On March 17, 2025 Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) reported that the Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria or ‘ANVISA’) has approved Illuccix (kit for the preparation of gallium-68 (68Ga) gozetotide injection) the Company’s lead prostate cancer imaging agent (Press release, Telix Pharmaceuticals, MAR 17, 2025, View Source [SID1234651200]). Illuccix is the first and only PSMA-PET[1] prostate cancer imaging agent to receive full regulatory approval in Brazil.

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Illuccix, after radiolabeling with 68Ga, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

With suspected metastasis who are candidates for definitive initial therapy treatment, and
With suspected recurrence based on an elevated specific antigen (PSA) level in the serum.
The marketing authorization is granted to Telix’s partner R2PHARMA, Brazil’s leading cold kit manufacturer, nuclear pharmacy and cyclotron network, and a subsidiary of GSH Corp Participações S.A. (Grupo GSH). Telix has provided Grupo GSH with an exclusive license to manufacture, distribute and market Illuccix in Brazil[2].

PSMA-PET is a diagnostic technology demonstrated to detect advanced prostate cancer. ANVISA becomes the latest regulatory body worldwide to approve Illuccix[3], which is already commercially available in Australia, Canada, New Zealand and the United States, and has recently been approved in the United Kingdom and in multiple countries within the European Economic Area (EEA).

Dr. Sérgio Altino de Almeida, nuclear medicine specialist, at Rede D’Or, the largest integrated healthcare network in Brazil said, "The ANVISA approval of Illuccix provides access to advanced prostate cancer imaging for men across Brazil, a large and rapidly growing market for gallium-68 based radiopharmaceuticals. The ‘cold kit’ format with generator-produced gallium will facilitate broad equity of access for men living with prostate cancer, regardless of whether they are based in regional, rural or metropolitan areas."

JV to manufacture and distribute radiopharmaceuticals for clinical and commercial use in Brazil

Telix also announces a joint venture (JV) with R2PHARMA to commercialize and distribute Telix’s therapeutic and diagnostic radiopharmaceutical products in Brazil, building on the existing partnership established in 2019. The JV further strengthens this relationship with a commitment to jointly bring to market innovative and first-in-class therapeutic radiopharmaceuticals and imaging agents in Brazil.

The market for radiopharmaceuticals in Brazil is experiencing significant growth driven by the increasing prevalence of chronic diseases such as cancer, advancements in imaging technologies, and a growing senior population. Over the next decade, the Brazilian radiopharmaceuticals market is projected to reach US$330 million[4], with this growth supported by rising investments in the healthcare industry, public health awareness, and the introduction of new and advanced radiopharmaceuticals.

Under the agreement, Telix and R2PHARMA will establish a JV company in Brazil (Telix Innovations Brazil, Ltda.). Telix Innovations Brazil will hold the exclusive licence to commercialize and distribute Illuccix as well as future product candidates from Telix’s industry-leading theranostic pipeline. Telix Innovations Brazil will leverage the local knowledge and expertise of R2PHARMA to obtain the necessary licenses and governmental authorizations in Brazil[5].

Raphaël Ortiz, CEO Telix International, added, "Telix is pleased to bring Illuccix to Brazil and Latin America, with this new imaging modality now recognized in leading clinical practice guidelines and already being adopted in other parts of the world. We would like to acknowledge our partner R2PHARMA for their commitment to gallium-based PSMA-PET and the hope this brings for men living with prostate cancer in Brazil. The JV takes our collaboration to the next stage with the aim to address unmet need for therapeutic and diagnostic radiopharmaceuticals across a range of disease areas."

R2PHARMA Nuclear Medicine & Innovation Vice-President, Rafael Madke, continued, "We are delighted to have been granted this marketing authorization for Illuccix in Brazil. The combination of Telix’s innovative theranostic pipeline and R2PHARMA’s manufacturing and distribution capabilities will support widespread access for patients and physicians to Illuccix and future additional products that until now have not been available in Latin America."

About Prostate Cancer in Brazil

Prostate cancer is the most commonly diagnosed male cancer in Brazil with an estimated 71,730 new cases in 2023[6]. Prostate cancer was also the second most common cause of cancer death in men (after lung cancer), with approximately 20,000 men dying from their disease in 2022. More than 250,000 men in Brazil were estimated to be living with prostate cancer in 2022[7].

About Illuccix

Illuccix is a kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection, a radioactive diagnostic agent indicated for PET imaging combined with computerized tomography (CT) scan in case of suspicion of prostate cancer relapse in adult males to detect and localize recurrent cancerous lesions. 68Ga gozetotide injection targets PSMA, a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells. Illuccix enables gozetotide (PSMA-11) to be labelled with the radionuclide 68Ga directly before injection by medical professionals.

