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Rare But Real: How One Startup Is Willing Itself To Lift China Orphan Drug Market

by brian.yang@informa.com

Executive Summary

Today medical sciences have developed several options learningworksca.org cheapest cialis which would help men in getting rid of their sexual health and the factors which might be responsible for erectile dysfunction. One just needs to order the drug via ecommerce shop. get viagra overnight He was a committed runner, and when stomach pain persisted he buy cialis canada simply ran harder. Besides that, the temperature of testis cannot be adjusted normally as viagra pills uk scrotum is surrounded by compression, so that the temperature must be 15 to 30 degree c. As a promising market for orphan drugs, China has seen several approvals in this space in the past six months,
mostly from multinationals. But Beijing-based CANbridge believes that a smaller biotech also has a good shot at a leadership role, despite a lack of funding and reimbursement and prickly pricing issues.

Click here to read the full story

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Scrip Asks… What’s The Current Climate For Deal-Making? (Part 1)

Scrip Asks… What’s The Current Climate For Deal-Making? (Part 1)

  • 16 Oct 2017

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Joseph Haas Joseph.Haas@informa.com

Executive Summary

Following Gilead’s acquisition of Kite, buzz grew that the deal might catalyze a surge in deal-making. Scrip asked a broad cross-section of biopharma insiders and observers about the deal-making environment – first up are responses from small biotechs.

Gilead Sciences Inc.‘s recent buy-out of Kite Pharma Inc. for $11.9bn to super-charge its cancer pipeline ended a long period of speculation about what Gilead would do with its stockpile of cash – and set off a new round of speculation about the state of the deal-making environment across the biopharma industry.

What’s Gilead Getting From Kite For Nearly $12bn?

By Mandy Jackson 29 Aug 2017

The $180 per share that Gilead’s paying for CAR-T maker Kite was deemed too high by some and just right by others, but the big biotech expects a lot from its new cell therapy platform.

Read the full article here

Scrip asked a cross-section of people in the industry – from large and small companies, market analysts and other industry observers – what they make of the current climate for deal-making. Here, in their own words, are the responses from the biotech sector, defined here as smaller, clinical-stage firms. Part two will provide the responses from big pharma and other respondents.

Having Their Say:

Biotech: Epizyme Inc., Erytech Pharma SA, Kura Oncology Inc., Zavante Therapeutics Inc., CytomX Therapeutics Inc., Fortress Biotech Inc., CANbridge Life Sciences Ltd., Athersys Inc., Corbus Pharmaceuticals Holdings Inc.

Susan Graf, Chief Business Officer, Epizyme

Susan Graf

The current deal-making environment is a positive one-two punch for biopharma. First, today’s equity climate is fueling biopharma companies in their work to discover and develop innovative therapies. Second, big pharma companies continue to need promising new assets to fill their pipelines.

This exciting combination creates a variety of options for biopharma companies as they consider the best way to add more value to their companies, while continuing to do what they do best: innovating new medicines, particularly in areas of large unmet patient need.

Jean-Sebastien Cleiftie, Chief Business Officer, Erytech

Jean-Sebastien Cleiftie

Our perspective on the current climate: although not at the level of 2015, 2017 year-to-date biotech deal-making levels have been robust, especially when we look at licensing in oncology, immuno-oncology and immunology, which will continue to drive transaction activity.

Biotech M&A levels have been contained through the summer, although one transaction can have a dramatic effect on deal statistics, as shown by the recent acquisition of Kite Pharma by Gilead. Furthermore, Q4 is generally an active quarter for deal making, so all in all it is too early to predict what 2017 will look like on the M&A front.

Troy Wilson, CEO, Kura Oncology

Troy Wilson

Although uncertainty around tax reform and drug pricing remains, we continue to see a constructive deal-making environment for biopharma. Companies and investors continue to seek deal premiums, and buyers appear to be exercising discipline. Large pharma are willing to pay a premium when products have been significantly de-risked while smaller companies must compete aggressively as they look to challenge the incumbents.

As a result, we are seeing companies such as Incyte Corp., Tesaro Inc., Clovis Oncology Inc. and others begin to expand their scope and become strategic partners in their own right. In general, it makes for a pretty healthy biopharma ecosystem.

