On June 24, 2021 Mevion Medical Systems reported that the first proton center in the Mountain West, the Senator Orrin G. Hatch Center for Proton Therapy, has opened at Huntsman Cancer Institute (HCI) at the University of Utah (U of U) and began treating patients on May 11th with the MEVION S250i Proton Therapy System (Press release, Mevion Medical Systems, JUN 24, 2021, View Source [SID1234584331]). Despite the challenges of the COVID-19 pandemic, the Mevion team successfully installed the MEVION S250i in 7 months from the delivery of the accelerator.

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HCI is the only National Cancer Institute-designated Comprehensive Cancer Center in the Mountain West and serves a geographic region that includes all of Utah, Idaho, Montana, Nevada, and Wyoming.

"After more than a decade of monitoring and evaluating the evolution of proton therapy technology, along with the needs of our patients, we are excited to officially launch our proton center and to provide this extraordinary treatment option to our patients," said Bill Salter, Ph.D., Senior Director of Radiation Oncology at HCI and Professor and Chief of the Division of Medical Physics at the U of U. "Our initial experience of treating both adult and pediatric tumors has already made evident the unique clinical capabilities of proton technology."

The center features Mevion’s industry leading HYPERSCAN pencil beam scanning technology and Adaptive Aperture pMLC. The powerful duo provides faster and more precise dose delivery and minimizes damage to surrounding healthy tissue and sensitive organs at risk. HCI has also integrated a diagnostic CT on-rail system and a surface-guidance tracking system, enabling a state-of-art Image-Guided Proton Therapy (IGPT) configuration to align and treat patients with the upmost accuracy.

Thanks to the reduced size and complexity of the MEVION S250i, the HCI Center for Proton Therapy was placed in a small available space alongside HCI’s existing radiation therapy department. This significantly decreased the project construction and operation cost and allows the cancer center to share existing resources and give patients access to all of HCI’s cancer treatment and research offerings under one roof.

"It is to our greatest pleasure that the underserved patients in the Mountain West now have access to proton therapy," said Tina Yu, Ph.D., chief executive officer of Mevion Medical Systems. "We are honored to partner with HCI to make this happen and look forward to our many years of collaboration and research to further advance this superior treatment modality."

As the leading supplier of compact proton therapy systems in the United States, Mevion has been selected by more leading cancer centers, including NCI-Designated Cancer Centers, and has treated over 6,000 patients worldwide.

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 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, reported that Thierry Guillaudeux, Ph.D., SVP Immuno-oncology at Kineta, participated on multiple panel presentations during the virtual symposium "VISTA: A New Immune Checkpoint in Cancer, Autoimmunity and Beyond," that took place on June 18, 2021 (Press release, Kineta, JUN 24, 2021, View Source;utm_medium=rss&utm_campaign=kinetas-thierry-guillaudeux-participated-on-multiple-panel-presentations-during-virtual-symposium-on-vista-a-new-immunotherapy-approach-to-treating-cancer [SID1234584382]).

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"It was a great pleasure to participate in this symposium focused on VISTA", said Thierry Guillaudeux of Kineta. "The scientific presentations and discussions from the different panelists clearly emphasized how VISTA is a promising new immuno-oncology target for treating patients with advanced tumors. Its unique mechanism of action involving both an innate and adaptive immune response illustrates that antibody therapy targeting VISTA could be an important new path in cancer treatments with this new generation of checkpoint inhibitors."

The scientific symposium focused on the emerging checkpoint inhibitor VISTA, its function, the role it plays in several oncology and current development programs. The event was hosted by Randolph Noelle, Ph.D., Professor of Microbiology and Immunology, Department of Microbiology and Immunology, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth; and Padmanee Sharma, M.D., Ph.D., Professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, University of Texas, MD Anderson Cancer Center.

"Kineta has made tremendous progress developing KVA12.1, our novel anti-VISTA antibody currently in preclinical evaluation", said Thierry Guillaudeux of Kineta. "We nominated KVA12.1 as our lead clinical candidate earlier this year and have initiated IND enabling studies. We expect to initiate Phase 1 safety and tolerability studies in mid-2022".

On June 24, 2021 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that the first patient has been dosed in the Phase 1b portion of KOMET-001, a Phase 1/2 clinical trial of the Company’s oral, potent and selective menin inhibitor, KO-539, in patients with relapsed or refractory acute myeloid leukemia (AML) (Press release, Kura Oncology, JUN 24, 2021, View Source [SID1234584316]).

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KO-539 demonstrated a wide therapeutic window in the Phase 1a dose-escalation portion of KOMET-001, with promising single-agent activity from 50 mg to 800 mg in an all-comer population of patients with relapsed or refractory AML, including patients with NPM1 mutations and KMT2A rearrangements. The Phase 1b portion of the study is designed to determine the lowest dose of KO-539 that provides maximum biologic and clinical effect in two expansion cohorts – a low dose (200 mg) and a high dose (600 mg) – each enriched with NPM1-mutant and KMT2A-rearranged relapsed/refractory AML patients. Both doses have demonstrated preliminary evidence of biologic and clinical activity and were determined to be safe and well tolerated in the Phase 1a portion of the study.

Kura expects to enroll at least 12 patients in each of the Phase 1b expansion cohorts and assess those patients for safety and tolerability, pharmacokinetics, pharmacodynamics and efficacy in order to determine the recommended Phase 2 dose. In addition, the Phase 1b gives the Company flexibility to enroll up to 18 additional patients per cohort, as appropriate. Kura believes that data from patients enrolled in the cohort selected as the recommended Phase 2 dose can be included as part of the registration-directed portion of the KOMET-001 trial.

