On July 17, 2024 Faeth Therapeutics (Faeth), a clinical-stage biotechnology company, reported that Oliver Maddocks, Co-Founder and Chief Scientific Officer, and Debbie Chirnomas, M.D., Chief Medical Officer, will present today at the Raymond James Biotech Private Company Showcase (Press release, Faeth Therapeutics, JUL 17, 2024, View Source [SID1234644945]). Oliver and Debbie will discuss Faeth’s lead PIKTOR program development plans and participate in a Q&A following the presentation.

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Faeth’s lead program, FTH-001/003 or "PIKTOR," features the combination of serabelisib, a PI3Kɑ inhibitor, and sapanisertib, an mTORC 1/2 inhibitor. This combination effectively targets and shuts down the PI3K pathway, one of the most frequently mutated pathways in cancer. PIKTOR has demonstrated impressive outcomes in a Phase 1b trial across endometrial, ovarian, and breast cancers in conjunction with paclitaxel. Additionally, Faeth’s second clinical initiative involves FTH-002, a specially designed amino acid sachet administered alongside an amino acid-restricted diet and radio/chemotherapy.

Faeth boasts a strong clinical and preclinical pipeline, fueled by its MetabOS discovery platform. This platform utilizes AI, machine learning, and carefully selected data sets to pinpoint targets tailored to specific tumor genotypes.

Established by luminary oncology researchers including Drs. Lew Cantley, Siddhartha Mukherjee, and Karen Vousden, Faeth is dedicated to developing therapies that target cancer metabolism. While the significance of metabolism in cancer growth is recognized, it is still largely underutilized in treatment, with only a handful of therapies available. Faeth employs a unique strategy that combines an in-depth understanding of cancer metabolism, functional genomics, and computational biology to create effective, less toxic treatments.

On July 17, 2024 Orion reported that the Phase III ARANOTE trial, investigating darolutamide plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC), has met its primary endpoint of rPFS (Press release, Orion, JUL 17, 2024, View Source [SID1234644909]). Darolutamide plus ADT significantly increased rPFS compared to placebo plus ADT. The safety data were comparable between both treatment arms and reconfirm the established tolerability profile of darolutamide in advanced prostate cancer.

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Darolutamide is already approved under the brand name Nubeqa for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease, and patients with metastatic hormone-sensitive prostate cancer (mHSPC, in combination with ADT and docetaxel).

"The results of the ARANOTE trial reconfirm that darolutamide, a compound discovered by Orion scientists, is a viable treatment option for patients with metastatic hormone-sensitive prostate cancer. In these patients, darolutamide has now shown efficacy with and without docetaxel, and thus, pending regulatory approval, can provide choices for the personalised treatment regime. I would like to thank all the patients and the investigators who participated in the ARANOTE trial," said Professor, M.D., Ph.D. Outi Vaarala, Senior Vice President of Innovative Medicines and Research & Development at Orion.

Detailed results of the ARANOTE trial are planned to be presented at a forthcoming scientific congress. Bayer plans to submit the data from the study to relevant global health authorities to support expanded use of darolutamide in men with mHSPC.

ARANOTE is part of a robust clinical development program investigating darolutamide across various stages of prostate cancer, which includes the Phase III ARASTEP trial evaluating darolutamide plus ADT versus ADT alone in hormone-sensitive high-risk biochemical recurrence (BCR) prostate cancer, who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline. Furthermore, darolutamide is also being investigated by Bayer in the collaborative Phase III DASL-HiCaP (ANZUP1801) trial led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). The study evaluates darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence.

About the ARANOTE trial
The ARANOTE trial is a randomized, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of darolutamide plus ADT in patients with mHSPC. A total of 669 patients were randomized to receive 600mg of darolutamide twice daily or matching placebo in addition to ADT.

The primary endpoint of this study is rPFS, measured as time from randomization to date of first documented radiological progressive disease or death due to any cause, whichever occurs first. Secondary endpoints include overall survival (time to death from any cause), time to first castration-resistant event, time to initiation of subsequent anti-cancer therapy, time to prostate-specific antigen (PSA) progression, PSA undetectable rates, time to pain progression, and safety assessments.

