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Friday, May 25, 2018

GlaxoSmithKline veteran Zhi Hong launches Brii Biosciences with $260M


Zhi Hong, an 11-year veteran of GlaxoSmithKline, is striking out on his own with a startup geared to improve public health in China. Brii Biosciences’ mission is to overcome the challenges that have prevented the spread of innovative medicines throughout China. It starts its journey with $260 million in committed capital and a trio of partnerships.
“The pace of innovation has accelerated over the past decade, resulting in dramatically better treatments and cures for life-threatening diseases, but the reach of those innovations in China has been limited,” he said in a statement.
The regulatory structure in China has been a “big issue,” but with recent rapid changes, Hong hopes it will soon no longer be a barrier to innovation. Other obstacles include the time it takes to secure reimbursement in China, Big Pharma’s tendency to prioritize other markets over China, and the inability for the majority of Chinese people to pay for, and access, high-quality healthcare, Hong told FierceBiotech.
To address these issues, Brii is taking a three-pronged approach: partnerships, best-in-class R&D and the application of digital and data insight. The company is based in Shanghai and has operations in Beijing, San Francisco and Durham, North Carolina.
The first of its three partnerships is with Vir Biotechnologies. Brii has the option to license up to four assets from Vir’s pipeline. While Vir has kept pretty quiet on its programs, it identified its first focus to be areas of significant unmet need: chronic infectious diseases, such as HIV, tuberculosis and hepatitis B; respiratory diseases; and healthcare acquired infections.

The startup has inked a deal with WuXi that gives it access to WuXi AppTec and WuXi Biologics’ R&D capabilities. It’s doing so because Hong sees no reason to reinvent the wheel: “We will really leverage their decadelong investment into their capabilities and don’t need to reproduce it on our own. Instead, we will focus our team on core competency of therapeutic areas, as well as production strategies,” he said.
Under its third partnership, with Alibaba, the duo will work on digital approaches to improve the development and delivery of new drugs. For example, Hong said, digital means could be used to educate patients about their medications and the importance of adherence. This would be particularly useful in a country where patients may get limited time with their physician, he said. Another application is collecting hospital data to help in the design of clinical trials.
The massive $260 million financing was led by ARCH Venture Partners alongside a group of Greater China-based investors: 6 Dimensions Capital, Boyu Capital, Yunfeng Capital, Sequoia Capital, and Blue Pool Capital.
“How much runway that gives us depends on how successful we are in forming partnerships,” Hong said. “The more successful we are, the shorter the runway.”
At GSK, Hong served as a VP and led the pharma company’s infectious disease business. Under his leadership, the unit created a “very strong R&D pipeline,” establishing a sizable presence in the space. He enjoyed his work but started thinking about his next chapter.
“One thing I learned at GSK is that there is a much bigger picture. You can’t just focus on R&D. You have to think about how to deliver innovation to as many people as you can [because] no matter how innovative your product can be, if it cannot be utilized by as many people as possible, then the value of the innovation is not fully realized,” he said.

Bicycle Therapeutics Gets Milestone; Expands Deal with ThromboGenics


 Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) product platform, today announced the receipt of a milestone payment in connection with the initiation of a Phase 1 clinical study evaluating THR-149, under its ophthalmology alliance with ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on developing treatments for vitreo-retinal disorders.
THR-149 is a novel plasma kallikrein inhibitor identified and optimized by the Bicycle technology platform. The open-label, multicenter, dose escalation study will evaluate the safety of intravitreally administered THR-149 for the treatment of diabetic macular edema (DME). Initial study results are anticipated in mid-2019.
In addition, Bicycle Therapeutics announced the expansion of the alliance, which aims to identify and optimise additional Bicycles for the treatment of ophthalmic diseases.
“As the second Bicycle in the clinic, THR-149 will enable us to further evaluate the tremendous potential for Bicycles to treat significant human diseases with unmet need,” said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. “Our decision to expand our alliance is a testament to both the highly collaborative nature of the relationship and our ability to develop novel Bicycles as therapeutics for patients with ophthalmic diseases. We are excited to continue our work with ThromboGenics to develop innovative therapeutics.”
Bicycles have unique properties that make them particularly suited for diabetic macular edema (DME),” said Patrik De Haes, M.D., Chief Executive Officer of ThromboGenics. “Progressing THR-149 to the clinic is a significant achievement and marks an important milestone in our collaborative efforts to bring novel treatments to patients suffering from diseases of the eye. We are excited to build on the learnings we have made in our existing partnership with Bicycle in our extended collaboration.”

Bluebird call on ASCO presentation June 1


Management discusses the data presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on a conference call to be held on June 1 at 7:30 pm. Webcast: https://edge.media-server.com/m6/p/s962ercw

Pivotal bioVenture Partners debuts $150M China-focused biotech fund

The Nan Fung Group’s venture capital firm Pivotal bioVenture Partners has raised a $150 million venture fund to help early-stage life science companies located within China.
The new fund will focus on in-licensing products and technologies that can serve the “unmet medical needs of the growing China market,” and will be led by Pivotal China’s managing partner Jimmy Wei, who says additional fundraising could follow later this year in the form of a $50 million renminbi fund.
Last year, Pivotal bioVenture Partners announced an inaugural $300 million fund last year that is focused on biotechs in the U.S. and Europe, which in the interim has backed a handful of companies including infectious disease specialists Entasis, Iterum and Sutrovax as well as ocular therapeutics player Oculus.

