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PPD Doubles Down in China and Inks a Deal with Immvira
戴佳凌·2019-07-05
PharmaDJ
T3011 is a single therapeutic agent of three distinct cancer therapies: the targeting of cancer cells by oncolytic viruses, the stimulation of the immune system by IL12 and the production of immunotherapeutic antibodies against PD-1.


Seeing Soaring Clinical Demand, PPD Doubles Down in China and Inks a Deal with Immvira


Written by Jialing Dai

July 5, 2019


Seeing capital flowing into China, and driving innovation and increasing demand for clinical studies, PPD, a leading global contract research organization (CRO), is doubling its investment in China and signed a deal last month with Immvira, a biotech company established in Shenzhen, China.Under the agreement, PPD will provide clinical consulting and service to Immvira for its leading candidate T3011, an oncolytic virus targeting the human immune system to treat solid tumors.



Immvira is developing a vibrant pipeline of therapeutic agents targeting cancer. The immediate products include engineered oncolytic HSV (oHSV) that expresses immunostimulatory cytokines alone or in combination with checkpoint inhibitors. For maximum effectiveness and to minimize side effects, the oHSV is designed to be delivered by intratumoral injection. Its first product is to be tested either alone or in combination with other immnomodulators in Phase I clinical trials in multiple solid tumor indications. 


In January, Immvira raised $15 million from its Series A+ round to advance its leading candidate T3011 to clinical stage. T3011 is a single therapeutic agent of three distinct cancer therapies: the targeting of cancer cells by oncolytic viruses, the stimulation of the immune system by IL12 and the production of immunotherapeutic antibodies against PD-1.

 


“There are two trends that are occurring that are having a big impact on demand for clinical services in China and also outside China,” David Simmons, chairman and CEO of PPD, headquartered in Wilmington, North Carolina in the United States, told PharmaDJ in an interview. Simmons joined PPD after 15 years with Pfizer Inc., including serving as vice president of emerging markets and established products.

 

With recent regulatory reform at National Medical Product Administration (NMPA), formerly known as CFDA, Simmons noted, China has shortened its IND review timeline to three months from up to 12 months or longer in the past.

 

“So now, one, it’s great for companies that are filing INDs in China, but it has a bigger impact,” he said. “Meaning that if you look at a typical company in pharmaceuticals, like a U.S. or European multinational, Pfizer, Glaxo or one of these, in the past they used to look at China and say, we’re going to develop a new product, like the [T3011] project, their version of a new product. And they would say, okay, when I think about China, I’m going to introduce that product to China after I do the rest of the world. 

 

“So I’m going to run the study in Europe, United States, maybe Japan. That’s more recent as well in Japan. But because the regulatory timelines are long, we don’t want to delay the program, so we’ll come back to China later. Now these same companies are saying there is no delay if I consider China. And the access to patients and the diversity of patients in the trial now is tremendously positive for the conduct of the trial. So the customers are asking us, how fast can you increase your scale in China?”

Now these same companies are saying there is no delay if I consider China. And the access to patients and the diversity of patients in the trial now is tremendously positive for the conduct of the trial. So the customers are asking us, how fast can you increase your scale in China? --  David Simmons, chairman and CEO of PPD

Now these same companies are saying there is no delay if I consider China. And the access to patients and the diversity of patients in the trial now is tremendously positive for the conduct of the trial. So the customers are asking us, how fast can you increase your scale in China? --  David Simmons, chairman and CEO of PPD


Simmons is seeing capital flowing into biotechnology companies in China. “And some of the money is flowing from the state, but also venture capital and private placement monies are coming in,” he said. “We have seen $7 billion flow into the market in 2018, for example. And for PPD, we look at these companies, and now we’re looking at China and different cities in China, the same way we look at Boston and San Francisco.   

 

“Up until this time, the biotechnology clusters of concentration, where innovation is occurring at its most prolific form, tended to be in Boston and south San Francisco in the United States. And we’ve adapted PPD to address that. Now we’re seeing all this money flow into China, so we’re telling ourselves, we have to get as good at engaging and working with companies like Immvira to the same level we’ve done in Boston and south San Francisco. So the model will be similar, but not the same.

 

“The two dynamics are this surge of innovation by biotechnology companies in China that will want to develop a product outside of China. They’ll need a global quality standard that the FDA will accept and the European authorities will accept. And then this regulatory change in China, which has all these companies outside of China wanting to do more work in China. And PPD is right in the middle of all of this. We have to adapt and we’re going to invest significantly to build up our scale and support both of these phenomena.

 


Grace Zhou, cofounder and CEO of Immvira, told PharmaDJ, “We have been consulting with PPD’s experts since last year to prepare an IND filing to the U.S. FDA. That is how we built our trust.” The company plans the initial Phase I trial in Australia and to file the IND in the U.S. by the end of year. 



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戴佳凌 个人用户

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