 10 patients on the control arm
For patients with TP53 mutation who received Iomab-B, the median OS was 5.49 months compared to a median 1.66 months in pts who did not receive Iomab-B (HR=0.23; 95% CI [0.10, 0.52])
These results support Iomab-B’s differentiated mechanism of action to overcome the negative impact of TP53 mutation typically associated with a dismal prognosis in these patients
Exploratory Analysis of Bone Marrow Dosimetry from the Randomized Phase 3 SIERRA Trial of Iomab-B (131I-apamistamab) Prior to HCT in Relapsed/Refractory Acute Myeloid Leukemia

Iomab-B safely delivers high doses of myeloablative targeted radiation to the diseased bone marrow at greater amounts than what would be achieved with total body irradiation
Myeloablative doses were safely delivered to patients irrespective of age, performance status and other metrics
A median of 16Gy of radiation was delivered to the bone marrow while normal healthy organs received significantly less exposure, including the heart (2.6 Gy), lungs (2.5 Gy), small intestine (2.4 Gy), stomach (3.6 Gy), kidneys (4.1 Gy) and the whole body (3.3 Gy)
Mathematical Modeling of Exposure Measurements Following High-Dose Targeted Therapy Using 131I-apamistamab: Analysis From the Large Multicenter Phase III SIERRA Trial

SIERRA patients received up to 1,030 mCi (range: 300-1,030) of Iodine-131 via Iomab-B
Iomab-B is administered via a single infusion 12 days prior to BMT
Data from SIERRA show that the median time for patients to reach the release criteria was 5 days, including in patients receiving greater than 800 mCi
Actinium’s Proprietary Linker Technology SNMMI presentation and highlights:

Evaluation of novel DOTA-based linkers for improved targeted radiotherapy delivery to solid tumors

Novel linkers showed significantly lower kidney and liver uptake compared to standard DOTA linkers
SPECT/CT imaging showed high tumor uptake and in vivo stability in preclinical models
Successful design, efficient conjugation and pharmacological properties support further advancement of these novel linkers
Actinium has two wholly owned U.S. patents covering its novel bifunctional linker technology with each having a patent term extending into 2043 and a pending international patent application
Sandesh Seth, Actinium’s Chairman and CEO, said, "At this year’s SNMMI, we are proud to highlight Actinium’s broad ARC pipeline and capabilities. Building on our leadership position in hematology focused ARCs through Iomab-B and Actimab-A, we are excited to highlight the potential to treat patients with high-risk relapsed or refractory AML and overcome TP53 mutations or extensive prior therapy including Venetoclax. Hematology represents an area with potential for significant growth for the field of nuclear medicine and there is great excitement from the community around our efforts. Consistent with our vision to build a leading specialty radiotherapeutics company, we are also eager to highlight our novel linker technology for solid tumor ARCs. Finally, SNMMI provides the opportunity to showcase our proprietary Actinium-225 cyclotron-based manufacturing technology that has the potential to produce highly pure medical grade Actinium-225 at a scale and cost that is not currently achievable, which has been met with great enthusiasm given the industry emphasis on Actinium-225 supply."

About the SNMMI Annual Meeting

The SNMMI Annual Meeting is recognized as the premier educational, scientific, research, and networking event in nuclear medicine and molecular imaging. The four-day event, taking place each June, provides physicians, technologists, pharmacists, laboratory professionals, and scientists with an in-depth view of the latest research and development in the field as well as providing insights into practical applications for the clinic.

On June 10, 2024 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported the completion of enrollment as well as positive initial data from the ongoing Phase 2a trial of SLS009, a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML) (Press release, Sellas Life Sciences, JUN 10, 2024, View Source [SID1234644225]).

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"We are pleased to announce the completion of enrollment in the initial portion of our Phase 2a trial representing a significant milestone in the development of SLS009 in AML," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "There has been a high level of enthusiasm from the clinical sites, trial investigators, and patients, reflecting the significant unmet need in the AML patient population previously treated with venetoclax-based regimens. We are extremely grateful to everyone who has helped us achieve this important milestone ahead of schedule."

Dr. Stergiou continued: "In addition, we are excited to share very promising initial data from this Phase 2a trial. Efficacy was demonstrated across all cohorts far exceeding the targeted ORR of 20% and median overall survival (mOS) of 3 months. The results also showed that SLS009 was well-tolerated across all doses. These data give us increased confidence in SLS009 as a potential new treatment for AML. We remain committed to advancing the treatment landscape for this underserved patient population and we look forward to continuing the trial, mainly the expansion cohorts, and reporting additional study updates and data in Q3 of this year."

