The new immuno-oncology revolution

January 16, 2015 ctheodoropulos

Immuno-oncology is new again, fueled by research that has many scientists thinking a cure for cancer may be possible within their lifetimes. After the cancer vaccine misses of seven years ago, investors’ interests are once again piqued. The challenge is identifying exactly where in this fast-moving, complicated space to invest, according to Stephen Dunn, President and Senior Managing Partner, LifeTech Capital, speaking at Biotech Showcase™ 2015.

High prices and long reimbursement cycles chilled investment in the early immune-oncolytics, but today’s prices are even higher. As a timeline, in 2008 Gardasil® cost about USD 400–500. In 2009, Provenge® was introduced at USD 93,000 for a 12-month treatment. In 2011, three new drugs—Yervoy® and Opdivo® by Bristol-Myers Squibb, and Keytruda® by Merck—pushed the price to USD 150,000 for four cycles or one year of therapy.

Bahija Jallal, AstraZeneca/Medimmune

Bahija Jallal, AstraZeneca/MedImmune

 

Developers may justify these very high prices, however. As Bahija Jallal, Executive VP, AstraZeneca/MedImmune, said, “We’re talking years of survival, not just incremental improvements measured in months. These aren’t medicines a patient will use forever, and drug prices are only a single element in the cost of care.”

Most of this new immuno-oncology work focuses on the adaptive immune system—the section that can learn and be manipulated—and, within it, the many types of T cells. Specifically, researchers are suppressing inhibitory receptors—notably CTLA-4, PD-1 and PD-L1—effectively taking the brakes off the immune system, Dunn explained. They also are identifying additional receptors to stimulate the immune system for combination therapies.

Large pharmas are teaming up to explore particularly the PD-1 and PD-L1 field, Dunn said, citing Pfizer’s licensing of Merck’s anti-PD-L1 candidate for USD 850 million.

“The greatest challenge was understanding that we had to partner,” recalled Catherine-Anne Pickering, Head of Oncology Licensing and Global Business Development at Merck Serono. “We could develop the candidate ourselves, but to maximize its value, we needed a big player.” Pfizer, which has its own compound focused on monotherapy, “has a lot that will combine with our PD-L1 approach,” Pickering said.

Valuation was a concurrent challenge, and one that is common in the immune-oncology space. “These compounds work across so many tumor types, they’re hard to value. We went from a few billion to hundreds of billions in the course of a week.” Potential partners were similarly challenged, presenting significantly different valuations.

AstraZeneca is developing an anti OX40 stimulator as well as checkpoint inhibitors. While Jallal wouldn’t speculate as to which will be most effective, she pointed out that the therapies today “are more laser-focused. You know the molecules and the pathways to tweak the immune system.”

Combination therapies are likely to have significant benefits. As Jallal elaborated, “We are in a completely new area in oncology, and this is an ongoing experiment. In cancer, we’ve learned you need a multi-pronged approach. There are several nodes in the immune system and several things can go wrong in any of them.” Therefore, she advocated as comprehensive a therapeutic approach as possible, including checkpoint inhibitors, stimulators, small molecules, radiation therapy, etc. “We’re trying to shut down pathways, but only see the tip of the iceberg in terms of combining therapies and even in understanding the biology. The hope is to tailor combinations to specific patients and specific tumors. This will be the breakthrough in this area.”

Stephen Dunn, President and Senior Managing Partner, LifeTech Capital

Stephen Dunn, President and Senior Managing Partner, LifeTech Capital

 

China has 25% of the world’s cancer cases, Dunn pointed out, yet lags behind the West in this field. Cellular Biomedicine Group Inc., which develops and markets drugs in China, is quietly moving into this field. Wei “William” Cao, CEO, said that to bring these innovative drugs to China they first must be proven effective in other countries.

“The regulatory environment in China is relatively friendly to new technology once safety is demonstrated,” Cao said. Jallal challenged that statement, however, saying it takes “six to seven years to get drugs already approved in Europe or the US approved in China.”

Cao admited that “particularly for cell therapy, it can be a very complex process—especially if the product is autologous. You need a good infrastructure and dialog with the community and regulators. We feel this is very challenging because of the need to translate the most advanced technology in a way that makes regulators understand that an autologous product can be a new drug.

“Chinese society accepts cellular medicine, though. And, with six patients diagnosed with cancer every minute, there’s no shortage of patients for clinical trials.” However, despite the low cost of cancer insurance—about USD 50 to 100—that is available in about one-third of China’s provinces, “patient dropout is high for cancer. About 25% of liver cancer patients drop out of trials, while in osteo-arthritis, for example, it is quite low.”

Globally, “immuno-oncology is an exciting space and it’s just beginning,” Jallal said. In terms of investment, Dunn compared it to “the Wild West.” Some 30 combination trials are underway and expect to release data in the next few years, and data from trials involving single tumor types is expected later this year, he said. “This could be a USD 40 billion market within 10 years. There are so many opportunities…and institutional funds are paying attention.”

 

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