“Biotech companies today are in a state of emerging confusion when it comes to partnering. There are thousands of biotech technologies, so established companies have tons of options from which to choose,” points out Philip Kenner, principal, ClearView Healthcare Partners.
Sorting the ‘wheat from the chaff,’ so to speak, consumes large companies’ time and resources and begs for a streamlined approach to review. For small companies seeking partners, this plethora of options increase competition in what is an already highly competitive atmosphere.
The likely winners are those small companies that narrow their focus to a few options, and that match those options to the interests of potential partners.
For small companies, prioritizing their efforts may involve waiting out the industry. For example, Kenner says, “You may want to embark on one clinical path, but may need to wait for a Phase III readout from a larger company. Those results could change the clinical landscape, sending your project in another direction or potentially making your project irrelevant. The challenge then is how to advance your programs in the face of uncertainty and to prepare a data package that will be compelling a year or two from now, when you’re ready to look for a suitor.”
The solution, Kenner says, may be to rest after a trial to let the data play out, or to broaden your trial design to ensure it provides enough data—and the right data—to pivot later if necessary.
Another approach is to accelerate development. “For those with truly compelling early efficacy data, it sometimes makes sense to skip the middle phases and go directly to pivotal trials. The best approach obviously varies based upon what you’re trying to accomplish,” Kenner underscores.
For example, a few years ago, companies often designed immuno-oncology trials to show their particular drugs could be effective adjutant therapies with Bristol-Myers Squibb’s Opdivo® or Merck’s Keytruda®. After the failure of Incyte’s epacadostat combination therapy in pivotal trials last May, however, companies are reevaluating that stance. In the overall picture, it may be that “combination therapy data may be less important than monotherapy data,” Kenner says. “Small companies need to show their drugs have potential as a monotherapy as well as in combination.”
Therapeutic opportunities in oncology
Kenner foresees partnering opportunities in non-personalized, broad spectrum immunogenic-boosting compounds as well as in mRNA vaccines and CAR T therapeutics.
“I think the non-personalized, broad spectrum immunogenic-boosting compounds may have the greatest partnering opportunities. Lots of companies are interested and the therapies target many different tumor types, so there are more potential buyers,” Kenner explains.
Likewise, recent technological innovations around mRNA vaccines have overcome their stability problems, so they could become a viable alternative to conventional cancer vaccines. Interest is continuing among CAR T cell therapies, too, despite the challenges of developing the clinical infrastructure to safely deliver these highly efficacious therapies.
“CAR T developers have the same issues as antibody developers in the late 1990s,” Kenner says. “Developing the infrastructure needed to make them work is very challenging, and companies are still learning how to do that.”
Partnering considerations are changing
With so many new, potentially disruptive therapies in development, partnering considerations are changing on both sides of the partnering desk.
“The market seems eager to see companies go public, and venture rounds are increasing in size,” Kenner points out. “So, in some ways, there’s less pressure to partner early. That allows young companies to retain more of their value. The risk is that if they wait too long, they may spend time and resources developing data they don’t need.”
Large companies have a different set of challenges. Cutting through the noise and the clutter of so many competing projects to find synergistic programs for their flagship assets can be daunting—particularly in the dynamic field of oncology. “Every potential partner seems to take a run at PD1 or PDL1 inhibitors, either alone or as a combination therapy,” Kenner says. The number of options makes it difficult for even large companies to focus tightly on any one thing. Merck’s Keytruda is an example. “It’s being used in approximately 400 clinical trials with 80 different mechanisms, so none of those trials receive the focus from Merck that they might if there were fewer trials.”
Despite the high numbers of clinical trials for all therapeutics, “there’s not a lot of compounds in Phase II that have a high degree of compelling data,” Kenner says. Even when efficacy data is outstanding, “there’s always a blemish.”
Large companies, consequently, “have resigned themselves to this and are shifting their interests to therapeutics in earlier stages of development. There’s greater comfort now in looking earlier and taking bigger risks with newer platforms like CAR T therapies or even with unproven mechanisms of action but good animal data,” he says.
Strategic thinking attracts suitors
It’s difficult for larger companies to stratify potential partners based on preclinical data. “But, when you ask ‘what’s next?’ this becomes easier,” Kenner says. At that point, the strategic goals and operational maturity of the company come into play. The companies that become most attractive have thought about these aspects.
“Small companies that are fostering relationships with tertiary care centers or that are developing the clinicians who will run their clinical trials, along with those with a strong strategic focus, garner interest from more established firms,” he says. Rather than taking a broad, shotgun approach, to their portfolio, they are limiting their efforts to targets that are of interest to specific companies. “That strategic vision makes a more compelling story.” That said, companies with platform technologies should attract interest.
Small companies engaged in immuno-oncology work, and especially PD1 compounds are obvious contenders for oncology partnering, Kenner continues. “But small firms seeking partners also should watch the companies that have limited, defined franchises, especially in hematology and oncology, like AbbVie and Celgene. To build their franchises, they have to bring in more assets.”
Kenner will continue this discussion at BioPharm America™, Thursday, September 6, where he will moderate a panel discussing partnering opportunities in oncology.