Tim Blauwkamp, CSO
Closely-held Karius has developed and commercialized a next-generation sequencing test that can identify and quantify microbial cell-free DNA from more than 1,300 bacteria, viruses, fungi and parasites using a non-invasive blood sample.
“Pathogens leave traces of genomic DNA in the bloodstream and by sequencing these traces, we can identify a broad list of pathogens and help physicians treat acute infections through a single test,” Tim Blauwkamp, CSO, says in an interview with BioTuesdays.
While the concentration of cell-free DNA varies with pathogen-load over time, “we have designed controls that allow us to make very accurate measurements of an infection load,” he contends. “In many cases, a quantitative measurement of a relative infection level is an important guide to therapy.”
The Karius Test can detect more than 750 types of bacteria, including those that cause pneumonia and tuberculosis; more than 100 types of DNA viruses such as herpes, adenovirus and human bocavirus; and more than 350 molds, fungi and other eukaryotic parasites, including candida and penicillium species.
“To date, we’ve been able to identify pathogens in hundreds of cases where the pathogen was fastidious or unculturable,” he says. “In many cases, we’ve sequenced and identified pathogens that physicians had no idea were causing the infection.”
Dr. Blauwkamp explains that the process for a Karius Test begins with a physician collecting a five-milliliter blood draw from a patient suspected of having an infectious disease. Ideally, the blood sample is collected in a plasma preparation tube, which can be spun on site before being sent to the Karius lab at Redwood City, Calif.
Karius Test Process
The company processes the specimen with fully automated equipment that isolates the cell-free nucleic acids from the plasma and removes unnecessary human DNA using Karius’ proprietary processes. The specimen is then sequenced and the data are analyzed using the company’s bioinformatics pipeline.
Karius then compares the data from each specimen to a library of controls so that only those microbes from a patient’s specimen are identified on a final report. The final report identifies those pathogens that are contributing greater than expected levels of cell-free nucleic acids in the blood, along with the number of cell-free nucleic acid molecules per microliter of plasma for the specific pathogen identified.
Dr. Blauwkamp says the Karius Test has a list price of $2,000. The test is mostly given to acutely ill patients in hospitals and is covered under diagnosis-related group codes that hospitals bill Medicare for cost effective patient treatment.
The College of American Pathologists and California’s clinical laboratory improvements amendments (CLIA) regulate the Karius Test. “We obtained our license at the end of 2016 and since then, we’ve upgraded the biology and informatics portions, and launched a quantitative version of the test in May 2018,” Dr. Blauwkamp says. The company’s Redwood City plant can run hundreds of tests at one time and “we have plenty of space to build out additional capacity.”
Infectious diseases represent the second leading cause of death worldwide after cardiovascular diseases. Some 1,500 people die every hour around the world from infectious disease. “In many cases, those deaths are caused by a lack of effective diagnostics and that’s the gap we’re trying to fill,” he adds.
In October 2018, Karius made its first international foray, inking a deal with Dasa, the largest medical diagnostic company in Latin America, to make its test available to hospitals in Brazil to better diagnose infections and use targeted treatments quicker. Brazilian samples are processed at Karius’ Redwood City lab, with results typically available the day after the sample is received.
Dr. Blauwkamp points out that conventional diagnostic methods have their limitations.
Blood culture has a low sensitivity and is unable to grow some pathogens, but is widely used because it is inexpensive. And if a patient is pretreated with antibiotics to stabilize an infection, as in sepsis, the antibiotics can interfere with results from a blood culture. “Cell-free DNA sequencing enables us to get to that species resolution, even if the pathogen is not growing in a blood culture,” he adds.
Dr. Blauwkamp says that in many cases with existing technologies, deep infections require invasive organ biopsies to identify the pathogen causing the infection. By sequencing the genomic DNA fragments left in the blood by deep-seated infections, diagnostic biopsies can often be avoided.
Dr. Blauwkamp cites the case of a five-year-old with leukemia admitted to hospital with fever and neutropenia. Blood cultures were positive for Kiebsiella pneumoniae and treatment with cefepime cleared the fever. However, the fever returned and a battery of blood and fungal blood cultures and PCR tests were negative.
