GlyTherix and Adcendo Announce Agreement for Development of Antibody Drug Conjugate

On December 20, 2022 GlyTherix Ltd ("GlyTherix"), an Australian immuno-oncology company reported an MTA & Option License with Adcendo ApS ("Adcendo"), a Danish biotech company focused on the development of breakthrough antibody-drug conjugates (ADCs) for the treatment of underserved cancers, to develop an Antibody Drug Conjugate (ADC) against the innovative solid tumor target GPC-1 (Press release, Glytherix, DEC 20, 2022, View Source [SID1234625402]).

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Under the terms of the agreement, Adcendo’s planned pre-clinical ADC development program will be based on GlyTherix’s lead anti-GPC-1 monoclonal antibody, Miltuximab.

Brad Walsh, CEO of GlyTherix, said: "Initial studies have demonstrated a strong patient safety profile with no adverse events from relevant doses of the antibody. We are very excited to be partnering with Adcendo to further develop our antibody candidate. Successful pre-clinical studies have the potential to lead to a licensing agreement to clinically develop and globally commercialize the anti-GPC-1 ADC for several hard-to-treat solid tumor indications."

Michael Pehl, CEO of Adcendo, said: "We are delighted to be partnering with GlyTherix as we continue to develop ADCs for the treatment of underserved cancers. The GlyTherix team has accomplished outstanding work in ensuring a deep understanding of the target in solid tumors and developing Miltuximab. GPC-1 is a highly suitable target for ADCs and our collaboration is a great opportunity to bring a novel treatment option to patients with hard-to-treat solid tumor cancers while we are building and advancing a pipeline of highly differentiated ADCs at Adcendo."

Bioasis Technologies Inc. Announces Amendments to Arrangement Agreement with Midatech Pharma plc

On December 19, 2022 BIOASIS TECHNOLOGIES INC. (OTCQB:BIOAF; TSX.V:BTI) (the "Company" or "Bioasis"), a multi-asset rare and orphan disease biopharmaceutical company developing clinical stage programs based on epidermal growth factors and a differentiated, proprietary xB3 platform for delivering therapeutics across the blood-brain barrier ("BBB") and the treatment of central nervous system ("CNS") disorders in areas of high unmet medical need, reported the following amendments to the terms of the previously announcement arrangement agreement with Midatech Pharma plc (NASDAQ:MTP; AIM:MTPH) ("Midatech") (Press release, Bioasis Technologies, DEC 19, 2022, View Source [SID1234625696]):

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Midatech is no longer required to seek delisting from AIM following completion of the arrangement; and
the US$750,000 bridge loan to be provided by Midatech to Bioasis will now be advanced in three equal tranches of US$250,000 (on December 19, 2022, January 3, 2023 and February 6, 2023) instead of the entire amount being advanced immediately, as previously contemplated.

GlyTherix and Adcendo Announce Agreement for Development of Antibody Drug Conjugate

On December 19, 2022 GlyTherix Ltd ("GlyTherix"), an Australian immune-oncology company reported an MTA & Option License with Adcendo ApS ("Adcendo"), a Danish biotech company focused on the development of breakthrough antibody-drug conjugates (ADCs) for the treatment of underserved cancers, to develop an Antibody Drug Conjugate (ADC) against the innovative solid tumor target GPC-1 (Press release, ADCendo, DEC 19, 2022, View Source [SID1234625597]).

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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

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Under the terms of the agreement, Adcendo’s planned pre-clinical ADC development program will be based on GlyTherix’s lead anti-GPC-1 monoclonal antibody, Miltuximab.

Brad Walsh, CEO of GlyTherix, said: "Initial studies have demonstrated a strong patient safety profile with no adverse events from relevant doses of the antibody. We are very excited to be partnering with Adcendo to further develop our antibody candidate. Successful pre-clinical studies have the potential to lead to a licensing agreement to clinically develop and globally commercialize the anti-GPC-1 ADC for several hard-to-treat solid tumor indications."

Michael Pehl, CEO of Adcendo, said: "We are delighted to be partnering with GlyTherix as we continue to develop ADCs for the treatment of underserved cancers. The GlyTherix team has accomplished outstanding work in ensuring a deep understanding of the target in solid tumors and developing Miltuximab. GPC-1 is a highly suitable target for ADCs and our collaboration is a great opportunity to bring a novel treatment option to patients with hard-to-treat solid tumor cancers while we are building and advancing a pipeline of highly differentiated ADCs at Adcendo."

Entry into a Material Definitive Agreement

On December 19, 2022, ITI Limited, a wholly-owned subsidiary of Intra-Cellular Therapies, Inc. (the "Company"), reported that it has entered into Amendment No. 1 (the "Amendment") to the Master Services Agreement dated as of January 10, 2017 (the "MSA") by and between Lonza Ltd ("Lonza") and ITI Limited, to, among other items, extend the current term of the MSA until December 31, 2028 and provide for certain minimum annual purchase commitments by the Company for the years 2025 through 2028 for Lonza’s manufacture of CAPLYTA (Filing, 8-K, Intra-Cellular Therapies, DEC 19, 2022, View Source [SID1234625541]).

