On May 29, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported favorable safety and tolerability, and early efficacy in the fourth patient enrolled in the Company’s Deltacel-01 Phase 1 clinical trial (Press release, Kiromic, MAY 29, 2024, View Source [SID1234643792]). Deltacel-01 is evaluating Deltacel (KB-GDT-01), Kiromic’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies.

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Preliminary results of this first patient in the second cohort obtained six weeks after beginning treatment show a favorable safety and tolerability profile, while imaging shows promising early efficacy for the Deltacel treatment. Scans showed disease stabilization, no new sites of metastatic disease and an 8.5% reduction in the tumor size. Additionally, this patient experienced quality-of-life benefits from Deltacel treatment including stopping their previous need for prescription pain medication. This patient is being treated at the Beverly Hills Cancer Center (BHCC).

"The fourth patient in Deltacel-01 suffered from metastatic squamous cell carcinoma. They were enrolled in this trial after failing chemotherapy, antibody-based immunotherapy and standard radiotherapy. The six-week follow-up visit revealed stable disease, no new lesions and an 8.5% reduction in tumor size compared with pre-treatment measurements. In addition, while at the time of study enrollment this patient was taking a medication for cancer pain, it was not necessary any longer after receiving Deltacel, indicating a quality-of-life improvement," said Afshin Eli Gabayan, M.D., Medical Oncologist, Medical Director and Principal Investigator at BHCC.

"These encouraging clinical findings represent a strong start to the second cohort in our Deltacel-01 trial. We are particularly encouraged by the reduction in size of the tumor observed in this patient, and by the significant improvement in quality of life as evidenced by the reduction in cancer-related pain. Our team remains committed to advancing Deltacel-01 and we look forward to reporting preliminary results from the remainder of the three-patient second cohort in June," said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma.

About Deltacel-01

In Kiromic’s open-label Phase 1 clinical trial, titled "Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer" (NCT06069570), patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the Deltacel-01 trial is to evaluate safety, while secondary measurements include objective response, progression-free survival, overall survival, time to progression, time to treatment response and disease control rates.

About Deltacel

Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of stage 4 metastatic NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is the leading candidate in Kiromic’s GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial clinical focus on NSCLC, which represents about 80% to 85% of all lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.

On May 29, 2024 Florida Cancer Specialists & Research Institute, LLC (FCS) physicians reported that it will present findings from multiple clinical studies that are contributing to global advancements in cancer care at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago (Press release, Florida Cancer Specialists & Research Institute, MAY 29, 2024, View Source;research-institute-share-cancer-care-discoveries-at-2024-asco-annual-meeting-302158316.html [SID1234643808]). Clinical research originating from trials conducted at the three FCS Phase 1 Drug Development Units and late-phase studies at FCS clinics throughout Florida are among those being published or presented during the five-day international gathering of oncology physicians and professionals.

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Florida Cancer Specialists & Research Institute research featured in 37 presentations/publications at 2024 ASCO (Free ASCO Whitepaper).

"It is gratifying to see how FCS continues to expand the understanding of cancer worldwide," said FCS President & Managing Physician Lucio N. Gordan, MD. "Our clinical research efforts are patient centric. Each discovery enables us to target treatments with greater precision and impact for patients."

Manish Patel, MD, FCS director of drug development, notes that much of the clinical research being presented is focused on targeted treatments and biological combinations. Dr. Patel said, "The phase 1/2 trials offered at FCS provide patients early access to the most promising therapies and consistently lead to expedited FDA approvals that expand availability on a global scale."

Several FCS principal investigators are first authors of four abstracts that will be presented throughout the meeting:

Manish Patel, MD
Preliminary results from a phase 1 study of AC699, an orally bioavailable chimeric estrogen receptor degrader, in patients with advanced or metastatic breast cancer
Safety and preliminary efficacy of EIK1001 in combination with atezolizumab in participants with advanced solid tumors.
Dr. Patel is a co-author of eight additional presentations
Judy Wang, MD, FCS associate director of drug development
Phase 1/2 study of NGM707, an ILT2/ILT4 dual antagonist antibody, in advanced solid tumors: Interim results from dose-escalation.
She also is first author of the published abstract, A novel oral microtubule inhibitor utidelone capsule (UTD2): A phase 1 clinical study to assess the tolerability, safety, and efficacy in advanced solid tumors, of which Dr. Manish Patel is a co-author.
Dr. Wang is also a co-author of six additional presentations
Maen Hussein, MD – NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naïve patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): Updated overall survival analysis with 29-month follow-up of NAPOLI 3.
FCS hematologist and medical oncologist Cesar Augusto Perez, MD will present an oral education session titled, "Emerging Data for Antibody Drug Conjugates in Head and Neck Squamous Cell Carcinoma."

