Gilead joins GSK, J&J in offering coronavirus vaccine options

PharmaTimes | February 05, 2020

With the death toll in China topping 425, the coronavirus, now officially classified as a global health threat by the World Health Organisation (WHO), is showing no signs of slowing down. More than 20,000 cases have been confirmed around the world, with more than 20 nations reporting cases – some involving locals who had not even travelled to China. The pharma industry has been rallying together in a joint effort to develop a vaccine for the virus, which is also known as 2019-nCoV or Wuhan coronavirus. Gilead is the latest industry giant to lend a hand, providing doses of remdesivir (GS-5734) – initially developed to fight the Ebola crisis - to doctors for the emergency treatment of "a small number of patients" who have contracted the potentially deadly disease.

Spotlight

We explain Chronic Traumatic Encephalopathy (CTE, a neurodegenerative brain disease found in people who have experienced repetitive hits to the head. It can affect anyone, As kids head back to school, you may want to rethink whether your child should play tackle football. “Our main objective, our overarching goal, is to help the people that are living. To be able to diagnose this disease during life,” said Ann McKee, chief of neuropathology at the VA Boston Healthcare System, which houses the world’s largest brain bank devoted to CTE research.

Spotlight

We explain Chronic Traumatic Encephalopathy (CTE, a neurodegenerative brain disease found in people who have experienced repetitive hits to the head. It can affect anyone, As kids head back to school, you may want to rethink whether your child should play tackle football. “Our main objective, our overarching goal, is to help the people that are living. To be able to diagnose this disease during life,” said Ann McKee, chief of neuropathology at the VA Boston Healthcare System, which houses the world’s largest brain bank devoted to CTE research.

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PHARMACY MARKET

McKesson Collaborates with Vanderbilt Health Rx Solutions to Expand Integrated Pharmacy Services

McKesson Corporation, Vanderbilt Health Rx Solutions | March 18, 2021

McKesson Corporation, a worldwide healthcare organization, reports another cooperation with Vanderbilt Health Rx Solutions (VHRxS), a public chief in specialty pharmacy technique and execution, to offer VHRxS's full suite of specialty pharmacy consulting services to McKesson's health system clients. This new, specialized offering from VHRxS will supplement the experience of McKesson, which has offered industry-driving pharmacy services for over 40 years, by bringing the skill of VHRxS, which was established by Vanderbilt University Medical Center to propel the mission of health systems specialty drug stores cross country. The new help will offer altered specialty pharmacy services and development procedures to emergency clinics and health systems in each period of their development. VHRxS's portfolio of strong specialty pharmacy consulting services will help health systems improve patient and supplier fulfillment while making new income transfers by fully coordinating pharmacy services into specialty centers. Scott Miller, president of McKesson Health Systems, shares, “Our teams work closely with customers to understand their challenges and this was a clear need for health systems addressing their specialty pharmacy capabilities. Along with our existing portfolio of services and solutions, this is one more way customers can achieve more for their hospitals and patients by creating new or strengthening existing revenue streams.” McKesson's pharmacy chiefs and the VHRxS group of experienced, involved counsels comprehend the requirements and difficulties of health system specialty drug stores. The groups have profound experience working with health systems altogether phases of development, from creating and carrying out starting specialty pharmacy development methodologies to improving existing activities to arrive at the following level. Jim Hayman, president of VHRxS and Chief Pharmacy Officer at Vanderbilt Health, states, “By collaborating with McKesson, we can better extend our expertise as a leading health system-based specialty pharmacy provider to help our peers. We know from experience that investing in your specialty pharmacy operations boosts patient and provider satisfaction, which reaps seen and unseen benefits many times over.” About McKesson Corporation McKesson Corporation is a global leader in healthcare supply chain management solutions, retail pharmacy, community oncology and specialty care, and healthcare information solutions. McKesson partners with pharmaceutical manufacturers, providers, pharmacies, governments and other organizations in healthcare to help provide the right medicines, medical products and healthcare services to the right patients at the right time, safely and cost-effectively. United by our ICARE shared principles, our employees work every day to innovate and deliver opportunities that make our customers and partners more successful all for the better health of patients. About Vanderbilt Health Rx Solutions Vanderbilt Health Rx Solutions (VHRxS) is a national specialty pharmacy strategy and management company founded and operated by Vanderbilt University Medical Center (VUMC), Middle Tennessee’s largest private employer and the largest academic medical center in the Mid-South with over 2.5 million patient encounters annually. VHRxS uniquely and effectively addresses the specialty pharmacy needs of companies, hospitals and health systems through building patient-centered, clinically integrated specialty pharmacy programs in collaboration with health system clients and leading employers. Founded on VUMC’s historic global leadership in clinical pharmacology, best-in-class specialty pharmacy operations and employee health plan performance, VHRxS draws on years of hands-on experience creating and executing specialty pharmacy strategies to help clients build successful programs of their own.

