On May 30, 2024 Anocca, a leading T-cell receptor-engineered T-cell (TCR-T) therapeutics company, and Shinobi Therapeutics (Shinobi), developer of immune-evasive induced pluripotent stem cell (iPSC)-derived CD8 αβT-cell therapies (iPS-T), reported a strategic partnership to use Shinobi’s proprietary immune evasive iPS-T cell platform with novel candidate TCRs, discovered and validated by Anocca, to develop a new class of off-the-shelf allogeneic TCR engineered iPS-T-cell therapies (TCR-iPS-T) for solid tumors (Press release, Anocca, MAY 30, 2024, View Source [SID1234655349]).

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"Anocca has made tremendous progress using our unique technology platform to systematically map cancer targets and build potent and highly specific TCR libraries to deliver personalized TCR-T treatments. As we prepare to progress our first gene-edited autologous TCR-T product into the clinic, we are excited to partner with Shinobi and work together to develop innovative off-the-shelf TCR-T cell therapies," said Anocca’s CEO and co-founder, Reagan Jarvis. "Shinobi’s Katana platform has the potential to offer treatment options for most cancer patients when combined with Anocca’s ability to systematically unlock the largely unexploited landscape of TCR-T targets."

"Combining Shinobi’s immune evasive iPS-T cell platform with Anocca’s world-class TCR discovery platform will accelerate our mission of building a comprehensive pipeline of TCR and CAR-targeted off-the-shelf T-cell therapies," said Dan Kemp, Shinobi’s CEO. "This is an ideal partnership between two emerging biotechs where the alignment of our technologies could realize a shared goal of making transformative TCR-iPS-T cell therapies and making them accessible to cancer patients on a global scale."

Shinobi’s ‘Katana’ technology specifically enables the efficient introduction of antigen-targeting TCR and/or CAR constructs into its immune evasive iPS-T cells in a plug-and-play manner. Anocca has developed a unique deep-tech discovery platform that uses programmable human cells to recreate and manipulate T-cell immunity and deliver libraries of highly specific, clinically deployable TCR candidates for the treatment of solid cancers. In this joint program, Shinobi and Anocca will work together to produce TCR engineered CD8 αβiPS-T-cells against validated cancer targets and deliver pre-clinical proof of concept. A successful outcome will pave the way for the development of novel off-the-shelf treatments in solid tumor indications for the broadest patient populations.

On May 30, 2024 Alpha Fusion Co., Ltd. reported that its joint research partner, a research team led by Lecturer Naofumi Watanabe of the Department of Radiation Medicine at the Graduate School of Medicine, Osaka University, will begin a new physician-initiated clinical trial targeting standard treatment-resistant prostate cancer in June 2024 at the Department of Nuclear Medicine, Osaka University Hospital (Press release, Alpha Fusion, MAY 30, 2024, View Source [SID1234647193]).

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The astatine-labeled drug ([At-211]PSMA-5) used in a new alpha-ray therapy targeting prostate-specific membrane antigen (PSMA) expressed in prostate cancer, developed by Lecturer Watanabe’s research team, has been confirmed to have a long-lasting tumor regression effect after a single administration in a prostate cancer model mouse. Due to its strong effect in model mouse experiments, it is considered to be a particularly promising drug candidate compound.

[At-211]PSMA-5 has been selected for the Japan Agency for Medical Research and Development (AMED) Translational Support Research Program (Seeds F) "Project name: Conducting an investigator-initiated clinical trial for the practical application of an innovative alpha-ray therapy targeting prostate-specific membrane antigen (PSMA)" due to its usefulness, path to practical application, and the collaborative system between Osaka University and Alpha Fusion. Alpha Fusion will contribute to the practical application of this investigational drug as the world’s first prostate cancer treatment using astatine. This investigator-initiated clinical trial

is a phase I clinical trial to confirm the tolerability, safety, pharmacokinetics, and efficacy after administration of [At-211]PSMA-5 to patients with castration-resistant prostate cancer who have difficulty in implementing and continuing standard treatment. This is the first time that this investigational drug will be administered to humans in the world. The design is a dose-escalation design, starting with a low dose as an anticancer drug clinical trial and gradually increasing the dose.

[Study name] Phase I investigator-initiated clinical trial of a new alpha-particle nuclear medicine treatment for patients with castration-resistant prostate cancer.
・Subjects: Patients with castration-resistant prostate cancer for whom standard treatment is difficult to implement or continue
・Investigational drug: PSW-1025 (compound name: [At-211]PSMA-5)
・Period: June 2024 to March 2027 (planned)
・Planned number of cases: 15 cases
・Principal investigator: Naofumi Watanabe (Department of Nuclear Medicine, Osaka University Hospital)

On May 30, 2024 Oncopeptides reported its first quarter 2024 financial results (Presentation, Oncopeptides, MAY 30, 2024, View Source [SID1234644676]).

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On May 30, 2024 Incyte (Nasdaq:INCY) reported that it has completed its acquisition of Escient Pharmaceuticals, a clinical-stage drug discovery and development company advancing novel small molecule therapeutics for systemic immune and neuro-immune disorders (Press release, Incyte, MAY 30, 2024, View Source [SID1234643897]).

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"The acquisition of Escient and its first-in-class oral MRGPR antagonists bolsters our Inflammation and Autoimmunity portfolio and our commitment to creating innovative solutions that address the urgent needs of patients living with severe inflammatory diseases," stated Hervé Hoppenot, Chief Executive Officer, Incyte. "We are excited to continue the work started by the Escient team and accelerate the clinical development of these promising therapies."

