Selecta Biosciences and Ginkgo Bioworks Announce Partnership to Advance Treatments for Orphan and Rare Diseases

On October 26, 2021 Selecta Biosciences, Inc. (Nasdaq: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, and Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming, reported a collaboration to design novel and improved enzymes with transformative therapeutic potential to advance treatments for orphan and rare diseases. This partnership leverages the unique platforms of both companies (Press release, Selecta Biosciences, OCT 26, 2021, View Source [SID1234593960]).

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"We are excited to partner with Ginkgo and expect that our ImmTOR technology, in combination with Ginkgo’s high throughput enzyme discovery, design, and screening capabilities will bring us one step closer to improving the sustained efficacy of novel biologic therapeutics," said Carsten Brunn, PhD, CEO at Selecta Biosciences. "Further, this collaboration builds on extensive preclinical as well as strong clinical data from Selecta’s Phase 2 COMPARE trial for the treatment of chronic refractory gout that further supports ImmTOR’s potential for sustained therapeutic benefit when combined with immunogenic enzymatic therapies. We look forward to expanding our pipeline and ultimately delivering on our shared mission to improve the lives of patients in need."

Jason Kelly, CEO at Ginkgo Bioworks, commented, "Ginkgo works with a growing list of industry leaders that are addressing outstanding medical challenges with diverse therapeutic modalities, and we are thrilled to partner with Selecta in an effort to discover, engineer, and develop next generation therapeutic enzymes. We are excited to support Selecta in its mission to improve the quality of life for patients with unmet medical needs by expediting and maximizing Selecta’s capabilities."

Under the terms of the collaboration, Ginkgo is eligible to earn upfront research and development fees and milestones, including certain milestone payments in the form of Selecta common stock, clinical and commercial milestone payments of up to $85M in cash, as well as further downstream value in the form of royalties on sales.

Istari Oncology Enters Into Manufacturing Agreement With FUJIFILM Diosynth Biotechnologies to Advance its Viral Immunotherapy PVSRIPO

On October 26, 2021 FUJIFILM Diosynth Biotechnologies (FDB) and Istari Oncology reported that they have entered into an agreement for the manufacturing of Istari Oncology’s viral immunotherapy, PVSRIPO, currently being investigated for the treatment of solid tumors (Press release, Istari Oncology, OCT 26, 2021, View Source [SID1234593959]).

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FUJIFILM Diosynth Biotechnologies is a leading Contract Development and Manufacturing Organization (CDMO) with experience in the development and manufacture of recombinant biopharmaceuticals and viral gene therapies. Istari Oncology is a clinical-stage biotechnology company focused on novel immunotherapies for the treatment of solid tumors.

Istari Oncology selected FUJIFILM Diosynth Biotechnologies as its partner for drug substance manufacturing and filling of its recombinant viral immunotherapy PVSRIPO, which is based on the Sabin Type 1 poliovirus vaccine. Drug substance manufacturing and filling will be carried out in FUJIFILM Diosynth Biotechnologies’ state-of-the-art cGMP manufacturing facility in College Station, Texas. Manufacturing at FDB will support Istari Oncology’s three ongoing clinical trials being conducted across six potential indications including glioblastoma, melanoma, bladder cancer, and head and neck cancer, as well as studies planned in the future.

"Our decision to collaborate with FUJIFILM Diosynth Biotechnologies on the manufacturing of PVSRIPO has already paid off in multiple ways," said Jamie Iudica, chief manufacturing officer, Istari Oncology. "Despite manufacturing constraints other biotechnology companies have experienced due to the pandemic, FDB has demonstrated a patient focused mindset and has continued to support Istari by working tirelessly to identify and mitigate supply risks for our clinical trials."

"We are proud of our role as a manufacturing partner to Istari Oncology. Supporting the supply of potential therapies to oncology patients is at the core of what we do every day," said Gerry Farrell, chief operating officer, FUJIFILM Diosynth Biotechnologies, Texas site. "Our entire FDB team is honored to be playing a critical part of the clinical journey of PVSRIPO."

