On September 20, 2023 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) reported that scientific updates in presentations selected for European and American conferences: at the 7th International Cancer Immunotherapy (CICON) Conference in Milan, Italy (September 20 – 23), at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting in San Diego, CA, US (November 1 – 5) and at the 15th Annual Protein & Antibody Engineering Summit (PEGS) Europe Summit in Lisbon, Portugal (November 14 – 16) (Press release, OSE Immunotherapeutics, SEP 20, 2023, View Source [SID1234635300]). The communications will feature the latest progress on the Company’s research programs in immuno-oncology, namely CLEC-1 (novel myeloid immune checkpoint), CYTOMASK, a new and innovative CIS-demasking cytokine linker technology, BiCKI-IL-7 (bifunctional therapy targeting PD-1 and IL-7), and Tedopi (T-cell epitope-based cancer vaccine).

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Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: "OSE will be presenting 9 communications at upcoming leading international scientific conferences. We are proud of the achievements from our researcher teams on the advancement of our innovative programmes. We are committed to progressing those programmes with the most relevant academic and/or pharma partners to further clinical stage studies and ultimately bring breakthrough immunotherapies to patients with high unmet needs."

DETAILS OF THE OSE IMMUNOTHERAPEUTICS NEXT PRESENTATION:

CICON23
Seventh "International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper): Translating Science into Survival"
SEPTEMBER 20-23, 2023 – MILAN, ITALY

NUMBER

TITLE

SESSION

FIRST AUTHOR

P269

ANTAGONIST ANTIBODIES INHIBITING THE BINDING OF MYELOID CHECKPOINT CLEC-1 TO NOVEL ENDOGENOUS LIGANDS DEMONSTRATE HIGH ANTI-TUMOR EFFICACIES IN HUMANIZED PRECLINICAL MODELS

POSTER SESSION B
Friday, Sept. 22

Irène BACELLI

P270

CIS-DEMASKING CYTOKINE LINKER TECHNOLOGY ALLOWS SELECTIVE CYTOKINE DELIVERY TO ACTIVATED IMMUNE CELLS WHILE SPARING OTHERS AND PERIPHERAL TOXICITY

POSTER SESSION A
Thursday, Sept. 21

Caroline MARY

P271

ANTI-PD-1/IL-7V IMMUNOCYTOKINE FAVORS PROLIFERATION & SURVIVAL OF TCF1+ STEM LIKE MEMORY T CELLS ANDA DURABLE IN VIVO EFFICACY IN MONOTHERAPY OR USING COMBINATORIAL STRATEGY

POSTER SESSION B
Friday, Sept. 22

Aurore MORELLO

On September 20, 2023 Merck, a leading science and technology company, reported two new strategic drug discovery collaborations aimed at harnessing powerful artificial intelligence (AI)-driven design and discovery capabilities, further advancing the company’s research efforts (Press release, Merck & Co, SEP 20, 2023, View Source [SID1234635299]). The partnerships, with BenevolentAI, London, U.K., and Exscientia, Oxford, U.K., are expected to generate several novel clinical development drug candidates with first-in-class and best-in-class potential in key therapeutic areas of oncology, neurology and immunology.

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"With the convergence of science, data, and AI, we’re determined to fast-track the development of new and truly innovative candidates, forging a path to previously unimaginable medical breakthroughs"

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"With the convergence of science, data, and AI, we’re determined to fast-track the development of new and truly innovative candidates, forging a path to previously unimaginable medical breakthroughs," said Danny Bar-Zohar, Global Head of Research & Development and Chief Medical Officer for the Healthcare business sector of Merck. "The partnerships with industry-leading AI technology firms BenevolentAI and Exscientia will complement our internal research capabilities and expertise, aligning with our broader strategy to enhance R&D productivity and the output of our pipeline in a sustainable manner."

Under the terms of the agreements, three potential first-in-class and best-in-class targets have been selected to initiate each partnership with the possibility of identifying and nominating additional targets in the future. The collaborative efforts are focused on advancing small molecule development candidates which Merck will select for further pre-clinical and clinical development. Both partners will each receive low double digit million US dollar upfront payments and will be eligible for discovery, development, regulatory and commercial milestone payments and tiered royalties based on net sales.

