On August 1, 2021 LISCure Biosciences, Inc. ("LISCure") reported that it has entered into a know-how license and development collaboration agreement, and stock purchase agreement with Mayo Clinic to advance LISCure’s microbiome therapeutics in non-alcoholic steatohepatitis (NASH) (Press release, LISCure Biosciences, AUG 1, 2021, View Source [SID1234585495]).

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The two entities previously entered a research collaboration agreement in the first half of 2021 for NASH candidates.

Under the agreement, the company will receive Mayo Clinic’s know-how to establish a new drug development of NASH program. As part of the agreement, Mayo Clinic will become a shareholder in LISCure, the first Korean biotech company receiving equity investment from Mayo Clinic.

The two entities will pursue the common goal of maximizing the value of LISCure’s therapeutics in metabolic diseases by expanding research and development activities such as discovering new indications and additional value-added candidates. LISCure plans to minimize trial and error in preparation for phase 2 clinical trial of its NASH candidate in the US in 2022 by jointly cooperating with Mayo Clinic.

"This collaboration will provide innovative treatment opportunities to patients with high medical needs in various metabolic diseases. We are very excited to establish a collaboration with Mayo Clinic," said a company official. "We are also proud of Mayo Clinic becoming our shareholder and look forward to continuing a long-term collaboration."

LISCure plans to enter the global clinical trial for NASH candidate as well as auto-immune disease candidate in the second half of this year, and to initiate clinical trial in the US for the world’s first novel microbe-mediated cancer therapeutics in the first half of 2022.

On August 1, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that through a priority review process, the South Korean Ministry of Food and Drug Safety (MFDS) has approved the company’s New Drug Application (NDA) for the Orphan Drug-designated first-in-class oral inhibitor of XPO1, selinexor (XPOVIO), in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (rrMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (penta-refractory); and as a monotherapy for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) who have received at least two prior lines of treatment (Press release, Antengene, AUG 1, 2021, View Source [SID1234585496]).

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Introduction of a practice-changing therapy for MM and DLBCL patients

Most patients with MM eventually suffer from relapse or become refractory diseases. For patients who have failed in one therapy, diffuse large B-cell lymphoma (DLBCL) has poor prognosis and the chance of cure or long-term disease-free survival declined every time getting worse after treatment. At present, there is no cure for rrMM and rrDLBCL and it is in dire need for safer and more effective therapies.

In October 2020, selinexor was granted an Orphan Drug Designation (ODD) in South Korea, where the term "Orphan Drug" is defined by the MFDS as therapies used to treat diseases affecting 20,000 or fewer patients and therapies used to treat diseases for which no appropriate therapy has been developed, or therapies that have demonstrated significant improvement in safety and/or efficacy compared to existing treatments.

A new mechanism of action with a broad therapeutic window

Selinexor’s novel mechanism of action (MoA) which is based on the selective inhibition of the nuclear export protein XPO1, is different from that of all currently approved therapies. The drug can be combined with various therapies to deliver improved treatment outcomes in these diseases. To date, five selinexor-based regimens have been added to the National Comprehensive Cancer Network (NCCN) Guidelines.

In addition, a number of international multicenter clinical trials in respect of selinexor are jointly carried out in places such as North America, Europe, Australia, Asia. These include the study of XPORT-DLBCL-030 in international multicenter clinical trials in combination with R-GDP for the treatment of rrDLBCL, and the study of SIENDO in international multicenter clinical trials of monotherapy of endometrial neoplasms.

Minyoung Kim, General Manager of Antengene, commented: "We are very encouraged by the MFDS’ approval of selinexor. I am confident that this oral selective inhibitor of nuclear export protein, with its practice-changing therapeutic utility, will improve the quality of life of patients with rrMM and rrDLBCL in South Korea, and bring renewed hope to this patient population."

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion.

On July 30, 2021 EORTC reported that Prostate cancer is the fourth most common cancer worldwide, and the second most common among men (Press release, EORTC, JUL 30, 2021, View Source [SID1234585466]). Radical prostatectomy (surgery) and external-beam radiotherapy (EBRT) in combination with androgen deprivation therapy (ADT) are recommended treatment options for patients with localised intermediate risk prostate cancer . Adding ADT to EBRT to patients with localised intermediate risk prostate cancer significantly increases their event-free survival (EFS)1 and disease-free survival (DFS)2, and these effects are still evident after 12 years of median follow-up, say the investigators in the latest results from an EORTC trial published in The Journal of Clinical Oncology this week*.