The Karius Test, however, detected Rhizopus oryzae, a mold that causes invasive disease in immuno-compromised patients. The patient received targeted therapy and recovered. “This case demonstrates the utility of a non-invasive, accurate, and rapid infectious disease test,” he says.
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Stanley Erck, President and CEO
Novavax (NASDAQ:NVAX) is scheduled to report pivotal data in the current quarter for ResVax, its RSV (respiratory syncytial virus) F vaccine, using aluminum phosphate as an adjuvant, in infants via maternal immunization.
“We are the only company with an RSV vaccine in a pivotal clinical trial,” Stanley Erck, president and CEO, says in an interview with BioTuesdays.
“There has been 60 years of unsuccessful research to develop an RSV vaccine, where maternal immunization offers the best method of protecting infants through the first months of life.”
Earlier this month, Novavax reported positive Phase 2 results for NanoFlu in older adults. The trial compared safety and immune responses of various quadrivalent formulations of NanoFlu, with or without its Matrix-M adjuvant, with two U.S.-licensed influenza vaccines in 1,375 healthy adults 65 years of age and older.
“The Phase 2 clinical trial results with NanoFlu demonstrate the potential impact our vaccine can make in preventing serious disease caused by influenza in older adults, a high-risk population that has proven difficult to protect in recent years,” Mr. Erck contends.
“Our goal remains to advance to the market an improved vaccine that addresses the serious global public health threat that exists for older adults, and ultimately to make NanoFlu available to all populations,” he adds.
Novavax plans to discuss the NanoFlu data with the FDA during the first half of 2019, with hopes of starting a pivotal trial later this year. The FDA previously agreed that NanoFlu could be eligible for an accelerated approval pathway.
Mr. Erck explains that unlike traditional egg-based production of vaccines, Novavax’s recombinant nanoparticle vaccines and adjuvants target antigens with epitopes essential for viral function.
“Unlike traditional vaccines that mimic viruses and elicit naturally occurring immune responses, our nanoparticles are engineered to elicit differentiated immune responses, which may be more efficacious than naturally-occurring immunity,” he contends. “As a result, our vaccine technology has the potential to be broadly applied to a wide variety of human infectious diseases.”
RSV is the second leading cause of death in children under one year of age worldwide. It is also the leading cause of hospitalization of infants in the U.S. and is especially serious from birth through six months of age. He points out that 69% of infants under the age of one-year-old contract RSV in the U.S., with 2% to 4% of infants under the age of six months admitted to hospital.
“All babies are at risk of RSV disease and 85% or more of RSV hospitalizations should be vaccine preventable,” Mr. Erck suggests. “If we are successful, we hope to see doctors recommending that nearly every pregnant mother be given ResVax.”
Maternal vaccination is becoming a priority for healthcare providers and policy makers. For example, neonatal tetanus, whooping cough and influenza are currently recommended vaccines to be given to pregnant mothers.
According to Mr. Erck, ResVax represents a greater than $1.5-billion revenue opportunity in North America, as well as other major markets in the UK, Italy, France, Spain, Germany, Japan, Korea and Taiwan. With additional significant market opportunity in China, India, Eastern Europe, Australia and Latin America, Mr. Erck says, “If ResVax is approved, our plan is to partner with a Big Pharma distributor.”
In its Phase 3 PREPARE study, Novavax enrolled 4,636 third trimester pregnant women, with 3,000 receiving ResVax. “According to our agreement with the FDA, an efficacy analysis of this enrollment will be sufficient to support a future BLA filing for marketing approval,” he says.
In December 2017, a Data Safety Monitoring Board statistician conducted an informational analysis of RSV-positive lower respiratory tract infections in the first 1,307 infants from the PREPARE trial.
Data from the informational analysis allowed Novavax, which was blinded to the data, to calculate an observed vaccine efficacy estimate in the range of 45% to 100% at that time.
“We believe the informational analysis significantly de-risked the trial’s outcome,” Mr. Erck contends.
The PREPARE study is being conducted at 87 clinical sites in 11 countries, with top-line efficacy data expected to be released this quarter. The primary endpoint of the study is the incidence of RSV lower respiratory tract infection. The safety assessment includes one-year follow-up of infants, which suggests Novavax could be in a position to file a BLA with the FDA and a marketing authorization with the European Medicines Agency in the first quarter of 2020.
