On September 21, 2022 Helsinn Group ("Helsinn"), a fully integrated, global biopharma company with a diversified pipeline of innovative oncology assets, reported that two scientific abstracts have been accepted for oral presentation at the upcoming EORTC CLTG (European Organisation for Research and Treatment of Cancer Cutaneous Lymphoma Tumors Group) Annual Meeting 2022, taking place in Madrid, Spain from the 22-24 September (Press release, Helsinn, SEP 21, 2022, View Source [SID1234619715]).

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Details on the presentations are below:

Presentations:

Title: A Post-hoc Analysis of Clinical Trial Data Shows that Prior Phototherapy Does Not Affect Response to Chlormethine Gel in Patients with Mycosis Fungoides

Authors: Chalid Assaf, Christiane Querfeld, Marta Scandurra, Marco Turini, Julia J. Scarisbrick

Date/Time: 23 September, 6:36pm CET

Presenter: Chalid Assaf, Prof. Dr. med., Chief Physician of the Clinic for Dermatology and Venerology, Helios Klinikum Krefeld, Germany

Title: Combination Therapy with Chlormethine Gel and Narrow-Band Ultraviolet B for Patients with Mycosis Fungoides: a Case Series

Authors: Laura Gleason, Daniel Joffe, Neda Nikbakht MD, PhD

Date/Time: 23 September, 5:12pm CET

Presenter: Laura Gleason, MD, Thomas Jefferson University, Department of Dermatology and Cutaneous Biology, Philadelphia, US

During the conference Helsinn will also be sponsoring a satellite symposium which will focus on chlormethine’s mechanism of action. The symposium, entitled "A multi-level analysis of chlormethine: from skin cells to clinical cases", will involve experts in the field of mycosis fungoides, including Prof. Pablo Ortiz-Romero, Head of Dermatology at University Hospital 12 de Octubre in Madrid, Spain and Prof. Emmanuella Guenova, Dermatologist at the Lausanne University Hospital, Switzerland and one of the leading researchers of the chlormethine molecule.

Satellite symposium

Title: A multi-level analysis of chlormethine: from skin cells to clinical cases

Date/Time: Thursday 22 September/1:30-2:30pm CET

Presenters: Emmanuella Guenova and Pablo Ortiz-Romero

Dr. Silvia Sebastiani, Group Head of Medical Affairs, commented: "It’s fantastic to see the growing body of data emerging from in vitro, clinical and case studies of LEDAGA/VALCHLOR for the treatment of this rare skin lymphoma. We’re pleased to be taking part in EORTC CLTG, sharing our own findings, as well as hearing the latest insights from across the cutaneous lymphoma research landscape. We remain committed to support the global MF-CTCL patient population."

Prof. Pablo Ortiz-Romero Head of Dermatology at University Hospital 12 de Octubre, added: "There is currently no cure for patients living with MF-CTCL and treatment goals are mainly aimed at reducing the abnormal appearance of the skin and to control any itching or other symptoms. I am delighted to Chair the Helsinn satellite symposium where emerging new data regarding chlormethine’s mode of action will be discussed, as well as interesting insights from Professor Guenova‘s clinical experience. The latest research further delineates the mechanism of LEDAGA/VALCHLOR in the treatment of this rare skin cancer."

Chlormethine gel 0.016%, also known as mechlorethamine gel, is approved in multiple countries, including the EU and US, and is marketed under the trade names LEDAGA and VALCHLOR. The authorized use for each country varies based on the design of the registrational trial and the individual health authority requirements. For more details, please refer to the approved product information for each respective jurisdiction.

On September 20, 2022 Integra Therapeutics reported the company has been awarded €1-million grant from Eurostars, the largest funding programme of the European Commission that supports innovative SMEs in developing collaborative transnational projects geared towards the market (Press release, Integra Therapeutics, SEP 20, 2022, View Source [SID1234654531]). The company applied for the call as part of a consortium with Caszyme, a Lithuanian company that specialises in CRISPR technology and molecular tools development and application.

