1stOncology™: Cancer Intelligence Service – Page 8217 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Clarity and Cardinal Health enter into Agreement for Targeted Copper Theranostics

On December 2, 2021 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address the growing needs in oncology, and Cardinal Health (NYSE: CAH), reported that the companies have entered into an agreement covering Clarity’s Targeted Copper Theranostics (TCT) platform (Press release, Clarity Pharmaceuticals, DEC 2, 2021, View Source [SID1234596385]).

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!

Cardinal Health will provide cGMP product manufacturing of ready-to-use TCT for Clarity’s U.S.-based clinical trials from its Center for Theranostics Advancement in Indianapolis, Indiana. TCT are investigational radiopharmaceuticals that pair copper-64 (64Cu) and copper-67 (67Cu) for diagnosis and therapy.

With more than 40 years of experience in the radiopharmaceutical industry, Cardinal Health provides radiopharmaceutical development support, manufacturing, preparation, commercialization, and business and practice management solutions across the care delivery continuum from origin to patient administration. Its Center for Theranostics Advancement is helping shape the future of precision medicine by providing radiopharmaceutical innovators the solutions they need at every stage of the product lifecycle.

Clarity’s Executive Chairman, Dr Alan Taylor, said, "We are pleased to have further strengthened and expanded our U.S. manufacturing capabilities, ensuring seamless product supply for our clinical trials, including those in cancer indications with large patient populations. Cardinal Health has an intricate understanding of the supply chain requirements for copper-based products and the capability to mass-produce these products.

"This is a testament to Clarity’s pairing of copper isotopes fitting into the ‘goldilocks zone’ of half-lives when considering biological half-life of the targeting moieties, centralized manufacture, and broad distribution. The half-life of copper-64 is nearly identical to that of iodine-123, for which Cardinal Health has an established and robust distribution system across the U.S. For the therapeutic isotope copper-67, centralized distribution is well proven in an isotope of comparable half-life, yttrium-90, or the much shorter half-life of samarium-153."

Cardinal Health Nuclear & Precision Health Solutions President Mike Pintek, said, "We are excited to be working together with Clarity on the manufacturing and pharmacy dispensing of the TCT platform of investigational products. The 64Cu and 67Cu isotope pairing holds great promise for the field of radiopharmaceuticals as they are ideally suited for central manufacturing of cGMP ready-to-use products; they will fit easily within our broad distribution network. We are very pleased to enter this agreement and hope it will be another avenue for us to help improve access to next-generation radiopharmaceuticals for diagnosis and treatment of a range of cancers."

Dr Alan Taylor said, "Clarity’s TCT platform is clearly differentiated in the radiopharmaceutical field as all products, once approved by the FDA, can be provided as ready-to-use to patients in any location in the U.S. from a single manufacturing site. The manufacturing agreement with Cardinal Health, in addition to the recent manufacturing agreement signed with Evergreen Theragnostics and other partners, will enable Clarity to create redundancies in the supply of our products – ensuring that we can provide a reliable, seamless supply of TCT that is unique for a company in the radiopharmaceutical field. This agreement further enables Clarity to continue to pursue our ultimate goal of improving treatment of children and adults with cancer."

This announcement has been authorized for release by the Executive Chairman of Clarity Pharmaceuticals.

Astellas and Dyno Therapeutics Announce Research Collaboration to Develop Next-Generation AAV Gene Therapy Vectors for Skeletal and Cardiac Muscle

On December 1, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Dyno Therapeutics, Inc. (President and CEO: Eric Kelsic, Ph.D., "Dyno") reported an option and license agreement was signed on November 23 to develop next-generation adeno-associated virus (AAV) vectors for gene therapy directed to skeletal and cardiac muscle using Dyno’s CapsidMap platform (Press release, Astellas, DEC 2, 2021, View Source [SID1234596344]).

Dyno’s CapsidMap platform represents a transformative approach applying in vivo experimental data and machine learning to create novel AAV capsids – the cell-targeting protein shells of viral vectors – designed to optimize tissue targeting and immune-evading properties, in addition to improving packaging capacity and manufacturability. Unlike traditional approaches, CapsidMap is uniquely well-suited to simultaneously optimize capsids for delivery across multiple organs, with the goal of enabling more effective whole-body treatment for many diseases.

With the establishment of the Astellas Gene Therapies Center of Excellence following the 2020 acquisition of Audentes Therapeutics Inc., Astellas is a leader in genetic medicines, working alongside its world-renowned partners to build a portfolio of potentially life-changing gene therapies. This research collaboration combines Dyno’s AI-powered AAV vector engineering capabilities with Astellas Gene Therapies global leadership in AAV-based pipeline assets.

"Through our efforts in gene therapy and the Astellas Gene Therapies Center of Excellence, Astellas strives to identify, develop and deliver transformative gene-based therapies for patients with genetic diseases who currently have few or no effective treatment options. Our principal focus is on developing adeno-associated virus delivered therapies for the treatment of well-defined serious diseases," said Naoki Okamura, Chief Strategy Officer and Chief Financial Officer, Chief Business Officer at Astellas. "We are dedicated to delivering novel approaches and utilizing new technologies that can deliver transformational value for patients."

"We are so happy to be partnering with Astellas, a world leader in developing gene therapies. Dyno and Astellas each bring unique strengths to this collaboration, together enabling more rapid creation of new therapies for patients with great unmet need," said Dyno’s CEO and co-founder Eric D. Kelsic, Ph.D. "This partnership demonstrates the flexibility of Dyno’s platform to precisely design the delivery properties of gene therapy vectors towards multi-organ and disease-specific profiles, applying the scientific insights we are rapidly learning across all our partnered and internal vector engineering programs using CapsidMap."

