On May 25, 2021 Almac Sciences, a member of the Almac Group, reported that it has invested £325,000 in continuous flow chemistry equipment to further its most recent laboratory expansion, a £5 million, two-storey R&D centre for flow chemistry, biocatalysis and peptide technologies (Press release, Almac, MAY 25, 2021, View Source [SID1234580513]).

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Sited within a dedicated laboratory in the new 32 fumehood technology centre, Almac Sciences’ 10-strong custom and flow chemistry team, can rapidly screen new processes to demonstrate reaction validity under continuous flow and the added value of technology implementation for clients. Success affords the opportunity to move immediately to kilo scale and subsequent delivery of product with seamless "flow".

Dr. Scott Wharry, Almac Sciences’ Custom and Flow Chemistry Manager commented: "The recent investment is critical for our strategic growth and highlights Almac Sciences’ commitment to offering our clients the best available technology solutions. Our technology development has included the installation and commissioning of high pressure hydrogenation pilot rig (with capability range up to 300◦C and 100 Bar pressure) and from Chemtrix both lab (Labtrix ) and kilo (Protrix)scale flow rigs. These enhanced capabilities enable us to deliver superior solutions driving projects from proof of concept to kilo manufacture rapidly in response to our customers’ critical timelines".

Additional flow equipment within the facility includes: microreactors, photocatalysis flow rig, Continuous Stirred-Tank Reactors (CSTR’s), Vapourtec E series flow rig, in-house built cryogenic rigs, microbubble and pressure technology, as well as, spray drying, UF/DF and liquid-liquid separation technology.

Professor Tom Moody, VP Technology Development and Commercialisation, Almac Sciences and Arran Chemical Company commented: "This investment highlights our commitment to ensure continual innovation and world-class technology platforms to meet the increasing demand of our global clients across the pharmaceutical, biotechnology, life sciences and fine chemicals sectors. This, coupled with our established expertise demonstrates our long-term commitment to advancing our capability and innovative range of services for our clients."

Almac Sciences has seen rapid growth over the last five years and an anticipated continued trajectory with significant investments in its global non-GMP and GMP manufacturing plants, in addition to enhanced analytical solutions to support increased client manufacturing demands. Further announcements are expected in the coming months.

On May 25, 2021 Ascletis Pharma Inc. (HKEX code: 1672) reported that following the consultation with China National Medical Products Administration (NMPA), the clinical trial application of ASC40 combined with bevacizumab to treat patients with recurrent glioblastoma (rGBM) has been accepted for review by China NMPA (Press release, Ascletis, MAY 25, 2021, View Source [SID1234580504]).

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Lipid metabolism has been reported to play a critical role in various cancers. Fatty acid synthase (FASN) is one of the most important proteins which regulate lipid metabolism. Many solid and hematopoietic tumors overexpress FASN, including rGBM, non-small cell lung, breast, ovarian, prostate, colon, pancreatic cancers, and non-Hodgkin lymphoma.

ASC40 (known as TVB-2640 outside China) is a potent, selective and safe oral small molecule inhibitor of FASN. The positive results were demonstrated from the investigator sponsored Phase II trial of ASC40 (TVB-2640) in combination with bevacizumab in patients with first relapse of high-grade astrocytoma i.e. rGBM, which was completed in the United States (ClinicalTrials.gov Identifier: NCT03032484). The data from this Phase II trial have shown that the overall response rate (ORR) for ASC40(TVB-2640) plus bevacizumab was 65% including the complete response (CR) of 20% and partial response (PR) of 45%. Furthermore, the data indicate that the progression-free survival at six months (PFS6) observed for ASC40 (TVB-2640) plus bevacizumab was 47%, representing a statistically significant improvement in PFS6 over historical bevacizumab monotherapy (BELOB16%, P=0.01). ASC40 (TVB-2640) in combination with bevacizumab was safe and well tolerated in such patient population.

"Since the announcement on March 30 this year for investment escalation in R&D of cancer lipid metabolism and oral checkpoint inhibitors, this is a key step forward for the Company’s oncology pipeline." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis.

On May 25, 2021 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, and Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, reported the signing of a Master Supply Agreement for the therapeutic radioisotope copper-67 (Cu-67) (Press release, Clarity Pharmaceuticals, MAY 25, 2021, View Source [SID1234580503]). Under the agreement, NorthStar will supply Cu-67 exclusively to Clarity Pharmaceuticals as an active pharmaceutical ingredient used to support Clarity’s Targeted Copper Theranostics (TCT) programs.

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Cu-67 is a beta-emitting radioisotope with clinical applications as a radiopharmaceutical to directly target and deliver therapeutic doses of radiation to destroy cancer cells in patients with serious disease.

