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.

On July 14, 2020 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that Brian H. Santich, PhD, from Memorial Sloan Kettering ("MSK") will present an update on the Company’s SADA technology platform at the Society of Nuclear Medicine and Molecular Imaging ("SNMMI") Virtual Annual Meeting on July 14, 2020 (Press release, Y-mAbs Therapeutics, JUL 14, 2020, View Source [SID1234561861]). The SADA technology was licensed by the Company from MSK and Massachusetts Institute of Technology ("MIT") earlier this year.

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Dr. Santich will present how the SADA technology’s 2-step payload delivery can be achieved in an in-vitro setting, where tumors were shown to shrink or completely disappear, while other tissues were spared. No clearing agent was needed, and no significant toxicity to bone marrow, kidneys or liver tissues was observed. We believe that the SADA technology may allow for rapid clearance of the compound, while maintaining high target uptake, and thereby causing less immunogenicity. In addition, the SADA technology appears to be modular, whereby any DOTA-modified radioactive payload combined with any therapeutic antibody seems possible.

"We are excited about the prospects of SADA technology, and this far we have four SADA targets in pre-clinical development. This includes our new construct, B7-H3 SADA, which we intend to use for the treatment of prostate cancer," stated Thomas Gad, Founder, Chairman and President.

Dr. Claus Moller, Chief Executive Officer, continued, "We look forward to further advancing the SADA technology, and plan to submit the first IND for a SADA construct in 2021. We have high hopes to see Liquid RadiationTM transform today’s cancer treatments."

Researchers at MSK including Dr. Santich, developed the SADA technology for radioimmunotherapy, which is exclusively licensed by MSK to Y-mAbs. Dr. Santich has intellectual property rights and interests in the technology, and as a result of this licensing arrangement, MSK has institutional financial interests in the technology and Y-mAbs.

On July 14, 2020 Orgenesis Inc. (NASDAQ: ORGS) ("Orgenesis" or the "Company"), a pioneering global biotech company committed to accelerating commercialization and transforming the delivery of cell and gene therapies (CGTs), reported that it has entered into a Collaboration Agreement with Educell Ltd., a premier European cell therapy company (Press release, Orgenesis, JUL 14, 2020, View Source [SID1234561860]). Under the agreement, the parties plan to conduct one or more collaborative cell-based research projects aligned with local medical centers.

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The companies will leverage the Orgenesis Cell and Gene Therapy (CGT) Biotech Platform which includes point of care (POCare) Networks, POCare Therapeutics and a POCare Technologies suite of proprietary and in-licensed technologies that have been engineered to create customized processing systems. The agreement is part of the Orgenesis strategy of growing and expanding the POCare Network, which includes leading hospitals and research institutes around the world. The first collaboration under the agreement will focus on the clinical development of CAR-T and whole cell-based vaccine platform for use in cancer immunotherapies.

Vered Caplan, CEO of Orgenesis, stated, "This latest collaboration with Educell expands our activities in Europe and we believe that it should help us launch our therapies into additional European hospitals, as well as help Educell commercialize their therapies around the world. We also believe that this collaboration reinforces the significant value proposition and flexibility of our CGT Biotech Platform. We look forward to benefiting from the expertise of Educell as we seek to expand our automated T-cell culturing approach into clinical validation and commercialization phases."

Dr Miomir Knežević, CEO of Educell, commented, "We are excited to team with Orgenesis to potentially advance these breakthrough therapies into clinical trials using cutting edge technologies. This collaboration reflects our commitment to bringing new, effective and affordable cell and gene therapy products to cancer patients worldwide while highlighting Educell’s ability to ensure safety in the process and help to reduce overall manufacturing costs."

Together, the companies are working to address significant unmet market needs for producing novel cell therapies in a cost effective, high quality and scalable manner. The joint clinical development program seeks to provide safe, simplified, and cost-effective processing in an automated and controlled environment from start to finish with minimal operator intervention.