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]).

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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]).

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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.

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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.

On July 14, 2020 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to development of next-generation medicines to improve the lives of patients with immune-mediated diseases, reported block sales of an aggregate of 4,580,361 shares of common stock to Perceptive Advisors, LLC and Avidity Partners Management LP, two leading healthcare-focused investment funds, under Aldeyra’s previously announced at-the-market offering program (Press release, Aldeyra Therapeutics, JUL 14, 2020, View Source [SID1234561863]). The shares were sold for a price of $4.25 per share. Aggregate gross proceeds, before deducting commissions, were approximately $19.5 million. The sales completed Aldeyra’s previously disclosed at-the-market offering program and no further sales will be made under this program. Jefferies, LLC served as sales agent under the at-the-market offering program.

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Aldeyra anticipates using the net proceeds from the sales for the continued development of the company’s lead compound reproxalap and other product candidates, as well as for debt maintenance, working capital, and other general corporate purposes. Based on current operating plans, cash, cash equivalents, and marketable securities are sufficient to fund operations through the end of 2022, including potential NDA approvals for reproxalap, a first-in-class topical ocular reactive aldehyde species (RASP) inhibitor, in dry eye disease and allergic conjunctivitis, assuming positive clinical trial results, and planned NDA submissions, acceptances, and approvals. Use of proceeds are also expected to include the continuation of Part 1 of the Phase 3 GUARD Trial for proliferative vitreoretinopathy, a rare retinal disease with no approved therapy, and Phase 2 clinical testing of ADX-629, an orally administered RASP inhibitor, in inflammatory diseases.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the company’s common stock nor shall there be any sale of such common stock in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On July 14, 2020 Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported the appointment of Tony Kingsley as president and chief executive officer, effective August 1, 2020 (Press release, Scholar Rock, JUL 14, 2020, View Source [SID1234561862]). Mr. Kingsley, who was appointed to Scholar Rock’s Board of Directors in May, replaces Nagesh K. Mahanthappa, Ph.D., MBA, who has chosen to step down after serving in this role since 2012. Dr. Mahanthappa will also be stepping down from the Board of Directors on August 1, 2020, after which he will serve as a scientific advisor to the company.

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"Scholar Rock is at an exciting inflection point, with great scientific strength, two product candidates in clinical development and multiple milestones in 2020 and 2021," said Mr. Kingsley. "I look forward to working with our extraordinary team to continue advancing our highly innovative research and platform capabilities, as well as lead the company through its next phase of growth, bringing desperately needed therapies to patients who often have limited treatment options."

Mr. Kingsley is an experienced CEO and a leader with a track record of driving growth, strategy and all facets of corporate operations. He was most recently president and chief executive officer of Taris Bio, prior to its acquisition by Janssen Pharmaceuticals at the end of 2019. Prior to Taris, he served as president and chief operating officer of The Medicines Company, and from 2010 to 2015, Mr. Kingsley led global commercial operations at Biogen, Inc. as executive vice president. Prior to Biogen, he held leadership roles in the medical device industry, including senior vice president and general manager of the gynecological surgical products business at Hologic, Inc. and division president, diagnostic products at Cytyc Corporation (now part of Hologic, Inc.), and was also a partner at McKinsey & Company. He received his undergraduate degree from Dartmouth College and an MBA from Harvard Business School.

"Nagesh has been a remarkable executive, building upon breakthrough academic research to lead Scholar Rock through the initial start-up phase to create a special company now poised to move multiple product candidates through clinical development and hopefully to patients in real need. On behalf of the entire board of directors, we want to thank Nagesh for his vision and leadership over the past eight years," said David Hallal, Chairman of the Scholar Rock Board of Directors. "Building on the tremendous foundation Nagesh has established, Tony’s clinical development, strategic, and commercial acumen will lead and drive Scholar Rock to further the company’s great potential. Tony has extensive experience in launching and growing franchises and companies, and we are thrilled that he’s taking the helm of the company at this pivotal time."

Dr. Mahanthappa is the founding employee of Scholar Rock, serving as president, CEO and a member of the Board of Directors since 2012. Under his leadership, the company has created a proprietary platform for the discovery of innovative antibody therapeutics focused on exploiting the structural differences of the precursors, or latent forms, of protein growth factors. During Dr. Mahanthappa’s tenure as president and CEO, he has been instrumental in developing the company’s breakthrough research through to clinical trials for two distinct product candidates, securing approximately $250 million in capital including an initial public offering, establishing value-creating collaborations with Gilead Sciences, Inc. and Janssen Biotech, Inc., and building a team of more than 100 talented employees.

Scholar Rock has two product candidates in clinical development: SRK-015 in a Phase 2 trial for the improvement of muscle function in patients with Spinal Muscular Atrophy (SMA), and SRK-181 in a Phase 1 trial in patients with solid tumors to overcome resistance to checkpoint inhibitor therapies. Both programs emerged from in-house discovery programs and have the potential to deliver multiple clinical readouts this year. The company is also advancing a strategic collaboration with Gilead to develop highly selective inhibitors of latent TGFβ activation for the treatment of fibrotic disorders and continues to build upon its research excellence to bring new antibodies to the clinic.