Children’s Cancer Research Fund Supports AOST-2121 PhIIb Clinical Trial in Recurred, Resected Osteosarcoma

On June 23, 2021 Children’s Cancer Research Fund (CCRF) reported the support of OS Therapies, a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat and cure Osteosarcoma (OS) and other deadly cancers in kids and adults (Press release, Children’s Cancer Research Fund, JUN 23, 2021, View Source [SID1234584299]). The investment, made possible by the Zach Sobiech Osteosarcoma Fund at CCRF, will help OS Therapies initiate a much-anticipated trial in Osteosarcoma: a deadly cancer of the bone that usually targets teenagers.

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"Children’s Cancer Research Fund and Zach’s Fund are excited to join other non-profits, investors and OS Therapies to do something about this horrible disease," said Daniel Gumnit, CEO of CCRF. "OS Therapies is working to achieve the goals of CCRF, particularly to give every survivor of childhood cancer a long, healthy life after treatment."

Funding will support a national Phase IIb trial of 39 patients with Osteosarcoma that has returned (recurred) after initial treatment with failed chemotherapy and radiation. OST-HER2 (OST31-164 Listeria monocytogenes) stimulates the patient’s immune system to target the micro-metastasis seeking out soft tissue and oxygen so readily found in the lungs and brain.

"We are thrilled that CCRF would join us in this battle against Osteosarcoma. They are a leader in the research, advocacy and support of families and patients with childhood cancer," said Paul Romness, CEO of OS Therapies. "Fortunately, we have a technology that has shown great success in treating Osteosarcoma in dogs – now we need to see if it will work as well in our kids with OS."

ImmuneID Announces Close of $50 Million Series A Financing to Develop Precision Immunology Therapeutics

On June 23, 2021 ImmuneID, Inc., a precision immunology company employing a proprietary platform to identify and therapeutically target antibody interactions that drive immune diseases, reported that it has raised $50 million in Series A financing (Press release, ImmuneID, JUN 23, 2021, View Source [SID1234584298]). This Series A financing brings the total amount raised by ImmuneID since its December 2020 launch to over $70 million. Proceeds from the financing will be used to advance the development of therapeutic candidates to treat autoimmune diseases, severe allergies, cancer and infectious diseases.

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"ImmuneID’s advanced platform leverages technologies such as next-generation sequencing, robotic automation and artificial intelligence to provide insights that can be used to develop precision immunology therapeutics," said Stephen Elledge, Ph.D., ImmuneID co-founder and SAB chair, Lasker Award winner and The Gregor Mendel Professor of Genetics and Medicine at Harvard Medical School. The platform was first featured in Science and additional applications of the platform in multiple disease areas have been published in leading journals such as Science, Cell, PNAS and Nature Communications.

"ImmuneID’s unique and powerful immunological target identification platform unlocks the complexity of human immune responses to guide the development of precision immunology therapeutics in areas where there remains significant unmet patient need," said Longwood Fund’s Christoph Westphal, M.D., Ph.D., ImmuneID co-founder and Executive Chair.

This Series A round was led by new investor Alta Partners and included new investors Alexandria Venture Investments, Redwood Capital Investments, Section 32 and Tekla Capital Management. All existing investors participated in the financing, including Arch Venture Partners, Longwood Fund, Pitango HealthTech, In-Q-Tel, Xfund and others. This Series A financing follows a $22 million seed financing round that was led by founding investor Longwood Fund.

"This financing from an exceptional group of investors positions us to execute on our ambitious plans to develop a new generation of precision immunology therapeutics," said ImmuneID CEO David Donabedian, Ph.D., who brings more than 20 years of experience in biotech company formation and business development to ImmuneID. Dr. Donabedian previously has held various leadership roles at biopharmaceutical companies including AbbVie (NASDAQ: ABBV) and GlaxoSmithKline (NYSE: GSK).

Dan Janney, Managing Partner of Alta Partners, said, "We are excited to lead the Series A financing and join the current syndicate to further support ImmuneID and their promising approach to developing highly targeted therapeutics to treat diseases related to the immune system."

As part of the Series A Financing, Mr. Janney and Dr. Steve Kafka, Managing Partner, Section 32, will join ImmuneID’s board of directors.

About ImmuneID’s Platform and Technology

ImmuneID’s technology platform and the underlying technology is designed to provide insights into human immune response throughout the course of disease progression for the identification of high-quality therapeutic targets. The technology was originally developed in the lab of Stephen Elledge, Ph.D., ImmuneID co-founder and Chair of ImmuneID SAB, Lasker Award winner and The Gregor Mendel Professor of Genetics and Medicine, Harvard Medical School.

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.