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Lilly, Biotech Partner on Fast-Acting Insulin Analog

Adult testing a child's blood glucose (NIH)

(National Institutes of Health)

19 December 2014. The pharmaceutical company Eli Lilly and Company and biotechnology company Adocia are collaborating on commercial development of Adocia’s fast-acting synthetic insulin product. Adocia, based in Lyon, France, can gain as much as $570 million in the deal, not counting royalties on future sales.

Adocia develops enhanced formulations of protein-based therapies either on the market or previously approved by regulators. The company’s technology platform that it calls BioChaperone engineers polymers and small-molecule organic compounds to interact with proteins to form complexes that speed the action and absorption, or reduce dosage and frequency of protein-based therapies.

Among Adocia’s products in development is a line of fast-acting insulin analogs designed for people with type 1 or 2 diabetes to control their glycemic or blood glucose levels around mealtime. The company says its BioChaperone-enhanced BC Lispro insulin analogs work even faster than other comparable products, making it possible for people with diabetes to inject themselves during meals to maintain glycemic control. BC Lispro also could be formulated for insulin pumps or artificial pancreas devices.

The company’s regular formulation of BC Lispro is in intermediate-stage clinical trials, while a concentrated form of BC Lispro is scheduled to begin early stage trials. Adocia’s lead product, known as platelet derived growth factor-BB or PDGF-BB is a treatment for diabetic foot ulcers, currently in late-stage trials.

Under the deal, Lilly gains a worldwide license for further development, commercialization, and manufacturing of BC Lispro in regular and concentrated forms. Adocia in return receives an initial payment of $50 million, and reimbursement for certain reserch and development expenses. In addition, the company becomes eligible for $280 million in future payments based on achievement of development and regulatory milestones. Adocia can also receive another $240 million in sales milestone payments as well as royalties on sales.

Lilly already has an extensive line of insulin analogs, including fast-acting lispro products. Enrique Conterno, president of Lilly’s diabetes division, says in a joint company statement, “An ultra-rapid acting insulin would be a natural fit in our growing portfolio.”

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Juno Therapeutics Raises $265 Million in IPO

Wall Street signs

(A. Kotok)

19 December 2014. Juno Therapeutics, a biotechnology company spun-off from research labs in Seattle and New York, raised some $265 million yesterday in its initial public stock offering. The Seattle enterprise developing cancer therapies that harness the immune system issued 11 million shares of common stock priced at $24.00, and trades on the Nasdaq exchange under the symbol JUNO.

Juno employs two technologies to encourage white blood cells in the immune system, known as T-cells, to target invading cancer cells without damaging healthy tissue. One process genetically modifies T-cells with molecules called chimeric antigen receptors to better identify and attack cancer cells on their own, without invoking immune-system signals that could target non-cancerous cells. The second technique also reprograms T-cells by adding molecules known as human leukocyte antigens that target corresponding proteins in tumors.

The company harvests blood cells from cancer patients and separates their T cells for enrichment with the required genetic sequences in the cells’ DNA, then grown in the lab into dosage quantities for infusion back into the patient. In the body, the engineered T-cells multiply in the presence of target proteins and attack their corresponding tumor cells.

Juno Therapeutics is a joint spin-off from Fred Hutchinson Cancer Research Center in Seattle, Memorial Sloan-Kettering Cancer Center in New York, and Seattle Children’s Research Institute, with founding scientists from all three institutions. The company started in December 2013 and completed two venture rounds gaining a total of $310 million in capital.

The company’s therapies are receiving expedited review from the U.S. Food and Drug Administration. In November, FDA granted orphan drug and breakthrough status to Juno’s chimeric antigen receptor candidate code-named JCAR015 as a treatment for acute lymphoblastic leukemia. Orphan drug status provides incentives to advance a therapy’s development and marketing. A breakthrough designation provides more intensive guidance from FDA and eligibility for priority review.

Early clinical trials also show promise for Juno’s products addressing leukemia and other blood-related cancers. The company reported this month patients receiving JCAR015 show high rates of tumor reduction and remission rates of 89 percent. Other early trials testing therapies for acute lymphoblastic leukemia and non-Hodgkin’s lymphoma show evidence of T-cell expansion and persistence, foreshadowing their clinical benefits.

At 11:30 this morning (19 December) Juno’s shares were trading at about $38.00, up some 14 percent from yesterday’s close. The company’s market capitalization is estimated at $2.9 billion.

