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Stem Cells Launched on Current SpaceX Flight

SpaceX launch

Launch of the SpaceX Falcon rocket, 19 February 2017 (SpaceX)

20 February 2017. Yesterday’s SpaceX launch from NASA’s Kennedy Spaceflight Center includes a shipment of adult stem cells to test their growth and proliferation in weightless conditions. These stem cell experiments originated in the lab of physician-scientist Abba Zubair at the Mayo Clinic in Jacksonville, Florida.

Zubair and colleagues study stem cells for regenerative medicine, particularly as treatments for cancer, stroke, and other disorders. One obstacle to greater use of stem cells is the difficulty producing adequate numbers for treatments. Some therapies require as many as 200 million stem cells, which under current practices can take weeks to produce. Some simulations, however, suggest stem cells can reproduce quickly and reliably in microgravity, or weightless conditions, maybe even comparable to their environment as they develop in the body.

An early use of higher-speed stem cells could be treatments for stroke. “Stem cells are known to reduce inflammation,” says Zubair in a Mayo Clinic statement. “We’ve shown that an infusion of stem cells at the site of stroke improves the inflammation and also secretes factors for the regeneration of neurons and blood vessels.”

But the slow expansion of stem cells is holding back development of these treatments. “It’s further complicated, because some patients are unable to donate cells for themselves,” Zubair adds, “and, sometimes, there aren’t enough donors who are a good match, as sometimes occurs for minorities.”

Zubair’s lab provided stem cells derived from human bone marrow launched yesterday for experiments on board the International Space Station. Crew members on the space station will measure growth and proliferation of the cells, and record their characteristics while in microgravity, compared to a similar collection of cells that remains on earth. If the evidence supports the hypothesis that stem cells proliferate faster in microgravity, it could eventually lead to development of a commercial-scale bioreactor in space.

The experiments are also looking for qualitative changes in stem cells under microgravity, where crew members report on molecular alterations. “We’ll be looking to see if there are genes activated in microgravity and analyzing the stages of the cell cycle,” Zubair notes. “We may discover proteins or compounds that are produced that we can synthesize on Earth to encourage stem cell growth without having to go to microgravity.”

Space station crew members will also report on the feasibility of growing stem cells in microgravity. If the crew can readily conduct these initial tests, the prospects for expanded and eventually commercial stem cell production improve. Increasing numbers of missions and commercial-scale facilities in space could make stem cell production in microgravity cost effective.

Once experiments are completed, the stem cells will then be returned to Earth, where the Mayo Clinic team will evaluate the cells for functionality and safety as treatments. Zubair tells more about the project in the following video.

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Software to Simplify Big Data Curation

Computer vision

(Melmark, Pixabay)

17 February 2017. A software package in development aims to simplify the process of cleaning up large data sets, known as curation, to improve the quality of analysis from those data. The software, called Vizier, is being developed by a University at Buffalo computer science lab, funded by a three-year  $2.7 million award from National Science Foundation awarded in January 2017.

Vizier is a creation of Buffalo’s Online Data Interactions or ODin Lab in Amherst, New York, led by Oliver Kennedy, a computer science and engineering professor. Kennedy and ODin Lab colleagues study databases, with the goal of making self-service analytics possible for subject matter experts, who neither want nor need to also become experts at database planning and  design.

In this project, Kennedy and colleagues seek to make it easier for keepers of large data sets to prepare for the rigors of database analytics by first locating the messy errors that find their way into even the best kept data collections. This curation process is needed to organize the data, remove duplicates, and find missing and erroneous entries, as the data sets are refined and merged. While curation is needed to prevent crippling analytical errors later on, it’s also slow and costly.

In its proposal, the ODin Lab team gave as an example the mass of data generated by taxis in New York City. Meters in taxis capture data on some 500,000 trips, transporting 600,000 people each day. The meters collect GPS data on pick-up and drop-off locations, along with times, fares, and tip amounts, all accumulated by the city’s Taxi and Limousine Commission. The city government uses these data to better understand living and working patterns, with implications for transportation and housing policies. A quality review of the data set made by one of the co-investigators, however highlighted errors such as negative values for miles traveled and fares, GPS coordinates outside the U.S., and a tip valued at $938.02.

