1:36 PM
 | 
Jan 26, 2019
 |  BioCentury  |  Product Development

Raising the BD bar

Why partnering for new modalities is all about proof of mechanism

Innovator biotechs say that the business development bar has been raised for companies developing new modalities, with potential partners seeking proof of mechanism on top of proof of efficacy.

A host of products based on new modalities is likely to come to market in the next few years, with at least 40 in Phase III testing or registrational studies (see “A Pathway to BioPharma 3.0”).

Most biotechs continue to seek larger biopharma partners to take on late-stage development or commercialization, but history has shown that the big players are slow to bring new technologies in-house and skittish about committing to deals.

Even modalities such as siRNA and antisense took time to gain the attraction of partners; Alnylam Pharmaceuticals Inc. told BioCentury last year that readouts of on-target effects in early stage trials was key to getting partner buy-in (see “Amplifying Oligos”).

While partners considering small molecule programs tend to be satisfied with a competitive efficacy profile, their lack of expertise around new technologies means they are taking their time and soliciting mechanistic data before spending the money to in-license or acquire new programs.

“What is fascinating for us is the amount of data that they are looking for from a mechanistic standpoint.”

Leslie Williams, ImmusanT

“Pharma can wait. They can wait to get the data that is sufficiently predictive of later effectiveness,” said Thomas Lingelbach, president, chairman and CEO of vaccine company Valneva SE.

In the CAR T space, deals went through only after the therapies were close to the finishing line. Kite Pharma Inc. was weeks away from FDA approval of Yescarta axicabtagene ciloleucel when Gilead Sciences Inc. made its $11.9 billion bid for the biotech. Likewise, Juno Therapeutics Inc. was completing pivotal studies of its lead therapy JCAR017 when Celgene Corp. proposed to acquire the biotech for $9 billion. Both deals came after Novartis AG had launched the first CAR T Kymriah tisagenlecleucel.

Moreover, when pharmas do bring in new modalities, they frequently keep the acquired companies or assets in standalone units because they lack the internal know-how to drive the programs (see “Self-driving CARs”).

In a panel discussion with BioCentury at the J.P. Morgan Health Care...

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