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Sunday, December 16, 2018

LunaDNA Offers Stock for Data in Bid to Build Research Database


Henrietta Lacks’s “immortal cells” contributed enormously to the progression of scientific discovery, but Lacks, a poor, black woman who died from cervical cancer in 1951 months after her cells were harvested, never personally benefited from or consented to the medical research the HeLa cell line enabled.
Dawn Barry, a former executive at San Diego genome sequencing powerhouse Illumina (NASDAQ: ILMN) who co-founded LunaDNA last year, says her company is committed to compensating those who help it build a database of anonymized health and DNA information.
LunaDNA, which is based in San Diego’s Solana Beach community, plans to share its equity and anticipated profits with people who hand over their health and genomic data, and hopes the feel-good boost from potentially contributing to medical advances and a bit of pocket change will incentivize potential contributors.
The company expects to generate revenue from researchers paying to use its database of health information. LunaDNA is one of a number of companies that aim to build a database of health and genomic data that researchers will want to mine for insights. For Boston’s Nebula Genomics, users are incentivized in the form of “credits,” which the company says will be transferable for free services, such as genome sequencing.
Another San Diego company, Seqster, offers users a consumer-friendly interface that seamlessly integrates different types of health information—data from a wearable fitness tracker plus electronic medical records from a hospital visit, for example—to provide someone with an overall view of their health. Co-founder and CEO Ardy Arianpour has likened the platform to personal finance site Mint.com.
At first, LunaDNA said it planned to offer its own cryptocurrency in exchange for data donations. But with the regulatory uncertainty around digital currencies, the company instead turned to another novel idea: offering equity.
“It’s really important to us to have a model that’s well-established, that’s very transparent, [and] that’s in line with current regulations,” Barry said.
In a traditional stock offering, companies exchange shares for money. This week the SEC qualified LunaDNA’s offering of $50 million worth of its shares in exchange not for cash, but for data.
Los Angeles-based law firm Sheppard Mullin advised LunaPBC, the public benefit corporation that manages LunaDNA.
John Tishler, a partner in the corporate practice group in the firm’s San Diego office, led the effort to explain the unusual offering to the SEC. Tishler said the offering was unusual in a number of ways, and the resulting back-and-forth with the regulators expanded the typical timeline of preparing for such an equity sale.
Shareholders can request their data be removed from the database at any time. They can also share their data with as many data repositories as they’d like. The company, in turn, has the right to change the terms under which it accepted the data, as long as it gives appropriate notice. (If contributors don’t like the changes, they can’t vote against it—but they can remove their information.)
“I thought the idea was brilliant,” Tishler says.
SEC exemption Regulation A “does expressly allow for non-cash contributions or investments, but nobody had this type of thing in mind—I don’t believe—when it was invented,” he adds.
LunaDNA says it is the first such platform to offer stock in exchange for health and DNA data.
According to the offering, LunaDNA is selling more than 714 million shares at 7 cents apiece. A complete genome sequencing is valued at $21 (300 shares); 20 days of data from a nutrition tracker, 14 cents (two shares).
LunaDNA’s platform currently accepts the results of genomic tests such as those offered by 23andMe and Ancestry.com and its own health surveys, according to its website. It will eventually accept other data types, such as whole genome and exome DNA files, electronic health records, and information collected by wearable devices.
If LunaDNA makes money, shareholders could later get a cut of it via a dividend payment.
“The more people that come in, the more value is created, [and] when that value is created, it’s shared,” Barry said.
The shares are being offered through what’s often referred to as equity crowdfunding, a process by which a company sells equity without having to register with the SEC. The amount that can be raised that way is limited to $50 million, but it’s generally less expensive and time-consuming than an IPO, and therefore more appropriate for some small, private companies.
It’s also available to unaccredited investors, although there are still financial limits on who can participate. (Individuals are considered accredited if they have a net worth of $1 million, alone or jointly with a spouse, not including a primary residence, or an income of at least $200,000 (or $300,000, jointly with a spouse) for two years and the expectation it will be at least that much in the year of the investment.) Under equity crowdfunding regulations, individuals are limited to investing the greater of 10 percent of either their annual income or their net worth.
Of course, asking for data instead of cash means the company won’t be adding to its financial coffers—the usual reason to do an offering.
LunaPBC said in May that it had raised $4 million to date. Backers include Illumina’s corporate venture arm and Arch Venture Partners.
For LunaDNA and its competitors, the more data collected, the more valuable their databases could be.
“[Offering equity] fixes earlier issues of imbalance and value in research,” Barry said. “Now our go-forward is to acquire members, to invite people to make a statement that this is the right way to do research…and to create that scale and continuous nature of data so that we can usher in an era of next-generation research.”