Vizier, says its developers, will make it possible to highlight those kinds of errors and improve data quality as part of a routine workflow, rather than as a separate laborious step in compiling a database. The software will offer an interface similar to familiar automated spreadsheets and notebooks, with built-in data cleaning steps for data curation. Vizier will also track step-by-step history of curation processes, providing an audit trail if previous steps in the curation need to be reversed. Capturing the history will also offer the ability to give recommendations for further curation steps based on the context of what came before.

“We are creating a tool,” says Kennedy in a university statement, “that’ll let you work with the data you have, and also unobtrusively make helpful observations like ‘Hmm… have you noticed that two out of a million records make a 10 percent difference in this average?”

Co-principal investigators for the Vizier project are Juliana Freire, professor of computer science and engineering at New York University, and Boris Glavic, assistant professor in the Department of Computer Science at the Illinois Institute of Technology. The team plans to release the software as a free, open-source package.

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Online Pharmacies Seen Fueling Antibiotic Overuse

Pills in blister packs

(Public Domain Pictures, Pixabay)

17 February 2017. A study of pharmacies selling drugs online shows many of these sites offer antibiotics to consumers in the U.K. without prescriptions, which would be illegal in retail drug stores. Researchers from Imperial College London published their findings in today’s issue of the Journal of Antimicrobial Chemotherapy.

Resistance to antibiotic drugs is a growing public health problem that results from microbes evolving to evade treatments from currently prescribed antibiotics. That evolution can occur naturally, but the routine use and over-reliance on antibiotics is speeding the process, with grave consequences for people suffering from infectious diseases. World Health Organization says diseases such as pneumonia, tuberculosis, and gonorrhea are now more difficult to treat as current antibiotics become less effective.

A team from the lab of senior author Alison Holmes, professor of infectious diseases at Imperial, examined the role of online-only pharmacies in the U.K. that provide antibiotics on demand. In the U.K., pharmacies are required by law to sell antibiotics to consumers only with a valid prescription. The availability of antibiotics in the U.K. from online-only vendors, however, is an open question, as well as any safeguards or guidance for patients they provide.

Project leader Sara Boyd, a clinical fellow in infectious diseases and microbiology at Imperial, and colleagues searched Google and Yahoo with the term “buy antibiotics online.” The team then collected distinct URLs for online pharmacies from the first 10 entries on the first returned page, which reflects common Internet search engine practice. From these searches, the researchers explored antibiotic sales practices of 20 online pharmacies serving consumers in the U.K., to the point of paying for their purchases.

Of the 20 pharmacies in the sample, 5 sites were physically located in the U.K., and registered with national authorities. Of the remaining 15 pharmacies, the locations of 10 sites were unclear, with the others located in India (3) or Cyprus (2). All pharmacies offered oral antibiotics, with one site selling antibiotics in intravenous form.

The results show many of the online pharmacies sampled ignore laws requiring prescriptions for antibiotics, with some sites providing little, if any guidance on their use or safety to consumers. Nearly half — 9 of 20 online pharmacies — provide antibiotics without a prescription. All 5 of the U.K.-based and registered sites are among those requiring a prescription. The 11 sites requiring a prescription allow for one or more of online, mail, or fax deliveries of the document.

The team rated the online pharmacies as either consumer- or prescriber-driven in their interactions with visitors. A consumer-driven site lets visitors choose the antibiotic, as well as the dosage and quantity. Prescriber-driven sites first require an online consultation describing the ailment that result in recommendations for purchase. Researchers found only 4 of the sites are prescriber-driven, while 16 sites or 80 percent of the pharmacies are consumer driven. All 4 of the prescriber-driven sites are located and registered in the U.K.

Many of the online pharmacies exhibit little concern for patient safety, say the authors. Some 14 out of 20 pharmacies, or 70%, offer no health questionnaire when buying antibiotics. In addition, 6 of the pharmacies provide no information before purchase on side effects or situations where the drugs should be avoided.

The researchers conclude these online sales practices can contribute to the growing problem of antibiotic resistance. “Improper use of antibiotics,” says Holmes in a university statement, “can mean that infections are not being treated appropriately, or that people are being unnecessarily exposed to antibiotics. This allows bacteria to become resistant to the drugs that once killed them. As a result, it is essential that antibiotics are prescribed only when they are needed.”