ResVax vaccine also has fast track approval from the FDA, making it potentially eligible for priority review, which could reduce the agency’s standard review period by up to four months. The ResVax program is supported by an $89-million grant from the Bill and Melinda Gates Foundation.
In an initiation report last month, Ladenburg Thalmann analyst, Michael Higgins, said Novavax is approaching a “major turning point” with both pivotal RSV vaccine data and Phase 2 NanoFlu data in the first quarter of 2019. He believes NanoFlu “could become the new standard of care,” if testing is successful.
In June, The New England Journal of Medicine published a peer-reviewed letter to the editor detailing the positive results from Novavax’s Phase 1/2 clinical trial in older adults. According to the letter, NanoFlu demonstrated significantly improved immune responses against a panel of homologous and drifted A (H3N2) influenza viruses, compared with the leading licensed egg-based, high-dose flu vaccine in older adults.
Mr. Erck points out that some 87% of flu vaccine doses are grown in eggs. “We are advancing an improved flu vaccine made from recombinant nanoparticles and an Matrix-M adjuvant, which enhances immunogenicity.
“This process has the potential to produce an exact genetic match to the recommended strains of virus in the next flu season, unlike egg-based models,” he adds. “And by providing a broader immune response, NanoFlu also addresses antigenic drift.”
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Dane Hallberg, EVP and Chief Commercial Officer
Titan Pharmaceuticals’ (NASDAQ:TTNP) relaunch of its Probuphine implant for the long-term maintenance treatment of opioid use disorder (OUD) demonstrated promising results with a meaningful increase in product shipments in the second half of 2018.
“While activities during the fourth quarter were focused on building our commercial infrastructure, we also commenced implementing our integrative sales initiative and market segmentation strategy, which clearly had a major impact despite limited initial resources,” Dane Hallberg, EVP and chief commercial officer of Titan, says in an interview with BioTuesdays.
Titan reacquired the rights to FDA-approved Probuphine from Braeburn Pharmaceuticals at the end of May 2018 and began the transformation from a drug developer to a commercial-stage company in the U.S.
Probuphine is the only product that provides six months of steady release of buprenorphine, the gold standard medication for OUD. Buprenorphine is typically taken orally on a daily basis. Probuphine’s four soft, one-inch implants can be inserted subdermally and removed in a doctor’s office, and have been highly praised by patients since reaching the market in July 2016.
While Mr. Hallberg declined to comment on Braeburn’s performance, various industry analysts have cited a failure to appropriately segment the market at launch; inadequate systems to support distribution, reimbursement and patient/physician education; and a strategy primarily focused on training some 2,800 physicians. Braeburn essentially abandoned its sales and marketing of Probuphine in January 2018.
Mr. Hallberg, who had been consulting with Titan prior to his appointment in October 2018, says the company began building the foundation for a relaunch in the fourth quarter of 2018 in preparation for a full launch in the current quarter.
“We put together an entire legal and state compliance program, developed a go-to-market strategy based on regionally focused distribution, trained an internal support team and our sales reps, determined the right physicians to call on and tested an integrated selling initiative,” he adds. “Having studied Braeburn’s approach, we had the benefit of some key takeaways.”
Mr. Hallberg, who has launched several CNS drugs and a subdermal implant in the past, explains that an integrated selling initiative involves a focused approach on health care providers with a patient base that would benefit from Probuphine. “We’re not peppering doctors’ offices across the entire country but taking a more streamlined approach while adding value to the total office visit. The feedback from our core messaging and patient response has been very positive,” he adds.
Mr. Hallberg says that Titan also has had discussions with payers who would typically be expected to provide coverage for Probuphine. “We’ve reacquainted them with our product and assured them that we’re dedicated and plan to stay in the OUD market. And when our sales and marketing managers talk to physicians, they know the landscape of managed care coverage and the correct patient population [that would] benefit from Probuphine,” he points out.
“Our goal in 2019 is to ensure that clinicians and patients are aware that Probuphine is an important maintenance treatment option and that Titan is fully committed to supporting them,” he contends. “We need to instill trust that when our drug is implanted, it’s going to do what we claim it’s going to do: and help patients get on with their lives, in conjunction with substance abuse counselling or a 12-step program.”
