On February 20, 2024 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported it will host a virtual event discussing updated clinical data for PSMA-TRACTr JANX007 and EGFR-TRACTr JANX008 on Monday, February 26th, 2024, at 4:30PM ET (Press release, Janux Therapeutics, FEB 20, 2024, View Source [SID1234640312]).

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David Campbell, Ph.D., President & Chief Executive Officer will discuss interim clinical updates for JANX007, a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 dose escalation clinical trial in adult subjects with metastatic castration-resistant prostate cancer (mCRPC) and JANX008, a TRACTr that targets epidermal growth factor receptor (EGFR) and is being investigated in a Phase 1 dose escalation clinical trial in adult subjects with non-small cell lung cancer, renal cell carcinoma, colorectal cancer, and squamous cell carcinoma of the head and neck. Specifically, the company will provide clinical efficacy and safety updates to report on progress towards identifying doses for expansion studies with JANX007, and on early dose escalation data for JANX008.

The company anticipates providing an update on identifying doses to be evaluated in expansion cohorts for JANX007 in 2H 2024.

A live question and answer session will follow the formal presentation. To register for the event, please click here.

Janux’s TRACTr and TRACIr Pipeline

Janux’s first clinical candidate, JANX007, is a TRACTr that targets PSMA and is being investigated in a Phase 1 clinical trial in adult subjects with mCRPC. Janux’s second clinical candidate, JANX008, is a TRACTr that targets EGFR and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including non-small cell lung cancer, renal cell carcinoma, colorectal cancer, and squamous cell carcinoma of the head and neck. Janux is also applying its proprietary technology to develop a TRACTr designed to target TROP2, a clinically validated anti-tumor target that is overexpressed in various cancer types, such as breast, lung, urothelial, endometrial, ovarian, prostate, pancreatic, gastric, colon, head and neck, and glioma. Janux’s TRACIr drug candidate, JANX009, is designed for targeting both the programmed death-ligand 1 (PD-L1) receptor as well as the costimulatory CD28 receptor on T cells for the treatment of solid tumors. In addition to named programs, Janux is generating a number of unnamed TRACTr and TRACIr programs for potential future development.

On February 20, 2024 NextPoint Therapeutics, a clinical-stage biotechnology company developing a new class of precision oncology therapeutics targeting the novel HHLA2 pathway, reported that the first patient has been dosed with NPX887 in a Phase 1 first-in-human clinical trial for the treatment of patients with solid tumors expressing HHLA2/B7-H7, a tumor antigen strongly upregulated in many human tumors independently of PD-L1 (Press release, NextPoint Therapeutics, FEB 20, 2024, View Source [SID1234640311]).

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The study is a Phase 1a/1b open-label, multi-center trial (NCT06240728) consisting of a dose escalation and an expansion stage to evaluate the tolerability, pharmacokinetics, immunogenicity and biomarker-based selection of NPX887 in patients with solid tumor malignancies including non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), colorectal carcinoma (CRC) and other solid tumor types known to express HHLA2/B7-H7.

"The launch of NPX887, our second clinical program targeting the HHLA2/B7-H7 axis, marks an important step in broadening our therapeutic targeting of this novel pathway to reactivate the immune system to fight cancer," commented Leena Gandhi, MD, PhD, Chief Medical Officer of NextPoint Therapeutics. "Together with NPX267, our first clinical program targeting the KIR3DL3 receptor for HHLA2, we are well-positioned to interrogate how best to exploit this pathway to effectively treat patients whose tumors express HHLA2 as an independent checkpoint of tumor-immune response from PD-L1. Our goal for both clinical programs is to leverage HHLA2 as a biomarker to enable precision selection of patients most likely to benefit. Both NPX267 and NPX887 have the potential for monotherapy benefit in selected patient populations."

About NPX887

NPX887 is a fully human monoclonal antibody targeting HHLA2 (B7-H7), a novel immune checkpoint and tumor target antigen highly expressed in many cancers independently of PD-L1. NPX887 is designed to prevent immune escape in solid tumors by blocking KIR3DL3-mediated immunosuppression which results from binding to HHLA2. Treatment with NPX887 is believed to promote both T and NK cell antitumor activity within the tumor microenvironment. To learn more, visit www.clinicaltrials.gov (NCT06240728).