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Patent Office Decides for Broad and Editas in Crispr Case

Feng Zhang

Feng Zhang (Mass. Institute of Technology)

16 February 2017. The U.S. Patent and Trademark Office decided that the genome editing processes developed by Broad Institute and licensed to Editas Medicine do not interfere with techniques for genome editing created by University of California at Berkeley. The decision, handed down on 15 February, enables Editas Medicine, founded by geneticist Feng Zhang and colleagues from Broad Institute — a medical research center affiliated with Harvard University and MIT — to continue developing therapies based on its version of Crispr genome editing.

Crispr, short for clustered regularly interspaced short palindromic repeats, is based on bacterial defense mechanisms that use RNA to identify and monitor precise locations in DNA. The actual editing of genomes with Crispr uses an enzyme known as Crispr-associated protein 9 or Cas9. With this approach to Crispr, RNA molecules guide Cas9 proteins to specific genes needing repair, making it possible to address root causes of many diseases.

UC-Berkeley disputed Broad Institute’s patent awards for Crispr, claiming that the institute’s technology would not have advanced without taking advantage of UC-Berkeley’s discoveries, made by molecular biologists Jennifer Doudna and Emmanuelle Charpentier, now at Max Planck Institute for Infection Biology in Berlin. Thus claimed UC-Berkeley, Broad Institute and by implication its licensees, are interfering with UC-Berkeley’s patents and gaining rewards as a result.

Broad Institute, however, claimed Zhang’s and colleagues’ discoveries are sufficiently different from Doudna’s and Charpentier’s to be considered a separate technology. Broad pointed out that Zhang’s work with Crispr focuses on eukaryotes, plant and animal cells where genetic material is found in the nucleus. The UC-Berkeley research, in contrast, is conducted with prokaryotes, organisms without a cell nucleus, such as bacteria and other single-cell microorganisms. These differences, said Broad, call for different methods and techniques.

In its arguments, Broad Institute cited an interview published in 2012 where Doudna noted that “it is not known whether such a bacterial system would function in eukaryotic cells.” Another interview cited by Broad and published in 2013 quotes Doudna as saying, “the techniques for making these modifications in animals and humans have been a huge bottleneck in both research and the development of human therapeutics.”

The Patent Trials and Appeal Board or PTAB hearing the case found Broad Institute’s arguments more persuasive. The three administrative patent judges said in their decision

We agree that the statements by and attributed to the UC inventors do not demonstrate a reasonable expectation of success. Although the statements express an eagerness to learn the results of experiments in eukaryotic cells and the importance of such results, none of them express an expectation that such results would be successful.

Thus Broad’s technology would not have been an obvious derivative of UC-Berkeley’s discoveries.

The judges conclude as well that the technologies are sufficiently different that UC-Berkeley’s approach to Crispr-Cas9 does not interfere either with Broad Institute’s processes. “Because UC’s claims would not anticipate Broad’s claims either,” say the judges, “we conclude that the parties’ claims are not drawn to the same patentable subject matter and that there is no interference-in-fact between them.”

Because of this conclusion by the judges, UC-Berkeley plans to pursue a separate patent for Crispr-Cas9 covering all type of cells, not just eukaryotes. The university statement also notes that further legal steps are possible challenging the decision. “UC will carefully consider all options for possible next steps in this legal process,” says the statement, “including the possibility of an appeal of the PTAB’s decision.”

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Tissue Regeneration Start-Up Gains $33M in Early Funds

Finance, calculator

(stevepb, Pixabay)

15 February 2017. A new enterprise founded by researchers at Stanford University aims to discover and develop drugs that repair and regenerate tissue from stem cells. Surrozen Inc. in South San Francisco, California is starting out with $33 million raised in its first venture funding round.

Surrozen plans to create treatments for tissue repair and regeneration based on research by the founders on the Wnt signaling pathway,  a set of proteins with signaling molecules that regulate cell interactions during tissue development. Mutations in genes affecting this pathway are associated with interruptions in stem cell control that in some cases lead to birth defects and diseases including cancer. Wnt target genes are activated by Beta-Catenin signals that are shown to affect stem cells’ ability to regenerate into adult tissue cells.

