Six factors associated with invasive breast cancer recurrence after DCIS diagnosis

news-medical | April 25, 2019

Six factors associated with invasive breast cancer recurrence after DCIS diagnosis
Current guidelines recommend surgical excision of DCIS, often followed by radiotherapy and sometimes endocrine therapy, yet most cases will likely not progress or become life-threatening. As a result, many women are overtreated. "There is a large unmet need to distinguish harmless from potentially hazardous DCIS," said senior author of the study Wesseling. "We hope our work will help reduce the burden of intensive treatment that thousands of women with low-risk DCIS undergo annually."

Spotlight

Follow-on drugs, also referred to as ‘next-generation drugs’, are ‘an established practice’ among drug innovators. They are one of the most effective R&D strategies implemented by drug innovators, and can be considered a cannibalization or switching strategy. In a nutshell, it is a timely switch from a mature/firstgeneration drug to its next-generation, improved version. Given the fixed patent term and limited market exclusivity of drugs, cannibalization has been instrumental in maintaining the market share for drug makers.


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RESEARCH

DEBIOPHARM INVESTS IN VERISIM LIFE'S $15M SERIES A ROUND TO ADVANCE AI-ENABLED DRUG RESEARCH

Debiopharm International SA | January 11, 2022

Debiopharm a Swiss biopharmaceutical company, announced their co-investment in California-based start-up VeriSIM Life's $15 Million Series A Round to advance their mission to accelerate drug development via technology powered by artificial intelligence. VeriSIM Life's computational platform reduces time and cost of drug development as well as reduces the need for animal testing that, in the vast majority of cases, does not translate well to humans. Debiopharm's co-investment in VeriSIM contributes to the growth plan of the start-up and will help to expand and establish transformational partnerships with industry and academia using their first-in-class 'virtual drug development engine' BIOiSIM™. The investment aligns with Debiopharm's focus to invest in digital health solutions that improve the cancer patient journey, transform pharmaceutical R&D, and shift healthcare towards a more patient-centric approach. With the financing round led by Morpheus Ventures, Debiopharm Innovation Fund joins new investors including Colorcon Ventures along with existing investors OCA Ventures, Intel Capital, Serra Ventures and Susa Ventures. Founded in 2017 by Jo Varshney, DVM and PhD alongside a cross-functional team of pharmaceutical scientists, software engineers and AI/ML and simulation experts, the start-up offers a range of translational-based solutions, customized for pre-clinical and clinical programs. "We're moving into a time where AI-based technology will play a critical role in drug development. We absolutely need to reduce the time, costs & risks of drug development in order to be more efficient – that's exactly what the BIOiSIM™ is proven to do. The value of using this AI-based platform is the potential decrease in the need for animal testing and the acceleration of the pre-clinical, translational stage, helping drug research companies to more quickly select which early-stage medicines will most likely benefit patients and cure their disease." Tanja Dowe, CEO of the Debiopharm Innovation Fund More than 90% of drugs tested in animals fail to pass human clinical trials, resulting in delayed development and high costs. VeriSIM's BIOiSIM platform, driven by AI and machine learning (ML), de-risks R&D decisions by providing meaningful insights much earlier in the drug development process with unprecedented accuracy and scalability. VeriSIM's platform solves this decade-old translatability problem within the drug development phase and ensures clinical success of drugs intended for highly unmet needs. With its first-in-class platform, VeriSIM is transforming the way pharmaceutical and biotech companies address the most challenging diseases impacting humankind. About VeriSIM Life VeriSIM Life has developed a sophisticated computational platform that leverages advanced AI and ML techniques to significantly improve drug discovery and development by greatly reducing the time and money it takes to bring a drug to market. BIOiSIM is a first-in-class 'virtual drug development engine' that offers unprecedented value for the drug development industry by narrowing down the number of drug compounds that offer anticipated value for the treatment or cure of specific illnesses or diseases. The program not only reduces the time and cost of drug discovery and development, it also greatly reduces the need for animal testing that, in the vast majority of cases, does not translate to humans. Debiopharm's commitment to patients Debiopharm develops, manufactures and invests in innovative therapies and technologies that respond to high unmet medical needs in oncology and bacterial infections. We aim to provide strategic funding and guidance for companies with Smart Data & Digital Health solutions with the ambition to change the way drugs are developed and the way patients are treated. Our growing portfolio company achievements includes 18 FDA clearances or CE marks and 2 IPOs. Since 2018 Debiopharm has invested over USD 120 million, typically leading the investment rounds of its 16 portfolio companies.

