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WuXi Advanced Therapies Receives FDA Approval to Manufacture Iovance’s AMTAGVI™ (lifileucel) for Advanced Melanoma

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AMTAGVI is the first and only one-time, individualized T cell therapy to receive U.S. FDA approval for a solid tumor cancer.

PHILADELPHIA, Feb. 20, 2024 /PRNewswire/ — WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec, today announced that the U.S. Food and Drug Administration (FDA) has approved its Philadelphia site to begin the analytical testing and manufacturing of AMTAGVI for Iovance, which received FDA accelerated approval of its Biologics License Application (BLA) on February 16, 2024.

AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. AMTAGVI is also the first and only one-time, individualized T cell therapy to receive U.S. FDA approval for a solid tumor cancer.

With this announcement, WuXi ATU’s Philadelphia site becomes the first U.S. external manufacturing site and the first third-party contract testing, development, and manufacturing organization (CTDMO) to be approved by the FDA to support the commercial manufacturing and release of an individualized T cell therapy for a solid tumor cancer.

“We congratulate Iovance on this major milestone in their quest to address unmet patient needs in the treatment of advanced melanoma. WuXi ATU has partnered with Iovance since 2015, and we are thrilled to help them through each step of the drug development pipeline – from research to clinical manufacturing to FDA approval,” said Edward Hu, Chief Executive Officer of WuXi ATU and Vice Chairman of WuXi AppTec. “We are proud of our track record of enabling healthcare innovators to advance medical discoveries and deliver groundbreaking treatments to patients globally.” 

Iovance, (NASDAQ: IOVA) is headquartered in San Carlos, California with an FDA-approved built-to-suit custom manufacturing facility, the Iovance Cell Therapy Center (iCTC), adjacent to WuXi ATU in the Navy Yard Philadelphia. The company is committed to innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies, including gene-edited cell therapies, for patients with cancer.

“The accelerated approval of AMTAGVI™ is the first step in realizing Iovance’s ambition to usher in the next generation of cell therapy by bringing this breakthrough to patients with advanced solid tumors,” said Frederick Vogt, Ph.D., J.D., Interim Chief Executive Officer and President of Iovance. “Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients. WuXi ATU has partnered with us to manufacture this cell therapy for close to a decade. It is a great benefit to both Iovance and the healthcare community to have a contract testing, development, and manufacturing partner adjacent to our facilities. Working together, our teams can make a meaningful difference for patients.”

About Iovance Biotherapeutics, Inc.

Iovance Biotherapeutics (NASDAQ: IOVA) aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance’s AMTAGVI™  is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer. For more information, please visit www.iovance.com.

About WuXi Advanced Therapies (WuXi ATU)

As the advanced therapies business unit of WuXi AppTec, WuXi Advanced Therapies is a Contract Testing, Development and Manufacturing Organization (CTDMO) that offers advanced platforms and end-to-end solutions that enable the discovery, development, testing, manufacturing, and commercialization of cell and gene therapies. Our services and solutions accelerate time to market and support customer programs around the world. For more information visit www.advancedtherapies.com

About WuXi AppTec

As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the pharmaceutical and healthcare industry around the world to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, and cell and gene therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2023 and its open-access platform is enabling more than 6,000 customers from over 30 countries to improve the health of those in need – and to realize the vision that “every drug can be made and every disease can be treated.”

CONTACTS

WuXi Advanced Therapies 
Amy Lamperti
Executive Director, Global Marketing
215-218-7100
[email protected] 

WuXi AppTec
Davy Wu
Executive Director, Brand & Corporate Communications
[email protected]

Iovance Biotherapeutics, Inc:
Sara Pellegrino, IRC
Senior Vice President, Investor Relations & Corporate Communications
650-260-7120 ext. 264
[email protected]

Jen Saunders
Director, Investor Relations & Public Relations
267-485-3119
[email protected]

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Invitation to presentation of EQT AB’s Q1 Announcement 2024

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STOCKHOLM, April 5, 2024 /PRNewswire/ — EQT AB’s Q1 Announcement 2024 will be published on Thursday 18 April 2024 at approximately 07:30 CEST. EQT will host a conference call at 08:30 CEST to present the report, followed by a Q&A session.

