On April 6, 2022 Stilla Technologies, the multiplex digital PCR company, and Promega Corporation reported a co-marketing agreement that combines sample preparation with the latest Maxwell systems and digital PCR on the six-color naica system (Press release, Stilla Technologies, APR 6, 2022, View Source [SID1234611532]). With this partnership, the companies will offer an optimized workflow for a wide range of applications including liquid biopsy, sentinel pathogen testing, infectious disease assays, overall cancer research and drug discovery. Representative data of the liquid biopsy workflow will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 on April 10, 2022.

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"The strategic partnership with Promega enhances our value proposition by bringing a fully-validated sample-to-answer solution for biomarker testing," said Philippe Mourère, President and CEO, Stilla Technologies. "Promega has demonstrated exceptional quality of results from samples processed with their proven reagents on Maxwell systems, which have been adopted globally for liquid biopsies. I am truly excited about the combined reach and strength that we can bring to the market through a strategic partnership."

The 6-color naica platform is being quickly adopted, with end-users developing high multiplex dPCR assays that have been previously unattainable. This adds to the growing body of evidence for the need to study more molecular targets per sample to provide actionable insights.

"In liquid biopsy clinical research, we see a desire to conduct more near-patient testing with faster time to results, lower costs, higher sensitivity, and a highly standardized process from sample preparation to results," said Tom Livelli, VP, Life Sciences Products & Services, Promega Corporation. "This new end-to-end solution, pairing the Maxwell system with the naica system, will facilitate the move of highly multiplex genomic signatures from liquid biopsies, typically performed through NGS in centralized labs, to decentralized testing."

At the AACR (Free AACR Whitepaper) Annual Meeting 2022, the companies will present data demonstrating ultrasensitive 32-plex detection from liquid biopsy samples of EGFR mutations in non-small cell lung cancer, in addition to PIK3CA mutations and HER2 amplification in breast cancer. These data will be presented during the following session on April 10, 2022, 1:30 PM – 5:00 PM:

Poster #527 / 2 – A streamlined workflow for liquid biopsy extraction and highplex digital PCR analysis using the Maxwell system and 6-color Crystal Digital PCR
The Stilla and Promega teams will also showcase their combined solution to the scientific community at booths #1807 (Stilla) and #730 (Promega) throughout the AACR (Free AACR Whitepaper) Annual Meeting from April 10-13, 2022, in New Orleans. Further data will be released covering a broader range of application areas over the coming months.

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."