On April 15, 2025 Illumina Inc. (NASDAQ: ILMN) and Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, reported a collaboration to accelerate clinical adoption of next-generation sequencing tests through novel evidence generation (Press release, Illumina, APR 15, 2025, View Source [SID1234651950]). The collaboration will combine leading Illumina AI technologies with Tempus’s comprehensive multimodal data platform to train genomic algorithms and ultimately accelerate clinical adoption of molecular testing for patients.

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"In the era of true precision medicine, every patient who is battling complex disease should be routed to the optimal therapy based on molecular insights," said Everett Cunningham, chief commercial officer of Illumina. "We envision a world where the full range of molecular profiling is available as part of the standard of care—not just in cancer, but in cardiology, neurology, immunology, and every other category of disease."

Today, patients frequently miss the benefit of precision medicine because molecular profiling is not yet standard across disease areas and regions. This collaboration will leverage Tempus multimodal data to further improve Illumina’s AI-driven molecular analysis technologies and generate new insights supporting the clinical value of sequencing. These insights will be used to build evidence packages needed to standardize use of comprehensive genomic profiling and other molecular testing across all major diseases.

"By expanding our collaboration with Illumina, we are combining our strengths in technology and data analytics with their strengths in developing new sequencing technologies to drive forward innovation and advance precision medicine," said Terron Bruner, chief commercial officer of Tempus.

The program builds on a long-standing collaboration between the companies, which has focused on developing tools and assays to address gaps in testing needs from preemptive screening through therapy selection, health economics, and bioinformatics pipelines to improve patient outcomes and research.

On April 15, 2025 Artios Pharma Limited ("Artios"), a clinical-stage biotech company led by pioneers of DNA damage response ("DDR") drug development, reported that the company’s abstract featuring clinical trial results from its ongoing Phase 1/2a study of ART0380 in combination with low dose irinotecan has been selected for an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting 2025, taking place in Chicago from April 25 to 30, 2025 (Press release, Artios Pharma, APR 15, 2025, View Source [SID1234651932]). Artios will also present posters on preclinical data from its ART0380 and ART6043 programs.

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Details of the oral presentation:

Abstract Title: First results of ART0380 (an ATR kinase inhibitor) with low dose irinotecan in advanced or metastatic tumors

Presenter: Susanna Ulahannan, MD, Associate Professor, Stephenson Cancer Center at the University of Oklahoma/SCRI, OK, USA

Date: Tuesday, April 29, 2025

Time: 3:50 pm – 4:00 pm CDT

Location: Room S406 (Vista Ballroom) – McCormick Place South (Level 4)

Details of the poster presentation on ART0380:

Abstract Title: Combination of the ATR inhibitor, ART0380, with irinotecan for treating ATM-negative tumors

Presenter: Helen M. R. Robinson, VP of Biology, Artios

Session: PO.ET06.02 – DNA Damage Response and Modulation of DNA Repair 1

Date Monday, April 28, 2025

Time: 2:00 pm – 5:00 pm CDT

Location: Section 16

The full poster abstract is available on the AACR (Free AACR Whitepaper) Annual Meeting website.

Details of the poster presentation on ART6043:

Abstract Title: DNA polymerase theta inhibitor, ART6043, potentiates the efficacy of 177Lu- and 225Ac-based radioligand therapies in vitro and in vivo

Presenter: Marco Ranzani, Associate Director, Artios

Session: PO.ET06.02 – DNA Damage Response and Modulation of DNA Repair 1

Date Monday, April 28, 2025

Time: 2:00 pm – 5:00 pm CDT

Location: Section 16

The full poster abstract is available on the AACR (Free AACR Whitepaper) Annual Meeting website.

On April 15, 2025 Toragen, Inc., a San Diego-based clinical-stage biotechnology company focused on developing uniquely selective drugs targeting cancers caused by viruses, reported positive safety data from its Phase 1 trial of TGN-S11, a small molecule inhibitor of the human papillomavirus (HPV) E5 oncogene protein, in patients with cancers associated with HPV (Press release, Toragen, APR 15, 2025, View Source [SID1234651951]).

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This Phase 1 trial was an open-label, non-randomized study in multiple cohorts of patients with relapsed, resistant, or metastatic HPV-associated cancers. The study has been conducted in two parts: Part 1 was escalating doses of TGN-S11 as monotherapy and Part 2 was TGN-S11 in combination with Keytruda (pembrolizumab), a PD-1 checkpoint inhibitor. The dose escalation part consisted of four Cohorts of three to six patients on monotherapy with increasing doses of TGN-S11. The Keytruda combination part consisted of three Levels of three to six patients with increasing doses of TGN-S11 and the standard dose of Keytruda.

In Part 1, 18 patients were treated with TGN-S11 as monotherapy in 4 dose cohorts with no serious adverse events identified. In the 4th dose cohort, 2 patients developed non-serious dose-related toxicities; therefore, the maximum tolerated dose (MTD) was determined to be 300mg/day. One-third of the patients who received TGN-S11 monotherapy showed drug activity with decreases in tumor size and decreases in Tumor Tissue Modified Viral (TTMV) HPV DNA as measured by the NavDx test. In addition, 10 patients were treated in Part 2 in 3 dose levels evaluating TGN-S11 in combination with Keytruda with no safety issues. Half of these patients in this portion of the study showed drug activity with decreases in tumor size and/or decreases in TTMV-HPV DNA score. One of these patients had a 92% reduction in TTMV-HPV DNA score and 3 patients remain on treatment.