In their natural state, Wnt proteins have not been shown effective as drugs, due in large part to problems with solubility. Surrozen founder Christopher Garcia, professor of molecular and cellular physiology and structural biology at Stanford’s medical school developed a technology for creating synthetic proteins that act as surrogates for Wnt pathway activators with drug-like properties. Surrozen is licensing that technology from Stanford as its primary platform.

“Wnt pathway activation has been a biochemical puzzle for decades,” says Garcia in a company statement. “Our technology opens the door to address fundamental biological and therapeutic questions in tissue repair for the first time.”

Claudia Janda, a research scientist and postdoctoral researcher in Garcia’s lab at Stanford, is also an inventor of Surrozen’s technology, and a co-founder of the company. Janda will be the company’s senior scientist.

Joining Garcia and Janda as Surrozen founders are Roeland Nusse and Calvin Kuo, from the Stanford medical school faculty. Nusse is a recognized pioneer on Wnt signaling, as well as chair of Stanford’s developmental biology department and director of the school’s cancer stem cell research program. Kuo is professor of chemical and systems biology, and leader of the cancer biology program at Stanford’s medical school.

Surrozen is raising $33 million in its first financing round, led by The Column Group, a venture capital company specializing in early-stage drug discovery companies. No other investors were revealed. Surrozen plans to apply the funds to implementing its drug discovery platform.

Tim Kutzkey, a managing partner at The Column Group is Surrozen’s acting CEO. Wen-Chen Yeh, the company’s chief scientist says, “There is perhaps no field within human biology that has more exciting and untapped potential than Wnt signaling. Surrozen’s foundational technology has the potential to generate a broad pipeline of Wnt pathway agonists that elicit tissue regeneration for a diverse array of conditions with great medical need.”

Joining Surrozen’s board is Harold Varmus, co-recipient of the 1989 Nobel Prize in Physiology or Medicine and discoverer of the first Wnt gene, with company co-founder Roeland Nusse, in 1982.

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Biotech Group Withholds Support for Germline Trial Report

Gene editing illustration

(NIH.gov)

15 February 2017. A biotechnology industry association in the U.S. says its members are not ready to support recommendations in a new report permitting future clinical studies of genome editing for inheritable disease-causing traits. James Greenwood, president of the Biotechnology Innovation Organization, or BIO, announced the group’s position after release of the report — Human Genome Editing: Science, Ethics, and Governance — by a committee of National Academy of Sciences and National Academy of Medicine on 14 February.

The report addresses quickly emerging technologies for removing or replacing disease-causing genetic variations passed on from parents to children in their DNA, known as germline or reproductive cell editing. Among the leading techniques is clustered, regularly interspaced short palindromic repeats or Crispr, a technology based on bacterial defense mechanisms that use RNA to identify and monitor precise locations in DNA. The actual editing of genomes with Crispr uses an enzyme known as Crispr-associated protein 9 or Cas9. With this approach to Crispr, RNA molecules guide Cas9 proteins to specific genes needing repair, making it possible to address root causes of many diseases.

Rapid advances in Crispr-Cas9 research led to an international summit in December 2015 on human gene editing and qualified support for clinical trials of genome editing for somatic, or non-inheritable conditions and basic research, but drawing the line at germline cell editing. The National Academies committee now is recommending clinical trials of germline cell editing with Crispr-Cas9, only for disease-causing conditions and under a set of specified conditions.

The committee’s report notes advances in the precision of Crispr-Cas9 genome editing as one of the reasons for revisiting the topic. As reported in Science & Enterprise, techniques devised in the lab of Broad Institute geneticist Feng Zhang reduced erroneous off-target edits that sometimes occur in Crispr-Cas9.

BIO’s president James Greenwood says current regulations already restrict germline cell editing, referring to legislation passed in 2015 that prevents Food and Drug Administration from reviewing “research in which a human embryo is intentionally created or modified to include a heritable genetic modification.” Greenwood continues that “BIO shares the view reached by other leaders in the scientific and regulatory community that clinical applications of genome editing in somatic cells can be appropriately evaluated within existing, well-established regulatory frameworks for gene therapy.”

And Greenwood adds, “Our members remain focused on clinical applications of genome editing in somatic cells (not inheritable cells).”