On February 20, 2024 AffyImmune Therapeutics, a clinical-stage biopharmaceutical company committed to developing novel, first-in-class, affinity-tuned CAR T cell therapies, reported that Matt Britz, President, will participate in a virtual fireside chat at the Evercore ISI 2024 Emerging Biotech Conference on February 29, 2024 (Press release, AffyImmune Therapeutics, FEB 20, 2024, View Source [SID1234640310]).

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The discussion will be available via a listen-only live webcast accessible at View Source The webcast will be available for replay at View Source starting March 4, 2024, and will remain archived following the conference.

On February 20, 2024 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies, reported the announcement by Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, that patient enrollment has been completed in the Phase 3 RINGSIDE study evaluating AL102 in desmoid tumors (Press release, Immunome, FEB 20, 2024, View Source [SID1234640309]).

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Earlier this month, Immunome announced that it entered into a definitive asset purchase agreement with Ayala to acquire AL102 and related drug candidate AL101. Completion of the transaction remains subject to customary closing conditions.

"We are pleased with the progress of the RINGSIDE trial," said Bob Lechleider, M.D., Chief Medical Officer of Immunome. "The robust enrollment of the Phase 3 portion affirms our excitement for the potential of AL102. We are also encouraged by the rapidity and depth of the tumor responses observed in Phase 2. We look forward to closing the purchase of AL102 later this quarter or early in the second quarter."

On February 20, 2024 Blue Earth Therapeutics, a Bracco company and emerging leader in the development of innovative next generation therapeutic radiopharmaceuticals, reported the publication of promising early clinical data with 177Lu-rhPSMA-10.1 from independent clinical experience by physicians at the University Hospital Augsburg, Germany (Press release, Blue Earth Therapeutics, FEB 20, 2024, View Source [SID1234640308]).

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NOTE: this early clinical experience with 177Lu-rhPSMA-10.1, manufactured by the University Hospital Augsburg and used under German legislation, reflects use of an investigational agent for which safety and efficacy have not been established by the U.S. Food and Drug Administration.

The manuscript, "First Safety and Efficacy Data with the Radiohybrid 177Lu-rhPSMA-10.1 for the Treatment of Metastatic Prostate Cancer," has been published in the Journal of Nuclear Medicine (DOI View Source). In the 4 consecutive patients with metastatic prostate cancer who were evaluated, when looking at radiologic progression free survival (rPFS), 2 patients had not progressed at 24 and 18 months of follow-up. The other 2 patients had a rPFS of 12 and 15 months, respectively. Starting prostate-specific antigen (PSA) levels were reduced by 100%, 99%, 88% and 35% for the 4 individual patients. There were no serious treatment-related adverse events.

177Lu-rhPSMA-10.1 is an investigational radiohybrid (rh) Prostate-Specific Membrane Antigen-targeted radiopharmaceutical for the treatment of prostate cancer, and the lead candidate in Blue Earth Therapeutics’ development of next generation therapeutic radiopharmaceuticals. The Company’s investigational Phase 1/2 clinical trial (NCT05413850) evaluating the safety, tolerability, dosimetry and anti-tumor activity of 177Lu-rhPSMA-10.1 in eligible men with metastatic castrate-resistant prostate cancer (mCRPC) is underway in the United States.

"Although this experience with 177Lu-rhPSMA-10.1 represents a small number of patients, we find the results encouraging, with durable radiologic responses for patients with metastatic castrate resistant prostate cancer, including a complete response to therapy sustained beyond two years," said Prof. Dr. med. Constantin Lapa, Department of Nuclear Medicine, University Hospital, Augsburg, Germany. "This followed our previous dosimetry work with the same patients, which showed that 177Lu-rhPSMA-10.1 achieved a high Therapeutic Index (TI), delivering a high dose to tumors relative to the absorbed dose to the kidneys, and we look forward to the results of Blue Earth Therapeutics’ ongoing Phase 1/2 trial."

"We are pleased that these exciting data, from University Hospital Augsburg’s independent experience with 177Lu-rhPSMA-10.1, have been made available to the physician community," said David Gauden, D. Phil., Chief Executive Officer of Blue Earth Therapeutics. "These promising clinical data give us further optimism in advancing 177Lu-rhPSMA forward in clinical development, with the hope to help treat patients with metastatic prostate cancer. 177Lu-rhPSMA-10.1 is based on innovative radiohybrid PSMA theranostic technology, with a carefully optimized pharmacokinetic profile designed to increase retention in cancer deposits while encouraging clearance from normal tissues as rapidly as possible. We then match these properties with long-lived isotopes to maximize the therapeutic index and dose to tumor."