About metastatic hormone-sensitive prostate cancer
Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide.1 In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, and about 375,000 died from the disease worldwide.2

At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. mHSPC is a stage in the disease where the cancer has spread outside of the prostate to other parts of the body. Up to 10% of men will already present with mHSPC when first diagnosed.3, 4, 5 For patients with mHSPC, ADT is the cornerstone of treatment, often in combination with chemotherapy docetaxel and/or an androgen receptor inhibitor (ARi). Despite treatment, most men with mHSPC will eventually progress to castration-resistant prostate cancer (CRPC), a condition with limited survival.

About darolutamide
Darolutamide is an oral ARi with a distinct chemical structure that binds to the androgen receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. The low potential for blood-brain barrier penetration for darolutamide is supported by preclinical models and neuroimaging data in healthy humans. This is also supported by the overall low incidence of central nervous system (CNS)-related adverse events (AEs) compared to placebo as seen in the ARAMIS Phase III trial and the maintained verbal learning and memory observed in the darolutamide arm of the Phase II ODENZA trial.

Darolutamide is approved under the brand name Nubeqa in more than 85 countries around the world for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. It is also approved in combination with ADT and docetaxel for the treatment of patients with mHSPC in over 80 markets including the U.S., Japan, EU, and China. The product is developed jointly by Orion and Bayer.

On July 17, 2024 Draupnir Bio ("Draupnir"), a biotechnology company harnessing the natural machinery of the lysosome to develop oral, small molecule degraders of extracellular disease-causing proteins, reported equity investments totalling €12 million to support the Company’s ambition to revolutionise the field of targeted protein degradation (TPD).

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TPD is a rapidly emerging field in drug development, exploiting a cell’s own destruction machinery to tackle disease-causing proteins that have historically been highly challenging to target with conventional therapies. Yet first-generation approaches are exclusively limited to cytosolic targets, leaving extracellular and membrane-bound proteins – 40% of the human proteome – untouched.

Draupnir is extending the potential of TPD to target extracellular and membrane-bound proteins in a pioneering approach using its novel and differentiated, proprietary technology platform, utilising lysosome receptors, which holds the potential to revolutionise the field of TPD.

MP Healthcare, the corporate venture group of Mitsubishi Tanabe Pharma Corporation, and the Export and Investment Fund of Denmark (EIFO), a financing fund backed by the Danish government, join Draupnir’s existing investors, Gilde Healthcare Partners, Inkef Capital and Novo Holdings, investing a total of €12 million into the Company.

The proceeds from the financing will be used to further develop Draupnir’s risk-diversified preclinical pipeline of oral, small molecule protein degraders, which have been proven against targets that are validated and those that have been traditionally difficult to drug.

"Draupnir has a bold ambition to pioneer the next frontier of extracellular protein degradation. Our novel technology platform targeting extracellular and membrane-bound disease proteins for degradation holds great promise for targets that have previously been difficult to target with small molecules or have been undruggable, and enables the development of new therapeutic approaches for complex conditions. We are delighted to welcome MP Healthcare and the Export and Investment Fund of Denmark as investors in the Company and thank our existing investors, Gilde Healthcare Partners, Inkef Capital and Novo Holdings, for their continued support. Andrew Hotchkiss, Chief Executive Officer of Draupnir Bio.

(Press release, Draupnir Bio, JUL 17, 2024, View Source [SID1234662184])

On July 17, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that its collaborator, Cleveland Clinic, has received a "Decision to Grant" notice from the Japan Patent Office (JPO) for the patent application titled "Vaccine Adjuvants and Formulations (Press release, Anixa Biosciences, JUL 17, 2024, View Source [SID1234644916])."

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"This new Japanese patent extends the claims for this novel breast cancer vaccine technology to an additional geographic region, beyond the U.S. and European patents previously awarded," stated Anixa Chairman and CEO Dr. Amit Kumar. "As the exclusive worldwide licensee of the technology, we value the additional protection this patent provides as we continue clinical development."