Merck systematically explores data science and AI approaches to accelerate the discovery and delivery of breakthrough medicines. Integrating AI across R&D processes from identifying targets to clinical trials and product lifecycle management, is aimed at transforming drug discovery and development, bringing new medicines to patients faster and with higher probability of success. As the field evolves Merck will continue to deepen its existing AI and advanced analytics expertise while expanding partnerships and collaborations, ensuring the company remains at the forefront of innovation.

All Merck press releases are distributed by e-mail at the same time they become available on the Merck website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

On September 20, 2023 Kyowa Kirin International (KKI), a wholly owned subsidiary of Kyowa Kirin Co. Ltd, reported the acceptance of an extensive programme of data to the annual meeting of the European Organisation for Research and Treatment of Cancer’s Cutaneous Lymphoma Tumour Group (EORTC-CLTG), taking place from the 21st – 23rd of September 2023 in Leiden, the Netherlands (Press release, Kyowa Hakko Kirin, SEP 20, 2023, View Source [SID1234635298]).

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Four studies across a range of European countries, the USA and the UAE, aim to collect robust evidence in a real-world clinical setting for Poteligeo (mogamulizumab), the first-in-class humanised monoclonal antibody (mAb) therapy approved in Europe for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.

Danie du Plessis, Executive Vice President of International Medical Affairs, Kyowa Kirin, commented: "The studies presented at EORTC-CLTG demonstrate our long-term commitment to expand the evidence base for the effectiveness of mogamulizumab in real-world settings. Our ongoing research programme in CTCL extends across a wide geographic area, recognising the patient perspective, clinical endpoints and the diversity of healthcare systems, all part of our ambition to improve outcomes for those affected by mycosis fungoides and Sézary syndrome."

Data from OMEGA (France) represents the first published real-world evidence generated by KKI regarding the effectiveness of mogamulizumab. OMEGA, a completed, retrospective, real-world, non-interventional observational study, described real-world effectiveness and tolerability of mogamulizumab in patients with MF and SS.

Alongside the data from OMEGA, interim data from two of the other studies – MINT (Germany) and MIBERIC (Spain and Portugal) – support the effectiveness of mogamulizumab in real-world clinical practices and are in line with efficacy and safety data demonstrated in global clinical trials. Across all three trials no new safety signals were seen. The fourth study – PROSPER (USA, UAE, Spain, Italy, Netherlands, UK) – is an ongoing study investigating the impact of mogamulizumab in patients with MF and SS from the patient perspective assessing symptoms and health-related quality of life, as well as impact on their primary care partners, also in the real-world clinical setting.

Professor Chalid Assaf, Director of the Department of Dermatology, HELIOS Klinikum Krefeld, and lead author of the MINT study, commented: "CTCL can have a severely detrimental impact on patients’ health-related quality of life, with sometimes far-reaching consequences for those living with the disease as well as their families. The real-world evidence being generated by Kyowa Kirin raises the standard of information available to those involved in treating mycosis fungoides and Sézary syndrome helping to inform decisions that support optimal patient care."

Table 1. Overview of mogamulizumab study programme for presentation at EORTC-CLTG

Trial Name and Presentation Type

Lead Author

Abstract Title

OMEGA

(oral abstract)

Prof. Marie Beylot-Barry, Bordeaux Institute of Oncology, France

Efficacy and tolerability of mogamulizumab in patients with Mycosis Fungoides or Sézary syndrome. Retrospective and real-world data from centres of the French Study Group of Cutaneous Lymphoma

MINT

(oral abstract)

Prof. Chalid Assaf, Helios Hospital, Germany

Mogamulizumab in patients with mycosis fungoides or Sézary syndrome: Interim analysis of the German non-interventional MINT study

MIBERIC

(poster)

Prof. Pablo Ortiz Romero, Hospital Universitario 12 de Octubre, Spain

Real-world effectiveness of mogamulizumab in patients with Sézary syndrome or mycosis fungoides in Spain and Portugal: The MIBERIC study

PROSPER (poster)

Prof. Julia Scarisbrick, University Hospital Birmingham, United Kingdom

A Real-World International Observational Study of Mogamulizumab in Adult Patients with Mycosis Fungoides and Sézary Syndrome (PROSPER study NCT05455931) – UK

To view the full press release, click here.

