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CASI Pharmaceuticals Announces Partner Juventas Completion Of Series C Financing Of $63 Million (RMB410 Million) For Acceleration Of CNCT19 Pivotal Trials And Commercialization

On October 25, 2021 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that Juventas Cell Therapy Ltd. ("Juventas") has completed a Series C financing round through which it raised more than RMB410 million (approximately $63 million (USD)) (Press release, CASI Pharmaceuticals, OCT 25, 2021, View Source [SID1234591919]). Juventas states that the funds will be used to pursue a new drug application in China and launch implementation of a commercialization and international research and development plan for CNCT19.

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CASI shares global co-commercial and profit-sharing rights with Juventas and indirectly owns a 12.0098% equity stake in Juventas on a fully diluted basis following completion of the Series C financing round. The Juventas’ financing was led by CICC Capital.

Dr. Wei-Wu He, CEO and Chairman of CASI comments: "CASI, through its commercialization of Evomela in China, has built a robust commercial team in the hematology-oncology market. Juventas is a leading cell therapy innovator in China. The collaboration between CASI and Juventas will speed up the adoption of CAR-T therapy in China, helping thousands of patients in need of this breakthrough therapy."

About CNCT19

CNCT19 targets CD19, a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies. CD19- targeted CAR constructs from several different institutions have demonstrated consistently high antitumor efficacy in children and adults with relapsed B-cell acute lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), and B-cell non-Hodgkin lymphoma (B-NHL). CD19 antigen is the most frequently used target in the CAR-T cell therapy clinical trials for hematological malignancies such as leukemia and lymphoma. Juventas is responsible for the development of CNCT19. CASI and Juventas will co-commercialize CNCT19 under the direction of the program’s joint steering committee.

BioMarin to Participate in Four Upcoming Virtual Investor Conferences

On October 25, 2021 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported that management will participate in four upcoming virtual investor conferences (Press release, BioMarin, OCT 25, 2021, View Source [SID1234591918]). An audio webcast of the presentations will be available live. You can access the webcasts at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.

Varian and the Cincinnati Children’s/UC Health Proton Therapy Center Complete Enrollment of FAST-01, First Human Clinical Trial of FLASH Therapy for Cancer

On October 25, 2021 Varian, a Siemens Healthineers company, and the Cincinnati Children’s/UC Health Proton Therapy Center reported the completion of enrollment in FAST-01 (FeAsibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases), the first human clinical trial of FLASH therapy (Press release, Varian Medical Systems, OCT 25, 2021, View Source [SID1234591917]).

The FAST-01 trial, which is evaluating clinical workflow feasibility of the FLASH therapy and treatment-related side effects, met its enrollment target of 10 participants with bone metastases in the extremities. The clinical trial, informed by years of preclinical work, was designed by experts at Varian and multiple centers in the FlashForwardTM Consortium, including Cincinnati’s Children’s/UC Health Proton Therapy Center and the New York Proton Center.

The FAST-01 trial is being led by John C. Breneman, M.D., principal investigator, and Medical Director of the Cincinnati Children’s/UC Health Proton Therapy Center, UC Health radiation oncologist, and professor emeritus at the University of Cincinnati College of Medicine. "The completion of enrollment brings the clinical community one step closer to making an informed evaluation of FLASH therapy," said Dr. Breneman. "The team is looking forward to reviewing and sharing the findings, while also looking ahead toward the next clinical phase of research," he added.

The trial is supported by Emily Daugherty, M.D., assistant professor of radiation oncology at UC and a UC Health radiation oncologist, and Anthony Mascia, PhD, DABR, adjunct assistant professor of radiation oncology at UC and Director of Medical Physics at the Cincinnati Children’s/UC Health Proton Therapy Center.

"Clinical trial investigators have worked diligently to complete enrollment of FAST-01 over the last year. Achieving this significant milestone is a vital step forward to demonstrating the feasibility of using FLASH therapy in a clinical setting and not just in a laboratory," said Agam Sharda, Vice President of Flash Solutions at Varian. "We are grateful to the trial subjects who, by virtue of their participation, have contributed to the advancement of FLASH technology, for the potential future benefit of others who may one day need to undergo treatment for cancer."

"Initial findings indicate that the Varian ProBeam system, modified to deliver FLASH therapy, is performing as planned during the study. To date, none of the trial participants have suffered any serious adverse events related to FLASH," said Ricky Sharma, M.D. Ph.D., Vice President of Clinical Affairs at Varian. "There is still much work and research to be done, and we are eager to explore all the clinical trial data."

