On June 14, 2021 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that it has entered into an agreement to divest its rights for the antiepileptic agent Zonegran (generic name: zonisamide) in Europe, the Middle East, Russia, and Australia to Advanz Pharma (Headquarters: London, CEO: Graeme Duncan) (Press release, Eisai, JUN 14, 2021, View Source [SID1234583984]).

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Zonegran is an antiepileptic drug (AED) originally created by Dainippon Pharmaceutical Co., Ltd. (currently Sumitomo Dainippon Pharma Co., Ltd.), for which Eisai holds the exclusive rights in a number of European countries, the Middle East, Russia, Australia, Canada, Mexico, and Asian countries. Under this agreement, Eisai will divest its rights associated with Zonegran in such European countries, the Middle East, Russia, and Australia to Advanz Pharma. Eisai will continue to act as the distributor in Russia, through its local affiliate Limited Liability Company Eisai, and Australia through its local affiliate Eisai Australia Pty. Ltd., for an agreed transition period. In addition, Eisai and Advanz Pharma have agreed to enter into a supply agreement under which Eisai’s UK affiliate, Eisai Manufacturing Ltd., will serve as Advanz Pharma’s supplier of Zonegran for the transferred territory for an agreed transition period.

Eisai will retain its rights to Zonegran in Canada, Mexico and Asian countries and continue to distribute the product in certain licensed Asian countries.

Eisai believes that this divestiture agreement with Advanz Pharma will lead to maximization of the antiepileptic agent’s product value. In addition, the agreement will enable Eisai to strategically reallocate resources to other mid-to-long-term business growth areas so as to continue to make further contributions to address the diversified needs of, and increase the benefits provided to, patients and their families.

On June 14, 2021 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company pioneering a new class of small-molecule medicines that selectively destroy disease-causing proteins through degradation, reported that the first patient has been dosed in the Company’s clinical trial of CFT7455, an orally bioavailable MonoDAC targeting IKZF1/3 for the treatment of multiple myeloma and non-Hodgkin’s lymphomas, including peripheral T-cell lymphoma and mantle cell lymphoma (Press release, C4 Therapeutics, JUN 14, 2021, View Source [SID1234583950]).

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"Initiating enrollment in the CFT4755 Phase 1/2 trial is a significant milestone in the clinical development of this innovative treatment for hematologic malignancies and reflects C4T’s focus on advancing programs in our portfolio that have the potential to improve outcomes for patients with cancer," said Andrew Hirsch, chief executive officer of C4 Therapeutics. "We are excited to learn more about the safety and efficacy of CFT7455 in the current clinical trial and expect to share data from this study in 2022."

The Phase 1/2 trial will primarily investigate safety, tolerability, and anti-tumor activity, with secondary and exploratory objectives to characterize the pharmacokinetic and pharmacodynamic profile of CFT7455. The Phase 1 portion of this study will explore CFT7455 as a single agent in patients with relapsed or refractory (R/R) multiple myeloma (MM) and non-Hodgkin’s lymphomas (NHL), and in combination with dexamethasone in R/R MM patients. Following identification of recommended dosage, the Phase 2 portion of the trial is expected to expand to four investigational arms: (1) relapsed/refractory MM, single agent CFT7455; (2) relapsed/refractory MM, CFT7455 combined with dexamethasone; (3) peripheral T-cell lymphoma, single agent CFT7455; and (4) mantle cell lymphoma, single agent CFT7455. Across the Phase 1/2 trial, C4T plans to enroll a total of approximately 160 patients.

"Dosing our first patient with CFT7455 is a pivotal event for C4T that demonstrates the progress we have made to efficiently design highly potent degrader medicines with our TORPEDO platform," said Marc Cohen, executive chairman and co-founder of C4 Therapeutics. "With our first program now in the clinic, we look forward to leveraging our expertise across discovery and clinical development to advance our pipeline and reach the goal of having four programs in the clinic by year-end 2022."

About CFT7455

CFT7455 is an orally bioavailable MonoDAC (Monofunctional Degradation Activating Compound) designed to bind with high affinity to the E3 ligase adapter protein, cereblon, to target and degrade IKZF1/3 for the treatment of multiple myeloma (MM) and non-Hodgkin’s lymphomas (NHLs), including peripheral T cell lymphoma (PTCL) and mantle cell lymphoma (MCL). In preclinical studies, CFT7455 has demonstrated potent and selective protein degradation with favorable pharmacological properties. C4T submitted an IND for CFT7455 in December 2020, for which the Company received clearance from the U.S. Food and Drug Administration in January 2021. The Company initiated a Phase 1/2 clinical trial for CFT7455 in June 2021. More information about this trial may be accessed at www.clinicaltrials.gov (identifier: NCT04756726).