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RESEARCH

DisperSol Technologies Announces Collaboration with Ajax Therapeutics to Develop Enhanced KinetiSol Drug Formulations

DisperSol Technologies | December 18, 2021

DisperSol Technologies LLC announced that it is has entered into a research collaboration with Ajax Therapeutics, Inc. to apply its KinetiSol technology to enhance the bioavailability of an Ajax drug candidate in development for the treatment of hematologic malignancies. “Ajax is taking an innovative approach to developing a pipeline of selectively targeted small molecules and we look forward to applying our proprietary KinetiSol technology to help enhance the bioavailability of one of these promising drug candidates. This collaboration is another example of our partnering strategy with our KinetiSol technology platform to help improve the bioavailability of next generation targeted therapies to provide new treatments for patients in need.” Dr. Edward Rudnic, CEO of DisperSol Technologies About DisperSol Technologies DisperSol is a clinical-stage drug development company focused on developing new treatments for patients utilizing its proprietary KinetiSol® technology platform. KinetiSol has proven capable of creating novel therapeutics from poorly bioavailable drugs to deliver unique clinical benefits to patients. The platform enables a drug development path forward to patients when other options fail to make a difference. DisperSol’s active programs include, DST-0509 about to enter Phase 3 for iron overload disorder and DST-2970 in Phase 2 for refractory metastatic prostate cancer. Additional earlier-stage programs include DST-5407 for non-squamous non-small cell lung cancer. About Ajax Therapeutics Ajax Therapeutics, Inc. is pursuing uniquely selective approaches to develop novel therapies targeting key cytokine signaling pathways that drive hematologic malignancies. By combining the deep cancer and structural biology insights of our founding scientists with the industry’s most advanced computational drug discovery and protein structure platforms from our founding partner, Schrödinger, Inc., we aim to discover and develop more precisely designed therapies to address significant unmet needs for patients with hematologic malignancies.

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RESEARCH

Hemogenyx Pharmaceuticals and Selexis SA Will Advance Hemogenyx’s Acute Myeloid Leukemia (AML) CDX Bispecific Antibody to Human Trials

Hemogenyx Pharmaceuticals plc | January 13, 2022

Hemogenyx Pharmaceuticals plc the biopharmaceutical group developing new therapies and treatments for blood diseases, and Selexis SA, a JSR Life Sciences company, have signed a service agreement to develop the cell line for Hemogenyx’s CDX bispecific antibody for the treatment of acute myeloid leukemia (AML). Under the agreement, Hemogenyx will leverage Selexis’ proprietary SUREtechnology Platform™, a suite of cell line development tools and technologies that significantly reduces the time, effort, and costs associated with developing high-performance mammalian cell lines. The CDX bispecific is made using the Hemogenyx’s proprietary humanised monoclonal antibody against a target on the surface of AML cells. CDX was co-developed by Hemogenyx Pharmaceuticals and Eli Lilly and Company (“Lilly”). This cutting-edge application of immune therapy offers a potentially more benign and effective form of treatment that, if successful, could have a significant impact on treatment and survival rates for AML. CDX is planned to be the Company’s second therapeutic candidate to enter clinical trials. Following the completion of the co-development phase, Lilly granted the Company an exclusive worldwide license to certain intellectual property developed by Lilly related to the CDX bispecific antibody for all uses, including the treatment of AML and other blood cancers. “We are delighted to partner with Selexis, and access its proprietary protein expression tools and technologies, IP and know-how. The partnership is key to advancing our CDX programme into clinical trials and accelerating the timeline to deliver this innovative therapy to patients in need of a more benign and effective treatment for AML.” Dr. Vladislav Sandler, Chief Executive Officer and co-founder of Hemogenyx Pharmaceuticals Mr. Dirk Lange, CEO of Selexis, added, “There’s an urgent need for effective treatments for AML, and we at Selexis are pleased to apply our technologies to help Hemogenyx advance the CDX bispecific antibody to the clinic. We’ve built a reputation for delivering cell lines rapidly and cost-effectively, without compromising safety. This is an exciting milestone for Hemogenyx and we welcome the opportunity to join the company on its journey toward delivering a promising and effective therapy for patients with AML.” Selexis’ modular SUREtechnology Platform™ facilitates the rapid, stable, and cost-effective production of recombinant proteins and vaccines, providing seamless integration of the development continuum from discovery to commercialization. About Hemogenyx Pharmaceuticals plc Hemogenyx Pharmaceuticals is a publicly traded company headquartered in London, with its US operating subsidiaries, Hemogenyx Pharmaceuticals LLC and Immugenyx LLC, located in New York City at its state-of-the-art research facility. The Company is a pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases. Hemogenyx Pharmaceuticals is developing several distinct and complementary product candidates, as well as a platform technology that it uses as an engine for novel product development. For more than 50 years, bone marrow transplantation has been used to save the lives of patients suffering from blood diseases. The risks of toxicity and death that are associated with bone marrow transplantation, however, have meant that the procedure is restricted to use only as a last resort. The Company’s technology has the potential to enable many more patients suffering from devastating blood diseases such as leukemia and lymphoma, as well as severe autoimmune diseases such as multiple sclerosis, aplastic anemia and systemic lupus erythematosus (Lupus), to benefit from bone marrow transplantation. About Selexis SA Selexis SA, a JSR Life Sciences company, is the global leader in cell line development with best-in-class modular technology and highly specialized solutions that enable the life sciences industry to rapidly discover, develop and commercialize innovative medicines and vaccines. Our global partners are utilizing Selexis technologies to advance more than 146 drug candidates in preclinical and clinical development and the manufacture of eight commercial products. As part of a comprehensive drug development process, the Company’s technologies shorten development timelines and reduce manufacturing risks.

