On July 14, 2020 Celyad Oncology SA (Euronext & Nasdaq: CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, reported that the company’s Investigational New Drug (IND) application for CYAD-211, the company’s first-in-class short hairpin RNA (shRNA)-based allogeneic CAR T candidate and second non-gene edited off-the-shelf program, is in effect with the U.S. Food and Drug Administration (FDA) (Press release, Celyad, JUL 14, 2020, View Source [SID1234564455]). The company’s lead allogeneic candidate from its next-generation CYAD-200 series, CYAD-211 targets B-cell maturation antigen (BCMA) for the treatment of relapsed / refractory multiple myeloma (r/r MM). CYAD-211 is engineered to co-express a BCMA-targeting chimeric antigen receptor and a single shRNA, which interferes with the expression of the CD3ζ component of the T-cell receptor (TCR) complex.

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!

"The FDA’s permission to begin the Phase 1 clinical trial of our lead shRNA-based allogeneic candidate CYAD-211 is a watershed moment for our organization," commented Filippo Petti, Chief Executive Officer of Celyad Oncology. "Today’s announcement demonstrates our ability to advance in parallel multiple off-the-shelf product candidates based on differentiated non-gene edited allogeneic technologies into the clinic. In addition, our team has delivered on incredible timelines for the CYAD-211 program, moving the project from concept to an effective IND in under two years. We are excited to have the CYAD-211 IND in effect to initiate the Phase 1 trial by year-end 2020 for this first-in-class CAR T candidate for patients with multiple myeloma and look forward to accelerating the development of additional shRNA-based allogeneic candidates from our CYAD-200 series towards clinical trials."

Celyad Oncology’s shRNA-based Platform for Allogeneic CAR T

Celyad Oncology is advancing a pipeline of proprietary, non-gene edited allogeneic CAR T candidates from its CYAD-200 series, which is underpinned by its shRNA technology platform. The shRNA platform coupled with the company’s all-in-one vector approach provides flexibility, versatility, and efficiency to the design of novel, off-the-shelf CAR T candidates through a single step engineering process. Next-generation candidates exploring the breadth and depth of the Celyad Oncology shRNA platform are currently under preclinical development. Combining shRNA knockdown with additional functional components in a single CAR T construct may also offer therapeutic optionality to the non-gene edited allogeneic CYAD-200 series of product candidates. In 2018, Celyad Oncology signed an exclusive agreement with Horizon Discovery Group for the use of its SMARTvector shRNA technology for the development of allogeneic CAR T therapies.

On July 14, 2020 Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, reported the commencement of a proposed underwritten public offering of 8,000,000 shares of its common stock (6,000,000 of which are being offered for sale by Adaptive and 2,000,000 of which are being offered for sale by a selling shareholder) (Press release, Adaptive Biotechnologies, JUL 14, 2020, View Source [SID1234561952]). In addition, Adaptive expects to grant the underwriters a 30-day option to purchase up to 1,200,000 additional shares of common stock at the public offering price, less underwriting discounts and commissions. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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!

Adaptive intends to use the net proceeds from the offering, after deducting underwriting discounts and commissions and estimated offering expenses payable by Adaptive, primarily to accelerate investments in Adaptive’s TCR-Antigen Map activities, scale commercial and marketing activities associated with immunoSEQ Dx clinical products and services, and support continued research and development for drug discovery initiatives. A portion of the net proceeds may also be used to scale Adaptive’s laboratory operations and capacity to support commercial growth plans and for working capital and other general corporate purposes. Adaptive will not receive any of the proceeds from the sale of the shares of its common stock being offered by the selling shareholder.

J.P. Morgan, Goldman Sachs & Co. LLC and BofA Securities are acting as joint lead book-running managers for the offering.

The public offering is being made pursuant to an automatic shelf registration statement on Form S-3 that was filed by Adaptive with the U.S. Securities and Exchange Commission (SEC) on July 14, 2020 and automatically became effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus may also be obtained by contacting: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204 or by email at [email protected]; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at [email protected]; or BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On July 14, 2020 EXACT THERAPEUTICS AS ("EXACT-Tx" or the "Company") (Oslo: EXTX-ME), a clinical stage precision medicine company evaluating Acoustic Cluster Therapy (ACT) across multiple therapeutic areas, reported that its shares have been admitted to trading on Oslo Stock Exchange’s Merkur Market under the ticker EXTX-ME with first day of trading 14 July 2020, following the successful completion of a NOK 155 million private placement (Press release, Exact Therapeutics, JUL 14, 2020, View Source [SID1234561866]).

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!

