On September 18, 2024 GlyTherix Ltd (GlyTherix) an Australian targeted radiotherapy company specializing in developing antibody radiopharmaceuticals for solid tumors reported a new global clinical supply agreement with Wisconsin-based SHINE Technologies, a pioneer in next-generation fusion-based technology and North America’s largest producer of non-carrier added lutetium-177 (n.c.a. Lu-177) chloride (Press release, Glytherix, SEP 18, 2024, View Source [SID1234646729]). SHINE will supply its n.c.a. Lu-177 chloride, Ilumira, for use in GlyTherix’s clinical trials focused on innovative treatments for aggressive and invasive cancers.

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As GlyTherix advances its clinical trials using the medical radioisotope Lu-177, it is building a global supplier network with proximity to major global markets, capable of consistently delivering high-quality, n.c.a. Lu-177 to patients. SHINE will supply n.c.a. Lu-177 for use in GlyTherix’s clinical trials with a particular focus on the expansive U.S. market.

GlyTherix’s radiotherapy combines Lu-177 with a molecule targeting Glypican-1, a protein in aggressive cancers, to deliver localized radiation while sparing healthy tissue. Their 177Lu-DOTA-Miltuximab will enter Phase Ib trials in early 2025.

GlyTherix will use 177Lu-DOTA-Miltuximab targeting tumors expressing Glypican-1 in its planned Australian Phase Ib therapeutic dose escalation trial scheduled to commence early 2025. Glypican-1 is an attractive tumor target that occurs in several aggressive and invasive cancers including prostate, pancreatic, bladder, lung, glioblastoma and ovarian cancer.

Dr. Brad Walsh, GlyTherix’s Chief Executive Officer said, "SHINE’s investment in high-quality isotope production places them at the forefront of the radiopharmaceutical supply chain with particular strength in servicing the U.S. market. This supply agreement for the medical radioisotope Lu-177 adds to GlyTherix’s global clinical supplier network, which also includes a clinical supply agreement with the Australian Nuclear Science and Technology Organization (ANSTO)".

Greg Piefer, SHINE founder and CEO added, "Our partnership with GlyTherix, a true pioneer in targeted radiotherapy, represents an important step in advancing next-generation cancer treatments. GlyTherix’s innovative approach has the potential to transform cancer care for patients with some of the most challenging solid tumors. By providing a reliable supply of high-quality Ilumira, we’re proud to support their groundbreaking work that could offer new hope to patients with limited treatment options."

SHINE’s Ilumira is produced in the company’s Cassiopeia facility in Janesville, Wisconsin – the largest of its kind in North America. With an initial production capacity of 100,000 doses per year and the potential for expansion to 200,000 doses annually, SHINE is well-positioned to meet the growing demand for Lu-177 in cancer therapies.

This partnership with GlyTherix marks another significant milestone in SHINE’s mission to harness nuclear technology for human health. By providing a reliable, high-quality supply of Ilumira for innovative clinical trials, SHINE is playing a crucial role in advancing targeted radiotherapy. As SHINE continues to expand its production capabilities and pursue vertical integration in Lu-177 supply, collaborations like this have the potential to transform cancer treatment worldwide, offering new hope to patients facing aggressive and hard-to-treat cancers.

On September 18, 2024 Brenus Pharma, a biotech company specializing in the development of cancer vaccines, reported the completion of a $25 million Series A financing round (Press release, Brenus Pharma, SEP 18, 2024, View Source [SID1234646715]).

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The round is led by Angelor, an investment fund bringing together a cluster of investors from the Auvergne-Rhône-Alpes (AURA) region, including UI Investissement for the Fonds régional Avenir industrie Auvergne-Rhône-Alpes, Crédit Agricole Centre-France and Crédit Agricole Centre-Est, with 2 family offices. Belgian funds Noshaq and Investsud complete this significant deal. Together, they join co-founder and lead investor Jacques Gardette (BIOJAG) and long-time investor Stéphane Legastelois (33 CALIFORNIE). In addition, Brenus Pharma has received non-dilutive funding from the French government and Bpifrance, as beneficiary of the France 2030 call for projects.

Jacques GARDETTE, BIOJAG Chairman commented: "Brenus Pharma has taken a major step forward. The arrival of investment professionals in our young company confirms the interest we are arousing. After the creation and sale of Biocorp to Novo Nordisk in 2023, Brenus Pharma now has our full attention to help the company achieve its ambitious goals. I’m convinced that the constant commitment and innovation of the Brenus team have built a solid foundation for tackling one of the world’s most complex therapeutic challenges. During it’s rapid development, Brenus has demonstrated boldness, achievement and resilience in the biotech field."

The proceeds will be used to fully fund the STC-1010 cancer vaccine’s first-in-human proof-of-concept, in first line settings for metastatical colorectal cancer patients. STC-1010 is the first vaccine candidate based on the STC ‘Stimulated-Tumor-(ghost)-Cells’ technology platform developed by Brenus Pharma. Adaptive and innovative, this platform uses an in-depth understanding of the complexity of cancer to offer a new type of precision treatment, enabling Brenus Pharma to give patients’ immune systems a head-start by anticipating the progression of their disease.