“This feels more like a slowdown as [big pharma] integrate their previous acquisitions and they assess what is going to happen with pricing and reimbursement.” – Zavante’s Schroeder

Ted Schroeder, President and CEO, Zavante Therapeutics

Ted Schroeder

I would characterize the current deal climate as active, but cautious. I find the current situation interesting for two reasons 1) Money is still relatively cheap and 2) Most companies remain under-valued. While I don’t have great insight into the minds of big pharma, this feels more like a slowdown as they integrate their previous acquisitions and they assess what is going to happen with pricing and reimbursement.

Allergan PLC’s shift to deals that are accretive in the short term (e.g. aesthetics) likely gives the rest of the players the sense that they don’t have to be quite so aggressive for therapeutic deals. (Also see “Allergan Adds Accretive Aesthetics Assets In $2.9bn LifeCell Acquisition” – Scrip, 21 Dec, 2016.) Novel oncology assets still seem to be in high demand. Big pharma and biotech still need to fill their pipelines so I expect a steady deal flow going forward, but perhaps not quite like 2016.

Debanjan Ray, CFO and Head of Corporate Development, CytomX

Debanjan Ray

We find the current biopharma deal-making environment to be strong. Our recent interactions with pharma suggest that these companies value innovation, and are willing to think creatively to access innovative programs and platforms that have the potential to make a difference for patients.

In the past 18 months, we’ve closed collaborations with AbbVie Inc., Bristol-Myers Squibb Co.and Amgen Inc. In these collaborations, our partners have been willing to structure deals that bring value to CytomX in the near term and the long term – for example, retention of certain development responsibilities and profit splits on certain products. This sort of creativity in deal structuring is highly valued by biotech companies such as CytomX, and tend to result in more productive collaboration discussions between biotech and pharma.

Lindsay Rosenwald, CEO, Fortress Biotech

Lindsay Rosenwald

I think the climate is as good as it’s ever been. There’s a great feel of demand for novel drug therapies in big pharma, big biotech, specialty pharma and even mid-sized and smaller companies so it all looks good right now. Which is always scary, right?

When I go to conferences, they’re very crowded with lots of inquiries, lots of interest and it’s like a bazaar, there’s so many people interested in so many different programs. If you look at the announcements of all the deals, it seems there’s a good volume of them.

From my perspective, because we’re involved in lots of different technologies, lots of different companies, there is certainly a lot of interest from all parts of the industry and it seems like the demand for novel agents addressing unmet medical needs – I’ve never seen the demand as great as it is right now.

“Capital market access for follow-on offerings has become somewhat more challenging since the peaking of sector performance in 2015. We believe this creates a very favorable environment for deal-making, as companies look to identify alternative funding sources.” – CANbridge’s Xue

James Xue, Founder, Chairman and CEO, CANbridge Life Sciences

James Xue

We are very optimistic about the current deal-making environment in the biopharma industry, which has seen historic inflows of capital over the last five years and a record number of IPOs. With that influx of capital, exciting new therapeutic candidates have received much needed initial funding to support their advancement. However, capital market access for follow-on offerings has become somewhat more challenging since the peaking of sector performance in 2015. We believe this creates a very favorable environment for deal-making, as companies look to identify alternative funding sources.

Our particular model is to identify validated Western drug candidates for development and commercialization in China and northern Asia. In this sector, we are observing a rise in cross-border transactions between Western and Chinese companies, such as the recently announced agreement between Celgene Corp. and BeiGene (Beijing) Co. Ltd. (Also see “Celgene Eyes IO Growth With BeiGene China Pact” – Scrip, 6 Jul, 2017.) These types of deals can allow companies access to markets not otherwise easily accessed, as well as additional non-dilutive capital, which we believe will continue to make them attractive and a growing component of the environment.

Gil Van Bokkelen, CEO, Athersys

Gil Van Bokkelen

There is substantial interest in technologies that have the potential to address areas of significant unmet medical need, and we believe that will continue to be the case. This is especially true for innovative technologies targeted at indications that are related to the unprecedented demographic transition now occurring, with the large increase in the number of people age 65 and older as the baby boom generation gets older. This will have a massive global impact on health care, since there are quite a few diseases and conditions that will become more prevalent as the global population ages.

Unfortunately, many of these conditions currently lack effective treatment solutions, and for the patients that may mean institutional care, family care or professional home health care, and most families and societies around the world are simply unprepared for that. That need creates opportunities for innovative companies developing safer and more effective treatment solutions that can help improve quality of life for patients.