The offering attracted strong interest from existing shareholders including Canica, Sundt, Andenaess, Investinor and P53/TDVeen who anchored the financing, and Norwegian family offices and institutions including Nordea. The offering was significantly upsized on the back of strong demand.

The net proceeds from the private placement will be used for:

completion of phase I study of ACT in liver metastases
initiate planning and conduct supporting studies for multi-indication oncology basket trial
further development of ACT-therapy ultrasound probe
preclinical development within other indications
reinforce management and clinical team
Comment

"We are delighted with the success of this financing and the interest from investors is a strong recognition of both the broad potential of ACT as well as the continued progress of the phase I ACTIVATE study evaluating ACT co-administered with chemotherapy in patients with metastatic colorectal and pancreatic cancer," says Dr Rafiq Hasan, CEO designate of EXACT-Tx.

Chair of the Board and healthcare investor Dr. Masha Strømme further comments: "The Merkur listing facilitated the strengthening of the shareholder base which will help further our mission to extend and enrich patient lives through targeted ACT therapeutic enhancement."

On July 14, 2020 Ashion Analytics LLC reported that Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostic Services Program (MolDX), has awarded coverage to its proprietary cancer profiling test, GEM ExTra, one of the nation’s most comprehensive genomic cancer analysis tests (Press release, Ashion Analytics, JUL 14, 2020, View Source [SID1234561865]).

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!

GEM ExTra, Ashion’s flagship clinical assay, detects tumor-specific mutations, allowing physicians to make the best-available treatment recommendations for patients with advanced solid tumors. The leading-edge test provides treating physicians with vital interpreted information that they need to understand changes to a patient’s genomic profile. It outlines a therapeutic treatment plan best suited for each patient. Conditions that may benefit from this approach include treatment of refractory, rare or aggressive cancers.

"GEM ExTra was designed to be fast and accurate, and now with Medicare coverage, it is also more affordable for a larger set of patients," said Ashion Medical Director Janine LoBello, D.O. "GEM ExTra differs from other genomic tests on the market due to its versatility, breadth and depth, including the power to sensitively detect mutations with low tumor purity."

GEM ExTra features whole exome sequencing, a molecular-level analysis of each patient’s entire protein-coding DNA. The proprietary test identifies point mutations, amplifications, deletions, translocations and transcriptome sequencing. It flags the expression of both rare and common fusion genes and alternatively spliced transcripts (ARv7, EGFRvIII and others). Positive findings in this data may guide patient treatment, leading to more targeted, effective therapies. As an example, the test includes reporting on immuno-oncology markers, providing clinicians with important information on the potential utility of powerful immune checkpoint treatments.

GEM ExTra is available for use with a variety of biological sample types, including formalin-fixed paraffin-embedded (FFPE) tissue specimens and fresh-frozen tissue for solid tumors. Results are reported back to physicians within 14 calendar days.

"Medicare coverage of GEM ExTra allows Ashion to offer a test to the broader market that is optimized for detection of common and rare mutations and is able to identify more actionable cancer mutations than most other commercially available tests," said Audrey Ozols, Ashion’s head of market access. "The company is well positioned for growth with payers and physicians alike by offering 44 million more patients access to a best-in-class comprehensive genomic cancer test."

Ashion Analytics was founded by the Translational Genomics Research Institute (TGen), an affiliate of City of Hope. TGen is a pioneer in the use of genomics to identify treatment options for cancer patients.

"City of Hope patients have had access to GEM ExTra’s comprehensive exome sequencing for more than two years," said Michael Caligiuri, M.D., president of City of Hope National Medical Center and the Deana and Steve Campbell Physician-in-Chief Distinguished Chair. "This sequencing tool often enables clinical teams to offer precision medicine so that patients are given the care most likely to put them into long-term cancer remission and improve their quality of life."

About GEM ExTra

To achieve complete analytic coverage of the human genome, Ashion uses a proprietary test called GEM ExTra, which covers all protein coding regions of DNA (known as the exome), and an analysis of all RNA, the messengers of DNA (known as the transcriptome). GEM stands for Genomic Enabled Medicine, and ExTra stands for Exome and Transcriptome. Ashion’s GEM ExTra sequences both the individual patient’s normal genome and the patient’s cancer genome. Then the two sets of genomic data are compared to find gene changes, known as mutations, that are specific to the tumor and that may be potentially driving the patient’s cancer.

Study highlighting RNA role presented at recent ASCO (Free ASCO Whitepaper) meeting

An Ashion study poster presented at the 2020 annual meeting of the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) details the importance of using RNA as part of the analysis to give cancer physicians the best possible options for treating their patients: Employing RNA Sequencing to Enhance Treatment Options for Cancer Patients.