Illuccix has been approved by the U.S. Food and Drug Administration (FDA)[8], by the Australian Therapeutic Goods Administration (TGA)[9], by Health Canada[10], by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)[11], by the Brazilian Health Regulatory Agency (ANVISA)[12] and in multiple countries within the EEA[13] following a positive decentralized procedure (DCP) opinion by the German medical regulator, BfArM.

On March 17, 2025 Tract Bio, a biotechnology company discovering and developing novel therapies for cancer and inflammatory disease, reported the publication of preclinical research in Gastroenterology (Press release, Tract Bio, MAR 17, 2025, View Source [SID1234651199]). The article, "Evolution of Esophageal Adenocarcinoma from Precursor Lesion Stem Cells" describes results from a preclinical study applying the Company’s proprietary stemECHO epithelial stem cell cloning technology, where regenerative stem cells were cloned from epithelial tissues to analyze the evolution of esophageal adenocarcinoma (EAC) and identify potential therapeutic targets and drug combinations.

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In the study, each of the precursor lesions in the evolution of EAC, including Barrett’s esophagus (BE), low-grade dysplasia (LGD), and high-grade dysplasia (HGD), were shown to possess discrete populations of clonogenic cells that are potential therapeutic targets. DNA sequencing of these clones revealed intralesional heterogeneity and clonal resolution of the mutation progression in patients with BE, LGD, HGD, and EAC. High-throughput chemical screens against BE stem cells reveal drug combinations that are similarly effective against stem cells of LDG, HGD, and EAC. Synthetic lethal combinations were then developed that appear effective against BE, LGD, HGD, and EAC, both in vitro and in vivo, while simultaneously promoting normal esophageal stem cells.

"EAC, as with all metastatic cancers, is the result of an evolutionary process which is dominated by a succession of precursor lesions," said Frank McKeon, Ph.D., Interim Chief Scientific Officer of Tract Bio. "In this study, our unique and proprietary epithelial stem cell cloning platform, stemECHO, allowed us to clone epithelial stem cells while preserving their genetic integrity, enabling the discovery of the underlying mechanism. By maintaining the genetic consistency of the cloned cells, we are able to study disease mechanisms with unprecedented precision, opening the door to new diagnostic tools and therapies. We look forward to continuing this important work."

"The clonogenic cells in each of the regenerative lesions described in this paper, BE, LGD, HGD and EAC, each display functional properties of stem cells. Given the role of stem cells of normal epithelia in the regenerative growth of these tissues, the lesional stem cells could represent important therapeutic targets within tumors," said Richard Russell, Chief Executive Officer of Tract Bio. "Toward this end, our synthetic lethal strategies identified highly effective drug combinations against BE stem cells that showed similar efficacy against stem cells from each lesion in the progression to EAC and EAC itself. Based on these findings, we expect that the continued development of these drug combinations may lead to clinically effective treatments to prevent or treat EAC and perhaps other epithelial cancers by targeting the root causes of these conditions."

On March 17, 2025 Partex NV and Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company, reported a strategic collaboration aimed at identifying and evaluating biopharmaceutical compounds using artificial intelligence (AI) for potential acquisition or licensing by Fortress (Press release, Fortress Biotech, MAR 17, 2025, View Source [SID1234651198]).

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Partex will deploy its proprietary AI-based drug discovery and development technology platform, which delivers diverse recommendations on alternative targets or indications and helps search and evaluate compounds across therapeutic areas.

"This strategic collaboration leverages the synergistic strengths of both organizations," said Dr. Frank Grams, Chief Commercial Officer, Partex. "Fortress’ expertise in identifying promising biopharmaceutical assets and advancing them through clinical development to their full potential, coupled with Partex’s advanced AI-driven platform, will enable a highly efficient and data-rich approach to identifying, evaluating, and potentially repositioning promising bio-pharmaceutical assets."

Partex’s platform will provide comprehensive analyses, including target identification, indication expansion, and molecular profiling, ultimately accelerating the process of bringing innovative therapeutics faster to market.

Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, also added, "In addition to the advancement of our robust late-stage pipeline of compelling product candidates at Fortress along with our partner companies and subsidiaries, plus the launch of two recently approved medicines and a third with a Prescription Drug User Fee Act (PDUFA) action date in the third quarter of this year, we are also focused on business development opportunities and expanding our portfolio. This collaboration with Partex will allow us to expeditiously identify and evaluate assets using their AI platform in conjunction with our already-established large network of Key Opinion Leaders in various therapeutic areas. The Fortress business model is focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue. We believe utilizing AI technology will allow us to scale more efficiently and cost effectively going forward."