Thirty heavily pretreated patients were recruited in 5 centers across the US, reflecting the high unmet need of this refractory/relapsed patient population. Except for one, all patients in this Phase 2a trial had unfavorable/poor cytogenetic and/or molecular genetics risk (97%) and were treated with continued venetoclax – azacytidine combination therapy after having failed it or similar venetoclax combinations, often more than once. The expected overall survival in those patients is approximately 2.5 months.

Key Highlights from the Initial Data:

Safety:

SLS009 was generally well-tolerated with no safety issues observed across all doses.
There were no dose-limiting and no high-grade treatment-related non-hematologic toxicities. Hematologic toxicities profile was not different from that of venetoclax-based regimens alone.
27 patients had at least one efficacy assessment as of May 25, 2024, and were considered evaluable for efficacy.
Efficacy:

The overall response rate was 29.6% in all evaluable patients, and across all SLS009 doses, with the highest response rate of 50% observed at the dosing regimen of 30 mg BIW.
In the first dose level (safety level, one dose level below recommended Phase 2 dose) of 45 mg once a week (QW), the median overall survival among evaluable patients followed for survival was 5.4 months, compared to the expected survival of 2.5 months in patients refractory to and relapsed on standard venetoclax in combination with hypomethylating agents.
In the second dose level, 60 mg, administered once a week, 3 out of 9 evaluable patients (33%) achieved an overall response defined as leukemia-free status that includes complete response (CR), complete response with incomplete hematologic recovery (CRi), and morphologic leukemia-free state (MLFS). Median survival has not been reached.
In the third dose level of 30 mg twice a week, 4 out of 8 patients (50%) evaluable to date achieved overall response defined as leukemia-free status that includes complete response (CR), complete response with incomplete hematologic recovery (CRi), and morphologic leukemia-free state (MLFS). Median survival has not been reached.
Observed efficacy outcomes exceeded the target ORR of 20% and mOS of 3 months.
The highest response rates were observed among patients harboring ASXL1 mutations as previously reported. Notably, responses were highly correlated with mutational status, with 6 out of 8 responding patients having myelodysplasia-related somatic mutations and 5 having specifically ASXL1 mutations.
A 100% overall response rate (CR/CRi/MLFS) was achieved in patients with ASXL1 mutations in the 30 mg BIW cohort to date.
Based on the preliminary findings from this Phase 2a trial, the trial has been expanded to include two additional cohorts consisting of dosing at 30 mg BIW. One cohort will enroll AML patients with ASXL1 mutations and the other AML patients with myelodysplasia-related molecular mutations other than ASXL1. Study enrollment continues and additional updates and data are expected in Q3.
The Phase 2a clinical trial of SLS009 is an open-label, single-arm, multi-center study designed to evaluate the safety, tolerability, and efficacy of SLS009 in combination with venetoclax and azacitidine at two dose levels, 45 and 60 mg. In the 60 mg dose cohort patients were randomized into either a 60 mg dose once per week or a 30 mg dose two times per week. The target response rate at the optimal dose level is 20% with a target median survival of at least 3 months. In addition, the study aims to identify biomarkers for the target patient population and enrichment for further trials. For more information on the study, visit clinicaltrial.gov identifier NCT04588922.

On June 10, 2024 Royalty Pharma plc (the "Issuer") reported offering of $500 million aggregate principal amount of 5.150% Senior Notes due 2029 (the "2029 Notes"), $500 million aggregate principal amount of 5.400% Senior Notes due 2034 (the "2034 Notes") and $500 million aggregate principal amount of 5.900% Senior Notes due 2054 (the "2054 Notes" and, together with the 2029 Notes and the 2034 Notes, the "Notes") (Filing, 8-K, Royalty Pharma , JUN 10, 2024, View Source [SID1234644224]). The Notes were issued under the indenture (the "Base Indenture"), dated as of September 2, 2020, among the Issuer, Royalty Pharma Holdings Ltd (the "Guarantor") and Wilmington Trust, National Association, as trustee (the "Trustee"), as supplemented by a third supplemental indenture (the "Third Supplemental Indenture" and, together with the Base Indenture, the "Indenture"), dated as of June 10, 2024, among the Issuer, the Guarantor and the Trustee. The Notes are guaranteed on a senior unsecured basis by the Guarantor.

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The 2029 Notes bear interest at a fixed rate of 5.150% per annum, and interest will be payable on March 2 and September 2 of each year, beginning March 2, 2025, until the maturity date of September 2, 2029. The 2034 Notes bear interest at a fixed rate of 5.400% per annum, and interest will be payable on March 2 and September 2 of each year, beginning March 2, 2025, until the maturity date of September 2, 2034. The 2054 Notes bear interest at a fixed rate of 5.900% per annum, and interest will be payable on March 2 and September 2 of each year, beginning March 2, 2025, until the maturity date of September 2, 2054. The Issuer may redeem the Notes at such times and at the redemption prices as provided for in the Indenture. The Indenture also contains certain covenants as set forth in the Indenture and requires the Issuer to offer to repurchase the Notes upon certain change of control events.

