FivepHusion’s Strategic Partnerships for Success

18 October 2023 11:46

FivepHusion recently embarked on a strategic partnership with pharmaceutical powerhouse Pfizer, facilitated through its manufacturing subsidiary Pfizer CentreOne®. This was not the first time the small biotech company used a mutually beneficial collaboration to its advantage.

Earlier in the year, FivepHusion entered into a tripartite partnership with Treehill Partners and Syneos Health. The deal augments FivepHusion’s strategic capabilities, bringing vertically integrated, full service drug development capabilities to the company.

Treehill Partners provides expertise in various aspects of global business development, operations, strategy, and transactions. Whilst, the collaboration with Syneos Health substantially bolsters FivepHusion’s clinical development and commercialisation capabilities, enabling rapid, diligent advancement of Deflexifol™ development and global commercialisation.

The partnership with Allarity Therapeutics, announced in July, facilitates a Clinical Collaboration in which the companies are working together to evaluate opportunities to identify likely patient responders to Deflexifol™ and other cancer drugs. This precision medicine approach is closely aligned with FivepHusion’s goal of optimising cancer therapy to improve patient treatment and quality of life.

FivepHusion CEO and Managing Director Dr. Christian Toouli commented that this is a very exciting time for the Company.

“We are at a crucial stage in our growth strategy” he said.

“By collaborating with Pfizer, Treehill, Syneos and Allarity, FivepHusion has established access to world-class ‘big pharma’ capabilities and cutting-edge technology to develop Deflexifol™ for global markets, including the US, Europe and Asia. These collaborations are a calculated strategy to substantially de-risk drug development, retain value and maximise the commercial opportunities for Deflexifol™.”

Deflexifol™, a novel enhanced co-formulation of proven cancer drugs, has demonstrated exciting clinical results across two clinical trials in solid tumour patients and has recently commenced investigation in a national clinical trial in children, with the aim of being developed as one of few available treatment options for paediatric brain cancer.

This innovative therapy features a proprietary, optimised, co-formulation of the chemotherapeutic agent 5-fluorouracil (5-FU) with its biomodulator leucovorin, a combination known to enhance 5-FU’s anti-cancer efficacy. Deflexifol™ uniquely allows the concurrent administration of the of these two key anti-cancer agents at a physiological (safer) pH.

Treehill Partners: International Corporate Strategy

Treehill Partners, headquartered in New York, is a specialised international strategic and financial advisory firm with a focus on healthcare industry transactions.

The firm provides comprehensive support to healthcare clients across the asset lifecycle, encompassing buy-side acquisitions, investments, value enhancement, growth strategies, and sell-side disposals and divestments.

The Firm’s primary areas of concentration involve identifying and executing value-creating transactions while seamlessly integrating them into successful corporate evolution strategies.

In its partnership with FivepHusion, Treehill Partners offers operational, strategic, and transactional expertise, along with business development enhancement and guidance.

Treehill Partners Co-founder and Partner Ali Pashazadeh said in the companies’ joint press release in May that the collaboration signifies a novel model of integrated services spanning various disciplines.

“[This partnership model is] designed to allow US and non-US emerging players to play a key role on the global stage, and we’re proud to work alongside FivepHusion and Syneos Health,” he said.

“By merging the scientific prowess of our clients with the clinical and commercial expertise of Syneos Health and Treehill’s healthcare advisory and execution capabilities, we are providing a unique ecosystem designed to help companies to flourish despite the current challenging market environment.”

Syneos Health: Clinical Development and Commercialisation

Syneos Health is a prominent, fully integrated biopharmaceutical solutions organisation dedicated to expediting customer achievements. Its clients include major pharma companies, speciality pharma, biotech companies and academic institutions, who engage Syneos to develop and commercialise their products globally.

Syneos is headquartered in North Carolina, USA, and has a presence in 110 countries, with 29,000 employees. Its services and expertise encompass clinical development, medical affairs, pre- and post-registration and commercialisation strategy and implementation.

Leveraging its extensive global network and expansive reach, the Company delves into comprehending patient and physician behaviours and meticulously analysing market dynamics. Syneos Health harnesses cutting-edge technologies and advanced business strategies to expedite the delivery of crucial therapies to patients.

Syneos Health’s Chief Business Officer Christian Tucat said at the announcement of the partnership the Company was excited about collaborating with FivepHusion and Treehill Partners to facilitate the availability of Deflexifol™ to patients.

