Oncology latecomers put early assets in partnering frame

Investors will be heartened to learn that there might still be life in assets that lack a competitive edge or are destined to enter crowded markets long after the first movers. Two separate deals struck today by a pair of oncology latecomers – Sanofi and Boehringer Ingelheim – make precisely this bet.

Deal bankers should now be keen to pitch assets like Astellas’s ASP8273 after Boehringer surprisingly bought into HM61713, a competing laggard from Hanmi. And Sanofi’s latest tie-up with Regeneron shows that anti-PD-1 MAbs are still the rage, despite the near-unassailable position built up by pharma’s front runners.

The Sanofi/Regeneron deal looks like a tacit admission of the French firm’s trailing position in oncology against groups like Bristol-Myers Squibb, Merck & Co, Roche and AstraZeneca. The immediate bet is on Regeneron’s anti-PD-1 MAb REGN2810, which started phase I in March.

It will have escaped nobody’s attention that Opdivo and Keytruda are already marketed, atezolizumab will be filed shortly, and MEDI4736 and Pfizer’s avelumab are in large phase III studies. Despite this Sanofi has committed a large amount of cash to the Regeneron tie-up, including $640m up front, and over $1bn in funding; work will also comprise earlier-stage immuno-oncology projects.

If REGN2810 has legs then so could Tesaro’s and Sorrento’s respective preclinical anti-PD-1s, TSR-042 and STI-A1110; even Curis/Aurigene’s odd foray into small-molecule PD-L1 blockade might generate interest. Last year, CureTech’s largely forgotten anti-PD-1 MAb was picked up by Medivation (Biotech’s immuno-oncology laggards place their bets, October 24, 2014).

Astra vs Clovis

A similar case in point exists as regards secondary EGFR-mutated lung cancer, where the immediate battle is being waged between AstraZeneca’s AZD9291 and Clovis’s rociletinib.

HM61713, a related agent in development by Hanmi, has always been seen as the poor cousin of these two, at least considering the available data. Yet today the South Korean group scored a partnering deal for it with Boehringer worth $50m up front.

Of course, such an addition makes perfect sense for Boehringer, which is already marketing Gilotrif, a drug for primary-EGFR-mutated lung cancer. The blueprint is Astra, which has Iressa available for the primary mutation and should shortly file ADZ9291 for treating patients that have T790M resistance, which is responsible for roughly 60% of secondary EGFR mutations.

But one question is why Boehringer did not, for instance, license Clovis’s rociletinib, which was recently filed for approval. The answer probably lies in the price: Boehringer is private, and thus has no access to cash that others might raise in new equity, while Clovis’s bargaining position has strengthened thanks to a $316m fund raising.

There are tolerability issues, too, with rociletinib being linked to hyperglycaemia in up to 36% of patients (Asco preview – Clovis turns the tables on Astra, May 15, 2015). Efficacy-wise, however, Astra and Clovis are ahead, with median progression-free survival figures of 13.5 and eight months respectively in T790M-positive patients, versus HM61713’s four months or so.

At Asco Hanmi reported a 59% overall response rate at the highest dose, in 34 T790M-positive patients from a 173-patient phase I study. A phase II trial in first-line use is recruiting, mirroring Astra and Clovis’s Aura and Tiger-1 studies.

At best, therefore, Hanmi is playing catch-up, though the fact that this has not discouraged Boehringer points to the potential of even earlier-stage EGFR-targeted agents like Astellas’s ASP8273 and Novartis’s EGF816. ASP8273 showed a promising 80% response rate at Asco, though this was among Japanese patients.

In terms of licensing there might be little interest in the US until better ex-Japan data are generated, while Astellas will be unlikely to relinquish control in its home market. This might not stop deal bankers from pitching the deal all the same.

To contact the writer of this story email Jacob Plieth in London at [email protected] or follow @JacobPlieth on Twitter

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