Avacta Group makes solid development progress

Biotherapeutics developer Avacta Group updated the market on its trading on Monday, as investors gathered for its annual general meeting.

The AIM-traded firm highlighted its “major” development partnership and license agreement, potentially worth more than $300m, that had been established with South Korean company LG Chem Life Sciences, to develop its ‘Affimer’ therapeutics for oncology and the treatment of inflammatory diseases.

In its Affirmer Therapeutics unit, it said it was continuing to make “good progress” towards its primary objectives for therapeutics, which consisted of generating first-in-human data for the Affimer drug platform as soon as possible; building a pipeline of innovative Affimer drugs with high clinical and commercial value; and securing significant partnerships and licensing deals for Affimer therapeutics.

The company explained that it was continuing to build the in-vivo pharmacology data packages for its lead immune checkpoint programmes - PDL1 and LAG3 antagonists - and was aiming to initiate first-in-human clinical studies for the Affimer drug platform in 2020.

A research collaboration and licensing agreement to access novel drug conjugate technology developed at Tufts University Medical School in Boston, United States, had been established to underpin the pipeline of ‘TMAC’ Affimer drug conjugates and combination therapies.

Pre-clinical development of the first TMAC drug conjugate had started, Avacta said, with initial in-vivo efficacy data from a combination of the lead Affimer PD-L1 candidate with a DDP8/9 inhibitor said to be looking “very promising”.

It was also progressing with its collaboration with Moderna to finalise pre-clinical research and development, with an update planned for the first half of 2019.

With its Affimer research and diagnostics reagents, Avacta said the reagents were shown to be better than leading products in the ‘anti-idiotypic’ reagents market which was estimated to be worth between $10m and $20m per annum.

Good commercial progress was made in the last six months, the board said, with multiple large pharma customers placing orders for Affimer reagents for the detection and quantification of antibody products in clinical studies and manufacturing.

A commercial license with New England Biolabs (NEB), which Avacta described as a “global leader” in the discovery and production of enzymes for molecular biology applications, had been agreed, allowing NEB to commercialise a product using the Affimer technology for use in both life science research and diagnostics assays.

Multiple further licensing deals were expected through 2019.

Avacta also said it was building a small proprietary pipeline of Affimer reagents against specific diagnostic targets, to create licensable assets with the supporting data packages to accelerate the company's business development efforts.

Looking at its board and senior management, Avacta noted that Dr Jose Saro was appointed in November to the role of chief medical officer to lead the pre-clinical and clinical development of the Affimer therapeutic platform.

It said he had more than 20 years of experience in the pre-clinical, translational and early clinical development of oncology assets, spanning small molecules, biologics and drug conjugates.

Dr Saro joined Avacta from Roche, where he held the role of senior translational medicine leader at the Roche Innovation Center, Zurich.

On the financial front, half-year revenue, operating losses and cash balances were expected to be in line with market forecasts.

“It has been a period of very strong progress and I am particularly pleased to have been able to report on a number of major commercial partnerships for Affimer therapeutics and reagents which further validate the technology and business model,” said chief executive Dr Alastair Smith.

“The partnership with LG Chem, a fully integrated pharmaceutical company with world class biologics manufacturing and clinical development capabilities, is a major milestone for the company.

“This deal, potentially worth over $300m and with a significant upfront payment, was made possible by the excellent progress in our in-house programmes that have generated the pre-clinical data which are essential to successful business development activities.”

Dr Smith said that as it expanded those data-sets across its in-house programmes, he was “very confident” that the firm would see additional significant licensing deals that would transform the company.

“The research collaboration with leading scientists at Tufts University Medical School is a major step forward for Avacta.

“If we are to deliver our vision of extending the benefit of immunotherapies to patients who do not respond to simple immune-checkpoint therapies, then we must build a pipeline of innovative Affimer immunotherapies and the Tufts collaboration will underpin that effort.

“The combination of PD-L1 and LAG-3 antagonists, plus other Affimers targeting different immune-checkpoint pathways with the Tufts drug conjugates, has the potential to both stimulate the innate immune response whilst synergising with the adaptive immune response.”

He described it as an “exciting prospect” that had got numerous large pharmaceutical partners interested in the Affimer TMAC programme.

“The licensing deal with New England Biolabs is a perfect example of the type of deals we have in the pipeline of Affimer reagent evaluations and I expect that we will see more of these deals emerge in 2019 with both large and small partners across multiple markets.

“I am delighted that Jose Saro has joined the senior management team as chief medical officer.

“As we move our first programmes into the clinic we are all looking forward to working with Jose to validate the Affimer platform in-human and build an exciting pipeline of valuable therapeutic assets.”

Avacta aid it would issue its results for the six months ending 31 January on 9 April.