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NORTH CHICAGO, Ill., May 19, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLYTM (epcoritamab-bysp), as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade Bcell lymphoma (HGBL), after two or more lines of systemic therapies.EPKINLY is approved under the FDA's Accelerated Approval program based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. EPKINLY is being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration.

DLBCL is a type of aggressive, fast-growing non-Hodgkin's lymphoma (NHL), a cancer that develops in the lymphatic system and affects B cells, a type of white blood cell. DLBCL is the most common type of NHL, comprising of an estimated 30,400 U.S. cases in 2022 and 150,000 new cases each year globally. DLBCL patients are typically treated with chemoimmunotherapy-based regimens. For R/R patients, several targeted therapies including T-cell mediated treatments have recently emerged. However, single agent and ready-available or off-the-shelf treatment options are limited.1,2,3,4,5

"DLBCL is an aggressive cancer type that can rapidly progress and resist treatment. The FDA approval of EPKINLY represents a new treatment mechanism of action for third line DLBCL patients. As a non-chemotherapy, single-agent treatment for DLBCL patients, we hope that EPKINLY can effectively treat this aggressive cancer type and can be used for patient care quickly and in an off the shelf form for physicians," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. "The approval is just the first step, with our partner Genmab, towards a shared goal of developing a core therapy for patients with B-cell malignances."

AbbVie is committed to transforming standards of care across blood cancers and advancing a dynamic cancer research and treatment pipeline. EPKINLY marks the third approved blood cancer treatment available as part of AbbVie's growing oncology portfolio, aswe strive to make a remarkable impact for people living with cancer.

"Patients with DLBCL who relapse or are refractory to currently available therapies have limited options. Generally, the prognosis for these patients is poor and management of this aggressive disease can be challenging," said Tycel Phillips, M.D., City of Hope Associate Professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation. "Epcoritamab is a subcutaneous bispecific antibody that offers an additional treatment option for this patient population. With this approval, patients who are in need of additional therapy may have the opportunity to receive epcoritamab after failure to respond or relapse after two or more systemic therapies."

"The FDA approval of EPKINLY represents a new treatment for diffuse large B-cell lymphomas among patients who have relapsed or have refractory disease and are looking for a new medication," said Meghan Gutierrez, chief executive officer, Lymphoma Research Foundation.

Highlights of the Phase 1/2 EPCORE NHL-1 clinical trial supporting the approval:

About EPKINLYTM (epcoritamab-bysp)EPKINLY is a prescription medicine used to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that has come back (relapsed) or that did not respond to previous treatment (refractory), and who have received 2 or more treatments for their cancer. EPKINLY is approved based on patient response data. A study is ongoing to confirm the clinical benefit of EPKINLY. It is not known if EPKINLY is safe and effective in children.

EPKINLY is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody technology. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types. It is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T cell mediated killing of CD20+ cells.5,6,7

AbbVie and Genmab are evaluating EPKINLY as a monotherapy, and in combination, across multiple lines of therapy in a range of hematologic malignancies. This includes an ongoing Phase 3, open-label, randomized controlled trial evaluating EPKINLY as a monotherapy in patients with R/R DLBCL (NCT: 04628494) and two Phase 3, open-label, randomized controlled trials evaluating EPKINLY combination regimens in patients with newly diagnosed DLBCL (NCT: 05660967) and R/R follicular lymphoma (NCT: 05409066). The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.AbbVie will continue to pursue regulatory submissions for epcoritamab across international markets throughout the year.

IMPORTANT SAFETY INFORMATION

Important WarningsEPKINLY can cause serious side effects, including:

Due to the risk of CRS, you will receive EPKINLY on a "step-up" dosing schedule. The step-up dosing schedule is when you receive smaller "step-up" doses of EPKINLY on day 1 and day 8 of your first cycle of treatment (cycle 1). You will receive your first full dose of EPKINLY on day 15 of cycle 1. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule. Before each dose in cycle 1, you will receive medicines to help reduce your risk of CRS. Your healthcare provider will decide if you need to receive medicine to help reduce your risk of CRS with future cycles.