Probuphine is the only FDA-approved subdermal implant designed to deliver buprenorphine continuously for six months following a single treatment. There are no other products in the market that provide for more than 30 days of sustained therapy for OUD.
How Probuphine Works
Of the 2.3 million people in the U.S. diagnosed with OUD in 2016, less than 50% were receiving medication-assisted therapy, drug counseling and abstinence-based programs. “A hundred and fifteen people in America die every day from overdosing on opioids and it’s a crisis that needs to be reined in,” Mr. Hallberg points out.
About 52,000 physicians, representing 5% of the nation’s doctors, are currently certified to prescribe oral buprenorphine and about 6,000 of those physicians write some 90% of all prescriptions for buprenorphine. Still, about one-half of U.S. counties don’t have a single buprenorphine prescriber.
“Probuphine is designed to address the potential challenges of daily dosed buprenorphine products,” Mr. Hallberg contends. These include poor compliance; abuse and diversion; the stigma associated with daily dosing, which can potentially reinforce drug behavior; and daily dosing itself, which can result in varying levels of buprenorphine in the bloodstream.
Titan has established a small commercial team to support Probuphine’s initial uptake, including five sales and marketing managers, each with an assigned territory; three medical science liaison (MSL) reps; and in-house Titan personnel to support physicians and patients.
The MSL team is available to help train and educate physicians in an FDA-required risk evaluation and mitigation strategy (REMS) program, which assists the health care providers minimize risks of the implant insertion and removal procedures, and select the right patients who would benefit from treatment with Probuphine. Doctors need to be federally certified to prescribe buprenorphine, and only REMS-trained doctors are allowed to prescribe Probuphine.
According to Mr. Hallberg, Titan has identified some 21,000 physicians that value long term therapy, and mapped them against 2,800 previously REMS-trained doctors to determine which physicians could identify the right patients who would benefit from Probuphine.
The company has identified four key markets: certified healthcare providers, residential treatment facilities, academic addiction programs and the criminal justice system.
“Our initial emphasis is to engage with the 75-to-100 highest Probuphine prescribers and enhance reimbursement support and specialty pharmacy coverage,” Mr. Hallberg says, noting that Titan has used the services of ValueCentric, a business intelligence platform, to obtain key competitive insights. And to expand awareness among certified healthcare providers, Titan plans to create investigator-initiated research programs to generate additional clinical data for Probuphine.
“Following the success of Probuphine’s relaunch, we would like to also pursue commercial partnerships to expand the reach and support growth among certified healthcare providers,” he adds.
Mr. Hallberg says Titan is looking forward to getting the Probuphine message to residential treatment facilities around the country. “Probuphine is well suited for patients that are stabilized on buprenorphine and returning home.”
Titan also is actively investing in education and has started to engage with teaching hospitals in the U.S. “We are leveraging our existing relationships with key opinion leaders to reintroduce the benefits of Probuphine and the REMS program. Hospitals also represent an opportunity for Titan to support healthcare providers on the front line by providing educational resources and tools to aid in effectively engaging patients and caregivers in an effort to manage this crisis,” he adds.
It is estimated that about 25% of people currently incarcerated in U.S. prisons suffer from OUD. According to a study by the National Institute on Drug Abuse, less than 1% of U.S. prisons and jails allow access to medication for OUD and only 11% of inmates who need OUD treatment receive any form of it. In a recent Rhode Island study, opioid overdose deaths dropped by nearly two-thirds when medication-assisted therapy was provided to all state inmates.
As part of a plan to identify state correction programs as potential centers of excellence for early Probuphine use, Titan has initiated a pilot program in collaboration with the Nevada Center for Behavioral Health to evaluate a medication-assisted treatment program utilizing Probuphine for OUD patients in Nevada’s criminal justice system.
“We believe Probuphine can be an important part of helping to solve the opioid crisis and we’re confident we’ve identified the right stakeholders in order to help them become more successful with their programs,” Mr. Hallberg adds.
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Dr. Lan Huang, Co-Founder, Chairman and CEO
BeyondSpring (NASDAQ:BYSI) is preparing to file NDAs with the China FDA during the next six months for its lead asset, first-in-class agent Plinabulin, for the treatment of non-small cell lung cancer (NSCLC) and prevention of chemotherapy-induced neutropenia (CIN), with hopes for regulatory approvals of both indications before the end of 2019.
