On July 7, 2022 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard-to-treat cancers, reported it has entered into a manufacturing agreement with Catalent Pharma Solutions LLC ("Catalent"), which will include cGMP manufacturing for the Company’s recombinant protein, Human DNase I (Press release, Xenetic Biosciences, JUL 7, 2022, View Source [SID1234616530]).

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Catalent is the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities.

"We are pleased to be working with a preeminent contract development and manufacturing organization such as Catalent, and to have the opportunity to leverage their broad expertise and successful track record with early-stage development through commercial manufacturing. We are excited to take this step forward on the path to the clinic and look forward to investigating systemic DNase as an adjunctive therapy for locally advanced or metastatic cancers," commented, Jeffrey Eisenberg, Chief Executive Officer of Xenetic.

"This agreement is an important step towards long-term collaboration betweenCatalent and Xenetic," added Vikalp Mohan, Global Vice President, Head of Drug Substance at Catalent Biologics. "We look forward to leveraging Catalent’s proven biomanufacturing expertise at our site in Madison, Wisconsin to support the advancement of Xenetic’s DNase clinical development program and accelerating their path to first-in-human studies."

Xenetic’s interventional DNase based oncology platform is aimed at improving outcomes of existing treatments, including immunotherapies. The Company exclusively licensed intellectual property for uses of DNases in cancer include systemic co-administration of DNases along with standard therapies, including chemotherapy, radiation and checkpoint inhibitors, or along with conventional chimeric antigen receptor (CAR) T therapies.

The DNase platform is designed to target neutrophil extracellular traps ("NETs"), which are weblike structures composed of extracellular chromatin coated with histones and other proteins. NETs are expelled by activated neutrophils, in response to microbial or pro-inflammatory challenges. However, excessive production or reduced clearance of NETs can lead to aggravated inflammatory and autoimmune pathologies, as well as creation of pro-tumorigenic niches in the case of cancer growth and metastasis.

The Company is working toward its planned first-in-human study to evaluate DNase combined with immune checkpoint inhibitors or chemotherapy.

On July 7, 2022 RefleXion Medical, a therapeutic oncology company pioneering the use of biology-guided radiotherapy (BgRT)* for all stages of cancer, reported a non-exclusive, worldwide licensing agreement with Mirada Medical (Press release, RefleXion Medical, JUL 7, 2022, View Source [SID1234616549]). The agreement allows for the integration of Mirada’s RegEngine image registration algorithms into the RefleXion X1 treatment planning software. The algorithms align patient anatomy between different imaging modalities or between radiotherapy treatments.

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"Day-of-treatment modifications, called adaptive radiotherapy, are critical for responding to changes in patient anatomy that occur as a result of cancer treatment, and to lowering toxicity to improve outcomes," said Thorsten Melcher, Ph.D., chief business officer at RefleXion. "In challenging patients, such as those with metastatic disease where more than one tumor may be treated, adaptation requires robust tools such as Mirada’s sophisticated RegEngine software, so that clinicians can quickly assess patient anatomy and, in the future their biology, to implement changes to the treatment plan.

"Mirada’s extensive industry experience and development expertise were key factors in our decision to pursue this agreement," continued Melcher.

Image registration is a complex series of algorithms that align the images of a patient’s anatomy taken at different points in time and using different imaging modalities. For radiation oncology, where millimeters matter in order to preserve healthy tissue, registration of the tumor target to be treated, as well as nearby anatomy to avoid, is critical. Precise targeting may also result in lowering toxicity, thereby improving outcomes for patients.

BgRT is designed to one day overcome the technical limitations of existing radiotherapy approaches by using a PET radiotracer to create a unified motion management solution for one or multiple tumors. As the PET tracer binds to tumor cells, it produces emissions that signal the cancer’s location. BgRT uses this real-time biological information to deliver a tracked radiation dose to the cancer. Integrating RegEngine into BgRT will allow clinicians to rapidly adapt the daily treatment plan by precisely registering images and image components crucial for treatment planning and dose calculation.

A difficult challenge occurs when the frames of reference of the images are similar, but the patient’s anatomy has changed from biological processes, such as breathing or digestion, or changes in position during the imaging procedures. To assist clinicians in accounting for these changes, RegEngine "warps" or "deforms" the images pixel by pixel, a process called deformable image registration.

"Our relationship with RefleXion is another example of our ability to work with cutting edge oncology companies," said Jon DeVries, CEO at Mirada. "RefleXion’s biology-guided radiotherapy has the potential to offer a new treatment option for patients with all stages of cancer, and we are excited and proud to have RegEngine selected as a key component of the treatment planning process in this exciting novel technology."

On July 7, 2022 Cardinal Health (NYSE: CAH) reported to release fourth-quarter and year-end financial results for its fiscal year 2022 on August 11, prior to the opening of trading on the New York Stock Exchange (Press release, Cardinal Health, JUL 7, 2022, View Source [SID1234616532]). The company will webcast a discussion of these results beginning at 8:30 a.m. Eastern.

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Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. (PRNewsfoto/Cardinal Health)

To access the webcast and corresponding slide presentation, visit Cardinal Health’s Investor Relations page. No access code is required. Presentation slides and a webcast replay will be available until August 10, 2023.

