On April 6, 2022 Ultivue, Inc. an industry leader in multiplexing tools powered by their emerging novel AI-driven image analysis solutions for tissue biomarker studies, reported that data from its FlexVUE formatting for panel design and its newest mouse panel offering for multiplex immunofluorescence (mIF) and spatially resolved biomarker analysis will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 (Press release, Ultivue, APR 6, 2022, View Source [SID1234611530]). The meeting runs April 8th to April 13th in New Orleans, LA.

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Accepted abstracts during the AACR (Free AACR Whitepaper) conference will feature new data from a streamlined pre-optimized protocol enabling mIF staining on mouse tissue for an improved workflow to investigate T-cell infiltration and additional analysis of the tumor immune microenvironment (TiME) to address the mechanisms of action of immune-related drugs in preclinical syngeneic or GEMM mouse models. The company will also spotlight an early access program for mouse researchers interested in exploring the use of advanced pre-clinical tools to probe the dynamic nature of events occurring in the TiME. Additional abstracts feature the new flexible mIF assays (FlexVUE panels) for discerning relevant distributions of infiltrating immune cells in tumors coupled with UltiStacker software for producing detailed spatial characterizations of specific cell phenotypes. Further datasets showcase the integrated capabilities from Fluidigm and Visiopharm to demonstrate a unique tissue phenotyping workflow combining complementary methods that can unravel the complexity of the tumor microenvironment. Ultivue’s newest workflow to be highlighted at this year’s AACR (Free AACR Whitepaper) will be available through the Company’s CLIA services lab and features a multi-omics analysis that demonstrates the versatility of Ultivue’s InSituPlex technology (ISP) through an integrated workflow for co-detection of protein and RNA on a single tissue section. For more information about the poster presentations and to schedule an onsite meeting with one of our scientists, please refer to View Source

Ultivue will also host their 2nd annual Biomarker Insights Summit on April 8th, 2022, ahead of the annual AACR (Free AACR Whitepaper) meeting. This symposium is designed to promote thought leadership and has been exclusively curated for those working towards the eradication of cancer via immuno-oncology approaches. Scientists from AstraZeneca, Takeda, Gilead, Merck, Bayer and many more will be onsite to share successes and lessons learned to better inform therapeutic efforts and explore how innovative digital pathology insights can provide benefit to clinical trials. For more information, https://biomarkerinsightssummit.com/.

On April 6, 2022 Medikine, Inc., a privately-held biopharmaceutical company focused on the discovery and development of cytokine mimetics for the treatment of cancer, autoimmune disorders, and infectious diseases, reported that it will deliver a poster presentation at the AACR (Free AACR Whitepaper) Annual Meeting 2022 (Press release, Medikine, APR 6, 2022, View Source [SID1234611529]). The poster highlights preclinical data on Medikine’s lead program MDK-703, an Fc-peptide fusion protein incorporating an IL-7 PEPTIKINE discovered using Medikine’s innovative platform technology. PEPTIKINES are cytokine receptor agonists that are smaller in molecular size than, and structurally unrelated to, the natural cytokine proteins they emulate.

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The poster presents data on the effects of MDK-703 on CD8, CD4, and memory T-cell populations in human cells in vitro and when administered to non-human primates and CD34-engrafted humanized mice. In addition to increasing the number of CD8 and CD4 T-cells, MDK-703 increased memory T-cells, particularly T memory stem cells (Tscm), a subset of memory lymphocytes endowed with the stem cell-like ability to self-renew, and the multi-potent capacity to reconstitute the entire spectrum of memory and effector subsets.

Dr. Joseph Leveque, President and Chief Medical Officer of Medikine, commented, "I believe that MDK-703 has best-in-class potential as a therapy with the ability to differentiate, maintain, and increase survival of T-cells with critical anti-tumor properties. An additional important feature of MDK-703 is that, as a consequence of its novel structure, it would not be expected to generate neutralizing antibodies to native IL-7, an issue observed with other IL-7-based therapies in clinical development."

Medikine expects MDK-703 to enter first-in-human clinical trials in mid-2022.

Poster Presentation Details

Title: In vitro and in vivo properties of MDK703: An Fc-peptide fusion IL-7Rαγc agonist unrelated in structure to IL-7
Abstract #: 2066
Presenter: Angie Park, PhD, Medikine
Session Title: Immunomodulatory Agents and Interventions 1
Date/Time: Monday, April 11, 2022, from 1:00-5:00 p.m. ET
The poster will be available on the Medikine website at www.Medikine.com following the presentation.

On April 6, 2022 Paige, a global leader in clinical AI applications in pathology, reported it received CE-IVD and UKCA marks for Paige Breast Lymph Node (Press release, Paige AI, APR 6, 2022, View Source [SID1234611528]). The newly launched AI medical device software helps pathologists detect if breast cancer has metastasized to lymph nodes, concurrent with pathologists’ own interpretive review . With the CE-IVD and UKCA designations, laboratories and hospitals in the European Economic Area, Switzerland and the UK can now use the product in the course of clinical diagnosis.*

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"Paige’s aim is to provide pathologists with innovative, care enhancing technology so they can provide the best possible insights to patients. Through Paige Breast Lymph Node, pathologists can more efficiently identify tumor metastases of any size, including small micrometastases," said Juan Retamero, M.D., Medical Director, Digital Pathology Transformation at Paige. "The CE-IVD and UKCA marks for Paige Breast Lymph Node are a vital step towards increasing the adoption of our new tool in European hospitals and laboratories."

