Alentis to Present Data at the EASL International Liver Congress 2021

On June 23, 2021 Alentis Therapeutics reported that it will present data at the European Association for the Study of the Liver (EASL) International Liver Congress 2021, being held virtually from June 23-26, 2021 (Press release, Alentis Therapeutics, JUN 23, 2021, View Source [SID1234584264]).

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Data to be presented includes research from Alentis and academic collaborators that provides preclinical proof-of-concept in patient-derived cell-based and mouse models of CLDN1-specific mAbs for treatment of advanced liver fibrosis and prevention and treatment of hepatocellular carcinoma (HCC).

Presentations at the Digital International Liver Congress are listed below

Oral Presentation GS-2069: Claudin-1 is a target for treatment of advanced liver fibrosis and cancer prevention

Presenter: Natascha Roehlen, Inserm U1110, Institut de Recherche sur les Maladies Virales et Hépatiques, Strasbourg, France; Université de Strasbourg, Strasbourg, France
Presentation Date and Time: June 24, 2021, 4:00 p.m. CEST

Oral Presentation OS-2190: A humanized Claudin-1 specific monoclonal antibody for treatment of hepatocellular carcinoma

Presenter: Natascha Roehlen, Inserm U1110, Institut de Recherche sur les Maladies Virales et Hépatiques, Strasbourg, France; Université de Strasbourg, Strasbourg, France
Presentation Date and Time: June 25, 2021, 3:15 pm CEST

HUYABIO International Receives Regulatory Approval for HBI-8000 Monotherapy of Adult T-cell Leukemia/Lymphoma in Japan

On June 23, 2021 HUYABIO International (HUYABIO), the leader in accelerating global development of China’s pharmaceutical innovations, reported the regulatory approval for HBI-8000 monotherapy of relapsed or refractory (R/R) adult T-cell leukemia/lymphoma (ATL) by the Japanese Pharmaceuticals and Medical Devices Agency (Press release, HUYA Bioscience, JUN 23, 2021, View Source [SID1234584297]).

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"Relapsed and/or refractory ATLL carries a grim prognosis with limited treatment options. Data from the registration study of HBI-8000 has demonstrated meaningful disease response despite the advanced stage of disease, and acceptable safety profile, to address an important unmet medical need in this patient population", said Dr. Atae Utsunomiya, honorary hospital director of Imamura General hospital in Japan.

The drug was approved based on data from a Phase 2b study that involved 23 patients with aggressive ATL in Japan. These patients, having few effective treatment options, all had advanced disease either refractory to or relapsed after receiving mogamulizumab. HBI-8000 40mg orally administered twice weekly resulted in disease response in a clinically meaningful proportion of patients with an acceptable safety profile.

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, "This first regulatory approval for our lead oncology drug, HBI-8000, is a major milestone for the Company. The durability and strong immuno- oncology properties of HBI-8000 set the stage for improved cancer treatment of both solid and liquid tumors. Synergy with PD-1/PD-L1 inhibitors hold particular promise for major solid tumor advances."

About HBI-8000
HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. This oral agent targets class I histone deacetylases (HDAC) and suppresses the expression of the viral oncogene HTLV-I bZIP factor, nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and the inflammasome in ATL cells. Furthermore, HBI-8000 may induce latent viral antigen expression making ATL cells more sensitive to immune cytotoxicity targeting.

New article published in Urologic Oncology: Macro and Microeconomics of Blue Light Cystoscopy with Cysview in Non-Muscle Invasive Bladder Cancer

On June 23, 2021 Photocure, The Bladder Cancer Company, reported the publication of a study in the journal Urologic Oncology (Press release, PhotoCure, JUN 23, 2021, View Source [SID1234584296]). The study objective was to determine the estimated budget impact to practices that incorporate blue light cystoscopy (BLC) with hexaminolevulinate HCl (HAL) for the surveillance of non-muscle-invasive bladder cancer (NMIBC) in the clinic setting.

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The study utilizes real world data from a large Academic Hospital Urology practice in the U.S. to estimate the net cost when Blue Light Cystoscopy with Cysview is utilized for both surveillance and TURBT* in all NMIBC patients based on National Medicare Reimbursement rates alone. The objective of this budget impact model was to quantify the impact of using BLC with HAL when used in patients who were undergoing cystoscopy for the detection of NMIBC, including carcinoma in situ (CIS), among patients suspected or known to have lesion(s). The model compared the costs and outcomes of two different scenarios in NMIBC: white light cystoscopy (WLC) in the office, followed by WLC during TURBT, versus BLC in the office, followed by BLC during TURBT.In a simulated facility with 50 newly diagnosed bladder cancer patients, the model illustrates that the additional use of BLC in surveillance identified 9 additional recurrences over two years compared to WLC alone. Use of flexible BLC for surveillance marginally increased costs to the practice, with a net difference of $0.76 per cystoscopy over 2 years.