Deadline approaching in Cigna/Tenet-Saint Francis contract dispute


The proverb that there are two sides to every story seems apt for the protracted contract negotiations between one of Memphis’ largest hospital systems and a national health insurer.
And, failing to find a resolution to that contract impasse could affect thousands of Memphians.
National health insurance company Cigna and one of the largest for-profit health systems, Tenet Healthcare, have failed to reach a contract agreement following 11 months of negotiations. The current contract expires Jan. 1, 2019. Tenet is the parent company of Memphis-based Saint Francis Healthcare.
Saint Francis’ health system includes the 479-bed Saint Francis Hospital-Memphis and the 196-bed Saint Francis Hospital-Bartlett, as well as various other health care entities locally. Combined, the two hospitals saw about 100,000 patients in their emergency rooms, had about 23,000 patient admissions, and had 164,000 outpatient visits in 2017. Cigna has about 3,000 Memphis-area physicians that participate in its health insurance plans, according to Memphis Business Journal research.
When asked for comment on contract negotiations, both Tenet and Cigna supplied statements.
Statement provided by a Tenet representative:
“Since February, we have been negotiating with Cigna to reach a resolution as we are committed to the Memphis community. We are negotiating in good faith and Cigna insists on misrepresenting the facts and taking steps backwards, demanding excessive, unreasonable rate cuts that will result in the wrong outcome for our patients, employees, and the communities we serve. In Memphis, Tenet employs over 2,700 men and women in the community, and we have been providing compassionate care for nearly 45 years. If Cigna kicks us out of network, in order to increase their profit, patients who want to use their Cigna benefits will be left with no choice but a single health system for their care. We urge Cigna to come to the table committed to a reasonable and fair solution so that our Memphis community can have uninterrupted access to Saint Francis Hospital and the high-quality care they know and trust.”
Statement provided by a Cigna representative:
“We continue to negotiate in good faith with Tenet and hope to reach an agreement that will provide our Memphis commercial customers and local employers with access to affordable, quality health care in the metropolitan area. Unfortunately, Tenet is demanding that we sign a national contract before they will negotiate locally. We are offering reimbursement rates that are competitive in the community, support local providers, and protect our clients and customers – the vast majority of whom are self-insured and are therefore paying health care costs directly.”
Beyond the contract negotiations behind closed doors, Cigna and Tenet have taken to public forums to express their respective sides of the stalemate. Cigna created a website, saveourhealthcare.com, specifically to address the standoff with Tenet. Saint Francis Healthcare’s CEO, Audrey Gregory, wrote a letter to the editor that published Dec. 5 in The Commercial Appeal, and the company has taken out advertisements in local media, including in the Memphis Business Journal.
In July 2013, Cigna and Tenet were locked in a prior contract dispute, with Cigna notifying customers served by Saint Francis’ two Memphis-area hospitals that those facilities would no longer be in the carrier’s network after Sept. 5, 2013. In August of that year, Cigna and Tenet reached a contract extension, about two weeks before Saint Francis was to be dropped from coverage.
Then, in May 2014, Cigna and Saint Francis Healthcare signed a multi-year contract extension, keeping all of Saint Francis’ health system entities in-network.
At the time of the 2014 multi-year deal, the former CEO of Saint Francis, David Archer, said, “Cigna is one of our largest and most important payer relationships. This agreement provides multi-year coverage stability for their customers.”