On July 7, 2022 SunHo BioPharmaceutical Co., Ltd. ("SunHo"), a clinical-stage leading biopharma in immunocytokines with full-set of capabilities from discovery to commercialization, reported that IAP0971 (PD1-IL15 immunocytokine) and IAE0972 (EGFR-IL10 immunocytokine), two first-in-class immunocytokines developed in-house for the treatment of locally-advanced or metastatic malignant tumors have entered Phase 1/2 clinical trials (Press release, SunHo BioPharmaceutical , JUL 7, 2022, View Source [SID1234616550]). The first patient has been dosed respectively in June.

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"We are excited for achieving this important milestone, which also marked the first step to what we hope will ultimately allow us to bring an innovative cancer immunotherapy to patients who otherwise do not respond to or become relapsed/refractory of current therapies", said Dr. Liusong Yin, the Executive President and Chief Science Officer of SunHo, "We focus on innovative immunocytokines to build the next leading global biopharma of immunotherapy, and to bring perceivable benefits and affordable medicine to patients worldwide, by innovation and collaboration."

About IAP0971

IAP0971 is the world’s first PD1-IL15 immunocytokine receiving IND approval from both FDA and NMPA. It was developed by SunHo based on their own proprietary and patented AICTM (Armed ImmunoCytokine) platform.

SunHo designed IAP0971 based on the deep understanding of the tumor microenvironment and limitations of current immunotherapy. On the one hand, IL15/IL15Rα complex in IAP0971 specifically binds to the IL2/15Rβ and IL2/15Rγ expressed on T cells and NK cells and promotes the proliferation and activation of T cells and NK cells, without activation of Treg cells or inducing apoptosis of activated T cells which are common side effects of IL2-based therapies. On the other hand, the expression of PD1 on CD8+ T cells in tumor microenvironment is much higher than that in peripheral blood and peripheral lymphoid organs, so that anti-PD1 antibody in IAP0971 can specifically target IL15 into the tumor immune microenvironment, to recruit, activate and reinvigorate immune cells, and achieve a much-enhanced anti-tumor immunity. IAP0971 fuses the anti-PD1 antibody and IL15 cytokine, acts in the same location and on the same cells at the same time showing great cis-synergy, which will further improve the effectiveness and therapeutic window of IAP0971.

The indications of IAP0971 include lung cancer, cervical cancer, head and neck squamous cell carcinoma, liver cancer, lymphoma, and other locally-advanced or metastatic malignant tumors.

About IAE0972

IAE0972 is the world’s first EGFR-IL10 immunocytokine receiving IND approval from both FDA and NMPA. It was also developed by SunHo based on their own proprietary and patented AICTM (Armed ImmunoCytokine) platform.

IAE0972 was designed to solve the problems of immune cell exhaustion in current immunotherapy, and to lift the limitations of current EGFR-based monoclonal antibodies. IL10 in IAE0972 is a potent activator of antigen-specific CD8+ T cells in the tumor microenvironment and can restore the tumor-killing activity of tumor-infiltrating lymphocytes by restoring the oxidative phosphorylation metabolism of Terminally Exhausted T cells. Anti-EGFR antibody can specifically enrich IAE0972 in tumor microenvironment, so that IL10 can reinvigorate antigen specific CD8+ T cells and facilitate its proliferation, while preserving the tumor cell proliferation inhibition activities of EGFR antibody. Relying on the synergy of EGFR antibody and IL10 cytokine, IAE0972 can effectively and specifically activate the immune system to kill EGFR-positive tumor cells, solving the drug resistance, high skin toxicities, and other clinical problems of existing drugs.

The indications of IAE0972 include colorectal cancer, head and neck squamous cell carcinoma, squamous non-small cell lung cancer, and other locally advanced or metastatic malignant tumors.

On July 6, 2022 Cardinal Health (NYSE: CAH) reported that it has acquired the Bendcare group purchasing organization (CPO-GPO) entity and made a minority investment in the Bendcare management services organization (MSO) (Press release, Cardinal Health, JUL 6, 2022, View Source [SID1234616496]). Following the acquisition of the CPO-GPO, current Bendcare-affiliated CPO-GPO members will transition to Cardinal Health’s Cornerstone Rheumatology GPO, and Cardinal Health will be the exclusive distributor for those practices.

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This acquisition demonstrates Cardinal Health’s strategy of prioritizing investment in strategic growth areas and expands distribution opportunities and technology solution offerings for specialty practices. Financial terms of the transaction were not disclosed.

"Bendcare is a leader in delivering real-world technology, specialty practice management and research solutions that empower physicians and patients in the specialty rheumatology market," said Dan Duran, Senior Vice President and General Manager, Provider Solutions, Cardinal Health Specialty Solutions. "We are excited to combine their solutions with our best-in-class distribution to support rheumatology providers so they can ultimately focus on achieving cost-effective patient outcomes and care."

Combining the expertise and capabilities of Cardinal Health and Bendcare together will create an integrated suite of clinical, practice management and distribution solutions to help support the success of rheumatology practices nationwide.

"Rheumatology providers and patients are navigating a number of industry challenges," said Andrew S. Ripps, CEO, Bendcare. "Cardinal Health is an industry leader in distribution and technology solutions. Our synergistic cultures, combined with our service and technology innovation and expertise, will ignite our ability to continue to lead in the rheumatology space as we expand into other specialties and improve patients’ experience, care and value."

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 provides reliable distribution and advanced technology solutions to community-based practices across the nation with specialties in rheumatology, oncology, urology, nephrology, gastroenterology, ophthalmology, neurology, immunology and multi-specialty infusion centers.