“China is catching up in healthcare innovation,” says Wei, who was formerly managing partner at iBridge Capital and a partner at Kleiner Perkins Caufield & Byers (KPCB) China, helping with the formation of companies such as Zai Lab, JHL Biotech, XW Lab and iMab. Prior to that, he held senior positions at Hutchison MediPharma and Burrill & Co.
He explains that the intention is to create an ecosystem of new companies that can funnel technologies developed around the world—including therapeutics, medical devices and diagnostics and healthcare services—more quickly and efficiently to patients in China.
“We are doing this by building one of the most experienced teams among our peers, and by combining a broad global exposure with strong expertise in the local Chinese market,” says Wei.
So far just one company is highlighted on Pivotal China’s website, namely Shanghai and Boston biotech Oncologie, which is developing next-generation biologics and small molecules in the area of immuno-oncology. Its lead in-licensed candidates are toll-like receptor 9 agonist lefitolimod, in late-stage development, and TIM/TAM antibody candidate bavituximab in phase 2 for head and neck cancer.
Pivotal bioVenture Partners firm was created by the Nan Fung Group, a Chinese property developer in Hong Kong.

Promoting blood vessel growth in bone could treat osteoporosis


The drugs that are on the market to treat osteoporosis work by either blocking cells that break down bone or by boosting osteoblasts—the cells that build bone. Despite the popularity of these drugs, osteoporosis still causes 9 million fractures per year, says the International Osteoporosis Foundation.
Researchers at Weill Cornell Medicine in New York say they’ve discovered a potential new target for treating osteoporosis—the blood vessels inside of bones. And they have promising results in mice showing a molecule that promotes the growth of those blood vessels reverses the weakening of bones and helps fractures heal.
The molecule is a protein called SLIT3, which is best known for boosting nerve growth, according to a statement from Weill Cornell. The scientists discovered it by examining mice that had abnormally high bone mass as a result of being engineered to lack another protein, called SHN3.
When they studied the osteoblasts from those animals, they found that the cells secreted stable amounts of virtually every substance that’s known to promote the growth of blood vessels in bone. But they also produced unusually high amounts of SLIT3.

“We next asked if we could use SLIT3 to treat mice with skeletal disease, especially osteoporosis and fracture healing,” said co-author Matthew Greenblatt, M.D., an assistant professor of pathology and laboratory medicine at Weill Cornell, in the statement.
So they tried it in a mouse model of postmenopausal osteoporosis. It worked, counteracting bone loss the mice had suffered. The researchers published their results in the journal Nature Medicine.
The effort to combat osteoporosis by finding new ways to restore bone-building has been lucrative for some companies. Among them is Amgen, which is expected to bring in $4 billion in sales this year for its bone-strengthening drug Prolia. Earlier this week, Amgen won FDA approval for Prolia’s fifth indication, to treat patients with glucocorticoid-induced osteoporosis.
Still, there have been some setbacks in osteoporosis research. Last year, Amgen and UCB announced that their experimental osteoporosis drug Evenity (romosozumab) reduced fracture risk by 27%, but questions about whether the drug raises the risk of cardiovascular side effects cast doubts on its blockbuster potential.
Greenblatt believes drugs targeting the SLIT3 pathway could hold promise for treating seniors with osteoporosis either on their own or in combination with existing drugs. They could also benefit young people with hard-to-treat bone injuries. “Some of those people’s fractures don’t heal because they can’t grow the right type of blood vessels at the site of the fracture,” he explained.

Celgene webcast from ASCO May 31


Analyst and Investor Event will be held in conjunction with the American Society of Clinical Oncology’s (ASCO) Annual Meeting in Chicago on May 31 at 7:30 pm. Weblink: https://edge.media-server.com/m6/p/j598ynwn

Bayer cuts Monsanto synergy target by $300 million due to divestments


Bayer said positive synergy effects from the planned takeover of U.S. seeds maker Monsanto would be about $300 million (224 million pounds) below its previous target because it will sell more businesses than initially expected to get antitrust approval.

Bayer Chief Executive Werner Baumann again threw his weight behind the deal, despite higher antitrust hurdles and delays in the regulatory reviews, speaking to shareholders at the annual general meeting on Friday.
“I’m convinced that this acquisition has very great potential for creating value for our company, our stockholders and our customers,” Baumann said, adding he expected the deal to be approved and closed in the near future.
If the deal is not closed by June 14, Monsanto could withdraw from the takeover agreement and seek a higher price.
The last major hurdle to clear is the go-ahead from U.S. regulators for the deal, worth $62.5 billion including debt, but Bayer has already come to an agreement in principle on the terms of approval with the Department of Justice.
It has agreed to sell assets, which include seed, crop chemicals and digital farming activities, with revenues of 2.2 billion euro ($2.6 billion) for 7.6 billion euros to rival BASF.
Combining with takeover target Monsanto will have synergy effects of about $1.2 billion on adjusted earnings before interest, taxes, depreciation and amortisation (EBITDA) from 2022, Bayer said – less than the $1.5 billion targeted when the transaction was agreed in September 2016.