On June 14, 2021 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported that two poster presentations of new clinical data and analyses related to imetelstat, the Company’s first-in-class telomerase inhibitor, are now available on Geron’s website as well as to participants of the EHA (Free EHA Whitepaper)2021 Virtual Congress (Press release, Geron, JUN 14, 2021, View Source [SID1234583987]).

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"These poster presentations further support imetelstat’s differentiated approach to potentially target the malignant stem and progenitor cells in the bone marrow by inhibiting telomerase activity," said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. "Through this novel mechanism of action, imetelstat has the potential to alter the course of MDS and MF which distinguishes it from other treatments currently approved or in development. We look forward to confirming these results in our ongoing Phase 3 clinical trials, IMerge Phase 3 in lower risk MDS and IMpactMF in refractory MF."

Title: Efficacy of Imetelstat is Independent of Molecular Subtypes in Heavily Transfused Non-Del(5q) Lower Risk MDS (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESA)
Poster Code: EP910

New data and analyses were presented on the clinical efficacy of imetelstat in molecularly defined subtypes based on cytogenetic and mutation profiles for patients in the IMerge Phase 2 clinical trial. As reported at previous EHA (Free EHA Whitepaper) meetings, meaningful and durable transfusion independence were observed in patients from IMerge Phase 2, including transfusion-free periods greater than one year, as well as substantial increases in hemoglobin. The current presentation reported clinical responses across different cytogenetic and molecularly defined categories whereby responses were independent of mutation status or number of mutations. These data support the unique telomerase inhibition mechanism of action of imetelstat and the potential to target the malignant stem and progenitor cells of the underlying disease.

Title: Imetelstat Demonstrates an Acceptable Safety Profile in Myeloid Malignancies
Poster Code: EP1106

Safety data from the Phase 2 IMbark and IMerge trials were further analyzed to understand the characteristics of hematologic and non-hematologic adverse events. These analyses highlighted that the imetelstat-related cytopenias are short, reversable and with limited clinical consequence when managed with the dose modification guidelines in the protocols. These data are further evidence for the on-target effect of imetelstat based on the selective reduction of malignant cells in the bone marrow through telomerase inhibition resulting in the observed meaningful clinical benefits for patients in the Phase 2 trials.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Data from Phase 2 clinical trials provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in hematologic myeloid malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis-stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment.

On June 14, 2021 Veracyte reported that $600 million to buy Decipher Biosciences and its genomic prostate cancer test (Press release, Veracyte, JUN 14, 2021, View Source [SID1234583986]). Now, that diagnostic has racked up new data showing it can help identify patients most likely to benefit from specific drugs.

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Veracyte picked up urologic cancer specialist Decipher—itself once known as GenomeDx—in March in a cash deal to expand its diagnostic portfolio to seven of the 10 most common tumor types.

Its prostate test is already included in national cancer treatment guidelines, while its kidney and bladder cancer tests are in development, with the latter expected to launch later this year.

The new data—taken from a retrospective analysis of a phase 3 study of men with non-metastatic, castration-resistant prostate cancer, or nmCRPC, and published in JAMA Oncology—showed the test could use genomic data to judge which patients are most likely to see gains from early treatment with Janssen’s Erleada (apalutamide) alongside androgen-deprivation therapy.

RELATED: Veracyte drops $600M to acquire cancer tester Decipher Biosciences

The study is "the first clinical evaluation and demonstration of the Decipher test’s utility in the nmCRPC setting," said Veracyte’s senior VP for scientific and clinical operations in urologic cancers, Elai Davicioni, who added that the data helps demonstrate the test’s usefulness in multiple types of prostate cancer.

Previously, the study showed that Erleada combined with ADT could extend overall survival by 14 months and cut the risk of death by 22%. It also showed improvements in metastasis-free survival and other secondary endpoints. Annually, nmCRPC is estimated to affect about 60,000 men in the U.S.

The Decipher diagnostic relies on gene expression profiling to split patients into groups with low, average and high risks of metastasis, as well as by their tumor’s genetic subtype—with those with higher risks seeing the greatest benefits from Erleada therapy.

RELATED: J&J won’t pursue Erleada, Zytiga prostate cancer combo after trial results disappoint

The results "suggest that genomic testing provides useful information to guide treatment decisions that may improve outcomes among men with locally advanced disease, a population for which we’ve previously lacked genomic biomarkers," said the paper’s primary author, Felix Feng, vice chair for translational research in the department of radiation oncology at the University of California, San Francisco.

In addition, the molecular signature can help guide treatment decisions for years after an initial diagnosis, once the cancer has advanced locally, the company said.

RELATED: ASCO (Free ASCO Whitepaper): New data set up Veracyte’s nasal swab lung cancer test for launch later this year

The Decipher genomic classifier is currently being tested in seven randomized phase 3 prostate cancer trials sponsored by the National Cancer Institute, plus 13 more phase 2/3 trials, as well as more than 20 retrospective studies of phase 3 data, according to Veracyte.

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 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 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.

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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.