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.

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.

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 Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, reported new data from Cohort 2 of the ongoing Phase 1 study evaluating JK07, the Company’s lead drug candidate, for the treatment of heart failure with reduced ejection fraction (HFrEF) (Press release, Salarius Pharmaceuticals, MAY 23, 2022, View Source [SID1234614954]). The Company also announced the submission of the first clinical trial application (CTA) in Europe for its lead oncology program, JK08, and the appointment of Arian Pano, M.D., as Chief Medical Officer.

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"Our study of JK07 in heart failure with reduced ejection fraction continues to demonstrate favorable safety and promising signals of clinical activity, and we look forward to gaining further insights as we enter Cohort 3," said Sam Murphy, Chief Executive Officer of SalubrisBio. "In addition, we’re thrilled to announce that the first CTA has been filed in Europe for JK08, to evaluate this novel CTLA-4/IL-15 antibody fusion protein in the treatment of solid tumors. We have made considerable progress this year across our pipeline and remain laser-focused on advancing these important programs to bring differentiated complex biologics to patients with unmet needs," concluded Murphy.

New Cohort 2 Data for JK07 Shows Favorable Safety and Further Promising Activity in Patients with HFrEF

In this ongoing randomized, double-blind, placebo-controlled, dose-escalation Phase 1b study evaluating JK07, patients treated in Cohort 2 (n=5) demonstrated a favorable safety profile and encouraging signals of clinical activity. In addition, dose-dependent increases in biomarker surrogates of target engagement have been observed across the two completed cohorts. Enrollment in Cohort 3, of five planned cohorts, has commenced in this Phase 1b study and SalubrisBio plans to report additional data from this study at future medical meetings.

CTA for JK08 Submitted in Europe

The first CTA has been filed in Europe seeking approval to initiate a Phase 1/2 study evaluating JK08 monotherapy for the treatment of advanced solid tumors. JK08 augments the T-regulatory cell targeting of a CTLA-4-specific antibody with an IL-15/sushi domain fusion peptide, which locally induces NK cell activation and antibody-dependent cellular cytotoxicity (ADCC), two biological hallmarks predictive of response to CTLA-4 targeted therapy. The study will assess the safety, pharmacokinetics, and anti-tumor activity of JK08 at multiple dose levels and will include multiple expansion cohorts following selection of the optimal biologic dose. Upon obtaining regulatory approvals, the Company plans to initiate recruitment during the third quarter of 2022.

Appointment of Arian Pano, MD as Chief Medical Officer

Dr. Pano comes to SalubrisBio from Kiniksa Pharmaceuticals, where he served as SVP of Clinical Development, overseeing all functional groups, including medical, research, clinical operations, regulatory, safety, biometrics, and medical writing. Previously he served as SVP of Clinical Development for Galapagos NV, and concurrently served as the US country head and Global Head of Safety. Dr. Pano has an extensive background in research and development with a focus on cardiovascular, metabolic rare diseases, inflammation and fibrosis. He earned his MD degree from the University of Tirana, Albania, completing fellowships in invasive cardiology and pediatrics. In addition, he holds an MPH in Healthcare Management from Harvard’s School of Public Health.

"Since clinical data is the currency of our industry, and as we are now generating meaningful clinical results, the time was right to expand and strengthen the leadership team by bringing on Ari to build our clinical organization, chaperone our drugs through mid- and late-stage development, and ensure our data management and pharmacovigilance functions support future planned regulatory filings," added Murphy.

About JK07

JK07 is a recombinant fusion protein consisting of a fully human immunoglobulin IgG1 monoclonal antibody and an active polypeptide fragment of the human growth factor neuregulin [NRG-1]. NRG-1 is a clinically validated growth factor that has shown promising activity in HFrEF and undesirable side effects. Research has shown that NRG-1 induces signaling through interaction with two different receptors – HER3 and HER4. The HER4 pathway appears to be responsible for the regenerative effects in the heart, while the HER3 pathway appears primarily responsible for safety and tolerability limitations of recombinant NRG-1. By blocking HER3 signaling with an antibody fusion design, JK07 selectively stimulates the HER4 pathway with a favorable pharmacokinetic profile, which has the potential to significantly widen the therapeutic window of NRG-1 and yield better clinical effects.

About JK08

JK08 is a recombinant fusion protein consisting of a CTLA-4-specific antibody and an IL-15 fusion domain. The JK08 design builds upon a breadth of clinical studies with CTLA-4 antibodies and recombinant IL-15 molecules, which together portend synergistic effects in an antibody fusion construct. The CTLA-4-specific antibody ipilimumab validated CTLA-4 as a target for cancer therapy, but response rates are limited. Analysis of clinical samples demonstrated that NK cell activity signatures and ADCC biomarkers correlate with ipilimumab responses. Recombinant IL-15 has exhibited potent stimulation of NK cell expansion and enhancement of ADCC in pre-clinical and clinical studies. Through the incorporation of a CTLA-4 antibody and IL-15 into a single molecule, JK08 can channel the potent immune stimulation of IL-15 through the CTLA-4 antibody domain towards depletion of T-regulatory cells and targeted reversal of immunosuppression which may contribute to cancer progression.

On May 23, 2022 Modra Pharmaceuticals ("Modra") reported that the company will present new data from its Phase 2b trial evaluating ModraDoc006/r, a boosted oral taxane therapeutic versus the standard-of-care IV chemotherapy docetaxel, in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC) at the upcoming ASCO (Free ASCO Whitepaper) General Annual Meeting held from June 3 – 7, 2022 virtually and in-person in Chicago, IL, USA (Press release, Modra Pharmaceuticals, MAY 23, 2022, View Source [SID1234614953]).

Please see below for details on the poster abstract.

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Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Poster Title: A phase 2 randomized study of oral docetaxel plus ritonavir (ModraDoc006/r) in patients with metastatic castration-resistant prostate cancer (mCRPC).

Presenter: Ulka N. Vaishampayan, MD | University of Michigan

Location: In-Person & Live Stream | Arie Crown Theater

Session Date and Time: June 6, 2022 from 16:30 CDT – 18:00 CDT

Abstract Number: 5016

Poster Number: 200

About metastatic Castration-Resistant Prostate Cancer (mCRPC)

mCRPC is an advanced form of prostate cancer and the fourth most common cause of cancer death overall. mCRPC is not amenable to surgical treatment and resistant to androgen deprivation therapy, a hormone therapy used as initial disease management to reduce growth of prostate cancer cells.

About ModraDoc006/r

ModraDoc006/r is a proprietary boosted taxane therapy based on docetaxel, an intravenously administered therapy, that is very broadly used in a variety of tumor types. ModraDoc006 – an oral docetaxel tablet – is given in combination with ritonavir (r), which acts as a booster to increase the systemic bioavailability of ModraDoc006. ModraDoc006/r is designed to combine the convenience and practicality of taking chemotherapy treatment at home with the potential for an improved safety profile, as compared to standard IV docetaxel.