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GENinCode announces major US commercialisation partnership with EVERSANA

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."

EISAI TO DIVEST RIGHTS FOR ZONEGRAN® IN EUROPE AND OTHER REGIONS TO ADVANZ PHARMA

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]).

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.

Inceptor Bio Launches Next-Generation CAR-T, CAR-M, and NK/NKT Platform Focused on Advancing Cell and Gene Therapies to Cure Difficult-To-Treat Cancers

On June 14, 2021 Inceptor Bio, a Research Triangle Park, North Carolina-based cell and gene therapy biotech, reported that it is developing multiple next-generation cell and gene therapy platforms to cure difficult-to-treat cancers (Press release, Inceptor Bio, JUN 14, 2021, View Source [SID1234583979]). Inceptor Bio will create a portfolio of companies focused on specific platform technologies, supported by its Advanced Manufacturing Platform (AMP+) and other shared infrastructure.

Inceptor Bio was established to pursue a diversified portfolio of cell therapy platforms across multiple cell types, including CAR-T, CAR-M, and CAR-NK/NKT, with novel mechanisms that enhance immune cell performance within the tumor microenvironment. The company collaborates with leading scientists at premier academic institutions to license groundbreaking cell and gene technologies.

Inceptor Bio’s Advanced Manufacturing Platform (AMP+) is a shared cell and gene therapy manufacturing facility that is central to executing the company’s differentiated strategy. AMP+ is a fit-for-purpose, capital efficient, and scalable manufacturing facility that provides expertise and capacity for critical viral vector and cell therapy operations serving all portfolio companies.

Inceptor Bio is led by a management team, Board of Directors, and Scientific Advisory Board that represent an unparalleled breadth of experience in the cell and gene therapy sector, with a track record of execution and successful development of pioneering medicines at industry leaders such as Precision BioSciences, Juno Therapeutics, Brammer Bio, Catalent, and Roche.

Shailesh Maingi, Founder, Chairman and CEO of Inceptor Bio, said, "We started Inceptor Bio with a simple purpose – to provide better options for patients with difficult-to-treat cancers. In solid tumors, where there are limited treatment options, patient outcomes remain poor, and cures are elusive. But there is hope with advances in cell and gene therapy. Our mission is consequently to advance multiple next-generation CAR-T, CAR-M and CAR-NK/NKT platforms in collaboration with leading universities to cure these cancers.

Maingi continued, "We are privileged to have an outstanding team of pioneers in cell and gene therapy executing our vision. Our operations strategy starts with AMP+, our Advanced Manufacturing Platform for viral vector and cell therapy operations, which allows us to maintain internal control of development and manufacturing. We are delighted to partner with leading academic collaborators in our shared mission to end cancer."

The seed round was led by the Kineticos Disruptor Fund. Frank Lis, Kineticos Ventures President and CEO, said, "We are delighted to lead the seed round for Inceptor Bio, which has an exceptional cell and gene therapy team, dedicated manufacturing in AMP+, and a unique collaborative model with top research universities. The products being developed by Inceptor Bio will have a profound impact on the lives of many cancer patients."

Inceptor Bio has also launched a new website at www.inceptor.bio to provide information on the company’s vision and activities.

Hummingbird Bioscience to Speak at 2021 Virtual Symposium: "VISTA: A New Immune Checkpoint in Cancer, Autoimmunity and Beyond"

On June 14, 2021 Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets, reported that its Chief Scientific Officer and co-founder, Dr Jerome Boyd-Kirkup, will be speaking at the 2021 virtual symposium "VISTA: A New Immune Checkpoint in Cancer, Autoimmunity and Beyond", taking place on June 18, 2021 (Press release, Hummingbird Bioscience, JUN 14, 2021, View Source [SID1234583978]).

Hosted by Randolph Noelle, PhD, Professor of Microbiology and Immunology, Department of Microbiology and Immunology, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth; and Padmanee Sharma, MD, PhD, Professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, University of Texas, MD Anderson Cancer Center, the event gathers leading immunology experts across industry and academia to discuss the emerging checkpoint molecule, VISTA, including its function, the role it plays in several disease areas and current development programs.

Hummingbird will be speaking in the following sessions:

Session Title: VISTA regulation of the tumor microenvironment in human cancer
Date/Time: June 18, 2021 from 9:50 AM to 10:35 AM ET

Session Title: VISTA advances into clinical development
Date/Time: June 18, 2021 from 12:20 PM to 1:05 PM ET

"The presence of VISTA is increasingly implicated as a resistance mechanism to other immune checkpoint therapies, including anti-PD-1 and anti-CTLA-4 antibodies. This conference is an excellent opportunity to share insights and knowledge, including Hummingbird’s experience with our highly differentiated clinical stage anti-VISTA antibody, HMBD-002," said Dr Boyd-Kirkup.