Due to the risk of CRS and neurologic problems, you should be hospitalized for 24 hours after receiving your first full dose of EPKINLY on day 15 of cycle 1. Your healthcare provider will monitor you for symptoms of CRS and neurologic problems during treatment with EPKINLY, as well as other side effects, and treat you if needed. Your healthcare provider may temporarily stop or completely stop your treatment with EPKINLY if you develop CRS, neurologic problems, or any other side effects that are severe.

Do not drive or use heavy or potentially dangerous machinery if you develop dizziness, confusion, tremors, drowsiness, or any other symptoms that impair consciousness until your symptoms go away. These may be symptoms of CRS or neurologic problems.

EPKINLY can also cause other serious side effects, including:

Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects.

Before you receive EPKINLY, tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of EPKINLY include CRS, tiredness, muscle and bone pain, injection site reactions, fever, stomach-area (abdominal) pain, nausea, and diarrhea.

These are not all the possible side effects of EPKINLY. Call your doctor for medical advice about side effects.

You are encouraged to report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatchor to GenmabUS, Inc. at 1-855-4GENMAB (1-855-443-6622).

Please see Medication Guide, including Important Warnings.

About AbbVie in OncologyAt AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visithttp://www.abbvie.com/oncologyand ourBlood Cancer Press Kit page.

About AbbVieAbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at http://www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking StatementsSome statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2022 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

1 Sehn LH, Salles G. N Engl J Med. 2021;384:842-858.2 What is Lymphoma. Lymphoma Coalition. https://lymphomacoalition.org/what-is-lymphoma/. Accessed April 24, 2023.3 Kanas G, Ge W, Quek RGW, et al. Leukemia & Lymphoma. 2022;63(1):54-63.4 Crump M, Neelapu SS, Farooq U, et al. Blood. 2017;130(16):1800-1808.5 Chao MP. Cancer Manag Res. 2013;5:251-269.6 Engelberts PJ, Hiemstra IH, de Jong B, et al. "DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing." EBioMedicine. 2020;52:102625. DOI: 10.1016/j.ebiom.2019.1026257 Rafiq S, Butchar JP, Cheney C, et al. "Comparative Assessment of Clinically Utilized CD20-Directed Antibodies in Chronic Lymphocytic Leukemia Cells Reveals Divergent NK Cell, Monocyte, and Macrophage Properties." J. Immunol. 2013;190(6):2702-2711. DOI: 10.4049/jimmunol.12025888 Singh V, Gupta D, Almasan A."Development of Novel Anti-Cd20 Monoclonal Antibodies and Modulation in Cd20 Levels on Cell Surface: Looking to Improve Immunotherapy Response." J Cancer Sci Ther. 2015;7(11):347-358. DOI: 10.4172/1948-5956.1000373

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EPKINLY (epcoritamab-bysp) Approved by U.S. FDA as the First ... - AbbVie

May 19, 2023

Its a small program that attracts international students to the University of Manitoba and has an outsized influence on the art scene in Winnipeg, Manitoba and Canada. From May 23 June 23, the five artists graduating from the School of Arts Master of Fine Arts program are set to show their work at the 2023 MFA Thesis Exhibition.

The show includes work from each of the MFA candidates Hamideh Behgar, Timothy Brown, Sonny Cai, Ashkan Nejadebrahimi, and Niki Saghar who have designed their own installations, after receiving professional training in curatorial practices and exhibition design last fall in a week-long workshop with curators Rodney Latourelle and Louise Witthoefft from Berlin, specialists in exhibition installation, public art, colour and light concepts.

It will be an eclectic mix of works ranging from video and performance, through sculpture to drawing, says, Oliver Botar, associate director, graduate studies and research at the School of Art.