Through this transaction, Incyte has added EP262 and EP547 to its portfolio. EP262 is a first-in-class, potent, highly selective, once-daily small molecule antagonist of Mas-related G protein-coupled receptor X2 (MRGPRX2). By blocking MRGPRX2 and degranulation of mast cells, EP262 has the potential to effectively treat multiple mast cell-mediated diseases including chronic inducible urticaria (CIndU), chronic spontaneous urticaria (CSU) and atopic dermatitis (AD). EP547 is a first-in-class oral MRGPRX4 antagonist with the potential to treat cholestatic pruritus and other conditions with severe pruritus.

"Over the past six years, Escient has pioneered the characterization of MRGPR biology and advanced two novel candidates, EP262 and E547, into clinical development," commented Joshua Grass, Chief Executive Officer of Escient Pharmaceuticals. "The close of this transaction represents the recognition of value of the innovation by the Escient team, and also represents an exciting transition to Incyte, a global biopharmaceutical company that is well positioned to advance these novel candidates to address the unmet needs of patients worldwide."

As previously disclosed, under the terms of the agreement, Incyte has acquired Escient and its assets for $750 million plus Escient’s net cash remaining at the close of the transaction, subject to customary adjustments.

Centerview Partners LLC and Goldman Sachs & Co. LLC advised Escient on the transaction, and Fenwick & West LLP acted as legal counsel for Escient. Covington & Burling LLP acted as legal counsel for Incyte.

About EP262

EP262 is a potent, highly selective once-daily small molecule antagonist of MRGPRX2, a receptor expressed on mast cells that is activated by numerous ligands, including many peptides released from sensory neurons as well as other cell types. In response to MRGPRX2 activation, mast cells release histamine, tryptase, chymase, chemokines and cytokines, which can cause itchy hives, angioedema, type 2 inflammation (through engagement of the adaptive immune system) and chronic pruritus and pain. Preclinical data demonstrate that, by blocking activation of MRGPRX2, EP262 has the potential to effectively treat a broad range of mast cell-mediated conditions, with an initial focus on chronic urticarias and atopic dermatitis.

About EP547

EP547 is a potent, highly selective antagonist that blocks the activation of MRGPRX4 by various bile acids, bilirubin and urobilin. By virtue of this disease-specific mechanism of action, EP547 has the potential to be a highly targeted and efficacious treatment for cholestatic and uremic pruritus.

On May 30, 2024 OncoNano Medicine, Inc. ("OncoNano"), a clinical-stage biotechnology company pioneering the development of polymeric micelles encapsulating anti-cancer payloads, reported that it will present a Trials in Progress poster at the upcoming 2024 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago, Illinois, May 31st–June 4th, 2024 (Press release, OncoNano Medicine, MAY 30, 2024, View Source [SID1234643896]).

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The poster will highlight the study objectives and design of the ongoing ON-5001 study, a phase 1/1b, multicenter, open label, non-randomized dose escalation and dose expansion to examine the safety, tolerability and optimal dosing of ONM-501, a dual-activating STING (STimulator of INterferon Genes) agonist, as a monotherapy and in combination with cemiplimab (Libtayo) in patients with advanced solid tumors and lymphomas (NCT06022029).

Details for the ASCO (Free ASCO Whitepaper) Annual Meeting Trials in Progress poster presentation are as follows:

Presentation Overview:

TITLE: A phase 1 dose-escalation and expansion study of an intratumorally administered dual STING agonist (ONM-501) alone and in combination with cemiplimab in patients with advanced solid tumors and lymphomas.

PRESENTER: Julia Foldi, M.D., Ph.D., Assistant Professor of Medicine, Oncology, University of Pittsburgh Medical Center

SESSION: Developmental Therapeutics—Immunotherapy

POSTER: Poster Board #160a; Abstract TPS2693

DATE/TIME: June 1, 2024; 9:00 AM-12:00 PM CDT

Once presented the poster will be made available on the OncoNano website at Publications — OncoNano (www.onconano.com/publication).

About ONM-501

ONM-501 is a next generation dual-activating STING (STimulator of INterferon Genes) agonist currently in phase 1 development for the treatment of solid tumors. STING activation mediates a multifaceted type-1 interferon response that is critical in the activation of innate and adaptive immunity against infection and, potentially, cancer. ONM-501 is a pH-sensitive polymer, PC7A, carrying a cyclic guanosine monophosphate–adenosine monophosphate (cGAMP) payload, that together induce prolonged STING activation. In preclinical models, when delivered to the tumor microenvironment, ONM-501 produces dendritic cell maturation and cytotoxic T cells priming, while demonstrating antitumor efficacy. ONM-501 is currently being evaluated in a phase 1, multicenter, open label, non-randomized dose escalation and dose expansion trial to examine the safety, pharmacokinetics, pharmacodynamics, and early activity of ONM-501 as a monotherapy and in combination with an anti-PD-1 checkpoint inhibitor, cemiplimab, in patients with advanced solid tumors and lymphomas. The trial is open in the United States and planned to open in Australia in 2H2024; visit clinicaltrials.gov (NCT06022029) for more details. ONM-501 development has been supported in part by a grant from the Cancer Prevention and Research Institute of Texas.