Marie CHAMBODUT, Partner, and Investment Director at Angelor, added: "We are proud to lead this strategic transaction for Brenus Pharma to support the clinical development of their cancer vaccines, including STC-1010, the first and most advanced program to emerge from the platform. We look forward to joining Paul and his exceptional team in transforming Brenus into a global player in precision immuno-oncology, bringing solutions to millions of patients experiencing treatment failure, and contributing to the development of the French biotherapeutics industry."

Hélène SABATEL, Investment Manager at Noshaq, said: "Together with our colleagues at InvestSud, we are delighted to support the Brenus Pharma team in the development of this cutting-edge technological platform, as we are convinced of its future impact for patients currently without concrete therapeutic solutions. We are also enthusiastic about the prospect of welcoming a Brenus R&D branch to the Liège region soon, and we hope that this new Franco-Belgian collaboration between two biotech ecosystems will provide the company with optimal support for its development."

The funds raised will enable the STC platform to be deployed in humans from the end of the year, starting with STC-1010, which will be administered as a first-line treatment in patients with unresectable metastatic colorectal cancer (mCRC) resistant to immunotherapies (pMMR/MSS and dMMR/MSI-H). At the same time, STC-1010 will be extended to other types of gastric tumors, such as those of the pancreas and liver. Finally, Brenus Pharma intends to accelerate the development of its portfolio in other solid tumor indications, notably with STC-1020, our second candidate in development.

Paul BRAVETTI, Chief Executive Officer of Brenus Pharma, added: "We are delighted to welcome top-tier investors who have been part of recent French success stories (Mablink, Amolyt Pharma). This is an important milestone for Brenus Pharma, confirming the potential of the STC platform, and of STC-1010, which has already demonstrated solid proof of efficacy in various preclinical models. I would like to thank all our team for their motivation and their passionate work to rapidly bring a new therapeutic solution to patients. Our shared ambition is to position our platform at the forefront of the national and international scene, and to become a leader in next-generation cancer immunotherapies."

A PRESSING NEED FOR SOLUTION

This cutting-edge technology is based on proteomics-guided anti-cancer vaccines, and sparked from the ambition to produce, in France, an innovative biotherapy on an industrial scale capable of responding to a significant public health challenge: 90% of patients treated for solid tumors will suffer a relapse, while by 2022, 10 million of them will have reached a therapeutic dead-end leading to their death. This figure is set to rise by 70% by 2045 (Source: Cancer Tomorrow | IARC – View Source).

The technology developed by Brenus Pharma not only treats the immediate threat, but also defends the immune system against tumors that may appear later, thereby reducing the risk of relapse. To achieve this, STC reproduces in the laboratory the resistance and escape mechanisms of tumor cells, to educate the patient’s immune system to detect and destroy them, thanks to the widest panel of therapeutic targets currently available (over 200 tumor antigens).

With proven expertise in CMC and a standardized, ready-to-use production process, it ensures rapid availability to patients in need, with controlled costs and supply chain, outpacing personalized approaches and autologous vaccines in development.

THE "BREAK-CRC" STUDY IS DESIGNED TO CONFIRM THE THERAPEUTIC POTENTIAL OF STC-1010

STC-1010’s phase I/IIA "BreAK-CRC" study is currently under review by the European regulatory authorities and will be conducted with the participation of expert clinicians in early-phase immuno-oncology units in Europe, and subsequently in the United States. It is based on very positive preclinical studies obtained in vitro, in ovo and ex vivo, showing extremely encouraging safety and efficacy results, validated by a committee of international immuno-oncology experts.

Phase I will evaluate the tolerability of different dose levels of STC-1010, combined with low-dose immunostimulants and standard chemotherapy. Subsequently, the Phase IIA study will further evaluate treatment efficacy, with a particular focus on progression-free survival at 12 months. Innovative exploratory assays will evaluate the immune response and the dynamics of circulating tumor DNA (ctDNA). The ambition is to make STC platform products a permanent part of precision medicine by anticipating patient responses, thanks to a set of analyses unprecedented at this level of development.

On September 18, 2024 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported the approval of the Investigational New Drug (IND) to conduct the clinical trial of B-cell lymphoma-2 (BCL2) inhibitor ICP-248 in combination with azacitidine for acute myeloid leukemia (AML) in China (Press release, InnoCare Pharma, SEP 18, 2024, View Source [SID1234646730]).

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Acute myeloid leukemia (AML) is a malignant hematological disease originating from hematopoietic stem/progenitor cells, accounting for about 80% of acute leukemia in adults. The risk of developing AML increases with age and is more common in middle-aged and elderly people. AML is also not uncommon in individuals under 18 years old, representing about 15-20% of pediatric leukemia and 80% of leukemia in neonates and infants1.