The National Academies committee made its recommendations in the event current regulatory restrictions are removed in the U.S. or elsewhere. In that case, clinical trials of genome editing to prevent inheritable disease traits could proceed, but only where no alternatives are available, genes are convincingly demonstrated to be causing the condition or a predisposition for it, credible preclinical or other clinical data on risks and benefits are available, ongoing and rigorous oversight is provided, long-term multi-generational follow-up is included, and health and societal benefits and risks are continually reassessed with ongoing public input.

The committee stopped this time at germline cell editing for enhancement of traits rather than disease prevention. “Human genome editing holds tremendous promise for understanding, treating, or preventing many devastating genetic diseases, and for improving treatment of many other illnesses,” notes Alta Charo, University of Wisconsin bioethics and law professor that chaired the committee. “However, genome editing to enhance traits or abilities beyond ordinary health raises concerns about whether the benefits can outweigh the risks, and about fairness if available only to some people.”

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Skin Health Data Collected by App Offered for Research

Mole Mapper app screens

Mole Mapper app screens (play.google.com)

14 February 2017. A smartphone app collecting images and data about moles on the skin of volunteers is now available to researchers for studies of cancer and other disorders. The Mole Mapper data set, collected by Sage Bionetworks in Seattle and Oregon Health and Science University in Portland, is described in a paper published today in the journal Scientific Data, and can be accessed by researchers from a portal at Synapse.org.

Mole Mapper was started by Dan Webster, a postdoctoral researcher at National Cancer Institute, part of National Institutes of Health in Bethesda, Maryland and the study’s lead author. The project, which continues to collect data, aims to show if crowd-sourced data from smartphones can reveal skin conditions for diagnostics and research. “In designing the study,” says Webster in a Sage Bionetworks statement, “we first wanted to know if research run remotely and entirely through an app could find the same melanoma risks as years of rigorous epidemiology and genetics research.”

Volunteers in the Mole Mapper project download an app written for both Apple and Android smartphones, which captures photos of moles growing on their skin. Participants provide the images and measurements of their moles over time that can indicate if the mole shows signs of becoming melanoma, an aggressive form of skin cancer. People with the app can also choose to share their non-identified data with medical researchers. One part of the app, was designed with Apple’s ResearchKit that provides modules for tracking activity, conducting surveys, and gaining user consent.

The current data set offers data from more than 2,000 participants providing 2,422 images, 3,274 mole measurements, and responses to 1,920 demographic surveys since October 2015. The data show the average mole size is nearly 4 millimeters, and individuals with red hair were more likely to be diagnosed with melanoma. Webster adds that, “This is in alignment with previously published data showing that people with red hair caused by mutations in the MC1R gene have a higher risk for melanoma.”

The accumulation of data from large numbers of participants offers opportunities for more intensive analysis by algorithms that process vast amounts of image and medical data with artificial intelligence making it possible for an automated diagnosis of melanoma. A paper published last month in the journal Nature shows the feasibility of this technique.

“They are close to having a computer with artificial intelligence that performs as well as board-certified dermatologists in its ability to discriminate melanomas from moles using digital images,” notes Sancy Leachman, professor and chair of dermatology at Oregon Health in a university statement. “If the technology lives up to its potential, users that need to be seen can get into their physician more quickly and those who have nothing of concern can avoid making an unnecessary trip to the doctor.” Leachman is one of the Scientific Data paper’s senior authors.

Sage Bionetworks says Mole Mapper is its second research project collecting data with smartphone apps designed with ResearchKit. The first initiative collects data on Parkinson’s disease, with the data set described in Scientific Data in March 2016.

Oregon Health tells more about the Mole Mapper app and study in the following video.

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Cancer Drug Shown to Improve Survival Time in Dogs

Antonella Borgatti

Antonella Borgatti with Copper, one of her patients (University of Minnesota)

14 February 2017. A drug to treat a deadly cancer in dogs was shown in a clinical trial to extend the survival time of canine patients by 6 months or more, with potential applications in humans. The team from University of Minnesota veterinary medical school published its findings in the 13 February issue of the journal Molecular Cancer Therapeutics.