Under the terms of the agreement, Dyno will design novel AAV capsids with improved functional properties for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities, including manufacturing, of gene therapy product candidates using the novel capsids. Dyno will receive an $18 million upfront payment and be eligible to receive additional payments during the research phase of the collaboration as well as clinical and sales milestone payments and royalties for any resulting products. The aggregate potential value of future milestone and royalty payments to Dyno exceeds $235 million per product and over $1.6 billion in total value.

C-Biomex and Triore sign PDC joint development agreement

On December 1, 2021 C-BioMex, a company specializing in the development of new peptide drugs, and Triore, an innovative company in novel antibody-drug conjugates, reported that they have signed a joint development agreement for a next-generation PDC drug utilizing both companies’ proprietary platform technologies.

Under this agreement, we plan to discover PDC candidate substances for two anticancer targets by utilizing CUSTM, a chemical-based peptide discovery platform technology from C-BioMex, and SIGT, a linker-toxin platform technology developed in-house by Triore.

Now that initial verification of the platform technologies of both companies has been completed, we aim to proceed with research and development rapidly and finalize candidate substances within two years.

Triore linker-toxin technology is a technology that can enhance the efficacy and safety of various therapeutic agents through a safe structure that is very stable in the blood and releases drugs only in specific environments.

The two companies plan to develop a PDC with both global competitiveness and marketability by applying triore linker-toxin technology to two target peptides that were discovered through C-BioMex’s proprietary platform technology (CUSTM) and demonstrated high binding affinity and selectivity in in-vivo models.

"With this contract, we have expanded our company’s research scope from existing peptide-based radiotherapeutics to drug conjugates," said C-BioMex CEO Cha Jun-hoe. "We are very pleased to collaborate with Triore, which possesses expertise in the linker-toxin field, and we have high expectations that we can develop an excellent PDC based on the expertise and passion of both companies."

"Through this research agreement, we look forward to developing a safe and highly effective PDC by combining C-BioMex’s expertise in the peptide field with our technology," said Woo Seong-ho, CEO of Triore. "We will cooperate closely with both companies to ensure the rapid development of new therapeutic agents."

(Press release, TriOar Biotechnology, DEC 1, 2021, View Source;idx=1 [SID1234664782])

ZetaMet™ (Zeta-BC-003) Receives Breakthrough Device Designation from U.S. Food and Drug Administration (FDA) for Treatment of Metastatic Bone Cancers

On December 1, 2021 Zetagen Therapeutics, a private, clinical-stage, biopharmaceutical company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and osteologic interventions, reported it has received Breakthrough Device designation from the Centers for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) for its ZetaMet (Zeta-BC-003) technology (Press release, Zetagen Therapeutics, DEC 1, 2021, View Source [SID1234643705]). Previously known as ZetaFuse, ZetaMet (Zeta-BC-003) is a synthetic, small-molecule, inductive biologic technology being developed to target and resolve metastatic bone lesions while inhibiting future tumor growth and regenerating bone.

"We are pleased to receive this important designation from the Agency and look forward to partnering with them," said Joe C. Loy, CEO of Zetagen Therapeutics. "Our researchers have discovered an entirely new pathway for an established molecule which, if proven successful in human clinical trials, could create a new treatment paradigm for the hundreds of thousands of patients living with cancers that involve metastatic bone lesions."

ZetaMet (Zeta-BC-003) works through a mechanism of action (MOA) which is a novel and patented molecular pathway. The small molecule, precisely-dosed, delivered to the affected area through a proprietary drug-eluting carrier, stimulates stem cells, activating cells to grow healthy bone known as "osteoblasts", and inhibits cells associated with bone degradation called "osteoclasts". The combination technology has, thus far, in preclinical studies, demonstrated its ability to resolve existing metastatic bone lesions, inhibit pain and stimulate targeted bone regeneration.

Bone metastases are common among cancer patients and occur when cells from the primary cancerous tumor relocate to the bone. When these cancers relocate, they can cause changes to the bone, damaging it in a process called osteolysis. Osteolysis can cause small holes within the bone, weakening it and increasing the risk of breakage. These holes are called "lytic lesions." Among cancers which metastasize to bone, Breast and Prostate are most prevalent, amounting to approximately 70-percent of cases.[1]

ZetaMet (Zeta-BC-003) has successfully passed its preclinical trials and is being prepared for its first human clinical trial in early 2022.

Accropeutics Bioscience inks over $50M series B round

On December 1, 2021 Accro Bioscience (Suzhou) Limited ("Accropeutics Bioscience"), a China-based leadingbiotechnology company, reported that the company has recently raised over $50 million in an oversubscribed Series B round (Press release, Accro Bioscience, DEC 1, 2021, View Source [SID1234632773]). The financing was led by HongtaiAplus with participation from South China Venture Capital, Shenzhen Capital Group, Suzhou Oriza Holdings, and others.

"Accropeutics Bioscience will leverage the funds to advance clinical development, pre-clinical research and international partnerships," said Dr. Xiaohu Zhang, co-founder and CEO of Accropeutics Bioscience, "We are very pleased with the support and confidence of our current and new investors."

"We appreciate the R&D and execution capabilities of the team, and look forward to the continuous breakthroughs of Accropeutics Bioscience in the future," said Morningside.

"We are optimistic about the development of Accropeutics Bioscience," said HongtaiAplus, "We are delighted to lead this round of financing and look forward to the in-depth cooperation with Accropeutics Bioscience in the future."