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Akoya Announces Publication of the MITRE Study, the First Multi-Institutional Analytical Demonstration of a Spatial Biology Workflow, in the Journal for ImmunoTherapy of Cancer

On July 19, 2021 Akoya Biosciences, Inc., (Nasdaq: AKYA) The Spatial Biology Company, reported that the Phenoptics mIF solution was used in a multi-site study to demonstrate and validate an automated end-to-end workflow that characterizes PD-1/PD-L1 immune checkpoint signaling in tumor tissue samples (Press release, Akoya Biosciences, JUL 19, 2021, View Source [SID1234590277]). The paper titled, "Multi-institutional TSA-amplified Multiplexed Immunofluorescence Reproducibility Evaluation (MITRE Study)," was published in the Journal for ImmunoTherapy of Cancer (JITC) in July 2021. The MITRE results are an important step toward standardizing an automated mIF-based spatial biology workflow that provides the level of performance needed to support clinical trials and that can be applied to clinical testing in the future.

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Top immuno-oncology and pathology experts from five institutions collaborated with Akoya to conduct the MITRE study, including Johns Hopkins University School of Medicine, Yale University School of Medicine, Earle A. Chiles Research Institute, The University of Texas MD Anderson Cancer Center, and Bristol Myers Squibb.

"I am very excited by the results of this study because it is the first multi-institutional study of its kind involving mIF, representing an approach that should be part of every effort to develop a biomarker platform for trials and eventual clinical use," said Dr. David Rimm, Professor of Pathology at Yale University School of Medicine and one of the lead principal investigators on the study.

Immunotherapy utilizes the patient’s immune system to fight cancer and has delivered durable benefit to some subsets of patients with advanced disease, representing a significant step forward in the quest to conquer cancer. However, a majority of the patients still do not respond to treatment. There is a pressing need for accurate, predictive biomarkers to differentiate responders from non-responders. Recent studies have demonstrated that spatial biomarkers are able to predict immunotherapy response with greater accuracy than current methods1,2.

Spatial biology, a rapidly emerging field of science, allows researchers to map the interactions of tumor and immune cells across an entire tumor tissue section, without destroying the spatial context of the tissue, enabling a more accurate assessment of tumor-immune biology.

With the MITRE study, the authors sought to develop and validate a spatial biology workflow that is transferable among sites and delivers site-independent and reliable quantitative data for immunotherapy research.

Study details

The multi-institutional effort optimized an automated 6-plex biomarker assay focused on the PD-1/PD-L1 axis and assessed the inter- and intra-site reproducibility of the assay by measuring spatial biology parameters of tumor and immune cells within tissue samples. Among the parameters examined were tumor cell and immune cell subset densities, PD-L1 expression and location, and PD-1/PD-L1 spatial proximity.

Akoya’s Phenoptics workflow, which enables spatial phenotyping using mIF, demonstrated high concordance across multiple institutions. The study confirmed that quantitative measures of multiple biomarkers in a tissue section are reproducible at levels aligned with typical clinical testing standards. The authors also reported that quantitative mIF substantially outperforms challenging visual assessments, such as assessing PD-L1 positivity in immune cells, particularly in non-small cell lung cancer (NSCLC) samples.

"The foundational requirement for any platform including those delivering spatial phenotyping is the ability to fully demonstrate analytical robustness with a workflow that has the necessary throughput for large scale clinical studies. With the MITRE study and the robust end-to-end Phenoptics workflow, we believe Akoya is ideally positioned to support our customers’ translational and clinical research needs," said Brian McKelligon, CEO of Akoya. "Along with our recent announced partnerships with AstraZeneca and Johns Hopkins, the MITRE Study is another significant milestone in moving spatial biology into the realm of patient phenotyping and improving immunotherapy outcomes in the future."

For more information about Phenoptics, go to: akoyabio.com/Phenoptics

G1 Therapeutics Receives Fast Track Designation from U.S. Food and Drug Administration for COSELA™ (Trilaciclib) in Combination with Chemotherapy for the Treatment of Locally Advanced or Metastatic Triple Negative Breast Cancer

On July 19, 2021 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to COSELA (trilaciclib) investigation for use in combination with chemotherapy for the treatment of locally advanced or metastatic triple negative breast cancer (TNBC) (Press release, G1 Therapeutics, JUL 19, 2021, View Source [SID1234587574]). COSELA is currently being evaluated in PRESERVE 2, a pivotal Phase 3, randomized, double-blind, placebo-controlled study (NCT04799249) in patients receiving first- or second-line gemcitabine and carboplatin chemotherapy for TNBC.

Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill unmet medical needs. The purpose is to get important new drugs to the patient earlier. A drug that receives Fast Track designation may be eligible for more frequent engagements with the FDA to discuss the drug’s clinical development plan, eligibility for Accelerated Approval and Priority Review, and Rolling Review in which the Company can submit completed sections of its New Drug Application (NDA) for FDA review rather than waiting until every section of the NDA is completed before the entire application can be reviewed.

"Fast Track designation underscores the urgent need for innovative drugs that can significantly improve TNBC patient outcomes," said Raj Malik, M.D., Chief Medical Officer at G1 Therapeutics. "It provides an important pathway to help expedite the development and regulatory review of COSELA in this indication. We look forward to working closely with the FDA as we advance this pivotal program in TNBC and continue to work to unlock the broader potential of this pipeline-in-a-molecule compound that we hope will help patients across multiple tumor types."

About Triple Negative Breast Cancer (TNBC)
According to the American Cancer Society, nearly 300,000 new cases of invasive breast cancer are diagnosed annually in the U.S. Triple-negative breast cancer makes up approximately 15% to 20% of such diagnosed breast cancers. TNBC is cancer that tests negative for estrogen receptors, progesterone receptors, and excess HER2 protein. Because TNBC cells lack key growth-signaling receptors, patients do not respond well to medications that block estrogen, progesterone, or HER2 receptors. Instead, treating TNBC typically involves chemotherapy, radiation, and surgery. TNBC is considered to be more aggressive and have a poorer prognosis than other types of breast cancer. In general, survival rates tend to be lower with TNBC compared to other forms of breast cancer, and TNBC is also more likely than some other types of breast cancer to return after it has been treated, especially in the first few years after treatment. It also tends to be higher grade than other types of breast cancer.

Theradiag announces half-year 2021 revenue of € 5.5 million, up 12.5%

On July 19, 2021 THERADIAG (ISIN: FR0004197747, Ticker: ALTER), a company specializing in in vitro diagnostics and Theranostics, reported its half-year turnover and its cash level at June 30, 2021, data under audit (Press release, Theradiag, JUL 19, 2021, View Source [SID1234587268]).

At June 30, 2021, Theradiag achieved a turnover of 5.5 million euros against 4.9 million in the
1 st half of 2020, an increase of 12.5% despite an economic context characterized and health by the persistence in all countries of difficulties in accessing hospital care for patients undergoing immunotherapy.

The Theranostics business continued to grow with growth this semester of + 14.7%, driven in particular by the dynamic sales of the i-Track 10 machine . Marked by strong growth for several semesters, the Theranostics activity represents for the first time the majority of Theradiag’s revenues over these first six months of 2021.

Theranostics activity carried out in the United States in partnership with HalioDX reached 0.5 million euros, in line with the company’s development plan, and grew by 33.6%. In exports, the company maintains a very sustained level of activity with an increase in sales of 27.4% to 1.3 million euros. Penalized by maintaining white planes in hospitals, activity in France slowed slightly, it is set back from 5.2% to 1.0 million euros compared to the 1 st half of 2020.

The In Vitro Diagnosis (IVD) activity posted revenue growth of + 10.4% to reach 2.7 million euros as of June 30, 2021.

Cash position

As of June 30, 2021, Theradiag’s available net cash amounted to € 1.4 million compared to €
3.5 million as of December 31, 2020. This difference results from cash mismatches resolved to date amounting to 0.5 million euros, as well as investments in R&D and international development in line with Theradiag’s strategic plan.