"We believe KO-539 has the potential to be both a first-in-class and a best-in-class menin inhibitor," said Stephen Dale, M.D., Chief Medical Officer of Kura Oncology. "We intend to conduct a comprehensive clinical development plan for KO-539, both as a monotherapy and in front-line combination studies. A critical component of this plan is the determination of an optimal dose, particularly given the compelling efficacy, safety and wide therapeutic window of KO-539. These Phase 1b expansion cohorts enable us to gather a more robust dataset in our targeted populations and help refine selection of a recommended dose for Phase 2 and beyond, while maintaining an aggressive development timeline for the program. We look forward to presenting data at a future medical meeting."

In December 2020, Kura reported preliminary clinical data from the KOMET-001 clinical trial of KO-539 at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. These data were highlighted by single-agent activity in patients with relapsed or refractory AML, including patients with NPM1 mutations and KMT2A rearrangements. KO-539 also demonstrated a favorable safety and tolerability profile, with no drug discontinuations due to treatment-related adverse events and no evidence of QTc prolongation.

About Acute Myeloid Leukemia

AML is the most common acute leukemia in adults and begins when the bone marrow makes abnormal myeloblasts (white blood cells), red blood cells or platelets. Despite the many available treatments for AML, prognosis for patients remains poor, especially in the relapsed/refractory setting. More than 50% of patients with AML who achieve a CR after induction therapy relapse within one to three years, and less than 10% of those with relapsed/refractory AML are alive at three years. Prognosis is poor in patients with KMT2A rearrangements and in those with co-mutations that may include NPM1.

About KOMET-001

KOMET-001 (Kura Oncology Menin Inhibitor Trial) is a Phase 1/2, first-in-human, open-label trial to determine the safety, tolerability and anti-tumor activity of KO-539 in patients with refractory or relapsed AML. The Phase 1b portion is currently open to enroll patients with NPM1 mutations or KMT2A-rearrangments. A Phase 2 registration-enabling expansion portion is planned following determination of the optimal Phase 2 dose. Additional information about KOMET-001 can be found at kuraoncology.com/clinical-trials-komet.

About KO-539

KO-539 is a novel, once-daily, oral investigational drug candidate targeting the menin-KMT2A/MLL protein-protein interaction for treatment of genetically defined AML patients with high unmet need. In preclinical models, KO-539 inhibits the KMT2A/MLL protein complex and exhibits downstream effects on HOXA9/MEIS1 expression and potent anti-leukemic activity in genetically defined preclinical models of AML. KO-539 has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of AML.

On June 24, 2021 Foundation Medicine, Inc. and its collaborators reported results from a Dana-Farber Cancer Institute-led study that used genomic testing, including Foundation Medicine’s liquid-based comprehensive genomic profiling (CGP) test, FoundationOneLiquid CDx, among several assays, to investigate resistance mechanisms in 38 patients with cancer treated with a KRAS G12C inhibitor (Press release, Foundation Medicine, JUN 24, 2021, View Source [SID1234584332]). The study found a complex landscape of acquired resistance mechanisms, with putative resistance mechanisms identified in 45% of patients. These mechanisms were diverse, and some patients (18%) had multiple resistance alterations. Study findings support the need for development of additional KRAS inhibitors and combination treatment strategies and reinforce the utility of liquid biopsy assays in evaluating resistance. The study, "Acquired Resistance to KRAS G12C Inhibition in Cancer," was published yesterday in The New England Journal of Medicine.

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The KRAS oncogene encodes a protein frequently altered in cancer, and mutations typically occur at hotspots in the protein, increasing the activity of KRAS and driving pro-tumorigenic signaling. Although KRAS mutations are among the most common cancer drivers, only recently have investigational KRAS inhibitors entered clinical development, with the first KRAS inhibitor just approved for certain patients with lung cancer. In this study of patients receiving an investigational therapy, researchers identified multiple resistance pathways – in some cases even within a single sample – through the use of genomic testing from several labs. These findings help researchers better understand the landscape of acquired resistance to KRAS inhibitors to inform the development of additional therapeutics targeting KRAS alterations or combination therapies designed to block oncogenic signaling and result in clinical responses.

"Resistance mechanisms to cancer treatment are often complex, which is challenging for oncologists and researchers to describe and effectively counter. That’s why we were excited to help incorporate genomic testing though Foundation Medicine’s comprehensive liquid biopsy assay into this study – one of the first analyzing resistance mechanisms to KRAS inhibitors," said Alexa Schrock, Ph.D., Director, Clinical Development at Foundation Medicine. "Comprehensive liquid biopsy assays not only enable widespread access to genomic testing, which is particularly appealing to patients with treatment resistance, but they also provide insights to help drive the development of new therapeutic approaches for these patients."

The study included a total of 38 patients, 27 with non-small cell lung cancer (NSCLC), 10 with colorectal cancer and one with appendiceal cancer. Using multiple genomic tests, mechanisms of putative resistance to adagrasib monotherapy were detected in 17 patients (45% of the cohort), eight of whom had multiple resistance mechanisms. In one patient with NSCLC (tested with FoundationOne Liquid CDx), testing revealed acquired KRAS alterations including H95D, R68S​, G12W​ and G12V, as well as acquired RTK and MAPK pathway alterations.

This clinical analysis was aided by a deep mutational scanning screen of a library of KRAS G12C variants that systematically defined potential secondary alterations conferring resistance to KRAS G12C inhibition. The findings suggest a diverse landscape of KRAS G12C inhibitor resistance mechanisms, which can help inform novel therapeutic strategies to effectively overcome this drug resistance in patients with cancer.

About FoundationOneLiquid CDx

FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.