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PHARMA TECH

CSL Limited announces tender offer to acquire Vifor Pharma Ltd

Vifor Pharma Group | December 15, 2021

Global biotechnology leader CSL Limited and Vifor Pharma Ltd, a global specialty pharmaceutical company with leadership in iron deficiency, nephrology & cardio-renal therapies, announced that they have entered into a definitive agreement for CSL to acquire Vifor Pharma for an aggregate equity value for Vifor Pharma of US$ 11.7 / CHF 10.9 billion. CSL has offered to acquire Vifor Pharma in an all-cash tender offer of US$179.25 per share, payable in U.S. dollars.1 The offer assumes a dividend of CHF 2 expected to be declared at the AGM of 26 April, consistent with past practice. The tender offer represents an implied premium of approximately 61% to the unaffected closing price of Vifor Pharma on 1 December 2021 and a 47% premium to Vifor Pharma’s unaffected 1-month VWAP as of 1 December 2021.2 Patinex AG, Vifor Pharma’s largest shareholder holding 23.2% has agreed to tender its shares into the offer. The Transaction remains subject to the conditions and further terms including: Minimum acceptance rate of 80% of all Vifor Pharma shares on a fully diluted basis; and further customary offer conditions, including regulatory approvals. The tender is currently expected to commence around 18 January 2022 and the transaction is expected to complete around mid-2022. The Board of Directors of Vifor Pharma considers that the proposed transaction respects the interests of all stakeholders and is unanimously recommending the offer to shareholders. There is committed financing for the deal and a strong commitment to pursue regulatory clearances. “Vifor Pharma's strategy has been to focus towards continuing being a market leader in iron deficiency, nephrology and cardio-renal therapies. The offer provides an excellent strategic opportunity for Vifor Pharma to optimize future market opportunities from a position of strength and to create substantial value for all stakeholders.” Jacques Theurillat, Chairman of the Board of Directors Vifor Pharma Group The transaction will enable Vifor Pharma to leverage CSL’s global reach, balance sheet and capabilities to bring more products to patients within its key categories. The transaction also enables Vifor Pharma to accelerate growth in cardiovascular-metabolic, renal and transplant. Centerview Partners UK LLP is acting as exclusive financial advisor to Vifor Pharma on the transaction. IFBC have been retained as Fairness Opinion providers by the Vifor Pharma Board of Directors. About Vifor Pharma Group Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange About CSL CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat hemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL — including our two businesses, CSL Behring and Seqirus- provides life-saving products to more than 100 countries and employs more than 25,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest.

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Spotlight

Follow-on drugs, also referred to as ‘next-generation drugs’, are ‘an established practice’ among drug innovators. They are one of the most effective R&D strategies implemented by drug innovators, and can be considered a cannibalization or switching strategy. In a nutshell, it is a timely switch from a mature/firstgeneration drug to its next-generation, improved version. Given the fixed patent term and limited market exclusivity of drugs, cannibalization has been instrumental in maintaining the market share for drug makers.

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