On May 30, 2021 Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets reported that its abstract reporting pre-clinical results from its V-domain immunoglobulin suppressor of T cell activation (VISTA) antibody, HMBD-002, has been selected for publication at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held June 4-8, 2021 (Press release, Hummingbird Bioscience, MAY 30, 2021, View Source [SID1234583287]).

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The abstract reports pre-clinical studies that demonstrate HMBD-002’s ability to induce an effective anti-tumor immune response, both as a monotherapy and in combination with the checkpoint inhibitor pembrolizumab in multiple syngeneic and humanized xenograft models.

HMBD-002 is the only IgG4 isotype anti-VISTA antibody currently in development for the treatment of cancers with VISTA-mediated immune suppression, including triple negative breast cancer and non-small cell lung cancer. The Phase 1 clinical trial for HMBD-002 is anticipated to commence later this year.

The full abstract is now available on ASCO (Free ASCO Whitepaper)’s Meeting Library: View Source

Details of the publication are as follows:

Abstract Title:

HMBD-002 is a novel, neutralizing, anti-VISTA antibody exhibiting strong preclinical efficacy and safety, being developed as a monotherapy and in combination with pembrolizumab

Abstract Number:

e14569

About HMBD-002

HMBD-002 is a unique anti-VISTA neutralizing antibody, and the only IgG4 isotype anti-VISTA antibody currently in development. It was engineered to bind to VISTA at a specific site that is predicted to be essential for ligand-binding and function, thus inhibiting VISTA and neutralizing its immunosuppressive activity without depleting VISTA expressing cells that play many important roles in the immune system.

Pre-clinical studies have shown that HMBD-002 as a monotherapy inhibits tumor growth and significantly prolongs survival, with no observed toxicity. It has also shown synergy when used in combination with anti-PD-1 therapy.

HMBD-002 is being developed for multiple cancers that have strong evidence of VISTA mediated suppression both as a monotherapy and in combination with PD-1 inhibitor.

Hummingbird’s first-in-class anti-VISTA therapeutic antibody is advancing to clinical trials with support from a US$13.1 million product development grant from the Cancer Prevention and Research Institute of Texas (CPRIT).

On May 28, 2021 Novartis reported that it received approval from the US Food and Drug Administration (FDA) for the first targeted therapy for cancer, known as a tyrosine kinase inhibitor (TKI) (Press release, Novartis, MAY 28, 2021, View Source [SID1234583265]). This was a watershed moment in drug discovery, transforming the treatment landscape for chronic myeloid leukemia (CML), and opening the door to reimagining possibilities for other forms of cancer and blood disorders.

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The development of the first TKI was an unlikely success story. Back in the 1950s, scientists had a limited understanding of cancer, and specifically, how genes influence the disease. Nevertheless, research was intensified over the next few years, with hopes that the emerging understanding of genomics could bring forth lasting change. One particular gene, discovered by Drs Peter Nowell and David Hungerford from Philadelphia, was identified as a common factor in patients with CML. Soon after, it was learned that this gene, dubbed as the Philadelphia chromosome, was also the root cause of a faulty tyrosine kinase protein that was directly responsible for the blood cancer.

In the decades following Nowell and Hungerford’s discovery, Novartis had started to look more closely into this class of proteins. We collaborated with scientists and clinicians, including Dr Brian Druker, researcher at Oregon Health and Science University. It was Dr Druker who suggested that Novartis explore ways of developing a molecule with the ability to inhibit the faulty kinase – a drug that would target this disease trigger, different than the therapies available at that time. There was a pressing need; CML was a fatal disease and in the mid-1970s, the estimated five-year survival rate was only 22%.

I had one goal at the time – to find a company that had an inhibitor for BCR-ABL and to bring it into the clinic.

Brian Druker, MD, Director, Knight Cancer Institute at Oregon Health & Science University
What Came After
This milestone approval helped evolve treatment goals in CML and demonstrated Novartis’ commitment to research and innovation.

Looking Ahead: A bold Pursuit
Today, the five-year survival rate for patients with CML is estimated above 70%. Despite important advancements in CML care over the past 20 years, cancer and serious blood disorders are a devious enemy, and one breakthrough is not enough. Significant unmet needs still remain, particularly for patients in later lines of CML, who have experienced resistance or intolerance to available treatments. That’s why Novartis won’t stop in the continuous pursuit of bold science and striving to transform the lives of patients with CML.

At Novartis, we are relentless in the pursuit of cutting-edge medicines, from targeted therapies to treatments that harness the immune system and beyond. Like with CML, we must continue to take a bold approach with science to tackle some of the toughest-to-treat diseases and seek solutions for incredibly challenging public health issues facing our society today.

Novartis is a company for science and innovation. We have a big vision as a company, and that is to reimagine medicine – that is what we strive for. If you really want to change something, you must be bold and have the courage to take risks.

Susanne Schaffert, PhD, President of Novartis Oncology
With a heritage in developing transformative, first-in-class therapies for blood disorders, we open our minds to all scientific possibilities and reach further for new and different endpoints in hematologic diseases.

On May 28, 2021 Fluxion Biosciences reported the publication of a paper on ERASE-Seq liquid biopsy with molecular amplification pools (MAPs) (Press release, Fluxion Biosciences, MAY 28, 2021, View Source [SID1234583281]). The paper, "Sensitivity, specificity, and accuracy of a liquid biopsy approach utilizing molecular amplification pools", published in Nature Scientific Reports on May 24, is co-authored by researchers at Fluxion and the Hospices Civils de Lyon Cancer Institute. Data showed the ERASE-Seq/MAPs approach to have a 98.8% concordance to the benchmark droplet digital PCR (ddPCR) approaches.

