Bayer’s regorafenib kicks off brain cancer platform trial

Pharmaphorum | June 20, 2019

Bayer’s regorafenib kicks off brain cancer platform trial
Bayer has become the first pharma company to take part in a new platform trial designed to find new treatments for brain cancer. GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) is an international trial testing several therapies for patients with newly diagnosed and recurrent glioblastoma. Using a master protocol, several therapies or combinations of therapies from pharma companies can be tested simultaneously, with potential treatments added or dropped from the phase 2/3 trial over time. The idea is to adopt a more efficient approach to testing new therapies for glioblastoma, and Bayer is starting proceedings by opening enrolment for US patients in an arm evaluating its cancer drug regorafenib. Sponsored by the non-profit charitable organisation the Global Coalition for Adaptive Research (GCAR), by the end of the year GBM AGILE will open in over 40 academic medical centres and community-based institutions across the US. There are plans to expand across Europe, China, Canada, and Australia through 2020. GCAR aims to expand and replicate what is learned using this model for GBM to benefit patients with other rare and deadly diseases. A similar approach has already been used in breast cancer, where the I-SPY trials have used a platform design to test several different breast cancer drugs against the same control group. This represents a more efficient and ethical approach that reduces the number of patients required, and limits exposure to the potentially less effective standard therapy.

Spotlight

According to UPI, a new study found that a vegan diet can help reduce blood sugar and body weight. Men who ate vegan meals saw a boost in their gastrointestinal hormones, which help manage weight. The beneficial gut hormones also enhance insulin secretion, regulate blood sugar, and keep us feeling full longer. The study's lead author said this research "has important implications for those with type 2 diabetes or weight problems." According to the National Institutes of Health, approximately 30 million people in the U.S. have diabetes.


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PHARMACY MARKET

The McQuade Center for Strategic Research and Development and Mindset Pharma Collaborate to Develop Psychedelic Medicines

McQuade | January 06, 2022

The McQuade Center for Strategic Research and Development, LLC, a member of the global Otsuka family of pharmaceutical companies, and Mindset Pharma Inc. announce a collaboration that will support the development of psychedelic medicines. MSRD has made a strategic investment to support the discovery and development of novel chemical entity assets of Mindset, a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet medical needs. “Exploring multiple paths is essential as we work to address the unique needs of individuals living with mental health conditions. We look forward to collaborating with Mindset on these assets and are hopeful that medical psychedelics could be approved to treat mental illness in the future.” Robert McQuade, Ph.D., president, McQuade Center for Strategic Research and Development, LLC, and chief strategic officer, Otsuka Pharmaceutical Development & Commercialization, Inc MSRD, which identifies and supports early-stage opportunities that can change the landscape of treatments for mental illness and renal disorders, will financially and operationally support the development of two families of Mindset’s novel medical psychedelic compounds through Phase 1a and Phase 1b clinical trials. MSRD has made an upfront cash payment of $5 million USD to Mindset and under the terms of the agreement, MSRD and Mindset may agree to expand the collaboration to continue to develop the compounds as pharmaceutical products. In addition, Mindset has granted MSRD a right of first refusal with respect to any asset sale, exclusive licensing or collaboration opportunities pertaining to the drugs and a right of first negotiation with respect to a merger, acquisition or asset sale related to Mindset, both in exchange for the upfront payment, further collaboration, and funding of the development of Mindset’s novel compounds. MSRD also has the ability to potentially receive single-digit percentage royalty payments under certain circumstances when the right of first refusal is not consummated or the agreement is terminated. “It is our great pleasure to collaborate with MSRD, a member company of Otsuka, to further the development of two of our families of novel psychedelic compounds. We look forward to leveraging their extensive experience in drug development and CNS indications to accelerate and de-risk our development pathway as we prepare to launch clinical trials,” said James Lanthier, chief executive officer of Mindset. “There is a high unmet need for innovative treatments of mental illness. This collaboration further validates our belief that optimized and patentable next-generation psychedelic compounds will be the future of treatments for mental illness.” Mr. Richard Patricio, chairman of Mindset’s board, added, “This transformational transaction is a validation of what our team has accomplished over the last several years. We are ecstatic that Otsuka has chosen to collaborate with Mindset in the novel psychedelic drug development space and see this as a pivotal moment in Mindset’s maturation. Our team is excited to work closely with MSRD to help meet the unmet needs of millions of people worldwide suffering with a variety of mental disorders. The future is truly exciting.” About Mindset Pharma Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established in order to develop next generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin as well as its own proprietary compounds. For further information on Mindset, About the McQuade Center for Strategic Research and Development (MSRD) Established in 2019, by the Otsuka pharmaceutical business in the U.S., the mission of MSRD is to search for, identify, and fund innovative early-stage research and development programs that have the potential to build the future portfolio of Otsuka products. Otsuka is dedicated to investing in innovative and creative products in areas of unmet need and MSRD was created as an extension of this commitment to support and identify early-stage opportunities that can change the landscape of treatments for mental illness and renal disorders. About Otsuka Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