Hummingbird’s rationally targeted anti-VISTA neutralizing antibody, HMBD-002, is the only IgG4 isotype anti-VISTA neutralizing antibody that is currently in development for the treatment of cancers with VISTA-mediated immune suppression, including triple negative breast cancer and non-small cell lung cancer. Pre-clinical studies have shown that HMBD-002 as a monotherapy inhibits tumor growth and significantly prolongs survival, with no observed toxicity. It has also shown synergy when used in combination with anti-PD-1 therapy. The Phase 1 clinical trial for HMBD-002 is anticipated to commence later this year.

To learn more about the symposium and register to attend, please visit: https://bit.ly/3hBzIUj.

About HMBD-002

HMBD-002 is a unique anti-VISTA neutralizing antibody, and the only IgG4 isotype anti-VISTA antibody currently in development. It was engineered to bind to VISTA at a specific site that is predicted to be essential for ligand-binding and function, thus inhibiting VISTA and neutralizing its immunosuppressive activity without depleting VISTA expressing cells that play many important roles in the immune system.

Pre-clinical studies have shown that HMBD-002 as a monotherapy inhibits tumor growth and significantly prolongs survival, with no observed toxicity. It has also shown synergy when used in combination with anti-PD-1 therapy.

HMBD-002 is being developed for multiple cancers that have strong evidence of VISTA mediated suppression both as a monotherapy and in combination with PD-1 inhibitor.

Hummingbird’s first-in-class anti-VISTA therapeutic antibody is advancing to clinical trials with support from a US$13.1 million product development grant from the Cancer Prevention and Research Institute of Texas (CPRIT).

Fusion Pharmaceuticals Announces Preliminary Safety and Dosimetry Results from its Single-Dose Portion of the Phase 1 Study of FPI-1434

On June 14, 2021 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported the presentation of preliminary Phase 1 data from the single-dose portion of the study at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Virtual Annual Meeting (Press release, Fusion Pharmaceuticals, JUN 14, 2021, View Source [SID1234583977]). The presentations and posters highlight the potential of Fusion’s targeted alpha therapies (TATs) to enable delivery of alpha particle emitting isotopes (225Ac) to targeted tumor cells.

"The data from our ongoing clinical study of FPI-1434 presented at SNMMI demonstrated that treatment with our actinium-based targeted alpha therapy was well tolerated, and imaging shows uptake of the drug across multiple tumor types," said Chief Executive Officer John Valliant, Ph.D. "Importantly, these data supported our ability to initiate the multi-dosing portion of the study, in which we would expect to begin reaching total cumulative levels of radiation necessary to demonstrate anti-tumor activity."

In both the oral session and the poster titled, "Preliminary Dosimetry Results from a First-in-Human Phase 1 Study Evaluating the Efficacy and Safety of [225Ac]-FPI-1434 in Patients with IGF-1R Expressing Solid Tumors," results from the first three patient cohorts (n=12) demonstrated a favorable safety profile for [225Ac]-FPI-1434. No drug-related serious adverse events and/or dose limiting toxicity were reported in administered activity up to 40 kBq/kg body weight and dosimetric results were within normal organ radiation tolerability limits. The single dose escalation portion of the study has concluded, while enrollment into the multi-dosing cohorts are ongoing.

Preclinical Results Combining FPI-1434 with DNA Damage Response Inhibitor (DDRi) and Immune Checkpoint Inhibitors
In separate oral and poster presentations, Fusion presented preclinical data demonstrating synergistic efficacy against olaparib-resistant colorectal and radioresistant lung cancer xenografts when combining FPI-1434 with olaparib.

The combination of the two therapeutics, using doses that were non-effective as single agents, resulted in anti-tumor efficacy against colorectal and non-small cell lung cancer tumor models. The strongest combination effect appeared to occur at the lowest single agent doses, as FPI-1434’s efficacy dominated at higher dose levels.

Fusion also presented preclinical data showing that treatment with FPI-1434 in combination with immune checkpoint inhibitors resulted in complete tumor eradication. Additionally, an increase in antigen-specific CD8 positive T cells and a strong "vaccine" effect were observed with the combination of IGF-1R TAT and immune checkpoint inhibitors, as noted by the prevention of tumor growth in animals that were reinoculated with the same tumor cells.

Dr. Valliant continued, "We are excited by our preclinical data that show the power of combining a potent TAT with the latest generation of cancer therapies, such as checkpoint inhibitors and DDRis. We view these combinations as an opportunity to bring these next-generation radiopharmaceuticals into earlier lines of therapy for patients, and we look forward to initiating combination studies in human once we have achieved the recommended Phase 2 dose for FPI-1434 monotherapy. Our previously announced collaborations with both Merck and AstraZeneca provide us with multiple opportunities to explore these exciting combination therapies."

Following the conclusion of the SNMMI Annual Meeting, copies of the presentations can be found at View Source

About FPI-1434
FPI-1434 is a radioimmunoconjugate designed to target and deliver alpha emitting medical isotopes to cancer cells expressing IGF-1R, a receptor that is overexpressed on many tumor types. FPI-1434 utilizes Fusion’s Fast-Clear linker to connect a human monoclonal antibody that targets IGF-1R with actinium-225, a powerful alpha-emitting isotope with desirable half-life and decay chain properties.