Bertrand de Castelnau, CEO of Theradiag commented:"The 12.5% revenue growth in a delicate health context once again proves that Theradiag’s business model is based on solid fundamentals. In the first half of 2021, the Theranostics activity continued to grow thanks to the deployment of the i-Track solution, the marketing of which had been launched in full containment in 2020. The particularly strong Theranostics dynamic in the United States highlights the success of our partnership with Halio DX in this strategic country. The first semester was also marked by the kick-off of the Humabdiag project with the University of Tours, which will allow us to obtain high quality antibodies which are strategic for the future of the company. For the rest of the 2021 financial year, We are maintaining our investments in innovation and our international deployment efforts, particularly in the United States. "

Pierre Morgon, Chairman of the Board of Directors of Theradiag continues: " This first semester underlines the robustness of the model shaped for years by the Theradiag teams who have demonstrated their performance in times of crisis. World leader in the monitoring of biotherapies, Theradiag has a real technological lead and continues to maintain it thanks to its judicious investment policy. This positive dynamic is supported by an ambitious and clear strategic plan which can only offer a bright future to Theradiag. "

Of the main events of the 1 st half 2021

January 2021: CE marking of the four new i-Tracker test kits from the TRACKER Vedolizumab and Ustekinumab range on the originator molecules and biosimilars
January 2021: Signature of a contract for the supply of quality control reagents with Orgentec
May 2021: Participation in the Humabdiag project, a large-scale research project aimed at bio-production of monoclonal antibodies in Tours
Financial calendar:

Results of the 1 st half of 2021 , Monday, September 20, 2021

Eluminex Biosciences Exclusively Licenses FibroGen’s Biosynthetic Cornea Technology and Recombinant Collagen III Platform

On July 19, 2021 Eluminex Biosciences (Suzhou) Limited (Eluminex), an ophthalmology-focused biotechnology company headquartered in Suzhou, China with a US-subsidiary office in San Francisco Bay Area, California, reported that it has exclusively licensed global rights for the development and commercialization of an investigational biosynthetic cornea derived from recombinant human collagen Type III intended to treat patients with corneal blindness, from FibroGen, Inc. (FibroGen; NASDAQ: FGEN) (Press release, FibroGen, JUL 19, 2021, View Source [SID1234586988]).

"We are extremely excited to bring this novel technology initially to the China market to help meet a large unmet medical need for an alternative to human donor cornea tissue," commented Dr. Jinzhong ("JZ") Zhang, Chairman and CEO of Eluminex. "Over 100,000 cases of corneal blindness occur each year in China due to scarring from traumatic injury or infection that could be treated with a surgically implanted bioengineered cornea. Typical treatments in China include human donor corneal transplantation or use of corneal tissue harvested from genetically modified pigs. There is a significant shortage of human donor tissue and porcine corneas have issues with a lack of optical clarity and durability, however, and both methods require the need for additional immunosuppressive medications to prevent graft rejection. The biosynthetic cornea, that is optically clear, offers an alternative using human Type III collagen, a key structural protein that is found in normal human corneas and therefore does not require immunosuppressive medications."

Under the terms of the agreement, Eluminex will make an $8 million upfront payment to FibroGen. In addition, FibroGen may receive up to a total of $64 million in future manufacturing, clinical, regulatory, and commercial milestone payments for the biosynthetic cornea program, as well as $36 million in commercial milestones for the first recombinant collagen III product that is not the biosynthetic cornea. FibroGen will also be eligible to receive royalties based upon worldwide net sales.

Eluminex also announced that Edward Holland, M.D., has joined the company’s Scientific Advisory Board (SAB). Charles Semba, M.D. and Chief Medical Officer of Eluminex commented, "We are excited to introduce Dr. Edward Holland, Professor of Ophthalmology at the University of Cincinnati and Director of the Cornea Service at the Cincinnati Eye Institute and past Chairman of the Eye Bank Association of America, as the newest member of our SAB. He is an internationally recognized expert in corneal allograft surgery and ocular surface disease. Additionally, over the past three decades, he has taught and lectured in China regarding corneal transplant techniques and will provide us critical insights into our biosynthetic cornea program."

"The possibility for an abundant global supply of a biosynthetic human corneal tissue substitute has real potential to transform the lives of the hundreds of thousands of patients around the world in regions where corneal donations are scarce and who otherwise are unlikely to receive a sight-saving corneal transplant," said Dr. Holland.