The collaboration is expected to expedite and support the process of search and evaluation to in-license differentiated assets, with both companies committed to utilize AI to its fullest potential.

On March 17, 2025 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported that results from the clinical trial evaluating Actimab-A in combination with the chemotherapy CLAG-M in patients with relapsed/refractory acute myeloid leukemia (r/r AML) have been published in the peer-reviewed journal Leukemia (Press release, Actinium Pharmaceuticals, MAR 17, 2025, View Source [SID1234651197]). The publication highlights data including long-term survival outcomes from two-year follow-up and better outcomes in high-risk patients. Actimab-A is a novel targeted radiotherapeutic that uses the Actinium-225 (Ac-225) isotope payload directed against CD33, a marker expressed ubiquitously on AML blasts. The trial was conducted at the Medical College of Wisconsin (MCW) which has extensive experience treating relapsed refractory AML patients with CLAG-M.

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Actimab-A + CLAG-M Trial Data Highlights from Publication:

18.4 month median Overall Survival (OS) in patients who received 1 or 2 lines of prior therapy
52% of patients in the Actimab-A +CLAG-M trial had TP53 mutations, 56% had prior allogeneic stem cell transplant and 56% of patients had prior Venetoclax therapy
Actimab-A + CLAG-M outcomes compare favorably to the results from historical data with CLAG-M alone in the pre-Venetoclax era from MCW’s study (median OS of 13.3 months). Typically, patients who have failed Venetoclax treatment demonstrate median survival between 2.4 – 4.6 months as reported in the literature and the patients with a TP53 mutation even have more dismal survival outcomes. Hence this data supports the use of Actimab-A plus CLAG-M for these patients.
Actimab-A + CLAG-M produced high rates of measurable residual disease negativity (MRD-) including 75% across all patients, 83.3% in patients with a TP53 mutation and 100% in patients with prior Venetoclax therapy
71% of eligible patients received a bone marrow transplant (BMT) and median OS in these patients was 24.05 months
Dr. Sameem Abedin, Associate Professor of Medicine at the Medical College of Wisconsin and Principal Investigator of the Actimab-A + CLAG-M study said, "We are delighted that the Actimab-A + CLAG-M results have been published in the peer-reviewed journal Leukemia. Despite advancements in treatment, patients with r/r AML, particularly those with high-risk features including TP53 mutations and prior Venetoclax therapy like those in our study, continue to have dismal outcomes and limited treatment options. We are excited that the combination of Actimab-A and CLAG-M produced high response rates with deep remissions including high rates of MRD negativity, improving access to potentially curable BMT resulting in enhanced survival outcomes. Importantly, we observed that responses were retained in high-risk patients. We believe these results support the utility of targeted radiotherapy for the treatment of AML and its mutation agnostic mechanism of action. We look forward to the initiation of the Phase 2/3 trial of Actimab-A + CLAG-M and further advancing this potentially important therapeutic modality in this patient population with a high unmet need."

Actinium has aligned with the FDA on a pivotal Phase 2/3 operationally seamless trial that will study Actimab-A + CLAG-M in r/r AML patients. The trial will optimize the dose of Actimab-A in combination with CLAG-M, that will be studied in the Phase 3 portion of the trial, which will be a randomized trial comparing overall survival and other outcomes of patients with r/r AML receiving Actimab-A + CLAG-M to CLAG-M alone. The trial is expected to be initiated in 2025.

Sandesh Seth, Actinium’s Chairman and CEO, said, "There is significant momentum for Actimab-A with the publication of these positive results in Leukemia and the recent initiation of the frontline AML triplet combination with Venetoclax and the hypomethylating agent ASTX-727 under our NCI CRADA. Actinium is committed to addressing the needs of the over 100,000 patients with AML and MDS in the U.S. and Europe with Actimab-A to realize its multi-billion-dollar market opportunity. Over the course of 2025, we expect to generate additional clinical data further supporting Actimab-A’s mutation agnostic, backbone therapy potential for radiation sensitive myeloid malignancies."

On March 17, 2025 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated dual PARP/Wnt pathway inhibitor— reported the presentation of new clinical data from its ongoing Phase 2 trial with stenoparib monotherapy in advanced Ovarian Cancer at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting on Women’s Cancer, held March 14-17 in Seattle, Washington (Press release, Allarity Therapeutics, MAR 17, 2025, View Source [SID1234651196]). SGO is the world’s premier organization for professionals working to lessen the impact of gynecologic cancers, and the Annual Meeting on Women’s Cancer is the premier educational and scientific event for gynecologic oncologists and others dedicated to advancing gynecologic cancer care.