Three out of five of the students are originally from Iran, and a theme of displacement runs through the works, he says.

Botar encourages people to come out. He points to the calibre of artists who have graduated from the MFA program over the last 12 years of its history.

The School of Art has produced a long roster of artists that have gone on to local, national and indeed international fame, including a goodly list of international art stars, some of whom continue to live here, and others whove gone on to major careers in larger Canadian art centres such as Toronto, Montreal and Vancouver, but also to New York, Chicago and Berlin, says Botar. In other words, through our graduates and our network, we are an art school that is present way beyond our borders.

As a female artist who grew up in an environment full of restrictive societal norms, Hamideh Behgar experienced many boundaries, limitations, and high expectations. Through her artistic journey, she has explored the societal pressure to achieve perfection, despite the inherent imperfections that exist in the natural world beyond our control. Her current artistic practice is inspired by childhood imagination and the importance of free play and play sculptures.

Timothy BrownProcessor 1 (still), 2022videoImage courtesy of the artist

Wavesis a temporal conversation taking place across a variety of media, in which Timothy Brown addresses the grief and trauma from the loss of his mother while also re-examining his identity in relation to the birth of his son. The exhibition utilizes audio, video, installation, drawing, and text whilealso inviting the viewer into the exhibition space as a participant. WithWaves, history, lineage, identity, grief, trauma, control, and emotion collide, re-examining the relationship between viewer, artist, and artwork.

Sonny CaiImage courtesy of the artist

The exhibition title,Three Begat All Things, comes from the description of Yinyang in Tao Te Ching: the existence of the laws of Yinyang, the human understanding of these laws, and the physical manifestation of these laws. These three concepts come together to form Tao and produce all things. The direct translation of Yinyang from Chinese to English is Sun and Shadow, which is perfectly embodied within Sonny Cais choice of medium: The seriesThree Begat All Thingsuses Cyanotype techniques creating a beautiful blue visual effect in accordance with the sun and its shadows.

Ashkan NejadebrahimiImmersion I, 2023Mixed media (wire, wood, clear acrylic sheets, ink, spray paint), 70 x 70 x 35 cmImage courtesy of the artist

Ashkan Nejadebrahimi makes abstract drawings on 2D surfaces and sometimes the lines he draws move into three-dimensional space, taking on sculptural qualities. Drawing for him is an act of probing what is going on inside and around him. He employs Surrealist Automatist techniques, which allow him to suppress conscious control over the creative process. Ashkans work researches the interactions between Self and Other in psychological and social senses, and in his studio, subjects such as monsters, the unconscious, and the quality of non-finito, that is unfinishedness, meet on the ground of drawing.

Niki SaghariImage courtesy of the artist

Niki Saghari is an Iranian multidisciplinary artist currently based in Canada. Her work encompasses photography, performance, video, sound, and installations. She aims to draw attention to the seemingly mundane aspects of daily life and transform them into works that challenge our preconceptions. Through her art, she explores the complexities of human relationships and identity, as well as the passage of time and the impermanence of all things. By revealing the unconscious and exposing our shared experiences, Saghari aims to promote empathy and understanding between people from different cultures and backgrounds. Saghari will be presenting a performance as part of her thesis show at 6PM.

May 23-June 23School of Art Gallery

Opening reception: May 26; 5 8 p.m.

Botar notes that the School of Art and the MFA program have a lot to offer the city and the province. The School of Art is the only art school with a graduate program between Regina/Saskatoon and Toronto/London, and there is no such program in North Dakota or Northern Minnesota. This points to high demand for the graduate program.

With the establishment of our MFA Program some 12 years ago, we also began to attract a good number of international students from countries such as Iran, China, Korea and Latin America (among others), that has helped internationalize our art scene.

