US FDA awards Supplemental Orphan Drug Designation to SurVaxM to now include treatment of Malignant Glioma

On May 30, 2024 MimiVax Inc, a clinical-stage biotechnology company developing immunotherapeutics for cancer and autoimmune diseases, reported that the United States Food and Drug Administration (FDA) has awarded a supplemental orphan drug designation to MimiVax’s SurVaxM vaccine to now include malignant glioma (Press release, MimiVax, MAY 30, 2024, View Source;utm_medium=rss&utm_campaign=us-fda-awards-supplemental-orphan-drug-designation-to-survaxm-to-now-include-treatment-of-malignant-glioma [SID1234643861]). Currently, SurVaxM vaccine is being studied as a treatment for newly diagnosed glioblastoma (nGBM) in a phase 2b randomized clinical study (the SURVIVE trial) which will assess the efficacy of SurVaxM in a large patient population with nGBM. This supplemental orphan drug designation greatly expands the potential for SurVaxM’s use in other forms of pediatric and adult malignant gliomas. An orphan drug designation plays a critical role in encouraging the development of treatments for rare diseases, ultimately improving the lives of patients who might otherwise have few or no treatment options.

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Gliomas are brain tumors that are initiated from glial cells that and support nerve cells in the brain and spinal cord. Gliomas comprise about 80% of all malignant primary brain tumors and include such tumors as astrocytomas, oligodendrogliomas and ependymomas.

"Receiving orphan drug designations for SurVaxM emphasizes the critical demand for novel and enhanced therapeutic options for people living with malignant gliomas," said Michael Ciesielski, Ph.D., CEO of MimiVax. "We hope that this designation may help to advance SurVaxM’s application for important indications beyond adult GBM including for pediatric brain cancers."

Orphan designation is granted by the FDA to advance the evaluation and development of new therapies intended to treat a rare disease or condition that generally affects fewer than 200,000 individuals each year in the United States. Under the Orphan Drug Act, regulatory agencies may offer certain benefits to expedite the approval process for orphan drugs, recognizing the urgent need for treatments for rare diseases. This can include accelerated review timelines and flexibility in clinical trial design, tax credits for qualified clinical trials, FDA user-fee benefits, and seven years of market exclusivity in the United States after new drug approval.

Labcorp to Present Multiple Abstracts across Precision Oncology at the 2024 ASCO Annual Meeting

On May 30, 2024 Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, reported that it will present several abstracts at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago (May 31 – June 4, 2024) (Press release, LabCorp, MAY 30, 2024, View Source [SID1234643860]).

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Labcorp’s oncology research highlights the company’s dedication to advancing meaningful and actionable insights that enhance the understanding of tumor biology and immune system mechanisms. These insights will contribute to facilitating patient access to novel targeted therapies with the end goal of improving patient outcomes.

"Labcorp is committed to deepening the understanding of cancer biology and enhancing therapeutic strategies. Through our presentations at the ASCO (Free ASCO Whitepaper) Annual Meeting investigating critical aspects of triple-negative breast cancer, liquid biopsy, and employing advanced machine learning algorithms for tumor profiling, we are paving the way for more accurate diagnostics and effective treatments," said Shakti Ramkissoon, M.D., Ph.D., MBA, vice president, medical lead for oncology at Labcorp. "These studies exemplify Labcorp’s deep scientific and medical expertise enabling delivery of compelling evidence through internal and external collaborations to drive advancements in precision oncology."

Of the eight abstracts to be presented at the ASCO (Free ASCO Whitepaper) Meeting, four were internal studies by Labcorp researchers and four were conducted in collaboration with research partners from premier academic institutions and medical centers.

Among those being presented by Labcorp researchers, the findings of two studies examine various aspects of triple-negative breast cancer (TNBC) to provide a deeper understanding of the factors causing tumor progression and therapy resistance in the disease. Triple-negative breast cancer accounts for approximately 10-15% of all breast cancers but disproportionately impacts Black women in the U.S., who have almost twice the rate of the disease compared to white women.

Session: Breast Cancer-Metastatic
Abstract: 1096 – Interaction between VEGF-A and immune checkpoint targets in triple-negative breast cancer suggests a mechanism of immune evasion and tumor progression.
Poster Board: 74
Date: Sunday, June 2, 9:00 a.m. – 12:00 p.m. CDT
Vascular endothelial growth factor (VEGF) promotes angiogenesis and potentially modulates tumor immune evasion in breast cancer. Labcorp researchers performed comprehensive genomic and immune profiling on 143 formalin-fixed paraffin-embedded breast cancer samples to investigate the interaction between VEGF and immune gene expression. In triple-negative breast cancer (TNBC) samples, VEGF was co-expressed with immune checkpoint genes such as PD-1 and PD-L1. Labcorp’s findings support that angiogenesis mediators may enhance immunosuppression, leading to immune evasion and tumor progression in TNBC.