Innovent, Incyte in Licensing Deal for 3 Product Candidates in China


Innovent Biologics, Inc. (Innovent) (HKEX: 01801) and Incyte (NASDAQ:INCY) today announced that the companies, through their respective subsidiaries, have entered into a strategic collaboration agreement for three clinical-stage product candidates discovered and developed by Incyte—pemigatinib (FGFR1/2/3 inhibitor), itacitinib (JAK1 inhibitor) and parsaclisib (PI3Kδ inhibitor). Under the terms of the agreement, Innovent will pay Incyte US$40 million in cash up front, and Incyte shall be eligible to receive an additional US$20 million in consideration in connection with the first investigational new drug (IND) application by Innovent in China, which is expected to be achieved in 2019. Innovent will receive the rights to develop and commercialize the three assets in hematology and oncology in Mainland China, Hong KongMacau and Taiwan.
“The collaboration and partnership with Innovent provides us with an important and strategic opportunity to further serve the oncology community around the world by potentially bringing new, innovative medicines to patients with high unmet medical needs in China,” said Hervé Hoppenot, Chief Executive Officer of Incyte. “We believe Innovent’s experienced leadership team and sizeable clinical network will expand our clinical trials for itacitinib, pemigatinib and parsaclisib, and, if any of these product candidates are approved, will provide access to our innovative therapies to patients and healthcare providers in China.”
“We’re very pleased to enter into this collaboration with Incyte, a well-recognized innovative global biopharmaceutical company. This collaboration not only strengthens our portfolio by adding three potentially best-in-class clinical-stage targeted therapies, but, we believe, also proves that Innovent is an ideal partner for world-class pharmaceutical companies coming to China—transforming Innovent from a company primarily focused on monoclonal antibodies to one with a broader oncology focus that develops potentially innovative treatments regardless of molecule size,” said Michael DC Yu., Ph.D., Chief Executive Officer and President of Innovent. “Based on the compelling clinical data reported to-date, we believe pemigatinib, itacitinib and parsaclisib may be poised, if further development is successful and approvals in China are granted, to dramatically alter the treatment landscape for patients in China with FGFR-altered cholangiocarcinoma and urothelial carcinoma, graft-versus-host-disease after bone marrow transplant and non-Hodgkin lymphoma, respectively, and other cancers. These three novel medicines from Incyte complement our rich pipeline of immune-oncology-focused monoclonal antibodies and also enable the exploration of combination treatment approaches with the potential to further improve patient outcomes worldwide.”
Per the terms of the collaboration agreement, Innovent will pay Incyte US$40 million in cash up front and Incyte will be eligible to receive an additional US$20 million in consideration in connection with the first IND filing in China, which is expected to be achieved in 2019. Innovent will receive rights to develop and commercialize three product candidates (pemigatinib, itacitinib and parsaclisib) in hematology and oncology in the Innovent territory of Mainland China, Hong KongMacau and Taiwan. In addition, Incyte will be eligible to receive up to US$129 million in potential development and regulatory milestones, and up to US$202.5 million in potential commercial milestones. Incyte will also be eligible to receive tiered royalties from the high teens to the low twenties on future sales of products resulting from the collaboration. Incyte retains an option to assist in the promotion of the three product candidates in China.
The transaction is effective immediately upon the execution of the strategic collaboration agreement. Further financial details were not disclosed.