BCL2 is an important regulatory protein of apoptosis pathway, and its abnormal expression is related to the development of various hematologic malignancies. ICP-248 is a novel, orally bioavailable BCL2-selective inhibitor. It has anti-tumor effect by selectively inhibiting BCL2 and restoring the mechanism of programmed cell death.

Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare, said, "With strong pipeline in hemato-oncology, InnoCare is dedicated to developing therapeutics with diverse mechanisms of action (MoA) to achieve comprehensive coverage of blood tumor indications. ICP-248 is an important global asset of our company in the field of hematology. We will accelerate clinical development and look forward to bringing greater benefits to patients with hematological malignancies early."

On September 18, 2024 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the peer-reviewed journal Nature Medicine published results from the SCRUM-Japan GOZILA study confirming that selecting targeted therapy on the basis of Guardant360 CDx liquid biopsy results may significantly extend survival for patients with advanced cancer (Press release, Guardant Health, SEP 18, 2024, View Source [SID1234646731]).

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The study, led by a research group out of National Cancer Center Hospital East in Kashiwa, Japan, investigated the effects of personalized treatment based on results of the Guardant360 CDx test in 4,037 patients with advanced cancer. The results showed that 24% of participants were able to receive targeted treatment tailored to them based on comprehensive genomic profiling results from the test, which analyzes 74 cancer-related genes. The patients who received targeted treatment guided by liquid biopsy results lived approximately twice as long as those who did not.

"Compared to conventional tissue biopsies, liquid biopsies have several advantages: they are less invasive for patients, allow for repeated testing, and can simultaneously examine cancer characteristics from various parts of the body. However, until now, it was unclear whether treatment selection using liquid biopsies actually helped improve patient outcomes," said Yoshiaki Nakamura, M.D., Ph.D., chief, International Research Promotion Office, Department of Gastroenterology and Gastrointestinal Oncology at National Cancer Center Hospital East in Kashiwa, Japan, and a co-lead author of the study. "The GOZILA study is the first to demonstrate the survival-extending effect of liquid biopsy-based personalized cancer treatment on a large scale across various cancers. The results of this study have the potential to bring about a paradigm shift in cancer treatment."

Selecting therapies for patients based on the liquid biopsy results enabled study investigators to identify targeted treatment options they could not discern using traditional methods. The researchers then followed the progress of treated patients and analyzed their treatment response and survival time. Patients who received targeted therapy had a median survival of 18.6 months compared to 9.9 months for those who did not.

"The GOZILA study adds significantly to the body of evidence supporting the clinical utility of the Guardant360 CDx liquid biopsy to guide therapy selection in advanced cancer," said Craig Eagle, M.D., Guardant Health chief medical officer. "These study results confirm, across a large study population and multiple tumor types, that personalized therapy guided by liquid biopsy has the potential to significantly extend patient survival."

About Guardant360 CDx

The first FDA-approved comprehensive liquid biopsy for all advanced solid tumors, Guardant360 CDx provides oncologists with genomic profiling results from a simple blood draw in less than seven days to pair patients with targeted therapies. The test detects guideline-recommended actionable biomarkers across all four major alteration classes, with a panel that assesses 74 genes.1 Guardant360 CDx is FDA-approved as a companion diagnostic (CDx) for multiple targeted therapies in non-small cell lung cancer (NSCLC) and is the only FDA-approved CDx to identify patients eligible for breast cancer therapy targeting ESR1 mutations.

On September 18, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that it will present at the Ovarian Cancer Research Alliance’s ("OCRA") International Gynecologic Cancer Conference taking place online September 25-27, 2024 (Press release, Anixa Biosciences, SEP 18, 2024, View Source [SID1234646717]).

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The presentation, entitled "Autologous T Cells Engineered to Target Follicle Stimulating Hormone (FSH) Receptor in Recurrent Ovarian Cancer, A Phase 1 Trial," will be presented by Dr. Pamela Garzone, Anixa’s Chief Development Officer, and will discuss the clinical development of Anixa’s novel chimeric antigen receptor T cell (CAR-T) therapy for ovarian cancer. The presentation will take place at 3:00PM ET on September 25.

The International Gynecologic Cancer Conference is organized by OCRA. OCRA is the leading organization in the world fighting ovarian cancer from all fronts while supporting women and their families.

More information about the event may be found at: International Gynecologic Cancer Conference – Ovarian Cancer Research Alliance (ocrahope.org).

About Anixa’s CAR-T Approach (Follicle Stimulating Hormone Receptor-Mediated CAR-T technology)
Anixa’s chimeric antigen receptor-T cell (CAR-T) technology approach is an autologous cell therapy comprised of engineered T cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunologically relevant levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone (chimeric endocrine) receptor, and the target-binding domain is derived from its natural ligand, this technology is known as CER-T (chimeric endocrine receptor-T cell) therapy, a new type of CAR-T. Anixa’s FSHR-mediated CAR-T technology was developed by Jose R. Conejo-Garcia, M.D., Ph.D., Professor of Immunology in the Department of Integrative Immunobiology at the Duke University School of Medicine. Anixa holds an exclusive world-wide license to the technology from The Wistar Institute.