Enrolment numbers have been kept small despite the demand says Botar, running to an intake of about five per year for the competitive program which typically see 85 applicants per year. Students accepted to the program get a large studio, receive personalized instruction in small groups from an outstanding roster of faculty, and their degree culminates in a professional MFA thesis show that includes a hard-cover publication of the exhibition.

And the program is growing. We have just doubled our potential intake to 10 due to the demand, which will ensure a larger, more dynamic cohort of students, something that is beneficial for artists at the start of their careers, says Botar. The newly established MA Program in Art and Architectural History (beginning Fall 2023) will further increase the annual cohort by two for the time being.

That personalized instruction, along with outstanding production facilities and full technical support in the award-winning ARTlab are large draws for the program, along with numerous professional development opportunities including workshops, studio visits from top curators, artists and journal editors, says Botar.

We also currently have an artist-in-residence, Prof. Emeritus Erwin Huebner (Biology), who offers one-on-one instruction in scientific imaging techniques and art making to my knowledge the only such instruction and facility in an art school in the country, says Botar.

Without this art school, that was founded together with the Winnipeg Art Gallery in 1912, Winnipeg would not be the cultural centre that it is. Our graduates are the foundation of a complex and rich art scene in Winnipeg, including not only the WAG-Quamajuq, but also many artist-run centres in the fine arts, including video/moving image, installation, printmaking, craft, ceramics, and more.

UM Today Staff

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UM Today | School of Art | It's time for the 2023 MFA Thesis Exhibition - UM Today

Binances spot trading is now integrated with professional charting and trading platform, TradingView, enabling users to perform technical and fundamental analysis, as well as trade through charts without leaving the site.

TradingView and Binance, the largest cryptocurrency exchange in the world, have announced the expansion of their partnership to include spot trading. This comes after the successful introduction of Binance Futures on the TradingView platform in 2022.

Binance announced the integration in a blog post on Thursday, highlighting that it allows users to manage their trades efficiently and learn new strategies with an active community. The influential exchange, known for its impressive market presence, boasts a daily spot trading volume of around $20 billion and offers over 1,400 spot pairs for trading. They can access additional features by simply connecting to the platform using theirBinance accounts.

In 2022, we were excited to introduce Binance Futures to TradingView users and provide access to the largest derivatives cryptocurrency exchange in the world. Today, our partnership has evolved further, and we are officially expanding our integration with Spot trading. All you need to do is go to Binance profile, click Trade, connect your Binance account to the TradingView platform and leap to trading, the statement reads.

TradingView users, who are also Binance customers, are able to trade USD-Margined futures perpetual and delivery contracts directly within TradingViews browser and desktop apps.

With this integration, users with a Binance account will be able to log in and trade a whopping 350 tokens directly through TradingView charts. This impressive range includes renowned cryptocurrencies like Bitcoin and Ethereum, as well as intriguing alternative tokens such as ApeCoin and Chiliz.

According to theweb-based charting provider, registered users can simply scroll down to see the list of available broker partners. Then, they can search to find Binance icon, type in their exchange credentials, and start experiencing new opportunities, the company explains.

The alliance could boost interest inBinances offering after it was forced to wind down its futures and derivatives product in many countries amid a growing crackdown by regulators. The influential exchange has come under increasing regulatory scrutiny in the US, Europe and Asia amid concerns about compliance and protection for investors.

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TradingView and Binance extends integration to spot trading - FinanceFeeds

Binance [BNB] has cemented its place as one of the top centralized exchanges in the crypto sector. Its native stablecoin BUSD, however, did not see the same dominance and has struggled to keep up with the likes of Tether [USDT] and Circle [USDC].

Is your portfolio green? Check out the BNB Profit Calculator

Binances recent burn of BUSD could improve its position in the stablecoin race. Arkham Intelligences data indicated that Binance burned 700M BUSD to the Null Address on 18 May. They also burned $250M USDC by the Mint and Burn address.

For context, a Mint and Burn address is used in cryptocurrency systems for creating new tokens (minting) and permanently removing tokens from circulation (burning). It serves as a mechanism to regulate token supply and maintain stability.

