Aldeyra Therapeutics to Present at H.C. Wainwright Global Investment Conference

On May 23, 2022 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company developing innovative therapies for the treatment of immune-mediated diseases, reported that Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra, will participate in a fireside chat at the H.C. Wainwright Global Investment Conference (Press release, Aldeyra Therapeutics, MAY 23, 2022, View Source [SID1234614961]).

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Dr. Brady’s conversation with Matthew Caufield, Vice President, Equity Research for H.C. Wainwright, will be available on demand beginning at 7:00 a.m. ET Tuesday, May 24, 2022. To view the webcast, log in to the Investors & Media section of the Aldeyra Therapeutics website at View Source The event will remain archived on the website for 90 days.

Xcovery SHP2 Inhibitor IND Approved by US FDA

On May 23, 2022 Xcovery Holdings, Inc., an oncology focused bio-pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has accepted its investigational New Drug application (IND) of BPI-442096 , a small molecule Src homology region 2 domain-containing phosphatase 2 (SHP2) inhibitor, in solid tumors. Xcovery will initiate a phase I clinical trial in the United States to assess the tolerability, safety, and efficacy of BPI-442096 (Press release, Xcovery, MAY 23, 2022, View Source [SID1234614960]).

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BPI-442096 is a new molecular entity developed by Betta Pharmaceuticals in China. In preclinical studies, BPI-442096 demonstrated significant activity against a variety of cancer cells, including those with KRAS G12C mutation, KRAS G12D mutation, KRAS G12V mutation, KRAS G12A mutation, BRAF Class III mutation, NF1 LOF mutation, RTK mutation.

"I am very pleased to see BPI-442096 IND’s US approval," said Dr. Liu Fuqiang, Vice President of CMC at Betta Pharmaceuticals and at Xcovery. "Currently, there’s no SHP2 inhibitor drug on the market and we can fill the unmet need by bringing this compound to patients. With the earlier approved IND of BPI-361175, a 4th generation EGFR inhibitor, Betta and Xcovery are co-developing two very exciting assets in the US."

Giovanni Selvaggi, M.D., Xcovery’s CEO and CMO, commented, "The FDA’s acceptance of our INDs is an important validation of both Betta and Xcovery’s global capabilities in pre-clinical and clinical development in oncology. Together with BPI-361175, we can now establish our own small molecules pipeline against solid tumors."

Thermo Fisher Scientific and Qatar Genome Program Partner to Advance Precision Medicine

On May 23, 2022 Thermo Fisher Scientific, the world leader in serving science, and Qatar Genome Program (QGP), a member of Qatar Foundation (QF), reported that they have partnered with the goal of accelerating genomic research and clinical applications of predictive genomics in Qatar as a step toward expanding the benefits of precision medicine across Arab populations globally (Press release, Thermo Fisher Scientific, MAY 23, 2022, View Source [SID1234614957]).

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Under the agreement, Thermo Fisher and Qatar Genome Program will develop an Axiom* custom genotyping array for pan-Arab populations using whole genome sequencing data from 19 Arab countries. The array, with about 800,000 variants, aims to help drive scientific research and insights into conditions including diabetes, cardiovascular and metabolic diseases, autism, inherited genetic disorders and cancer. Once available through Thermo Fisher’s global commercial channels in late 2022, the array is intended to provide a cost-effective alternative to whole genome sequencing for Arab populations, enabling increased diversity in large genome-wide studies.

"Qatar’s national vision is to provide a high standard of living for our people, and that includes providing access to genomics data, technology and insights to improve population health across the country," said Dr. Radja Badji, genome operations manager at Qatar Genome Program. "Our collaboration with Thermo Fisher will not only help us advance precision medicine in Qatar but also among people of Arab identity worldwide."

Thermo Fisher began working with Qatar Genome Program in 2018 to establish the first microarray designed specifically for the Qatari population. The Q-Chip detects genetic alterations that increase individuals’ risk of both prevalent and rare diseases. As part of the new agreement, the organizations will continue to refine algorithms and define clinically actionable content to assess polygenic risk scores, a measure of disease risk, and clinically relevant variants, including those related to pharmacogenomics.