Annual Changes to the NASDAQ Biotechnology Index


Nasdaq (Nasdaq:NDAQ) today announced the results of the annual re-ranking of the NASDAQ Biotechnology Index (Nasdaq:NBI), which will become effective prior to market open on Monday, December 24, 2018.
The following 60 securities will be added to the Index:
EXCHANGESYMBOLCOMPANY NAME
NasdaqACIUAc Immune SA
NasdaqACRXAcelRx Pharmaceuticals, Inc.
NasdaqADVMAdverum Biotechnologies
NasdaqAGLEAeglea BioTherapeutics, Inc.
NasdaqAKRXAkorn Inc.
NasdaqALLKAllakos Inc.
NasdaqAMRSAmyris Inc.
NasdaqAPLSApellis Pharma Inc.
NasdaqAPTXAptinyx Inc.
NasdaqAQSTAquestive Therapeutics
NasdaqARGXArgenx Se Ads
NasdaqARQLArQule Inc.
NasdaqAUTLAutolus Therapeutics Ltd.
NasdaqAVROAVROBIO Inc.
NasdaqCBAYCymaBay Therapeutics
NasdaqCRNXCrinetics Pharmaceuticals
NasdaqDCPHDeciphera Pharmaceuticals
NasdaqDNLIDenali Therapeutics Inc.
NasdaqDRNADicerna Pharmaceuticals Inc.
NasdaqEIDXEidos Therapeutics Inc.
NasdaqEIGREiger BioPharma
NasdaqELOXEloxx Pharman
NasdaqEOLSEvolus Inc.
NasdaqEYPTEyePoint Pharma Inc.
NasdaqFATEFate Therapeutics Inc.
NasdaqFIXXHomology Medicines Inc.
NasdaqFTSVForty Seven Inc.
NasdaqHCMHutchison China MediTech
NasdaqKNSAKiniksa Pharma Ltd.
NasdaqMGTAMagenta Therapeutics
NasdaqMNOVMedicinova Inc.
NasdaqMRTXMirati Therapeutics Inc.
NasdaqOCULOcular Therapeutix Inc.
NasdaqOPTNOptiNose Inc.
NasdaqPRQRProQR Therapeutics N.V.
NasdaqPTIProteostasis Therapeutic
NasdaqQTRXQuanterix Corporation
NasdaqRCKTRocket Pharmaceuticals
NasdaqREPLReplimune Group Inc.
NasdaqRUBYRubius Therapeutics
NasdaqRYTMRhythm Pharmaceuticals
NasdaqSIGASIGA Technologies Inc.
NasdaqSLDBSolid Biosciences Inc.
NasdaqSTIMNeuronetics, Inc.
NasdaqSURFSurface Oncology Inc.
NasdaqSYBXSynlogic Inc.
NasdaqSYRSSyros Pharmaceuticals
NasdaqTBIOTranslate Bio Inc.
NasdaqTCDATricida Inc.
NasdaqTORCresTORbio Inc.
NasdaqUBXUnity Biotechnology
NasdaqUMRXUnum Therapeutics Inc.
NasdaqURGNUroGen Pharma Ltd.
NasdaqVSTMVerastem Inc.
NasdaqWVEWave Life Sciences
NasdaqXENEXenon Pharmaceuticals
NasdaqXERSXeris Pharmaceuticals
NasdaqXONIntrexon Corporation
NasdaqZFGNZafgen Inc.
NasdaqZLABZai Lab Ltd.
The Index is designed to track the performance of a set of securities listed on The Nasdaq Stock Market® (NASDAQ®) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark (ICB).
As a result of the re-ranking, the following 26 securities will be removed from the Index:
EXCHANGESYMBOLCOMPANY NAME
NasdaqAKAOAchaogen Inc.
NasdaqARDXArdelyx Inc.
NasdaqAVDLAvadel Pharmaceuticals PLC
NasdaqBLCMBellicum Pharmaceuticals
NasdaqCALACalithera Biosciences
NasdaqCLDXCelldex Therapeutics, Inc.
NasdaqCLXTCalyxt, Inc.
NasdaqCMRXChimerix, Inc.
NasdaqCRISCuris Inc.
NasdaqCRVSCorvus Pharma
NasdaqJNCEJounce Therapeutics, Inc.
NasdaqMRNSMarinus Pharmaceuticals
NasdaqMRSNMersana Therapeutics
NasdaqNBRVNabriva Therapeutics PLC
NasdaqNEOSNeos Therapeutics Inc.
NasdaqNHNantHealth Inc.
NasdaqNKNantKwest Inc.
NasdaqNLNKNewLink Genetics Corporation
NasdaqRGENRepligen Corporation
NasdaqSGYPSynergy Pharmaceuticals Inc.
NasdaqSHPGShire PLC
NasdaqSNDXSyndax Pharmaceuticals
NasdaqSNNASienna Biopharmaceuticals
NasdaqTLGTTeligent Inc.
NasdaqTTPHTetraphase Pharmaceuticals Inc.
NasdaqVTLVital Therapies Inc.

