On January 23, 2024 Hummingbird Diagnostics GmbH, a leader in reading blood-based small RNAs for early disease detection and characterization, reported the initiation of its clinical study evaluating the diagnostic performance of miLungDx, a blood-based small RNA panel engineered to detect non-small cell lung cancer (NSCLC) (Press release, Hummingbird Diagnostics, JAN 23, 2024, View Source [SID1234639445]).

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The primary endpoint of the prospective, longitudinal, observational study (NCT05987189) is to detect the absence or presence of lung cancer, as determined by all follow-up imaging and pathological data obtained throughout the duration of the study. Based in the United States, the study will include 2,000 patients with the expected patient enrollment to be completed within 12 months after study initiation.

"The initiation of patient recruitment for this clinical study marks an exciting milestone for the team at Hummingbird Diagnostics and underscores our mission to improve human health through the development of novel small RNA blood tests," remarked Bruno Steinkraus, PhD, Chief Scientific Advisor of Hummingbird Diagnostics. "We believe miLungDx has the best performance reported from a blood test for early-stage lung cancer to date. We look forward to the continued development of this RNA panel."

Hummingbird Diagnostics has reported best in class performance for early detection of lung cancer published in the Journal of Thoracic Oncology and presented at ASCO (Free ASCO Whitepaper) 2023.

On January 23, 2024 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive, accurate tests for the detection of early-stage cancer and lung disease, reported that India’s Office of the Controller General of Patents, Designs and Trade Marks has issued a Certificate of Grant of Patent to bioAffinity subsidiary OncoSelect Therapeutics, LLC for its compositions and methods to treat cancer using chemotherapeutic agents conjugated to porphyrins, resulting in targeted delivery of the drugs (Press release, BioAffinity Technologies, JAN 23, 2024, View Source [SID1234639444]).

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The Indian patent, titled "Porphyrin Compounds and Compositions Useful for Treating Cancer" is an important addition to bioAffinity Technologies’ patent portfolio, which includes 16 awarded U.S. and foreign patents and 23 pending patent applications related to its porphyrin-based diagnostic platform and cancer treatment therapeutics.

"India’s patent is an acknowledgement of the value of our ongoing research, development and commercialization of porphyrin-based diagnostics and targeted treatments for lung cancer and other diseases," bioAffinity Technologies’ President and CEO Maria Zannes said. "We are committed to improving the outcome for cancer patients around the world, beginning with lung cancer, the deadliest cancer killer. Strong intellectual property protection for our innovative science benefits not only patients in need of treatment and their physicians, but also our research team and our shareholders as well."

bioAffinity Technologies’ first product, CyPath Lung, is a porphyrin-based diagnostic test for early-stage lung cancer. Physicians use CyPath Lung for patients at high risk for developing lung cancer, often after recommended screening reveals indeterminate pulmonary lung nodules that may or may not be malignant. CyPath Lung is a noninvasive test that uses advanced flow cytometry and artificial intelligence to differentiate patients with cancer from those who do not have the disease.

On January 23, 2024 BostonGene, a leading provider of AI-driven molecular and immune profiling solutions, reported a master agreement with Duke University School of Medicine, one of the nation’s leading institutions for healthcare education, clinical healthcare provision, biomedical research, and community engagement, to collaborate on multiple research projects across lung cancer, gastrointestinal, genitourinary and skin cancers (Press release, BostonGene, JAN 23, 2024, View Source [SID1234639443]).

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The strategic partnership allows Duke physicians and researchers to leverage BostonGene’s expertise to drive the molecular and cellular characterization of the patient’s tumor, microenvironment and immune system and test its predictive value in response to treatment. For cancer patients undergoing treatment at Duke University, including those participating in clinical trials, BostonGene will provide state-of-the-art analytics, interpretation and visualization of big data obtained from analysis of patients’ genomic, transcriptomic, cell phenotyping, proteomic and imaging studies.