"Thermo Fisher’s Axiom microarray technology is designed to help accelerate precision medicine, and we are honored to partner with the Qatar Genome Program as they take bold steps to leverage the power of genomics to improve the standard of care for human health," said Chad Carter, vice president and general manager of microarray genetic solutions at Thermo Fisher Scientific. "Together, we’re creating building blocks for implementing comprehensive precision medicine initiatives at scale for population health."

Thermo Fisher provides a range of predictive genomics solutions used globally to assess gene-related disease risk and drug response. For more information, please visit thermofisher.com/predictive-genomics.

*For research use only. Not for use in diagnostic procedures.

Immunome Provides Research & Development Update on Lead Oncology Candidate Targeting IL-38

On May 23, 2022 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, reported updates to the ongoing development of its lead oncology program, IMM-ONC-01, a novel immuno-oncology agent that inhibits IL-38, an immunosuppressive cytokine (Press release, Immunome, MAY 23, 2022, View Source [SID1234614956]).

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Preclinical research conducted by Immunome, and literature evidence1,2, suggests IL-38 dampens natural anti-tumor immune response. In animal testing, blocking IL-38 activity using Immunome’s antibody produced an anti-tumor effect.

To help guide clinical development of IMM-ONC-01, Immunome conducted an extensive expression profile assessment of IL-38 mRNA using a proprietary commercial database of over 60 cancer sub-types established by Tempus Labs. The analysis identified high frequency of IL-38 mRNA expression in several cancers, notably in Gastroesophageal Squamous Carcinoma (>80%), Head and Neck Squamous Carcinoma (>60%) and Skin Squamous and Basal Cell Carcinoma (>70%). The Company plans to share results from the study at an upcoming oncobiology conference.

"We are hopeful that IMM-ONC-01 could provide a new treatment option for people with cancers with high unmet need and may also be synergistic when combined with PD-1 inhibitors," said Purnanand Sarma, PhD, President and CEO of Immunome. "The results of this important assessment will allow us to better identify the patient populations most likely to respond to treatment with IMM-ONC-01 and streamline overall clinical development. We are on track to file an IND later in 2022 and will work as quickly as possible to advance this potentially differentiating therapy for the patients who are waiting."

To support the next steps in the development of IMM-ONC-01, Immunome is collaborating with Fox Chase Cancer Center to directly measure IL-38 protein in patient tumors to confirm its prevalence in specific cancer types. The Company will pursue additional partnerships as necessary to use this information and further refine its clinical development plan.

"We look forward to working closely with Immunome’s team to investigate the role of IL-38 in head and neck cancer, supporting the emphasis of our NIH-funded Specialized Program in Research Excellence project on this cancer," said Erica Golemis, PhD, professor and W.W. Smith Chair in Cancer Research at Fox Chase Cancer Center. "If the results are confirmed in patient samples for head and neck and other hard-to-treat cancers, it would not only allow Immunome to efficiently advance a potential new treatment, but also expand our understanding of the processes that drive IL-38 expressing cancers."

IL-38 is increasingly being regarded as a key cytokine in inflammation and cancer research.1,2 Preclinical research has confirmed that blocking IL-38 function with an antibody could restore immune response and allow the body to fight tumors. IL-38 was originally identified as a novel target through Immunome’s technology platform, which can capture thousands of patient-derived memory B cells and convert them into stable hybridomas. The growing recognition of IL-38’s role in cancer and other diseases suggests that Immunome’s platform has potential to identify other highly relevant targets that are yet undiscovered in oncology and inflammatory disease.

About IMM-ONC-01

IMM-ONC-01 is a first-in-class antibody therapeutic targeting IL-38, an innate immune checkpoint that is a member of the IL-1 family of cytokines. When expressed, IL-38 reduces immune cell infiltration of the tumor microenvironment. Immunome’s preclinical research has confirmed that the use of IMM-ONC-01 to block expression of IL-38 boosts anti-tumor immunity and could serve as an effective treatment for cancers that have a high expression of IL-38, including Gastroesophageal Squamous Carcinoma, Head and Neck Squamous Carcinoma and Skin Squamous and Basal Cell Carcinoma. Immunome intends to submit an IND for IMM-ONC-01 in the second half of 2022.

Guardant Health to Present New Data from its Broad Portfolio of Blood Tests at 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

On May 23, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that it will present new data at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 3-7 in Chicago (Press release, Guardant Health, MAY 23, 2022, View Source [SID1234614955]). Among the 19 abstracts are oral presentations highlighting the use of real-world data to identify resistance to early treatment in advanced breast cancer and the use of enhanced biomarker analysis to evaluate progression-free survival data in metastatic breast cancer therapy.