The company also is on track to file NDAs in the U.S. for the same two indications in the next 12-to-18 months.
“Multiple clinical trials have confirmed that Plinabulin has an immune benefit, and is a potentially effective agent for NSCLC and prevention of chemotherapy-induced neutropenia,” Dr. Lan Huang, co-founder, chairman and CEO of BeyondSpring, says in an interview with BioTuesdays.
1) NSCLC indication
In its lung cancer program, Dr. Huang says BeyondSpring is positioning Plinabulin as a second-and third-line treatment for EGFR (epidermal growth factor receptor) wild-type patients that accounts for 70% to 85% of the patient population. “Approved tyrosine kinase inhibitor (TKI) therapies do not address EGFR wild-type NSCLC genotypes, with limited survival at six-to-eight months, creating a significant opportunity,” she adds.
According to industry estimates, there are about 1.8 million people diagnosed with lung cancer globally each year, of which 87% are NSCLCs. Nearly one-third of all patients are in China. Between 2015 and 2025, the global NSCLC market is forecast to grow to $17.6-billion from $5.9-billion, largely due to premium-priced checkpoint inhibitors, especially in the first-line setting.
Plinabulin’s anti-cancer effect
In an earlier Phase 2 NSCLC study, Plinabulin plus docetaxel chemotherapy demonstrated a durable response and survival benefit greater than current treatments, with no cardiovascular adverse effects.
The company expects to report an interim analysis in early 2019 from an ongoing Phase 3 trial of 554 NSCLC patients at approximately 60 sites in the U.S., Australia and China. The primary endpoint is overall survival in patients receiving Plinabulin plus docetaxel, compared with docetaxel alone.
If the interim Phase 3 results are positive, BeyondSpring expects to file an NDA in China in the first half of 2019, with potential approval before the end of 2019. Final data is slated for release in 2020, which could lead to an NDA filing in the U.S.
2) CIN prevention indication
Dr. Huang explains that CIN is a common side effect in cancer patients undergoing chemotherapy, characterized by the destruction of neutrophils, a type of white blood cell, which act as a patient’s first line of defense against infections. Patients with severe neutropenia have an abnormally low concentration of neutrophils, making them more susceptible to bacterial and fungal infections and sepsis, which may require hospitalization and can be fatal.
The National Comprehensive Cancer Network (NCCN) guidelines require that patients with severe neutropenia decrease chemotherapy dosing, or delay or discontinue chemotherapy, which can have a negative effect on the long-term outcomes of cancer care.
The current standard of care to prevent CIN is G-CSF (granulocyte-colony stimulating factor) therapies, such as Amgen’s Neulasta and Neupogen. However, over 90% of patients on chemotherapy and G-CSF monotherapy may still experience severe neutropenia, In addition, up to 70% of patients may experience bone pain and up to 27% severe bone pain, while on therapy.
Thus the ideal CIN drug can prevent CIN, does not cause a reduction or delay of chemotherapy, but also adds to chemo’s anti-cancer benefit.
“This is a severe unmet medical need because neutropenia can adversely affect the compliance of chemotherapy, impacting patients’ survival, so we are targeting Plinabulin for the prevention of CIN in all cancers,” Dr. Huang says. “Our trials have been led by world renowned key opinion leaders and we believe Plinabulin has the potential to be included in the National Comprehensive Cancer Network (NCCN) treatment guidelines on approval, which would support our marketing efforts.”
According to industry estimates, there are some 4.3 million G-CSF cycles administered globally a year, representing a market of more than $9-billion. “Plinabulin can potentially be used with each cycle of G-CSF to improve neutropenia therapy,” she adds.
According to Dr. Huang, studies of Plinabulin's mechanism of action indicate that Plinabulin activates GEF-H1, a guanine nucleotide exchange factor. The GEF-H1 pathway induces dendritic cell maturation and T-cell activation that kills cancer cells and also reduces the breakdown of neutrophils, potentially preventing neutropenia. “Plinabulin is a new first-in-class agent, with GEF-H1 as a novel target,” she adds.