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Hat tip: Fortune/Term Sheet

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Autoimmune Therapy Developer Raises $23M in Early Funds

Hands with arthritis (NIH)

(National Institutes of Health)

18 December 2014. Padlock Therapeutics, a biotechnology company creating treatments for diseases where the immune system attacks the body, gained $23 million in its first venture funding round. Financing for the Cambridge, Massachusetts enterprise was led by Atlas Venture, with participation from Index Ventures, MS Ventures, and Johnson & Johnson Development Corporation, the company’s venture division. MS Ventures is the venture arm of pharmaceutical company Merck.

Padlock specializes in medicines for autoimmune disorders, diseases where the body’s immune system is tricked into attacking healthy cells rather than invading bacteria or viruses. Among the better known autoimmune diseases are rheumatoid arthritis, multiple sclerosis, and lupus. Women have a higher risk for autoimmune diseases, which are often characterized by inflammation, resulting in swelling and pain.

The company’s technology is designed to address a set of proteins known as protein-arginine deiminase or Pad enzymes. These 5 enzymes are believed to instigate a chemical process called citrullination that removes a positive charge from the surface of proteins, which can affect their structure and functions. In some people, citrullinated proteins are perceived by the immune system in a similar way as invading pathogens, triggering a response from the immune system. Thus, Pad enzymes are considered to play a key role in producing autoantigens, substances provoking the immune responses characteristic of autoimmune diseases.

Padlock’s technology is based on research on Pad enzymes at Scripps Research Institute by Kerri Mowen and Paul Thompson, now at University of Massachusetts Medical School. Mowen and Thompson are scientific founders of Padlock. The company was founded in January 2014 by Atlas Venture, with Mowen, Thompson, and CEO Michael Gilman, and incubated at Atlas Venture as part of its seed program.

The company plans to use the financing proceeds to further its understanding of Pad enzymes in autoimmune diseases. Padlock intends to discover therapies inhibiting activity of Pad enzymes implicated in rheumatoid arthritis, lupus, and multiple sclerosis, although the enzymes act differently in each of the three disorders. The founders believe the company’s approach, to inhibit production of autoantibodies, sets it apart from other therapies that suppress immune system activity.

Atlas Venture, also in Cambridge, is an early stage venture capital company specializing in life science and technology start-ups. Atlas produced 9 separate funds since its founding in 1980, backing some 350 enterprises in 16 countries.

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Simpler, Lens-Free Microscope Developed

Aydogan Ozcan (UCLA)

Aydogan Ozcan (UCLA)

18 December 2014. Engineers and medical researchers at University of California in Los Angeles designed a new type of microscope that combines holograms with computational techniques to generate images of pathology samples with quality comparable to lens-type microscopes. The team led by electrical and biomedical engineering professor Aydogan Ozcan published its findings yesterday in the journal Science Translational Medicine (paid subscription required).

Four of the paper’s authors, including Ozcan, filed a patent application for the technology. Ozcan also co-founded the company Holomic LLC to commercialize mobile lens-free holographic microscopes and other medical optic discoveries.

The UCLA team is seeking a simpler and less-expensive alternative to traditional lens-based microscopes, particularly for point-of-care diagnostics in low-resource regions. Not only are conventional microscopes expensive, they have a small field of view that requires recording multiple images from larger specimens, such as tissue samples. In addition, advances in optics, sensor chips, and computational techniques reduced many obstacles, including costs, of applying these technologies to microscopes.

Ozcan and colleagues use light-emitting diodes or lasers to illuminate the specimen on a slide. An array of sensors on a microchip, similar to the kind found in smartphones and digital cameras, then records the patterns of shadows from the slide. Those patterns are processed into a series of holograms, two-dimensional surfaces that display precise three-dimensional images with a field of view 100 times larger than conventional microscopes.

One of the continuing obstacles faced by developers, however, was the inability to generate clinical-quality images from holograms, for which the researchers devised algorithms to overcome. The computational techniques reconstruct recorded images that can be 3-D digitally focused to any depth within the field of view, without mechanical focus adjustments, and can correct for tilting or height variations in the specimen. The algorithms can also add or enhance coloring without manual adjustments.

The researchers tested the hologram-microscope with large area beast cancer tissue samples, Pap smears indicating cervical cancer, and sickle-cell blood samples that returned images with enough resolution and contrast for clinical evaluation. An independent review by a pathologist of 75 hologram- and lens-based microscope images of breast cancer tissue showed an accuracy of about 99 percent for the hologram device.

The authors note their hologram microscope may have a simpler low-cost design than conventional lens-based devices, but it still needs more refined and packaged software, including user-friendly controls, to make it operational for end-users. They point to a comparable early stage in the development of personal computers, however, foreshadowing wide-scale adoption of that technology.

