Kezar Life Sciences to Participate in the Jefferies Global Healthcare Conference

On May 29, 2024 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases and cancer, reported that Chris Kirk, Co-founder and Chief Executive Officer, will participate in a fireside chat at the Jefferies Global Healthcare Conference on Wednesday, June 5, 2024, at 12:30 pm ET in New York, NY (Press release, Kezar Life Sciences, MAY 29, 2024, View Source [SID1234643824]).

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A webcast of the panel discussion will be available on the "Events & Presentations" section of the Company’s website at www.kezarlifesciences.com. Following the event, an archived webcast will be available on the Kezar website for 90 days.

Atara Biotherapeutics Presents Preclinical Data on ATA3219, an Allogeneic CD19-Targeted CAR T Therapy for the Treatment of B-Cell Driven Autoimmune Diseases, at the ISCT 2024 Annual Meeting

On May 29, 2024 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported preclinical data supporting the potential of ATA3219, an allogeneic, anti-CD19 chimeric antigen receptor (CAR) T-cell therapy candidate for the treatment of B-cell driven autoimmune diseases (Press release, Atara Biotherapeutics, MAY 29, 2024, View Source [SID1234643775]). Findings demonstrate that ATA3219 maintains comparable cytotoxic function and potency while inducing lower levels of pro-inflammatory cytokines compared to autologous benchmark CD19 CAR T cells. The data will be presented in a poster session at the International Society for Cell & Gene Therapy (ISCT) 2024 Annual Meeting taking place May 29 to June 1, 2024, in Vancouver, Canada.

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ATA3219 consists of allogeneic CD19-directed CAR EBV T cells that have been optimized to offer a potential best-in-class profile and off-the-shelf availability. It incorporates multiple clinically validated technologies including a modified CD3ζ signaling domain (1XX) that sustains potent effector function while modulating activation and inflammation; a less differentiated phenotype for robust expansion and persistence; and no modification of the endogenous T-cell receptor (no gene editing) as a key T-cell survival signal.

"Following exciting early clinical data with autologous CD19 CAR T in autoimmune patients, we believe there is an opportunity to further improve long-term efficacy, reduce toxicity and simplify treatment through our optimized allogeneic CD19 CAR T cells," said Cokey Nguyen, Ph.D., Executive Vice President, Chief Scientific & Technical Officer at Atara. "We are pleased to share promising preclinical data that shows ATA3219 mediates robust B-cell depletion against SLE and multiple sclerosis patient derived immune cells. Importantly, ATA3219 is an off-the-shelf option that shows a favorable inflammatory profile that may lead to less toxicity and improved tolerability in the clinic. We look forward to continued evaluation of ATA3219 for the treatment of non-Hodgkin’s lymphoma, lupus nephritis, and in a recently announced cohort expansion for severe SLE without lymphodepletion."

The ATA3219 preclinical data demonstrate potent CD19 antigen-specific cytotoxic activity against CD19+ targets in vitro and in vivo. Data highlights comparing ATA3219 to an autologous benchmark CD19 CAR T include:

More robust central memory cell population as a result of the 1XX co-stimulatory domain and optimized manufacturing process
Complete CAR-mediated B-cell depletion against SLE and MS patient peripheral blood mononuclear cells with comparable potency
Reduced inflammatory profile with decreased secretion of pro-inflammatory cytokines IFN-γ, TNF-α and IL-6, as well as T helper 2 (Th2) cytokines IL-4 and IL-5, while achieving comparable B-cell depletion
These preclinical results support advancing ATA3219 towards clinical evaluation in patients with B-cell driven autoimmune diseases.

ATA3219 is currently being investigated in a Phase 1 trial (NCT06256484) for the treatment of relapsed/refractory B-cell non-Hodgkin’s lymphoma (NHL) with initial clinical data expected in the fourth quarter 2024. Additionally, ATA3219 will be evaluated in a multi-center, Phase 1, open-label, single-arm, dose-escalation study for the treatment of LN with lymphodepletion and a separate cohort in severe SLE without lymphodepletion. Initial data for LN and severe SLE without lymphodepletion is anticipated in the first half and second half of 2025, respectively.

Poster Presentation Details:
Title: ATA3219: Allogeneic CD19 CAR EBV T Cells for the Treatment of B-Cell Driven Autoimmune Diseases
Presenting Author: Alfonso Brito, M.S., Preclinical & Translational Sciences, Atara Biotherapeutics, Inc., Thousand Oaks, CA
Date & Time: Wednesday, May 29, 2024, at 7:00 – 8:30 p.m. PDT
Poster Number: 1025
Session: Poster Networking Session 1
Location: Exhibit & Poster Hall, Vancouver Convention Centre, West Building

About ATA3219

ATA3219 combines the natural biology of unedited T cells with the benefits of an allogeneic therapy. It consists of allogeneic Epstein-Barr virus (EBV)-sensitized T cells that express a CD19 CAR construct for the treatment of CD19+ relapsed or refractory B-cell malignancies, including B-cell non-Hodgkin’s lymphoma and B-cell mediated autoimmune diseases including systemic lupus erythematosus (SLE) and lupus nephritis. ATA3219 has been optimized to offer a potential best-in-class profile, featuring off-the-shelf availability. It incorporates multiple clinically validated technologies including a modified CD3ζ signaling domain (1XX) that optimizes expansion and mitigates exhaustion, enrichment during manufacturing for a less differentiated phenotype for robust expansion and persistence and retains the endogenous T-cell receptor without gene editing as a key survival signal for T cells contributing to persistence.

Next-Generation Allogeneic CAR T Approach

Atara is focused on applying Epstein-Barr virus (EBV) T-cell biology, featuring experience in over 600 patients treated with allogeneic EBV T cells, and novel chimeric antigen receptor (CAR) technologies to meet the current limitations of autologous and allogeneic CAR therapies head-on by advancing a potential best-in-class CAR T pipeline in oncology and autoimmune disease. Unlike gene-edited approaches aimed at inactivating T-cell receptor (TCR) function to reduce the risk for graft-vs-host disease, Atara’s allogeneic platform maintains expression of the native EBV TCR that promote in vivo functional persistence while also demonstrating inherently low alloreactivity due to their recognition of defined viral antigens and partial human leukocyte antigen (HLA) matching. A molecular toolkit of clinically-validated technologies—including the 1XX costimulatory domain designed for better cell fitness and less exhaustion while maintaining stemness—offers a differentiated approach to addressing significant unmet need with the next generation CAR T.

Kiromic BioPharma Reports Favorable Results at Six Weeks from Fourth Patient in Deltacel-01 Clinical Trial

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.

Sixteen Researchers from Florida Cancer Specialists & Research Institute Share Cancer Care Discoveries at 2024 ASCO® Annual Meeting

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

Median Technologies to Participate in the 2024 ASCO Annual Meeting, May 31 – June 4, 2024, McCormick Place, Chicago, IL, USA

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