Burning tokens can be seen as a measure taken by Binance to enhance stability and instill confidence in the remaining token holders. By reducing the overall supply, Binance aims to mitigate inflationary pressures and maintain the value and integrity of BUSD and USDC tokens.

However, the burning of these tokens did not result in much positivity for the stablecoins. According to Santiments data, the market cap for BUSD and USDC continued to decline, whereas USDT dominated in this sector.

Even though the BUSD stablecoin still had a long way to go to get to the top of the stablecoin market, the Binance protocol was doing relatively well.

According to data from Coingecko, there has been a significant increase in trading activity on the Binance exchange over the past week.

The increased trading activity on the Binance exchange suggests growing market interest and participation, which can potentially lead to higher revenue for Binance through transaction fees.

It may also indicate a strengthening position for Binance as a preferred platform for cryptocurrency trading, attracting more users and fostering liquidity.

Realistic or not, heres BNBs market cap in BTCs terms

Despite the popularity of the Binance exchange, the state of its native token BNB continued to see problems. Notably, BNBs price reduced from $342.58 to $309 in the last week. In tandem with the declining price, the volume of BNB being traded also fell materially during this period.

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Binance burns BUSD, USDC: How will the stablecoin market react - AMBCrypto News

Binance, the worlds largest cryptocurrency exchange, is set to celebrate the 13th anniversary of Bitcoin Pizza Day with global community meet-ups, highlighting the immense growth and acceptance of digital currencies since the first-ever Bitcoin transaction.

The worlds premier cryptocurrency exchange, Binance, is poised to celebrate the 13th anniversary of the momentous Bitcoin Pizza Day. This event marks the day when two pizzas were exchanged for 10,000 BTC in 2010, signaling the dawn of a new era in the world of cryptocurrencies. The celebration serves to underscore the paradigm shift this event instigated within the realm of digital currencies.

Kicking off in Naples, Italy the home of pizza on May 21, Binance plans to host a series of engaging community meet-ups around the globe. The festivities will continue with unique pizza-themed celebrations in ten countries: Brazil, Bahrain, Pakistan, Vietnam, Sri Lanka, Cambodia, Uruguay, Mexico, Argentina, and New Zealand. The festivities will be marked by Binances takeovers of local pizzerias and pizza vans, infusing the crypto theme into this universally loved delicacy.

Simultaneously, the crypto community worldwide is invited to partake in the festivities virtually via social media and the Binance app. Participants stand a chance to win the crypto equivalent of a years supply of pizza by sharing their unique Binance-themed pizzas using the hashtag #BinancePizza, or by successfully collecting all the Pizza Flavours in the Binance app. The online celebration will culminate in a virtual live meet-up on May 22, featuring Binance CEO CZ and prominent Binance Feed creators discussing the enduring significance of Bitcoin Pizza Day.

Binance sees Bitcoin Pizza Day as a powerful symbol of community strength and the growing acceptance of Bitcoin in our everyday lives, says Yi He, Binance co-founder, and CMO. She further emphasizes Binances commitment to fostering mass adoption and creating practical use cases for crypto in daily life. Each Pizza Day event promises activities, rewards, free pizza, and opportunities to win Binance merchandise. For instance, the first 500 event registrants in Naples will enjoy free Binance style pizza and drinks and participate in a pizza-making contest for Binance prizes.

Bitcoin Pizza Day represents a monumental milestone in the crypto industry. It showcases the industrys incredible growth and the path it has paved for digital currencies over the last 13 years. As always, Binance remains steadfast in its mission to enhance monetary freedom, believing that rising crypto adoption will further expand opportunities for financial liberty. Binance is honored to commemorate this significant day alongside its dedicated and progressive community.

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Binance Marks 13th Bitcoin Pizza Day with Global Celebrations: A ... - FinanceFeeds