Paige Breast Lymph Node uses the same underlying AI technology as Paige Prostate and can be deployed in any laboratory or hospital setting that is on the Paige Platform.

For more information about Paige Breast Lymph Node, visit View Source or contact [email protected].

*Paige Breast Lymph Node is available for "Research Use Only" in the United States, not for use in diagnostic procedures.

On April 6, 2022 Alvotech Holdings S.A. ("Alvotech"), a global biopharmaceutical company focused solely on the development and manufacture of biosimilar medicines for patients worldwide, has reported the resolution of all intellectual property disputes with AbbVie in Europe and selected markets outside of Europe, related to its AVT02 biosimilar candidate (Press release, Alvotech, APR 6, 2022, View Source [SID1234611527]). This paves the way for Alvotech’s exclusive strategic partner STADA to commercialize AVT02, a citrate-free, high-concentration (100 mg/mL) biosimilar to Humira (adalimumab) in European countries under the HUKYNDRA brand name.

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Under the terms of the European patent resolution, AbbVie has granted Alvotech a non-exclusive, royalty bearing license to AbbVie’s intellectual property relating to Humira in Europe and in selected markets outside of Europe, thus paving the way for greater patient access to adalimumab.

"This resolution is an important step in Alvotech’s mission to bring more sustainable healthcare to patients in need and we look forward to launching our first biosimilar in the European market with STADA," said Robert Wessman, Founder and Chairman of Alvotech.

With all intellectual-property issues now resolved, STADA is preparing to launch the HUKYNDRA citrate-free, high-concentration biosimilar broadly across Europe. STADA is Alvotech’s exclusive strategic partner for commercializing AVT02 in Europe and selected other territories.

"HUKYNDRA will be the first of what we anticipate will be a continuous stream of biosimilar launches across a broad range of therapeutic categories through our partnership with Alvotech.," said Peter Goldschmidt, CEO of STADA. "We are committed to working with partners to bring competition to the biologic medicines sector, thereby delivering value and facilitating patient access."

HUKYNDRA is the first of seven molecules covered by an exclusive biosimilars agreement signed between Alvotech and STADA in November 2019. This broad partnership includes biosimilar candidates aimed at treating autoimmunity, oncology, and ophthalmology conditions.

In December 2021, the partners announced that they had received approval from the European Commission for AVT02 (adalimumab), now called HUKYNDRA in Europe, the company’s citrate-free, 100 mg/mL high concentration biosimilar to Humira, for the 27 member countries of the European Union plus Norway, Iceland and Liechtenstein.

HUKYNDRA is authorized for use in treating a range of inflammatory conditions including rheumatoid arthritis, plaque psoriasis and Crohn’s disease. Adalimumab inhibits tumor necrosis factor alpha, which is a protein in the body involved in inflammation. Humira was the highest grossing medicine in the world in 2021 (excluding COVID-19 vaccines) with global sales of over $20 billion.

In February 2022, the US Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for ATV02 (100 mg/mL), Alvotech’s citrate-free, high-concentration biosimilar, that includes new data supporting interchangeability between ATV02 and Humira, for the U.S. market. The application was supported by positive results from a switching study that demonstrates bioequivalence and comparable efficacy, safety and immunogenicity of repeated switches between administration of Humira and AVT02.

On December 7, 2021, Alvotech and Oaktree Acquisition Corp. II (NYSE: OACB.U, OACB, OACB WS), a special purpose acquisition company sponsored by an affiliate of Oaktree Capital Management, L.P., announced they had entered into a definitive business combination agreement. Upon completion of the transaction, the combined company’s securities are expected to be traded on NASDAQ under the symbol "ALVO."

On April 6, 2022 Tegmine Therapeutics reported an investment from Alloy Therapeutics and a collaboration to accelerate the development of antibody therapeutics that target proteins carrying cancer-associated glycan post-translational modifications (PTMs) (Press release, Alloy Therapeutics, APR 6, 2022, View Source [SID1234611526]). Tegmine will generate immunogens and cell line screening reagents which reflect patient biology and Alloy will lead the antibody discovery and hit validation.

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Tegmine’s programs address highly specific antibody targets in solid tumor indications with unmet needs, where expression of aberrant glycosylation has been shown to be a hallmark of immune suppression, metastasis, and resistance to chemotherapy. Tegmine’s discovery capabilities include CRISPR-engineered TegMiner Cells which recapitulate cancer-associated aberrant glycosylation and custom mass spectrometry workflows to identify proteins and PTM-epitopes expressed in primary tumor tissues.

"We are driven to develop novel therapeutics which account for disease-specific protein modifications, enabling the targeting of cancer driver proteins and providing hope for patients without great options," said Jeff Bernstein, co-founder and CEO of Tegmine. "The technology to measure and understand the impact of glycans on cancer progression is rapidly advancing. Using our proprietary TegMiner Cells and mass spectrometry, we are identifying more specific, cancer-modified epitopes. We are very enthusiastic about this collaboration with Alloy Therapeutics. Alloy has a superior platform for identifying the best human antibodies using its comprehensive offering of in vivo, in vitro, and in silico technologies which, combined with our tumor-specific immunogens, will go far in developing the next generation of cancer therapies."

"We are proud to partner with Tegmine on this promising program to address unmet needs in cancer treatment," said Errik Anderson, CEO of Alloy Therapeutics. "Pairing Tegmine’s robust mass spectrometry discovery platform with Alloy’s best-in-class, fully human antibody discovery services offering unlocks the powerful ability to identify epitope-specific antibodies specific to patient cancer biology."