The following FCS principal investigators will have their abstracts presented during oral presentations of research results and other clinical findings which they have co-authored:

Kapisthalam Kumar, MD, FACP – Are we bridging the gap? A ten-year probe into NIH grants for early-career and independent investigators in oncology.
Manish Patel, MD – Safety and preliminary efficacy of EIK1001 in combination with pembrolizumab in participants with advanced solid tumors
Vipul Patel, MD – Primary results from the phase 3 EVOKE-01 study of sacituzumab govitecan (SG) vs docetaxel (doc) in patients (pts) with metastatic non-small cell lung cancer (mNSCLC) previously treated with platinum (PT)-based chemotherapy (chemo) and PD(L)-1inhibitors (IO).
Cesar Augusto Perez, MD, Amir Harandi, MD, MS – Phase 2 study of petosemtamab (MCLA-158) with pembrolizumab as first-line (1L) treatment of recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC)
Cesar Augusto Perez, MD – Updated phase 1 results of efficacy and safety of sigvotatug vedotin, an investigational ADC, in non-small cell lung cancer
FCS Associate Director of Drug Development Judy Wang, MD, Gail Lynn Shaw Wright, MD, FACP, FCCP, Fadi Kayali, MD — H3B-6545 in women with locally advanced/metastatic estrogen receptor-positive (ER+), HER2 negative (–) breast cancer (BC).
"We’re winning. We’re beating cancer," said Bradley Monk, MD, gynecologic oncologist and FCS medical director of late-phase clinical research. "Our discoveries through clinical trials are helping patients live longer and better lives." Dr. Monk is co-author of four presentations at ASCO (Free ASCO Whitepaper), including the results of the international phase 3 OUTBACK trial of racial disparities and survival outcome of patients with locally advanced cervix cancer.

Results from additional FCS co-authors will also be presented in various sessions, 26 in total, highlighting a variety of cancer types and treatment modalities:

Faithlore Gardner, MD
Todd Gersten, MD
Lucio N. Gordan, MD with FCS Senior Director of Partnerships, Managed Care Kiana Mehring
Joel Grossman, MD
Elizabeth Guancial, MD
"Our commitment to oncology research is stronger than ever and clearly demonstrated by sheer volume of abstracts presented by FCS researchers at this global symposium," stated FCS Chief Executive Officer Nathan H. Walcker. "The insights and breakthroughs revealed here fortify our resolve to tirelessly innovate and improve outcomes for patients worldwide."

FCS will be featured in 37 presentations and publications over the course of the conference. All abstracts and presentations are available to view at ASCO (Free ASCO Whitepaper) 2024 Annual Meeting.

The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) represents nearly 50,000 physicians and oncology professionals representing 150 countries who care for people living with all forms of cancer. ASCO (Free ASCO Whitepaper) works to conquer cancer through research, education, policy and promotion of high quality and equitable patient care.

View a full list of the FCS abstracts presented here: FLCancer.com/FCS-2024-ASCO-Presentations-052924.pdf

On May 29, 2024 Median Technologies (FR0011049824, ALMDT, PEA/PME scheme eligible, "Median" or "The Company") reported that the Company will be participating in the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place from May 31 to June 4, McCormick Place, Chicago, IL, USA (Press release, MEDIAN Technologies, MAY 29, 2024, View Source;June-4-2024-McCormick-Place-Chicago-IL-USA [SID1234643825]). The Median team, with iCRO and eyonis representatives will be pleased to welcome the ASCO (Free ASCO Whitepaper) participants at booth #15142, South Building, Hall A, McCormick place, from June 1 to 3 (exhibition dates), from 9:00 am to 5:00 pm.

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Median Technologies’ abstract selected for online publication is available on the ASCO (Free ASCO Whitepaper) platform:

Abstract #e23010: Double reading performance and the impact of adjudication on progression-free survival estimations: Findings from a lung clinical trial
The FDA recommends Blinded Independent Central Review (BICR) with double reads for imaging in clinical trials, but inter-reader variability raises concerns. Our study examined this variability in lung cancer clinical trials using RECIST. We analyzed 5 phase III trials with 7 readers forming 11 teams, covering 1,017 patients. The study focused on Discrepancy Rate (DR), bias, endorsement rate, and the impact of adjudication on Progression-Free Survival (PFS) estimates. Results showed significant bias among readers, affecting double readings but no correlation between bias and DR. Additionally, adjudication significantly affects PFS estimates. These outcomes highlight the need to improve monitoring in clinical trials.

