Wednesday, January 2, 2019
Flexion enrolls first patient in Phase 3 trial of ZILRETTA
Flexion Therapeutics announced that, on December 26, 2018, the first patient was enrolled in a Phase 3 clinical trial to evaluate the safety and efficacy of ZILRETTA in patients with hip osteoarthritis. Similar to knee OA, hip OA is a degenerative disease which has no cure, and it is estimated that roughly 25% of the U.S. population may develop symptomatic hip OA in their lifetime. The initiation of the Phase 3 hip registration trial was supported by findings from a Phase 2, randomized, open-label, pharmacokinetic study in the shoulder and hip joints, known as the SHIP study. The results from the SHIP study demonstrated that ZILRETTA was generally safe and well tolerated, and the PK profile of ZILRETTA observed in both joints was consistent with previous PK studies in the knee. Results also showed that an injection of ZILRETTA into the hip resulted in 6-fold lower peak plasma levels and reduced systemic exposure compared to immediate-release triamcinolone acetonide in crystalline suspension. The data on the hip cohort have been submitted for presentation. https://thefly.com/landingPageNews.php?id=2842805
Welltower to acquire 55 medical buildings for $1.25B
Welltower and CNL Healthcare Properties announced that they have entered into a definitive agreement under which Welltower will acquire a Class A medical office and outpatient facilities portfolio comprised of 55 buildings from CNL Healthcare Properties for $1.25B. The sale is expected to close during the first half of 2019, subject to customary closing conditions, governmental and other third-party consents.
https://thefly.com/landingPageNews.php?id=2842823
https://thefly.com/landingPageNews.php?id=2842823
Chipotle Introduces New ‘Lifestyle Bowls’ for Keto, Paleo and Whole30 Diets
Chipotle announced plans for a new menu of “Lifestyle Bowls” that will offer “diet-driven” options for people who want to eat healthier. The bowls will include meals for paleo, ketogenic, and Whole30 diets.
The new menu will begin on Wednesday with four new burrito bowls that will adhere to the aforementioned diets.
“These first-to-category, diet-driven menu offerings are helping those who have committed to living a healthier lifestyle by making it easy to order delicious bowls that only contain the real ingredients permitted by certain diet regimens,” Chipotle said in a statement.
The new bowls include the following:
- A Whole30 Salad Bowl, made with romaine lettuce, carnitas, fajita veggies, tomato salsa, and guacamole
- The Paleo Salad Bowl is a mix of romaine lettuce, barbacoa, fajita veggies, green salsa, and guacamole
- The Keto Salad Bowl combines romaine lettuce, carnitas, red salsa, cheese, and guacamole
- The Double Protein Bowl is made with white rice, black beans, chicken, steak, red salsa, romaine lettuce, and sour cream.
Chipotle has taken steps toward reinventing itself in recent years, following a number of public health concerns, including an E.coli outbreak across 11 statesin 2015; customers reporting nausea, vomiting, and diarrhea after eating at a restaurant in Los Angeles in December 2017; and a Norovirus outbreak that same year in Virginia.
The company has tried to come back from its food safety scares and re-build confidence in consumers with a number of offerings. Chipotle announced plans for a new drive-thru, in addition to offering breakfast burritos, and queso sauce nationwide.
The chain’s new Lifestyle Bowls are another step toward restoring its image. Chipotle’s stocks jumped 40% last year.
Atlas Venture raises $250M for later-stage investments
Atlas Venture has raised $250 million to invest in existing portfolio companies. The fund, the first of its kind operated by Atlas, will enable the VC shop to support its startups through series B and beyond.
Massachusetts-based Atlas made its name creating, incubating and investing in biotechs out of its space in Kendall Square. The early-stage operation has supported a string of startups, such as Padlock and Unum Therapeutics, to IPOs and trade sales. But the focus of the fund rendered Atlas unable to keep bankrolling its biotechs as their financial requirements ramped up.