“Leveraging our deep therapeutic and global expertise, Syneos Health is pleased to contribute to accelerating the clinical development and commercialization of this important new therapy,” he said.

Pfizer CentreOne®: Scalable manufacture for global markets

FivepHusion’s recent collaboration with Pfizer CentreOne® brings substantive commercial manufacturing capabilities and expertise to the company, with a pedigree that few companies can match.

FivepHusion selected Pfizer after a global search for a manufacturing partner during 2022, which ultimately led to a short list of seven global contract development and manufacturing organisations.

Pfizer’s extensive expertise and well-established capabilities in the commercial production of cytotoxic drugs, coupled with its global supply network, positioned it as the ideal partner for manufacturing Deflexifol™.

The Pfizer global centre for cytotoxic drug manufacturing is conveniently located in Mulgrave, Melbourne, Australia. This facility currently manufactures and exports 5-FU and leucovorin to sixty countries.

Pfizer is working with FivepHusion to scale-up the Good Manufacturing Practice (GMP) manufacture of Deflexifol™ at a global quality and commercial standard required for future clinical trials and commercialisation. This includes producing Deflexifol™ for a planned global phase III registration trial in the first-line treatment of metastatic colorectal cancer.

By partnering with Pfizer, FivepHusion is able to benefit from the company’s established experience in scaling and quality, alongside the alignment with Pfizer’s global reputation and history. This partnership serves as a pivotal enabler for the development and delivery of Deflexifol™ for patients in global markets.

FivepHusion CEO and Managing Director Dr. Christian Toouli expressed the Company’s enthusiasm for collaborating with Pfizer CentreOne.

“The wealth of experience in handling the two active constituents of our drug, Deflexifol™, is really important, as are the advantageous capabilities that Pfizer CentreOne brings to this collaboration,” he said.

“Pfizer CentreOne’s world-class expertise and capabilities in the commercial manufacture of cytotoxic drugs, and reputation for excellence, de-risks Deflexifol™ development.”

Allarity Therapeutics: Enabling Precision Oncology

In July, FivepHusion and USA-headquartered Allarity Therapeutics (NASDAQ:ALLR) announced a Clinical Collaboration Agreement, in which Allarity will support FivepHusion’s future clinical development of Deflexifol™ for the treatment of solid tumours.

Allarity will provide FivepHusion with access to its world-class drug-specific DRP® companion diagnostics platform, including its validated DRP®-5FU companion diagnostic, to potentially select patients for enrolment into Deflexifol™ clinical trials. Allarity’s DRP® platform is a leading proprietary technology to identify patient responders to particular cancer drugs.

The Allarity collaboration enables FivepHusion to potentially identify those patients most likely to respond to Deflexifol™ across a variety of tumour types. Higher response rates should correspond to lower development risk, and on approval, the opportunity to negotiate premium drug pricing due to the greater likelihood of patients receiving treatment benefit.

FivepHusion has negotiated a first option to obtain from Allarity a global, exclusive license to use and commercialize the DRP®-5FU test together with other DRP® tests relevant to drug combinations with Deflexifol™, enabling potential new revenue streams for FivepHusion via commercialisation of these diagnostic tests.

At the announcement of the deal, Allarity Therapeutics’ CEO James G. Cullem said Allarity was thrilled to work together with FivepHusion to support the clinical advancement of Deflexifol™.

“Together with the FivepHusion team, we look forward to advancing true personalized cancer care by using DRP® companion diagnostics to help provide Deflexifol™ to patients that will most likely benefit from this promising therapeutic candidate,” he said.

Partnerships to De-risk and Accelerate Deflexifol™ Development

The strategic partnerships with TreeHill Partners, Syneos Health, Pfizer CentreOne and Allarity Therapeutics position FivepHusion to rapidly develop and commercialise Deflexifol™ for global markets.

The established expertise, capabilities and resources that these organisations contribute significantly de-risks Deflexifol™ development. Moreover, these partnerships abrogate the common requirement for biotech companies to license to larger pharma companies to gain such capabilities, allowing FivepHusion to retain and create long term value in its pipeline by developing Deflexifol™ through to market itself.

Dr Toouli commented on the partnerships.

“These partnerships are a deliberate strategy to de-risk and build capability as we set our sights on late-stage clinical development and commercialisation of Deflexifol™ as an optimised new standard of care therapeutic for the treatment of adult and paediatric solid tumour patients globally.”

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