"Our collaboration with BostonGene is a testament to our commitment to excellence in healthcare and research. This study will enable us to explore the boundaries of predictive biomarkers and potentially offer new treatment options to patients," said Jeffrey Clarke, MD, Associate Professor of Medicine at Duke University School of Medicine.

"The partnership with Duke University signifies a pivotal step in actualizing AI-driven molecular insights to transform patient care," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "Our combined expertise will study the complex genetic landscape of a patient’s tumor, microenvironment and immune system, paving the path towards personalized treatments for all patients."

In its flagship study, led by Dr. Clarke at Duke and BostonGene molecular profiling and comprehensive analyses will be conducted on a meticulously annotated real-world cohort of non-small cell lung cancer (NSCLC) patients who received treatment with either checkpoint inhibitors alone or in conjunction with chemotherapy. The study’s primary objective is to assess predictive biomarkers that can more accurately pinpoint the subset of patients poised to derive maximum benefits from immunotherapy in the context of metastatic NSCLC.

On January 23, 2024 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the first pediatric patient has been dosed in clinical trial with its second generation pan-TRK inhibitor zurletrectinib at Sun Yat-sen University Cancer Center (Press release, InnoCare Pharma, JAN 23, 2024, View Source [SID1234639442]). This is the first time that zurletrectinib will be evaluated in a clinical study of pediatric (2 to 12 years old) patients, after demonstrating good safety and efficacy in adult and adolescent patients (12 to 18 years old).

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Zurletrectinib, developed by InnoCare, is a pan-TRK inhibitor which markedly inhibits the activity of the wild type TRKA, TRKB and TRKC, as well as mutant TRKA with resistant mutations G595R or G667C. Zurletrectinib could overcome acquired resistance to the first-generation TRK inhibitors.

InnoCare has been advancing the registrational trial of zurletrectinib in China and is expecting to submit the new drug application in the second half of 2024. An overall response rate (ORR) of 80-90%, indicating favorable efficacy, was observed in adult patients with various cancers carrying NTRK gene fusion who received dosages of 8 mg or more.

Dr. Jasmine, the Co-founder, Chairwoman, and CEO of InnoCare, said, "NTRK gene fusion is a driving factor for various adult and pediatric cancers. It is inspiring that we continue to make positive progress in our clinical research of zurletrectinib for patients of different ages with NTRK gene fusion. We expect to see our innovative assets benefit solid tumor patients in the near future."

In some rare tumor types, such as congenital infantile fibrosarcoma, the incidence of NTRK gene fusion is as high as 90%. NTRK gene fusion is associated with at least 19 tumor types in adults and children, including lung cancer, colorectal cancer, breast cancer, pancreatic cancer and melanoma.

On January 23, 2024 Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage specialty pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy (RT), reported that Dr. Anatoly Dritschilo, Chief Executive Officer, will participate in a fireside chat and host one-on-one meetings with investors at the Lytham Partners 2024 Investor Select Conference, taking place virtually on February 1, 2024 (Press release, Shuttle Pharmaceuticals, JAN 23, 2024, https://www.prnewswire.com/news-releases/shuttle-pharma-to-participate-in-a-fireside-chat-at-the-lytham-partners-2024-investor-select-conference-on-february-1-2024-302042226.html [SID1234639441]).

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At the conference, Dr. Dritschilo will discuss details of the Company’s recent FDA approval to proceed with the Phase II clinical trial of Ropidoxuridine for treatment of patients with glioblastoma, as well as other key areas of progress as Shuttle aims to improve the lives of cancer patients by developing therapies that are designed to maximize the effectiveness of RT while limiting the side effects of radiation in cancer treatment.

Company Webcast

The webcasted fireside chat will take place at 1:15pm ET on Thursday, February 1, 2024. The webcast can be accessed at View Source or on the Company’s website at View Source The webcast will also be available for replay following the event.

1×1 Meetings

Management will be participating in virtual one-on-one meetings throughout the event. To arrange a meeting with management, please contact Lytham Partners at 1×[email protected] or register for the event at View Source

Further information on the conference is available at View Source