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.

On June 10, 2024 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that the European Commission has approved a Chugai originated anaplastic lymphoma kinase (ALK) inhibitor Alecensa (generic name : alectinib) monotherapy, as adjuvant treatment following tumour resection for adult patients with ALK-positive non-small cell lung cancer (NSCLC) at high risk of recurrence (Stage IB [tumors ≥ 4 cm]–IIIA NSCLC [7ᵗʰ edition UICC/AJCC]) (Press release, Chugai, JUN 10, 2024, View Source [SID1234644221]). Data from the Phase III ALINA trial, where Alecensa demonstrated a 76% reduction in the risk of disease recurrence or death in people with resected ALK-positive NSCLC, supported the marketing authorisation application.1

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"We are very pleased that Alecensa, a Chugai originated medicine, received approval in Europe following the U.S. approval for adjuvant treatment of ALK-positive early-stage NSCLC. We believe that this approval will have a significant impact, providing a new treatment opportunity for patients who have dealt with the risk of recurrence even after undergoing tumor resection. We remain committed to working with Roche to bring the benefits of this drug to patients around the world." said Chugai’s President and CEO, Dr. Osamu Okuda.

In the ALINA study, Alecensa reduced the risk of disease recurrence or death by 76% (hazard ratio [HR]=0.24, 95% CI: 0.13-0.43, p<0.0001) compared with platinum-based chemotherapy in people with completely resected IB (tumors ≥ 4 cm) to IIIA (UICC/AJCC 7th edition) ALK-positive NSCLC.1 In an exploratory analysis, an improvement of central nervous system disease-free survival was observed (HR=0.22; 95% CI: 0.08-0.58) compared with platinum-based chemotherapy.1 This is of particular importance for people with ALK-positive NSCLC, who are at greater risk of developing brain metastases than those with other types of NSCLC.2 The safety and tolerability of Alecensa in the ALINA trial were generally consistent with previous trials in the metastatic setting and no unexpected safety findings were observed.1 These data were published in the New England Journal of Medicine in April 2024.

Alecensa is the preferred treatment option for patients with advanced ALK-positive NSCLC. Approved in more than 100 countries as a first- and second-line treatment, more than 94,000 patients with advanced disease have been treated with Alecensa in clinical practice. Following its approval in the adjuvant treatment setting, Alecensa could play a pivotal role in ALK-positive resectable disease, where there is a significant unmet medical need. Today’s approval in Europe follows the April 2024 U.S. Food and Drug Administration (FDA) approval of Alecensa as adjuvant treatment following tumor resection for patients with ALK-positive NSCLC (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test. Submissions to additional health authorities worldwide are ongoing to bring this new treatment option to as many patients as possible.

To support clinicians’ decision-making, testing of resected surgical tissue or biopsy for ALK, EGFR and PD-L1 biomarkers in patients with stage IB to IIIA and selected IIIB (UICC/AJCC 8th edition) NSCLC, in addition to in the advanced setting, is recommended by international guidelines, including the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines).

About the ALINA study
The ALINA study [NCT03456076] is a Phase III, randomized, active-controlled, multicenter, open-label study evaluating the efficacy and safety of adjuvant Alecensa (alectinib) compared with platinum-based chemotherapy in people with resected Stage IB (tumors ≥ 4 cm) to IIIA (UICC/AJCC 7th edition) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). The study included 257 patients who were randomly assigned to either the Alecensa or chemotherapy treatment arm. The primary endpoint is disease-free survival. Secondary outcome measures include overall survival and percentage of patients with adverse events.

About Alecensa
Alecensa is a highly selective, central nervous system-active, oral medicine created at Chugai, a member of the Roche Group, for people with NSCLC whose tumors are identified as ALK-positive. Alecensa is already approved in over 100 countries as an initial (first-line) and second-line treatment for ALK-positive, metastatic NSCLC, including in the United States, Europe, Japan and China. Alecensa was approved by the U.S. Food and Drug Administration (FDA) in April 2024 as adjuvant treatment following tumor resection for patients with ALK-positive NSCLC (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test, and in June 2024 by the European Commission, as a monotherapy for adjuvant treatment following tumor resection for adult patients with ALK-positive NSCLC at high risk of recurrence (Stage IB [tumors ≥ 4 cm]–IIIA NSCLC [7ᵗʰ edition UICC/AJCC]). In Japan, Alecensa has also been approved for the treatment of recurrent or refractory ALK fusion gene-positive anaplastic large cell lymphoma.

About lung cancer
Lung cancer is one of the leading causes of cancer death globally.3 Each year 1.8 million people die as a result of the disease; this translates into more than 4,900 deaths worldwide every day.3 In Japan, 127 thousand people are affected by this disease (2019).4 Lung cancer can be broadly divided into two major types: non-small cell lung cancer (NSCLC) and small-cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.5 Today, about half of all people with early lung cancer (45-76%, depending on disease stage) still experience a cancer recurrence following surgery, despite adjuvant chemotherapy.6 Treating lung cancer early, before it has spread, may help prevent the disease from returning and provide people with the best opportunity for a cure.7

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