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]).

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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.

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.

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"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.

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.

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"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."

On December 1, 2021 Molecular Targeting Technologies, Inc. (MTTI) and Evergreen Theragnostics, Inc., reported an agreement in which Evergreen will manufacture MTTI’s EvaThera platform of radiopharmaceuticals (Press release, Molecular Targeting Technologies, DEC 1, 2021, View Source [SID1234632260]).

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The EvaThera platform is a new generation of Evans blue-based molecules with strong affinity for albumin, which extends the blood half-life of the radiopharmaceutical, potentially leading to improved outcomes. MTTI’s leading pipeline candidates are both Lu-177 based radiotherapeutics: EBTATE, targeting neuroendocrine and other SSTR2 expressing tumors, and EBRGD, targeting integrin expressing cancers like glioblastoma multiforme.

"The Evergreen team brings deep experience in manufacturing and nationwide distribution of Lu-177 products. This agreement is key to a robust and reliable supply in North America for our upcoming clinical trials and beyond," said Chris Pak, President & CEO of MTTI.

Evergreen will manufacture MTTI clinical supplies from its newly commissioned facility in Springfield, NJ and will leverage the team’s broad experience with Lu-177 based radiotherapeutics by providing comprehensive supply chain management from isotope sourcing to drug delivery at the clinical trial site.

"We are very pleased to support MTTI by providing quality GMP manufacturing for their very promising platform of products. The technology behind the EvaThera platform has the potential to make a meaningful improvement in the lives of patients," said James Cook, President & CEO of Evergreen.

On December 1, 2021 Propella Therapeutics, Inc. reported that Presented at the MedInvest Oncology Conference on December 7, 2021 (Press release, Propella Therapeutics, DEC 1, 2021, https://propellatx.com/2021/12/01/presentation-forthcoming-medinvest-oncology-conference-december-7-10-2021/ [SID1234596636]).

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