Medivir clears key hurdles ahead of phase IIb
While currently conducting a rights issue, Medivir has rapidly progressed the development of the drug candidate fostrox for the treatment of liver cancer. Firstly, they have completed the development of an updated formulation of fostrox suitable for commercial manufacture. Additionally, they have secured agreements for the manufacturing of fostrox GMP substance for clinical trials. The goal is to expedite necessary activities to initiate a pivotal phase IIb study in 2024, with the aim of accelerated approval in 2027.
Pharmaceutical company Medivir is developing fostrox for the treatment of hepatocellular carcinoma (HCC), the most common form of primary liver cancer. One in five patients do not respond to today’s first-line treatment (Tecentriq/Avastin), so Medivir wants to position fostrox as a new alternative when first-line treatment is not effective.
Fostrox is currently being evaluated in a fully recruited phase Ib/IIa study in combination with the cancer drug Lenvima. Interim data indicate clinical benefits when fostrox is combined with Lenvima in second-line HCC.
The goal is to initiate a pivotal phase IIb study in 2024 and obtain accelerated approval in 2027, without the need to conduct a phase III study. Such approval would therefore reduce the development time significantly.
Finalised formulation for commercial development
Medivir took further steps forward on its way to initiating the phase IIb study recently when it announced the completed development of an updated formulation of fostrox suitable for commercial manufacturing. This is an important advancement since regulatory authorities require that the same formulation be used in the pivotal clinical trial as would be used in the commercialised version. UK-based Quotient Sciences, Medivir’s partner for formulation development and manufacturing of pharmaceutical products, has carried out the development work.
In a press release, Medivir’s CEO Jens Lindberg states:
“We are very pleased with our collaboration with Quotient Sciences on this updated, commercial formulation and having the formulation at this stage enables us to keep maximum momentum in the fostrox development programme.”
Agreement for the manufacture of pharmaceutical substances
Another essential part of the development work with fostrox is the production of GMP substance. GMP, or Good Manufacturing Practice, describes the minimum standard that a pharmaceutical manufacturer must meet in its production processes.
On December 13, Medivir signed an agreement with the Swiss chemical and pharmaceutical company Lonza for GMP manufacturing of fostrox’s drug substance for the planned phase IIb study. The goal is to enable access to study drugs by the end of 2024.
Lonza has already developed a process suitable for commercial manufacturing of fostrox, and initiated work to secure the final optimisation, qualification and validation activities required to support conditional approval after the planned phase IIb study.
CEO Jens Lindberg also commented on this in a press release:
“This is another important step in our efforts to ensure speed and momentum in the fostrox development programme. It has the potential to become the first, approved treatment option for patients that have progressed on current first line standard of care and it is imperative that we move ahead with as much speed as possible. We are very pleased with our collaboration with Lonza to ensure continued momentum.”.
Rights issue ends on December 21
Medivir is in a period of intensified planning for the upcoming phase IIb study – where fostrox is evaluated in combination with Lenvima, compared to administering Lenvima as monotherapy. The company is also carrying out a rights issue of up to approximately 148 million SEK. The proceeds will accelerate necessary activities for the pivotal phase IIb study in 2024, with the aim to receive accelerated approval from the FDA in 2027. The rights issue period began on December 7 and will end on December 21. Read more here and a CEO interview here (in Swedish).
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