Bayer’s regorafenib kicks off brain cancer platform trial

Pharmaphorum | June 20, 2019

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

The Yellow Card Scheme acts as an early warning system for identifying previously unrecognised adverse drug reactions, but also provides valuable information on recognised side effects. This allows the MHRA to identify and refine understanding of potential safety issues that may affect the treatment of patients. It is used to update prescribing advice for health professionals.


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Theralink® Technologies Expands Adoption of its Precision Medicine Technology in the Biopharmaceutical Industry

Theralink Technologies | April 20, 2022

Theralink Technologies a precision medicine company with a novel phosphoprotein-based assay for breast cancer, today announced that it has significantly expanded the adoption of its Laser Capture Microdissection and Reverse Phase Protein Array precision medicine technology to biopharmaceutical companies, including multinational healthcare corporations. The Company has supported 41 preclinical and clinical studies for 18 biopharma companies and is currently undergoing discussions to develop Companion Diagnostics with several of its existing clients. "We have partnered with some of the largest and most innovative global biopharma companies, driven by the unique value of our patented phosphoprotein precision medicine technology and our dedicated Theralink team of experts. I am encouraged by the rapid uptake of our biopharma offerings and excited by the significant market potential to develop Companion Diagnostics–tests required for oncologists to prescribe targeted drug therapy. We look forward to further expanding our technology across the industry to help bring life-saving therapies to patients in need, as well as equipping oncologists with insights to develop targeted treatment programs for their patients." Mick Ruxin, M.D., President & CEO of Theralink Technologies Leveraging its novel phosphoprotein-based assay, Theralink enables biopharma clients to expedite drug development and ultimately shorten time to market, which can potentially save millions of development dollars, by providing invaluable insights into a drug's biological impact. Theralink supports its partners across the entire drug development continuum from discovery to clinical market with services including: phosphoproteomic profiling in preclinical models and clinical samples, the evaluation of drug target inhibition within laser capture microdissected tumor samples, and interrogation of compensatory feedback mechanisms and pathways after drug target inhibition. In addition, the Company is in early discussions with several biopharma companies for the development of Companion Diagnostics. The development of Companion Diagnostics using Theralink's assays is a potentially large catalyst for Theralink, as well as its biopharma partners, as it is a required test by oncologists to determine a drug's suitability for their cancer patients. About Theralink Technologies, Inc. Theralink Technologies is a proteomics-based, precision medicine company with a CLIA-certified laboratory located in Golden, Colorado. Through its unique and patented phosphoprotein and protein biomarker platform and LDTs, Theralink's technology targets multiple areas of oncology and drug development. Theralink provides precision oncology data through its powerful Theralink® Reverse Phase Protein Array assays to assist the biopharmaceutical industry and clinical oncologists in identifying likely responders and non-responders to both FDA-approved and investigational drug treatments. Theralink intends to help improve cancer outcomes for patients, help reveal therapeutic options for oncologists, and support biopharmaceutical drug development by using a beyond-genomics approach to molecular profiling that directly measures drug target levels and activity.

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BUSINESS INSIGHTS

Virpax Pharmaceuticals Enters Into CRADA With The U.S. Army Institute of Surgical Research

Virpax® Pharmaceuticals, Inc. | May 06, 2022

Virpax® Pharmaceuticals, Inc. a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system (CNS) disorders and anti-viral indications, today announced that it has entered into a cooperative research and development agreement with the U.S. Army Institute of Surgical Research to evaluate Virpax’s Probudur™, an injectable long-acting liposomal bupivacaine in a hydrogel formulation that is injected at the wound site. Probudur is being developed to significantly reduce or eliminate the need for opioids after surgery in approved indications. Probudur is a local anesthetic that binds to the sodium channel, preventing pain signals from reaching the brain. In pre-clinical trials, Probudur has shown long duration pain control for at least 96 hours. The USAISR is the U.S. Department of Defense’s (DOD) primary laboratory for developing solutions for trauma and critical care challenges in combat casualties. “We are excited to announce this CRADA with the DOD as these military and government research collaborations are an integral part of our non-dilutive funding strategy,” Anthony P. Mack, chairman and CEO of Virpax In August of 2020, Virpax entered into a CRADA with the National Center for Advancing Translational Sciences, an institute of the National Institutes of Health (NIH), for the development of Envelta™, it’s intranasal spray product candidate for severe post-cancer pain and non-cancer pain. Under that agreement, multiple contracts to support the research, development, and manufacturing of Envelta have been awarded by the NIH to continue the product’s progress. About Virpax Pharmaceuticals Virpax is developing branded product candidates for non-addictive pain management and neurological disorders using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval of its three patented drug delivery platforms. Epoladerm™ is a topical diclofenac spray film formulation being developed to manage osteoarthritis pain. Probudur™ is a single injection long-acting liposomal bupivacaine formulation being developed to manage post-operative pain. Envelta™ is an intranasal Molecular-Envelope Technology (MET) enkephalin formulation being developed for the management of post-cancer pain and non-cancer pain, as well as post-traumatic stress disorder (PTSD) under the name PES200. MET technology is also used in AnQlar™, Virpax’s product candidate to inhibit viral replication caused by influenza or SARS-CoV-2. Virpax recently acquired global rights to VRP324, a product candidate for the nasal delivery of a pharmaceutical-grade cannabidiol (CBD) for the management of rare pediatric epilepsy.

