On July 9, 2024 Curium, a world leader in nuclear medicine, reported that it has submitted its 505(b)(2) New Drug Application for Lutetium Lu 177 Dotatate Injection, which, if approved by the U.S. Food and Drug Administration (FDA), would be intended for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETS) (Press release, Curium, JUL 9, 2024, View Source [SID1234644743]). Curium’s submission represents a major step in its strategy to become a key player in the promising nuclear medicine therapeutic field.

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Curium has been developing its formulation over the past several years and has ensured that its formulation avoided infringement of any Orange Book listed patents in order to expedite its path to market. Curium is excited to embark on the next phase of its journey toward delivering cancer therapies to the market as part of its mission to redefine the experience of cancer through its trusted legacy in nuclear medicine.

Curium will work closely with the FDA through the review and approval process. Curium looks forward to potential approval of its Lutetium Lu 177 Dotatate formulation so that more patients suffering from GEP-NETS may have access to the potential benefits of radioligand therapy.

Michael Patterson, Curium North America CEO commented: "Curium’s 505(b)(2) new drug application for Lutetium Lu 177 Dotatate Injection marks another important milestone for Curium in its evolution to bring new tools for patients and healthcare providers to both diagnose and now potentially treat disease. Nuclear medicine-based cancer therapies must continue to be more widely and reliably available for patients and their caregivers."

Curium will provide further updates as it proceeds with its application through the FDA’s review process.

On July 08, 2024 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported that C4T management will participate in a fireside chat at the UBS Targeted Protein Degradation (TPD) Day taking place virtually on July 15, 2024 (Press release, C4 Therapeutics, JUL 8, 2024, View Source [SID1234644707]).

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On July 8, 2024 Epsilogen, a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer, reported that the Clinical Trial Application for the Phase Ib trial of MOv18 IgE has been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) (Press release, Epsilogen, JUL 8, 2024, View Source [SID1234644727]).

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The Phase Ib study is expected to initiate later in 2024 and will evaluate the efficacy of MOv18 IgE in patients with platinum-resistant ovarian cancer (PROC).

Dr Tim Wilson, Chief Executive Officer of Epsilogen, said: "This CTA is another significant milestone for Epsilogen and the clinical development of MOv18 IgE. We look forward to progressing MOv18 IgE into a Phase Ib efficacy study later this year as we continue to demonstrate the potential of IgE antibodies as a new, differentiated class of cancer treatments."

About MOv18 IgE

MOv18 IgE is an immunoglobulin E (IgE) antibody targeting the folate receptor alpha (FR alpha) antigen. FR alpha is present on a variety of cancers including ovarian, endometrial, lung and triple negative breast cancer. Epsilogen has successfully completed a Phase I safety study of MOv18 IgE in PROC patients. The results of the study, published in Nature Communications, found MOv18 IgE to be safe and well tolerated, with evidence of anti-tumour activity observed. Epsilogen, alongside its partner Lonza, also announced the successful completion of large-scale Good Manufacturing Practice (GMP) manufacturing of MOv18 IgE earlier this year.

About the Phase Ib study

The Phase Ib study is designed to confirm the safety and tolerability of MOv18 IgE and demonstrate efficacy in PROC. Following the dose escalation, an expansion cohort will be recruited to make a preliminary assessment of the anti-tumour activity of MOv18 IgE at a selected dose. In addition, delay to disease progression will be assessed along with a number of translational elements to generate further understanding of MOv18 IgE in the study population.

On July 8, 2024 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-270 for the potential treatment of patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC) who have been treated with an immune checkpoint inhibitor and a vascular endothelial growth factor inhibitor (Press release, Adicet Bio, JUL 8, 2024, View Source [SID1234644726]).

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"We are pleased that ADI-270, our first ever gamma delta 1 CAR T cell therapy candidate to enter clinical trials for solid tumors, has been granted Fast Track Designation by the FDA," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "ccRCC is the most common type of kidney cancer, and this significant milestone underscores our commitment to advancing innovative treatments to these patients as quickly as possible."

Fast Track Designation is a process designed to facilitate development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need.

About ADI-270

ADI-270 is an armored allogeneic "off-the-shelf" gamma delta CAR T cell therapy candidate targeting CD70-positive cancers. CD70 is a compelling target due to its high expression in both solid and hematological malignancies. ADI-270 is engineered with a third-generation CAR designed to target CD70 using its natural receptor, CD27, as the binding moiety and is further armored with a dominant negative form of the transforming growth factor-β receptor II (dnTGFβRII) to provide functional resilience to the immunosuppressive tumor microenvironment. ADI-270 is also designed to increase exposure and persistence by reducing susceptibility to host vs. graft elimination. These properties of ADI-270 combined with the potent tumor infiltration demonstrated with gamma delta 1 T cells aim to improve clinical responses of RCC patients and other patients with CD70+ tumors.

On July 8, 2024 Bracco and Blue Earth Diagnostics Ltd, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported the appointment of Marco Campione as its new Chief Executive Officer (CEO), reporting to Bracco Imaging CEO Fulvio Renoldi Bracco (Press release, Blue Earth Diagnostics, JUL 8, 2024, View Source [SID1234644725]). Mr. Campione also joins the Blue Earth Diagnostics Ltd Board of Directors and will serve as Vice Chair of the Blue Earth Diagnostics Inc. Board of Directors. Dr. David Gauden, a co-founder of Blue Earth Diagnostics and with the Company since 2014, assumes the role of full-time CEO of Bracco subsidiary Blue Earth Therapeutics. The changes reflect a carefully planned strategy to drive continued growth, development and opportunity for both companies and Bracco.

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"I congratulate Marco Campione on this CEO appointment and we look forward to drawing upon his strategic, operational and broad general business expertise as we increase our global leadership throughout the diagnostic radiopharmaceutical industry," said Fulvio Renoldi Bracco, CEO of Bracco Imaging. "Marco joins the Bracco Group at a transformative point in our evolution, as the company matures, broadens its horizons globally and expands its commercial presence."

Mr. Renoldi continued, "I also want to take this opportunity to recognize the many contributions of David Gauden in advancing the success of Blue Earth Diagnostics, and I wish him the best of success in now leading Blue Earth Therapeutics as its full-time CEO."

"I am excited and honored to assume the role of CEO at Blue Earth Diagnostics," said Mr. Campione. "The Company is a recognized leader throughout the nuclear medicine and oncology communities, having a strong reputation grounded in successful innovation, execution and dedicated service on behalf of patient health. I look forward to applying my experience towards expanding availability of the Company’s PET imaging products for prostate cancer, advancing its development programs in PET neuro-oncology and solid tumors, and in exploring additional opportunities and collaborations."

Marco Campione brings more than 25 years of experience from GE HealthCare, where he most recently served as Executive Director and Global Head of Contrast Media, General Manager Pharmaceutical Diagnostics North America and President GE HealthCare Inc.