"We are pleased to enter into this agreement with Eluminex and license this technology to a seasoned ophthalmology team," said Enrique Conterno, CEO of FibroGen. "This transaction enables FibroGen to focus on development of next generation biopharmaceutical therapies in our core areas of cancer, autoimmune and fibrotic diseases, and anemia."

About the Eluminex Biosynthetic Cornea Program
The Eluminex biosynthetic cornea (EB-301) is a clinical stage corneal stromal substitute that will be initially developed for the China market. EB-301 is regulated as a Class III medical device and is anticipated to enter a clinical market authorization registration study in China in 2H 2022 to confirm its safety and effectiveness. The corneal device has been implanted in 10 patients in Europe with 4 years of follow-up and has demonstrated excellent biocompatibility, maintenance of optical clarity, and significantly improved visual acuity without immunosuppression. (Fagerholm et al, Biomaterials, 35 (2014): 2420-2427).

About Corneal Blindness in China
According to the World Health Organization, corneal diseases are one of the leading causes of blindness globally. Approximately 180,000 sight-restoring corneal transplantations are performed worldwide in which nearly a quarter are conducted in the United States. China is the largest most populous developing country in the world and corneal diseases are the second leading cause of blindness with an estimated 2-3 million patients with corneal blindness in at least one eye. However, due to the scarcity of donor corneas, only approximately 5000 to 9000 corneal transplants are conducted in China each year. Corneal porcine xenografts have been available in China since 2015 but technical issues remain with the lack of optical clarity and secondary immunologic complications (eg, graft dissolution and graft rejection). An unmet need exists for a suitable corneal stromal tissue replacement as an alternative to the shortage of donated human cornea and an alternative to porcine xenografts.

Subscription to raise £1,000,000

On July 19, 2021 Sareum Holdings plc (AIM: SAR), the specialist drug development company, reported that it has raised £1,000,000, before expenses, through a subscription by a high net worth individual (the "Subscriber") for 14,285,714 new ordinary shares of 0.025p each in the capital of the Company ("Ordinary Shares") (the "Subscription Shares") at a price of 7p per share (the "Subscription Price") (the "Subscription") (Press release, Sareum, JUL 19, 2021, View Source [SID1234586708]).

Under the terms of the Subscription, the new Subscriber will also be issued one five-year warrant, exercisable at the Subscription Price, for every Subscription Share issued (the "Subscription Warrant"), which can only be exercised following the Company’s closing middle market share price being above 9p per Ordinary Share for five consecutive days. The Subscription Price represents a premium of approximately 4.5 per cent. to the closing middle market price for Sareum Shares on 16 July 2021.

The net proceeds from the Subscription will be used to progress the Company’s SDC-1801 and SDC-1802 TYK2/JAK1 inhibitor drug development programmes as well as for working capital purposes. As noted in the Company’s Trading Update of 25 May 2021, the Company is targeting the completion of preclinical studies for SDC-1801 in Q3 2021, subject to successful progress. Clinical trial plans, including priority autoimmune indications and potential Covid-19 application, will also be developed in parallel, subject to additional funding being raised.

Application will be made for the 14,285,714 Subscription Shares, which will rank pari passu with the Company’s existing Ordinary Shares, to be admitted to trading on the AIM market of the London Stock Exchange ("AIM") ("Admission"). It is anticipated that Admission will become effective at 8.00 am on 23 July 2021. The Subscription is subject to normal conditions including, inter alia, Admission.

Total Voting Rights

For the purpose of the Disclosure Guidance and Transparency Rules, following the above issue of equity, the issued share capital of the Company will comprise 3,353,579,936 Ordinary Shares. The above figure may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, the Company, under the Disclosure Guidance and Transparency Rules.

Dr Tim Mitchell, CEO of Sareum Holdings plc, said: "We are delighted that our proprietary TYK2/JAK1 development programmes are attracting such interest and new investment. With this new subscription, the total funds raised from recent subscriptions and warrant exercises is over £3.5 million. These new funds will allow us both to advance SDC-1801 into clinical development in autoimmune diseases, including the immune overreaction to Covid-19 and other viral infections, and to progress the preclinical development of our second TYK2/JAK1 inhibitor SDC-1802 against cancers."