1stOncology™: Cancer Intelligence Service – Page 8775 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Labcorp and OnmiSeq Launch Insight, Next-Generation Sequencing Platform to Advance Precision Oncology

On June 10, 2021 Labcorp (NYSE: LH), a leading global life sciences company, and OmniSeq, a CAP-accredited, molecular diagnostic innovation of Roswell Park Comprehensive Cancer Center, reported the launch of OmniSeq INSIGHTsm, a comprehensive genomic and immune profiling, tissue-based test that integrates next-generation sequencing (NGS) technology (Press release, OmniSeq, JUN 10, 2021, View Source [SID1234583930]). The test is designed to advance precision oncology and improve patient outcomes, as part of Labcorp’s commitment to empower better health decisions for patients through the addition of cutting-edge diagnostic tools in precision medicine.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

Schedule Your 30 min Free Demo!

"There continue to be significant advancements in the oncology space, including the identification of new biomarkers and therapies at an unprecedented pace," said Prasanth Reddy, M.D., MPH, senior vice president and oncology head at Labcorp and a triple board-certified oncologist. "This new test provides up-to-date, evidence-based treatment recommendations and incorporates current guidelines into a report that is easy to interpret, allowing clinicians to make the best treatment choices for their patients, including potential clinical trials."

OmniSeq INSIGHT is a pan-cancer, solid tumor test that combines two different treatment paradigms— genomic and immune profiling, including tumor mutational burden, microsatellite instability, and immune gene expression, which enhances the characterization of the unique genomic biomarkers in a patient’s tumor. The results from the test are presented in an easy-to-read report, summarizing all FDA-approved therapies and immunotherapies that match the patient’s tumor profile. This enables clinicians to provide the most up-to-date treatments for their patients, in addition to identifying clinical trials for which patients may be eligible within 200 miles of their homes. The report provides evidence-based recommendations specific to the individual test results through the use of a proprietary database sourced from numerous biologic and scientific literature, including National Comprehensive Cancer Network (NCCN) guidelines, giving clinicians access to the most advanced treatment options.

OmniSeq INSIGHT is available to U.S.-based clinicians exclusively through Labcorp, and across Canada through Dynacare, a Labcorp company. The test is also available to global biopharmaceutical companies exclusively through Labcorp Drug Development. This can help reduce development time and costs while maximizing patient stratification by accelerating biomarker selection in preclinical and clinical development, and in targeted therapeutic and companion diagnostic development.

Labcorp Drug Development has a proven track record of providing a range of solutions and can offer the scalability required, backed by global expertise, regulatory guidance and informatics systems that are tailored to the biopharmaceutical partner’s unique development needs.

"We are excited to advance our partnership with Labcorp, continuing to provide increased access to oncology care for patients leveraging Labcorp’s extensive footprint and oncology experience," said Margot Schoenborn, CEO of OmniSeq. "We are making this test available globally to biopharmaceutical customers for incorporation into their clinical trials for biomarker stratification, and to support new precision medicine oncology approaches to drug and companion diagnostic development."

OmniSeq INSIGHT is NYS CLEP approved and leverages Labcorp’s broad national coverage, including in-network with most major health plans and 1,600 contractual relationships with plans, payers and other health care organizations.

Valo Health to go public via Khosla-backed SPAC, gaining $500M-plus

On June 10, 2021 Valo Health reported that unveiled plans to go public by merging with a special purpose acquisition company formed by Khosla Ventures(Press release, Valo Health, JUN 10, 2021, View Source [SID1234583927]).

The combined company will have about $750 million in the bank when the deal closes sometime in the third quarter. That includes $250 million from Valo, $333 million from the SPAC, Khosla Ventures Acquisition Co., and $168.5 million through a private financing from the likes of Khosla Ventures, Koch Disruptive Technologies and Flagship Pioneering.

Khosla Ventures Acquisition Corp., or KVAC for short, raised $300 million in its Nasdaq IPO in March and went on the hunt for one or more companies "addressing large market opportunities with highly differentiated proprietary technology" to merge with or acquire, the SPAC said in a securities filing. It could have gone into several other sectors, such as food and agriculture or climate, but ultimately landed on Valo, a biotech using computational technology to transform drug development and trim years off R&D timelines.

RELATED: Valo Health grabs $110M top-up, bringing series B to $300M

The proceeds from the deal will propel Valo’s preclinical and clinical programs, develop its software platform and support "new and existing growth initiatives," Valo said in a statement Wednesday.

Valo revealed its first four preclinical programs in January when it closed the first $190 million of its series B round. Those comprise cancer treatments targeting a mixture of known targets and new targets: PARP1, NAMPT, USP28 and HDAC3. Two of its programs have since entered the clinic, the company said in the statement, though it did not specify which ones. And that’s not all—its bench is much deeper than that, with 15 prioritized preclinical programs in total across oncology and neurodegeneration as well as cardiovascular, metabolic and renal diseases, according to the statement.

The company’s pipeline is based on its Opal Computational Platform, an end-to-end drug discovery and development platform. As the company develops its prospects, the Opal technology actively learns, so the company isn’t just advancing new medicines but also improving its discovery and development engine at the same time, said Valo CEO David Berry in a previous interview.

In the case of its PARP1 program, Valo used the platform to create a PARP inhibitor that could cross the blood-brain barrier without sacrificing efficacy and target PARP1 specifically rather than both PARP1 and PARP2, Berry said.

RELATED: Roivant catches the SPAC wave to Wall Street in $611M deal

It hopes to improve upon PARP inhibitors such as AstraZeneca and Merck’s Lynparza and Zejula from GlaxoSmithKline’s Tesaro, which have seen success in breast and ovarian cancers but don’t get into the brain. That stops them from being effectively used to treat cancers that spread to the brain as well as cancers that start in the brain.