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Janssen, Biotech Partner on Drug Delivery Technology



17 December 2014. Halozyme Therapeutics, a biotechnology company in San Diego, is licensing its drug delivery technology for under-the-skin injections to Janssen Biotech, one of the Janssen Pharmaceutical companies and a division of Johnson & Johnson. The deal is expected to bring Halozyme up to $581 million in initial and milestone payments.

Halozyme develops synthetic enzymes, proteins that affect the matrix or framework of cells. Its technology platform, called Enhanze, focuses on the enzyme hyaluronidase that acts by degrading hyaluronan, a naturally occurring gel-like substance in skin and cartilage, but also in tumor cells. When formulated for drug delivery, hyaluronidase can help biologics and drugs spread in the body, when injected under the skin.

The company says hyaluronidase can be programmed to operate under specified conditions, such as when patients show certain physical traits, or at times that minimizes side effects. The degradation of hyaluronan is temporary, says the company, which allows restoration of the degraded cell matrices.

Under the deal, Janssen, in Horsham, Pennsylvania, receives a worldwide license to design and commercialize up to 5 products, using Enhanze technology to combine hyaluronidase with compounds developed by Janssen. Halozyme receives $15 million upfront from Janssen, and is eligible for up to another $566 million on Janssen’s completion of development, regulatory, and sales milestones. In addition, Halozyme can receive royalties on sales of products using Enhanze technology.

Halozyme earlier established partnerships with pharmaceutical companies Hoffman-La Roche, Pfizer, and Baxter Healthcare applying Enhanze technology for delivery of biologics to treat cancer. The company’s product Hylenex is approved by the FDA for subcutaneous (under the skin) injections to improve absorption of radioactive compounds.

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Eye Tracking System Devised to Diagnose Brain Injuries

Uzma Samadani

Uzma Samadani (VA New York Harbor Healthcare System)

17 December 2014. Researchers at New York University Medical Center designed a technology that spots brain injuries in patients by tracking their eye movements while watching a few minutes of videos. The team led by neuroscience and physiology professor Uzma Samadani, with colleagues from other NYU departments and VA New York Harbor Healthcare System, published its proof-of-concept findings last week in Journal of Neurosurgery (paid subscription required).

Samadani — also Chief of Neurosurgery at VA New York Harbor Heathcare System — and colleagues were seeking faster and easier methods of diagnosing traumatic brain injuries, a continuing problem among returning Iraq and Afghanistan veterans, as well as the population in general. Centers for Disease Control and Prevention says in 2010 traumatic brain injuries led to 2.5 million hospitalizations and 50,000 deaths in the U.S. Some 4 in 10 cases are the result of falls, occurring more often in the oldest and youngest age categories. Unintentional blunt trauma, traffic accidents, and assaults each cause 10 to 15 percent of cases.

In the journal paper, the researchers recorded eye movements of 169 subjects with a commercial eye-tracking device while they watched a music video nearly 4 minutes in length. The subjects included 12 individuals with cranial nerve damage causing weakness in muscles controlling eye movement, alignment, and focus. The remaining 157 participants were neurologically healthy.

Cranial nerves emanate from the brainstem connecting the spinal cord to the brain, providing sensory and motor functions of vision and other senses. Among the causes of cranial nerve damage is head trauma.

People with functioning cranial nerves can move their eyes horizontally and vertically in about equal proportions, but when cranial nerves affecting vision are damaged, eyes cannot move in the direction of the damage. Eye-movement tests confirmed the hypothesis showing statistically reliable differences in movement patterns between people with damaged and healthy cranial nerves. The conditions of 9 patients with nerve damage were later treated with surgery, and in further tests showed normal eye movements.

“One of the reasons that clinical trials for treatment of brain injury have failed in the past,” says Samadani in an NYU statement, “is that brain injury is hard to classify and quantitate with existing technologies. This invention suggests a potential new method for classifying and quantitating the extent of injury.”

The test could be useful for diagnosing traumatic brain injuries caused by blasts or concussions, which can be difficult with standard imaging technologies. Other advantages of the technique are speed and ease of use. NYU says Samadani was able to assess 600 active military at Fort Campbell, Kentucky with the technology in the first week following their return from deployments in the Middle East.

Samadani and co-author Robert Ritlop founded the company Oculogica Inc. to commercialize the technology, with a device called Eyebox that they say can provide a faster, easier, more reliable, and less-invasive diagnosis for concussion and other traumatic brain injuries than imaging, blood and spinal fluid samples, physical exams, and congnitive tests. Oculogica won first prize in a technology venture competition at NYU in 2013 and received seed funding as well as more than $400,000 in grants.

