Affimed Therapeutics AG secured a first deal for its bispecific tandem diabody (Tandab) technology, with Johnson & Johnson. The agreement is being executed indirectly, through the financing of a single-asset subsidiary of Affimed, called Amphivena Therapeutics Inc., which has in-licensed an Affimed program.

Amphivena, which was established in Wilmington, Del., has received $14 million in a Series A round from MPM Capital, Aeris Capital – both of which are being funded by Johnson & Johnson – and from Affimed AG.

"They gave cash to the VCs to pay for it," Affimed CEO Adi Hoess told BioWorld International. "It has nothing to do with Affimed."

The transaction, which was designed for tax efficiency purposes, will fund preclinical development of a Tandab directed at a J&J-nominated target associated with an undisclosed hematological condition. The New Brunswick, N.J.-based pharma firm then has an option to acquire the project outright following investigational new drug application approval. In return for its option rights, J&J is paying Amphivena an up-front payment, and would also pay additional milestones.

Financial terms were not disclosed, but they are, said Hoess, quite generous. "The fees we get are pharma standard, not biotechnology standard," he said. "Around 50 percent is true upside for us." The deal is also heavily front-end-loaded. It does not involve late-stage clinical development milestones or sales royalties.

"We can earn all that money within the next five years, if things go well," Hoess said.

That would constitute a very rapid return on its investment. "It is a project that does not exist. It is very early," he said.

For Heidelberg, Germany-based Affimed, the deal also marks an important validation of its core technology. Tandabs are tetravalent, bispecific antibodies. Each Tandab molecule contains two binding sites for each of the two antigens it targets. Tandabs are generated by head-to-tail pairing between two polypeptide chains, each of which comprises four variable domains, connected via amino acid linkers.

The company recently completed a first-in-human Tandab study of its lead molecule, AFM13, in patients with relapsed or refractory Hodgkin lymphoma. The drug binds the tumor antigen CD30 and CD16A, an Fc receptor expressed by natural killer cells.

That trial was primarily intended to demonstrate safety, as well as to shed light on the pharmacokinetics of the Tandab format. It was dosed conservatively, Hoess said – patients received just one weekly dose, over a four-week study period.

The study revealed that Tandabs are less stable than conventional monoclonal antibodies – their serum half-life is shorter, Hoess said.

Even so, the company detected preliminary signs of efficacy, with an objective response rate of more than 20 percent. "What we need to get to is above the 30 percent space," Hoess said. The company plans to conduct a Phase II study itself. "A deal at this stage is not the preferred option," Hoess said.

A second drug candidate, AFM11, which binds CD19 and CD3, is expected to enter a Phase I study in patients with non-Hodgkin's lymphoma around early 2014.

Several other firms in the bispecific antibody space have already racked up multiple deals in the wake of the transaction that sparked renewed interest in this area, Amgen Inc.'s $1.16 billion acquisition last year of Micromet AG. Genmab A/S, of Copenhagen, Denmark, has entered multiproduct deals with Novartis AG, of Basel, Switzerland, and with J&J.

Macrogenics Inc., of Rockville, Md., has signed agreements with Gilead Sciences Inc., of Foster City, Calif.; with Suresnes, France-based Servier SA; with Boehringer Ingelheim GmbH, of Ingelheim, Germany; and with Pfizer Inc., of New York.

Removab (catumaxomab), the sole bispecific antibody to have received approval so far, changed hands recently, as Fresenius SE & Co. KGaA, of Bad Homburg, Germany, sold its biotech division to the owners of Neopharm Group, of Petach Tikva, Israel.

The drug, which targets the T-cell antigen CD3 and epithelial cell adhesion molecule (EpCAM; CD326), was approved in 2009 for treating malignant ascites (abdominal fluid) in cancer patients, but it only attained €4.1 million (US$5.3 million) in sales in 2012.