Atlas Venture Opportunity Fund I (AVOF I) is the VC shop’s remedy for that problem. Having wrapped up an oversubscribed fundraise, Atlas Venture has $250 million to support its portfolio companies as they get to series B and beyond.
By moving into later-stage investing, Atlas Venture is making use of the resources that have served it well in new company formation. That means the five investing partners responsible for building biotechs—Kevin Bitterman, Bruce Booth, Jean-François Formela, David Grayzel and Jason Rhodes—will also oversee the investment of AVOF I.
The creation of AVOF I follows similar moves by two funds that lead the early-stage space in Europe, namely Medicxi and Sofinnova Partners. Like Atlas, Medicxi and Sofinnova Partners built their reputations on seed and series A investments. Medicxi moved beyond that niche in 2017 when it raised a $300 million growth fund. Sofinnova followed in 2018 with a $340 million crossover fund.
In each case, the funds give the organization a chance to maintain a sizable stake in its portfolio companies as they advance and need more money to support their operations. Without such financial support, biotechs can be forced to accept partnering and buyout deals that offer suboptimal returns for investors.
Celgene invests in Chinese biotech Antengene again
China’s Antengene has raised another $120 million in a second-round financing, with partner Celgene contributing to the tally.
The series B comes after an initial $21 million opener in mid-2017 and a licensing deal with Celgene that gave Antengene East and Southeast Asian rights to ATG-008, a TORC1/2 inhibitor in late-stage testing for the treatment of hepatitis B virus-positive hepatocellular carcinoma.
The latest investment was led by Chinese VCs Boyu Capital and FountainVest, with Celgene, WuXi Corporate Venture Fund, Taikang, Qiming Venture Partners and TF Capital also joining the round.
Antengene said in an update that it will use the proceeds for the development of ATG-008—which is known by Celgene as CC-223 but doesn’t appear in the U.S. biotech’s current pipeline listing—as well as ATG-010 (selinexor), originally developed by Karyopharm and licensed in Asian markets by Antengene last May, along with “other clinical-stage assets.”
The latter include two other selective inhibitor of nuclear export (SINE) drugs—AGT-016 (eltanexor) and ATG-527 (verdinexor)—and a PAK4/NAMPT dual inhibitor (AGT-019), all of which are also licensed from Karyopharm.
ATG-010, billed as a first-in-class SINE, is in late-stage clinical trials for a range of blood cancers and solid tumors, including multiple myeloma, diffuse large B-cell lymphoma and liposarcoma.
Jay Mei, founder and CEO of Antengene—who has also seen stints at Celgene, Novartis and Johnson & Johnson—said: “This round of financing is critical for Antengene’s growth. We will continue to maintain and advance rigorous, science-driven, and patient-centered R&D, while actively preparing for the commercialization of our lead products in China and the Asia-Pacific region.”
The company is in the process of building a manufacturing and research facility in Shaoxing to provide clinical and commercial supply of its pipeline drugs.
Celgene has said previously it views its arrangement with Antengene as the foundation for a possible strategic partnership between the two companies, and its participation in the latest funding round suggests that is still in the cards. Celgene has suggested Antengene could operate as a conduit to bring some of its other novel drugs to Asian markets.
How heat and salt may contribute to multiple sclerosis
Worldwide, about 3 million people are afflicted by multiple sclerosis (MS), an incurable autoimmune disease in which the immune system attacks the fatty membrane (myelin sheath) that insulates the long extensions of nerve cells.
Damaged myelin prevents nerves from communicating with the brain properly, causing symptoms such as blurred vision, difficulty in walking, dizziness and muscular weakness.
Although there are therapies that can slow the progression of the disease — including the drug Copaxone developed at the Weizmann Institute of Science in Israel — the causes for MS onset are still not fully known.
Researchers from Prof. Roy Beck-Barkai’s lab at Tel Aviv University’s School of Physics, in collaboration with researchers from the Technion and the Weizmann Institute (including Prof. Ruth Arnon, one of Copaxone’s co-developers), set out to find how small structural changes in the membranes affect the myelin layer’s function.
