Regeneron star bispecific linked to 2 deaths — which was no help for its Q1 call

One of Regeneron’s star cancer drugs in the pipeline has run into trouble, and that’s contributing to some turbulence for the share price on Tuesday.

Regeneron execs chose to disclose in their Q1 call with analysts today that their closely watched bispecific REGN1979 was linked with two deaths from cytokine release syndrome in a small study involving 30 patients.
This bispecific hunts the B cell marker CD20 as well as the CD3 component of the T cell receptor, and Regeneron cancer research chief Israel Lowy spotlighted a 100% overall response rate at ASH late last year, with 8 complete responses and 2 partials among patients with follicular lymphoma. That’s very early-stage data from a tiny trial, but Phase I is the new Phase II in cancer research, and that kind of data always attracts attention in the field — particularly when it comes from a high-profile outfit like Regeneron.

SVB Leerink’s Geoffrey Porges was on the call, and reported back:

The trial had only enrolled 30 patients. Regeneron suggested the higher CRS toxicity was likely due to a heightened immune response, and noted the CRS was also seen in conjunction with increased tumor response. While the toxicity is a preliminary setback for the combination, Regeneron believe they can individually titrate doses and tune the sequence of drugs to help control the immune activation in a manner that captures the increased antitumor activity while limiting potential CRS. Management believe this tunability of dosing and sequencing is an advantage for their therapeutic approach versus CAR-T therapies.

But don’t look for Regeneron to back off. This company doesn’t back away from anything.

From Jefferies’ Biren Amin:

An update on REGN1979 CD20xCD3 bispecific is expected at 2 EU hematology mtgs in Jun ’19, including data on higher doses, LT follow-up, and efficacy in CAR-T failures. Mgmt intends to initiate 2 PII registrational studies for ‘1979, 1st in FL by mid-’19 and 2nd in DLBCL by YE ’19. A combo study of ‘1979 w/ Libtayo anti-PD-1 in 30 advanced lymphoma pts was also started….

Regeneron shares were down 6.5% late afternoon Tuesday, but that wasn’t just about any possible jitters about its bispecific. Increased R&D costs combined with flat Eylea sales — around the same time Novartis is expected to launch its rival brolucizumab — and a reduction in cash flow from its former partner Sanofi helped drive a miss on earnings per share and revenue.

Regeneron’s star bispecific is linked to 2 deaths in a small study — which was no help for its Q1 call