“We’ve been hearing from big pharma … that there is real concern over high valuations of late-stage public companies that could be targets.” – Corbus’ Cohen

Yuval Cohen, CEO, Corbus

Yuval Cohen

There has been a real drought in deals this year and so the recent Gilead/Kite deal was a very welcome change in that. It is probably too soon to see whether that was the start of a change or a one-off. What we’ve been hearing from big pharma is that there is real concern over high valuations of late-stage public companies that could be targets, but that is always counteracted by the ever-present need of big pharma for novel promising drugs in their pipelines. My feeling is that we will see a return to robust M&A activity shortly but perhaps more on the earlier (hence less expensive) side.

 

Posted on

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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UPDATED: China’s CANbridge files Taiwan IND for PhI/II anti-TNF candidate

FiercePharmaAsiahttp://www.fiercepharmaasia.com/story/chinas-canbridge-files-taiwan-ind-phiii-anti-tnf-candidate/2016-04-07

Topics:

Clinical trials | Partnering

UPDATED: China’s CANbridge files Taiwan IND for PhI/II anti-TNF candidate

Adds comments from Xue

April 7, 2016 | By EJ Lane

Share

Beijing-based CANbridge Life Sciences has sent the Taiwan FDA an Investigational New Drug (IND) application for candidate CAN-008 aimed at brain cancer immunotherapy that was in-licensed for China rights from Germany’s Apogenix.

 CEOJamesXue

CANbridge Chairman and CEO James Xue

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The Taiwan trials will see CAN-008 administered with temozolomide (Temodar) along with radiation therapy for 55 patients in the open-label, dose-escalation Phase I on safety, tolerability pharmacokinetics and preliminary efficacy, according to a press release.

The WuXi Biologics unit of Shanghai-based WuXi AppTec will manufacture the candidate in China, aiming to use the speedier IND process in Taiwan as a possible springboard into Mainland China, though the pathway relies on China FDA granting a fast-track review.

“We are delighted to join forces with WuXi, which will manufacture CAN-008 for the Chinese market, where we plan to begin the pre-clinical work immediately, preparatory to an IND submission,” James Xue, CANbridge Chairman and CEO, said in a statement. CANbridge will rely on WuXi for CD-95 fusion protein.

In a phone interview with FiercePharmaAsia, Xue said that patient enrollment should be finished by the end of the year and results for the Phase I leg out by the second quarter of 2017. He said the trial was being conducted under a 4 + 4 arrangement between Taiwan and China that recognizes clinical trial data from 4 hospitals in each country.

In that regard, CANbridge hopes to take successful Phase I data to the China FDA for an IND application and if the data is exceptional – aim for a straight shot into Phase II without having to repeat the Phase I in China.

With a bit more than $15 million raised up to Series A, Xue expects Series B cash this year at around twice that amount to carry on work through 2018, adding that he sees the biotech space in China moving to a “self-select” mode in funding in the coming years as excellent talent and candidates are in place now.

The multi-center, double-blind, randomized, placebo-controlled Phase II leg of the trial eyes efficacy and safety with a start date seen in August of this year.

Apogenix’s own efforts in a Phase II trial in Europe saw increased median survival to 16.1 months from 6.5 months and meeting efficacy endpoints and no serious adverse effects.

In March, CANbridge inked a deal worth a potential $134 million deal with Nasdaq-listed Aveo Oncology ($AVEO) for a clinical-stage ErbB3 (HER3) antibody candidate AV203.

CANbridge received $10 million in venture capital financing in October of last year, led by Qiming Venture Partners and TF Capital, the venture arm of Chinese CRO Tigermed, which built on angel investor funding of the same amount received in 2014.

Posted on

CANBRIDGE CAN-CAN

BY STEPHEN HANSEN, ASSOCIATE EDITOR

Canbridge Life Sciences Ltd.’s deal with Aveo Pharmaceuticals Inc. will see the Chinese biotech developing its first programs outside Asia. But Chairman and CEO James Xue says the company is not deviating from its strategy, which is focused on in-licensing clinical assets from the West to target diseases prevalent in Asia. In this particular case, it made sense to take rights to Aveo’s AV-203 in all territories outside North America because the target indication also plays to Canbridge’s experience with Orphan diseases in the West.
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CANbridge Looks Beyond Asia With AVEO’s Oncology Drug

PharmasiaNews

CANbridge 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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In this study, AV-203 was found to be generally safe and well-tolerated, with an early signal of activity consistent with preclinical data showing the potential for heregulin, the only known ligand for ErbB3, to serve as a biomarker predictive of AV-203 anti-tumor activity.