A team led by veterinary cancer specialist Antonella Borgatti is seeking better treatments for canine hemangiosarcoma or HSA, an aggressive cancer of the blood vessels that spreads quickly in the body. Canine HSA appears on the skin and in the spleen, although other organs such as liver, lungs, and kidney may be affected. When HSA appears in the spleen, surgical removal of the organ is the usual treatment. But according to the National Canine Cancer Foundation, the prognosis for patients with HSA in the spleen is dire, with survival ranging from 19 to 86 days.

In the study, the researchers evaluated a drug known as eBAT developed by Minnesota pharmacology colleague and senior author Daniel Vallera. eBat is a combination of cancer-killing toxin derived from Pseudomonas bacteria, a microbe associated with infections contracted in health care facilities, and epidermal growth factor, a protein that regulates cell growth. The drug also adds in a protein derived from kidney cells that targets receptors for urokinase plasminogen activator proteins implicated in both tumor development and growth of blood vessels that support the tumors.

Like some cancer drugs for humans, treatments for canine cancers can also be difficult for patients. “eBAT was created to specifically target tumors while causing minimal damage to the immune system,” says Vallera in a university statement, adding  that “eBAT was selected for this trial because it can simultaneously target the tumor and its vascular system.”

The clinical trial tested eBAT in 23 dogs of large and small breeds with HSA in their spleens that already had surgery to remove the organ. Participants received 3 eBAT treatments, followed by conventional chemotherapy.  Of that group, the median survival time was 8.1 months. Some 70 percent of eBAT recipients survived for another 6 months, while in a comparison group of dogs with HSA, less than 40 percent survived for that period. In addition, 6 dogs receiving eBAT lived for another 450 days or more. The researchers report eBAT was safe and well tolerated by the patients.

“In this trial,” notes Borgatti, “we aimed for a sweet spot by identifying a dose of eBAT that was effective to treat the cancer, but caused no appreciable harm to the patient. Essentially we’re treating the cancer in a safer and more effective way, improving quality of life and providing a better chance at survival.”

The study findings have implications for treating human sarcomas, cancers of connective tissues, where in lab cultures, eBAT kills cancer cells expressing similar epidermal growth factor and urokinase plasminogen activator receptor targets. The researchers point out that eBAT aims particularly at those targets, with the cancer-killing toxins ignoring other cells without the biomarkers.

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Ford Investing $1B in Artificial Intelligence Start-Up

Argo AI and Ford executives

L-R: Peter Rander, Argo AI COO; Mark Fields, Ford president and CEO; Bryan Salesky, Argo AI CEO; and Raj Nair, Ford executive vice president, Product Development, and chief technical officer. (Ford Motor Co.)

13 February 2017. Ford Motor Company is investing $1 billion in a start-up enterprise that applies artificial intelligence to the operation and management of autonomous vehicles. The equity stake in Pittsburgh-based Argo AI is expected to help Ford complete the software platform for its autonomous vehicles planned for 2021.

Argo AI develops software that combines artificial intelligence, machine learning, and computer vision to support a vehicle that largely replaces the driver, and as the company says in a white paper, “is connected, intelligent, and able to safely operate itself alone or as part of a shared fleet.” Argo AI anticipates shared fleets of self-driving vehicles will be a transformative advancement in transportation, providing greater safety, reduced traffic congestion, and mobility for people who cannot or find it difficult to drive themselves.

Ford plans to merge Argo AI’s software into its virtual driver system to support Ford’s goal of producing by 2021 a vehicle that meets SAE International’s standards for Level 4 indicating “high automation.” This automation level assigns all driving activity to an automated system, even if a human driver does not respond appropriately to a request to intervene. SAE level 5, the top level, indicates “full automation,” which assigns full-time dynamic driving to the autonomous system, including all encounters with roadway and environmental conditions.

Ford plans to invest $1 billion over 5 years, giving the company a majority stake in Argo AI. Argo AI is still expected to operate independently, with its employees given “significant equity participation,” although further financial details were not disclosed. Argo AI plans to grow its payroll to 200 employees, based in Pittsburgh, as well as sites in Michigan and California’s Bay Area.

Argo AI was founded by Bryan Salesky, now the company’s CEO, and Peter Rander, Argo AI’s chief operating officer. Both Salesky and Rander are alumni of National Robotics Engineering Center at Carnegie Mellon University and former leaders of self-driving vehicle projects at Google and Uber, respectively.