This study illustrates how the inclusion of BLC with Cysview throughout the continuum of care in NMIBC patients results in improved detection, and therefore improved patient risk stratification, without impacting overall cost in a Hospital outpatient setting.

"This model analyzes how incorporation of Blue Light Cystoscopy with Cysview impacts the cost to a practice in the continuum of care of NMIBC patients. We found that a practice’s patients could experience the benefits of earlier detection and improved risk stratification without a significant cost burden experienced by the practice. I believe future studies examining the economic impact of Blue Light Cystoscopy with Cysview are warranted and would further elucidate the direct and long-term cost benefits in the diagnosis, treatment and management of NMIBC patients," said Dr. Stephen B. Williams, MD, MS, FACS Chief of Urology, Professor (Tenured) of Urology and Radiology, Robert Earl Cone Professorship, Director of Urologic Oncology, Director of Urologic Research, Co-Director of the Surgical Outcomes Research Division, and lead author of the study.

Read the full article here: https://www.sciencedirect.com/science/article/pii/S1078143921002313?dgcid=author

In December 2020, Photocure communicated an abstract of this study, which was presented at the SUO congress prior to the manuscript undergoing peer review for publication: View Source

*TURBT: trans-urethral resection of bladder tumors

Note to editors:

All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA

About Bladder Cancer
Bladder cancer ranks as the seventh most common cancer worldwide with 1 720 000 prevalent cases (5-year prevalence rate)1a, 573 000 new cases and more than 200 000 deaths annually in 2020.1b

Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate with an average of 61% in year one and 78% over five years.2 Bladder cancer has the highest lifetime treatment costs per patient of all cancers.3

Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.

Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. In MIBC the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.4

1 Globocan. a) 5-year prevalence / b) incidence/mortality by population. Available at: View Source, accessed [April 2021].
2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
3 Sievert KD et al. World J Urol 2009;27:295–300
4 Bladder Cancer. American Cancer Society. View Source

About Hexvix/Cysview (hexaminolevulinate HCl)

Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLC). BLC with Hexvix/Cysview improves the detection of tumors and leads to more complete resection, fewer residual tumors and better management decisions.

Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S. and Europe, and has strategic partnerships for the commercialization of Hexvix/Cysview in China, Canada, Chile, Australia and New Zealand. Please refer to View Source for further information on our commercial partners.

Sosei Heptares Initiates Phase 1 Trial With Novel Small-Molecule CGRP Antagonist Under Collaboration With Biohaven

On June 23, 2021 Sosei Group Corporation ("the Company"; TSE: 4565) reported that the first healthy subject has been dosed with HTL0022562 in a Phase 1 clinical study (Press release, Sosei, JUN 23, 2021, View Source [SID1234584295]). HTL0022562 (also known as BHV3100) is a novel, small molecule CGRP* receptor antagonist discovered by Sosei Heptares and the lead compound in a portfolio of CGRP antagonists licensed to Biohaven Pharmaceutical Holding Company Ltd. ("Biohaven",NYSE: BHVN) in December 2020 for development as new therapies for CGRP-mediated disorders .

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The trial is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of a single ascending dose and multiple ascending doses of subcutaneous HTL0022562 in healthy adult subjects. The trial aims to enroll 88 subjects at a single center in the UK and is expected to complete in 2022.

Sosei Heptares has advanced HTL0022562 successfully though a preclinical development program demonstrating its promising and differentiated properties for further investigation in human trials.

Under the global collaboration and license agreement with Biohaven, Sosei Heptares will conduct the Phase 1 clinical trial itself, receiving a milestone payment for its initiation, and is also eligible for development costs for conducting the trial. Biohaven will lead all future studies and development activities and Sosei Heptares will be eligible for further milestone payments and royalties.

Although the event reported today has no significant impact on the consolidated financial results for the accounting period ending 31 December 2021, the Company considers that an important developmental milestone has been achieved with HTL0022562 becoming the tenth drug candidate overall generated from Sosei Heptares’ SBDD platform to enter clinical development, and therefore makes this announcement.

