Biontech deal sees Roche bet on mRNA

For the private German group Biontech this morning's deal with Roche marks its fifth pharma partner in the last 18 months, and the biggest of the lot. The tie-up with Roche’s Genentech subsidiary is worth $310m in the near term, and will see the two companies developing individualized mRNA-based cancer vaccines.

The deal marks a significant bet by the Swiss big pharma giant on mRNA, a field where progress has been slow, but which has seen companies like Moderna and Curevac attract large amounts of cash. The approach is one of many being pursued by the secretive private German group, which scored a coup in 2014 with the hire of Professor Katalin Karikó, a pioneer in this field; perhaps this is what swung the balance for Roche.

Biontech’s chief operating officer, Sean Marett, however, would not be drawn on the breakdown of the biodollars – and the company is being secretive about the project generally, declining to disclose which cancers the partners will target or when they hope to go into clinical trials.

“This is a highly competitive area,” he told EP Vantage. “Since we published our original Nature paper we’ve noticed a number of companies have announced they’re entering this area, so we want to keep that confidential” (The mRNA dollars spread beyond Moderna, November 03, 2015). 

Individualised

Biontech does say that the collaboration involves its IVAC Mutanome platform, with which it aims to develop cancer vaccines targeting neoantigens or neoepitopes – mutations unique to each tumour.

“We sequence each patient’s tumour and we select, with proprietary software, the most appropriate neoepitopes, which we then encode in an mRNA vaccine, which we produce for the individual patient,” Mr Marett explained.

Once delivered, it is hoped that the mRNA will prompt the patient’s own immune system to attack the cancer. As well as the aforementioned Nature study in mice, a paper published in the same journal in June 2016 suggested that this could work in humans – or, at least, in the first three melanoma patients treated in a phase I trial.

Of course, this approach, if it ever makes it to the market, would likely be very expensive (Interview – Biontech spreads bets in cancer immunotherapy, June 23, 2015). The deal with Roche does not cover Biontech’s non-neoepitope mRNA assets, which it will continue developing on its own.

Of its existing pipeline, the IVAC Mutanome project, which is being studied in melanoma, and IVAC Warehouse + Mutanome, which is in the TNBC-Merit trial in triple-negative breast cancer, use a neoepitope-based individualised approach.

The rest involve non-neoepitope vaccines. “These are the non-mutated antigens, and there are a number that are very good vaccine candidates for cancer,” said Mr Marett.

Biontech’s pipeline
Platform Studies Indication Status Trial ID
FixVac Merit Melanoma Completed phase I NCT01684241
Lipo-Merit Melanoma Recruiting phase I NCT02410733
Hare-40 Head & neck cancer Starting phase I/II in H2 2016 -
IVAC Warehouse Iris Breast cancer Starting phase I in H2 2016 -
IVAC Mutanome IVAC Melanoma Phase I active, not recruiting NCT02035956
IVAC Warehouse + Mutanome TNBC-Merit Triple negative breast cancer Starting phase I in H2 2016 NCT02316457
Cell & gene CAR T cells Ovarian cancer Starting phase I in H1 2017 -
Antibodies IAPACA Pancreatic cancer Starting phase I/II in H2 2017 -
Source: Company website.

Biontech is also developing a CAR-T therapy, and plans to start a phase I trial in ovarian cancer next year; however, Mr Marett would not give details of the target or construct.

More deals

The Roche agreement caps a busy period for Biontech that has also seen it partner with Sanofi in mRNA, Genmab in bispecific antibodies, Lilly in T-cell receptors and Bayer in animal health.

The Sanofi partnership deals with a different aspect of its mRNA technology than the Roche collaboration, Mr Marett explained. “Sanofi is using mRNA to develop a brand new innovative class of cancer immunotherapies, whereas the Roche project aims to develop an individualised cancer vaccine.”

Could Biontech be looking for more collaborators? Mr Marett does not rule it out. “We may partner still, because we have a broad portfolio, but the rate of partnering will probably be slower than it was in last 18 months.”

To contact the writer of this story email Madeleine Armstrong in London at madeleinea@epvantage.com or follow @medtech_ma on Twitter.

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