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]).

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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. 

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]).

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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.

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]).

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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.

On October 25, 2021 Palleon Pharmaceuticals, a company pioneering the field of glyco-immunology to treat cancer and inflammatory diseases, reported it will present new preclinical data on the company’s lead immuno-oncology program, E-602, at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in Washington, D.C., from November 10-14, 2021 (Press release, Palleon Pharmaceuticals, OCT 25, 2021, View Source [SID1234591914]).

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Palleon’s poster highlights recent preclinical data from in vitro and in vivo studies of the company’s most advanced therapeutic candidate, E-602 (formerly known as Bi-Sialidase). E-602 is part of the company’s novel cancer immunotherapy platform, EAGLE (Enzyme-Antibody Glycan-Ligand Editing), which utilizes engineered human sialidase to degrade immunosuppressive sialoglycans.

In addition to the poster presentation, Palleon will be hosting a hybrid (live and virtual) scientific symposium at SITC (Free SITC Whitepaper) on November 11th featuring Palleon Scientific Co-Founder Carolyn Bertozzi, Ph.D., Scientific Advisor James Paulson, Ph.D., and Chief Medical Officer David Feltquate, M.D., Ph.D. The session will review the most recent state of the science of sialoglycan-mediated immune regulation and its potential relevance for immuno-oncology therapeutics. To learn more and register to attend, visit this link.

"We’re looking forward to sharing more about the development of our EAGLE platform and the lead program E-602, which we believe is a uniquely powerful way to reverse the immunosuppressive effect of cell-surface sialoglycans," said Li Peng, Ph.D., Chief Scientific Officer. "These data will inform our upcoming Phase 1 clinical trial of E-602, as well as our growing pipeline of EAGLE therapeutic candidates in oncology."

Details of the poster presentation are as follows:

Title: Development and engineering of human sialidase for degradation of immunosuppressive sialoglycans to treat cancer

Number: 843

Presenter: Li Peng, Ph.D., Chief Scientific Officer

Details of the symposium are as follows:

Title: Sialoglycan-Mediated Immune Regulation: Glycobiology Meets Immuno-Oncology

Timing: November 11, 2021, 6:30 p.m. – 8:00 p.m. EST

Registration Link

Presenters:

Carolyn Bertozzi, Ph.D.

Anne T. and Robert M. Bass Professor of Chemistry at Stanford University; Baker Family Director of Stanford ChEM-H; Scientific Co-Founder, Palleon Pharmaceuticals

James Paulson, Ph.D.

Cecil H. and Ida M. Green Professor and Co-Chair, Department of Molecular Medicine, and Professor, Department of Immunology and Microbiology, Scripps Research Institute; Scientific Advisor, Palleon Pharmaceuticals

David Feltquate, M.D., Ph.D.

Chief Medical Officer, Palleon Pharmaceuticals

On October 25, 2021 Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company at the forefront of stem cell-based delivery of oncolytic viruses, reported its selection as a finalist for presentation during the Innovation Showcase at the upcoming sixth annual Oncolytic Virotherapy Summit, which will be held October 26 through October 28, 2021, in Boston, MA (Press release, Calidi Biotherapeutics, OCT 25, 2021, View Source [SID1234591913]).

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For the first time, the Oncolytic Virotherapy Summit will host the Oncolytic Virotherapy Innovation Showcase. Calidi Biotherapeutics has been selected as one of the 10 finalists to present its novel platform technology to the entire summit audience during the Pre-Conference Focus Day.

"We are very pleased with the decision of the prestigious selection committee to invite Calidi to present our stem cell-based technology for delivery and potentiation of oncolytic viruses," said Boris Minev, MD, President of Medical and Scientific Affairs at Calidi Biotherapeutics. "This meeting presents a valuable opportunity to understand the latest advances in our field and explore collaborative opportunities with potential clinical, academic, and industry partners. Ultimately, Calidi’s participation in this summit provides a significant platform to share our novel technology with a target audience both highly focused and experienced in our field."

Calidi’s presentation at the Oncolytic Virotherapy Innovation Showcase will focus on its proprietary stem cell-based delivery systems, shown to effectively protect, amplify, and potentiate oncolytic viruses from elimination by the patient’s immune system. The therapeutic utility of Calidi’s novel technology platforms is supported by clinical findings, published in The Lancet Oncology and Journal of Translational Medicine.