Plinabulin: Mechanism of Action
“Already in four clinical trials, Plinabulin has shown superior efficacy and safety, with statistical significance, compared with the standard of care in the treatment of CIN,” Dr. Huang contends.
BeyondSpring’s clinical trials for the CIN indication were designed to support approval of a broad label for Plinabulin for the prevention of all high and intermediate CIN in all cancer types.
“To support this broad label, we conducted Study 105 for Plinabulin in patients treated with docetaxel, an intermediate-risk chemotherapy, and a high-risk chemotherapy in Study 106 with Plinabulin in combination with a G-CSF in patients treated with a combination of three chemotherapies: taxotere, adriamycin and cyclophosphamide (TAC),” Dr. Huang says.
Earlier this month, the company announced that during an interim analysis of the Phase 3 Study 105, Plinabulin met its primary endpoint of non-inferiority versus Neulasta for the duration of severe neutropenia of the first cycle, with statistical significance in a pre-specified interim analysis.
In October, BeyondSpring also announced top line data from the Phase 2 portion of Study 106, where Plinabulin in combination with Neulasta demonstrated superiority in both efficacy and safety endpoints, with statistical significance versus Neulasta.
Dr. Huang says that, based on the results of these two studies, “we now have all the necessary data to submit an NDA to the China FDA or National Medical Products Administration for Plinabulin in CIN.” Moreover, Plinabulin has met all three criteria for regulatory approval as a drug: safety, efficacy and stability in chemistry, manufacturing and controls, she adds.
Dr. Huang explains that BeyondSpring’s clinical programs were designed to build a foundation for Plinabulin, initially developing the drug for the treatment of high-risk CIN, which represents a $9-billion global market and addresses 20% of all chemotherapy patients. Development then would progress to intermediate-risk CIN, which represents potentially a more than $20-billion global market and covers 60% of all chemotherapy patients.
“Plinabulin is the first product in the industry to demonstrate a favorable risk/benefit for intermediate-risk CIN,” she adds.
“Plinabulin, which is administered by IV, has been used in more than 450 patients to date, with good tolerability, and the potential to treat multiple cancer indications,” Dr. Huang contends. Plinabulin is protected by 74 global patents, including composition of matter granted in 34 countries globally, of which 18 are in the U.S., with protection until 2036.
“We are positioning Plinabulin in combination with G-CSF to potentially improve the current neutropenia treatment landscape without causing thrombocytopenia and bone pain in high-risk chemotherapy patients in all cancers,” she adds.
Neulasta, one of the leading G-CSF agents, is not approved in China, where generic long-lasting G-CSFs dominate the $350-million annual market, with annual growth exceeding 30%, according to IMS data. There are close to five million new cancer patients in China each year, with up to 65% using chemotherapy, while in the U.S., more than 650,000 patients annually receive chemotherapy.
3) BeyondSpring Pipeline
BeyondSpring’s early-stage pipeline also includes three new immune agents for cancer and a R&D platform using the ubiquitination pathway, which regulates degradation of cellular proteins, with Plinabulin combined with immuno-oncology agents to potentially enhance the efficacy and safety of checkpoint inhibitors, which are increasingly being used in cancer care.
A recent discovery published in the peer-reviewed journal, Immunity, suggested that PD-1 antibody efficacy could be greatly improved with mature dendritic cells and IL-12. “This is Plinabulin’s immune mechanism, which underscores its efficacy synergy with PD-1 antibody,” Dr. Huang notes.
BeyondSpring is conducting trials at UCSD and Fred Hutchinson Cancer Research Center of Plinabulin in combination with Opdivo in second-and third-line NSCLC.
In addition, BeyondSpring is investigating triple combination therapy, consisting of Plinabulin, and Bristol-Myers Squibb's Opdivo and Yervoy for the treatment of small-cell lung cancer (SCLC), which represents 10% to 15% of lung cancers.
A Phase 1/2 combined trial is expected to enroll about 15 SCLC patients in the Phase 1 portion and an additional 40 patients in the Phase 2 portion. The first patient received treatment on Sept. 11, 2018.
“Plinabulin is not just a compound, but a pipeline drug,” Dr. Huang says. “Up to this point, the research around Plinabulin has advanced positively and significantly.”
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