The vaccine is currently being studied in a phase one clinical trial at Cleveland Clinic.

Anixa’s breast cancer vaccine takes advantage of endogenously produced proteins that have a function at certain times in life, but then become "retired" and disappear from the body. One such protein is a breast-specific lactation protein, α-lactalbumin, which is no longer found post-lactation in normal, aging tissues, but is present in certain breast cancers. Activating the immune system against this "retired" protein provides preemptive immune protection against emerging breast tumors that express α-lactalbumin. The vaccine also contains an adjuvant that activates an innate immune response, which allows the immune system to mount a response against emerging tumors to prevent them from growing.

This vaccine technology was invented by the late Dr. Vincent Tuohy, who was the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research in the Department of Inflammation and Immunity at Cleveland Clinic’s Lerner Research Institute. Cleveland Clinic exclusively licensed this technology to Anixa Biosciences. Dr. Tuohy was entitled to a portion of the commercialization revenues received by Cleveland Clinic and also held equity in Anixa.

On July 16, 2024 Full-Life Technologies ("Full-Life"), a fully integrated global radiotherapeutics company, reported that it has entered into a license agreement with SK Biopharmaceuticals, a global biotech company, for exclusive worldwide clinical research, development, manufacturing, and commercialization rights to Full-Life’s "FL-091" radiopharmaceutical compound targeting neurotensin receptor 1 (NTSR1) positive cancers (Press release, Full-Life Technologies, JUL 16, 2024, View Source [SID1234644896]).

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This licensing deal worth $571.5 million includes an upfront payment, and development and commercial milestones, separate from royalties. Under the terms of the agreement, SK Biopharmaceuticals will in-license the NTSR1-targeting Radionuclide Drug Conjugate (RDC) program FL-091 – as well as its back-up compounds – aimed at developing and commercializing it as an innovative anti-cancer drug.

FL-091 is a small-molecule radioligand vector designed to deliver targeted radiation therapy to cancer cells by binding specifically to NTSR1, a receptor protein, which is selectively overexpressed in various types of solid tumors, including colorectal cancer, prostate cancer, and pancreatic cancer.

SK Biopharmaceuticals also has a right of first negotiation to license other pre-selected RDC programs of Full-Life.

Lanny Sun, Chief Executive Officer of Full-Life, said, "This agreement with SK Biopharmaceuticals highlights the potential of FL-091 in advancing cancer treatment and demonstrates SK Biopharmaceuticals’ unwavering commitment to building an oncology business around medical innovation. We look forward to future collaborations with SK Biopharmaceuticals, and to leveraging its expertise and resources to advance radiopharmaceutical therapy. The agreement is aligned with our strategic vision of fostering global partnerships and making a meaningful impact on patients worldwide."

Donghoon Lee, Chief Executive Officer and President of SK Biopharmaceuticals, said, "The licensing agreement with Full-Life not only brings the two companies closer together for future collaborations in the fastest rising biotech sector, but also most importantly, pushes SK Biopharmaceuticals forward to become a ‘Big Biotech’. Since the introduction of the company’s strategy roadmap to venture into radiopharmaceuticals last year, we have been on track toward our envisioned goal. We expect to further unveil and implement business plans for RPT (radiopharmaceutical therapy) this year, and actively pursue clinical development and commercialization in the near future to provide treatment options and create new value worldwide."

About FL-091

FL-091 is a novel small-molecule radioligand vector targeting NTSR1 positive solid tumors. Overexpression of NTSR1 has been associated with disease progression of multiple types of cancers, including colorectal, breast, pancreatic, and head and neck cancers. FL-091 radioligands have demonstrated favorable biodistribution profiles and enhanced binding affinity to NTSR1, as well as encouraging anti-tumor activities in preclinical studies. The development of the alpha-emitter therapy candidate 225Ac-FL-091 targeting NTSR1-positive tumors is currently in progress.