About PVSRIPO
PVSRIPO is an investigational immunotherapy based on the live attenuated Sabin type 1 poliovirus vaccine that has been genetically modified for safety. PVSRIPO targets cells using the poliovirus receptor CD155, which is widely expressed on both the malignant cells of most solid tumors and key antigen-presenting cells (APCs) within the tumor microenvironment. PVSRIPO targets tumors using three key mechanisms: 1) engagement and activation of APCs, leading to T cell priming and sustained, systemic anticancer immunity; 2) direct tumor cell killing and antigen release; and 3) amplification of the immune response via recall of poliovirus vaccine-specific T cells. PVSRIPO has been granted Breakthrough Therapy and Orphan Drug Designation status by the U.S. Food and Drug Administration in recurrent glioblastoma, and Fast Track and Orphan Drug Designation status in refractory melanoma.

Gastrologix and Cardinal Health Specialty Solutions Announce Agreement to Provide Distribution Services to GPO Members

On October 26, 2021 Cardinal Health Specialty Solutions and Gastrologix, the only gastroenterology (GI)-specific group purchasing organization (GPO) in the United States, working in conjunction with the Digestive Health Network (DHN), reported an agreement which designates Cardinal Health’s Metro Medical business as the primary supplier of pharmaceutical products for Gastrologix GPO and DHN members, providing expanded access to critical medicines for GI patients nationwide (Press release, Cardinal Health, OCT 26, 2021, View Source [SID1234593958]).

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"Gastrologix is a leader in providing technology and practice management solutions to the GI market. We are excited to marry their solutions with our best-in-class distribution capabilities to support the unique needs of independent gastroenterology practices, enabling providers to focus their time on positively impacting patient care," said Dan Duran, Senior Vice President and General Manager, Provider Solutions, Cardinal Health Specialty Solutions.

"Independent GI practices face many challenges in working to provide high quality care at lower costs. The members of our GPO deal daily with healthcare consolidation, rising costs and declining reimbursements, " said Stephen Somers, Principal at Gastrologix. "Cardinal Health Specialty Solutions is the perfect partner because they believe in tailoring programs to the individual needs of a practice and its patients. We look forward to working with them to provide our members with optimal contract pricing on specialty medications, as well as data analytics and specialized expertise. Our partnership with Cardinal Health will help our member practices thrive."

Cardinal Health has one of the largest healthcare supply chains in the U.S. with strategically located distribution centers that enable fast and efficient delivery anywhere in the U.S. Through Specialty Solutions, Cardinal Health supports community-based practices across the nation with specialties in oncology, urology, nephrology, rheumatology, gastroenterology, ophthalmology, neurology, and immunology.

Trillium Securityholders Approve Acquisition by Pfizer

On October 26, 2021 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL) ("Trillium" or the "Company") reported that its securityholders approved a statutory arrangement with PF Argentum ULC ("PF Argentum") a wholly-owned, indirect subsidiary of Pfizer Inc. (NYSE: PFE) ("Pfizer") at the special meeting of Trillium securityholders (Press release, Trillium Therapeutics, OCT 26, 2021, View Source [SID1234592006]). Pursuant to the arrangement, PF Argentum will acquire all of the issued and outstanding shares and warrants of Trillium, other than Trillium securities owned by Pfizer and its affiliates.

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The special resolution approving the arrangement was approved by: (i) 99.61% of the votes cast by Trillium shareholders voting as a single class present in person or represented by proxy and entitled to vote at the meeting; and (ii) 99.64% of the votes cast by Trillium shareholders and warrant holders, voting as a single class present in person or represented by proxy and entitled to vote at the meeting.

A non-binding resolution approving the compensation that may become payable to certain executive officers of Trillium in connection with the arrangement was also approved by 97.11% of the votes cast by holders of Trillium common shares present in person or represented by proxy at the meeting.

