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."

On February 20, 2024 BostonGene, a leading provider of AI-based molecular and immune profiling solutions, reported that it will participate in the 21st Japanese Society of Medical Oncology (JSMO) Annual Meeting (Press release, BostonGene, FEB 20, 2024, View Source [SID1234640307]). The research conference will be held at the Nagoya Congress Center from February 22 to 24, bringing together a diverse tumor-agnostic academic society focused on pharmacologic therapy with the objective of delivering research to enhance the quality of life for all cancer patients.

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BostonGene will deliver presentations demonstrating the utility of integrated genomic and transcriptomic profiling in identifying clinically relevant alterations for treatment decision-making and describe the development of AI-based analytical tools and pipelines to comprehensively understand each patient’s disease.

Details about the abstracts selected for presentation are below:

Oral presentations

1) An ML-based tool for predicting tissue of origin for cancer of unknown primary based on genomic and transcriptomic data
When: Friday, February 23 | 15:00 – 16:30 JST
Session: Oral Session 9
Speaker: Nathan Fowler, MD, Chief Medical Officer, BostonGene

2) Aggregated analysis of integrated whole exome (WES) and whole transcriptome (WTS) sequencing in 1,000 cancer patients
When: Saturday, February 24 | 8:20 – 9:20 JST
Session: Mini Oral Session 60
Speaker: Nathan Fowler, MD, Chief Medical Officer, BostonGene

3) An HRD scoring system based on long-focal copy number alterations that predicts PARP inhibitor response
When: Saturday, February 24 | 15:30 – 16:30 JST
Session: Mini Oral Session 53
Speaker: Nathan Fowler, MD, Chief Medical Officer, BostonGene

Poster presentation

4) Tertiary lymphoid structure (TLS) and stromal tumor-infiltrating lymphocyte (sTIL) AI-based detection in breast cancer
When: Friday, February 23 |11:30 – 12:15 JST
Session: Poster Session 77
Speaker: Nathan Fowler, MD, Chief Medical Officer, BostonGene

BostonGene Japan Inc. was established in 2023 as a Tokyo-based joint venture by BostonGene, NEC, and Japan Industrial Partners to advance personalized medicine and improve patient outcomes dramatically. Equipping cancer care centers in Japan with BostonGene solutions expands patient access to genomic testing and personalized treatments. Additionally, Japanese researchers and biopharmaceutical companies benefit from biomarker-driven therapy development through BostonGene industry solutions.

To learn more or schedule a meeting with BostonGene during the event, please contact Zlata Polyakova at [email protected].