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The funding of the project submitted by Integra Therapeutics and Caszyme will go towards discovery, characterisation and execution of in vivo studies on the 2.0 version of the Integra Therapeutics FiCAT gene-writing platform.

The key difference between FiCAT 1.0 and FiCAT 2.0 will be the addition of novel nucleases discovered by Caszyme, which have different characteristics from the Cas9 nucleases and expand their potential uses in advanced therapies. During the execution of the project, Integra and Caszyme will enhance the functionality of novel nucleases in human cells.

The partnership between Integra Therapeutics and Caszyme will unite scientific know-how and technology from top academic and industrial biomedical research. The founders of Caszyme are Prof. Virginijus Šikšnys, Dr. Giedrius Gasiūnas and Dr. Monika Paule, the first scientists to prove that CRISPR-Cas9 can be used to program DNA double-strand breaks in a genome of interest, opening a new era in gene editing.

The project is scheduled to kick off on the 1st of November 2022 and finish at the end of 2025.

The Eurostar programme is part of Horizon Europe and is managed by Eureka with a network of national coordinators from the 37 participating countries, which from Spain is the Centre for the Development of Industrial Technology (CDTI).

On September 20, 2022 GenScript USA Inc., the world’s leading life-science research tools and services provider and Avectas, reported a cell engineering technology leader, are partnering to develop an improved non-viral cell therapy manufacturing process (Press release, Avectas, SEP 20, 2022, View Source [SID1234626218]). The two companies share a goal of providing their customers with potent, new methods for developing cell therapies that offer an improved safety profile over viral and non-viral vector techniques.

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By combining Avectas’ cell engineering technology and know-how with GenScript’s expertise in synthetic long oligo production, the partnership aims to demonstrate a novel and efficient solution for cell therapy manufacturing and to improve editing efficiency and cell viability over traditional delivery methods.

CRISPR-based non-viral gene editing methods have gained popularity among research teams following concerns about the FDA’s recent draft guidance on the use of viruses for gene and cell therapy. GenScript is collaborating with both academic and industry partners in the development of CRISPR non-viral gene editing to enable next-generation gene- and cell-therapy R&D projects.

Intracellular delivery is integral to the generation of engineered ex vivo cell-based therapies, including genome editing approaches. But the limitations of current delivery modalities, both viral and non-viral, led Avectas to develop the non-viral solupore cell engineering technology, which enables efficient delivery of cargoes into cells for the development of next-generation therapies.

The research teams will apply solupore technology to permeabilize the target cell membrane so that engineered cargoes can be delivered while retaining very high levels of cell viability and functionality. GenCRISPR synthetic sgRNA and Cas9 protein are then complexed into a ribonucleic protein that is co-delivered with GenExact ssDNA HDR templates into the cell nucleus.

"GenScript is excited to partner with Avectas as part of our program to develop novel RNP and oligo delivery systems for non-viral cell engineering," said Ray Chen, PhD, president of GenScript USA Life Science Group. "We expect this method will provide our customers with more complete solutions for efficient gene editing using our GenCRISPR sgRNA and ss/dsDNA HDR templates."

"Avectas is delighted to partner with GenScript to combine its innovative editing tools together with our solupore delivery platform," said Michael Maguire, PhD, CEO of Avectas. "This will enable the development of next-generation cell therapies differentiated by the quality of the modified cells, which retain high viability, functionality, and post-process proliferation."

On September 20, 2022 Basilea Pharmaceutica Ltd, a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, reported that it has entered into an asset purchase agreement and a sub-license agreement with SillaJen, Inc. for Basilea’s novel kinase inhibitor, BAL0891, a potential first-in-class mitotic checkpoint inhibitor, that drives aberrant tumor cell division leading to tumor cell death (Press release, Basilea Pharmaceutica, SEP 20, 2022, View Source [SID1234625345]).

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Basilea in-licensed BAL0891 in 2018 from the Dutch precision medicine company NTRC. Under the asset purchase agreement Basilea is selling its intellectual property rights generated under the license and collaboration agreement with NTRC. In addition, Basilea is sub-licensing its rights and obligations under the license and collaboration agreement with NTRC to SillaJen.

