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.

On May 23, 2022 (the "Effective Date"), CASI Pharmaceuticals, Inc. ("CASI") reported that entered into a Business Loan Agreement, Commercial Security Agreement, Commercial Pledge Agreement and a Promissory Note (collectively, the " Agreement") with East West Bank ("EWB") (Filing, 8-K, CASI Pharmaceuticals, MAY 23, 2022, View Source [SID1234614975]). Under the Agreement, EWB made available to the Company a revolving line of credit up to a maximum of USD $10.0 million. The Agreement contains customary representations, warranties, financial covenants and ratios, reporting and other covenants, and events of default. The Agreement will mature on December 31, 2022, unless extended to April 30, 2024 subject to certain conditions as defined in the Agreement. Proceeds received under the Agreement are intended to finance short-term working capital needs.

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In general, amounts borrowed under the Agreement are secured by a lien on the Company’s assets, including first priority security interest in accounts receivable and inventory and pledge of available-for-sale securities. Under the Agreement, CASI shall maintain at least $2,500,000 cash on deposit at EWB. EWB shall, when certain conditions are met, partially or fully release this cash deposit requirement.

Upon the Effective Date, the Company was required to pay a closing fee equal to $50,000. Amounts borrowed under the Agreement bear interest, payable monthly. Such interest shall accrue based upon the daily Wall Street Journal Prime Rate (as quoted in the "Money Rates" column of The Wall Street Journal (Western Edition)) plus 0.35 % with a floor rate of 3.85%. Interest is calculated by applying the ratio of the interest rate over a year of 360 days, multiplied by the outstanding principal balance, multiplied by the actual number of days the principal balance is outstanding.

The foregoing description of the Agreement does not purport to be a complete description of the rights and obligations of the parties thereunder and is qualified in its entirety by reference to the full text of the Agreement that will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022.

On May 23, 2022 Chia Tai‑Tianqing Pharma (CTTQ), a Nanjing subsidiary of Sino Biopharma, reported that it will acquire global rights to an anti-LAG3 mAb from Symphogen A/S of Denmark (Press release, ChinaBio, MAY 23, 2022, View Source [SID1234615011]). Sym022 is a mAb that binds LAG3 to block the interaction with MHCII, which increases T cell proliferation and production of cytokines . In two Phase I trials, Sym022 proved itself to be safe and well-tolerated as a monotherapy and in combination with checkpoint inhibitors. Financial details of the transaction were not disclosed. Symphogen is the Antibody Center of Excellence for Servier, a privately held French biopharma.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On May 23, 2022 INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help protect people from infectious diseases and treat people with cancer and HPV-associated diseases, reported that Jacqueline Shea, Ph.D., President and CEO, and Jeffrey Skolnik, M.D., SVP of Clinical Development for Oncology and HPV Therapeutics, are scheduled to participate in a fireside chat and 1×1 investor meetings at the Jefferies 2022 Healthcare Conference on Wednesday, June 8th, 2022 at 1:00 PM EDT (Press release, Inovio, MAY 23, 2022, View Source [SID1234614935]).

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Jefferies 2022 Healthcare Conference
Date: Wednesday, June 8, 2022
Time: 1:00 PM EDT
Presentation Format: Fireside Chat

A webcast of the presentation will be available through the INOVIO Investor Relations Events page at View Source The presentation time is subject to change.

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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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.