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.

On July 27, 2021 Redx Pharma (AIM: REDX), the drug discovery and development company focused on cancer and fibrosis, reported it has selected 2 mg once daily as the dose of RXC004 for the planned Phase 2 monotherapy, proof of concept clinical trials based on the safety profile observed in Phase 1 (Press release, Redx Pharma, JUL 27, 2021, View Source [SID1234585437]). The studies are expected to start during the second half of 2021. RXC004 is the Company’s lead drug candidate and is a highly potent, orally active porcupine inhibitor being developed as a targeted therapy for Wnt-ligand driven cancer. Porcupine is a key enzyme in the Wnt pathway, well established as a key driver of both tumour growth and immune evasion.

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The selection of a dose and decision to move RXC004 into Phase 2, follows the successful recruitment of all patients to the monotherapy arm of the Company’s ongoing open label dose escalation Phase 1 study (NCT03447470). The primary objective of the Phase 1 study was to establish the safety and tolerability of RXC004 in patients. Preliminary data from the study in patients with unselected advanced solid tumours, showed that RXC004 2mg once daily was safe, tolerated and provided target coverage at levels required to assess monotherapy efficacy in Phase 2 clinical trials in selected patients with Wnt-ligand driven cancers. Whilst the Phase 1 study was in genetically unselected cancers, the data suggested a differential level of activity between Wnt-ligand driven cancers and non Wnt-ligand driven cancers, in line with observations of other molecules in this class. Redx plans to present the monotherapy results from the Phase 1 study at the ESMO (Free ESMO Whitepaper) Congress in September 2021.

Lisa Anson, Chief Executive Officer of Redx Pharma commented "Our Phase 1 monotherapy study supports our belief that RXC004 has the potential to be a significant, novel targeted medicine for the treatment of Wnt-ligand driven cancer. Our distinctive approach to drug discovery has enabled our highly talented scientific team to design our Porcupine Inhibitor to unlock the therapeutic potential of Wnt pathway blockade, a long sought-after oncology target. The decision to progress to Phase 2 and the selection of our monotherapy dose represent major milestones in the clinical development of our lead asset."

Jane Robertson, Chief Medical Officer of Redx Pharma added "The Redx team and our investigators are excited to move forward into Phase 2 clinical studies to evaluate the efficacy of RXC004 as monotherapy in selected patients with mCRC, pancreatic and biliary tract cancers, whose tumours have high Wnt-ligand dependency. We look forward to initiating these studies in the coming months."

About the Phase 2 programme

Redx plans to commence a global Phase 2 monotherapy programme in three tumour types to assess RXC004 efficacy in patients with Wnt ligand-driven cancers. In two tumour types, microsatellite stable metastatic colorectal cancer (MSS mCRC) and pancreatic cancer, the studies will enrol only patients whose tumours have high Wnt-ligand dependency resulting from specific genetic aberrations (RNF43 mutations and/or RSPO fusions). A third proof of concept study will enrol patients diagnosed with biliary tract cancer, a tumour known to have high Wnt-ligand dependency. All three of these cancer types have high unmet need with limited treatment options and poor 5-year survival rates of less than 3% for biliary and pancreatic cancer and 14% for mCRC. All three studies are planned to commence in H2 2021 and initial results could be available from 2022. RXC004 is also currently being investigated in a Phase 1 study in combination with nivolumab (OPDIVO – Bristol Myers Squibb, an anti-PD-1 antibody). The primary objective of this arm of the study is to evaluate the safety and tolerability of this combination in patients with unselected advanced malignancies. The results from this combination study are expected in H2 2021 and will be used to define a dose of RXC004 to be used in combination with standard dose nivolumab in a Phase 2 study in patients with genetically selected microsatellite stable (MSS) metastatic colorectal cancer (MSS mCRC).