Tim Tasker, Executive Vice President and Chief Medical Officer of Sosei Heptares, said: "We are pleased to initiate this new clinical trial with HTL0022562 following the successful discovery and preclinical development work conducted by Sosei Heptares. We are also delighted at the speed of progress and the positive collaborative approach that has developed between our team and our partners at Biohaven and the confidence they have shown in our early clinical development capabilities. Together, we are committed to developing this novel differentiated agent to treat CGRP-mediated diseases with unmet need."

*Abbreviations used: CGRP – calcitonin gene-related peptide

About the Agreement with Biohaven
Sosei Heptares and Biohaven entered a global collaboration and license agreement in December 2020 under which Biohaven received exclusive global rights to develop, manufacture and commercialize a portfolio of novel, small-molecule CGRP receptor antagonists discovered by Sosei Heptares for the treatment of CGRP-mediated disorders. Sosei Heptares received an upfront payment of US$10 million on signing in cash and Biohaven common shares and is eligible to receive additional research funding, up to US$370 million in development, regulatory and commercialization milestone payments, plus tiered royalties on net sales of products resulting from the collaboration.

About CGRP
CGRP is an important neuropeptide believed to be involved in multiple neuro-inflammatory and neuro-immune diseases. CGRP receptor antagonism interrupts pathologic signals in CGRP-mediated diseases, such as migraine. Following the success of this approach in migraine, Biohaven is exploring the potential of this approach in other neuro-inflammatory and neuro-immune diseases, including COVID-19.

FDA Grants Bionaut Labs Orphan Drug Designation to BNL-101 for the Treatment of Malignant Gliomas in Pediatric and Adult Patients

On June 23, 2021 Bionaut Labs, a company focused on revolutionizing the treatment of central nervous system disorders (CNS) with its Bionaut precision medicine treatment modality, reported that the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for BNL-101 for the local treatment of all malignant gliomas including diffuse intrinsic pontine glioma in pediatric and adult patients (Press release, Bionaut Labs, JUN 23, 2021, View Source [SID1234584294]). BNL-101 is a drug-device combination comprised of doxorubicin as the active drug component together with the company’s Bionaut microscale robots.

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"The granting of orphan drug designation for BNL-101 represents a significant milestone for Bionaut Labs as it recognizes the potential of our approach to transform the standard of care for devastating CNS diseases like malignant gliomas," said Michael Shpigelmacher, co-founder and CEO, Bionaut Labs. "The award of orphan drug designation is the first step in a program of regulatory optimization that Bionaut Labs has initiated to allow us to move BNL-101 into the clinic in the swiftest and most effective way possible. We believe BNL-101 has the potential to play a significant role in shifting the treatment paradigm for malignant gliomas, and we look forward to continuing to work with the FDA as we fulfill our mission of helping patients suffering from debilitating brain diseases who lack treatment options."

"Gliomas remain some of the most devastating tumors for which there are few, if any, effective treatment options and for which there remains significant unmet medical need," said Alex Kiselyov, chief science officer, Bionaut Labs. "Receiving orphan drug designation from the FDA is an important regulatory milestone as we believe it validates our Bionaut-based approach. We look forward to advancing our BNL-101 therapeutic program into the clinic."

The FDA’s Office of Orphan Drug Products grants orphan drug status to support development of drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. Orphan drug designation provides benefits to drug developers designed to support the development of drugs and biologics for small patient populations with unmet medical needs. These benefits include assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees, and seven years of marketing exclusivity.

About Bionaut Treatment
A Bionaut is a novel treatment modality that uses remote-controlled microscale robots to deliver biologics, nucleic acids, small molecule, gene or cellular therapies locally to targeted CNS disease areas. Through precise targeting, Bionaut therapeutics could offer better efficacy and safety that cannot be achieved by other traditional treatment or delivery modalities.

Bionauts can be constructed in different designs with custom geometries and surface characteristics. Smaller than a millimeter, they contain moving parts controlled remotely by a magnetic controller, allowing them to safely reach the target and release a therapeutic payload from the cargo compartment. Engineering flexibility provides a broad foundation for designing Bionaut therapies for nearly any disease of interest.

Bionaut Labs has demonstrated safe and controlled navigation of its therapeutic Bionaut to and from the treatment locus in the brain, in a large animal in vivo model. Furthermore, the Company has successfully treated human glioma tumors established in mice, utilizing guided delivery of therapeutic cargos directly into these tumors to eliminate systemic toxicity. These results pave the way to the clinical trials of the Bionaut platform.