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Biologics Blossoming: CANbridge Looks To Taiwan, WuXi Partners Juno

PharmasiaNewsBiologics Blossoming: CANbridge Looks To Taiwan, WuXi Partners Juno

By Brian Yang

Apr. 11, 2016 7:05 AM GMT

https://www.pharmamedtechbi.com/Publications/Pharmasia-News/2016/4/11/Biologics-Blossoming-CANbridge-Looks-To-Taiwan-WuXi-Partners-Juno?result=1&total=22&searchquery=%253fq%253dCANbridge

Executive Summary

New policies including the allowance of contract manufacturing under a new marketing holder system are fast changing the nascent biologics sector in China, where the just 2% market penetration for such products is offering plenty of room for a new crop of startups including CANbridge to grow and thrive.

BEIJING – Many seemingly unconquerable barriers of the past are fast melting away, and biotech companies in China are wasting no time to seize new opportunities.

One such obstacle has been manufacturing site requirements. Previously in China, drug makers must have had their own production facilities to be able to conduct clinical trials for their new drugs, but now a pilot program is allowing contractor manufacturers to be used instead (“Authorization Holder Scheme To Shake Up China R&D, Production” — PharmAsia News, Nov. 6, 2015 4:18 AM GMT).

That is opening doors for smaller biotech startups like CANbridge Life Sciences Ltd. With fewer than 20 people and a virtual development model, the Beijing-based firm simply has to rely on contract manufacturing organizations (CMOs) for any chance of developing a new drug in China.

Now, the company has a concrete solution. It has signed up with WuXi Biologics, a subsidiary of WuXi AppTec Inc. to produce CAN-008 in China. The molecule, also known as APG001, was licensed by CANbridge in July 2015 from Germany’s Apogenix GMBH for mainland China, Hong Kong and Macau, and is at the clinical stage elsewhere for glioblastoma multiforme, a type of brain cancer.

The partnership with WuXi will allow CANbridge to submit a planned IND for clinical trials to the China FDA. Wasting no time, the company has meanwhile completed an IND application (the venture’s first) to initiate a Phase I/II trial in Taiwan (which is now included in its licensed territories) to help expedite the regulatory process in the mainland, disclosed James Xue, CANbridge’s CEO.

“Due to a ‘four plus four’ agreement between the mainland and Taiwan, in which clinical trial study data from four selected facilities from each side are accepted by the [respective] regulatory agencies, we hope the data obtained from the Taiwan study will be used towards starting Phase II trials in the mainland, bypassing a Phase I study [in China],” explained Xue in a phone interview. Data from the Taiwan study are expected next year, he added.

Such a development approach is a direct result of a cross-strait clinical study collaboration agreement, a pathway that several Taiwanese biotechs including Taiwan Liposome Co. Ltd. are hoping to use to get their novel drugs approved in a far larger market (“Taiwan Liposome Eyes Phase II Liver-Cancer Drug Trials At Home, China” — PharmAsia News, Aug. 11, 2014 10:33 PM GMT).

CANbridge has also recently in-licensed global rights ex-US, Canada and Mexico to AVEO Oncology‘s clinical stage ErbB3 (HER3) inhibitor for esophageal squamous cell cancer (ESCC) (“CANbridge Looks Beyond Asia With AVEO’s Oncology Drug” — PharmAsia News, Mar. 24, 2016 7:59 AM GMT).

Clinical Benefits Matter

Unlike its biotech peers, which are focusing on cancer types that are prevalent in China such as lung, liver and gastric cancer, Xue’s firm is fixing its eyes on brain tumors and esophageal squamous cell carcinoma. The executive said that although patient numbers matter, identified patients and clinical benefits carry more weight.
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Glioblastoma multiforme is the most prevalent and aggressive form of brain cancer, and the current standard first-line treatment is Temodar (temozolomide injection), a chemotherapy agent developed by Merck & Co. Inc. and first marketed in 1999.