Upon closing of the arrangement, Trillium shareholders other than Pfizer and its affiliates will receive US$18.50 per share in cash subject to any applicable withholdings and other source deductions, and warrant holders will receive, at the holder’s election, (1) a cash payment equal to the amount by which US$18.50 exceeds the exercise price per share of such warrant, subject to applicable withholdings and other source deductions, or (2) a cash payment equal to the Black Scholes value of such warrant (as calculated pursuant to the terms and conditions of the certificate governing such warrant), subject to applicable withholdings and other source deductions.

The arrangement is subject to court and regulatory approvals and clearances, as well as other customary closing conditions. Subject to the satisfaction of such conditions, the transaction is expected to be completed in the fourth quarter of 2021 or the first half of 2022.

Evotec SE: Translational BRIDGE beLAB2122 in collaboration with Bristol Myers Squibb identifies first project

On October 26, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported the first project to be developed within beLAB2122, a collaboration between Evotec and Bristol Myers Squibb (Press release, Evotec, OCT 26, 2021, View Source;announcements/press-releases/p/evotec-se-translational-bridge-belab2122-in-collaboration-with-bristol-myers-squibb-identifies-first-project-6110 [SID1234591992]). beLAB2122 aims to bring together leading academic institutions from the Rhine-Main-Neckar region of Germany with the goal of efficiently advancing first-in-class therapeutic options across all therapeutic areas and formats into investable drug discovery and early development projects. After signing the beLAB2122 collaboration agreement in April 2021, the first project to be developed within this academic BRIDGE collaboration has now been nominated.

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Originating in the laboratory of Dr Darjus Tschaharganeh, Group Leader at the German Cancer Research Center ("DKFZ"), Heidelberg, and Professor at Heidelberg University, the project is based on the observation of synthetic lethal interactions in certain cancer types and aims at the development of small molecule inhibitors of a nutrient transporter essential for the survival of these cancer cells.

beLAB2122 will now leverage Evotec’s integrated discovery and development platform to validate and develop the project further. The goal of beLAB2122 is to develop academic projects to value inflection points that allow the formation of new jointly owned spin-off companies.

Dr Thomas Hanke, EVP & Head of Academic Partnerships at Evotec, commented: "We are pleased to further explore the promising approach from the DKFZ and Heidelberg University as the first funded project of beLAB2122. Evotec’s BRIDGE collaborations aim at seamlessly integrating academic innovations into the pharmaceutical value chain and accelerating them to new company formations. We look forward to progressing this and many more interesting academic projects using Evotec’s highly efficient integrated drug discovery & development infrastructure called the ‘Data-driven R&D Autobahn to Cures’. At the same time, we are pleased to receive additional promising applications from scientists working within the beLAB2122 member institutions at the EMBL, the German Cancer Research Center, the Goethe University Frankfurt, Heidelberg University and Tübingen University, and are looking forward to expanding the scope of the project portfolio further."

Dr Darjus Tschaharganeh, Group Leader at the German Cancer Research Center (DKFZ) and Professor at Heidelberg University, added: "We are excited to be chosen as the first beLAB2122 project and to be part of the collaboration bridge. Our project evolved from fundamental basic research and we are now at a point that our results clearly illustrate that pharmacological inhibitors for this target could be very successful for cancer treatment. The beLAB2122 initiative with strong pharmaceutical partners is ideally suited to pursue this project. We are looking forward to a close interaction with Evotec and Bristol Myers Squibb and hope that we can find potent inhibitors for our target in order to get to the next step and hopefully will be able to bring this in the future to the clinics for the benefit of patients."

beLAB2122 is backed by Evotec in collaboration with Bristol Myers Squibb. The total volume of US$ 20 m will allow for several more funding rounds. For more information on beLAB2122, visit www.belab2122.org.