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PHARMACY MARKET

Avacta Announces FDA Approval of its Investigational New Drug (IND) Application for AVA6000

Avacta | November 29, 2021

Avacta Group plc, a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer® and pre|CISION™ platforms, is pleased to announce that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for AVA6000. This will allow the Group to expand its Phase I clinical trial, ALS-6000-101, into clinical trial sites in the United States. AVA6000 is a novel form of doxorubicin that has been modified with Avacta’s pre|CISION™ platform to improve its safety and therapeutic index. Anthracyclines such as doxorubicin, a generic chemotherapy for which the market is expected to grow to $1.38bn by 20241, are widely used as part of standard of care in several tumour types, but their use is limited by cumulative toxicity. AVA6000 has been designed to limit cell penetration of the drug, and therefore its cell killing effect, until it is specifically activated by fibroblast activation protein α (FAP) which is in high concentration in many solid tumours compared with healthy tissues. The resulting reduced exposure of healthy tissues to active doxorubicin has the potential to significantly increase its therapeutic index by reducing the incidence of adverse effects, including cardiotoxicity and myelosuppression. The FDA has completed its 30-day review of Avacta’s IND application, which was submitted ahead of schedule in October 2021, and has concluded that the Group may proceed with its proposed clinical investigation. This allows Avacta to enroll eligible patients into US clinical trial sites for the company’s Phase I multi-centre study, ALS-6000-101. As previously announced in August 2021, the Company has begun recruiting and dosing patients for this study at several clinical trial sites in the UK, and continues to expect the dose escalation phase for this trial to complete by Q2 2022 followed by completion of the dose expansion phase around mid-2023. Enrollment in US clinical trial sites is expected to begin in early 2022. “We are delighted to have received approval from the FDA to add clinical trial sites in the United States as part of the Phase I study for AVA6000. This is a major milestone in our development of pre|CISION™ chemotherapies and is testament to the performance of our clinical development team and the quality of the pre-clinical data for AVA6000. Dr. Alastair Smith, Chief Executive of Avacta Group Provided that the study shows that the pre|CISION™ technology is effective in reducing systemic toxicity of Doxorubicin, then that would open up an extensive and proprietary pipeline for Avacta of next-generation pre|CISION™ chemotherapies with significant clinical and commercial advantages in a chemotherapy market that is expected to exceed $74 billion by 20272. We now look forward to opening up clinical trial sites in the United States and additional clinical trial sites in the UK.” Neil Bell, Chief Development Officer of Avacta Life Sciences, commented: “We are excited to bring the first FAP-activated chemotherapeutic to the clinic in the US, which has the potential to meaningfully impact patients with difficult-to-treat tumours. The clearance of the AVA6000 IND by the FDA enables the opening of key US sites to support the ALS-6000-101 clinical trial which is currently recruiting patients across clinical sites in the UK.”

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PHARMA TECH

Confo Therapeutics Enters Collaborative Agreement with Regeneron

Confo Therapeutics | December 01, 2021

Confo Therapeutics announced that it has entered into a collaborative agreement with Regeneron Pharmaceuticals, Inc. whereby Confo’s technology platform, which uses conformationally selective VHH antibodies – ConfoBodies® – to stabilize GPCRs in disease-relevant conformations, will be applied with the goal of enabling the discovery of novel therapeutic antibody drug candidates. The agreement will leverage Confo’s expertise in addressing two GPCR targets for which functional antibodies are needed. Confo will be entitled to an upfront payment, research funding, and potential clinical, regulatory, and commercial payments. Further details regarding the agreement have not been disclosed. Confo’s ConfoBody-based technology platform aims to overcome the limitations of drug discovery on GPCRs, the largest and most diverse group of membrane receptors targeted by approximately 30% of all commercialized drugs. “With ten medicines approved by regulatory authorities, Regeneron is regarded in our industry as one of the most effective antibody discovery and development companies, with a successful track record of translating scientific insight into effective and innovative treatments. Working with them underscores the significant potential of our technology platform, in particular our new application to generate antibody drug candidates, and its promise to unveil GPCR drug targets and overcome a range of limitations of current approaches,” Cedric Ververken, Chief Executive Officer of Confo Therapeutics Christel Menet, Chief Scientific Officer of Confo Therapeutics added: “We value this opportunity to showcase the strength of this new addition to our technology suite and participate in what we hope will be the development of successful new antibody-based therapies. Parallel to this, we continue on our own drug development path, and drive innovative small molecule and biological therapeutics into our own pipeline.” About Confo Therapeutics Confo Therapeutics’ unparalleled technology stabilizes functional conformations of GPCRs to uncover a wide range of previously inaccessible drug targets. This platform combined with the pharmacologic and biologic insight it provides, allows Confo to build a multi-indication pipeline of drug candidates with the vision of transforming therapeutic outcomes for patients with severe illnesses lacking disease-modifying treatments. Confo Therapeutics was spun out of Vrije Universiteit Brussel and VIB in 2015. Supported by international life-science focused investors and led by an experienced team of entrepreneurial professionals and scientists from successful biopharmaceutical companies, Confo Therapeutics benefits from the rich scientific and innovative ecosystem in Belgium.

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