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.

Posted on

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.

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Canbridge takes it to next level with $10M series A from local VC backers

Canbridge takes it to next level with $10M series A from local VC backers

By Shannon Ellis
Staff Writer

Wednesday, December 10, 2014

SHANGHAI – Canbridge Life Sciences Inc., a Beijing-based biopharma company started in 2012 with angel and private capital, has received $10 million in a series A investment from leading local health care venture capital funds Qiming Ventures and TF Capital. The investment will be used to further Canbridge’s two existing in-licensed programs and put cash in its pocket to bring in more assets.

The funding comes at a crucial time for the company’s pipeline. Its development-stage candidate, ATI-1123, licensed from nanotech specialist Azaya Therapeutics Inc., of San Antonio, is ready to progress to the next stage in the clinic. It is a liposomal formulation of docetaxel to treat non-small-cell lung cancer and is expected to start phase II testing in the U.S. in 2015. (See BioWorld Asia, Sept. 25, 2013.)

Canbridge will work jointly with Azaya, taking responsibility for the phase II trial in China at the same time.

The company also has taken on board an oral rinse for the treatment of mucositis resulting from cancer treatments. Classified as a medical device, those products typically can get on the market quickly with an expedited registration process, which James Xue, founder and CEO of Canbridge, said the firm is ready to start soon.

China presents unique challenges to R&D companies with no source of revenue. The development phase is long and uncertain, and while there are some cost savings, it is increasingly expensive to do trials here. Financiers that understand how to assess the risks of biotechnology are few and far between, and with Chinese venture capitalists (VCs) having shorter life cycles than their Western counterparts, it is typically difficult for start-up biotechs to find a good match with VCs.

It does not help that only companies with a three-year track record of profits are able to go public on Chinese exchanges, complicating exits for investors.

The Canbridge announcement highlights how several of those obstacles have been overcome.

From the outset, Xue has adopted a thoughtful strategy for Canbridge, focusing on innovation to meet China’s unmet medical needs but managing the inherent risks with a “portfolio” approach – looking for assets that are in development and then balancing those with products that are approved in other markets and/or devices that are easier to get on the market. Taking on discovery is not part of the plan.

That approach helped to make Canbridge appealing to TF Capital.

“Their products have high potential here. Xue has thoroughly considered the issue of time to market to reduce our investment risk,” Kevin Chiang, partner at TF Capital, told BioWorld Asia.

TF Capital is a relatively new VC fund, started as a spin-off of well-known local contract research organization Tigermed. With only six months under its belt, TF Capital has participated in roughly eight deals, said Chiang.

With respect to age related tinnitus one of the most recommended treatments being viagra uk without prescription . So no more worries of hair fall in these levitra professional countries. But now there are some effective medications available to increase the volume of corpus cavernosa, which are the structures in super active cialis the penis responsible for erection. cheap female viagra Past research has shown that a high number of traffic; needless to say, if they accept the severity, they do not actually seek for help. The Canbridge investment marks its third deal financing a biotech start-up with Qingming Partners, both of which supported promising biotech start-ups Zai Labs Inc. and Ark Biosciences Inc., both of Shanghai. (See BioWorld Asia, June 24, 2014, and Sept. 2, 2014.) Qingming Partners is also an investor in Tigermed.

Because the limited partners in TF Capital come from the health care industry, Chiang explained, the fund has a longer life cycle than many other funds, with a horizon of eight years plus a three-year extension.

Chinese VCs typically have five years plus two, making it difficult for many to invest in early stage biotech companies.

It also helps that the Canbridge investment comes at the beginning of TF Capital’s life cycle, which allows the venture firm to stay for the “long haul,” according to Chiang.

With so many industry contacts, “we believe that we have more information and connection to understand the risk better than most of the investment companies in the industry,” Chiang said. But he added, “the investment cycle is long so it is better [to] work with friends who have the appetite for risk.”