This Phase 1 trial met both primary endpoints of proving safety and reaching the maximum tolerated dose of TGN-S11. In addition, our data also shows that 53% of patients that reached at least 2 months of treatment showed drug activity.

Dr. Neil Clendeninn, CMO of Toragen, said, "TGN-S11 was well-tolerated as monotherapy and in combination with Keytruda and we are very excited to see evidence of activity based on the reduction in TTMV-HPV DNA score in this study in advanced cancer patients."

Based on these positive results, Toragen plans to proceed with the development of its second-generation inhibitor of the E5 oncogene protein, TGN-S15, which has demonstrated increased efficacy and decreased side effects in preclinical testing. TGN-S15 will advance to IND-enabling studies to support a first in human study in healthy volunteers and Phase 2 clinical trials targeting HPV-associated cancers.

On April 15, 2025 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) accepted a New Drug Application (NDA) for its new generation pan-TRK inhibitor zurletrectinib (ICP-723) for the treatment of adult and adolescent patients (12 to 18 years old) with advanced solid tumors harboring NTRK gene fusions (Press release, InnoCare Pharma, APR 15, 2025, View Source [SID1234651952]).

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In the registrational trial for adult and adolescent patients with NTRK fusion-positive solid tumors, zurletrectinib demonstrated outstanding efficacy with a good safety profile. Zurletrectinib was also shown to overcome acquired resistance to the first-generation TRK inhibitors.

Meanwhile, the Company is accelerating the registrational trial for pediatric patients (2 to 12 years old).

Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare, said, "Zurletrectinib has demonstrated outstanding efficacy and safety profile in adult, adolescent, and pediatric patients with tumors harboring NTRK fusion genes, bringing better treatment options for patients with solid tumors. The Company is expanding the scope of its solid tumor pipelines through a combination of targeted therapies, immune-oncology approaches, and cutting-edge ADC technology, looking forward to meeting the unmet needs of patients with solid tumors early."

NTRK fusion genes occur in various types of adult and pediatric tumors. In some rare tumors, such as salivary gland carcinoma, secretory breast cancer, and infantile fibrosarcoma, the incidence of NTRK gene fusion exceeds 90%1. It is estimated that there are about 6,500 new cases of NTRK fusion-positive solid tumors are diagnosed, in China each year. There are highly unmet clinical needs in this area due to lack of effective treatment options.

On April 15, 2025 TJ Biopharma ("TJ Bio" or "Company"), a fully integrated biotech company focusing on discovery, development, manufacturing and commercialization of innovative biologics in the areas of autoimmune diseases, oncology and metabolic disorders, reported completion of patient enrollment in the Phase 2 stage of its ongoing Phase 2/3 clinical study evaluating uliledlimab, a differentiated CD73 antibody, in combination with toripalimab (doublet study) as first-line treatment for non-small cell lung cancer (NSCLC) (Press release, TJ Bio, APR 15, 2025, View Source [SID1234654002]). The Company anticipates topline data readout in the first half of 2025 and intends to initiate a Phase 3 registrational study of the doublet study as planned.

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"Despite multiple challenges, our team successfully managed to complete the patient enrollment on track, demonstrating TJ Bio’s exceptional clinical operations capabilities," said Dr. Jingwu Zang, Founder and Chairman of TJ Bio. "The development of uliledlimab, a cornerstone of our staged pipeline, is accelerating steadily. We’re confident in the clinical value of this therapy and look forward to upcoming data analysis results as we prepare for the Phase 3 study launch, aiming to provide more effective and innovative treatment options for lung cancer patients."

Earlier this year, TJ Bio initiated and dosed the first patient in another Phase 2 clinical study evaluating uliledlimab in combination with sintilimab and chemotherapy (triplet study) as first-line treatment for NSCLC. The Company is actively advancing both studies in China as planned.

About Uliledlimab
Uliledlimab (also known as TJD5) is a differentiated, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine. Adenosine, in turn, binds to adenosine receptors on relevant immune cells and inhibits anti-tumor immune responses in the tumor microenvironment. Uliledlimab is expected to offer clinical benefits by suppressing tumor growth in concert with checkpoint therapies such as PD-(L)1 antibodies. Uliledlimab is effective in anti-tumor activities through a unique intra-dimer binding, leading to differentiated and favorable functional properties, as evident in preclinical and clinical studies.

Positive results from the Phase 1b/2 clinical study (NCT04322006) of uliledlimab in combination with toripalimab as first-line treatment for advanced non-small cell lung cancer (NSCLC) were presented at ASCO (Free ASCO Whitepaper) 2023: The combination therapy showed a 31% response rate in treatment-naïve NSCLC patients; notably, in patients with high CD73 expression and PD-L1 positivity, the response rate reached 63%. Biomarker analysis revealed a strong correlation between high tumor CD73 expression and treatment response, further supporting the potential of CD73 expression as a predictive biomarker. In September 2024, TJ Bio and Sanofi entered into strategic partnership for the development, manufacturing and commercialization of uliledlimab in Greater China.