PHARMACY MARKET

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

Avacta | November 29, 2021

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

Spotlight

Every viable pharmaceutical packaging system must comprise materials proven to protect its contents against moisture and other atmospheric variables, and be safe for use with the specified dosage form and the route of
administration1

Spotlight

Every viable pharmaceutical packaging system must comprise materials proven to protect its contents against moisture and other atmospheric variables, and be safe for use with the specified dosage form and the route of
administration1

Related News

BUSINESS INSIGHTS, PHARMA TECH

Xtalpi Partners with Singapore's Drug Discovery Platform to Find Better Cancer Treatments

XtalPi Inc. | December 29, 2022

One of the pioneering pharmaceutical technology companies - XtalPi, powered by artificial intelligence (AI) and automation, has recently announced a strategic collaboration with Singapore's national platform for drug discovery and development, the Experimental Drug Development Centre (EDDC), which is hosted by the Agency for Science, Technology, and Research of Singapore (A*STAR). The goal of this partnership is to find novel treatment candidates for non-small cell lung cancer (NSCLC). “According to Research and Markets, the size of the global market for NSCLC treatments will surpass USD 20 billion by 2027” Lung cancer is the second-most prevalent cancer worldwide and the leading cause of cancer-related mortality. NSCLC accounts for more than 80% of all lung cancer occurrences, while its incidence continues to rise worldwide. Despite growing interest and investment in drug research, there is a substantial unmet demand for effective targeted therapeutic alternatives for NSCLC patients to improve outcomes. In this partnership, EDDC and XtalPi will work together to find promising candidates against an NSCLC target chosen by EDDC. XtalPi will use its AI technology, automation platform, and expert domain knowledge. It will also use quantum physics and an AI-driven platform to create and test millions of molecules for the De-novo drug design. Iterations will be used in its robotics-powered synthesis and testing lab to confirm and improve the predicted top-performing molecules with desirable drug properties. EDDC will give helpful information and data about the new NSCLC target, which will speed up the process of finding new drugs and carry the program forward. XtalPi said in a statement that it is delighted to work with EDDC. It intends to help people all over the world by using AI and automation to improve the speed, size, variety, and success rate of drug research and development. In line with this, EDDC stated that it is excited to collaborate with XtalPi to translate science and research into practical and targeted cancer therapies. Furthermore, EDDC is confident that this collaboration will accelerate the development of much-needed targeted therapies for NSCLC patients due to XtalPi's experience in AI and automation technologies. About XtalPi XtalPi is a quantum physics-based, AI-powered drug R&D firm aiming to improve the speed, scale, novelty, and success rate of drug discovery. To meet the needs of its clients and partners, the company has offices in China and the United States. Frost & Sullivan cites the company as one of the world's first AI-powered drug R&D companies, with an iterative feedback loop between dry and wet lab capabilities.

Read More

PHARMA TECH

Douglas Pharmaceuticals Forms Lead Program R-107 Clinical Advisory Board

Douglas Pharmaceuticals | January 27, 2023

A clinical advisory board has been established to support Douglas Pharmaceuticals' lead program R-107, an oral extended-release dose of racemic ketamine being developed as an adjunctive or stand-alone therapy for treatment-resistant depression. Douglas Pharmaceuticals is a New Zealand-based pharmaceutical company specializing in the development of specialty generic and repurposed medications (TRD). Peter Surman, Chief Scientific Officer expressed, "We are very excited to bring together a group of world-class experts in the field of psychiatry, to help guide our late-stage development of R-107." "We believe their deep knowledge in the field, insights and contributions will be instrumental in charting an efficient course through pivotal clinical studies in TRD," he added. (Source – Cision PR Newswire) Some of the members of the clinical advisory board are as follows: • Prof. Paul Glue [MB, ChB (Otago), MD (Bristol), FRCPsych] • Prof. Alan F. Schatzberg, [MD] • Prof. Sanjay J. Mathew [MD] • Prof. Allan Young [MB, ChB, MPhil, Ph.D., FRCP (Edin.), FRCPC, FRCPsych] • Prof. Wiesław J. Cubała, [MD, PhD] • Prof. Colleen Loo [MBBS (Hons), FRANZCP, MD] About Douglas Pharmaceuticals New Zealand's largest private pharmaceutical and healthcare firm, Douglas Pharmaceuticals, employs over 700 people and exports to over 40 countries. The company provides creative, competitive, and high-quality healthcare solutions to 'improve lives'. It designs, manufactures, and distributes unique and generic products, preferring those with significant intellectual property and technological complexity in high-unmet need sectors. The company's presence in international markets continues to grow, exposing New Zealand to the world. It is dedicated to improving people's health all around the globe. Some of the products that the company works with cutting-edge partners to develop, make, market, and distribute are pharmaceuticals, nutraceuticals, automated compliance systems, and consumer healthcare items.