The presentation and a video link for the webcast will be available here from the time of the publication of the Q1 Announcement.

To participate by phone and ask questions during the Q&A, please register here in advance. Upon registration, you will receive your personal dial-in details.

The webcast can be followed live here and a recording will be available afterwards.

Information on EQT AB’s financial reporting

The EQT AB Group has a long-term business model founded on a promise to its fund investors to invest capital, drive value creation and create consistent attractive returns over a 5 to 10-year horizon. The Group’s financial model is primarily affected by the size of its fee-generating assets under management, the performance of the EQT funds and its ability to recruit and retain top talent.

The Group operates in a market driven by long-term trends and thus believes quarterly financial statements are less relevant for investors. However, in order to provide the market with relevant and suitable information about the Group’s development, EQT publishes quarterly announcements with key operating numbers that are relevant for the business performance (taking Nasdaq’s guidance note for preparing interim management statements into consideration). In addition, a half-year report and a year-end report including financial statements and further information relevant for investors is published. Finally, EQT also publishes an annual report including sustainability reporting.

Contact
Olof Svensson, Head of Shareholder Relations, +46 72 989 09 15
EQT Shareholder Relations, [email protected]

Rickard Buch, Head of Corporate Communications, +46 72 989 09 11
EQT Press Office, [email protected], +46 8 506 55 334

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/eqt/r/invitation-to-presentation-of-eqt-ab-s-q1-announcement-2024,c3956826

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https://mb.cision.com/Main/87/3956826/2712771.pdf

Invitation to presentation of EQT AB’s Q1 Announcement 2024

https://news.cision.com/eqt/i/eqt-ab-group,c3285895

EQT AB Group

 

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Kia presents roadmap to lead global electrification era through EVs, HEVs and PBVs

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  • Kia drives forward transformation into ‘Sustainable Mobility Solutions Provider’
  • Roadmap enables Kia to proactively respond to uncertainties in mobility industry landscape, including changes in EV market
  • Company to expand EV line-up with more models; enhance HEV line-up to manage fluctuation in EV demand
    • Goal to sell 1.6 million EVs annually in 2030, introducing 15 models
    • PBV to play a key role in Kia’s growth, targeting 250,000 PBV sales annually by 2030 with PV5 and PV7 models
  • Kia to invest KRW 38 trillion by 2028, including KRW 15 trillion for future business
  • 2024 business guidance : KRW 101 tln in revenue with KRW 12 tln in operating profit; operating profit margin of 11.9% on sales of 3.2 million units globally
  • CEO reaffirms Kia’s commitment to ESG management

SEOUL, South Korea, April 5, 2024 /PRNewswire/ — Kia Corporation (Kia) today shared an update on its future strategies and financial targets at its CEO Investor Day in Seoul, Korea.

Based on its innovative achievements in the years since the announcement of mid-to-long-term business initiatives, Kia is focusing on updating its 2030 strategy announced last year and further strengthening its business strategy in response to uncertainties across the global mobility industry landscape.

During the event, Kia updated its mid-to-long-term business strategy with a focus on electrification, and its PBV business. Kia reiterated its 2030 annual sales target of 4.3 million units, including 1.6 million units of electric vehicles (EVs). The 2030 4.3 million annual sales target is 34.4 percent higher than the brand’s 2024 annual goal of 3.2 million units.

The company also plans to become a leading EV brand by selling a higher percentage of electrified models among its total sales, including hybrid electric vehicles (HEV), plug-in hybrid (PHEV), and battery EVs, projecting electrified model sales of 2.48 million units annually or 58 percent of Kia’s total sales in 2030.

