On July 27, 2021 iOnctura SA, a clinical stage oncology company targeting core resistance and relapse mechanisms at the tumor-stroma-immune interface, announces the support of Innosuisse in a 2-year innovation project to explore the potential of iOnctura’s lead molecule, the PI3Kδ-inhibitor IOA-244, in the treatment of lymphoma (Press release, iOnctura, JUL 27, 2021, View Source [SID1234640245]).

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The Innosuisse grant of 596’828 CHF (approximately $652,000) will fund fifty percent of the project’s costs, covering the research carried out by Professor Francesco Bertoni of the Institute of Oncology Research (IOR) in Bellinzona, Switzerland.

The research project, scheduled to start in August 2021, will run alongside iOnctura’s expanding clinical program for IOA-244, focussed on the treatment of solid tumors (NCT04328844). Amongst other aspects, the new project will explore patient stratification biomarkers, combination interventions to increase treatment response rates in lymphoma and methods for minimizing potential resistance pathways.

"I am delighted iOnctura will be able to draw on the experience of Francesco Bertoni and his group to better understand the mechanisms of resistance in lymphoma. We want to understand precisely how to position IOA-244 in the treatment landscape of lymphoma in parallel to our clinical program in solid tumors." said Catherine Pickering, CEO of iOnctura. "In our ongoing solid tumor program with IOA-244 we are seeing clinical safety and activity behaviors consistently mirroring those we anticipated from our preclinical evaluations."

IOA-244 is highly selective for the PI3Kδ isoform and has a novel mechanism of target inhibition, binding the kinase without competing for ATP. This suite of properties contributes to IOA-244’s emerging unprecedented clinical profile. While first-generation PI3Kδ-inhibitors are being prescribed for the treatment of lymphoma, their use has been associated with compound-related toxicities, limiting their application as monotherapy and preventing their combination with standard therapies. Furthermore, resistance mechanisms associated with PI3kδ inhibitors remains an important field of research to address additional unmet medical need.

Professor Bertoni, the research partner at the IOR, commented, "Targeting PI3Kδ holds great promise for the treatment of patients with lymphoma. Unfortunately, previous drugs in this class have been hampered by safety issues and resistance. I am excited to be working on IOA-244, a novel PI3Kδ inhibitor, which not only has a unique binding mode, but based on initial clinical data also appears to be safe and combinable with other drugs – meaning we could translate our findings into meaningful treatment regimens for patients."

Project funding comes from Innosuisse, the Swiss national Innovation Agency which has a remit to promote science-based innovation to increase the competitiveness of small and medium-sized enterprises in Switzerland.

Project title: "Evaluation of non-ATP competitive PI3Kδ inhibition with IOA-244 in the treatment of lymphoma".

On July 27, 2021 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that James (Jim) Cassidy, M.D., Ph.D., has been appointed Chief Medical Officer (Press release, SpringWorks Therapeutics, JUL 27, 2021, View Source [SID1234591662]). Dr. Cassidy brings over 30 years of experience in oncology as an academic physician-scientist and a drug development leader in both biotechnology and pharmaceutical companies, with experience spanning from early-stage research to translational and clinical development to post-marketing medical affairs strategy and lifecycle management. Dr. Cassidy succeeds Jens Renstrup, M.D., MBA, who will be leaving the company.

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"Jim brings significant oncology experience as a physician-scientist and industry leader to our efforts at SpringWorks, where we remain intensely focused on continuing to build a leading targeted oncology company with a diversified portfolio of differentiated programs," said Saqib Islam, Chief Executive Officer of SpringWorks. "I am delighted to welcome Jim to SpringWorks. I would also like to thank Jens for his contributions to SpringWorks and wish him well in his future endeavors."

"Having had the pleasure of working closely with Jim several times throughout our careers, I am confident that the energy and expertise that he brings to developing drugs on behalf of cancer patients will prove exceptionally valuable to our efforts at SpringWorks," added Mike Burgess, M.B.Ch.B., Ph.D., Head of Research and Development at SpringWorks.

Dr. Cassidy joins SpringWorks from Regeneron Pharmaceuticals, where he was Vice President of Oncology Strategic Program Direction. Prior to Regeneron, Dr. Cassidy was Corporate Vice President of Translational Development at Celgene, where he oversaw translational science efforts for the company’s entire portfolio of programs addressing both hematological malignancies and solid tumors. Before that, he was Vice President of Oncology at Bristol-Myers Squibb, where he was responsible for all oncology assets from development candidate nomination through clinical proof-of-concept studies, including biomarkers and translational research, and was closely involved with late-stage development, commercial, and business development efforts as well. Prior to Bristol-Myers Squibb, Dr. Cassidy held several roles of increasing responsibility at Hoffmann La-Roche, including Global Head of Translational Research for Oncology and Acting Head of the Oncology Therapy Area. Before joining Roche, Dr. Cassidy had been a leading academic physician-scientist, most recently having served as Professor of Oncology, Head of the Department of Cancer Research and Head of the Division of Cancer Sciences and Molecular Pathology at the University of Glasgow in Scotland. Dr. Cassidy received his medical degree and doctorate from the University of Glasgow.

"I am very pleased to be joining SpringWorks during this important time of growth and evolution for the company and am excited by the breadth of oncology opportunities being advanced on behalf of patients with solid tumors and hematologic malignancies," said Dr. Cassidy. "I look forward to working with this talented team to continue accelerating the development of our pipeline with the goal of bringing innovative new medicines to cancer patients."

On July 27, 2021 Inspirata reported that Partners with King’s Health Partners ECMC and Guy’s and St Thomas’ NHS Foundation Trust to Evaluate the Application of AI Automation in Matching Patients with Cancer to Early Phase Clinical Trials (Press release, Lifescience Newswire, JUL 27, 2021, View Source [SID1234585498]).