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"We look forward to sharing an array of robust data at ASCO (Free ASCO Whitepaper) that demonstrate the utility of our blood tests to help healthcare professionals optimize care for patients at all stages of the disease—from detecting early-stage cancers to identifying the presence of residual disease and delivering insights that inform treatment to improve outcomes," said Helmy Eltoukhy, Guardant Health co-CEO. "We’ll be presenting data from retrospective and real-world analyses that show how blood-based tests provide critical insights at every step of a patient’s treatment journey, and analytics that contribute to the broader scientific community’s understanding of some of the most challenging cancers."

Full List of Guardant Health Presentations

Guardant360

Circulating tumor DNA profiling and serial analysis in salivary gland carcinomas reveal unique mutational subsets and actionable alterations (Abstract 6097)
Co-occurring alterations across molecular pathways in metastatic colorectal cancer (mCRC) (Abstract 3590)
Characterization of genomic landscape using comprehensive circulating cell-free tumor DNA next generation sequencing in advanced thyroid carcinoma (Abstract 3045)
Using cell-free circulating tumor DNA (cfDNA) to identify guideline-relevant biomarkers for therapy selection in 14,000 patients (pts) with metastatic colorectal cancer (mCRC) (Abstract 3601)
Prevalence of incidental pathogenic germline variants detected in cfDNA in patients with oncogene-driven non-small cell lung cancer (Abstract 10569)
KIT resistance mutations identified by circulating tumor DNA and treatment outcomes in advanced gastrointestinal stromal tumor (Abstract 11514)
RAS co-mutation and early onset disease represent an aggressive phenotype of atypical (non-V600) BRAF mutant metastatic colorectal cancer (Abstract 3592)
Variation in liquid biopsy cfDNA yield predicted by somatic mutation and clinical phenotypes across primary cancers (Abstract 13553)
Circulating tumor DNA profile in pancreatic ductal adenocarcinoma (PDAC) and potential targeted therapy (Abstract 4152)
Phase 3 trial of lorlatinib in treatment-naïve patients (Pts) with ALK-positive advanced non-small cell lung cancer (NSCLC): Comprehensive plasma and tumor genomic analyses (Abstract 9070)
Guardant Reveal

Clinician utilization of a plasma-only, multiomic minimal residual disease (MRD) assay in 2,000 consecutive patients with colorectal cancer (CRC) (Abstract 15586)
Guardant360 Response

Circulating tumor DNA (ctDNA) in HER2 exon 20 insertion mutations and responses in NSCLC HER2 exon 20 insertion treated with poziotinib (Abstract 3051)
Prognostic value of molecular response via ctDNA measurement in predicting response of systemic therapy in patients with advanced solid cancer (Abstract 13001)
GuardantINFORM

Use of real-world data (RWD) to assess the utility of cell-free circulating tumor DNA (cfDNA) in identifying resistance to early treatment in advanced breast cancer (aBC) (Abstract 1011). Oral presentation during Clinical Science Symposium.
GuardantOMNI

Fulvestrant plus capivasertib versus fulvestrant plus placebo after relapse or progression on an aromatase inhibitor in metastatic, estrogen receptor-positive breast cancer (FAKTION): Overall survival and updated progression-free survival data with enhanced biomarker analysis (Abstract 1005). Oral presentation during Metastatic Breast Cancer session.
Serena-1: Updated analyses from a phase 1 study (parts C/D) of the next-generation oral SERD camizestrant (AZD9833) in combination with palbociclib, in women with ER-positive, HER2-negative advanced breast cancer (Abstract 1032)
Shield LDT – CRC Screening

Validation of a multi-modal blood-based test for the detection of colorectal cancer with sub single molecule sensitivity (Abstract 3627)
Next generation Shield – Multi-Cancer Screening

Development of a highly-sensitive targeted cell-free DNA epigenomic assay for integrated screening of lung and colorectal cancer (Abstract 3542)
Trial in progress: Screening for high frequency malignant disease (SHIELD) (Abstract TPS1602)
The full abstracts will be available on the official ASCO (Free ASCO Whitepaper) website on May 26, 2022.