On July 14, 2020 Diaceutics PLC, (AIM: DXRX), reported that key partnerships on its DXRX platform, the world’s first diagnostic network for precision medicine, which will drive the global standardization of diagnostic testing (Press release, Diaceutics, JUL 14, 2020, View Source [SID1234561864]). Targos Molecular Pathology and HistoCyte Laboratories will join Diaceutics’ network of partners to enable the rollout of a global marketplace for labs later this year.

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!

Diaceutics research, published in its Pharma PM Readiness Report 2019, found that globally, 74% of oncology biomarker testing is carried out using laboratory-developed tests (LDTs). As a result, most testing for precision medicines is not standardized and maybe susceptible to inaccuracies. Diaceutics’ partnerships with Targos and HistoCyte will help to drive the standardization required to streamline testing and ensure every patient gets the treatment they deserve, when they need it. They will collaborate with a global network of stakeholders on DXRX, an end-to-end solution for the development and commercialization of precision medicine diagnostics, which places the laboratory at the center of the precision medicine ecosystem. The first pilot of the partnership has been launched and is focusing on PD-L1 testing.

With the support of its team of more than 100 pathologists and scientists, Targos Molecular Pathology validates and applies predictive biomarkers in international clinical trials to the highest quality level. As a network partner to DXRX, Targos will provide laboratories with its Targos Advance Expert training and quality assurance support – along with comparison studies and RING studies – as part of DXRX’s end-to-end service offering. In doing so, Targos will enable laboratories to benchmark their performance against other laboratories and ensure that every patient receives the same quality of testing.

HistoCyte Laboratories develops and manufactures a range of standardized analyte controls for use in immunohistochemistry (IHC) and fluorescence in-situ hybridisation (FISH) tests. By joining the DXRX network, HistoCyte will help laboratories to standardize and evaluate the performance of their IHC and FISH assays by providing them with single slide control materials.

Diaceutics research has found that a lack of standardized testing practices, accompanied by a lack of investment in diagnostic testing, is leading to average lag time of 4.5 years between the launch of a new oncology drug and the widespread availability of its companion diagnostic test. However, HistoCyte’s standardized, cost-efficient solution, which will be customized according to regulatory-approved biomarker assays and with hands-on support for implementation – combined with Targos’s insights, training and quality assurance support – will reduce this lag. The partnerships will streamline the development of diagnostic tests and accelerate their speed to market, therefore ensuring the successful launch and uptake of pharmaceutical companies’ new precision medicine drugs.

Gudrun Baenfer, Head of Targos Advance Training & Consulting Division, said: "Since 2005, Targos is vigorously pursuing a high level of international standardization for biomarker analysis. An important part of this has become the Targos Advance Expert Training program, which has been performed for more than 4,000 pathologists. We are excited to join Diaceutics in its effort to realize the full potential of precision medicine through standardization and training."

Colin Tristram, Co-founder and Director at HistoCyte said: "It is a very exciting project to be involved in, working with and alongside much respected people and brands in the pathology market. We are united by the same passion in quality control and delivery of the best service to patients. We at HistoCyte Laboratories are looking forward to working alongside our colleagues within the Diagnostic Network."

Karina Hjort, Senior Director, Innovation at Diaceutics, said: "Too many patients are still missing out on getting the right treatment at the right time due to inefficiencies in the testing ecosystem. These partnerships will enable the diagnostic testing standardization and training support needed at a global level to make precision medicine treatments accessible to every patient.

"For the last 10 years, Diaceutics has been building collaborations with industry-leading service providers in areas such as pathology training, health economics, reference standards, EQA and digital enablement to solve today’s broken testing ecosystem. These will all converge on DXRX, with the laboratory at the center of the network. We will arm labs with the tools, training and support that they need in real-time, to be ready for biomarker drug launches coming to market. We are delighted to have HistoCyte and Targos on board as global leaders in their field and look forward to announcing more collaborations that will enable precision medicines to transform healthcare and patient outcomes.

"We are delighted to commence our first DXRX pilot collaboration on the PD-L1 biomarker which still suffers from a lack of global standardization despite the reliance of multiple billion dollar cancer treatments on this biomarker. Among these are life-saving treatments for Non-Small Cell Lung Cancer, metastatic melanoma and bladder cancer."

Targos and HistoCyte’s services will be made available via this pilot collaboration to a select number of laboratories within Diaceutics’ network of over 2,500 labs. The lab network will have access to DXRX services such as on-slide controls, training and coaching free of charge.