The ASCO (Free ASCO Whitepaper) Annual Meeting is the world’s premier oncology conference, organized by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the largest oncology society in the world. Each year, the ASCO (Free ASCO Whitepaper) conference brings together more than 35,000 oncologists from all around the globe, and is attended by all medical, educational and industrial stakeholders involved in the field of oncology worldwide. More about the ASCO (Free ASCO Whitepaper) Annual Meeting: View Source

On May 29, 2024 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported its participation in Jefferies Global Healthcare Conference (Press release, Kura Oncology, MAY 29, 2024, View Source [SID1234643793]). Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in a virtual fireside chat at 3:00 p.m. ET / 12:00 p.m. PT on June 5, 2024. A live audio webcast of the fireside chat will be available in the Investors section of Kura’s website at www.kuraoncology.com, with an archived replay following the event.

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On May 29, 2024 Illumina Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, reported some of its latest research being presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, May 31–June 4 in Chicago (Press release, Illumina, MAY 29, 2024, View Source [SID1234643809]). Highlights include data from several studies in partnership with Labcorp, a global leader of innovative and comprehensive laboratory services; research with Sarah Cannon Research Institute (SCRI) demonstrating further evidence to support the use of comprehensive genomic profiling (CGP) over single-gene testing (SGT); and the latest data supporting the development of Illumina’s molecular residual disease (MRD) assay, which is currently underway in collaboration with major pharma companies. In total, Illumina had 14 abstracts accepted to the meeting.

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"Illumina is proud of our collaborations across all areas of the oncology, research, clinical, and payer communities to produce strong evidence to further enable genomic testing for patients with cancer," said Nicole Berry, head of the Americas region at Illumina. "Through this continued commitment, we can support our customers and partners to achieve their precision oncology goals for the benefit of patients everywhere."

Illumina and Labcorp: innovation-driven research

Illumina and Labcorp share five abstracts accepted at ASCO (Free ASCO Whitepaper). The organizations have a longstanding partnership working to build evidence of the clinical impact and value of comprehensive biomarker testing for patients across different cancer types, to ultimately increase community oncology physicians’ access to the latest genomic testing. Among the joint abstracts accepted is a poster presentation on the development and application of a machine learning algorithm trained on multiomics biomarkers for the detection of tumor microsatellite instability (MSI), which is common in certain cancers (Abstract 1554). The study analyzed samples from 1838 patients with colorectal cancer using comprehensive genomic and immune profiling (CGIP). The study findings indicate that the machine-learning-driven approach accurately assessed MSI status of colorectal cancer and endometrial adenocarcinomas using CGIP data.

"Through our partnership with Illumina, we are deploying innovative research opportunities that leverage the strengths of our respective teams," said Shakti Ramkissoon, MD, PhD, vice president, medical lead for oncology at Labcorp. "This algorithm is especially exciting as a potential tool to improve assessment of MSI status."

Greater evidence supporting CGP over SGT

Illumina continues to work with leading research institutions to validate the clinical utility and value of CGP testing. CGP is a single next-generation sequencing assay that assesses hundreds of genes, including relevant cancer biomarkers, for therapy guidance. This year, a real-world analysis done with SCRI will present data demonstrating the performance of CGP versus SGT in guideline-recommended biomarker selection in non-small-cell lung cancer (NSCLC) (Abstract 8640).

"The findings showed that patients with stage IV NSCLC who underwent SGT received results for all nine guideline-recommended biomarkers only 1.2% of the time, as compared to 71.7% of the time for patients tested with CGP testing," said Vivek Subbiah, MD, chief, Early-Phase Drug Development at SCRI. "Our findings clearly indicate that relying solely on single-gene testing or hot-spot testing leads to incomplete biomarker testing, which can compromise targeted therapy treatments for patients with NSCLC. To ensure optimal patient outcomes, it is imperative that we transition to comprehensive next-generation sequencing as the standard of care for NSCLC."

This work builds on evidence presented by Illumina and its collaborators at ASCO (Free ASCO Whitepaper) 2023, including a study with Labcorp that demonstrated that the initial use of SGT increases subsequent CGP test cancellations, and concluded that SGT practice in the community oncology setting does not meet practice guideline recommendations and negatively impacts the potential benefit of subsequent CGP for NSCLC patients (2023 Abstract 6506).

Data shows progress on MRD assay

At ASCO (Free ASCO Whitepaper) 2024, Illumina will present an analytical performance evaluation of its MRD assay, highlighting its fast turnaround time, low input requirements, and high sensitivity and specificity over existing market options (Abstract 3060). Earlier this year, Illumina announced collaborations with pharmaceutical companies to innovate on its MRD research assay, which is currently under development on a whole-genome backbone.

"We’re committed to delivering impactful research to help enable genomic testing in oncology care," said Pratheesh Sathyan, head of Oncology for the Americas region at Illumina. "The work being presented at ASCO (Free ASCO Whitepaper) this year, which includes research conducted with Eurofins, Labcorp, and SCRI, will help advance access to precision oncology solutions for patients."