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 CANbridge Pharmaceuticals, Inc., a leading China-based global rare disease-focused biopharmaceutical company committed to the research, development and commercialization of transformative therapies, reported that it has entered into a research collaboration and license agreement with Scriptr Global, Inc., for the development of a gene therapy treatment targeting dystrophinopathies (Press release, CANbridge Life Sciences, OCT 25, 2021, View Source [SID1234591931]). CANbridge will gain exclusive worldwide rights to develop, manufacture and commercialize a gene therapy candidate for the treatment of dystrophinopathies, using Scriptr Global’s Stitchr platform, a proprietary ribozyme-mediated RNA assembly technology. Scriptr Global will be responsible for research, while CANbridge will assume all responsibilities for development, manufacturing, regulatory, and commercialization.

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The financial terms of the agreement include an upfront payment, development and sales payments, upon hitting certain milestones, as well as royalties based on net sales.

"We are pleased to be aligning with Scriptr Global and the Stitchr technology platform, which we believe has the potential to revolutionize the dystrophinopathy gene therapy field," said James Xue, Ph.D., Founder, Chairman and CEO of CANbridge Pharmaceuticals, Inc.

"The need for a transformative therapeutic approach for those individuals and families impacted with dystrophinopathies is great. Scriptr Global is delighted to undertake this important work with CANbridge utilizing Scriptr Global’s novel platform technology," stated Keith Alkek, Co-Founder Chairman and CEO of Scriptr Global, Inc.

About dystrophinopathies

Dystrophinopathies are X-linked genetic muscular diseases which include Duchenne muscular dystrophy (DMD), Becker muscular dystrophy (BMD) and DMD-associated dilated cardiomyopathy (DCM). DMD usually presents in early childhood and is characterized by rapidly progressive muscle degeneration and weakness, leading to loss of ambulation by about 12 years of age. BMD is characterized by later-onset skeletal muscle weakness. Cardiomyopathy is a common cause of morbidity and death in both DMD and BMD patients. DCM is characterized by left ventricular dilation and congestive heart failure, usually with no clinical evidence of skeletal, or voluntary muscle involvement. The incidence of DMD is estimated to be 1/3,500 – 1/5,000 male births worldwide and 1/4,560 in China. The incidence of BMD is estimated to be 1/18500 – 1/30,000 male births, according to the National Organization for Rare Disease and published peer reviews. The prevalence of DCM is unknown.

On October 25, 2021 Alkermes plc (Nasdaq: ALKS) reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nemvaleukin alfa (nemvaleukin), the company’s novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy, in combination with pembrolizumab, an anti-PD-1 antibody, for the treatment of platinum-resistant ovarian cancer (Press release, Alkermes, OCT 25, 2021, View Source [SID1234591900]). The FDA previously granted Fast Track designation and Orphan Drug designation to nemvaleukin for the treatment of mucosal melanoma.

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"This Fast Track designation in platinum-resistant ovarian cancer highlights the potential clinical utility of nemvaleukin in combination with pembrolizumab in this difficult-to-treat disease for which there is no approved immunotherapy and there remains significant need for new treatment options," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "We are excited to initiate our planned ARTISTRY-7 phase 3 trial in platinum-resistant ovarian cancer, as we advance nemvaleukin toward potential registration and seek to help patients living with this disease."

Fast Track is an FDA process designed to facilitate the development, and expedite the review, of potential therapies that seek to treat serious conditions and fill an unmet medical need. A drug candidate that receives Fast Track designation is eligible for more frequent communication with the FDA throughout the drug development process and a rolling and/or priority review of its marketing application if relevant criteria are met. For more information on Fast Track designation, please visit the FDA’s website, available at View Source

About Nemvaleukin Alfa (nemvaleukin)
Nemvaleukin is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to preferentially expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by selectively binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating nemvaleukin as a potential immunotherapy for cancer. The ARTISTRY program is comprised of multiple clinical trials evaluating intravenous and subcutaneous dosing of nemvaleukin, both as a monotherapy and in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced solid tumors. Ongoing trials in the ARTISTRY program include: ARTISTRY-1, ARTISTRY-2, ARTISTRY-3 and ARTISTRY-6.

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 Mevion Medical Systems reported that it has signed a contract with Kansas City Urology Care (KCUC) for the purchase of a MEVION S250i Proton Therapy System with HYPERSCAN Pencil Beam Scanning technology (Press release, Mevion Medical Systems, OCT 25, 2021, View Source [SID1234591932]).

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Proton therapy is a precise form of radiation therapy that can reduce the amount of unnecessary radiation exposure to healthy tissue, which has the potential to reduce side effects, escalate dose, and lessen the risk of secondary malignancies. HYPERSCAN technology utilizes a unique combination of optimum spot sizes, hyper-fast layer switching and a novel multi-layer proton MLC. This powerful trio provides faster and more precise dose delivery and minimizes sensitivity to motion, allowing clinicians to deliver a full field of therapeutic radiation in a single breath-hold.

The size and cost of larger proton technologies has been a major impediment to the adoption of proton therapy. By reducing the size and complexity of a proton therapy system, Mevion has overcome the practical challenges of other technologies, and created a much more compact, affordable solution. Today, new proton therapy centers in the US are almost exclusively compact single-room systems and Mevion is the preferred compact provider in the US.

"Mevion has taken the lead and has democratized proton therapy to the point where centers of all sizes can participate in the incredible benefits proton therapy can provide to their patients," said Tina Yu, CEO of Mevion. "We are very excited to partner with KCUC to bring this technology to the patients of Kansas City."

Kansas City Urology Care is the premier center for urology care in Kansas City that assures cutting-edge treatment solutions for all forms of urological conditions. For more, information about Kansas City Urology Care, please visit, www.KCUC.com.

2021 ASTRO Annual Meeting

Mevion will attend the American Society of Radiation Oncology (ASTRO) 2021 Annual Meeting from October 24th-26th. After 2020’s virtual-only event, ASTRO 2021 returns live at McCormick Place in West Chicago, where Mevion will highlight its recent updates, including a FLASH Therapy* research kit, that is expected to be made available to users in 2022, to help empower research centers of all sizes to study the potential benefits of FLASH. Mevion also invite attendees to experience the speed and precision of HYPERSCAN with RayStation 11A and learn more about our 24/7 clinical availability and the fastest installation time in the industry at booth #601.

*FLASH Therapy is currently under preclinical research and is not yet available for commercial sale or clinical use.