Session: Breast Cancer—Metastatic
Abstract: 1095 – Novel HLA-Ilo/HLA-IIhi phenotype and immune evasion in triple-negative breast cancer.
Poster Board: 73
Date: Sunday, June 2, 9:00 a.m. – 12:00 p.m. CDT
Resistance and non-response to immunotherapy remain an unmet clinical need for patients with triple-negative breast cancer (TNBC). Aberrant expressions of human leukocyte antigens (HLAs) are one mechanism by which cancer cells evade immune response. Labcorp researchers performed a targeted RNA-sequence-based assay on 143 breast cancer patient samples, demonstrating that concurrent loss of HLA class I with increased HLA class II expression was associated with co-expression of biomarkers indicative of immune escape but not survival outcomes. These data offer an opportunity for developing novel approaches to overcome immunotherapy resistance in TNBC.

Session: Care Delivery/Models of Care
Abstract: 1554 – A machine learning algorithm based on multi-omics biomarkers for the detection of tumor microsatellite instability
Poster Board: 425
Date: Saturday, June 1, 9:00 a.m. – 12:00 p.m. CDT
Labcorp researchers will present data on an innovative machine learning model developed to predict microsatellite instability (MSI) status in patients with solid tumors using comprehensive genomic and immune profiling, independent of direct sequencing data from microsatellite sites. Researchers analyzed genomic and gene expression data from over 2,000 colorectal cancer samples to generate and test a model for predicting MSI status, which was confirmed using MSI status from The Cancer Genome Atlas (TCGA) studies of colorectal and endometrial carcinoma. This study highlights an algorithmic method to identify patients with potential MSI-high status for orthogonal screening when current methodologies fall short.

Session: Developmental Therapeutics-Molecularly Targeted Agents and Biology
Abstract: 3063 – Analytical Validation of the Labcorp Plasma Complete Test to Enable Precision Oncology Through Solid Tumor Liquid Biopsy Comprehensive Genomic Profiling
Poster Board: 208
Date: Saturday, June 1, 9:00 a.m. – 12:00 p.m. CDT
The Labcorp Plasma Complete test is a next-generation-sequencing, cell-free DNA comprehensive genomic profiling test that identifies actionable and clinically relevant variants in advanced and metastatic solid cancers across 521 genes. In this validation study, test performance demonstrated highly specific (>99.99%), accurate (97.3% positive percent agreement and >99.99% negative percent agreement) and sensitive (down to 0.35% or 1.63-fold) variant detection. Plasma samples from a broad range of solid tumors demonstrated that this assay offers a highly precise, accurate, and robust comprehensive genomic and immune profiling assay to complement tissue-based testing and inform clinical decision-making.

To connect with Labcorp at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, visit View Source

Immunocore to present at the Jefferies Global Healthcare Conference

On May 30, 2024 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported that management will participate in the Jefferies Global Healthcare Conference (Press release, Immunocore, MAY 30, 2024, View Source [SID1234643859]).

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Jefferies Global Healthcare Conference
Fireside Chat: Thursday, June 6, 2024, at 2:30 p.m. EDT
The presentation will be webcast live and can be accessed by visiting ‘Events & Presentations’, under ‘Events’, via the ‘Investors’ section of Immunocore’s website at www.immunocore.com. Following the event, a replay of the presentation will be made available for a limited time.

HOOKIPA Pharma to Host Investor Call on HB-200 Data Presented at American Society of Clinical Oncology 2024 Annual Meeting

On May 30, 2024 HOOKIPA Pharma Inc. (NASDAQ: HOOK, HOOKIPA or the Company), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that members of HOOKIPA’s Executive Team will host an investor call on June 4, 2024, at 4:15 p.m. ET (Press release, Hookipa Biotech, MAY 30, 2024, View Source [SID1234643858]). Complete details and registration information are included below. The call will detail the Company’s Phase 2 clinical data of HB-200 in combination with pembrolizumab for the treatment of human papillomavirus 16 positive head and neck cancer, including preliminary progression-free survival and overall survival data for patients with CPS ≥20.

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Call Details:
HOOKIPA HB-200 ASCO (Free ASCO Whitepaper) Data Update
Tuesday, June 4, 2024, 4:15 p.m. ET
Webcast Registration
Dial-in Registration

Genprex to Present at the 2024 BIO International Convention

On May 30, 2024 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its President, Chief Executive Officer and Chief Financial Officer, Ryan Confer, will be providing an overview of the Company’s gene therapies for cancer and diabetes at the upcoming 2024 BIO International Convention (Press release, Genprex, MAY 30, 2024, View Source [SID1234643857]).

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Event: 2024 BIO International Convention

Conference Dates: June 3-6, 2024

Presentation Date: Monday, June 3, 2024

Presentation Time: 2:00 p.m. PT

Venue: San Diego Convention Center in Theater 1

Presenter: Ryan Confer, Genprex’s President, Chief Executive Officer and Chief Financial Officer

Mr. Confer will deliver an overview of the Company’s pioneering gene therapies for cancer and diabetes and will be available for in-person one-on-one meetings with participating attendees through the conference platform.

For those interested in meeting Genprex management during the conference, please request a meeting through the conference portal or reach out to Investor Relations at [email protected].