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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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BUSINESS INSIGHTS

Dermaliq Therapeutics Signs USD 15 Million Series A Round to Advance Three Transformative Drug Therapies into Clinical Trials

Dermaliq Therapeutics | January 18, 2022

Novaliq GmbH, 3E Bioventures Capital and Beijing Whale Technology Corporation Ltd. today announced the establishment of Dermaliq Therapeutics, Inc (Dermaliq), a newly formed Delaware-based pharmaceutical development company, and the signing of a USD 15 million Series A financing round. 3E Bioventures Capital, a leading international life science investor, led the round and was joined by Beijing Whale Technology Corporation Ltd. Dermaliq's existing shareholder Novaliq has transferred, and licensed Intellectual Property (IP) related to the field of dermatology to Dermaliq. Skin diseases are the fourth leading cause of non-fatal disease burden worldwide, underscoring the role of dermatology in the growing field of global health. Skin conditions have significant impact on patients' well-being, mental health, and social participation. Although topical and local delivery of active ingredients to diseased skin is the preferred treatment route for the majority of patients, current therapies often lack satisfactory skin penetration and patient compliance. Dermaliq is developing the next generation of skin care therapies to enhance targeted penetration into skin tissues and to reduce unwanted side effects for millions of patients. The unique and proprietary technology now owned by Dermaliq, called hyliQ™, is designed to allow cutaneous drug delivery with unmatched bioavailability. The technology enables the development of superior, highly effective liquid drug products with exceptional cosmetic properties. The proceeds will be used to conduct three Phase 1/2a clinical dermatology programs with the goal to demonstrate safety and efficacy and to advance this novel skin care drug category to market to improve the lives of millions of patients: DLQ01 is a liquid drug candidate for the topical treatment of female and male androgenetic alopecia, targeting the prostamide E2 (PGE2) receptor in hair bulbs through specific follicular drug delivery. DLQ02 is a novel and liquid topical calcineurin inhibitor drug therapy for plaque psoriasis, particularly in difficult to treat areas. DLQ03 is a broad-spectrum liquid antibiotic drug candidate that targets topical treatment of bacterial skin and soft tissue infections, including the reduction of antibiotic-resistant strains. The Company has demonstrated proof-of-principle for enhanced topical drug delivery using hyliQ™ in nonclinical models for all three applications. "We are excited that 3E Bioventures Capital and Beijing Whale Technology Corporation have committed to support Dermaliq as new investors in the Series A round. Our spin-off from Novaliq and successful raising of significant funds provides us with the opportunity to build a leading specialty pharmaceutical company and expand the application of Novaliq's transformative drug delivery technology into dermatology." Dr. Frank Löscher, Chief Executive Officer of Dermaliq "3E is committed to investing in global leading life sciences and biomedical companies and help them grow with access to globalized resources and capabilities," said Karen Liu, Managing Director 3E Bioventures Capital. "Dermaliq is using a unique, and scientifically sound technology to achieve high efficiency drug delivery across the skin. The technology is already proven in ophthalmology and holds great promise for dermatology. We will be excited to explore additional drug pipelines in China and synergize with Dermaliq on both pre-clinical and clinical development." "Whale Technology values the solid science foundation of Dermaliq's proprietary hyliQ™ technology platform," said Ming Gao, founder and Chief Executive Officer of Whale Technology Co. Ltd. "Dermaliq's founding team