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.”
Insilico Medicine | January 18, 2022
Shanghai Fosun Pharmaceutical Co., Ltd, a leading innovation-driven international healthcare group in China and Insilico Medicine, an end-to-end artificial intelligence (AI)-driven drug discovery and development company, entered into a collaboration agreement to advance the discovery and development of drugs targeting a number of different targets globally through the use of AI technology.
This strategic collaboration includes an AI-driven drug discovery research and development (R&D) collaboration on four biological targets, as well as the co-development of Insilico's QPCTL program. Insilico will receive a total upfront payment of $13 million for the R&D collaboration projects and the co-development of the QPCTL program, potential milestone-based payments, and share commercialization profits from the QPCTL program. In addition, Fosun Pharma will make an equity investment in Insilico.
"We are pleased to enter into strategic collaboration with Insilico. Fosun Pharma is committed to promoting innovative R&D, and is oriented towards fulfilling unmet clinical needs and improving products' accessibility. We look forward to working with Insilico to leverage the technological and clinical development strengths of both companies, jointly improving the efficiency of innovative drug R&D, and benefiting more patients worldwide,"
Yifang Wu, Chairman and CEO of Fosun Pharma
The collaboration aims to combine Insilico's end-to-end AI-driven drug discovery platforms and Fosun Pharma's clinical development and commercial expertise to discover and develop a portfolio of novel therapeutics. Pursuant to the collaboration agreement, Insilico will take responsibility for delivering a preclinical candidate for the QPCTL program and advancing it to IND stage, after which, Fosun Pharma will then conduct human clinical studies and co-develop the candidate globally. In parallel, Fosun Pharma's R&D team will nominate four therapeutic targets to be assessed by Insilico's AI platform and R&D team, who are responsible of advancing drug candidates to IND stage.
As part of the collaboration, Fosun Pharma will secure access to Insilico's PandaOmics and Chemistry42 platforms in order to advance Fosun Pharma's internal AI-powered discovery and development efforts.
"In partnering with Fosun Pharma, a leading pharmaceutical company, we begin a new era of AI-powered end-to-end drug discovery and development as human-machine collaboration becoming the new normal in precision drug discovery and development. We previously demonstrated that AI can be used to discover novel targets and generate novel molecules that can be tested in humans in record time. Now, we are partnering with one of the leading scientific teams in the pharmaceutical industry to take this technology to the next level for the benefit of patients worldwide", said Alex Zhavoronkov, PhD, Founder and CEO of Insilico Medicine.
About Fosun Pharma
Founded in 1994, Shanghai Fosun Pharmaceutical Co., Ltd. is a leading innovation-driven international healthcare group in China. Fosun Pharma strategically operates businesses in the pharmaceutical and health industry, including pharmaceutical manufacturing, medical devices and medical diagnosis, and healthcare services. Through equity participation in Sinopharm Co., Ltd., Fosun Pharma's business extends to pharmaceutical distribution and retail.
About Insilico Medicine
Insilico Medicine, an end-to-end AI-driven drug discovery and development company, is connecting biology, chemistry, and clinical trials analysis using next-generation AI systems. Insilico Medicine has developed AI platforms that utilize deep generative models, reinforcement learning, transformers, and other modern machine learning techniques to discover novel targets and to design novel molecular structures with desired properties. Insilico Medicine is delivering breakthrough solutions to discover and develop innovative drugs for cancer, fibrosis, immunity, central nervous system diseases and aging-related diseases.
AvKARE | December 15, 2020
A conventional drugmaker with a Rolodex loaded with government customers is pulling an energizer and an erectile brokenness medications after the two were bundled together in similar containers.
Pulaski, Tennessee-based AvKARE reviewed one parcel of sildenafil 100-mg tablets and one parcel of trazodone 100-mg tablets after the items were stirred up by an outsider bundling provider, the organization said before the end of last week. The jugs had just been delivered to drug stores.
AvKARE markets its own private-name conventional medications to a record of government customers, including the branches of Defense, Veterans Affairs and the Health and Human Services. The organization additionally supplies the Indian Health Services, in addition to nongovernment clients around the world.
The customer level review influences parts sent to merchants and wholesalers and afterward delivered out from one side of the country to the other, the organization said. The sildenafil part has a March 2022 termination date, while the trazodone parcel lapses in June 2022.
AvKARE said it so far hasn't got any result reports from the reviewed parcels. Sildenafil—a nonexclusive rendition of Viagra—can blend inadequately with nitrate-containing drugs for diabetes, hypertension or coronary illness, conceivably bringing pulse down to perilous levels.
The upper trazodone hydrochloride, in the interim, can cause sluggishness, dazedness, stoppage and obscured vision, AvKARE cautioned. Those results represent a more serious danger of falls and impeded driving in more seasoned clients who may have bought the organization's erectile brokenness copycat.