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The poster presentation, titled "A Phase II Trial of Stenoparib (2X-121): A Novel Dual Tankyrase and PARP Inhibitor in Advanced, Recurrent Ovarian Cancer," will be presented by Dr. Fernanda B. Musa, MD, MS, Director of Clinical Trials in Gynecologic Oncology, Providence-Swedish Cancer Institute.

Session: Poster Tour Group 14: Clinical Trials Impacting Future Therapies
Date/Time: Monday, March 17, 10:30 a.m. PST
The poster presents data from the first Phase 2 study of stenoparib in advanced ovarian cancer and the first stenoparib study ever to dose twice daily. The study exclusively enrolled patients who had been previously treated with three or more lines of therapy and included patients with especially difficult-to-treat disease. Fourteen of the fifteen enrolled were platinum-resistant, while one patient had primary platinum-refractory disease that did not respond to first-line chemotherapy. There are very few effective treatment options for patients with platinum-resistant and refractory ovarian cancer, who unfortunately tend to have their disease recur within an average of three months. In this study, five patients stayed on therapy longer than four months, with four of these staying on beyond 20 weeks. Importantly, one patient showed a confirmed complete response (i.e., absence of measurable disease) that lasted more than 10 months. The patient with primary platinum-refractory disease remained on therapy beyond 40 weeks. Two patients remain on therapy currently—now more than 17 months.

The data also revealed significant clinical benefit in patients who typically do not get benefit from first-generation PARP inhibitors—those without mutations in the DNA repair gene, BRCA. One of the two patients still on therapy, now more than 17 months, did not have a BRCA mutation or other deficit in homologous DNA repair. Benefit in these BRCA wild-type patients may reflect the unique, dual therapeutic action of stenoparib in inhibiting not only PARP but also the Wnt pathway—a pathway activated in ovarian, colon, and other advanced cancers.

Key Findings:

First study to dose stenoparib twice daily optimizing inhibition of PARP and Tankyrase across every 24-hour period.
First stenoparib study to show potential durable clinical benefit in platinum-resistant and refractory patients.
Data continue to show that stenoparib is well-tolerated and does not elicit the bone marrow toxicity typical of first-generation PARP inhibitors.
Study shows clinical benefit across distinct genetic backgrounds including in both BRCA-mutant patients and in BRCA wild-type (non-mutated) patients, a larger patient group than those with BRCA mutation.
Study supports the unique mechanism of action for stenoparib, which inhibits PARP and the Wnt oncogenic pathway.
Study sets the stage for the newly announced protocol to evaluate stenoparib monotherapy dosed twice daily in platinum-resistant patients.
Dr. Fernanda B. Musa, MD, MS, site investigator for the study, commented, "This remains a challenging disease with limited therapies for patients who have already undergone many prior lines of treatment and who have been declared platinum-resistant or platinum-refractory. The findings from this study suggest that stenoparib may offer a new, well-tolerated therapeutic approach for a broader group of patients, including those with BRCA wild-type disease, who historically have had fewer options. It is a privilege to present these data at SGO 2025 and to share our findings with esteemed colleagues dedicated to advancing gynecologic oncology research."

Thomas Jensen, Chief Executive Officer of Allarity Therapeutics, stated, "These results are foundational for us as they show stenoparib monotherapy can provide durable clinical benefit to very heavily pre-treated patients, both platinum-resistant and refractory. These data also show clinical benefit in patients both with and without BRCA mutations, or defects in homologous DNA damage repair, and may reflect the unique dual action of stenoparib on both PARP and Tankyrase targets. The data also continue to show that stenoparib is well-tolerated and does not show the bone marrow toxicity of earlier PARP inhibitors. All in all, the results of this exploratory phase 2 study have helped us to craft a new protocol designed with Dr. Fernanda Musa, Dr. Kathleen Moore, and other ovarian cancer thought leaders that will deepen and enrich our understanding of stenoparib’s durable clinical benefit—even in heavily pre-treated patients, enhance our understanding of its unique mechanism of action and accelerate the advance of stenoparib toward regulatory approval."

Given the relatively heterogeneous patient population in this study, there are no direct comparisons to earlier studies. Importantly, this exploratory trial allowed enrollment of patients with very advanced disease, including massive ascites, following multiple prior lines of therapy. Some of these patients progressed very quickly in the study. The recently announced phase 2 protocol trial was expressly designed to narrow in on patients with platinum-resistant disease who have progressed through only a single, additional line of chemotherapy after the emergence of platinum resistance and who are without active evidence of ascites.

The poster presentation will be available on March 17 at 7:00 a.m. CT on Allarity’s website under the Scientific Publications section.

About Stenoparib
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the Wnt signaling pathway. Aberrant Wnt/β-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking Wnt pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121.