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16 July, 2018 - 12:08 By Tony Quested

Sky’s the limit for five-star F-star

F-star John Haurum

2018 is already proving to be a stellar year for F-star – one of the most exciting life sciences businesses on the planet.

Anchored at Babraham Research Campus in the world-renowned Cambridge BioMedTech cluster, F-star is a leader in the discovery and development of novel bispecific antibodies (mAb²) for the treatment of cancer.

The company has already raised over $200 million in non-dilutive capital & revenues from BD partnership and $43m in Venture Capital and public funding.

F-star’s leadership team has decades of combined experience from holding senior-level positions in both pharma and biotech and involving the development of dozens of biologics from target selection to clinical trials.

The company has enjoyed consistent success in recent years but things really blossomed in May with two significant breakthroughs in the space of nine days.

At the end of that month, San Francisco-based Denali Therapeutics – which is committed to battling neurodegenerative diseases – decided to trigger earlier than anticipated an option to acquire F-star Gamma Ltd, F-star’s asset-centric vehicle, for upfront payments of $24 million with further payments of up to $447m contingent on future milestones being reached.

In an ongoing collaboration between F-star and NASDAQ-quoted Denali announced in August 2016, the partners are developing Fcabs (Fc-domains with antigen-binding) against up to three different transporters in the blood-brain barrier. 

This original approach aims to address one of the biggest challenge in neuro-medicine: delivering effectively biologic therapies into the central nervous system. 

In addition to the early acquisition of F-star Gamma, Denali has exercised its right to nominate the two remaining Fcab targets under the terms of the original agreement. The acquisition of F-star Gamma provides Denali with exclusive rights to the Fcabs developed under the collaboration.

John Haurum, CEO of F-star said: “Denali’s early exercise of its option to acquire F-star Gamma is testimony to the progress of our collaboration. We are delighted that our Modular Antibody Technology™ is being applied to address significant unmet needs beyond F-star’s therapeutic focus in immuno-oncology.”

F-star says it is investing its proceeds from the transaction in progressing its proprietary pipeline of first-in-class immuno-oncology bispecific antibodies through clinical development.

Just nine days earlier, F-star had announced successful dosing of the first patient with FS118 in a Phase I clinical trial.

FS118 is a first-in-class immune-oncology bispecific simultaneously blocking two immune checkpoint molecules involved in tumour growth through attenuation of immune surveillance. In preclinical models, FS118 has demonstrated potent anti-cancer activity, as recently presented by F-star at the 2018 AACR meeting.

John Haurum said: “The initiation of a Phase I clinical study of FS118 is a pivotal milestone for F-star and validation of our unique bispecific technology and approach to improving cancer care. FS118 leverages novel biology that cannot be attained through combination approaches, we believe this is an important step forward in providing improved therapies for patients with advanced cancer.”

The first-in-human study is designed to assess the safety and tolerability of FS118 in patients with advanced malignancies that have progressed while on checkpoint monotherapy. The trial is being conducted at clinical centres in the US.

F-star’s chief scientific officer Neil Brewis revealed: “FS118 is positioned to address a clear unmet medical need as only approximately one in five patients treated with checkpoint inhibition monotherapy reach durable and clinically meaningful responses. FS118 has the potential to increase this response rate by overcoming tumour resistance and restoring anti-cancer immunity and responsiveness.”

The mAb² is under option to Merck KGaA in Germany as part of a collaboration announced in June 2017. Besides Denali and Merck, F-star has a strong track record with other Big Pharma world leaders having previously signed with partners such as Bristol-Myers Squibb Co., Abbvie Inc. and Boehringer Ingelheim GmbH. 

But the Denali deal probably drew a line in the sand for F-star, as John Haurum explains: “We’ve now reached the stage where it’s realistic for us to take programmes forward into the clinic and all the way to proof of concept,” Haurum said. 

“As a company, we continue to mature given our commercial success with these deals. Therefore, we could also potentially pursue a more conventional financing strategy in the company in the future.” 

• PHOTOGRAPH SHOWS: F-star CEO, John Haurum

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