Ritlop and Samadani tell more about the technology and company in the following video.

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Spin-Off Building Simplifed Signal Processing Connections

Peter Kinget

Peter Kinget (Columbia University)

16 December 2014. An engineering lab at Columbia University in New York is spinning off a new company aiming to design simpler connections between analog and digital signals as systems get smaller and performance becomes more demanding. Seamless Devices Inc., founded by electrical engineering professor Peter Kinget and former graduate student Jayanth Kuppambatti, began in business at the end of October 2014.

Kinget’s research group is part of Columbia’s Integrated Systems Laboratory that studies analog, radio-frequency, and power circuits for applications in communications, sensing, and power management. As digital devices get smaller and more ubiquitous, they’re called on to handle many more kinds of signals from a greater number and variety of sources in the analog or non-digital world. Kinget’s and Kuppambatti’s new company aims to make it easier for digital devices, including those microscopic in size and running on little power, to capture and integrate those analog signals.

Interconnections designed by Seamless Devices, say the founders, could be used in a range of industries such as consumer electronics, mobile communications, military, transportation, and health care, as well as linking previously unconnected appliances and systems in homes, cars, and businesses into what is called the Internet of things. In most of these applications, however, sensors and devices are capturing real-world analog information for processing on micro-and even nanoscale chips that still need to provide continuous high-quality performance, while drawing little power.

Research by Kinget and colleagues led to processing techniques for systems for translating signals between analog and digital modes, which became the intellectual property the company licensed from Columbia. One such patent, for an invention by Kinget, covers amplifier circuits running on less than 1 volt of power.

Seamless Devices plans to begin with solutions for the semiconductor industry, providing circuit designs for licensing into system-on-chip integrated circuits. Among the early planned applications are analog-to-digital converters for telecommunications that support high bandwidths and resolution, while still drawing little power.

The company operates in the San Francisco Bay area as a subsidiary of Allied Minds, a technology commercialization company that provides early-stage funding and management to help start-up enterprises based on discoveries in university labs. Allied Minds focuses on technologies with a defineable product or service addressing unmet needs, protected by intellectual property, and with potential to reach the market in 2 to 5 years.

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Pfizer, Opko Partner on Growth Hormone Drug

Human growth hormone, molecular graphic

Human growth hormone, molecular graphic (National Center for Biotechnology Information)

16 December 2014. The pharmaceutical company Pfizer is licensing an engineered compound to treat human growth hormone deficiency in adults and children from Opko Health Inc., a provider of therapeutics and diagnostics. The deal has a potential value to Opko of $570 million, plus royalties from sales.

Opko Health, based in Miami, offers drugs and diagnostic tests, that it commercializes from investments in and acquisition of intellectual property developed by other enterprises. In April 2013, Opko acquired the Israeli biotechnology company Prolor that designed a synthetic human growth hormone analog code-named hGH-CTP for both adults and children with growth hormone deficiencies.

Prolor’s CTP platform, based on research at Washington University in St. Louis, binds the natural peptide C-terminal peptide or CTP to therapeutic proteins and extends their activity time in the body. Clinical trials of hGH-CTP show it can reduce the dosing frequency for human growth hormone from the standard daily injections to one injection per week. The compound received orphan drug status in Europe and the U.S., and is currently in a late-stage clinical trial for adults and intermediate-stage trial with children.

Under the deal Pfizer gains an exclusive worldwide license to hGH-CTP. Opko will continue clinical development of hGH-CTP for growth hormone deficiencies in adults and children, as well as for growth failures in children born small for gestational age. Pfizer will be responsible for further applications of hGH-CTP, as well as all commercialization and manufacturing of the drug.

The agreement provides Opko with an initial payment from Pfizer of $295 million and up to another $275 million in regulatory milestone payments. Opko will also be eligible for royalties on sales of adult growth hormone products developed in the collaboration. Once a pediatric growth hormone product receives approval, royalties will shift to gross profit sharing on both hGH-CTP propducts and Genotropin, a drug currently offered by Pfizer for pediatric growth hormone deficiency.

In a company statement, Phillip Frost, Opko’s CEO, estimates the global human growth hormone market at $3 billion.

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Hat tip: FirstWord Pharma

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University Prof to Commercialize 3-D Printed Cell Platforms

Mark DeCoster

Mark DeCoster (Louisiana Tech University)

15 December 2014. A biomedical engineer at Louisiana Tech University in Ruston plans to develop a commercial platform for three-dimensional printing of artificial cells in research, education, and industrial applications. Mark DeCoster, an engineering faculty member at Louisiana Tech, received a $50,000 National Science Foundation I-Corps grant to further develop the idea into a marketable product.