About FLASH Therapy

FLASH therapy, an experimental treatment modality delivering radiation therapy at ultra-high dose rates in typically less than one second, may be over 100 times faster compared to conventional radiation therapy. The concept of ultra-high dose rate radiation delivery has been studied for many years. Dedicated research and development by the team at Varian and the clinical collaborators in the FlashForward Consortium has led towards the advancement of FLASH therapy to the clinical study stage. The FlashForward Consortium, a 25-member group of institutions from around the world, includes over 150 experts in radiation oncology, translational sciences and medical physics. 

Lantern Pharma to Host Third Quarter 2021 Operating & Financial Results Conference Call on Monday, November 1, 2021 at 4:30 p.m. ET

On October 25, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that it will host a conference call on Monday, November 1, 2021 at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time (Press release, Lantern Pharma, OCT 25, 2021, View Source;financial-results-conference-call-on-monday-november-1-2021-at-430-pm-et-301407949.html [SID1234591916]).

Management intends to discuss the financial and operating results for the third quarter ended September 30, 2021 and provide guidance on upcoming milestones. The call will be led by Panna Sharma, President and Chief Executive Officer of Lantern Pharma. He will be joined on the call by other members of the management team.

A replay of the conference call will be available on the investor relations section of the Company’s website: ir.lanternpharma.com.

Angel Pharmaceuticals Announces Approval of IND Application in China for ITK Inhibitor CPI-818

On October 25, 2021 Angel Pharmaceuticals Co., Ltd. ("Angel Pharma") reported that its IND application for CPI-818, a small molecule ITK inhibitor, has been approved by the Center for Drug Evaluation (CDE) to initiate clinical trials in patients with relapsed/refractory T-cell lymphomas (TCL) in China (Press release, Angel Pharmaceuticals, OCT 25, 2021, prnewswire.com/news-releases/angel-pharmaceuticals-announces-approval-of-ind-application-in-china-for-itk-inhibitor-cpi-818-301407424.html [SID1234591915]).

CPI-818, the first-and-only ITK inhibitor in clinical development, has been shown to selectively inhibit ITK (interleukin-2-inducible T-cell kinase) without effect on related kinases such as RLK (resting lymphocyte kinase) and BTK (Bruton’s tyrosine kinase). Angel Pharma licensed the rights to CPI-818 from Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS) for development, manufacturing and commercialization in China. Corvus is studying CPI-818 in a multi-center Phase 1b/2 clinical trial in patients with several types of TCL in the U.S. and Asia. Overall, CPI-818 has been shown to be well-tolerated, and has shown anti-tumor activity in peripheral T-cell lymphomas (PTCL) and in cutaneous T-cell lymphomas. As reported at the annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2020, 2 of 7 patients with refractory PTCL experienced responses to treatment with CPI-818; one complete response and one partial response.

"This marks an important milestone in our efforts to bring this potential first-in-class innovative drug to patients in China. We are excited about working with top lymphoma experts in China to accelerate the development of CPI-818 to address unmet clinical need." said Richard A. Miller, M.D., co-founder and chairman of Angel Pharmaceuticals.

Professor Song Yuqin, Director of the Chinese Society of Clinical Oncology (CSCO), Secretary-General of the Anti-Lymphoma Alliance of the CSCO, and Deputy Director of Lymphoma Department at Peking University Cancer Hospital, said: "Relapsed/refractory T-cell lymphoma is a challenging group of non-Hodgkin’s lymphoma. Current five-year overall survival rates for the majority of patients are 10-30%. We are very pleased that Angel Pharmaceuticals brought the only clinical phase ITK inhibitor to China. We hope that the clinical development of the product in China progress successfully to benefit patients with relapsed/refractory T-cell lymphoma."

About CPI-818

CPI-818 is an investigational small molecule drug given orally that has selectively inhibited ITK (interleukin-2-inducible T-cell kinase) in preclinical studies. It was designed to possess dual properties: to block malignant T-cell growth and to modulate immune responses. ITK, an enzyme, is expressed predominantly in T-cells and plays a role in T-cell and natural killer (NK) cell lymphomas and leukemias, as well as in normal immune function. Interference with ITK signaling can modulate immune responses to various antigens. The Company believes the inhibition of specific molecular targets in T-cells may be of therapeutic benefit for patients with T-cell lymphomas and in patients with autoimmune diseases. Corvus is conducting a Phase 1b/2 trial in patients with refractory T-cell lymphomas in the U.S. and Angel Pharmaceuticals, which has rights to CPI-818 in China, is leading a global trial in patients with relapsed/refractory (R/R) T-cell lymphomas.