Infections and cancer: The link could be stronger than we think


Bacteria could have a bigger involvement in cancer than scientists may have realized, according to recent research.
A study from the University of Maryland School of Medicine in Baltimore has uncovered a type of bacterial infection that can disrupt DNA repair in cells, which is a known cause of cancer.
The same type of infection could also weaken the effect of some anticancer drugs, says the PNAS report on the findings.
“Currently,” comments senior study author Robert C. Gallo, who is a professor of medicine and director of the university’s Institute of Human Virology, “approximately 20 percent of cancers are thought to be caused by infection, most are known to be due to viruses.”
The team began by investigating infections by a family of tiny bacteria that go by the name of mycoplasmas.
These bacteria “are associated with cancers, especially in people with HIV,” explains Prof. Gallo, who was one of the scientists who discovered that HIV is the virus that causes AIDS.

Mycoplasmas, DnaK, and cancer

Mycoplasmas are among the smallest “free-living microorganisms.” They do not have a cell wall and, for a long time, scientists thought that they were viruses.
The tiny bacteria contain a protein called DnaK that the researchers decided to focus on “because of its ability to interact with proteins.”
DnaK is a “chaperone protein” that protects other proteins from damage and ensures that they function properly by helping them to fold.
The team’s efforts uncovered two main links between DnaK and cancer.
They revealed that DnaK from mycoplasmas “interacts with and reduces the activities of human proteins” that are important for DNA repair.
Also, it appears that DnaK weakens the effect of certain drugs that aim to boost the activity of the natural anticancer protein p53.
DnaK reduces p53 by binding to an enzyme called USP10 that helps to regulate p53.

In their investigations, the researchers observed how quickly lymphoma developed in two groups of mice with compromised immune systems.
They infected one group of mice with a mycoplasma strain from a person with HIV.
The results showed that lymphoma developed more quickly in the mycoplasma-infected immune-compromised mice than their non-infected counterparts.
In addition, some of the cancer cells, but not all of them, contained DNA from the bacteria.
The researchers suggest that this means that the infection does not have to persist to be able to trigger cancer.
It seems that mycoplasma release DnaK and that this can enter uninfected cells that are nearby and trigger events that can lead to cancer in those cells.

Infection-cancer link may need a rethink

Finally, an analysis of amino acid composition revealed differences between DnaK proteins from cancer-associated bacteria and bacteria that researchers have not associated with cancer.
This could mean that there are other bacteria with a similar ability to promote cancer.
Prof. Gallo suggests that their research “changes how we need to think about infection and at least some cancers.”