DeCoster, with graduate student Kahla St. Marthe and Shafin Khan of the New Orleans Bioinnovation Center, will design and develop the 3-D cell printing concept, while starting up a new enterprise to take the concept to market. The idea is an outgrowth of research in DeCoster’s cellular neuroscience lab that studies communication among brain cells, as well as changes in cellular processes. Differences in cells and cellular activity, and their impact on brain networks, according to DeCoster, can also be modeled with software, and thus could test various conditions affecting brain cells using those computer models.

“It occurred to me,” says DeCoster in a university statement, “that we could develop artificial cells that could reflect how cells change with time and if we could make these of interest to researchers and to teachers, we could make products that could benefit students as well as basic and applied research such as at universities and in industry.” He adds that the lab is already using 3-D printers, which could 3-D print the artificial cells.

DeCoster and colleagues plan to apply 3-D printing to create artificial cells with standard plastics at first, to visualize and test dynamic models of cells in water-based environments. The printing technology would be combined with educational and visualization software aimed at maximizing the learning experience. Their goal would be to provide a learning experience that captures the complexity and dynamic nature of cellular processes, while making it possible for students to conduct experiments and test their own ideas.

While the Louisiana Tech team would start with standard 3-D printing plastics, they forsee adding dyes and chemicals that may better illustrate the variables being tested. Later, capabilities such as fluorescence and microscopic-scale measurements could be added, eventually leading to libraries of artificial cells and components for research and education.

I-Corps, short for Innovation Corps, is a National Science Foundation program that helps academic scientsts extend their research into the commercial world, including development of technologies with short-term benefits for the economy or society.  Academic researchers, with student entrepreneurs and business mentors, form teams that receive training and guidance to move their products or services into the marketplace. Since June, both National Institutes of Health and Department of Energy started I-Corps programs to commercialize biotechnology and energy innovations by their academic grant recipients.

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Nanomedicine Developer Secures $7.5M Venture Funds

Euro Notes and Coins (U.S. Mint)

(U.S. Mint)

15 December 2014. Cristal Therapeutics, a developer of medications formulated as nanoscale particles, raised more than €6 million ($7.5 million) in early-stage venture funds. The financing round for the company, based in Maastricht, The Netherlands, was led by Chemelot Ventures, with current seed investors Thuja Capital, BioGeneration Ventures, Nedermaas, Utrecht University Holding, and Beheer Innovatiefonds Provincie Limburg.

Cristal Therapeutics designs drugs delivered in nanoscale polymer particles — 1 nanometer equals 1 billionth of a meter — with its own process developed at University of Utrecht, also in The Netherlands, based on research by company co-founder Cristianne Rijcken. That process, known as CriPec, encloses a drug’s nanoparticles in an inert polymer shield, which when combined with various types of linking materials, make it possible to release the drug at a predetermined rate.

The company says CriPec also allows drugs to be targeted to more precisely, thus concentrating its effects and limiting adverse effects. The polymers in the nanoparticles naturally degrade and are cleared by the kidneys.

The company’s lead product is CriPec docetaxel, a nanoparticle formulation of a chemotherapy drug to treat solid tumors, such as those found in breast, lung, and prostate cancer. Docetaxel works by disrupting the internal structure of cancer cells as they rapidly divide and proliferate, leading to death of the cancer cells. CriPec docetaxel, says Cristal, makes it possible to concentrate higher doses of the drug at the cancer site, improving its effectiveness and tolerability.

Cristal says its preclinical tests of CriPec docetaxel with lab animals show the drug nanoparticles accumulate in higher concentrations and kill more cancer cells than conventional docetaxel. The company plans to use proceeds of the financing round to begin an early-stage clinical trial of CriPec docetaxel, testing its safety and clinical benefits with human subjects.

The company is also developing CriPec versions of peptides, short amino-acid chains, for delivery of biologics that would otherwise be too unstable when subject to the body’s metabolism. In addition, Cristal is testing what it calls active targeted nanoparticles that focus on connective molecules that bind to receptors and can enhance drugs designed to address specific tissues in the body. Still another program is testing a CriPec version of corticosteroids to treat inflammation, such as in arthritis. All of these subsequent products are in preclinical stages.

Chemelot Ventures, founded earlier this year and also located in Maastricht, is a venture capital company supporting life sciences start-ups, and new companies in advanced materials, located in The Netherlands. The company says it funds companies developing platform technologies as well as new products, in early and later stages of development.

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