On June 14, 2021 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that Douglas E. Onsi, President and Chief Executive Officer, will present a corporate overview at the Raymond James 2021 Virtual Human Health Innovation Conference on Monday, June 21, 2021 at 1:20 p.m. Eastern Time (Press release, Leap Therapeutics, JUN 14, 2021, View Source [SID1234583966]).

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The presentation will be webcast live and may be accessed on the Investors page of the company’s website at View Source, where a replay of the event will also be available for a limited time.

On June 14, 2021 GENinCode UK Limited, the cardiovascular disease company focused on predictive genetics for the prevention of cardiovascular disease, reported its partnership with EVERSANA Life Sciences LLC ("EVERSANA") as its launch and commercialisation partner to access the United States market for the GENinCode portfolio of polygenic cardiovascular disease ("CVD") products focused on genetic risk (Press release, EVERSANA, JUN 14, 2021, View Source [SID1234583985]).

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EVERSANA is a leading provider of global commercial services to the life sciences industry. In the United States, GENinCode will utilise EVERSANA’s COMPLETE Commercialisation model fully integrating services that include market access, agency services, clinical and commercial field teams, medical science liaisons, channel management, health economics and outcomes research and compliance, with each service optimised by data and predictive analytics. The suite of expertise will underpin and accelerate the launch of GENinCode’s first product Cardio inCode for the risk assessment of CVD in primary prevention. The EVERSANA group comprises over 4,000 employees.

GENinCode specialises in polygenic risk assessment for the onset of cardiovascular disease with the Company’s technology providing clinicians with genetic risk assessment and AI bioinformatics to inform, predict and prevent cardiovascular events. CVD is the leading cause of death and disability worldwide accounting for one in every four deaths in the United States. In 2010, the global cost of CVD was approximately US $863 billion. By 2030, this figure is set to rise to US $1,044 billion and is both a major health issue and global economic burden.

CVD is a broad disease classification which encompasses conditions such as coronary artery disease (causing angina, heart attacks, heart failure), cerebrovascular disease (causing stroke, and some dementia), peripheral vascular disease (causing limb ischaemia, and some chronic kidney disease) and venous thromboembolism.

GENinCode will deliver its portfolio of polygenic CVD products through its partnership with EVERSANA.

GENinCode and EVERSANA have a vision to inform patients about their cardiovascular risk and to improve public health by using the predictive capability of genomics to assist in making lifestyle choices and targeting treatment to improve patient outcomes. Over the past 15 years GENinCode has amassed significant investment in its research, data, bioinformatics technology and product development to assess disease risk to prevent the onset of CVD.

Matthew Walls, CEO, GENinCode said: "We have worked closely with the EVERSANA team over the past 12 months and are delighted to announce our US partnership. EVERSANA provide proven launch and commercialisation expertise to support our market access and will help accelerate our speed to market."

Jim Lang, CEO of EVERSANA said: "GEN inCode’s approach to understanding and addressing genetic risk is revolutionary and as such, these products demand a commercialisation model that bypasses traditionally strategies to acceleration launch, access and impact. EVERSANA is eager to put the full power of our platform to work."

On June 14, 2021 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported that data will be presented during two plenary sessions at the International Society for Stem Cell Research 2021 Virtual Annual Meeting, to be held Monday, June 21 through Saturday, June 26 (Press release, Sana Biotechnology, JUN 14, 2021, View Source [SID1234584008]).

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Chuck Murry, M.D., Ph.D., Sana’s Head of Cardiometabolic Cell Therapy, will be presenting "Genome Editing to Eliminate Engraftment Arrhythmia during Heart Regeneration" during the conference’s first plenary session, the Presidential Symposium titled ‘What’s in a Germ Layer?’ The session will begin on Monday, June 21 at 9:30 a.m. ET and will end at 11:45 a.m. ET.

Sonja Schrepfer, M.D., Ph.D., Sana’s Head of Hypoimmune Platform, will be speaking during the sixth plenary session on Cellular Therapy and Tissue Engineering, highlighting the Clinical Applications conference theme. She will present "Protecting Transplanted Stem Cells from Immune Rejection." The plenary session will begin on Saturday, June 26 at 9:30 a.m. ET and will end at 11:00 a.m. ET.

Both presentations will be rebroadcast at 9:30 p.m. ET on the day of their presentation and will be available to ISSCR registrants for on-demand viewing through July 31, 2021.