On March 17, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that its Chairman and Chief Executive Officer, Dr. Amit Kumar, will be presenting at the 2025 Cancer Advocacy Group of Louisiana ("CAGLA") NeauxCancer Conference taking place on March 27-29, 2025 at the The Roosevelt Hotel in New Orleans (Press release, Anixa Biosciences, MAR 17, 2025, View Source [SID1234651201]).

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Dr. Kumar’s presentation will provide an overview of Anixa’s pioneering programs in cancer treatment, including updates on its cutting-edge CAR-T therapy for solid tumors and its novel cancer vaccine initiatives. He will discuss the Company’s latest progress in clinical development and how Anixa is advancing next-generation immunotherapies to transform cancer care.

Details of the presentation are as follows:

Event: 2025 CAGLA NeauxCancer Conference
Date: March 28, 2025
Time: 10:00 AM CDT
Location: The Roosevelt New Orleans
Webcast: CAGLA 2025 Livestreams

The CAGLA NeauxCancer Conference is a premier gathering of leading oncology researchers, industry executives, investors and medical professionals focused on groundbreaking developments in cancer treatment and care.

For more information about the conference, visit View Source

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."