"Previously, the lack of an effective copper chelating technology has limited the clinical development of Cu-67 products and subsequent commercial production of Cu-67," said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. "Clarity Pharmaceuticals’ unique copper-chelating technology has enabled it to advance its product pipeline into a range of theranostic clinical trials that use copper-64 (Cu-64) for diagnostic imaging and Cu-67 as therapy. NorthStar is addressing the need for reliable Cu-67 radioisotope supply by advancing towards commercial-scale production. Our efforts use the proven expertise and innovative approach demonstrated in the successful development and commercialization of U.S.-produced, non-uranium molybdenum-99 (Mo-99) to generate technetium-99m. NorthStar is pleased to sign this agreement with Clarity Pharmaceuticals, and we look forward to supporting its plans for further clinical development and commercialization of Cu-67 based therapeutic radiopharmaceuticals to improve the lives of patients with serious disease."

"Consistent with other NorthStar production processes, the Cu-67 production process is also environmentally friendly and non-uranium based," said James T. Harvey, PhD, Senior Vice President and Chief Science Officer of NorthStar Medical Radioisotopes. "Cu-67 has an optimal half-life for a therapeutic radiopharmaceutical, is produced domestically in the United States without a nuclear reactor, has no long-lived contaminants or bi-products from the manufacturing process, and its starting material, zinc, is readily available. As opposed to other therapeutic isotopes in the market and under development, Cu-67 is ideally suited for commercial production to meet the growing demand for radiopharmaceuticals in large disease indications and we look forward to meeting Clarity’s anticipated future demands as it develops and commercializes its suite of products."

"Clarity leads the world in the development and commercialization of TCT," said Alan Taylor, PhD, Executive Chairman of Clarity Pharmaceuticals. "Access to large, commercial supply of Cu-67 at a suitable price-point enables us to apply our TCT approach not only to rare diseases such as neuroblastoma in children, but also other cancers with very large patient populations such as prostate and breast cancers. In essence, the availability of large scale production of Cu-67 in the United States will increase the speed of Clarity’s clinical trials across our SARTATETM, SAR-bisPSMA, SAR-Bombesin and discovery programs and will help us to achieve our ultimate goal of better treating children and adults with cancer."

About Copper-67 (Cu-67)

Copper-67 (Cu-67) is a short-range, beta-emitting radioisotope that is attractive for medical purposes due to its ability to carry sufficient radiation energy to cause cell death in targeted cells while having a sufficiently short half-life to limit unwanted radioactivity in patients. Cu-67 is being investigated for therapeutic purposes across a wide range of adult and childhood cancers. Potential radiotherapeutic targets include prostate cancer, breast cancer, neuroendocrine tumors (NETs), neuroblastoma, glioma, lymphoma, ovarian, and bladder cancers. A chelator, which strongly binds Cu-67 to the targeting agent, is required to develop safe and effective targeted therapies. Clarity has successfully developed a highly specific and highly stable chelator for copper isotopes and is progressing a range of radiopharmaceuticals based on its proprietary SAR Technology Platform. NorthStar is developing a proprietary process for commercial-scale production of Cu-67 to meet demand for clinical research and treatment purposes.

On May 24, 2021 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported it has signed a definitive agreement to sell Myriad RBM, Inc. to Q2 Solutions, a leading global clinical trial laboratory services organization, and a wholly owned subsidiary of IQVIA (Press release, Myriad Genetics, MAY 24, 2021, View Source [SID1234580517]). Q2 Solutions provides comprehensive testing, project management, supply chain, biorepository, biospecimen and consent tracking solutions. Myriad RBM, which specializes in contract research services for the pharmaceutical industry, will be added to the overall Q2 Solutions menu and offerings.

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"Our agreement with Q2 Solutions provides a good home for Myriad RBM teammates, delivers strong value, and provides significant capital for future growth," said Paul J. Diaz, president and CEO of Myriad Genetics. "The divestiture of Myriad RBM, along with other announced divestitures, allows us to accelerate the execution of our transformation plan and focus on advancing our core businesses in Women’s Health, Oncology and Mental Health."

The deal is subject to customary closing conditions, and Myriad expects the transaction to close in the third calendar quarter.
Cowen is acting as exclusive financial advisor and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is acting as legal advisor to Myriad Genetics.

On May 24, 2021 Scopus BioPharma Inc. (Nasdaq: "SCPS") reported the approval of an investigational new drug application ("IND") by the United States Food and Drug Administration ("FDA") for CpG-STAT3siRNA, the company’s distinctive immuno-oncology RNA therapy for the treatment of multiple cancers (Press release, Scopus BioPharma, MAY 24, 2021, View Source [SID1234580515]).

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A Phase 1 clinical trial for B-cell non-Hodgkin lymphoma will be initiated at City of Hope.

Scopus is a biopharmaceutical company developing transformational therapeutics based on groundbreaking scientific and medical discoveries. City of Hope is a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases near Los Angeles, California.

CpG-STAT3siRNA encompasses both RNA therapy and immunotherapy by synthetically linking siRNA to an oligonucleotide TLR9 agonist, creating the potential for targeted gene silencing with simultaneous TLR stimulation and immune activation in the tumor microenvironment. This highly-distinctive drug candidate was developed in the City of Hope laboratories of Hua Yu, Ph.D. and Marcin Kortylewski, Ph.D. Yu is co-leader of the Cancer Immunotherapeutics Program and Billy and Audrey L. Wilder Professor in Tumor Immunotherapy. Kortylewski is a professor in the Department of Immuno-Oncology.