On September 20, 2023 Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based, biopharmaceutical company aiming to establish tomorrow’s standard-of-care to cure cancer and infectious diseases, reported an exclusive option and license agreement with SunRock Biopharma (www.sunrockbiopharma.com), a Galician company supported by the regional government, Xunta de Galicia, through Xesgalicia, devoted to the development of antibodies against highly invasive tumors with an urgent clinical need in oncology, for the advancement of the development of specifically targeted antibodies (Press release, Debiopharm, SEP 20, 2023, View Source [SID1234635297]).

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The agreement offers Debiopharm licensing options to further develop SunRock’s antibodies integrating Debiopharm’s innovative linker technologies, Multilink and AbYlink, to create innovative antibody drug conjugates (ADCs). Novel ADCs will be developed with capacity to target tumor-specific antigens to fight cancers with high unmet need, including those tumor types expressing HER2/HER3.

ADCs are emerging as promising therapies in the fight against cancer due to their unique ability to target and destroy cancer cells selectively while minimizing damage to healthy tissues. These innovative therapeutics combine the precise targeting capabilities of monoclonal antibodies with the potent cytotoxic effects of small molecule drugs, resulting in a powerful synergistic effect. By harnessing the specificity of antibodies, ADCs can recognize and bind to tumor-specific antigens on the surface of cancer cells, ensuring that the toxic payload is delivered directly to its intended target. This precise approach not only enhances therapeutic efficacy but also reduces systemic toxicity and side effects commonly associated with traditional cancer treatments.

"Our partnership with SunRock could result in the creation of highly innovative antibody-drug conjugates with the potential to tackle cancer in a new way and ultimately improve the lives of cancer patients," commented Bertrand Ducrey, CEO of Debiopharm. "In a time when few new modalities show promise in effectively beating cancer, the potential of this collaboration is sparking scientific curiosity by combining biology and chemistry."

Advancements in linker technology have improved ADC stability in circulation, reducing premature drug release and further increasing treatment specificity and effectiveness. Debiopharm’s unique Multilink technology can be used to create ADCs that are significantly more effective and better tolerated as it allows the loading of multiple payloads on an antibody. AbYlink is an antibody conjugation technology suited to rapidly generate new antibody drug conjugates or imaging antibodies while preserving the original affinity of the antibody to its target.

"We’re highly motivated to uncover the potential of these antibodies with well-validated oncology targets such as HER2 and HER3," expressed Frederic Levy, Senior Executive Director, Search & Evaluation and Scientific Innovation. "Combining these promising molecules with our linker technology could really boost efficacy and safety to outsmart a wide variety of cancers with a high unmet medical need."

"We are really enthusiastic about the powerful synergy of SunRock antibodies and bispecific antibodies with Debiopharm’s ADC platform and clinical development capabilities," commented Laureano Simón, CEO of SunRock Biopharma.

About Multilink

Multilink is a new cleavable linker platform suited for multidrug attachment and compatible with any conjugation technology to produce ADCs with high DAR (drug-to-antibody ratio). This unique and innovative technology allows the loading of multiple payloads on an antibody for an enhanced therapeutic effect. This highly effective and well-tolerated linker platform is available for use by other specialty biotech or pharmaceutical companies to generate proprietary, clinical-stage ADCs.

About AbYlink

AbYlink is a versatile and rapid antibody conjugation technology for diagnostic purposes and ADC preparation. This site-selective method offers defined and invariable conjugation sites with no impact on antigen-binding regions. It facilitates a seamless, homogenous antibody conjugation process between antibodies and cytotoxic drugs, ensuring optimal stability and controlled drug release at the site of action. AbYlink empowers researchers to design ADCs with enhanced efficacy, safety, and specificity that can address unmet medical needs of patients through cutting-edge ADC innovation.