CHANGING REGULATORY LANDSCAPE

One of the risks is the quickly changing regulatory landscape. Xue intends to file the phase II trial for ATI-1123 as a multiregional clinical trial, or MRCT, the rules for which are going through a process of clarification. (See BioWorld Asia, Dec. 5, 2014.)

But Xue said he welcomes the government reforms as a way to help get more differentiated products on the market that offer greater value to patients. He said he has made a close read of the MRCT discussion document and is not expecting delays.

“People believe [the MRCT rules] will slow down regulatory approval. I don’t anticipate it will slow us down very much for the Azaya or Canbridge program – our MRCT is a true MRCT – vs. some other companies who may put the program under the cover of the MRCT,” he said. “We are going to file CFDA guidance as a MRCT phase II using the same protocol as our partners.”

As for T.F. Capital’s Chiang, he said he is happy to be working with Xue, who has both the scientific background and proven business experience, having set up the Genzyme China office.

He said the past year, with China’s enormous success in the internet and high-tech sectors, such as the listing of Jack Ma’s Alibaba Group for $24 billion, the biggest initial public offering (IPO) listing in history, has emboldened many of China’s best and brightest to become entrepreneurs. They are leaving cushy corporate jobs in droves to take a chance on China’s reforming economy that is growing the buying power of its middle class.

“The passion and the ego to be an entrepreneur in China is at an all-time high,” Chiang said. “You see all these success stories from the internet world now influencing pharma.”

“It is a different story now,” he added. “Everyone used to want to work for a company like McKinsey; now people are going out on their own, if they don’t, they feel they will regret it.”

That does not make finding an exit any more reliable, but it does help to find new investments.

The hope is that the IPO rules will change in the time frame of TF Capital’s investment, and Chiang added that “the challenge is finding the good people among ourselves and investors who have been in the industry for a long time, that we have a comfort level with. The exit is still challenging, but it is more friendly [amongst VCs]; so far, we feel comfortable, and there is the possibility of more exits opening up in the future.”

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How Chinese healthcare VC firm TF Capital is investing first fund

BIOCENTURY

14 WEEK OF December 8, 2014

EMERGING COMPANIES

How Chinese healthcare VC firm TF Capital is investing first fund

FAST FUNDING FOR CHINESE HEALTHCARE INNOVATORS

http://www.biocentury.com/biotech-pharma-news/finance/2014-12-08/how-chinese-healthcare-vc-firm-tf-capital-is-investing-first-fund-a13b

TF Capital plans to invest its inaugural China-focused VC fund in innovation and technology in that nation’s healthcare space. The firm, which has about $50 million to invest, has already made about eight investments, including last week’s $10 million series A round for in-licensing play

Canbridge Life Sciences Ltd.

 

“The whole healthcare sector has changed with the booming middle class, and we see a big

opportunity here,” said TF Capital’s Kevin Chiang.

The firm’s investors include CRO Hangzhou Tigermed Consulting Co. Ltd. (SZSE:300347) and specialty pharma Coland Holdings Ltd. (GreTai:4144), along with VC Qiming Venture Partners.

TF is investing up to $4 million per company and will invest its first fund in about 10-15 companies, including in-licensors as well as novel therapeutic plays and medtech.

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“The fund is focusing on and encouraging more early stage stuff than other funds in China,” said Chiang. He added that it has a duration of eight years, plus or minus two years.

According to Chiang, TF is investing the fund at a faster pace than expected and “very soon will have to raise a second one,” but he declined to disclose a timeline.

 

TF’s latest investment was last week’s Canbridge deal in which Qiming also participated.

Canbridge CEO James Xue said the company plans to use the funds for R&D for its two in-licensed programs and to add specialty care assets.

 

Early next year, CANbridge plans to file clinical trial application in China on phase II study of ATI-1123 in non-small cell lung cancer and will initiate CFDA registration process with Caphosol, an adjunct treatment for chemo and radiation induced oral mucositis.

Canbridge has rights in China, Taiwan and South Korea to ATI-1123, a protein-stabilized nanoparticle formulation of docetaxel, from Azaya Therapeutics Inc.; and rights from Jazz Pharmaceuticals plc (NASDAQ:JAZZ) to Caphosol in China and parts of North Asia.

TF and Qiming are also investors in Zai Laboratory Inc., another China-based in-licensing play.

Zai raised $32 million in an A round in September (see BioCentury, Sept. 22, 2014).