In a previous study done in 2016, they found that the myelin sheath’soptimal function as an insulating layer depends on how these membranes are organized.
When functioning at their best, myelin membranes are stacked on top of one another like layers of puff pastry. But sometimes myelin membranes instead are shaped like tubes, and this abnormal structure disrupts function and potentially leads to diseases such as MS.
“After discovering that structural changes in the membranes can affect disease development, we attempted to unveil the factors that may lead to these changes,” Beck explained.
Heat and salt
As physicists, the researchers already knew that temperature and salt concentration may affect the membranes’ molecular structure. They found additional clues supporting this theory, and took them in new directions.
The first clue came from studies showing a possible connection between a high-salt diet and disease progression, and the widely accepted recommendations to MS patients to maintain a balanced diet.
Another clue was found in the work of German doctor Wilhelm Uhthoff. As early as 1890, he observed that MS patients experience vision problems following hot showers or physical exercise. Unthoff therefore used hot baths as a tool for diagnosing the disease.
To test their hypotheses, the researchers used electron microscopy and x-ray diffraction to examine how changes such as temperature and salt concentrations in the cellular environment affected the structure of the myelin membranes isolated from pig and sheep brains.
They found that a high salt concentration or high temperature (42 degrees Celsius or 107.6 Fahrenheit) in the cellular environment indeed caused the membranes to shift from the normal stacked structure to the deformed tube-like structure.
The researchers believe that this structural change exposes the proteins important for maintaining the normal myelin structure to the immune system, which attacks them and damages the myelin itself.
The study was published in the journal Proceedings of the National Academy of Sciences (PNAS)
Though the experiments were conducted on membranes in a test tube, their results may mirror the cell changes that take place in a living organism, said Beck.
“These are directions that researchers have not previously looked into,” he said.
“While the cause for the disease is still not completely clear, the new finding takes us one step further to a deeper understanding of its mechanisms. Discoveries like ours further our understanding of the cellular mechanisms that may contribute to the development of diseases like MS, and can form the basis for the search for novel drugs and treatments.”
The study was led by PhD student Rona Shaharabani, and was conducted in collaboration with Prof. Yeshayahu Talmon and PhD student Maor Ram-On from the Technion.
Promethera looks to Asia with €10m investment
Belgium-based liver disease specialists Promethera Biosciences have received a leg-up for the Asian market in the form of a €10 million investment from Japanese business conglomerate ITOCHU Corporation.
ITOCHU is the first lead investor in Promethera’s Series D round, which the company expects to close in Q1 2019. Following the transaction, Tajio Enoki, manager, medical business team, chemicals division, energy & chemicals company, ITOCHU Corporation, will join the company’s Board of Directors as a director.
Beyond the investment, ITOCHU intends to support Promethera to advance its product and business development strategy in Asia. The scope of the relationship includes R&D support for Promethera’s HepaStem development program in acute-on-chronic liver failure (ACLF), non-alcoholic steatohepatitis (NASH) and urea cycle disorder (UCD) in selected Asian markets.
“We are very honored to have ITOCHU Corporation a premier Japanese conglomerate with a strong outreach to the wider Asian hemisphere, come in as the first lead investor in our next fundraising effort,” said John Tchelingerian, Promethera’s president and CEO.
“With HepaStem at the core of our relationship with ITOCHU, we expect to make important progress in our plan to develop the world’s first cell-based treatment for severe chronic and acute liver diseases as a tangible alternative to liver transplantation,” added Proffesor Etienne Sokal, CMO and founder of Promethera.
HepaStem consists of liver-derived Mesenchymal Stem Cells that are obtained from ethically healthy donated human organs and expanded in the lab. The product candidate is currently being evaluated in a phase 2a clinical trial in the indication ACLF with safety and initial efficacy results expected to be available early 2019. The initiation of clinical trials in NASH is expected for 2019.
In addition to the first tranche of the Series D round, Promethera has recently raised €14.6 million through the issuance of convertible bonds to existing and new investors, bringing the total amount raised in by the company to date to more than €90 million.
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