Garmin to develop wearables for clinical trials with ActiGraph


Tech-giant Garmin is stepping into the medical wearables space through a new collaboration with ActiGraph.
The partnership will explore health and activity monitoring innovations combining Garmin wearables with ActiGraph‘s CentrePoint data analytics platform for academic research, clinical trials, and remote patient monitoring.
The collaboration will help Garmin compete against rivals such as Apple and FitBit whose wearable devices have an increasing medical focus with tech like ECG readers.
ActiGraph provides wearable accelerometry monitors and a software technology platform for data monitoring, analysis, and managementActiGraph monitors are the most widely used and extensively validated devices of their kind, with clients at more than 1,500 pharmaceutical, academic, and scientific institutions in over 85 countries.
“ActiGraph is excited to work with an innovative company like Garmin,” said Jeremy Wyatt, ActiGraph’s chief technology officer and senior vice president of product development. “Garmin wearables produce high-resolution, accurate data streams that are ideal for scientific analysis and can provide additional, novel endpoints to the ActiGraph software platform. What’s more, the long battery life and ergonomic design of Garmin’s wearables means study participants can comfortably wear the devices for extended periods, leading to improved program adherence and study results.”
“Combining the sensor data from Garmin wearables with the data capture and analytical expertise of the ActiGraph platform creates a powerful solution for many different patient monitoring applications,” added Travis Johnson, Garmin Health global product lead.
In a statement Garmin added that it is committed to the development of wearables that can lead to the detection of serious health conditions and play an important role in the development of both traditional and digital therapeutics.
Healthcare systems and governments are increasingly warming to the idea of using wearables in care and clinical trials – in the UK, NICE this week unveiled new standardsfor digital tech that could help speed uptake of wearable devices on the NHS, while in the US health data firm Litmus Health has recently been awarded a contract with the National Cancer Institute to study the use of wearables in cancer R&D.

Biotech week ahead, Dec. 17


Biotech stocks staged a modest comeback this week ending along with the broader market. The week saw a spate of clinical trial results releases, sending stocks moving in either direction. The tally of new molecular entity approvals stands steady at last week’s level of 55.
Here’s what biotech investors will be focusing on in the coming week.

Conferences

  • 3rd World Liver Congress: Dec. 17-18, in Abu Dhabi, UAE.
  • World Congress on Polycystic Ovarian Syndrome and Fertility: Dec. 17-18 in Abu Dhabi.
  • 8th World Conference on Women’s Health and Breast Cancer: Dec. 17-18 in Abu Dhabi.

PDUFA Dates

ADMA Biologics Inc ADMA 6.21% awaits approval for its Prior Approval Supplement (PAS) filing for Bivigam, which is an intravenous immune globulin indicated for the treatment of primary humoral immunodeficiency.
The FDA granted approval to Bivigam to Biotest Pharma in December 2012, but production was halted in December 2016. Subsequently in June 2017, ADMA obtained ownership and all rights, title and interest in Bivigam through its Biotest Therapy Business unit asset acquisition.
ADMA then optimized the production process and submitted the PAS to amend the BLA for Bivigam in June and the PDUFA date was initially set at Oct. 25. This was extended by two months, as the FDA deemed the company’s response to its information request a major amendment. The decision date is Tuesday, Dec. 18.
The FDA is set to rule Thursday, Dec. 20, on Jazz Pharmaceuticals PLC JAZZ 1.17%‘s NDA for JZP-110, chemically solriamfetol, which is being evaluated for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea. The company’s shares have come significantly off their year’s high of $184, trending around $140.

Clinical Trial Results

Achillion Pharmaceuticals, Inc. ACHN 1.3% is scheduled to present interim Phase 2 data for its lead candidate ACH-447, which is being evaluated for two indications, namely C3 glomerulopathy, or C3G, and paroxysmal nocturnal hemoglobinuria, or PNH. C3G leads to decline in kidney function over time, while PNH is a rare acquired blood disorder resulting in lethal hemolysis. The company will also release interim Phase 1 data from separate trials evaluating its next-gen oral factor D inhibitors ACH-5228 and ACH-5548.
Apellis Pharmaceuticals Inc APLS 0.05% is scheduled to announce an update on APL-2 in the first half of December. APL-2 is being evaluated for geographic atrophy associated with age-related macular degeneration.

IPO Quiet Period Expiry

Taiwan Liposome Company, Ltd. TLC