On June 24, 2021 Fosun Kite Biotechnology reported its autologous CD19-directed CAR-T cell therapy Axicabtagene Ciloleucel (FKC876) (axicabtagene ciloleucel) has been approved by China National Medical Products Administration (NMPA) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma[1] (Press release, Fosun Kite Biotechnology, JUN 24, 2021, View Source [SID1234584347]).

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Axicabtagene Ciloleucel (FKC876) is an autologous CD19-directed CAR-T cell therapy manufactured in China pursuant to a license from Kite, a Gilead Company ("Kite") of Kite’s Yescarta (axicabtagene ciloleucel), which is the world’s first approved CAR-T cell therapy for adult patients with certain types of NHL. This NDA approval is based on results of a single-arm, open label, multi-center bridging trial which has evaluated and proven the efficacy and safety of Axicabtagene Ciloleucel (FKC876) in the treatment of Chinese patients with refractory intermediate invasive DLBCL.

WU Yifang, Chairman and CEO of Fosun Pharma, says, "CAR-T cell therapy is one of the significant cancer treatment breakthroughs in recent years. It is a great pleasure to work with Kite, a world-leading partner, to bring Axicabtagene Ciloleucel (FKC876) in China together, which is also an important milestone for Fosun Pharma’s global innovation and R&D cooperation. Thanks to NMPA for the rigorous review and recognition of China’s first CAR-T cell therapy. Focusing on unmet clinical needs, Fosun Pharma will continue to take innovative R&D as the core driving force and strive to provide patients with more high-quality, accessible and innovative medicines and treatment options."

MEI Jingping, Chairwoman of Fosun Kite, says, "As the first commercialized product of Fosun Kite, the approval of Axicabtagene Ciloleucel (FKC876) brings a revolutionary treatment option to cancer patients in China. We will continue to guard this innovative vein-to-vein treatment circle with high-quality and rigorous service chains to benefit more cancer patients."

Terence O’Sullivan, Vice President, International Region at Kite comments: "As the world’s first approved CAR-T cell therapy for NHL, Kite’s Yescarta (axicabtagene ciloleucel) has been used in thousands of patients around the world. Thank you to the dedicated healthcare professionals, patients and caregivers who worked with the team at Fosun Kite to make this fast and reliably manufactured treatment option, with the potential of survival for patients facing these challenging and aggressive cancers available in China."

Dr. MA Jun, Director of the Harbin Institute of Hematology & Oncology, Chief Supervisor of Supervisory Committee at the Chinese Society of Clinical Oncology, "Thanks to the reform of national medicines review and approval system in recent years, China’s lymphoma diagnosis and treatment level has progressed rapidly, and CAR-T cell therapies have seen even more significant changes. As China’s first CAR-T product approved by NMPA, Axicabtagene Ciloleucel (FKC876)’s approval for marketing. shows China’s innovation to establish new review guidelines and standards for cell therapies, and determination to bring in world-leading technologies and medicines to benefit cancer patients in China."

Dr. WU De-pei, Chair of the Department of Hematology at the First Affiliated Hospital of Soochow University, Co-Lead Investigator of Axicabtagene Ciloleucel (FKC876) clinical trial, "As a type of malignant cancer with heterogeneity in clinical manifestation, prognosis and other aspects, DLBCL is still facing a large number of unmet medical needs in China. As the first regulatory approved and commercially available CAR-T, the approval of Axicabtagene Ciloleucel (FKC876) provides oncologists with one more option and hope of long term survival to a patient population that previously exhausted all viable treatment options."

Dr. ZHAO Wei-li, Vice Chair of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Lead Investigator of Axicabtagene Ciloleucel (FKC876) clinical trial, comments, "The bridging trial results has demonstrated remarkable similarity between Axicabtagene Ciloleucel (FKC876) and Yescarta in terms of efficacy and safety in the treatment of Chinese adult patients with r/r LBCL. In the bridging trial, 79.2% of patients had achieved a response after a single infusion[1]; Zuma-1 data showed the best objective response rate was 83%, with 58% in complete remission[2]. Overall, Axicabtagene Ciloleucel (FKC876) has demonstrated durable response and survival rate with a manageable safety profile."

HUANG Hai, CEO of Fosun Kite, says, "We really appreciate NMPA’s recognition of Axicabtagene Ciloleucel (FKC876) manufacturing process, quality control and clinical efficacy. We will continue to fulfill our mission "focus on cancer cure". A big thanks to Professor ZHAO Wei-li’s team from Ruijin Hospital Affiliated to Shanghai Jiao Tong University as the Lead Investigator, together with Professor WU De-pei’s team from the First Affiliated Hospital of Soochow University, Professor Hu Yu’s team from Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and Professor . Zhang Hui-lai’s team from Tianjin Cancer Hospital, their trust and efforts in the registered clinical trials have promoted successful approval of Axicabtagene Ciloleucel (FKC876) in China. With patients at the center of what we do, Fosun Kite is working hard to make this revolutionary cancer treatment accessible to benefit patients in China as soon as possible."