Adesh Kaul, Chief Financial Officer of Basilea, said: "We are pleased to have found in SillaJen an experienced oncology partner for the further development of BAL0891. This transaction marks an important step on our path to be a focused anti-infectives company. We are proud to have advanced BAL0891 through preclinical development to the start of clinical studies. The unique inhibition profile of BAL0891, targeting both TTK and PLK1 kinases, differentiates the compound and offers the potential for development in multiple cancers. Through the structure of the transaction we continue to participate in the long-term value creation potential of this promising program."

Jaegyeong Kim, MD, CEO at SillaJen, Inc. stated: "We are excited to acquire the rights to BAL0891. This agreement for a first-in-class anti-cancer drug, demonstrates our commitment to enhance lives of patients suffering from advanced solid tumors. In addition to our leading pipeline of Pexa-Vec, and the next generation SJ-600 series of oncolytic virus modalities, we are committed to advance and further develop medicines that will address the greatest unmet needs in cancer treatment. We hope to successfully deliver these products and help alleviate the burden of cancer patients worldwide."

Under the terms of the agreement, Basilea will receive upfront and near-term milestone payments of USD 14 million. Basilea is also eligible to receive further payments of up to approximately USD 320 million upon the achievement of predefined development, regulatory and sales milestones and tiered royalties on net sales starting in the single digit range going up to double-digits. Basilea remains responsible for making milestone and royalty payments to NTRC according to the license and collaboration agreement with NTRC.

In February this year Basilea announced its intention to focus on becoming a leading anti-infectives company and therefore to separate its oncology assets. Basilea has already made significant progress in the implementation of the new strategy and expects no material expenses related to oncology activities beyond 2022. Basilea is on track to achieve sustainable profitability from 2023.

Basilea updates its full-year 2022 financial guidance. It expects higher total revenues of CHF 116 to 122 million (previously CHF 106 to 112 million), an improved operating result of CHF -10 to -15 million (previously CHF -20 to -25 million) and improved cash flow from operating activities of CHF 0 to -5 million (previously CHF -10 to -15 million).

About SillaJen, Inc.

SillaJen, Inc. (KOSDAQ:215600) is one of the leading biotech companies in the development of oncolytic vaccinia immunotherapy. It is headquartered in Seoul, South Korea, with research center and satellite offices in Busan, South Korea and San Francisco, CA. SillaJen, Inc. is conducting Phase 2 trials for the treatment of renal cell carcinoma with the company’s lead pipeline, Pexa-Vec. The company is also developing intravenous injectable oncolytic vaccinia virus pipelines (SJ-600 series) to be more applicable and efficacious against various tumors. Additional information about SillaJen, Inc. is available at www.sillajen.com.

About BAL0891

BAL0891 is a first-in-class mitotic checkpoint inhibitor that pushes cells through mitosis without adequate time for correct chromosome segregation. This results in aberrant tumor cell division leading to tumor cell death. The compound is a unique dual inhibitor of threonine tyrosine kinase (TTK) and polo-like kinase 1 (PLK1). Both kinases collaborate in activating the mitotic spindle assembly checkpoint (SAC), a cell division mechanism regulating correct chromosome alignment and segregation. The dual action of BAL0891 leads to a rapid disruption of the SAC driving cells through mitosis before the chromosomes are properly aligned, leading to premature cell division and tumor cell death. BAL0891 has shown anti-proliferative activity across diverse tumor cell lines in vitro and single agent efficacy in in-vivo models of solid human cancers. BAL0891 was in-licensed from NTRC in 2018.

On November 20, 2022 Elicio Therapeutics reported that it received a $2.8 million grant from the Gastro-Intestinal Research Foundation (GIRF) in Chicago to fund research for two therapeutic cancer vaccines (Press release, Elicio Therapeutics, SEP 20, 2022, View Source [SID1234623980]).

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