demonstrates a great combination of science, clinical experience and commercialization strength. We see great potential of Dermaliq's pipeline in the field of dermatology after Novaliq's proven clinical and commercial success in ophthalmology." "Dermatology is the logical next step into using Novaliq's proprietary technology platform outside eye care," said Dr. Christian Roesky, Chief Executive Officer Novaliq. "The spin-off into an independent company allows Dermaliq to greatly benefit from our experience in ophthalmology while being fully committed to the multiple product development activities in dermatology, and likely to further broaden its pipeline to other skin conditions." To reflect the new shareholder structure, Karen Liu of 3E Bioventures Capital will join Dermaliq's Board of Directors. Dr. Löscher has also transitioned from his role as Chief Technology Officer at Novaliq to lead Dermaliq as its CEO & President. About Dermaliq Dermaliq Therapeutics, Inc. is a private company founded in 2021 through a spin off from Novaliq to reimagine topical dermatology. The Company is incorporated in Wilmington (DE), USA under Delaware law. The company has signed a USD 15 million series A round to advance three transformative skin care drug therapies through clinical trials. Key shareholders are Novaliq GmbH, 3E Bioventures Capital and Beijing Whale Technology Corporation Ltd. About 3E Bioventures Capital 3E Bioventures Capital is a healthcare venture capital firm, dedicated to investing in cutting-edge life sciences and biomedical technologies, with a focus on breakthrough first-in-class therapies and disruptive cross-disciplinary innovations in medical devices and diagnostics. 3E Bioventures takes on a science-driven, entrepreneur-friendly investment philosophy by working closely with companies and research institutions to develop drugs or products that have strong unmet medical needs. With offices in Beijing, Shanghai, and the San Francisco Bay Area, 3E Bioventures leverages its experience, capabilities, and network to help companies tap into markets and resources across the Pacific and advance with greater speed and capital efficiency. The motto of 3E Bioventures Capital is captured in its name 3E: Expertise, Efficiency, Execution. About Beijing Whale Technology Corporation Ltd Beijing Whale Technology Corporation Ltd. is a China-based pharmaceutical group committed to the long-term sustainable development in the fields of chemistry, pharmaceuticals and aesthetics. With more than 20 years of history, Whale Tech. has developed two core business units. On one hand, Whale Pharmaceutical Co. Ltd., Whale Chemistry Co. Ltd. and Whale Pharmatech Co. Ltd. are grouped as pharmaceutical and chemistry business unit. On the other hand, Whale Biotech is a research stage biotech company with the focus of developing aesthetics products. About Novaliq Novaliq is a biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol®, the worldwide first water-free eyedrop technology. Novaliq offers an industry-leading portfolio addressing today's unmet medical needs of millions of patients with eye diseases. Novaliq GmbH is headquartered in Heidelberg, Germany and Novaliq Inc. has an office in Cambridge, MA, USA. The long-term shareholder is dievini Hopp BioTech holding GmbH & Co. KG, an active investor in Life and Health Sciences companies.

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Spotlight

According to UPI, a new study found that a vegan diet can help reduce blood sugar and body weight. Men who ate vegan meals saw a boost in their gastrointestinal hormones, which help manage weight. The beneficial gut hormones also enhance insulin secretion, regulate blood sugar, and keep us feeling full longer. The study's lead author said this research "has important implications for those with type 2 diabetes or weight problems." According to the National Institutes of Health, approximately 30 million people in the U.S. have diabetes.

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