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The foregoing summary of the Amendment does not purport to be complete and is qualified in its entirety by reference to the Amendment, a copy of which will be attached as an exhibit to the Company’s Annual Report on Form 10-K for the year ending December 31, 2022.

Fujifilm Announces Asset Purchase Agreement with Inspirata, Inc. to acquire the company’s Digital Pathology Business

On December 19, 2022 FUJIFILM Corporation (President and CEO, Representative Director: Teiichi Goto) reported the company has entered into an asset purchase agreement to acquire the global digital pathology business of Tampa, Florida-based Inspirata, Inc. Upon completion of this agreement, Inspirata’s Dynamyx digital pathology technology, employees and customers will become part of Fujifilm (Press release, Fujifilm, DEC 19, 2022, View Source [SID1234625537]). The addition of digital pathology will expand Fujifilm’s robust Synapse Enterprise Imaging offering to enable the integration of pathology images and data into a healthcare organization’s electronic health record system and help to streamline care delivery for oncology patients and provider teams.

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Building off the success of its established partnership with Inspirata, this acquisition marks Fujifilm’s full-scale, global entry into the largely unpenetrated digital pathology market, where 85% of U.S., 86% of European, and 90% of Asian healthcare organizations are still running on analog.

"Acquiring Inspirata’s digital pathology business allows Fujifilm to be an even stronger healthcare partner – bridging a technological gap between pathology, radiology and oncology to facilitate a more collaborative approach to care delivery across the enterprise," says Teiichi Goto, president and CEO, representative director, FUJIFILM Corporation. "We’re thrilled to welcome Inspirata’s digital pathology experts to Fujifilm’s growing medical informatics business, along with their renowned global customer base, as together we work to drive the digitization and advancement of healthcare."

Dynamyx is an open, vendor-agnostic, end-to-end digital pathology solution. Dynamyx’s software capabilities include using whole slide images from multiple scanning vendors to create an easier path for more pathology labs to digitize and realize the benefits of faster patient results, centralized imaging records, and enterprise access to images for all clinicians. It is installed in medical facilities that handle large volumes of pathological images across multiple lab locations, allowing the use of their preferred mix of laboratory and diagnostic technologies with confidence of full compatibility. According to a recent DeciBio article, Dynamyx is shown to have one of the largest partnership networks in the digital pathology space.

It will become part of Fujifilm’s Synapse Enterprise Imaging portfolio – an award-winning suite of healthcare IT solutions that unify imaging, data access and workflows across the health system. With the addition of digital pathology, Fujifilm will offer one of the most comprehensive enterprise imaging portfolios on the market consisting of a Best in KLAS winning VNA, Radiology PACS, and Cardiology PACS, as well as an enterprise information system, cloud services, and 3D advanced visualization. Future releases of Dynamyx will also create opportunities for Fujifilm to support pharmaceutical and contract research organizations with toxicity testing data management for drug development.

"A $320 million global industry in 2021 projected to reach $640 million* by 2025, the rising number of cancer cases and the demonstrated benefits of digital pathology are fueling significant demand and market growth in the hospital and pharmaceutical industries," says Henry Izawa, president and CEO, FUJIFILM Healthcare Americas Corporation. "These evolving clinical needs fuel Fujifilm’s investment and innovation in the digital revolution, and we look forward to introducing Dynamyx and its host of unique features and benefits to our Synapse customers and prospects as we strive to enable more efficient medical diagnosis and high-quality care."

"Since launching our European partnership with Inspirata three years ago, we’ve seen great success implementing our combined technologies in several healthcare organizations, notably in the UK," says Masa Fukumoto, managing director, FUJIFILM Healthcare Europe and senior vice president FUJIFILM Medical Systems Europe. "We’ve received feedback from customers anticipating digitizing pathology will be the most transformative thing they do for their practice, and we look forward to continuing our global expansion."

Digital pathology is the digitization of pathology slides to conduct software visualization analysis of a specimen rather than using microscopic slides. With a specialty as image and data heavy as pathology, digitization is key. Pathologists, clinicians, patients, researchers and biopharma companies alike may see benefits such as improved and more efficient workflows, enhanced collaboration, remote and centralized interpretation, faster patient results, overall cost savings, ROI, and increased precision of diagnosis. Fujifilm’s existing partnership with Inspirata has demonstrated success in implementing these benefits for several global healthcare organizations.

Dynamyx has been cleared and/or approved for use in the U.S., Canada, Europe and the UK by each region’s regulatory agency. Dynamyx technology ownership and ongoing development and engineering will be led in the U.S. by FUJIFILM Healthcare Americas Corporation and licensed to other regions. Timing for the completion of the transaction is subject to closing conditions and is scheduled for early 2023. Terms of the agreement have not been disclosed.