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."

On April 6, 2022 Enzychem Lifesciences (KOSDAQ: 183490), a late-stage biopharmaceutical company, reported that it will present new Phase 2 US clinical study data regarding its lead drug candidate, EC-18 for chemoradiation-induced oral mucositis (CRIOM) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 annual meeting, which will be held in-person on June 3-7th, 2022 in Chicago (Press release, Enzychem Lifesciences, APR 6, 2022, View Source [SID1234611525]).

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The abstract highlights the new clinical data from Enzychem’s Phase 2 US clinical trial evaluating the effect of EC-18 on severe oral mucositis (SOM) development in chemoradiation-treated head and neck cancer patients. Dr. Christina Henson, a board-certified Radiation Oncologist and Residency Program Director for Radiation Oncology at the University of Oklahoma will present the following abstract. She was also the highest enrolling site’s principal investigator of the Phase 2 study.

The details of the presentation are as follows:

Title: Phase 2, Randomized, Double-Blind Trial of EC-18 versus Placebo to Mitigate the Development and Time Course of Oral Mucositis from Concomitant Chemoradiation for Head and Neck Cancer
Presenter: Christina Henson, M.D
Date: June 4th, 2022
Time: 1:15-4:15 PM (CDT)

On April 6, 2022 In a new article appearing in the current issue of the Cell Press scientific journal iScience, AntiCancer Inc. of San Diego reported that has demonstrated that the addiction of cancer to the common amino acid methionine is the basis of the malignancy of cancer (Press release, AntiCancer, APR 6, 2022, View Source [SID1234611524]). The new article demonstrates that the excess methionine needed by cancer cells for their addiction is used to pathologically modify proteins that control gene expression (called histones), by a process called hyper-methylation. The new article shows that rare cancer cells that were selected in the laboratory to revert to non-addiction to methionine (methionine independence) also lost malignancy as well as histone hyper-methylation, behaving mostly as normal cells, thereby demonstrating the linkage of methionine addiction to histone hyper-methylation and malignancy.

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AntiCancer Inc.’s study began 50 years ago with the discovery of methionine addiction of cancer by AntiCancer’s Founder Robert M. Hoffman. Methionine addiction of cancer is termed the Hoffman Effect, named after Dr. Hoffman.

"The new study shows that methionine addiction is the fundamental basis of cancer," said Jun Yamamoto, lead author of the iScience article.

"Every cancer tested is methionine addicted and can be targeted by methionine restriction," said Qinghong Han, lead scientist for methionine restriction at AntiCancer Inc.

"Methionine addiction is therefore a very promising target for cancer therapy," said Mark Simon, Director of the Nutritional Oncology Research Institute.