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The trial was launched in 2001 and aimed to investigate whether giving 6 months of ADT concomitantly with EBRT at three doses of radiation (70, 74 and 78 Gy) to men with intermediate and limited high-risk prostate cancer would be beneficial, as compared to EBRT alone.

The primary endpoint in the multi-centre international study was EFS, and patients were randomised between ADT plus EBRT and EBRT alone. The first results, published in 2016 after a median patient follow-up of 7.2 years, showed an improvement in both EFS and DFS in the pooled group of intermediate and limited high risk disease patients. The effects on EFS and DFS were maintained in the longer term, at 12-year follow-up of the 481 patients classified as having intermediate risk and irradiated at a minimum target dose of 74 Gy. In the EBRT + ADT arm, 10-year EFS was 68.1%, as opposed to 49.3% in the EBRT-alone group. DFS was also improved in the experimental group, with 10-year DFS rates of 76.2% and 66.0%, respectively. The effects on distant metastasis-free survival (DFMS) and overall survival did not reach statistical significance.

"Nowadays, the benefit of ADT in intermediate risk prostate cancer patients remains a topic of debate given the conflicting results between studies in the literature. However, these are the most robust data from a randomised trial with long-term follow-up addressing this question. They shed light on the important clinical question of the value of ADT in men treated with radiation if dose escalation is used," say the authors, who were led by Professor Michel Bolla, from the Radiotherapy Department Grenoble, Grenoble Alpes University, Centre Hospitalier Universitaire de Grenoble, France.

However, the authors conclude, the results from the trial cannot be extrapolated to results obtained with modern radiotherapy alone. Treatment recommendations for prostate cancer patients have changed and radiation techniques have evolved into modern technologies that allow higher doses to be safely delivered.

1.Event-free survival is the length of time after the ending of primary treatment that the patient remains free of complications related to the cancer. EFS events include biochemical as well as clinical failures and deaths.

2.Disease-free survival is the length of time after treatment ends that a patient survives with no signs of their cancer. DFS events include only clinical failures and deaths.

*Short Androgen Suppression and Radiation Dose Escalation in Prostate Cancer: 12-Year Results of EORTC Trial 22991 in Patients with Localized Intermediate-Risk Disease

On July 30, 2021 Avidin, as part of a special German-Hungarian collaborative program reported that it has successfully developed a reagent prototype product based on new, specific and high-sensitivity biochemical tests in the frame of a grant (2018-2.1.3-EUREKA-2018-00016) (Press release, Avidin, JUL 30, 2021, View Source [SID1234585572]).

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Biomarkers of oxidative stress play an important role in understanding pathogenesis and in treatment of these diseases. In the frame of the EUREKA grant the Hungarian partner of the consortium, in close cooperation with the two German partners, identified new molecular targets that can lead to cell death and pathological changes that originate from the mitochondria. Avidin has successfully developed a reagent prototype product based on new, specific and high-sensitivity biochemical tests. Biochemical kits will be combined with a cellular sensor developed in SIZ and with the genomic platform developed in GenXPro; complementing each other will produce a competitive product line. Initial co-operation will open up further collaborative opportunities in the long term and will allow the development of the products created here for diagnostic purposes.

On July 30, 2021 Sareum Holdings plc (AIM: SAR), the specialist drug development company delivering targeted small molecule therapeutics to improve the treatment of cancer and autoimmune diseases, reported that the United States Patent and Trademark Office has issued a Notice of Allowance for a patent in respect of an invention associated with Sareum’s proprietary SDC-1802 TYK2/JAK1 Kinase Inhibitor Programme (the "SDC-1802 Programme") (Press release, Sareum, JUL 30, 2021, View Source [SID1234586709]).

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The patent (US Patent Application no. 16/343,639) will protect the SDC-1802 molecule and pharmaceutical preparations thereof as a therapeutic to treat cancer selected from pancreatic, colorectal and kidney cancers, melanoma, and B-cell lymphoma by inhibiting TYK2 kinase. This programme is in preclinical development.

The Company expects that the patent will be granted within three months, subject to certain formalities being completed.

Sareum’s CSO, Dr John Reader, commented:

"The granting of this patent in the US will provide a further layer of protection around SDC-1802 following the granting of patents protecting the molecule in the US and other major markets in recent years. These patents are important to enhancing the value of the programme as part of our discussions with potential partners."