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Oxilio announces start of its first clinical trial with OXL001

News & Announcements , Customer Milestone , Translational Pharmaceutics®

Oxilio announces start of its first clinical trial with OXL001

Oxilio and QS partnership

Oxford, UK; November 6th, 2022 - Oxilio, a pioneering drug development company repurposing existing drugs to address unmet needs in cancer treatment, announced that it has commenced the first human subject dosing with OXL001. This first study is designed to investigate the pharmacokinetics (PK) and safety of various doses of OXL001 in healthy volunteers.

Oxilio’s lead product, OXL001, has been developed utilizing a novel bio-enabling platform technology created by our development partner, TRx Biosciences, and Quotient Sciences' integrated drug development, manufacturing, and clinical testing platform Translational Pharmaceutics®.

Dr. Simon Yaxley, Director of Oxilio, said: “Working together with our partners Quotient Sciences and TRx Biosciences we are pleased to have been able to move rapidly into the clinic following recent approval for this study by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). This is an important milestone for the business, and we look forward to providing the resulting study data at the earliest opportunity.”

Dr. Robin Bannister, CEO of TRx Biosciences, added: “Our work with Oxilio and the unique development challenges in repurposing OXL001 into oncology have resulted in significant advancement of TRx’s underlying technology and we’re delighted to now see the progression of OXL001 into the clinic, given its immense potential as a pan-cancer therapy. We will continue to support Oxilio throughout its clinical development activities, which will further validate our targeted oral delivery platform”

Dr. Mark Egerton, CEO of Quotient Sciences, said: “Quotient Sciences is proud to have helped the Oxilio team achieve this important milestone. Our unique Translational Pharmaceutics® platform allowed us to rapidly progress OXL001 into the clinic and now both Oxilio and TRx Biosciences can make informed decisions based on emerging clinical data to improve the potential of downstream success. We will continue supporting Oxilio with our integrated capabilities to accelerate the development timeline of OXL001, and ultimately get this life-changing therapy to patients faster.” 


About Quotient Sciences

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast. For more information, please visit quotientsciences.com.

About Oxilio

Oxilio is a pioneering pharmaceutical drug development company improving cancer treatment through rapid, cost-effective drug development. Our mission is to identify, repurpose, and commercialize existing drugs to address unmet needs in cancer therapy. We find new uses for old drugs, a proven approach that involves less risk, time, and cost to bring a drug to the marketplace. Through repurposing, reformulation, and gold-standard modeling and simulations, we are fast-tracking disruptive drug development at speed and at low cost.

Oxilio Company Contact

[email protected]

Emplicure AB and Quotient Sciences Announce an Integrated Manufacturing and Clinical Testing Partnership for Emplicure’s First Clinical Pharmacokinetic Study for EMPLI03

Translational Pharmaceutics®

Emplicure AB and Quotient Sciences Announce an Integrated Manufacturing and Clinical Testing Partnership for Emplicure’s First Clinical Pharmacokinetic Study for EMPLI03

Quotient Sciences logo

Emplicure AB and Quotient Sciences Announce an Integrated Manufacturing and Clinical Testing Partnership for Emplicure’s First Clinical Pharmacokinetic Study for EMPLI03.

NOTTINGHAM, UK; November 29, 2022 – Quotient Sciences, a global drug development and manufacturing accelerator, today announced a partnership with Emplicure, a Swedish pharmaceutical company focused on chronic pain and abuse-deterrent formulations.

The partnership will see Quotient Sciences support the GMP manufacture and first clinical pharmacokinetic (PK) study for EMPLI03 using its unique Translational Pharmaceutics® platform.

Emplicure is developing EMPLI03 as an oral buccal tablet with extended-release properties intended for the treatment of moderate to severe pain. The formulation is also designed to limit the potential for manipulation of the tablet for abuse. 

Quotient Sciences’ integrated Translational Pharmaceutics platform has been used to establish the GMP manufacturing process for EMPLI03 and to perform the first clinical PK study. Dosing in the PK study has been successfully completed, and top-line data will be available at the beginning of 2023.

"We have achieved one of our milestones in the development of a Buprenorphine product for the treatment of moderate to severe pain. With properties that limit abuse, EMPLI03 may contribute to a safer medical treatment", said Håkan Engqvist, CEO of Emplicure.

Mark Egerton, PhD, CEO of Quotient Sciences, added, "We are delighted to partner with Emplicure on the development of a potential treatment for moderate to severe pain. Using our unique Translational Pharmaceutics platform, the GMP manufacturing and first PK study for EMPLI03 has been fully integrated, which is a proven approach to accelerate development timelines."

Quotient Sciences introduced its Translational Pharmaceutics platform in 2008 as a fully integrated drug development and clinical testing platform.

The platform integrates drug substance, drug product, and clinical testing activities under one organization to break down industry silos and accelerate molecules through development.


About Emplicure
Emplicure develops new and innovative products by combining existing and approved active substances with advanced materials science within ceramic biomaterials. The product portfolio is focused on chronic pain and on abuse-deterrent formulations. The subsidiary Amplicon AB develops consumer products with oral nicotine as the first product. The share is listed on Nasdaq First North Growth Market (EMPLI). Read more at emplicure.com.

About Quotient Sciences

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast. For more information, please contact us.

Download the press release (PDF)

Eleanor Row: Discovery to IND - SpeakPharma

Articles & Publications , Eleanor Row

Eleanor Row: Discovery to IND - SpeakPharma

Eleanor Row

Over the past 30 years, Quotient Sciences has worked on over 3,000 molecules across all stages of development. SpeakPharma interviews Eleanor Row, our Executive Director of Commercial who discusses the challenges that drug developers should be aware of when trying to quickly get their molecule from discovery to investigational new drug (IND) stage - and onward into the clinic.

Eleanor also talks about how our integrated approach can help accelerate a molecule’s pathway to IND and beyond while sheding light on the different development functions at an early stage of drug development.

Read more of Eleanor's SpeakPharma interview on the Pharma Compass website by following the link below.

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Case Studies , Formulation Development , Dr. Andy Lewis

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Case Studies , Formulation Development , Drug Substance

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Case Studies , Bioanalysis

Case Study: Insulin Analogues Analysis

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Case Studies , Microbiology , Analytical Services

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Case Studies , Radiosynthesis , Isotopic Labeling , Drug Substance

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Successful [14C] synthesis was carried out to support both non-clinical and clinical trials.

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Case Studies , Bioanalysis , Isotopic Labeling

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In most cases, a Stable Isotope Labelled (SIL) standard optimized analysis, results in a more robust high throughput assay.

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