OpenBench and Tavros Therapeutics Announce Collaboration to Pursue First-in-class Cancer Target

On December 2, 2021 Tavros Therapeutics, a privately held biotechnology company discovering first-in-class cancer therapies, and OpenBench, an emerging leader in AI-enabled small molecule discovery, reported a collaboration in which OpenBench will identify novel, potent antagonists against an undisclosed cancer target that was identified by Tavros’s proprietary functional genomics platform (Press release, Tavros Therapeutics, DEC 2, 2021, View Source [SID1234596421]).

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Under the terms of the agreement, OpenBench will receive payment for the identification and experimental confirmation of novel chemotypes that meet Tavros’s potency and developability criteria. In exchange, Tavros gains exclusive access to OpenBench’s proprietary screening technology with respect to the promising cancer target. Financial terms were not disclosed.

"Tavros is eager to identify quality hit molecules against this high-impact, first-in-class target, and we think OpenBench’s virtual screening platform is perfectly suited to accelerate our drug development timelines. We hope to continue this partnership and take on other promising drug targets identified by Tavros’s proprietary functional genomics discovery platform," said Tavros CEO Eoin McDonnell.

"We are excited to enrich Tavros’s efforts to make a breakthrough therapeutic discovery addressing a serious clinical need," said OpenBench CTO James Yoder. "We feel confident that the partnership will bear fruit and the OpenBench virtual screening platform will identify promising novel chemical material that maximizes the likelihood of Tavros’s success in lead optimization, translation, and clinical development campaigns."

OpenBench adds Tavros to a growing list of partners that includes HemoShear Therapeutics and two other undisclosed U.S.-based biotechnology companies.

Plus Therapeutics to Present at MedInvest Oncology Investor Conference

On December 2, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported that Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics, will present a company overview during the MedInvest Oncology Investor Conference on Tuesday, December 7th at 12:00 p.m. ET (Press release, Cytori Therapeutics, DEC 2, 2021, View Source [SID1234596403]).

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A webcast of the Company’s pre-recorded presentation, along with a live Q&A session, will be available under the ‘Events’ tab of the Investor Relations section of the Plus Therapeutics website at www.plustherapeutics.com or at https://bit.ly/3l2jsfW.

Leucid Bio and Lonza Enter Strategic Collaboration to Leverage the Cocoon® Platform for Automated Manufacturing of Personalised CAR T-Cells

On December 2, 2021 Leucid Bio ("Leucid" or the "Company"), a biotech company pioneering next-generation cell therapies for hard-to-treat cancers, reported that it has entered a strategic collaboration with Lonza to utilize Lonza’s Cocoon Platform for the Company’s forthcoming Phase I clinical trial, through to commercial manufacturing (Press release, Lonza, DEC 2, 2021, View Source [SID1234596422]).

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Under the terms of the collaboration, Leucid will utilise Lonza as its preferred manufacturer, aiming to deliver high quality cell therapies quickly and cost-effectively to patients in a decentralized manufacturing model. Leucid is, in turn, one of Lonza’s preferred collaborators on the Cocoon Platform, and both companies will work together to optimise and streamline the manufacturing process for Leucid’s CAR-T therapies. As a preferred collaborator, Leucid will have early access to new Cocoon Platform technologies.

Founded to translate 20 years of pioneering CAR-T research led by Dr John Maher at King’s College London, Leucid has developed a proprietary engine that builds upon Dr Maher’s novel parallel CAR-T model which positions these molecules in a more natural biological configuration. The Company’s technology confers properties on the CART-cells that enable them to consistently outperform previous generations of CAR-T therapies in pre-clinical studies. As a result, this leads to enhanced T-cell potency and persistent long-term response with reduced toxicity.

Artin Moussavi, Chief Executive Officer of Leucid Bio, said: "Following on from our successful Series A financing, we are delighted to be working with Lonza and its Cocoon Platform. This agreement will allow us to accelerate our path to the clinic, treating more patients sooner, potentially at point-of-care, and help to solve the key issues facing CAR-T therapeutics."

John Maher, Chief Scientific Officer of Leucid Bio, added: "This is a fantastic opportunity to collaborate with Lonza, enabling us to develop a state-of-the-art scalable manufacturing process. This will significantly help Leucid to efficiently transition our CAR-T pipeline for maximum patient benefit."

Nicholas Ostrout, Head of Commercial Development within Personalized Medicine at Lonza, commented: "We look forward to working with Leucid to bring its revolutionary, novel cancer immunotherapies to the clinic and patients. Use of the Cocoon Platform, coupled with the array of process development, manufacturing expertise and tools that Lonza brings, will provide a smooth route to commercial approval. By leveraging the Cocoon Platform’s unique capabilities, this collaboration aims to illustrate the promise and feasibility of manufacturing autologous immunotherapies in a decentralized model, into approved routine use."

CAR T-cell therapy is a revolutionary technology in which the patient’s own immune cells are reprogrammed so they can recognise and destroy cancer cells. This has proven to be a powerful therapy for refractory blood cancers, but has not yet been very effective for the treatment of solid tumours.

Leucid’s LEU-011 programme is a NKG2D-targeted CAR T-cell therapy in pre-clinical development for the treatment of solid tumours and haematological malignancies. The NKG2D receptor is an activating immune receptor that triggers cell death upon recognition of human NKG2D ligands expressed on transformed, infected or damaged cells. LEU-011 has potential for the treatment of multiple cancer types as NKG2D ligands are expressed on more than 80% of human tumour cells.

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]).

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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.

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]).

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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.