The average survival in the malignancy is roughly seven months, resulting in a large unmet medical need, Xue said.

A CD95-Fc fusion protein in the TNF family, APG101 is currently under Phase II study for glioblastoma and is the first targeted therapy for the indication in late-stage development, with Apogenix planning to start a Phase III program in Europe.

Although the drug is being studied as a second-line therapy in Europe, the 55-patient Taiwan study (set to start in August) will test it in the first-line setting in combination with temozolomide, during and after radiation therapy. The data generated are also expected to complement the Apogenix data obtained in Europe, Xue said.

“A clear pathway and potential benefits to patients” provided CANbridge with the main reasons to license the asset for greater China. Additionally, Xue said the company is also looking to expand to other cancer indications once it obtains proof-of-concept data. APG101 is already being developed for myelodysplastic syndromes, where CANbridge has an option to acquire selected rights.

Similarly, there is a lack of effective treatments for ESCC, which affects people in certain regions of China.

MAH Impact

China’s rollout of the marketing authorization holder (MAH) pilot scheme is enabling smaller biotechs like CANbridge to file for their own regulatory approvals for the first time. “MAH is opening the door,” Xue pointed out, adding that WuXi is one of the few CMOs with international standards.

Another factor is that WuXi has experience filing new drug approvals with the China FDA. Even as the goal is to develop the Apogenix asset into an international first-in-class drug, Xue said manufacturing such a product will even be a new challenge for WuXi.

In another move under the MAH scheme, German’s Boehringer Ingelheim GMBH has also set up a CMO subsidiary in China and has partnered with BeiGene (Beijing) Co. Ltd. to manufacture BeiGene’s anti-PD-1 monoclonal antibody BGB-A317 (“Beigene/Boehringer Biomanufacturing Bond Tests China MAH System” — PharmAsia News, Mar. 10, 2016 6:28 AM GMT).

WuXi Links With Juno

Meanwhile, WuXi – China’s largest contract research organization – has been busy signing other deals, including wit Juno Therapeutics Inc. to set up a 50/50 joint venture, JW Biotechnology (Shanghai) Co. Ltd, to develop immune-oncology products in China.

The JV will leverage Juno’s technology in chimeric antigen receptor (CAR) and T-cell receptor drugs and WuXi’s R&D and manufacturing capabilities, and plans to in-license the rights in China to Juno products in exchange for undisclosed upfront, milestone and royalty payments.

The new joint venture is being led by WuXi’s co-founding CEO James Li, formerly a partner with Kleiner Perkins and GM for Amgen Inc. in China, while WuXi chairman Ge Li serves as chairman. Other board directors include Juno CEO Hans Bishop, Juno CFO Steve Harr and WuXi CFO Edward Hu.

Juno is one of the portfolio firms that had previously received investment from WuXi Healthcare Ventures (“WuXi AppTec Aiming To Relist Biologics Unit In Hong Kong IPO” — PharmAsia News, Mar. 4, 2016 1:21 AM GMT).

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CANbridge Looks Beyond Asia With AVEO’s Oncology Drug

PharmasiaNewsCANbridge Looks Beyond Asia With AVEO’s Oncology Drug

By Jung Won Shin / Mar. 24, 2016 8:00 AM GMT

Executive Summary

In its first venture outside of Asia and a rare move by a Chinese biopharma firm, CANbridge Life Sciences is acquiring global rights to AVEO’s clinical-stage ErbB3 (HER3) inhibitory antibody candidate, in a step CANbridge’s CEO explains fits well with the company’s global strategy and therapeutic focus.

SEOUL – CANbridge Life Sciences Ltd. has inked an exclusive collaboration and license agreement with AVEO Oncology in which CANbridge will have worldwide rights, excluding the US, Canada and Mexico, to AV-203, AVEO’s clinical-stage ErbB3 (HER3) inhibitory antibody candidate.

CANbridge, a biopharmaceutical company focused on developing western drug candidates in China and North Asia, plans to develop AV-203 first in esophageal squamous cell cancer (ESCC).