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BUSINESS INSIGHTS

TherapeuticsMD and EW Healthcare Partners Announce Definitive Agreement for EW Healthcare Partners to acquire TherapeuticsMD

TherapeuticsMD, Inc | June 01, 2022

TherapeuticsMD, Inc. an innovative, leading women’s healthcare company, announced that it has entered into a definitive merger agreement to be acquired by an affiliate of EW Healthcare Partners, a private equity firm dedicated to making investments in rapidly growing healthcare companies. Under the terms of the transaction, which has been unanimously approved by TXMD’s board of directors, EW Healthcare Partners will commence a tender offer to acquire all outstanding shares of TXMD common stock for $10.00 per share in an all-cash transaction, followed immediately by a merger. The purchase price represents a premium of 367.3% over TherapeuticsMD’s closing share price on May 27, 2022. “We are very pleased to enter into this agreement with EW Healthcare Partners. Together, we will continue empowering women of all ages through a therapeutic focus in family planning, reproductive health, and menopause management. We have a deep appreciation for EW Healthcare Partners’s depth of expertise and track record and know they will bring an incredible value of knowledge and strategic guidance.” Hugh O’Dowd, Chief Executive Officer of TherapeuticsMD EW Healthcare Partners is one of the largest and oldest private healthcare investment firms with over $4B of capital raised since its inception. EW Healthcare Partners has made investments in over 150 rapidly growing healthcare companies in the pharmaceutical, medical device, diagnostics, and technology-enabled services sectors in the United States and in Europe. “We are pleased to welcome TherapeuticsMD to the EW Healthcare Partners portfolio and are deeply committed to the Company's mission of advancing women’s health. EW Healthcare Partners has already made a significant investment in women’s health through its acquisition of Majorelle. TherapeuticsMD represents a unique opportunity for Majorelle to enter the US market and is a perfect fit with our ambitious plans to create a fast-growing, premier trans-Atlantic women’s health platform. We bring an extensive network and capital to fund the further growth of the combined company,” said Evis Hursever, Managing Director at EW Healthcare Partners. “We look forward to working together with the company’s management team to enhance the patient experience, improve operational efficiency and create one of a very few trans-Atlantic specialty pharma companies dedicated to women’s health,” said Olivier Bohuon, Senior Adviser with EW Healthcare Partners and Chairman of Majorelle. About TherapeuticsMD, Inc. TherapeuticsMD, Inc. is an innovative, leading healthcare company, focused on developing and commercializing novel products exclusively for women. TherapeuticsMD’s products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. TherapeuticsMD is committed to advancing the health of women and championing awareness of their healthcare issues. About EW Healthcare Partners (“EW”) With over $4 billion raised since inception, EW Healthcare Partners is one of the largest and oldest private healthcare investment firms and seeks to make growth equity investments in fast growing commercial-stage healthcare companies in the pharmaceutical, medical device, diagnostics, and technology-enabled services sectors in the United States and in Europe. Since its founding in 1985, EW Healthcare Partners has maintained its singular commitment to the healthcare industry and has been a long-term investor in over 150 healthcare companies, ranging across sectors, stages and geographies. The team is comprised of over 20 senior investment professionals with offices in New York, Houston and London.

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BUSINESS INSIGHTS

Elligo Health Research® Partners With Peoples Rx

Elligo Health Research | April 21, 2022

Elligo Health Research, the largest healthcare-enabling research organization, announced they are expanding partnerships to include Peoples Rx, an Austin, Texas-based pharmacy chain. “We’re in a unique position at Peoples Rx to help inform more people about how they can participate in clinical research opportunities. Working with Elligo to offer research as healthcare to our customers helps support our mission to empower people to make educated health decisions.” Stephen Erickson, Peoples Rx president One of the first studies Peoples Rx will be working to share with Elligo is a study for people to advance screening diagnostics for cancer. “Our patients may not hear about clinical research opportunities otherwise, and this empowers patients with knowledge to become more proactive in their own healthcare journey while simultaneously supporting the advancement of health sciences,” Erickson said. Elligo began its mission to provide easy access to clinical research as care to more patients nearly six years ago. Specifically, Elligo is focused on accelerating clinical trials through healthcare by maintaining the integrity of the trusted patient and physician relationship, building local healthcare communities, and leveraging electronic health records. “Accomplishing this mission is made possible by the partnerships we have with real-world healthcare,” said Elligo CEO John Potthoff, Ph.D. “Peoples Rx has a positive impact on our local community and is a trusted partner for healthcare. This is also Elligo’s first partnership with a pharmacy, and it is our hope that this will lead to further opportunities to collaborate with more providers in the healthcare spectrum on similar initiatives and continue contributing to the changing clinical research landscape.” About Elligo Health Research® Elligo Health Research accelerates clinical trials through healthcare with access to known patients and their HIPAA-compliant healthcare data, our IntElligo® Research Stack technology, and our hybrid enrollment model, PatientSelect. Coupled with the largest Known Patient Access Network, Elligo’s Site Solutions enable healthcare practices and research sites to participate in clinical trials. By adaptive engagement of known patients and physicians, we accelerate the development of new pharmaceutical, biotechnology, and medical device and diagnostic products. About Peoples Rx Peoples Rx has been the local favorite pharmacy and wellness headquarters in Austin for over 40 years. Our integrative approach to health and wellness starts with our knowledgeable and experienced pharmacists and wellness specialists, and our cutting-edge, holistic, and professional products. We also compound custom medications in our state-of-the-art lab to meet customers’ specific needs. And because food is medicine too, our own in-house delis serve up scratch-made meals and snacks with the highest quality ingredients. With a mission to empower people to make educated health choices, several of our 170+ employees, including clinical nutritionists, herbalists, naturopaths, and homeopaths also offer their expertise through private consultations and educational events.

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Spotlight

The Yellow Card Scheme acts as an early warning system for identifying previously unrecognised adverse drug reactions, but also provides valuable information on recognised side effects. This allows the MHRA to identify and refine understanding of potential safety issues that may affect the treatment of patients. It is used to update prescribing advice for health professionals.

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