Previously known as Integral Health, Valo launched in September 2020, acquiring Forma Therapeutics’ hit discovery capabilities for $2.5 million upfront, $17.5 million in installments and $10 million in equity. It had also acquired Numerate, which gave Valo the engineers who created a platform with more than 30,000 models and 70 trillion molecules.

Ascentage Reports Bcl-2 Inhibitor Effective in Early Test

On June 10, 2021 Ascentage Pharma, a Suzhou company, reported promising data from an early test of its Bcl-2 inhibitor in hematologic malignancies. Lisaftoclax (APG-2575) showed an objective response rate of 80% in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma and other hematologic malignancies (Press release, Ascentage Pharma, JUN 10, 2021, View Source [SID1234583925]). Previously, patients had received a median of two treatments for their disease. The results were reported in an oral presentation at the 57th ASCO (Free ASCO Whitepaper) Annual Meeting, one of four Ascentage presentations at the meeting.

Astellas’ Xtandi bags NICE approval in prostate cancer

On June 10, 2021 Astellas reported that oral treatment Xtandi has received approval from the National Institute for Health and Care Excellence (NICE) for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) (Press release, Astellas, JUN 10, 2021, View Source [SID1234583924]).

The positive decision is supported by data from the Phase III ARCHES trial, which showed Xtandi (enzalutamide) plus standard androgen deprivation therapy (ADT) reduced the risk of metastatic progression or death by 61% compared to placebo plus ADT in mHSCPC patients.

Enzalutamide-01.svg
Prior to the NICE approval, the NHS provided interim special access to Xtandi during the pandemic as a ‘COVID-friendly’ oncology treatment.

Xtandi will now become widely available for mHSPC, an advanced form of prostate cancer where the cancer has progressed outside the prostate gland.

According to the National Prostate Cancer Audit 2020, up to 13% of men diagnosed with prostate cancer presented with metastases in the UK between April 2018 and March 2019 – men with metastatic prostate cancer typically have a 30% overall five-year survival rate.

"Every 45 minutes one man dies from prostate cancer in the UK, resulting in more than 11,500 deaths a year. The prevalence of advanced prostate cancer in the UK underlines the need for additional treatment options so that they can be tailored to suit individual patients" said Tim Patel, medical director, Astellas UK & Ireland.

"The NICE recommendation of enzalutamide promises another option to men with mHSPC, who face a poor prognosis, with hopes of providing them with another effective treatment choice," he added.

aTyr Pharma Presents Poster Demonstrating Functional Selectivity of Second Anti-NRP2 Antibody

On June 10, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, reported the presentation of a poster at the Antibody Engineering & Therapeutics Europe Virtual conference which was held June 8 – 10, 2021 (Press release, aTyr Pharma, JUN 10, 2021, View Source [SID1234583906]). The abstract and poster are available on the conference website.

The poster presents preclinical findings demonstrating in vitro and in vivo proof-of-concept that the anti-Neuropilin-2 (NRP2) antibody, aNRP2-14, is a high affinity, selective blocker of the Semaphorin 3F/NRP2 interaction. Class 3 Semaphorins are an important set of NRP2 ligands, with recent data implicating their role in sustaining chronic inflammation.

Details of the abstract and poster presentation are as follows:

Title: Engineering an anti-Neuropilin-2 (NRP2) antibody that selectively blocks NRP2 interactions with Semaphorin and Plexin
Authors: Kaitlyn Rauch, Luke Burman, Yanyan Geng, Liting Zhai, Yeeting E. Chong, Ann Menefee, Kristina Hamel, Zhiwen Xu, Nathaniel Bloom, Lauren Guy, Matt Seikkula, Christoph Burkart, Leslie A. Nangle. aTyr Pharma, San Diego, CA, Pangu Biopharma, Hong Kong.
Date: June 8 – 10, 2021

The poster is also available on the aTyr website.

"We are very excited to present these findings for aNRP2-14, which demonstrate the cutting-edge, in-house antibody engineering capabilities that the aTyr team has developed around creating highly specific, fully humanized, monoclonal antibodies targeting NRP2 and the different domains of the receptor," said Leslie Nangle, Ph.D., Vice President, Research at aTyr. "NRP2 interacts with several different protein ligands individually through these distinct domains to mediate signaling through diverse biological pathways associated with different disease states, and we have created a panel of antibodies targeting these distinct domains. While our lead anti-NRP2 antibody, ATYR2810, blocks the interaction with the VEGF ligand and is in preclinical development for cancer, aNRP2-14 targets the interaction between NRP2 and Sema3F/Plexin, a distinct signaling pathway modulated by this receptor. The data presented in this poster suggest that the blocking ability of aNRP2-14 could have potential utility as a therapeutic modality for targeting immune-mediated diseases where Sema3F/VEGF signaling is implicated and presents an additional pipeline opportunity for aTyr to explore."

About NRP2

Neuropilin-2 (NRP2) is a cell surface receptor that plays a key role in lymphatic development and in regulating inflammatory responses. In many forms of cancer, high NRP2 expression is associated with worse outcomes. NRP2 can interact with multiple ligands and co-receptors through distinct domains to influence their functional roles, making it a potential drug target with multiple distinct therapeutic applications. NRP2 interacts with type 3 semaphorins and plexins to impact inflammation and with forms of vascular endothelial growth factor (VEGF) and their receptors, to impact lymphangiogenesis. In addition, NRP2 modulates interactions between CCL21 and CCR7 potentially impacting homing of dendritic cells to lymphoid organs. aTyr is currently investigating NRP2 receptor biology, both internally and in collaboration with key academic thought leaders, as a novel target for new product candidates for a variety of diseases, including cancer and inflammation.