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Liquid biopsies offer the potential to improve treatment of cancer by providing affordable, non-invasive detection of actionable cancer mutations from a blood sample. However, the relative abundance of cancer DNA in blood is extremely low, limiting test sensitivity. Recent studies demonstrate good concordance between liquid biopsies when the cancer DNA exceeds 1% allele fraction (AF), but concordance falls off below 1% AF, where many variants are detected.

In this large-scale study, Fluxion’s ERASE-Seq approach was compared directly to benchmark ddPCR tests for EGFR variants that represent treatable biomarkers or indicate the onset of drug resistance mutations. Patient blood samples were drawn and split between the tests, allowing a direct, blinded head-to-head comparison for both sensitivity and specificity. ERASE-Seq demonstrated excellent concordance in the allele fraction of 0.05%-1%, where other sequencing-based liquid biopsies have reduced performance.

"Although ERASE-Seq is a sequencing-based test, it provides levels of sensitivity normally only associated with droplet digital PCR (ddPCR), an analytical technique that is considered the gold standard for sensitivity. ERASE-Seq can test for thousands of variants in a single sample, where ddPCR is limited to only a few variants per test, which means ERASE-Seq can assay many more actionable markers in one test. This is one of the largest liquid biopsy concordance studies ever conducted, and we’re excited to see that ERASE-Seq performs at this level," Fluxion CEO Jeff Jensen explains.

Fluxion offers Spotlight liquid biopsy panels utilizing the ERASE-Seq variant caller, with panels available for pan-cancer, myeloid, TP53, and others. Additionally, ERASE-Seq is easily incorporated with custom-designed panels based on user-selected genomic targets.

On May 28, 2021 Kuraray Group reported that FY2020 Earnings Announcement Presentation disclosed on February 10, 2021 (Press release, Kuraray, MAY 28, 2021, https://pdf.irpocket.com/C3405/M6bm/Wxzm/BKYp.pdf [SID1234583266]).

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1. Reason for correction
There was an error in the figures for CAPEX (Acceptance basis) for FY2020 in the sections on "Cash Flow for FY2020" (page 19) and "Forecast for FY2021" (page 22). There have been no changes to the previously disclosed Consolidated Financial Statements.

2. Correction details
Corrections have been made to the numbers circled in red.

On May 28, 2021 Ryvu Therapeutics (WSE: RVU), a clinical stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, reported that its Clinical Trial Application (CTA) to commence a single-agent, open-label Phase I/II trial, investigating the safety and efficacy of RVU120 (SEL120) in patients with relapsed/refractory metastatic or advanced solid tumors in Poland, has been fully approved by the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, and the respective Central Ethics Committee (Press release, Ryvu Therapeutics, MAY 28, 2021, View Source [SID1234583282]).

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Following the above-mentioned approvals, Ryvu Therapeutics will be able to initiate a clinical study and start enrolling patients in Poland.

The study is designed in two phases. Phase I part has the key objectives of assessing safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of RVU120 (SEL120) during dose escalating cohorts, and determination of the recommended phase II dose (RP2D), and the phase II part, subsequently will include specific tumor indications, enrolled at distinct study groups, such as Triple Negative Breast Cancer (TNBC).

"With approvals from Polish Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products and Central Ethics Committee, we are making another important step in the clinical development of our flagship RVU120 (SEL120) program. We are very excited to develop RVU120 (SEL120) as a potential treatment in both hematological and solid malignancies," comments Setareh Shamsili, MD, PhD, Chief Medical Officer, and EVP at Ryvu Therapeutics.

"We are delighted that the new Phase I/II RVU120 (SEL120) study in patients with solid tumors will be conducted in Poland. Clinical Trial Applications in other European countries will be submitted over the coming months," adds Setareh Shamsili.

About RVU120 (SEL120)

RVU120 (SEL120) is a highly selective first-in-class CDK8/CDK19 inhibitor, which has demonstrated efficacy in a number of solid tumor types in in vitro and in vivo models as well as in onco-hematological malignancies. The first-in-human (FIH) phase I study with RVU120(SEL120), in relapsed or refractory AML or high-risk myelodysplastic syndromes (HRMDS), is currently enrolling patients in 5 investigational sites in USA (View Source).

Current translational data suggest that RVU120 (SEL120) is particularly effective in undifferentiated AML STAT5-positive cancers. Administration of RVU120 (SEL120) in orthotopic AML patient derived xenograft models reduced tumor burden to the level undetectable in the peripheral blood, decreased splenomegaly and resulted in partial bone marrow recovery at well tolerated doses, providing therefore a strong rationale for the clinical development of RVU120 (SEL120) as an effective treatment for AML and potentially other hematological malignancies.

On March 25, 2020, the U.S. Food and Drug Administration (FDA) granted an orphan drug designation (ODD) to RVU120 (SEL120), for the treatment of patients with acute myeloid leukemia (AML).

On April, 2021 U.S. Food and Drug Administration, FDA, placed a partial clinical hold on the first in human Phase Ib, dose escalation clinical trial of RVU120 in patients with relapsed/refractory (R/R) AML and high-risk MDS. Patients who are currently taking RVU120 may continue treatment. Ryvu continues to work closely with the FDA to resolve the partial clinical hold with the objective of resuming enrollment in the study. RVU120 (SEL120) was discovered with the Ryvu Therapeutics discovery engine platform and has received support from The Leukemia & Lymphoma Society Therapy Acceleration Program (TAP), a strategic initiative to partner directly with innovative biotechnology companies and leading research institutions to accelerate the development of promising new therapies for blood cancers. More information about TAP program is available at: View Source