— Jennifer Rhodes

 

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CANbridge Life Science’s ‘portfolio’ bid aims to get cancer drugs to patients faster

Canbridge Life Science’s ‘portfolio’ bid aims to get cancer drugs to patients faster

By Shannon Ellis 

July 29, 2104

Staff Writer

SHANGHAI – Canbridge Life Sciences Inc., of Beijing, is on its way to bridging the gap that leaves many patients in China waiting anywhere from four years to six years for critical treatments approved in developed markets. With time of the essence, the firm is taking a portfolio approach to its in-licensing strategy, developing both clinical-stage and approved treatments, while mixing new drugs with treatments classified as medical devices.

In its second deal since forming last year, Canbridge will have the Chinese commercialization rights to Caphosol, an adjunct therapy for cancer patients that suffer from extreme dry mouth (oral mucositis) as a consequence of radiation or chemotherapy. According to CEO James Xue, there are no adequate treatments approved in China, even though Caphosol has been available in the U.S., Canada and the European Union.

Canbridge signed the deal with Eusa Pharma Ltd., the international division of Jazz Pharmaceutical plc, of Dublin.

“Drug development takes a lot of money capital and time,” Xue said. “If we only focus on products that are in clinical development stage . . . we have to take a lot of risks in terms of development risk.”

In the company’s inaugural deal, it did take on some of that risk. Canbridge licensed the China rights to co-develop ATI-1123, a liposomal formulation of docetaxel to treat non-small-cell lung cancer, from nanotech specialist Azaya Therapeutics Inc., of San Antonio. ATI-1123 had finished phase I in the U.S. for multiple solid tumor cancers. (See BioWorld Asia, Sept. 25, 2014.)

Developing novel therapeutics is a lengthy and costly process everywhere, but particularly so in China. And with so much unmet need, going after some low-hanging fruit can help a small start-up generate crucial income to temper the risk.

Xue said that Canbridge is hopeful Caphosol will launch in a “relatively more speedy way and with limited risk,” citing that those “products already approved by the U.S. FDA and EMEA have a pretty assured registration and approval process in China.”

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Oral mucositis is a startlingly common side effect of cancer treatment. It can lead to painful mouth sores, impede a patient’s ability to swallow or take in nutrition orally and, in some cases, cause life-threatening sepsis.

The company estimated some 40 percent of chemotherapy patients, 70 percent of bone marrow transplant patients and 97 percent of head and neck cancer patients receiving radiation therapy develop oral mucositis.

“This product has a vey attractive market potential. The number of cancer patients is at 3.5 million a year in China and most of these patients would experience a certain degree of mucositis,” Xue said. “The sheer number of patients is so large, even if we capture a small percentage of the market, it will still mean significant revenues for us.”

BUILDING A FULLY INTEGRATED COMPANY

With that deal, Canbridge is also a step closer to realizing its plans to be a fully integrated biotech company and will develop its commercial operation from the ground up. Its model is in the same mold as those of Sciclone Pharmaceutical Inc. and Hong Kong-based Lee’s Pharmaceutical Ltd., both of which have been successful in licensing the best of the West for China.

Xue brings regulatory and commercialization experience from his days as general manager at Genzyme China, and he said the current climate, with numerous pharma companies being probed for corrupt activities in their sales ranks, does not deter him. Echoing a sentiment shared by other speciality biotechs, he said, “there are ways to do it right; the precondition is the product you work with is unique enough to differentiate itself.”

Citing data from a study conducted last year by McKinsey Consulting, that 50 percent of big pharma revenues in China comes from off-patent therapies left to fight it out against cheaper generics, he said, “even big pharma has not done the proper work to bring original, patented life-saving therapies to China.”

Xue said his reception during his U.S. trips has been increasingly positive and he has seen a trend where “CEOs are taking a more active role in directing their China strategy at an earlier stage . . . to drive up the value of their equity in the face of their investors,” and, he adds, may be a little disappointed in the ability of the big pharmas to execute partnerships in China.

Canbridge may very well be on a roll. According to Xue, it has received special status from the Beijing municipality that will enable it to tap into government grants and other resources, and it has struck up a partnership with an undisclosed Chinese pharmaceutical with cash to invest. He said the company now has a very robust business development pipeline and expects to be making several announcements in the coming months