About Large B-cell Lymphoma

Lymphoma refers to a class of heterogeneous cancers that are specific to the lymphatic system. It is divided into two categories based on cell type: Hodgkin’s lymphoma (HL) and non-Hodgkin’s lymphoma (NHL), and the latter is much more common. Epidemiology estimates 88,090 newly diagnosed NHL patients in China in 2018[4]. LBCL is the most common subtype of NHL among adult lymphoma patients, and it is a type of malignant cancer with heterogeneity in clinical manifestation, prognosis and other aspects; DLBCL incidence is approximately one-third of all NHL in China[5]. Studies have shown 40%-50% of DLBCL patients would become relapsed or refractory after first line treatments[6,7], 73% r/r DLBCL patients would not respond to two or more lines of treatments[8]. A study of 603 patients with r/r DLBCL showed median overall survival of only 6.3 months[8] indicating the limitations with current standard of care, associated with poor outcomes and creating a high unmet need.

About Yescarta

Yescarta is an autologous CD19-directed CAR-T cell therapy of Kite, approved for the U.S. market on October 18, 2017 by FDA for the treatment of adult patients with r/r LBCL after two or more lines of systemic therapy, including DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, and high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma. According to an ongoing single-arm, multi-center, open-label clinical study (ZUMA-1) carried out by Kite evaluating efficacy and safety of axicabtagene ciloleucel in 101 adult patients with r/r LBCL, 1-year follow-up results showed the best objective response rate of 82%, with 54% of patients achieved a complete remission[9]; at a median follow-up of 27.1 months post-infusion, the best objective response rate was 83%, with 58% in complete remission and 39% remain in complete remission[2]; at a median follow-up of 51.1 months, 44% of patients were alive and the median overall survival was 25.8 months[3], confirming that axicabtagene ciloleucel can bring long-term survival benefits to patients.

On June 24, 2021 SkylineDx reported to invest in research and development in the field of Squamous Cell Carcinoma (SCC), as part of a Dutch consortium including the Erasmus MC Cancer Institute, University Medical Center Rotterdam (EMC) (Press release, SkylineDx, JUN 24, 2021, View Source [SID1234584346]). The collaboration focuses on the discovery and validation of a model that identifies the SCC patient at high risk of developing metastasis. These high-risk patients would benefit from an intensive surveillance program to closely monitor the progress of their disease. The second objective is to enrich the model by adding genomic information to identify the most aggressive tumors among high-risk patients. Those patients may benefit from more aggressive or adjuvant treatment to reduce their risk of metastasis. This collaboration has a unique starting point because the researchers have extensive experience and will work with the unique infrastructure of large national routinely collected health care datasets of metastatic SCC patients.

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Squamous Cell Carcinoma is the second most common form of skin cancer and is diagnosed approximately 1.8 million times per year in the United States [2]. Exact number of people who develop or die from SCC is unknown as this cancer is not well-tracked globally and notably understudied. In general, 95% of patients have a good prognosis and will not develop SCC-related metastasis.

"Unfortunately, we lack predictive models that can differentiate these patients with a good prognosis from the patients at high risk of developing metastasis. Consequently, in current clinical practice, the entire patient population receives an intensive 5-year follow-up regime, putting an unnecessary burden on both patients and the healthcare system", comments Dr. Marlies Wakkee, Dermatologist at EMC. "This consortium is a strong collaborative effort between different experts from a scientific and a business perspective to develop and translate the scientific project to clinical practice. Through the support of this investment, we have the opportunity to truly improve the diagnostic, treatment and follow-up pathways of patients with this type of skin cancer".

"There is a huge medical unmet need affecting millions of Squamous Cell Carcinoma patients globally each year. I am confident that together with EMC, we can develop the prediction models into actionable molecular tests, ready for clinical use", concludes Dharminder Chahal, CEO SkylineDx. "After several research and study initiatives in melanoma, we now continue to expand our scope and add value as a company in a broader field of skin cancer".

On June 24, 2021 IN3BIO Research Limited reported that the company has received the Clinical Trial Application approval from the Bulgarian Drug Agency and Ethical Committee to initiate a Phase I/II clinical trial of its colorectal cancer vaccine in Bulgaria (Press release, In3Bio, JUN 24, 2021, View Source [SID1234584345]).

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IN3BIO will trial its innovative anti-EGF vaccine IN01, in combination with small molecule inhibitors (SMIs) in patients suffering from KRAS or NRAS (Cohort A) or BRAF (Cohort B) mutated colorectal cancer.