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Trial Navigator utilises NLP to patient matchCancer informatics and digital pathology provider Inspirata announced today that King’s Health Partners ECMC and Guy’s and St Thomas’ NHS Foundation Trust will pilot its Trial Navigator software as part of an evaluation the organisations are conducting into how artificial intelligence based automation can improve the identification and efficiency of matching patients with cancer to early phase clinical trials. Trial Navigator’s introduction as part of a pilot evaluation within the Cancer Early Phase Trials Unit will see Inspirata collaborate with both King’s Health Partners and the Experimental Cancer Medicine Centre (ECMC) Network Programme Office.

Delays in candidate identification and the absence of real-time visibility of open studies introduces a risk that patients miss out on trials for which they could have ultimately proved eligible. By applying oncology-specific natural language processing (NLP) to interrogate both the patient’s individual medical reports and potential trial eligibility criteria, this project will explore the extent to which Trial Navigator can help to improve bottlenecks in both identifying and matching patients to relevant clinical trials.

"At the Cancer Centre at Guy’s, we’re constantly striving to get the best possible outcomes for our patients, and sometimes that means providing them with the opportunity to enrol on trials of new cancer drugs when conventional treatments have been unsuccessful. AI technology offers the potential to better match our patients to available trials, but we need to evaluate them first to prove that they can deliver on their promise," says Danny Ruta, Clinical Artificial Intelligence Lead, Guy’s and St Thomas’ NHS Foundation Trust. "We hope that the intelligent automation afforded by Trial Navigator will prove to be an effective solution for identifying greater numbers of our eligible cancer patient population for clinical trials."

"Our patients are looking to us for assurances that all possible options and avenues associated with their care have been thoroughly evaluated," says Debashis Sarker, Reader in Experimental Oncology in the School of Cancer and Pharmaceutical Studies of King’s College London, and Honorary Consultant in Medical Oncology at Guy’s and St Thomas’ NHS Foundation Trust. "I am hugely attracted to any toolset which serves to augment my own understanding of the different trial options available so that I can impart this confidence and where applicable, see more patients obtain prompt access to potential new treatments in a more timely manner."

While building on an underlying oncology NLP engine that has already been successfully deployed at over 400+ hospitals and cancer centres worldwide, Trial Navigator has been purposely designed to improve clinical trial matching by supporting both the clinician at the point of care, and trial coordinators with patient identification. Trial Navigator can also be deployed to perform instantaneous lookups against any relevant trial database.

"Digital technology will play a key role in ensuring that the UK remains one of the best places in the world to conduct experimental cancer medicine studies, so that our UK patients get access to novel therapies at the earliest opportunity. We are excited to support a project that seeks to aid clinicians in the complex and time-consuming task of matching patients to suitable trials," says Michelle Mitchell, Chief Executive of Cancer Research UK, which co-funds the ECMC network.

"We could not be more excited nor proud to work with Guy’s and St Thomas’, Kings Health Partners and ECMC on this project," says Oenone Duroe, General Manager, Inspirata Europe. "We look forward to collaborating closely with the team to validate the efficacy of AI in a clinical trial matching context, and by drawing on insights derived, support equivalent Trial Navigator engagements within the National Health Service."

On July 27, 2021 Zealand Pharma A/S ("Zealand") reported that initiated a share repurchase program to acquire Danish common stock for incentive programs in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (Press release, Zealand Pharmaceuticals, JUL 27, 2021, View Source [SID1234585458]).

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Zealand has entered an arrangement with Danske Bank A/S to act as exclusive manager under the program. Danske Bank A/S will buy back shares on behalf of Zealand and make related trading decisions independently of and without influence by Zealand.

Under the program, Danske Bank A/S will buy back shares on behalf of Zealand for an amount up to DKK 32,070,896. The share repurchase program is now completed. It was expected to be completed no later than July 29, 2021 and comprises up to 154,187 shares.

Since the announcement dated 20 July 2021, the following transactions have been made:

The details for each transaction made under the share repurchase program are included as an appendix to this announcement.

With the transactions stated above, Zealand owns a total of 218,410 shares with a nominal value of DKK 1 each as treasury shares, corresponding to 0.5% of the total share capital. The total share capital of the company is DKK 43,541,838 with a nominal value of DKK 1 each.

On July 27, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported it entered into an exclusivity agreement with ABX Advanced Biochemical Compounds GmbH (ABX) for the supply of a key component required to manufacture the drug substance in Rhenium-186 NanoLiposome (186RNL), the Company’s lead radiotherapeutic (Press release, Cytori Therapeutics, JUL 27, 2021, View Source [SID1234585439]).

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"In parallel to our clinical progress, we are simultaneously strengthening our commercial RNL supply chain for long-term success", said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "ABX has extensive experience manufacturing and supplying chemical components for the radiopharmaceutical industry and exclusivity provides us an additional layer of market protection around our RNL portfolio."

As part of the agreement, ABX will produce a high purity precursor that meets current Good Manufacturing Practices (cGMP) and all relevant requirements of the U.S. Food and Drug Administration and other similar global regulatory entities. Plus Therapeutics will have up to 10 years of exclusive access to the cGMP precursor. This strategic partnership secures the commercial supply chain for 186RNL and extends to future products under the RNL platform.

186RNL is being developed to potentially treat recurrent glioblastoma and other rare and difficult-to-treat cancers. Plus Therapeutics is currently enrolling patients with recurrent glioblastoma in the U.S. multi-center ReSPECT-GBM Phase 1 dose-finding clinical trial which is designed to safely, effectively and conveniently deliver high doses of radiation directly to brain tumors.