The foregoing summary of the Indenture and the Notes does not purport to be complete and is qualified in its entirety by reference to the full text of (i) the Base Indenture attached as Exhibit 4.1 hereto and (ii) the Third Supplemental Indenture attached as Exhibit 4.2 hereto and the form of the Notes included therein, which are incorporated herein by reference.

On June 10, 2024 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharmaceutical company focused on developing innovative treatments for cancer patients, reported data from the preclinical development of its novel first-in-class lead radiopharma program MNPR-101-Zr at the 2024 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in Toronto, Canada (Press release, Monopar Therapeutics, JUN 10, 2024, View Source [SID1234644223]). SNMMI is the premier educational, scientific, and research event in the radiopharma space. Monopar’s poster presentation can be found at the following link: View Source

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Monopar’s poster highlights the potential promise of both the urokinase plasminogen activator receptor (uPAR) as a radiopharma cancer target for solid tumors as well as MNPR-101 as a targeting agent against uPAR. The data presented demonstrate robust, durable tumor uptake of Zr-89 radiolabeled MNPR-101 (MNPR-101-Zr) in human tumor xenograft mouse models of triple-negative breast, colorectal, and pancreatic cancers. Monopar’s optimization of the MNPR-101-Zr construct achieved markedly higher tumor uptake and drug stability while minimizing accumulation in bone and healthy tissue.

Monopar recently initiated a first-in-human Phase 1 imaging and dosimetry clinical trial in advanced cancer patients with MNPR-101-Zr. The study is led by internationally recognized radiopharmaceutical physician Prof. Rodney Hicks, founder of the Melbourne Theranostic Innovation Centre (MTIC). Further information about the MNPR-101-Zr trial is available at www.ClinicalTrials.gov under study identifier NCT06337084.

On June 10, 2024 InDex Pharmaceuticals Holding AB (publ) (under name change to Flerie AB) ("InDex Pharmaceuticals" or the "Company") reported that the reverse merger with Flerie Invest AB ("Flerie"), pursuant to the agreement entered into and announced on May 20, 2024, has been completed (Press release, InDex Pharmaceuticals, JUN 10, 2024, View Source [SID1234644222]). As a result thereof, the Company changes its name to Flerie AB and a new board and management take office.

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Completion of the reverse merger
On May 20, 2024 InDex Pharmaceuticals entered into a conditional agreement, to acquire all shares in Flerie (the "Transaction"). The Transaction constitutes a so-called reverse merger whereby Flerie becomes a wholly-owned subsidiary of InDex Pharmaceuticals.

The completion of the Transaction was, among other things, conditional upon resolutions at extraordinary general meetings of the Company. The extraordinary general meetings, held on June 10, 2024, resolved to adopt all of the board’s proposed resolutions related to the Transaction. The resolutions are further described in the bulletin from the meetings that was announced by the Company earlier today. In addition to the resolutions at the extraordinary general meetings, the Company and Flerie agree that all other conditions of the Transaction have been fulfilled. The Transaction has therefore today been completed.

The purchase price in the Transaction has been paid through an issue in kind of 6,073,952,948 new shares in the Company (the "Consideration Shares"). The Consideration Shares have been subscribed for by the former shareholders of Flerie in exchange for all shares in Flerie. Following registration of the Consideration Shares, the former shareholders of Flerie will initially hold approximately 91.9 per cent of the total number of shares and votes in the Company, prior to completion of the capital raise outlined in the company description published by the Company on May 27, 2024.

At the extraordinary general meetings held today June 10, 2024, it was, among other things, resolved to change the company name of the Company to Flerie AB and to appoint Thomas Eldered, Cecilia Edström, Anders Ekblom and Jenni Nordborg as new board members of the Company, with Thomas Eldered as chairman. Flerie’s CEO Ted Fjällman has been appointed CEO of the Company and Flerie’s CFO and deputy CEO Cecilia Schéele has been appointed CFO and deputy CEO of the Company.

Company description
Following completion of the Transaction, the Company’s business consists of the business currently conducted by Flerie. In light of the substantial change in operations that the Transaction entails, the Company published a company description on May, 27 2024 with information about, inter alia, Flerie, InDex Pharmaceuticals, and the Transaction. The company description is available on Flerie’s website: www.flerie.com.

Admission to trading on Nasdaq Stockholm
In connection with completion of the Transaction, the Company intends to carry out an uplisting from Nasdaq First North Growth Market to Nasdaq Stockholm. The Company will prepare and publish a prospectus for admission to trading of the Company’s share on Nasdaq Stockholm. The prospectus is intended to be registered by the Swedish Financial Supervisory Authority and published around June 26, 2024. The first day of trading on Nasdaq Stockholm is planned to take place around June 27, 2024.