“Following our successful brand relaunch in 2021, Kia is enhancing its global business strategy to further the establishment of an innovative EV line-up and accelerate the company’s transition to a sustainable mobility solutions provider,” said Ho Sung Song, President and CEO of Kia. “By responding effectively to changes in the mobility market and efficiently implementing mid-to-long-term strategies, Kia is strengthening its brand commitment to the wellbeing of customers, communities, the global society, and the environment.”

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PDF – https://mma.prnewswire.com/media/2380040/Press_Release__2024_Kia_CEO_Investor_Day_240405.pdf

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BioVaxys Technology Corp. Provides Bi-Weekly MCTO Status Update

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VANCOUVER, BC, April 4, 2024 /PRNewswire/ — BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) (the “Company“) is providing this bi-weekly update on the status of the management cease trade order granted on February 29, 2024 (the “MCTO“), by its principal regulator, the Ontario Securities Commission (the “OSC“), under National Policy 12-203 – Management Cease Trade Orders (“NP 12-203“), following the Company’s announcement on February 21, 2024 (the “Default Announcement“), that it was unable to file its audited annual financial statements for the year ended October 31, 2023, its management’s discussion and analysis of financial statements for the year ended October 31, 2023, its annual information form for the year ended October 31, 2023, and related filings (collectively, the “Required Annual Filings“). Under National Instrument 51-102, the Required Annual Filings were required to be made no later than February 28, 2024.

As a result of the delay in filing the Required Annual Filings, the Company was unable to file its interim financial statements for the three months ended January 31, 2024, its management’s discussion and analysis of financial statements for the three months ended January 31, 2024, and related filings (collectively, the “Required Interim Filings“). Under National Instrument 51-102, the Required Interim Filings were required to be made no later than April 1, 2024.

The Company anticipates filing the Required Annual Filings by April 30, 2024. The auditor of the Company requires additional time to complete its audit of the Company, including the Company’s recent acquisition of all intellectual property, immunotherapeutics platform technologies, and clinical stage assets of the former IMV Inc. that closed on February 16, 2024. In addition, the Company anticipates filing the Required Interim Filings immediately after the filing of the Required Annual Filings.

Except as herein disclosed, there are no material changes to the information contained in the Default Announcement. In addition, (i) the Company is satisfying and confirms that it intends to continue to satisfy the provisions of the alternative information guidelines under NP 12-203 and issue bi-weekly default status reports for so long as the delay in filing the Required Annual Filings and/or Required Interim Filings is continuing, each of which will be issued in the form of a press release; (ii) the Company does not have any information at this time regarding any anticipated specified default subsequent to the default in filing the Required Annual Filings and Required Interim Filings; (iii) the Company is not subject to any insolvency proceedings; and (iv) there is no material information concerning the affairs of the Company that has not been generally disclosed.

About BioVaxys Technology Corp.

BioVaxys Technology Corp. (www.biovaxys.com), a biopharmaceuticals company registered in British Columbia, Canada, is a clinical-stage biopharmaceutical company dedicated to improving patient lives with novel immunotherapies based on the DPX™ immune-educating technology platform and it’s HapTenix© ‘neoantigen’ tumor cell construct platform, for treating cancers, infectious disease, antigen desensitization, and other immunological fields. The Company’s clinical stage pipeline includes maveropepimut-S which is in Phase II clinical development for advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL) and platinum resistant ovarian cancer, and BVX-0918, a personalized immunotherapeutic vaccine using it proprietary HapTenix© ‘neoantigen’ tumor cell construct platform which is soon to enter Phase I in Spain for treating refractive late-stage ovarian cancer. The Company is also capitalizing on its tumor immunology know-how and creation of a unique library of T-lymphocytes & other datasets post-vaccination with its personalized immunotherapeutic vaccines to utilize predictive algorithms and other technologies to identify new targetable tumor antigens. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF). For more information, visit www.biovaxys.com and connect with us on X and LinkedIn.

ON BEHALF OF THE BOARD

Signed “James Passin
James Passin, Chief Executive Officer
Phone: +1 646 452 7054

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