Read More

PHARMACY MARKET

Nephron and Sharps Announce Manufacturing and Research Partnership

Nephron Pharmaceuticals Corporation | November 15, 2022

Nephron Pharmaceuticals Corporation and Sharps Technology, Inc. announced a brand new partnership focused on developing and sharing best practices in innovative manufacturing, product development, customer support, and quality as Nephron prepares to launch the InjectEZ component of expansion. Sharps Technology is a medical device and pharmaceutical packaging company specializing in developing and manufacturing innovative drug delivery systems. Nephron Pharmaceuticals is known across the country to health systems and hospitals as a leader in the production of affordable generic inhalation solutions and suspension products, as well as pre-filled sterile syringes, luer-lock vials, IV bottles, and IV bags. InjectEZ is part of the Nephron investment of hundreds of millions of dollars of expansion in Lexington County, S.C., over the last two years. Lou Kennedy, Nephron CEO, knows that when launching an endeavor as ambitious as InjectEZ, partnerships are key. "We are excited to kick off a partnership with Sharps Technology, as our InjectEZ expansion project opens, for a variety of innovative initiatives, including research and development," said Kennedy. "Just as the InjectEZ syringe manufacturing facility is poised to play a critical role in assisting those with whom we work on tackling emerging public health crises, Sharps Technology also offers key solutions to healthcare challenges. We look forward to working with them." Sharps product lines have historically focused on low waste and ultra-low waste syringe technologies, which allow up to 40% more injections per vial of therapy while incorporating multiple passive safety features. These features protect front-line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. The partnership with Nephron opens up opportunities for Sharps to expand its portfolio and make an impact on the specialized pre-fillable syringe and drug delivery systems market. "Sharps Technology has identified a unique opportunity to collaborate with a leader in the industry like Nephron. Through my previous industry experience supporting and working with most of the leading healthcare and pharmaceutical companies in the world, it was easy for me to evaluate Nephron Pharmaceuticals as a potential partner. They truly are a leader in all areas of business and an example of best in class for the industry. I appreciate and look forward to the opportunity to work with Bill and Lou Kennedy and their leadership team to make this collaboration a success for both companies." Robert Hayes, CEO of Sharps Technology Sharps Technology brings extensive expertise in syringes to Nephron, including experience with specialized pre-filled syringe systems and ready-to-use processing. The pre-filled syringe lines will utilize the highly automated equipment and controlled environments established by Nephron. These premium pre-filled polymer offerings will be made from the highest quality raw materials, on the most innovative technology, and will be compliant with the USP standards required in the United States as well as the EP and JP international standards. The products that will be developed and commercialized provide solutions to support the current Nephron fill/finish strategies as well as their pipeline of new drug applications and sets forward a strategy to support branded pharma and advanced therapies, including ophthalmic and biologic applications. Sharps Technology will also be partnering with Nephron Pharmaceuticals in the development of a Pharmaceuticals Services Program designed to support healthcare customers that need innovative solutions and products to support their business. The development of this program will help create new fill/finish project opportunities for Nephron that will utilize innovative packaging solutions developed by Sharps Technology. These new customer projects will fuel the growth of both companies, and the opportunity to create new technologies to support the healthcare industry will be transformative for Nephron and Sharps as they navigate a bright future working together.

Read More