On September 20, 2023 IceCure Medical Ltd. (Nasdaq: ICCM), developer of the ProSense System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, reported that the U.S. Food and Drug Administration ("FDA") has at this time denied the Company’s De Novo Classification request for breast cancer which was submitted based on interim analysis from its ICE3 study (Press release, IceCure Medical, SEP 20, 2023, View Source [SID1234635296]). The FDA’s position on the De Novo Classification request for breast cancer has no effect on ProSense’s FDA cleared authorization for other indications in the U.S. and patients in the U.S. continue to have access to ProSense for those treatments. The Company is pursuing all avenues to address the FDA’s response as global adoption of ProSense outside of the United States continues to build. IceCure filed the De Novo request with the FDA in October 2022 based on interim data from its ICE3 breast cancer study for the Breakthrough Indication of early-stage (Luminal A T1 invasive) low-risk breast cancer patients who are at high risk to surgery (not suitable for surgical alternatives). IceCure continues its ICE3 clinical study, the largest clinical trial of its kind, which is expected to complete during the first quarter of 2024.

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"The positive expected five-year results based on the interim analysis of the ICE3 trial, which demonstrated a survival-based estimate for the 5-year ipsilateral breast tumor recurrence (IBTR) of 4.3%*, allowed us a rare and unique opportunity to submit a De Novo Classification request and make our minimally-invasive ProSense cryoablation procedure available to women sooner for this important and underserved indication," commented Eyal Shamir, Chief Executive Officer. "We, along with our regulatory consultants, believe the FDA’s response to the De Novo Classification request is largely due to the FDA’s need for additional scientific literature as a comparator rate of recurrence in patients treated with lumpectomy. We are committed to working with the FDA to address its comments by using the broadly available published scientific literature on recurrence outcomes in patients treated with lumpectomy. ProSense remains available in the U.S. under prior FDA clearances and we will continue to execute our plan and progress towards achieving our primary objective of completing the 5-year follow ups with our last patients in the ICE3 study by the first quarter of 2024, while we simultaneously evaluate all strategies to efficiently and effectively address the FDA’s comments."

The Company’s ProSense system was given a Breakthrough Device Designation by the FDA in March 2021, and previously received clearance in the U.S. for general minimally invasive cryoablation applications, including kidney, liver and benign breast tumors. ProSense is approved for the treatment of malignant breast tumors in other jurisdictions, including Europe, China, and Brazil.

ICE3 is the largest controlled multi-location clinical trial ever performed for liquid nitrogen (LN2)–based cryoablation of small, low-risk, early-stage malignant breast tumors without subsequently removing them. The trial began in 2014 and has 194 eligible patients) in 19 hospitals and medical centers across the U.S., including Columbia University Medical Center and Mount Sinai Beth Israel. The expected survival-based estimate for the 5-year IBTR was 4.3%* for patients who received ProSense system cryoablation treatment are free of recurrence, with one-third of patients reaching 5 years post treatment. Additionally, to date, there have been no significant device-related adverse events reported with no scarring or change in shape and size of the breasts, while 100% of doctors and 100% of patients reported satisfaction with the cosmetic results.

*Based on the last interim results release on October 19, 2022, there have been 6 cases of ipsilateral breast tumor recurrence ("IBTR") out of 194 patients, or 3.09%. The survival-based estimate for the 5-year IBTR is 4.3% with a one-sided 95% confidence level, upper bound of 8.4% for the entire study.

About ProSense

ProSense cryoablation is a minimally invasive, non-surgical, outpatient 40-minute procedure that only requires a local 1% lidocaine injection (similar to its use by dentists when performing certain dental procedures) enabling the patient to remain alert during the procedure and then walk out of the doctor’s office to resume their day. Cryoablation costs less than the current standard of care breast cancer surgery of lumpectomy or partial mastectomy which requires general anesthesia and has cosmetic consequences.