“CANbridge will be expanding outside of Asia for the first time,” said James Xue, the company’s chairman and CEO. “Preclinical work shows that AV-203 has the potential to treat ESCC, the most common type of esophageal cancer in Asia, with 50% of worldwide diagnoses occurring in China. Esophageal cancer is also prevalent in other parts of the world, particularly developing countries.

“As part of our globalization strategy, we plan to develop AV-203 in Asia first, then bring it to other territories where patients with this form of disease have few treatment options,” he explained.

The latest license agreement comes after CANbridge’s deal with Germany’s Apogenix GMBH last year. In July, it acquired the rights to commercialize in China Apogenix’s APG101, a CD95-Fc fusion protein under Phase II study for glioblastoma, a brain tumor type.

Strategic Focus

The Beijing-based drug discovery company will primarily concentrate on oncology for now, Xue told PharmAsia News.

“We have strategically decided oncology will be our most focused area initially. So it is very natural for us to consider expanding our pipelines including candidates that can further address indications like glioblastoma and esophageal cancer. Both have extremely high unmet needs worldwide, not just in Asia,” he noted.

“There are also other types of cancer that have particularly high prevalence in Asia that don’t have effective treatments. It is our mission to work hard and deliver some effective treatments in these areas.”

According to the World Health Organization, esophageal cancer is the eighth most common cancer globally, with over 450,000 cases diagnosed each year.

To date, AVEO, which is dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need, has completed a Phase I, open-label, dose-escalation study of AV-203 in patients with advanced solid tumors.

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Deal Details, Clinical Plans

Under the terms of the agreement with AVEO, CANbridge Life Sciences is obligated to pay AVEO an upfront payment of $1m plus up to $133m in potential reimbursement and milestone payments, assuming the successful achievement of specified development, regulatory and commercialization objectives.

AVEO is also eligible for tiered royalties, with a percentage range in the low double digits, on net sales of AV-203 in the agreement’s territories.

CANbridge Life Sciences will be responsible for costs associated with the execution of a development plan that includes additional manufacturing requirements as well as preclinical and clinical studies necessary to demonstrate proof-of-concept for AV-203 as a treatment for squamous cell esophagus cancer, including a Phase IIa proof-of-concept study meeting mutually agreed upon criteria.

“Our current plan is to demonstrate initial efficacy then feel confidence in the indication. Afterward, we will consider multinational studies. Whether in Asia or beyond Asia, we haven’t decided it yet,” the CEO said. “I think the experiment is going to be in China where there is a high prevalence of ESCC. We will start the Phase I in China next year.”

“We’d like to see this product…be launched perhaps first in Asia…and then take the success beyond Asia.” – James Xue, chairman and CEO, CANbridge

The company plans to conduct Phase IIa in China in a couple of years, he added.

Following completion of the proof-of-concept studies, AVEO and CANbridge will negotiate a possible agreement under which they may co-develop AV-203, with each party bearing a percentage of the cost of global development activities based on respective geographic rights.

If the parties fail to reach such an agreement, CANbridge may continue the development of AV-203 on its own in markets outside of the United States, Canada and Mexico.

Asia First, Global Second

Speaking on the company’s global strategy, the Xue said if the company has an effective and promising candidate which has global impact beyond China and Asia, it will be happy to see the therapy utilized.

“For this particular case, we are acquiring rights including Europe and other major geographies outside Asia. Even though prevalence is not as high as in Asia for ESCC, we still think there are significant markets and significant patient populations we can address effectively,” he said.

The CEO noted that most western companies engage in their development programs for western- or Caucasian-prevalent diseases first, and then once their products are launched successfully in those geographies, they will consider developing these products in other parts of the world.

“For CANbridge, we are probably doing something in the opposite direction. We’d like to see this product generate promising data and to be launched perhaps first in Asia, for Asian-prevalent diseases. And then take the success beyond Asia. That is our global strategy,” he said.