“We are at an inflection point in using artificial intelligence in a wide range of applications,” says Salesky in a Ford statement,” and the successful deployment of self-driving cars will fundamentally change how people and goods move.”

Joining the initiative is Ford Smart Mobility LLC, a subsidiary for designing and developing mobility services. When begun in March 2016, Ford said this unit would lead the company’s drive to become a mobility as well as an auto company. Ford defines “mobility,” in this sense as using autonomous vehicles to move goods and people, such as ride sharing, ride hailing or package delivery fleets.

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Hat tip: Fortune/Term Sheet

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Biotechs License Solid Tumor Therapy in $2.1B Deal

Chemotherapy vials

(National Cancer Institute)

10 February 2017. Biotechnology enterprise Immunomedics Inc. is licensing its enhanced antibody-based treatment for solid tumor cancers to Seattle Genetics, a developer of similar cancer drugs. The agreement can earn Immunomedics, in Morris Plains, New Jersey, as much as $2 billion in initial and milestone payments over the deal’s lifetime, plus a $57 million equity investment by Seattle Genetics.

Both Immunomedics and Seattle Genetics produce antibody-drug conjugates, which join highly-targeted synthetic antibodies with other compounds or additives to combine the targeting of antibodies with cancer-killing power of the drugs being delivered. The therapy licensed in this case is sacituzumab govitecan, code-named IMMU-132 by Immunomedics. IMMU-132 targets Trop-2 proteins that overproduce on the surface of tumor cells in a number of solid-tumor cancers and help drive tumor growth.

Immunomedics’s technology combines synthetic antibodies with cancer-killing compounds that by themselves would not be given to patients due to their toxicity. In the case of IMMU-132, an antibody called hRS7 that targets Trop-2 proteins is teamed with SN-38, a metabolite of the drug irinotecan and approved by FDA as a chemotherapy. The company says SN-38’s toxicity prevents it from being given directly to cancer patients, but when combined with an antibody like hRS7, the drug is more targeted to the tumor and safer for the patient.

IMMU-132 is currently being tested in an early and intermediate-stage clinical trial in patients with 17 different solid tumor cancers. The Food and Drug Administration assigned breakthrough status to IMMU-132 as a treatment for advanced metastatic triple-negative breast cancer, where tumors test negative for estrogen and progesterone receptors, as well as HER2 proteins. FDA also granted its fast-track designation to IMMU-132 for triple-negative breast cancer, small-cell lung cancer, and non-small cell lung cancer. In addition, IMMU-32 received orphan drug status from FDA and European Medicines Agency for pancreatic cancer.

The agreement gives Seattle Genetics, in Bothell, Washington, an exclusive license to further develop, commercialize, and manufacture IMMU-132. Seattle Genetics will be responsible for a late-stage clinical trial of the therapy for metastatic triple-negative breast cancer, as well as submitting a biologics license application to FDA for accelerated review. The companies will form a joint steering committee, chaired by Seattle Genetics, to determine further development, commercialization, manufacturing, and intellectual property strategy for IMMU-132.

Seattle Genetics is paying Immunomedics an initial payment of $250 million, plus another $50 million for negotiated economic rights to IMMU-132 outside the U.S., Canada, and EU countries. Immunomedics will be eligible for $1.7 billion in payments for achieving designated development, clinical, regulatory, and sales milestones over the course of the agreement. Immunomedics will be eligible as well for future royalties on sales of products developed from the deal. Immunomedics also can co-promote IMMU-132 in the U.S., by taking on half of the product’s sales work.

In addition, Seattle Genetics is taking a 2.8 percent equity stake in Immunomedics, buying 3 million shares of its stock at $4.90, a 10 percent premium over Immunomedics’s average share price for the previous 15 days. The stock purchase plus additional warrants that could expand the Seattle Genetics stake to 9.9 percent are valued at $57 million.

The agreement gives Immunomedics until 19 February to negotiate a better deal with another company. Should better offers come along, Seattle Genetics has the right to match those offers, and if Immunomedics decides to join with a different company, Seattle Genetics will be due an unspecified termination fee.

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