Erik D’Hondt, CEO of IN3BIO said "We are delighted to have reached this significant regulatory step to conduct our clinical trial in Bulgaria. This first approval will lead to patients being enrolled rapidly in centres in Bulgaria, then in clinical centres in other EU and non-EU countries".

About IN01

IN01 vaccine is a proprietary biologic fusion molecule designed and developed by IN3BIO. It is administered after mixing with an adjuvant Montanide ISA 51 VG ST to produce an extemporaneous water in oil emulsion (W/O) known to enhance the immune response of therapeutic vaccines.

The vaccination of IN01 produces anti-EGF antibodies which capture EGF and prevent it from binding to its target, i.e. EGF-receptor on cell surface. This prevents proliferation of tumour cells affected by EGF mediated pathways.

IN01 is manufactured in a contracted certified GMP facility in the EU. Extensive testing as a single molecule or in combination with SMIs showed no adverse effect in several pre-clinical studies.

On June 24, 2021 Shenzhen Chipscreen Biosciences’ licensing partner, HUYABIO International (HUYABIO), reported the regulatory approval for Tucidinostat (also known as Chidamide, Epidaza , HBI-8000) monotherapy of relapsed or refractory (R/R) adult T-cell leukemia/lymphoma (ATL) by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) (Press release, Shenzhen Chipscreen Biosciences, JUN 24, 2021, View Source;huyabio-international-receives-regulatory-approval-for-chidamide-monotherapy-of-adult-t-cell-leukemialymphoma-in-japan-301319258.html [SID1234584344]).

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"Relapsed and/or refractory ATLL carries a grim prognosis with limited treatment options. Data from the registration study of Chidamide has demonstrated meaningful disease response despite the advanced stage of disease, and acceptable safety profile, to address an important unmet medical need in this patient population", said Dr. Atae Utsunomiya, honorary hospital director of Imamura General hospital in Japan.

The drug was approved based on data from a Phase 2b study that involved 23 patients with aggressive ATL in Japan. These patients, having few effective treatment options, all had advanced disease either refractory to or relapsed after receiving mogamulizumab. Chidamide 40mg orally administered twice weekly resulted in disease response in a clinically meaningful proportion of patients with an acceptable safety profile.

Dr. Lu Xianping, Chairman and President of Chipscreen said, "this is an exciting news and important milestone for our licensing partner HUYABIO International and we wish them continue success in the global development of Chidamide for several other indications".

About Chidamide (Tucidinostat as INN also known as Epidaza , HBI-8000)

Chidamide is a first-in-class/best-in-class innovative medicine targeting selectively histone deacetylases (HDAC) 1, 2, 3 and 10, which was discovered and developed originally by Shenzhen Chipscreen Biosciences in China. It has unique epigenetic immunomodulatory activities approved and launched in Chinese market for the treatment of malignant T cell lymphoma at 2014 and metastatic breast cancer at 2019. It is currently at several late stage clinic studies for several other indications in China. The product’s ex-China rights were licensed out from Chipscreen to HUYABIO at 2006. Later on, HUYABIO partnered with Meiji Seika for Japanese market.

On June 24, 2021 Centene Corporation (NYSE: CNC) ("Centene" or the "Company") reported that it has commenced an underwritten public offering to sell $1,800,000,000 of senior notes due 2028 (the "Notes"), subject to market and other conditions (Press release, Centene , JUN 24, 2021, View Source [SID1234584343]).

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Centene intends to use the net proceeds from the offering of the Notes to finance a portion of the cash consideration payable in connection with Centene’s previously announced acquisition of Magellan Health Inc. ("Magellan Health" and such proposed acquisition, the "Magellan Acquisition") and to pay related fees and expenses. The closing of the offering is not conditioned on the closing of the Magellan Acquisition. If the Magellan Acquisition is not completed, Centene expects to use the net proceeds of the offering for debt repayment and general corporate purposes.

J.P. Morgan, Barclays, BofA Securities, Truist Securities and Wells Fargo Securities are acting as joint book-running managers for the offering of the Notes.

This offering is being made pursuant to an effective shelf registration statement and prospectus and a related preliminary prospectus supplement filed by the Company with the Securities and Exchange Commission (the "SEC"). Before you invest, you should read the prospectus and the related preliminary prospectus supplement, the registration statement and other documents that Centene has filed with the SEC for more complete information about Centene and this offering.

Copies of the prospectus supplement and related prospectuses for this offering can be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by calling +1 (866) 803-9204; from Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at [email protected], or by calling (888) 603-5847; from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department or by email at [email protected]; from Truist Securities by email at [email protected]; and from Wells Fargo Securities, LLC, 550 S. Tryon Street, 5th Floor, Charlotte, North Carolina 28202, Attention: Leveraged Syndicate.

This press release is neither an offer to purchase nor a solicitation of an offer to buy any securities, including the Notes. There shall not be any sale of the securities described herein in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.